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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________
Form 10-K
__________________
☒ ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2022
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from to .
Commission File No. 001-38403
__________________________
CRONOS GROUP INC.
(Exact name of Registrant as specified in its Charter)
__________________________
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British Columbia, Canada
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N/A |
(State or other jurisdiction of |
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(I.R.S. Employer |
incorporation or organization) |
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Identification No.) |
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111 Peter St., Suite 300 |
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Toronto, Ontario
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M5V 2H1 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code:
416-504-0004
____________________________
Securities registered pursuant to Section 12(b) of the
Act:
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Title of Each Class |
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Trading Symbol |
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Name of Each Exchange on Which Registered |
Common Shares, no par value |
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CRON |
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The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the Registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities
Act. Yes
o
No
x
Indicate by check mark if the Registrant is not required to file
reports pursuant to Section 13 or 15(d) of the
Act. Yes
o
No
x
Indicate by check mark whether the Registrant: (1) has filed
all reports required to be filed by Section 13 or
Section 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90
days. Yes
x
No
o
Indicate by check mark whether the Registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
Registrant was required to submit such files). Yes
x
No
o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
x |
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Accelerated filer |
o |
Non-accelerated filer |
o |
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Smaller reporting company |
☐ |
Emerging growth company |
☐ |
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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. ☐
If securities are registered pursuant to Section 12(b) of the Act,
indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an
error to previously issued financial statements.
☐
Indicate by check mark whether any of those error corrections are
restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant's executive officers
during the relevant recovery period pursuant to §
240.10D-1(b).
☐
Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the
registered public accounting firm that prepared or issued its audit
report. Yes
☒
No
o
Indicate by check mark whether the Registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes
☐
No
x
As of June 30, 2022, the last business day of the Registrant’s
most recently completed second fiscal quarter, the aggregate market
value of common shares held by non-affiliates of the Registrant
computed by reference to the closing price of $2.82 per common
share on June 30, 2022 was approximately $562,557,422.
As of February 24, 2023, there were 380,575,403 common shares of
the Registrant issued and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Certain information required by Part III of this Annual Report on
Form 10-K will either be incorporated into this Annual Report on
Form 10-K by reference to the registrant’s definitive proxy
statement for its 2023 Annual Meeting of Shareholders, or will be
included in an amendment to this Annual Report on Form 10-K to be
filed no later than 120 days after the registrant's fiscal year
ended December 31, 2022.
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Table of Contents |
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PART I
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Item 1. |
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Item 1A. |
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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PART II
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Item 5.
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Item 6.
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Reserved |
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 9C. |
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PART III
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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PART IV
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Item 15.
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Unless otherwise noted or the context indicates otherwise,
references in this Annual Report on Form 10-K (this “Annual
Report”) to the “Company”, “Cronos”, “we”, “us” and “our” refer to
Cronos Group Inc., its direct and indirect wholly owned
subsidiaries and, if applicable, its joint ventures and investments
accounted for by the equity method; the term “cannabis” means the
plant of any species or subspecies of genus
Cannabis
and any part of that plant, including all derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers; the term
“U.S. hemp” has the meaning given to term “hemp” in the U.S.
Agricultural Improvement Act of 2018 (the “2018 Farm Bill”),
including hemp-derived cannabidiol (“CBD”); and the term “U.S.
Schedule I cannabis” means cannabis excluding U.S.
hemp.
This report contains references to our trademarks and trade names
and to trademarks and trade names belonging to other entities.
Solely for convenience, trademarks and trade names referred to in
this report may appear without the ® or ™ symbols, but such
references are not intended to indicate, in any way, that their
respective owners will not assert, to the fullest extent under
applicable law, their rights thereto. We do not intend our use or
display of other companies’ trademarks or trade names to imply a
relationship with, or endorsement or sponsorship of us or our
business by, any other companies.
All currency amounts in this Annual Report are stated in U.S.
dollars, which is our reporting currency, unless otherwise noted.
All references to “dollars” or “$” are to U.S. dollars; all
references to “C$” are to Canadian dollars; all references to “A$”
are to Australian dollars; and all references to “ILS” are to New
Israeli Shekels.
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(Exchange rates are shown as C$ per $) |
As of December 31, |
|
2022 |
|
2021 |
|
2020 |
Average rate |
1.3017 |
|
1.2541 |
|
1.3411 |
Spot rate |
1.3554 |
|
1.2746 |
|
1.2751 |
All summaries of agreements described herein are qualified by the
full text of such agreements (certain of which are filed as
exhibits hereto).
PART I
Special Note Regarding Forward-Looking Statements
This Annual Report, the documents incorporated into this Annual
Report by reference, other reports we file with, or furnish to, the
U.S. Securities and Exchange Commission (“SEC”) and other
regulatory agencies, and statements by our directors, officers,
other employees and other persons authorized to speak on our behalf
contain information that may constitute forward-looking information
and forward-looking statements within the meaning of applicable
U.S. and Canadian securities laws and court decisions
(collectively, “Forward-Looking Statements”), which are based upon
our current internal expectations, estimates, projections,
assumptions and beliefs. All information that is not clearly
historical in nature may constitute Forward-Looking Statements. In
some cases, Forward-Looking Statements can be identified by the use
of forward-looking terminology, such as “expect”, “likely”, “may”,
“will”, “should”, “intend”, “anticipate”, “potential”, “proposed”,
“estimate” and other similar words, expressions and phrases,
including negative and grammatical variations thereof, or
statements that certain events or conditions “may” or “will”
happen, or by discussion of strategy. Forward-Looking Statements
include estimates, plans, expectations, opinions, forecasts,
projections, targets, guidance or other statements that are not
statements of historical fact.
Forward-Looking Statements include, but are not limited to,
statements with respect to:
•expectations
related to our announced realignment (the “Realignment”) and any
progress, challenges and effects related thereto as well as changes
in strategy, metrics, investments, reporting structure, costs,
operating expenses, employee turnover and other changes with
respect thereto;
•the
timing of the change in the nature of operations at our facility in
Stayner, Ontario (the “Peace Naturals Campus”) and the expected
costs and benefits from the wind-down of cultivation and certain
production activities at the Peace Naturals Campus;
•our
ability to effectively wind-down cultivation and certain production
activities at the Peace Naturals Campus in an organized fashion and
acquire raw materials from other suppliers, including Cronos
Growing Company Inc. (“Cronos GrowCo”), and the costs and timing
associated therewith;
•expectations
regarding the potential success of, and the costs and benefits
associated with, our joint ventures, strategic alliances and equity
investments, including the strategic partnership (the “Ginkgo
Strategic Partnership”) with Ginkgo Bioworks Holdings, Inc.
(“Ginkgo”);
•our
ability or plans to identify, develop, commercialize or expand our
technology and research and development (“R&D”) initiatives in
cannabinoids, or the success thereof;
•expectations
regarding revenues, expenses, gross margins and capital
expenditures;
•expectations
regarding our future production and manufacturing strategy and
operations, the costs and timing associated therewith and the
receipt of applicable production and sale licenses;
•the
ongoing impact of the legalization of additional cannabis product
types and forms for adult-use in Canada, including federal,
provincial, territorial and municipal regulations pertaining
thereto, the related timing and impact thereof and our intentions
to participate in such markets;
•the
legalization of the use of cannabis for medical or adult-use in
jurisdictions outside of Canada, the related timing and impact
thereof and our intentions to participate in such markets, if and
when such use is legalized;
•the
grant, renewal, withdrawal, suspension, delay and impact of any
license or supplemental license to conduct activities with cannabis
or any amendments thereof;
•our
ability to successfully create and launch brands and further
create, launch and scale U.S. hemp-derived cannabinoid consumer
products and cannabis products;
•the
benefits, viability, safety, efficacy, dosing and social acceptance
of cannabis, including CBD and other cannabinoids;
•laws
and regulations and any amendments thereto applicable to our
business and the impact thereof, including uncertainty regarding
the application of United States (“U.S.”) state and federal law to
U.S. hemp (including CBD and other U.S. hemp-derived cannabinoids)
products and the scope of any regulations by the U.S. Food and Drug
Administration (the “FDA”), the U.S. Drug Enforcement
Administration (the “DEA”), the U.S. Federal Trade Commission (the
“FTC”), the U.S. Patent and Trademark Office (the “PTO”) and any
state equivalent regulatory agencies over U.S. hemp (including CBD
and other U.S. hemp-derived cannabinoids) products;
•the
laws and regulations and any amendments thereto relating to the
U.S. hemp industry in the U.S., including the promulgation of
regulations for the U.S. hemp industry by the U.S. Department of
Agriculture (the “USDA”) and relevant state regulatory
authorities;
•the
anticipated benefits and impact of Altria Group Inc.’s investment
in the Company (the “Altria Investment”), pursuant to a
subscription agreement dated December 7, 2018;
•uncertainties
as to our ability to exercise our option (the “PharmaCann Option”)
in PharmaCann Inc. (“PharmaCann”), in the near term or the future,
in full or in part, including the uncertainties as to the status
and future development of federal legalization of cannabis in the
U.S. and our ability to realize the anticipated benefits of the
transaction with PharmaCann;
•expectations
regarding the implementation and effectiveness of key personnel
changes;
•expectations
regarding acquisitions and dispositions and the anticipated
benefits therefrom;
•our
ability to timely and effectively remediate any material weaknesses
in our internal control over financial reporting;
•expectations
of the amount or frequency of impairment losses, including as a
result of the write-down of intangible assets, including
goodwill;
•the
uncertainties associated with the COVID-19 pandemic, including our
ability, and the abilities of our joint ventures and our suppliers
and distributors, to effectively deal with the restrictions,
limitations and health issues presented by the COVID-19 pandemic,
the ability to continue our production, distribution and sale of
our products, and demand for and the use of our products by
consumers;
•the
impact of the ongoing military conflict between Russia and Ukraine
(and resulting sanctions) on our business, financial condition and
results of operations or cash flows;
•our
compliance with the terms of the settlement with the SEC (the “SEC
Order”) and the settlement with the Ontario Securities Commission
(the “OSC Settlement”), including complying with any
recommendations made by the independent consultant appointed
pursuant to the SEC Order (the “Consultant”); and
•the
impact of the loss of our ability to rely on private offering
exemptions under Regulation D of the Securities Act of 1933, as
amended (the “Securities Act”), and the loss of our status as a
well-known seasoned issuer, each as a result the SEC
Order.
Certain of the Forward-Looking Statements contained herein
concerning the industries in which we conduct our business are
based on estimates prepared by us using data from publicly
available governmental sources, market research, industry analysis
and on assumptions based on data and knowledge of these industries,
which we believe to be reasonable. However, although generally
indicative of relative market positions, market shares and
performance characteristics, such data is inherently imprecise. The
industries in which we conduct our business involve risks and
uncertainties that are subject to change based on various factors,
which are described further below.
The Forward-Looking Statements contained herein are based upon
certain material assumptions that were applied in drawing a
conclusion or making a forecast or projection, including: (i) our
ability to realize the expected cost-savings, efficiencies and
other benefits of our Realignment and employee turnover related
thereto; (ii) our ability to efficiently and effectively wind-down
our cultivation and certain production activities at the Peace
Naturals Campus, receive the benefits of the change in the nature
of our operations at our Peace Naturals Campus and acquire raw
materials on a timely and cost-effective basis from third parties,
including Cronos GrowCo; (iii) our ability to realize anticipated
benefits, synergies or generate revenue, profits or value from our
acquisitions and strategic investments; (iv) the production and
manufacturing capabilities and output from our facilities and our
joint ventures, strategic alliances and equity investments; (v)
government regulation of our activities and products including, but
not limited to, the areas of cannabis taxation and environmental
protection; (vi) the timely receipt of any required regulatory
authorizations, approvals, consents, permits and/or licenses; (vii)
consumer interest in our products; (viii) competition; (ix)
anticipated and unanticipated costs; (x) our ability to generate
cash flow from operations; (xi) our ability to conduct operations
in a safe, efficient and effective manner; (xii) our ability to
hire and retain qualified staff, and acquire equipment and services
in a timely and cost-efficient manner; (xiii) our ability to
exercise the PharmaCann Option and realize the anticipated benefits
of the transaction with PharmaCann; (xiv) our ability to complete
planned dispositions, and, if completed, obtain our anticipated
sales price; (xv) our ability, and the abilities of our joint
ventures and our suppliers and distributors, to effectively deal
with the restrictions, limitations and health issues presented by
the COVID-19 pandemic and the ability to continue our production,
distribution and sale of our products and customer demand for and
use of our products; (xvi) general economic, financial market,
regulatory and political conditions in which we operate; (xvii)
management’s perceptions of historical trends, current conditions
and expected future developments; and (xviii) other considerations
that management believes to be appropriate in the circumstances.
While our management considers these assumptions to be reasonable
based on information currently available to management, there is no
assurance that such expectations will prove to be
correct.
By their nature, Forward-Looking Statements are subject to inherent
risks and uncertainties that may be general or specific and which
give rise to the possibility that expectations, forecasts,
predictions, projections or conclusions will not prove to be
accurate, that assumptions may not be correct and that objectives,
strategic goals and priorities will not be achieved. A variety of
factors, including known and unknown risks, many of which are
beyond our control, could cause actual results to differ materially
from the Forward-Looking Statements in this Annual Report and other
reports we file with, or furnish to, the SEC and other regulatory
agencies and made by our directors, officers, other employees and
other persons authorized to speak on our behalf. Such factors
include, without limitation, that we may not be able to wind-down
cultivation and certain production activities at the Peace Naturals
Campus in a disciplined manner or achieve the anticipated benefits
of the change in the nature of our operations or be able to access
raw materials on a timely and cost-effective basis from
third-parties, including Cronos GrowCo; the risk that the COVID-19
pandemic and the military conflict between Russia and Ukraine may
disrupt our operations and those of our suppliers and distribution
channels and negatively impact the demand for and use of our
products; the risk that cost savings and any other synergies from
the Altria Investment may not be fully realized or may take longer
to realize than expected; failure to execute key personnel changes;
the risks that our Realignment, the change in the nature of our
operations at the Peace Naturals Campus and our further leveraging
of our strategic partnerships will not result in the expected
cost-savings, efficiencies and other benefits or will result in
greater than anticipated turnover in personnel; levels of revenues;
the lack of consumer demand for our cannabis and U.S. hemp
products; our inability to manage disruptions in credit markets or
changes to our credit ratings; unanticipated future levels of
capital, environmental or maintenance expenditures, general and
administrative and other expenses; growth opportunities not turning
out as expected; the lack of cash flow necessary to execute our
business plan (either within the expected timeframe or at all);
difficulty raising capital; the potential adverse effects of
judicial, regulatory or other proceedings, or threatened litigation
or proceedings, on our business, financial condition, results of
operations and cash flows; volatility in and/or degradation of
general economic, market, industry or business conditions;
compliance with applicable environmental, economic, health and
safety, energy and other policies and regulations and in particular
health concerns with respect to vaping and the use of cannabis and
U.S. hemp products in vaping devices; the unexpected effects of
actions of third parties such as competitors, activist investors or
federal (including U.S. federal), state, provincial, territorial or
local regulatory authorities or self-regulatory organizations;
adverse changes in regulatory requirements in relation to our
business and products; legal or regulatory obstacles that could
prevent us from being able to exercise the PharmaCann Option and
thereby realizing the anticipated benefits of the transaction with
PharmaCann; dilution of our fully diluted ownership of PharmaCann
and the loss of our rights as a result of that dilution; a delay in
our remediation of material weaknesses in our internal control over
financial reporting and the improvement of our control environment
and our systems, processes and procedures; and the factors
discussed under Part I, Item 1A “Risk
Factors”
in this Annual Report. Readers are cautioned to consider these and
other factors, uncertainties and potential events carefully and not
to put undue reliance on Forward-Looking Statements.
Forward-Looking Statements are provided for the purposes of
assisting the reader in understanding our financial performance,
financial position and cash flows as of and for periods ended on
certain dates and to present information about management’s current
expectations and plans relating to the future, and the reader is
cautioned not to place undue reliance on these Forward-Looking
Statements because of their inherent uncertainty and to appreciate
the limited purposes for which they are being used by management.
While we believe that the assumptions and expectations reflected in
the Forward-Looking Statements are reasonable based on information
currently available to management, there is no assurance that such
assumptions and expectations will prove to have been correct.
Forward-Looking Statements are made as of the date they are made
and are based on the beliefs, estimates, expectations and opinions
of management on that date. We undertake no obligation to update or
revise any Forward-Looking Statements, whether as a result of new
information, estimates or opinions, future events or results or
otherwise or to explain any material difference between subsequent
actual events and such Forward-Looking Statements. The
Forward-Looking Statements contained in this Annual Report and
other reports we file with, or furnish to, the SEC and other
regulatory agencies and made by our directors, officers, other
employees and other persons authorized to speak on our behalf are
expressly qualified in their entirety by these cautionary
statements.
ITEM 1. BUSINESS
General
Cronos is incorporated under the laws of the Province of British
Columbia with principal executive offices located at 111 Peter
Street, Suite 300, Toronto, Ontario M5V 2H1. Our telephone number
is +1-416-504-0004, our website is https://thecronosgroup.com/ and
the investor relations section of our website is
https://ir.thecronosgroup.com/. All references to our website are
inactive references, are for informational purposes only and are
not intended to incorporate any information from or referenced on
our website into this Annual Report.
Our common shares are currently listed on the Toronto Stock
Exchange (“TSX”) and on the NASDAQ Global Market (“Nasdaq”) under
the trading symbol “CRON.”
Description of the Business
Overview
Cronos is an innovative global cannabinoid company committed to
building disruptive intellectual property by advancing cannabis
research, technology and product development. With a passion to
responsibly elevate the consumer experience, Cronos is building an
iconic brand portfolio. Cronos’ diverse international brand
portfolio includes Spinach®,
PEACE NATURALS®
and Lord Jones®.
Strategy
Cronos seeks to create value for shareholders by focusing on four
core strategic priorities:
•growing
a portfolio of iconic brands that responsibly elevate the consumer
experience;
•developing
a diversified global sales and distribution network;
•establishing
an efficient global supply chain; and
•creating
and monetizing disruptive intellectual property.
Business Segments
Cronos reports through two segments: “United States” and “Rest of
World.” These two segments represent the geographic regions in
which the Company operates and the different product offerings
within each geographic region.
United States
Our U.S. operational subsidiaries (collectively, “Redwood”)
manufacture, market and distribute U.S. hemp-derived cannabinoid
products through e-commerce, retail and hospitality partner
channels in the United States under the Lord
Jones®
brand.
Strategic Investment in PharmaCann, Inc.
On June 14, 2021, Cronos USA Holdings Inc., a wholly owned
subsidiary of the Company, purchased an option (the “PharmaCann
Option”), with an exercise price of $0.0001 per share, to acquire
an approximately 10.5% ownership stake in PharmaCann, Inc.
(“PharmaCann”) on a fully diluted basis for total consideration of
approximately $110.4 million. PharmaCann is a leading vertically
integrated U.S. cannabis company that has a broad geographic
footprint in the U.S. and has built an efficient, effective and
scalable operating model. The PharmaCann Option exercise will be
based upon various factors, including the status of U.S. federal
cannabis legalization, as well as regulatory approvals, including
in the states where PharmaCann operates that may be required upon
exercise. Following the exercise of the PharmaCann Option, the
Company and PharmaCann will enter into commercial agreements that
would permit each party to offer its products through either
party’s distribution channels.
On February 28, 2022, PharmaCann closed its merger transaction with
LivWell Holdings, Inc. (“LivWell”) pursuant to which PharmaCann
acquired LivWell (the “LivWell Transaction”). LivWell is a
multi-state cannabis cultivation and retail leader based in
Colorado. As a result of the LivWell Transaction, the Company’s
ownership percentage in PharmaCann on a fully diluted basis
decreased to approximately 6.4%. As of December 31, 2022, the
Company’s ownership percentage in PharmaCann on a fully diluted
basis was approximately 6.3%. Under the terms of the Company’s
investment in PharmaCann, the Company’s rights to nominate an
observer or a director to the PharmaCann board of directors could
be lost if the Company’s ownership drops below 6% on a fully
diluted basis and it sells or transfers all or any portion of the
option (subject to certain exceptions). As a result, further
dilution could adversely affect the Company’s rights under the
PharmaCann Option.
No U.S. Schedule I Cannabis-Related Activities
On December 20, 2018, the 2018 Farm Bill was enacted in the U.S.,
removing U.S. hemp from the list of Schedule I controlled
substances under the U.S. Controlled Substances Act (the “CSA”),
and on January 19, 2021, the USDA issued a final rule establishing
a domestic U.S. hemp production regulatory program, effective March
2021. Though a number of states in the U.S. have authorized the
cultivation, distribution or possession of U.S. Schedule I cannabis
and U.S. Schedule I cannabis containing products to various degrees
and subject to various requirements or conditions, U.S. Schedule I
cannabis continues to be a Schedule I controlled substance under
the CSA. Therefore, the cultivation, manufacture, distribution and
possession of U.S. Schedule I cannabis violates federal law in the
U.S. unless a U.S. federal agency, such as the DEA, grants a
registration for a specific activity, such as research, with U.S.
Schedule I cannabis.
We do not engage in any activities related to U.S. Schedule I
cannabis in the U.S. The Ginkgo Strategic Partnership contemplates
the performance of licensed R&D activities in the U.S. in order
to produce cultured cannabinoids, but such activities are conducted
in compliance with all applicable laws regarding controlled
substances.
Rest of World
The Rest of World operating segment is involved in the cultivation,
manufacturing, and marketing of cannabis-derived products for
medical and adult-use markets.
In Canada, Cronos operates through two wholly owned license holders
under the Cannabis Act (Canada) (the “Cannabis Act”), Peace
Naturals Project Inc. (“Peace Naturals”), which has production
facilities near Stayner, Ontario (the “Peace Naturals Campus”) and
Thanos Holdings Ltd., known as Cronos Fermentation (“Cronos
Fermentation”), which has a production facility in Winnipeg,
Manitoba. Cronos has established two strategic joint ventures in
Canada and Israel and holds approximately 10% of the issued capital
of Vitura Health Limited (“Vitura”), formerly known as Cronos
Australia Limited, which is listed on the Australian Securities
Exchange under the trading symbol “VIT.” Cronos seeks to export
cannabis products to countries that permit the import of such
products.
Peace Naturals Campus / Cronos GrowCo
The production facilities at the Peace Naturals Campus and the
production facilities of Cronos GrowCo are licensed by Health
Canada under the Cannabis Act to engage in the cultivation,
processing, distribution and sale of dried cannabis flower,
cannabis resin, cannabis seeds, cannabis plants, cannabis extracts,
cannabis topicals and cannabis edibles, among other prescribed
activities.
Cronos Fermentation
The production facility at Cronos Fermentation is licensed by
Health Canada under the Cannabis Act to engage in the processing
and distribution and sale of cannabis seeds and cannabis plants,
among other prescribed activities, which includes the production of
cultured cannabinoids. The facility also holds a license for
Analytical Testing under the Cannabis Regulations.
Israel
In Israel, the Company operates under the IMC-GAP, IMC-GMP and
IMC-GDP certifications required for the cultivation, production and
marketing of dried flower, pre-rolls and oils in the Israeli
medical market.
Operations Outside of Canada, Israel, and the U.S.
Cronos anticipates expanding in the geographic markets outside of
Canada and the U.S. in which we currently participate and entering
new geographic markets. By leveraging operational, manufacturing
and regulatory expertise, quality standards and procedures and
intellectual property, we believe that we are well-positioned to
effectively access these markets. Subject to applicable regulatory
approvals, strategic international business opportunities pursued
by us could include:
•production,
distribution, sales and marketing in jurisdictions that have passed
legislation to legalize the production, distribution and possession
of cannabis products at all relevant levels of government;
and
•the
export of cannabis products to markets that permit the import of
such products.
We seek to conduct business only in jurisdictions where we believe
it is legal to do so and where such operations remain compliant
with our listing obligations with the TSX and Nasdaq. Determining
whether a business activity is legal in a jurisdiction may require
judgment since laws, rules, regulations and licenses may not be
clear and legal interpretation and advice of counsel may vary. If a
business activity in which we engage in any jurisdiction is
determined to be illegal, we could be subject to fines, penalties,
reputational harm, delisting from securities exchanges and material
civil, criminal and regulatory litigation and proceedings or be
enjoined from doing business in the applicable jurisdiction. See
“Risk
Factors -
Risks Relating to Regulation and Compliance
-
We operate in highly regulated sectors where the regulatory
environment is rapidly developing, and we may not always succeed in
complying fully with applicable regulatory requirements in all
jurisdictions where we carry on business.”
Joint Ventures/Strategic Investments
We have established two strategic joint ventures in Canada and
Israel. Additionally, we hold approximately 10% of the issued
capital of Vitura, which we account for as equity securities with a
readily determinable fair value, and approximately 13.7% of the
issued capital of NatuEra S.à.r.l. (“Natuera”), which we account
for as equity securities without a readily determinable fair value,
as of December 31, 2022.
Our ownership interest in each of our joint ventures is summarized
in the table below.
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Joint Venture |
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Jurisdiction |
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Ownership Interest(i)
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Cronos Israel(ii)
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Israel |
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70%/90% |
Cronos GrowCo(iii)
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Canada |
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50% |
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(i) We
define ownership interest as the proportionate share of net income
to which we are entitled; equity interest may differ from ownership
interest shown above. We consolidate the financial results of
Cronos Israel and account for our other joint ventures under the
equity method of accounting. See Note 1 “Background,
Basis of Presentation, and Summary of Significant Accounting
Policies”
and Note 3 “Investments”
to our consolidated financial statements in Item 8 of this Annual
Report.
(ii) A
strategic joint venture with Kibbutz Gan Shmuel (“Gan Shmuel”), an
Israeli agricultural collective settlement, for the production,
manufacturing and global distribution of medical cannabis,
consisting of a cultivation company (Cronos Israel G.S. Cultivation
Ltd.), a manufacturing company (Cronos Israel G.S. Manufacturing
Ltd.), a distribution company (Cronos Israel G.S. Store Ltd.) and a
pharmacy company (Cronos Israel G.S. Pharmacy Ltd., collectively,
“Cronos Israel”). We hold a 70% equity interest in the cultivation
company and a 90% equity interest in each of the manufacturing,
distribution and pharmacy companies.
(iii) A
strategic joint venture with a group of investors led by Bert Mucci
(the “Greenhouse Partners”), a Canadian large-scale greenhouse
operator. Each of Cronos and the Greenhouse Partners owns a 50%
equity interest in Cronos GrowCo and has equal representation on
its board of directors.
Brand Portfolio
We are committed to building a portfolio of iconic brands that
responsibly elevate the consumer experience.
In the U.S., we market and distribute U.S. hemp-derived cannabinoid
products through e-commerce, retail and hospitality channels under
the Lord Jones®
brand.
In Canada, we sell a variety of cannabis products through wholesale
channels under both our adult-use brand, Spinach®,
and under our wellness platform, PEACE NATURALS®.
In addition, PEACE NATURALS®
cannabis products are currently available in the Israeli medical
market.
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Brand Positioning |
Mainstream adult-use |
Wellness |
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Prestige adult consumer goods |
Product Offering |
Dried cannabis, pre-rolls, vaporizers, edibles |
Dried cannabis, pre-rolls, cannabis tinctures |
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|
U.S. hemp-derived cannabinoid products |
Geographic Availability |
Canada |
Canada and Israel
|
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|
U.S. |
Adult-Use
Brand
Spinach®
is the Company’s adult-use cannabis brand focused on friends, fun
and legendary cannabis. The Spinach®
brand portfolio includes cannabinoid products in a wide range of
formats including dried flower, pre-rolls, vaporizers and
edibles.
The Spinach®
brand also has two sub-brands, SOURZ by Spinach®
and SPINACH FEELZ™. SOURZ by Spinach®
is a line of dual-colored, dual-flavored edibles in a variety of
cannabinoid ratios in a distinctive “S” shared gummy, featuring
proprietary flavor masking technology. SPINACH FEELZ™ prominently
features rare cannabinoids in a range of product formats, designed
to deliver unique and enhanced experiences made possible through
proprietary blends of rare cannabinoids alongside common
cannabinoids, like THC and CBD. Each product is formulated to help
adult consumers, “Feelz. The Way You Want.”
Wellness Brand
PEACE NATURALS®
is a global wellness platform committed to producing high-quality
cannabis products. PEACE NATURALS®
is focused on building and shaping the global cannabis wellness
market and promoting a holistic approach to wellness. The Company
currently distributes products under PEACE
NATURALS®
for the Canadian and non-U.S. medical cannabis
markets.
U.S. Hemp-derived Cannabinoid Brands
The Company operates Lord Jones®,
a prestige U.S. hemp-derived cannabinoid brand in the U.S., for the
adult consumer goods market.
Happy Dance®
and
PEACE+®
were brands focused on the production and distribution of U.S.
hemp-derived cannabinoid products. The Company no longer produces
or distributes products under the Happy Dance®
and
PEACE+®
brands.
Cronos Marketing Code
In 2021, Cronos released its Marketing Code, which is designed to
responsibly move the emerging cannabis industry forward. Cronos
believes that those below the legal age of consumption should not
be targeted in an adult-use cannabis market. Cronos recognizes
there is a clear need for standards.
The principles in the Cronos Marketing Code apply to all marketing
activities of all Cronos brands globally and are communicated to
all business partners in any work they do on the Company’s behalf.
The Marketing Code represents Cronos’ commitment to responsible
marketing standards. The code standards are:
•Our
advertising will be targeted to adults.
•We
will highlight responsible cannabis consumption and any people
depicted in any imagery will be adults.
•Our
brand websites and social media will be designed for
adults.
•Our
marketing events will be targeted to adults and will promote
responsible cannabis consumption.
•We
will provide our customers with facts and substantiate our
claims.
Global Sales and Distribution - Principal Markets
Cronos has developed a diversified global sales and distribution
network. We have built a distribution footprint in Canada through
the adult-use market, as well as a distribution footprint for U.S.
hemp-derived cannabinoid products in the U.S. through e-commerce,
retail and hospitality channels. We have also built a distribution
channel for the Israeli medical market. Our PEACE
NATURALS®
medical cannabis products are sold in Canada through the Medical
Cannabis by Shoppers Drug Mart platform.
United States Market and Distribution
Through Redwood, the Company manufactures, markets and distributes
U.S. hemp-derived cannabinoid products through e-commerce, retail
and hospitality partner channels in the U.S. under the Lord
Jones®
brand. Redwood’s products use high-quality cannabinoids from U.S.
hemp extract that retains naturally occurring phytocannabinoids and
terpenes found in the plant. We plan to use our resources to
capitalize on market demand and to further create and scale U.S.
hemp-derived cannabinoid products and brands. We do not engage in
any commercial activities related to the cultivation, distribution
or possession of U.S. Schedule I cannabis in the U.S.
Rest of World
Canadian Market and Distribution
•Medical
Market.
Our PEACE NATURALS®
medical cannabis products are sold in Canada through the Medical
Cannabis by Shoppers Drug Mart platform.
•Adult-Use.
We currently sell dried flower, pre-rolls, vaporizers and edibles
through our adult-use brand, Spinach®,
to cannabis control authorities in all provinces of Canada and the
Yukon territory, except Saskatchewan, where we sell to
private-sector retailers, subject to the relevant province’s or
territory’s product or other restrictions and requirements. As the
Company’s supply chain grows, the Company continues to expand its
portfolio of cannabis products for the existing markets in
Canada.
Markets and Distribution Outside of Canada
•Israel.
Cronos Israel holds the IMC-GAP, IMC-GMP and IMC-GDP certifications
required for the cultivation, production and marketing of dried
flower, pre-rolls and oils in Israel. Cronos Israel distributes
PEACE NATURALS®
branded cannabis products to the Israeli medical cannabis market
through pharmacies. See “-
Licenses and Regulatory Framework in Israel.”
•Europe.
We have previously distributed PEACE NATURALS®
branded cannabis products in Germany.
•Australia
and Asia-Pacific.
Vitura holds an import license from the Australian Office of Drug
Control to import PEACE NATURALS®
branded cannabis products for sale in the Australian medical market
under the terms of the relevant permits, which Vitura applies for
on a case-by-case basis. On November 29, 2022, the shareholders of
Cronos Australia approved a proposal to change the name of the
company to “Vitura Health Limited” (the “CAU Name Change”), which
change became effective on February 6, 2023. On December 2, 2022,
in connection with the CAU Name Change, Vitura and the Company
mutually agreed to terminate the intellectual property license that
granted Vitura the right to use certain intellectual property of
the Company, including, but not limited to, the “Cronos” name and
the PEACE NATURALS®
brand. Vitura has 180 days following the date of termination to
cease all usage of the Company’s intellectual property. Vitura did
not import PEACE NATURALS®
branded cannabis products from the Company during
2022.
We continue to seek new international distribution channels in
jurisdictions that have legalized the production, distribution and
possession of cannabis products at all relevant levels of
government.
Global Supply Chain
Cronos is focused on establishing an efficient global supply chain
by seeking to develop industry-leading methodologies and best
practices at Cronos Fermentation and the Peace Naturals Campus and
leveraging this expertise to create beneficial production
partnerships. We plan to continue to develop a global supply chain,
which will employ a combination of wholly owned production
facilities, third party suppliers and global production
partnerships, all of which will support the manufacturing of
cannabinoid-based consumer goods.
United States
In the ordinary course of our business, we
enter into contract manufacturing agreements with suppliers of our
products. We may supply these third-party manufacturers with U.S.
hemp-derived cannabinoids or infused bulk product, and other inputs
such as packaging that we source from other third-party suppliers.
The contract manufacturers supply any other necessary ingredients
to manufacture products using our formulas and fill and package our
finished products. Our contract manufacturing and supply agreements
generally do not require us to purchase minimum quantities of
materials or products.
In producing our supplement products, we source our ingredients
from our suppliers on an ongoing as-needed basis. We have not
entered into any contracts that obligate us to purchase a minimum
quantity or exclusively from any supplier. Our supplements are
manufactured according to Good Manufacturing Practices (“GMP”),
which we employ at our facility in Los Angeles,
California.
Rest of World
Canadian Supply Chain
•Facilities
at Cronos Fermentation and Peace Naturals Campus.
Cronos Fermentation and the Peace Naturals Campus are licensed for
cannabis production and the manufacturing of certain cannabis
products. Cronos Fermentation engages in R&D to produce
high-quality cultured cannabinoids at commercial scale. In addition
to manufacturing cultured cannabinoids, scientists at the facility
create cannabinoid product formulations, and engage in product
development. The Peace Naturals Campus is engaged in processing,
finishing, packaging and shipping activities, as well as R&D
activities, including cannabinoid product formulation, product
development, tissue culture and micro propagation. The GMP
certificate issued under relevant European Economic Area GMP
directives by the national competent authority of Germany was
retracted in 2022 due to the announcement of the closure of the
Peace Naturals Campus.
•Cronos
GrowCo.
The Cronos GrowCo production facility is licensed for cannabis
production and the manufacturing of certain cannabis products.
Under its current licenses, Cronos GrowCo is permitted to sell
certain cannabis products to other license holders in the wholesale
channel, as well as to provincial cannabis control authorities.
Cronos GrowCo holds Global GAP and ICANN GAP certifications
(equivalent to IMC-GAP) for the export of dried cannabis to
Israel.
•Third
Party Supply and Manufacturing Agreements.
In the ordinary course of our business, we enter into spot market
purchase agreements and supply agreements with suppliers of dried
cannabis and other cannabis products. Our supply agreements, for
the most part, do not obligate us to purchase minimum quantities of
products and generally contain provisions permitting cancellation
of orders or termination on notice. We also enter into contract
manufacturing agreements with other license holders for certain
manufacturing and processing services related to our
products.
Supply Chain Outside of Canada
•Cronos
Israel.
Cronos Israel holds the IMC-GAP, IMC-GMP and IMC-GDP certifications
required for the cultivation, production, distribution, and
marketing of dried flower, pre-rolls and oils in Israel. Cronos
Israel distributes PEACE NATURALS®
branded cannabis products to the Israeli medical market. See
“-
Licenses and Regulatory Framework in Israel.”
Major Customers
Major customers are customers for which sales equaled or exceeded
10% of our consolidated net revenues for the year. We had three
major customers, Ontario Cannabis Retail Corporation, Alberta
Gaming, Liquor and Cannabis Commission, and Société Québécoise du
Cannabis (the “SQDC”), which accounted for approximately 28%, 17%
and 10%, respectively, of our consolidated net revenues, before
excises taxes, for the year ended December 31, 2022. We
mitigate credit risk through verification of the customers’
liquidity prior to the authorization of material
transactions.
Government Contracts
In Canada, we sell cannabis products to cannabis control
authorities in all provinces of Canada and the Yukon territory,
except for Saskatchewan (where we sell to private-sector
retailers), where each such cannabis control authority is the sole
wholesale distributor and in certain provinces, the sole retailer,
of cannabis products. We sell these products to the various
cannabis control authorities under supply agreements that are
subject to terms that allow for renegotiation of sale prices and
termination at the election of the applicable cannabis control
authority. In particular, the cannabis control authorities have in
the past and may in the future choose to stop purchasing our
products, may change the prices at which they purchase our
products, may return our products to us and, in certain
circumstances, may cancel purchase orders at any time including
after products have been shipped. For the year ended
December 31, 2022, we had approximately $77.6 million in
sales to cannabis control authorities in Canada.
Research and Development Activities and Intellectual
Property
Ginkgo
The collaboration and license agreement between Ginkgo and the
Company (the “Ginkgo Collaboration Agreement”) has enabled us to
produce certain cultured cannabinoids at commercial scale at a
fraction of the cost compared to traditional cultivation practices.
The Ginkgo Collaboration Agreement was amended in June 2021 to
enable accelerated commercialization of such cultured cannabinoids,
ultimately resulting in the Company’s launching of its first
cultured cannabinoid product containing cannabigerol (“CBG”) in the
second half of 2021. These cultured cannabinoid molecules are
identical to those produced by plants grown using traditional
cultivation but are created by leveraging the power of biological
manufacturing via fermentation. These cultured cannabinoids include
rare cannabinoids that are difficult to produce at high purity and
scale through traditional cultivation.
Cronos is able to produce large volumes of these cultured
cannabinoids from custom yeast strains, as they are successfully
created through the Ginkgo Strategic Partnership, by leveraging
existing fermentation infrastructure at Cronos Fermentation in
Winnipeg, Manitoba without incurring significant capital
expenditures to build new cultivation and extraction
facilities.
The Ginkgo Strategic Partnership contemplates the performance of
licensed R&D activities in the U.S. in order to produce
cultured cannabinoids, and such activities are to be conducted in
compliance with all applicable laws regarding controlled
substances. We intend to produce and distribute the target
cannabinoids globally, where permitted by applicable law, and have
received confirmation from Health Canada that this method of
production is permitted under the Cannabis Act.
Ginkgo has filed certain patent applications pertaining to
biosynthesis of cannabinoids to protect the intellectual property
developed as part of the research progressing under the Ginkgo
Strategic Partnership. Under the partnership, Cronos is the
exclusive licensee of the intellectual property covered by the
patent applications for the target cannabinoids.
Cronos Fermentation
Cronos Fermentation is a GMP-standard fermentation and
manufacturing facility in Winnipeg, Manitoba. The state-of-the-art
facility includes fully equipped laboratories covering
microbiology, organic and analytical chemistry, quality control and
method development as well as two large-scale microbial
fermentation production areas, chemical manufacturing production
areas, three downstream processing plants, and bulk product and
packaging capabilities. The facility provides the fermentation and
manufacturing capabilities we need in order to capitalize on the
progress underway with Ginkgo, by enabling us to produce the target
cannabinoids contemplated under the Ginkgo Collaboration Agreement
at commercial scale with high quality and high purity.
The Company is prioritizing rare cannabinoids, such as CBG, CBC and
THCV, over common cannabinoids, such as THC and CBD, and has been
sequencing commercial production and subsequent product launches
based upon this approach. The Company achieved its first two equity
milestones in 2021, and an additional three equity milestones in
2022. The achievement of equity milestones for the remaining target
cannabinoids generally will occur sequentially based on Ginkgo’s
ability to produce such target cannabinoids as contemplated under
the Ginkgo Collaboration Agreement.
Competitive Conditions
Competitive Conditions in the United States
We face competition in all aspects of our business in the U.S. hemp
market. In addition to numerous small companies and brands, we
compete with larger, national companies that may have larger
distribution capabilities with more developed and efficient supply
chain operations. The principal factors on which we compete with
other U.S. hemp brands are product quality, innovation,
intellectual property, brand recognition and price. In the second
quarter of 2022, the Company began a phased exit of the wholesale
beauty category in the U.S. business to focus the portfolio on
adult-use product formats within the direct-to-consumer channel. We
believe the Company’s strong capitalization resulting from the
Altria Investment, along with the Lord Jones®
brand recognition and differentiation in the U.S. hemp retail
channel, will enable us to provide better quality consumer
products, grow our U.S. hemp business and strengthen our market
position in the U.S. However, rapidly evolving and developing
federal and state regulatory frameworks affect all areas of our
business and could result in our inability to compete successfully
against our current and future competitors. See
“U.S.
Hemp Regulatory Framework”
for further information on regulatory framework on U.S.
hemp.
Competitive Conditions in Rest of World
Competitive Conditions in Canada
We face competition in all aspects of our business in the Canadian
adult-use and medical markets. As the demand for cannabis increases
as a result of the legalization of adult-use cannabis in Canada
under the Cannabis Act, we believe that new competitors will
continue to enter the market.
The principal factors on which we compete with other Canadian
license holders are product quality, innovation, intellectual
property, brand recognition and price. We believe the Company’s
strong capitalization resulting from the Altria Investment, along
with the Spinach®
brand recognition and differentiation in the Canadian adult-use
market, will enable us to provide better quality consumer products,
grow our Canadian business and strengthen our market position in
Canada. However, a rapidly evolving and stringent federal
regulatory framework affects all areas of our business. See
“—Regulatory
Framework in Canada”
for further information on the regulatory framework applicable to
our Canadian business.
We also face competition from illegal market participants that are
unlicensed and unregulated. As these illegal market participants do
not comply with the regulations governing the cannabis industry,
their operations may also have significantly lower costs. Any
inability of the Canadian federal or provincial law enforcement
authorities to enforce existing laws prohibiting the unlicensed
cultivation and sale of cannabis and cannabis-based products could
result in the perpetuation of the illegal market for
cannabis.
Competitive Conditions in Europe and Israel
We face competition when entering new markets. The principal
factors on which we compete are product quality, innovation,
intellectual property, brand recognition, price and physician
familiarity. We believe we are positioned to enter certain markets
in Europe in a meaningful way while continuing to operate and
penetrate the markets we currently serve, such as in Israel, due to
our strong capitalization resulting from the Altria Investment,
extensive experience and expertise in the highly regulated cannabis
industry in Canada, which can be leveraged when entering new
markets or growing existing operations, and strong partnerships
with local distributors. We believe these factors will enable us to
develop greater market penetration, provide a greater variety of
quality consumer products and enter into new markets and strengthen
our existing market position in Europe and Israel. However, a
patchwork of regulatory frameworks and federal regulations in these
various regions also affects our ability to compete in emerging
markets as evolving regulations and federal frameworks have the
potential to affect all areas of our business.
Altria Strategic Investment
Altria Investment and Investor Rights Agreement
As of December 31, 2022, Altria beneficially owned 41% of our
common shares and had the right to acquire additional common shares
under its pre-emptive and top-up rights as discussed under
“Pre-Emptive
Rights and Top-Up Rights”
below.
Warrant
Prior to December 16, 2022, Altria had the right to acquire up to
an additional
84,243,223 of our common shares at a per share exercise price of
C$19.00 (the “Warrant”).
On December 16, 2022, Altria notified the Company that its wholly
owned subsidiary, Altria Summit LLC, irrevocably relinquished the
Warrant
and all rights that it may have held in the Warrant or any common
shares underlying the Warrant for no consideration. The voluntary
irrevocable relinquishment of the Warrant does not affect any
rights of Altria under the Investor Rights Agreement between the
Company and Altria, dated March 8, 2019 (the “Investor Rights
Agreement”), and Altria continues to beneficially own 156,573,537
of our common shares.
Investor Rights Agreement
In connection with the Altria Investment, we entered into the
Investor Rights Agreement with Altria pursuant to which Altria
received certain governance rights that are summarized
below.
Board Representation
The Investor Rights Agreement provides that, for so long as Altria
and certain of its affiliates (the “Altria Group”) continue to
beneficially own at least 40% of our issued and outstanding common
shares and the size of our board of directors (the “Board”) is
seven directors, we agree to nominate for election as directors to
the Board four individuals designated by Altria (the “Altria
Nominees”). In addition, for so long as the Altria Group continues
to beneficially own greater than 10% but less than 40% of our
issued and outstanding common shares, Altria shall be entitled to
nominate a number of Altria Nominees that represents its
proportionate share of the number of directors comprising the Board
(rounded up to the next whole number) based on the percentage of
our issued and outstanding common shares beneficially owned by the
Altria Group at the relevant time. At least one Altria Nominee must
be independent as long as Atria has the right to designate at least
three Altria Nominees and the Altria Group’s beneficial ownership
of our issued and outstanding common shares does not exceed
50%.
The Investor Rights Agreement also provides that, subject to
certain exceptions, for so long as Altria is entitled to designate
one or more Altria Nominees, we agree to appoint to each committee
established by the Board such number of Altria Nominees that
represents Altria’s proportionate share of the number of directors
comprising the applicable Board committee (rounded up to the
next
whole number) based on the percentage of our issued and outstanding
common shares beneficially owned by the Altria Group at the
relevant time.
Approval Rights
The Investor Rights Agreement also grants Altria, until the Altria
Group beneficially owns less than 10% of our issued and outstanding
common shares, approval rights over certain transactions that may
be undertaken by us. We have agreed that, among other things, we
will not (and will use our commercially reasonable efforts to cause
our affiliates not to), without the prior written consent of
Altria:
•consolidate
or merge into or with another person or enter into any similar
business combination;
•acquire
any shares or similar equity interests, instruments convertible
into or exchangeable for shares or similar equity interests,
assets, business or operations with an aggregate value of more than
C$100,000,000, in a single transaction or a series of related
transactions;
•sell,
transfer, cause to be transferred, exclusively license, lease,
pledge or otherwise dispose of any of our or any of our significant
subsidiaries’ assets, business or operations in the aggregate with
a value of more than C$60,000,000;
•except
as required by applicable law, make any changes to our policy with
respect to the declaration and payment of any dividends on our
common shares;
•subject
to certain exceptions, enter into any contract or other agreement,
arrangement, or understanding with respect to, or consummate, any
transaction or series of related transactions between us or any of
our subsidiaries, on the one hand, and any related parties, on the
other hand, involving consideration or any other transfer of value
required to be disclosed pursuant to Item 404 of Regulation S-K
promulgated pursuant to the United States Securities Act of 1933,
as amended (the “Securities Act”); or
•engage
in the production, cultivation, advertisement, marketing,
promotion, sale or distribution of cannabis or any Related Products
and Services (as defined in the Investor Rights Agreement) in any
jurisdiction, including the U.S., where such activity is prohibited
by applicable law as of the date of the Investor Rights Agreement
(subject to certain limitations).
Exclusivity Covenant
Pursuant to the terms of the Investor Rights Agreement, until the
earlier of:
•the
six-month anniversary of the date on which the Altria Group
beneficially owns less than 10% of our issued and outstanding
common shares; and
•the
six-month anniversary of the termination of the Investor Rights
Agreement,
Altria has agreed to make us its exclusive partner for pursuing
cannabis opportunities throughout the world (subject to certain
limited exceptions).
Pre-Emptive Rights and Top-Up Rights
Pursuant to the terms of the Investor Rights Agreement and provided
the Altria Group continues to beneficially own at least 20% of our
issued and outstanding common shares, Altria has a right to
purchase, directly or indirectly by another member of the Altria
Group, upon the occurrence of certain issuances of common shares by
us (including issuances of common shares to Ginkgo under the Ginkgo
Collaboration Agreement (each, a “Ginkgo Issuance”)) (each, a
“Triggering Event”) and subject to obtaining the necessary
approvals, up to such number of our common shares issuable in
connection with the Triggering Event which will, when added to our
common shares beneficially owned by the Altria Group immediately
prior to the Triggering Event, result in the Altria Group
beneficially owning the same percentage of our issued and
outstanding common shares that the Altria Group beneficially owned
immediately prior to the Triggering Event (in each case, calculated
on a non-diluted basis). The price per common share to be paid by
Altria pursuant to the exercise of these pre-emptive rights will
be, subject to certain limited exceptions, the same price per
common share at which the common shares are sold in the relevant
Triggering Event; provided that if the consideration paid in
connection with any such issuance is non-cash, the price per common
share that would have been received had such common shares been
issued for cash consideration will be determined by an independent
committee (acting reasonably and in good faith); provided further
that the price per common share to be paid by Altria pursuant to
the exercise of its pre-emptive rights in connection with a Ginkgo
Issuance will be C$16.25 per common share.
In addition to (and without duplication of) the aforementioned
pre-emptive rights, the Investor Rights Agreement provides Altria
with top-up rights, exercisable on a quarterly basis, whereby,
subject to obtaining the necessary approvals and for so long as the
Altria Group beneficially owns at least 20% of our issued and
outstanding common shares, Altria has the right to subscribe for
such number of common shares in connection with any Top-Up
Securities (as defined below) that we may, from time to time, issue
after the date of the Investor Rights Agreement, as will, when
added to the common shares beneficially owned by the Altria Group
prior to such issuance, result in the Altria Group beneficially
owning the same percentage of our issued and outstanding common
shares that the Altria Group beneficially owned immediately prior
to such issuance. “Top-Up Securities” means any of our common
shares issued:
•on
the exercise, conversion or exchange of our convertible securities
issued prior to the date of the Investor Rights Agreement or on the
exercise, conversion or exchange of our convertible securities
issued after the date of the Investor Rights Agreement in
compliance with the terms of the Investor Rights Agreement, in each
case, excluding any of our convertible securities owned by any
member of the Altria Group;
•pursuant
to any share incentive plan of the Company;
•on
the exercise of any right granted by us pro rata to all
shareholders to purchase additional common shares and/or other
securities of the Company (other than a right issued in a rights
offering in which Altria had the right to
participate);
•in
connection with bona fide bank debt, equipment financing or
non-equity interim financing transactions with our lenders, in each
case, with an equity component; or
•in
connection with bona fide acquisitions (including acquisitions of
assets or rights under a license or otherwise), mergers or similar
business combination transactions or joint ventures undertaken and
completed by us,
in each case, other than (A) common shares issued pursuant to
Altria’s pre-emptive right and (B) common shares issued pursuant to
the Ginkgo Collaboration Agreement.
The price per common share to be paid by Altria pursuant to the
exercise of its top-up rights will be, subject to certain limited
exceptions, the volume-weighted average price of our common shares
on the TSX for the 10 full trading days preceding such exercise by
Altria; provided that the price per common share to be paid by
Altria pursuant to the exercise of its top-up rights in connection
with the issuance of common shares pursuant to the exercise of
options or warrants that were outstanding on the date of closing of
the Altria Investment will be C$16.25 per common share without any
set off, counterclaim, deduction or withholding.
Standstill Covenant
The Altria Group is permitted to acquire our common shares in the
open market upon the falling away of the standstill covenant under
the Investor Rights Agreement. The Investor Rights Agreement
specifies that the standstill covenant falls away on the expiry or
termination of the Warrant.
Registration Rights
The Investor Rights Agreement provides Altria with the right,
subject to certain limitations and to the extent permitted by
applicable law, to require us to use reasonable commercial efforts
to file a prospectus under applicable securities laws and/or a
registration statement, qualifying our common shares held by Altria
for distribution in Canada and/or the U.S. In addition, the
Investor Rights Agreement provides Altria with the right to require
us to include our common shares held by Altria in any proposed
distribution of common shares in Canada and/or the U.S. by us for
our own account.
Commercial Arrangements
In connection with the Altria Investment, we and Altria have
entered into certain commercial arrangements (the “Commercial
Arrangements”), pursuant to which Altria provides us with
consulting services on matters which may include R&D,
marketing, advertising and brand management, government relations
and regulatory affairs, finance, tax planning, logistics and other
corporate administrative matters. The services under the Commercial
Arrangements are provided on customary terms and for a services fee
payable by us that is equal to Altria’s reasonably allocated costs
plus 5%.
Protection of Intangible Assets
The ownership and protection of our intellectual property rights is
a significant aspect of our future success. Currently, we rely on
trademarks, patents, copyrights, trade secrets, technical know-how
and proprietary information. We seek to protect our intellectual
property by strategically seeking and obtaining registered
protection where appropriate, developing and implementing standard
operating procedures to protect inventions, germplasm, trade
secrets, technical know-how and proprietary information and
entering into agreements with parties that have access to our
inventions, germplasm, trade secrets, technical know-how and
proprietary information, such as our partners, collaborators,
employees and consultants, to protect confidentiality and
ownership. We also seek to preserve the integrity and
confidentiality of our inventions, germplasm, trade secrets,
trademarks, technical know-how and proprietary information by
maintaining physical security of our premises and physical and
electronic security of our information technology
systems.
In addition, we have sought trademark protection in many
jurisdictions, including Canada, Australia, the U.S., China, Israel
and Europe. Our ability to obtain registered trademark protection
for cannabis-related goods and services, in particular for cannabis
itself, may be limited in certain countries outside of Canada. For
example, in the U.S., registered federal trademark protection is
only available for goods and services that can be lawfully used in
interstate commerce; the PTO is not currently approving any
trademark applications for U.S. Schedule I cannabis, or certain
goods containing U.S. hemp-derived CBD (such as dietary supplements
and food) until the FDA provides clearer guidance on the regulation
of such products. In Europe, trademarks cannot be obtained for
products that are “contrary to public policy or accepted principles
of morality.” Accordingly, our ability to obtain intellectual
property rights and enforce intellectual property rights against
third party uses of similar trademarks may be limited in certain
jurisdictions.
Human Capital Resources
Cronos is an innovative global cannabinoid company committed to
building disruptive intellectual property by advancing cannabis
research, technology and product development. With a passion to
responsibly elevate the consumer experience, Cronos is building an
iconic brand portfolio. Our employees are critical to achieving
this mission. In order to compete and succeed in our highly
competitive and rapidly evolving industry, it is crucial that we
continue to attract, develop, motivate and retain skilled, talented
and passionate employees. The Company’s people strategy seeks to
build a winning team and to foster a community where everyone feels
included and empowered to do to their best work.
As of December 31, 2022, we had 447 full-time employees. Of our
full-time employees, 269 were in Canada, 69 were in the U.S., and
109 were in Israel. None of our employees are represented by a
labor union or covered by a collective bargaining
agreement.
Compensation and Benefits.
Our compensation program is designed to attract, motivate and
reward talented individuals who possess the skills necessary to
support our business objectives, assist in the achievement of our
strategic goals and create long-term value for our shareholders. We
believe we offer competitive compensation and benefits in each of
our locations, including long-term equity awards to eligible
employees under our 2020 Omnibus Equity Incentive Plan to reward
and retain talented individuals and align employee and shareholder
interests.
Safety, Health and Well-being.
The safety, health and well-being of our employees are paramount to
the Company. We provide our employees and their families with
access to a variety of health and welfare programs, including
benefits that support their physical and mental health by providing
tools and resources to help them improve or maintain their health
status. In response to COVID-19, we implemented extensive safety
measures throughout the Company to protect our employees from
COVID-19, including complying with social distancing and other
health and safety standards as required by federal, provincial,
state, local and municipal government agencies, taking into
consideration guidelines of applicable public health authorities.
These measures have included increased frequency of cleaning and
sanitizing throughout the workplace, providing hand sanitizer
and/or hand washing stations located throughout the workplace,
mandatory mask wearing in all office and production areas, social
distancing protocols at our production facilities, and travel
restrictions.
Currently, we continue to follow safety standards as recommended by
applicable public health authorities, which may include isolation
after symptoms and optional mask wearing.
Employee Engagement, Development and Training.
We are committed to developing our talent and building an agile and
resilient organization with a workforce with the skillset to
effectively adapt to changing business needs in order to best
position the Company for success. We seek to foster a culture of
employee learning, innovation and a drive to succeed through a
talent development strategy that adapts to changing business needs.
Management is an active enabler of our people strategy as we seek
to recruit, retain and engage top talent that will maximize our
business performance. Employees are enabled to succeed through our
communicated behaviors, development training opportunities, our
performance management program and pay for performance philosophy,
and using their voice in our employee engagement
survey.
Diversity, Equity and Inclusion and Ethical Business
Practices.
We believe that a diverse, equitable and inclusive work environment
mitigates the risk of groupthink, ensures that the Company has the
opportunity to benefit from all available talent and enhances,
among other things, our organizational strength, problem-solving
ability and opportunity for innovation. We continue to focus on
understanding our diversity and inclusion strengths and
opportunities and executing on a strategy to support further
progress. We are committed to hiring, developing, and promoting
employees with diverse backgrounds. We are actively reviewing
diversity across our Company to drive greater progress. We welcome,
embrace, and celebrate all our employees. We seek to ensure this
inclusivity is achieved through regular training and support for
our employees. We maintain a whistleblower policy and anonymous
hotline for the confidential reporting of any suspected policy
violations and provide training and education to our global
workforce with respect to our Code of Business Conduct and Ethics
and related policies.
Regulatory Framework in the U.S.
U.S. Hemp Regulatory Framework
We derive a portion of our revenues from the manufacture, marketing
and distribution of U.S. hemp-derived supplement and cosmetic
consumer products through e-commerce, retail and hospitality
channels in certain states in the U.S. All U.S. hemp-derived
products produced and sold by us constitute “hemp” (i) under the
2018 Farm Bill and (ii) the applicable state-law equivalent in all
states in which we produce and sell such U.S. hemp-derived
products. The 2018 Farm Bill was enacted in the U.S. on December
20, 2018. Prior to this enactment, cannabis was scheduled as a
controlled substance (marijuana) under the CSA with limited
exemptions based on the portion of the cannabis plant. The 2018
Farm Bill, among other things, removed U.S. hemp (which is defined
in the 2018 Farm Bill as “the plant Cannabis sativa L. and any part
of that plant, including the seeds thereof and all derivatives,
extracts, cannabinoids, isomers, acids, salts, and salts of
isomers, whether growing or not, with a delta-9
tetrahydrocannabinol concentration of not more than 0.3 percent on
a dry weight basis”) and its derivatives, extracts and
cannabinoids, including CBD, derived from hemp, from the definition
of “marijuana” in the CSA, thereby removing U.S. hemp and its
derivatives as controlled substances. The 2018 Farm Bill also
amended the Agricultural Marketing Act of 1946 to allow for
production and sale of U.S. hemp and its derivatives in the
U.S.
The 2018 Farm Bill tasked the USDA with promulgating regulations in
relation to the cultivation and production of U.S. hemp. The 2018
Farm Bill also directed the USDA to promulgate federal regulations
that would apply to the production of U.S. hemp in every state that
does not put forth a state U.S. hemp plan for approval by the
USDA.
The USDA’s final rule establishes a federal licensing plan for
regulating U.S. hemp producers in states that do not have their own
USDA-approved plans. In the absence of a state plan, U.S. hemp
producers will be subject to regulation directly by the USDA unless
the state prohibits U.S. hemp production. Additionally, the final
rule includes requirements for maintaining information on the land
where U.S. hemp is produced, testing U.S. hemp for THC levels,
disposing of plants with more than 0.3 percent THC on a dry-weight
basis and licensing for U.S. hemp producers. The USDA’s final rule
requires hemp producers to use a laboratory that is registered with
the DEA, although the USDA is delaying enforcement of this
requirement until December 31, 2022. The final rule also includes
provisions for producers to dispose or remediate violative hemp
plants without the use of a DEA-registered reverse distributor or
law enforcement.
States may adopt regulatory schemes that impose more stringent
levels of regulation and costs on the production of U.S. hemp.
Moreover, the 2018 Farm Bill provides that its provisions do not
pre-empt or limit state laws that regulate the production of U.S.
hemp. Accordingly, some states may choose to restrict or prohibit
some or all U.S. hemp production or sales within the state.
Variances in states’ laws and regulations on U.S. hemp are likely
to persist.
Further, each state has discretion to develop and implement its own
laws and regulations governing the manufacturing, composition,
marketing, labeling and sale of U.S. hemp products, which has
created a patchwork of different regulatory schemes applicable to
such products.
Under the 2018 Farm Bill, the FDA has retained authority over the
Federal Food, Drug, and Cosmetic Act-regulated products (e.g.,
drugs, food, dietary supplements and cosmetics) containing U.S.
hemp and U.S. hemp-derived ingredients, including CBD and other
cannabinoids. Moreover, states have retained regulatory authority
through their own analogues to the Federal Food, Drug, and Cosmetic
Act (the “FFDCA”), and the states may diverge from the federal
treatment of the use of U.S. hemp as, or in, food, dietary
supplements or cosmetic products.
The FDA has consistently taken the position that CBD, whether
derived from U.S. hemp or U.S. Schedule I cannabis, is prohibited
from use as an ingredient in food and dietary supplements. This
stems from its interpretation of the exclusionary clauses in the
FFDCA because CBD has been approved as a prescription drug and is
the subject of substantial clinical investigations as a drug, which
have been made public. The exclusionary clauses under the FFDCA
provide that a substance that has been approved or has been subject
to substantial clinical investigations as a drug may not be used in
a food or dietary supplement, unless the substance was first
marketed in a food or dietary supplement prior to the initiation of
substantial clinical investigations of the substance as a drug. The
exclusionary clause does not apply to cosmetics. Cosmetics
containing CBD could be viewed as drug products by the FDA if
disease claims are made, or if the FDA determines the use of CBD in
the product has a structure or function effect on the body (i.e., a
drug effect).
To date, the FDA has not issued regulations that elaborate on the
exclusionary clauses and the FDA has not taken any enforcement
action in the courts asserting a violation of the exclusionary
clauses. To date, the FDA has issued a number of warning letters to
companies unlawfully marketing CBD products. In many of these
cases, the manufacturers made unsubstantiated claims about the
product being able to treat medical conditions (e.g., cancer,
Alzheimer’s disease, opioid withdrawal, anxiety and COVID-19) and
had not obtained drug approvals. Others were issued to companies
marketing CBD products as dietary supplements despite those
products which contain CBD not meeting the definition of a dietary
supplement, adding CBD to human and animal foods and marketing CBD
products for infants and children and other vulnerable populations,
selling CBD products that people may confuse for traditional foods
or beverages and that may result in unintentional consumption or
overconsumption of CBD, and selling unapproved animal drugs
containing CBD that are intended for use in food-producing animals.
Some of these letters were co-signed with the FTC and cited the
companies for making claims about the efficacy of CBD and other
ingredients which were not substantiated by competent and reliable
scientific evidence. In December 2020, the FTC announced it had
entered into settlement agreements with six companies marketing CBD
products including oils, gummies, creams, and others with deceptive
health claims about serious health conditions. The settlements
included monetary penalties ranging from $20,000 to $85,000. The
FTC announced another such enforcement action and settlement in May
2021, ordering consumer redress of over $30,000. The FDA has also
issued warning letters to dietary supplement manufacturers
objecting to CBD supplements on the basis that CBD was not a
permissible dietary supplement ingredient.
The FDA periodically updates its “Consumer Update” on CBD. Through
these Consumer Updates, the FDA has noted that it has approved only
one CBD product, a prescription drug product to treat three rare,
severe forms of epilepsy. The FDA has also stated that it is
illegal to market CBD by adding it to a food or labeling it as a
dietary supplement, that the FDA has seen only limited data about
CBD safety and these data point to real risks that need to be
considered before taking CBD for any reason and that some CBD
products are being marketed with unproven medical claims and are of
unknown quality.
The FDA has stated that it recognizes the potential opportunities
and significant interest in drug and other consumer products
containing CBD, is committed to evaluating the agency’s regulatory
policies related to CBD and has established a dedicated internal
working group, the Cannabis Product Committee, to explore potential
pathways for various types of CBD products to be lawfully marketed.
The FDA held a public hearing in May 2019 to obtain scientific data
and information about the safety, manufacturing, product quality,
marketing, labeling and sale of products containing cannabis or
cannabis-derived compounds. The rules and
regulations and enforcement in this area continue to evolve and
develop. In July 2020, the FDA sent to the White House Office of
Management and Budget (the “OMB”) for review a draft guidance,
“Cannabidiol Enforcement Policy,” the details of which were not
made public. This guidance remained under review at the OMB until
January 2021, when it was withdrawn by the FDA as a part of the
regulatory moratorium Executive Order issued by President Biden. On
January 26, 2023, the FDA stated its views publicly that a new
regulatory pathway for CBD is needed and it is prepared to work
with Congress to create such a pathway. The timeline for further
CBD policy development remains uncertain while the administration
and the FDA face competing regulatory priorities.
Furthermore, with respect to Company’s development of CBG and other
cannabinoids and additional cannabinoid product lines, the FDA has
provided no guidance as to how cannabinoids other than CBD (such as
CBG) are to be regulated under the FFDCA, and it is unclear at this
time how such potential regulation could affect the results of the
operations or prospects of the Company or this product
line.
For more information regarding certain risks facing our business in
connection with the U.S. hemp regulatory framework in the U.S., see
the section below entitled “Risk
Factors - Risks Relating to Regulation and Compliance - Risks
Related to U.S. Regulations and Compliance.”
U.S. Cosmetics Regulation
On December 29, 2022, President Biden signed into law the
Modernization of Cosmetics Regulation Act of 2022, which
significantly expands the FDA’s enforcement authorities over
cosmetics products and imposes new obligations on the cosmetics
industry, including requirements relating to GMP, labeling, safety
substantiation, facility registration and product listing with the
FDA, adverse event reporting, recordkeeping, among others.
Under the new legislation, the FDA is required over the next
several years to issue additional regulations and reports to
clarify requirements. Most enforcement of requirements under the
new legislation will not go into effect until a year or later from
the date of enactment; however, we expect that regulation of our
cosmetic products in the U.S. will become increasingly complex, and
compliance with regulatory requirements may take significant
additional resources.
Regulatory Framework in Canada
Licenses and Regulatory Framework
On October 17, 2018, the Cannabis Act and the Cannabis Regulations
(the “Cannabis Regulations”) came into force. The Cannabis
Regulations establish six classes of licenses:
•cultivation;
•processing;
•sale
for medical purposes;
•analytical
testing;
•research;
and
•cannabis
drug.
The Cannabis Regulations also create subclasses for cultivation
licenses (standard cultivation, micro-cultivation and nursery) and
processing licenses (standard processing and micro-processing).
Different licenses and each sub-class therein carry differing rules
and requirements that are intended to be proportional to the public
health and safety risks posed by each category and
sub-class.
Federal Regime
The Cannabis Act provides a licensing and permitting scheme for,
among other things, the cultivation, processing, testing,
packaging, labeling, distribution, sale, possession and disposal of
adult-use cannabis, implemented by regulations promulgated under
the Cannabis Act. The Cannabis Act and Cannabis Regulations
include, among other things, strict specifications for the plain
packaging and labeling and analytical testing of all cannabis
products as well as stringent physical and personnel security
requirements for all federally licensed cultivation, processing and
sales sites.
On October 17, 2019, the Regulations Amending the Cannabis
Regulations (New Classes of Cannabis) (the “Further Regulations”)
came into effect. The Further Regulations amend the Cannabis Act
and Cannabis Regulations to, among other things, permit the
production and sale of cannabis extracts (including concentrates),
cannabis topicals and cannabis edibles, in addition to dried
cannabis, cannabis oil, fresh cannabis, cannabis plants and
cannabis seeds for parties holding the appropriate licenses. The
Cannabis Regulations set out certain requirements for the sale of
cannabis products, including limiting the THC content and serving
size of certain product forms.
Health Canada allows license holders to export cannabis products
with appropriate export permits. Export permits issued by Health
Canada are specific to each shipment and may only be obtained for
medical or scientific purposes. To apply for a permit to export
cannabis, a license holder must submit significant information to
Health Canada including information about the substance to be
exported (including description, intended use, quantity) and the
importer. As part of the application, applicants are also generally
required to provide a copy of the import permit issued by a
competent authority in the jurisdiction of final destination and to
make a declaration to Health Canada that the shipment does not
contravene the laws of the jurisdiction of the final destination or
any country of transit or transshipment.
The Cannabis Act requires the federal government to conduct a
review of the Cannabis Act after three years, which commenced in
September 2022.
The scope of this statutory review includes, among other things,
consideration of (i) the administration and operation of the
Cannabis Act, (ii) the impact of the Cannabis Act on public health,
(iii) the health and consumption habits of young persons, (iv) the
impact of cannabis on indigenous persons and communities and (v)
the impact of the cultivation of cannabis plants in a
dwelling-house. The report resulting from the statutory review may
recommend and/or lead to the amendment, removal or addition of
provisions in or to the Cannabis Act which could
adversely affect our business.
In addition to the current medical and adult-use regimes under the
Cannabis Act, Health Canada has also been considering the
implementation of a cannabis health product regime for products
with potential therapeutic uses that would not require practitioner
oversight. Between June and September 2019, Health Canada held a
public consultation titled “Potential Market for Cannabis Health
Products (CHPs) that would not Require Practitioner Oversight”. The
consultation sought feedback from Canadians on the kinds of
cannabis health products they would be interested in if such
products were made available in Canada. A summary report of the
consultation results was published by Health Canada in September
2020. Given the results of the consultation, Health Canada has
indicated that it intends to obtain external scientific advice on
the appropriate evidence standards required to demonstrate safety,
efficacy and quality in cannabis health products, with the
information it gathers informing the next steps on a potential
implementation of a cannabis health product regime.
In June 2021, Health Canada opened a consultation into the use of
flavors in inhaled cannabis extracts as it claims that the
availability of flavors is one of the factors that contributes to
the increase in cannabis vaping in youth and young adults. As part
of this consultation, Health Canada released proposed regulations
that contemplate restricting the production, sale, promotion,
packaging and labelling of inhaled cannabis extracts from having a
flavor, other than the flavor of cannabis. The proposed amendments
would apply equally to inhaled cannabis extracts sold for medical
and non-medical purposes. The proposed amendments were
pre-published in June 2021 and the consultation period closed in
September 2021. No expected in-force date has been publicly
announced.
Provincial and Territorial Developments
While the Cannabis Act provides for the regulation by the Canadian
federal government of, among other things, the commercial
production of cannabis and the sale of medical cannabis, the
various provinces and territories of Canada regulate certain
aspects of adult-use cannabis, including but not limited to
distribution, sale, minimum age requirements and places where
cannabis can be consumed.
The governments of each Canadian province and territory have
implemented regulatory regimes for the distribution and sale of
cannabis for adult-use purposes which continue to evolve over time.
Most provinces and territories have announced a minimum age for
possession and consumption of 19 years old, except for Québec and
Alberta, where the minimum age is 21 and 18, respectively. In
addition, provinces and territories may impose additional licensing
requirements and restrictions on sales, distribution and promotion
which are more stringent than those at the federal level. For
example, the SQDC, the exclusive distributor of cannabis in the
province and the sole retail and online vendor in Québec, does not
permit cannabis vaporizers or other high THC non-edible cannabis
products to be sold through its channels. The SQDC has also placed
significant restrictions on the types of edibles that may be sold
through its channels, prohibiting edibles that are sweet,
confectionary, dessert, chocolate or any other product attractive
to persons under 21 years of age. Similarly, the Prince Edward
Island Cannabis Management Corporation does not allow cannabis
vaporizers to be sold through its channels.
Licenses and Regulatory Framework in Israel
In Israel, cannabis is subject to the Israeli Dangerous Drugs
Ordinance [New Version], 5733 – 1973, and its sale and use are
prohibited unless applicable licenses have been obtained. Licenses
to cultivate, produce, possess and use cannabis for medical or
research purposes in Israel are granted by the Israel Medical
Cannabis Agency within the Israeli Ministry of Health (the “Yakar”
and the “Israeli MOH”, respectively). Patients also must obtain
licenses either directly from physicians who have been authorized
to grant patient licenses or from the Yakar following a request
from the patient’s physician in order to purchase and consume
medical cannabis.
In January 2019, the Israeli government approved, in principle, the
export from Israel of medical cannabis products that meet
applicable quality standards under the strict supervision of the
Israeli authorities. Only products that can be directly marketed to
patients (including smoking products, oils, and vaporizer products)
may be exported, and only to those countries that have signed the
United Nations Single Convention on Narcotic Drugs and that have
explicitly approved the import of cannabis. The export of plant
substances, including seeds and tissue cultures, is not permitted.
In October 2020, the Israeli MOH initiated a pilot program in which
certain medical cannabis companies were permitted to export their
products, and the Yakar issued guidelines relating to the export of
medical cannabis products. These guidelines set forth the process
and conditions for obtaining an export license, which can only be
issued to an applicant already holding a valid Yakar
license.
In December 2021, the Director General of the Israeli MOH announced
the appointment of a committee (the “CBD Committee”) intended to
examine the possibility of excluding CBD from being considered a
“dangerous drug” under the Israeli Dangerous Drugs Ordinance (the
“Ordinance”). In February 2022, the CBD Committee published its
recommendations. The CBD Committee concluded that it would be
advisable to exclude CBD from the Ordinance and to allow CBD use,
other than in food and cosmetics products, provided that the
aggregate concentration of THC does not exceed 0.2%. The CBD
Committee further recommended that during the next two years, CBD
components not be approved as a component in food, food
supplements, and cosmetics and that this issue be re-examined by a
committee designated by the Israeli MOH. In March 2022, the Israeli
MOH adopted the conclusions of the CBD Committee and published a
draft order for public comments which excludes CBD from the
Ordinance while setting the threshold of aggregate concentration of
THC (or any structural derivative of THC) in any product, to 0.3%.
Cosmetics and food products be handled by specific regulations in
such fields. As of January 2023, no final order was issued, and CBD
has yet to be excluded from the Ordinance.
On January 31, 2022, the Economic Affairs Committee of the Israeli
Parliament held a discussion regarding the adverse effect on the
local cannabis industry of significant import of medical cannabis.
The discussion was concluded with a request to the Israeli MOH to
study the matter and consider banning medical cannabis import until
a balance is reached in the market between the import and export of
medical cannabis. The Israeli MOH has not yet publicly issued a
study on the matter.
In July 2022, a committee appointed by the Director General of the
Israeli MOH concluded that it would be advisable to reform the
medical cannabis regulatory framework by transitioning from the
grant of personal patient licenses to the issuance of prescriptions
available through public healthcare services. In August 2022, the
new regulations adopting this reform (the “Reform Regulations”)
were presented for public comments. The Reform Regulations propose
to amend the Ordinance to allow medical cannabis to be prescribed
by trained and certified physicians and to be held and distributed
by pharmacies. The Reform Regulations will enter into effect 180
days following the adoption by the Israeli Parliament of the HMOs
collection plan. As of January 2023, the Reform Regulations have
not yet been adopted and are not yet in effect.
In June 2022, 11 cannabis manufacturers (including Cronos Israel
G.S Manufacturing Ltd.) (the “Petitioners”) filed an administrative
petition to the District Court in Jerusalem regarding the Yakar’s
decision to issue a constructive license (i.e., a license for
dealing with medical cannabis, without a direct contact with the
drug, such as brokering medical cannabis transactions) (the
“Constructive License”). The Petitioners claim that the procedure
and requirements for other licenses (e.g., for cultivation or
production), granted by the Yakar, are unreasonably more stringent
than those of the Constructive License. On January 5, 2023, the
District Court in Jerusalem ordered the Israeli MOH to stop the
issuance of Constructive Licenses, for 60 days, and to formulate a
clear policy regarding the issuance of such Constructive Licenses.
On February 12, 2023, the director general of the Yakar published a
decision regarding the Constructive Licenses, in response to the
District Court’s order. The decision clarifies the Yakar’s
authority to grant Constructive Licenses for the import/export of
medical cannabis.
Cronos Israel Licenses
Cronos Israel maintains the following certificates and
corresponding permits: (1) full Good Agricultural Practices (“GAP”)
certification, including a permit to propagate and cultivate at the
full capacity of the greenhouse; and (2) GMP and Good Distribution
Practices (“GDP”) certificates and permits to produce and
distribute dried flower, cannabis oils and pre-rolls.
Licenses and Regulatory Framework in Other
Jurisdictions
We and our joint venture partners and strategic investments are
subject to comprehensive and evolving regulations in each
jurisdiction we and they operate. All aspects of the production,
manufacture and distribution of cannabis products are regulated and
subject to licensing regimes. These regulations and licensing
regimes vary by jurisdiction and we, our joint venture partners and
strategic investments spend significant time, effort and money to
comply with the applicable requirements.
Available Information
We are subject to the informational requirements of the United
States Securities Exchange Act of 1934, as amended (the “Exchange
Act”), and, in accordance with the Exchange Act, we also file
reports with and furnish other information to the SEC. The public
may obtain any document that we file with or furnish to the SEC
from the SEC’s Electronic Document Gathering, Analysis, and
Retrieval system, which can be accessed at
www.sec.gov,
or via the System for Electronic Document Analysis and Retrieval,
which can be accessed at
www.sedar.com,
as well as from commercial document retrieval
services.
Copies of this Annual Report may be obtained on request without
charge from our Corporate Secretary,
corporate.secretary@thecronosgroup.com, telephone: +1-416-504-0004.
We also provide access without charge to all of our SEC filings,
including copies of this Annual Report, Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the
Exchange Act, as well as Section 16 reports on Forms 3, 4 or 5, as
soon as reasonably practicable after filing or furnishing, on our
website located at https://thecronosgroup.com. In addition, our
website includes, among other things, our Code of Business Conduct
and Ethics. The Code of Business Conduct and Ethics is also
available in print to any shareholder upon request without charge
from our Corporate Secretary,
corporate.secretary@thecronosgroup.com, telephone: +1-416-504-0004.
Within the time period required by the SEC, we will post on our
website any amendment to the Code of Business Conduct and Ethics
and any waiver applicable to any executive officer, director or
senior financial officer.
From time to time, we use our website, as well as the following
social media sites, as an additional means of disclosing public
information to investors, the media and others interested in the
Company.
•Facebook
(https://www.facebook.com/The-Cronos-Group-419168411987225);
•Twitter
(https://twitter.com/cronosgroup);
and
•LinkedIn
(https://www.linkedin.com/company/cronosgroupcron/).
It is possible that certain information we post on our website or
these social media sites could be deemed to be material
information, and we encourage investors, the media and others
interested in the Company to review the business and financial
information we or our officers post on our website or these social
media sites. None of the information on our website or disclosed
through these social media sites is incorporated by reference into
this Annual Report.
ITEM 1A. RISK FACTORS
An investment in us involves a number of risks. In addition to the
other information contained in this Annual Report and in other
filings we make, investors should give careful consideration to the
following risk factors. Any of the matters highlighted in these
risk factors could adversely affect our business, results of
operations and financial condition, causing an investor to lose
all, or part of, its, his or her investment. The risks and
uncertainties described below are those we currently believe to be
material, but they are not the only ones we face. If any of the
following risks, or any other risks and uncertainties that we have
not yet identified or that we currently consider not to be
material, actually occur or become material risks, our business,
prospects, financial condition, results of operations and cash
flows and consequently the price of our securities could be
materially and adversely affected.
Risk Factor Summary
•Certain
of our subsidiaries and joint ventures have limited operating
histories and our growth strategy may not be
successful.
•We
may not be able to achieve or maintain profitability and may
continue to incur losses in the future.
•Our
products are new; there is limited long-term data with respect to
the effects and the safety of our products, which is subject to
conflicting medical data; and our products have been and may be in
the future subject to recalls.
•The
production and distribution of our products is subject to
disruption, the risks of an agricultural business and the risk
third party suppliers and distributors may not perform their
obligations to us.
•Intellectual
property is key to our growth strategy, and we may be unable to
obtain or enforce our intellectual property rights.
•Our
entry into new markets is subject to risks normally associated with
the conduct of business in foreign countries.
•We
are subject to extensive regulation and licensing and may not
successfully comply with all applicable laws and
regulations.
•Our
businesses face highly competitive conditions.
•Altria
has significant influence over us.
•The
price of our common shares has been and may continue to be highly
volatile.
•We
have had two restatements and seven material weaknesses in our
internal control over financial reporting over the last four years,
and one material weakness remains unremediated at December 31,
2022.
•We
are subject to other risks generally applicable to our industry and
the conduct of our businesses.
Risks Relating to Our Growth Strategy.
Certain of our subsidiaries have limited operating histories and
therefore we are subject to many of the risks common to early-stage
enterprises.
We began carrying on business in 2013; Peace Naturals began
operations in 2012 and generated its first revenues in 2013;
Redwood began operations in 2017. In addition, many of our joint
ventures are in the early stages of their operations and have
generated little or no revenue.
We are therefore subject to many of the risks common to early-stage
enterprises, including limitations with respect to personnel,
financial, and other resources and lack of revenues.
We may not be able to achieve or maintain profitability and may
continue to incur losses in the future.
We have incurred significant losses in recent periods. We had
negative operating cash flow for the last five fiscal years. We may
not be able to achieve or maintain profitability and may continue
to incur significant losses in the future even in light of our
Realignment and the change in the nature of operations at the Peace
Naturals Campus and the exit of the wholesale beauty category in
the U.S. In addition, we expect to continue to incur significant
operating expenses as we implement initiatives to continue to grow
our business. If our revenues do not increase to offset these
expected costs and operating expenses, we will not be profitable.
If our revenue declines or fails to grow at a rate faster than our
operating expenses, we will not be able to achieve and maintain
profitability in future periods. As a result, we may continue to
generate losses. We may not achieve profitability in the future
and, even if we do become profitable, we might not be able to
sustain that profitability.
We may not be able to successfully manage our growth.
We are currently in an early development stage and may be subject
to growth-related risks, including capacity constraints and
pressure on our internal systems and controls, which may place
significant strain on our operational and managerial resources.
While our revenue has generally grown in recent years, our ability
to manage and sustain revenue growth will depend on a number of
factors, many of which are beyond our control, including, but not
limited to, changes in laws and regulations respecting the
production of U.S. hemp and cannabis products, competition from
other license holders, the size of the illegal market and the
adult-use market in Canada, and our ability to produce sufficient
volumes of our products to meet customer demand. Our ability to
manage growth effectively will require us to continue to implement
and improve our operational and financial systems and to expand,
train and manage our employee base. There can be no assurances that
we will be able to manage growth successfully. Any inability to
manage growth successfully could have a material adverse effect on
our business, financial condition and results of
operations.
Our use of joint ventures may expose us to risks associated with
jointly owned investments.
We currently operate parts of our business through joint ventures
with other companies, and we may enter into additional joint
ventures and strategic alliances in the future. Joint venture
investments may involve risks not otherwise present for investments
made solely by us, including: (i) we may not control the joint
ventures, either by virtue of our economic or legal ownership
share, or our ability to influence day-to-day operational
decision-making; (ii) our joint venture partners may not agree to
distributions that we believe are appropriate; (iii) where we do
not have substantial decision-making authority, we may experience
impasses or disputes with our joint venture partners on certain
decisions, which could require us to expend additional resources to
resolve such impasses or disputes, including litigation or
arbitration; (iv) our joint venture partners may become insolvent
or bankrupt, fail to fund their share of required capital
contributions or fail to fulfill their obligations as a joint
venture partner; (v) the arrangements governing our joint ventures
may contain certain conditions or milestone events that may never
be satisfied or achieved; (vi) our joint venture partners may have
business or economic interests that are inconsistent with ours and
may take actions contrary to our interests; (vii) we may suffer
losses as a result of actions taken by our joint venture partners
with respect to our joint venture investments; (viii) it may be
difficult for us to exit a joint venture if an impasse arises or if
we desire to sell our interest for any reason; (ix) our joint
venture partners may exercise termination rights under the relevant
agreements and (x) conflicts of interest may arise between our
joint ventures and Company personnel who are directors of our joint
ventures because of the fact that such directors are employed by
us. In addition, we may, in certain circumstances, be liable for
the actions of our joint ventures or joint venture partners. Any of
the foregoing risks could have a material adverse effect on our
business, financial condition and results of operations, and the
magnitude of these material adverse effects could be greater to the
extent we decide to rely on such joint ventures for certain goods
or services, such as the receipt of raw materials from Cronos
GrowCo, or decide to outsource certain operating activities to such
joint ventures.
There can be no assurance of continued growth in Israel and our
performance in Israel depends on, among other things, our ability
to continue to import cannabis into Israel and our joint venture
partners.
While our revenue in Israel has experienced a recent period of
significant growth, our prior performance is not indicative of any
potential future results in Israel. There can be no assurance that
our recent growth in the Israeli market can be sustained or will
continue. Our ability to manage and sustain revenue growth in
Israel will depend on a number of factors, many of which are beyond
our control, including, but not limited to, our ability to continue
to import cannabis into Israel, changes in laws and regulations
respecting the cultivation, production and marketing of dried
flower, pre-rolls and oils in Israel, increased competition, our
ability to produce sufficient volumes of our products to meet
customer demand and our ability to maintain or grow our market
share in Israel. Any of these factors could materially and
negatively impact our growth in Israel.
In connection with the Realignment, we have begun to further
leverage our strategic joint venture with Cronos GrowCo. Our
current efforts to wind-down the cultivation and certain production
activities at the Peace Naturals Campus have increased the
importance of Cronos GrowCo to our business and operations. Once
the cultivation and certain production activities at the Peace
Naturals Campus have ceased, Cronos GrowCo’s production facilities
will be our principal source of raw materials. Therefore, our
performance in Israel is reliant on our ability to acquire such raw
materials on a timely and cost-effective basis from Cronos GrowCo
and to continue to import such raw materials and cannabis products
to Israel from Cronos GrowCo’s production facilities. There is no
guarantee that we will be able to successfully execute our strategy
to expand production at Cronos GrowCo or that we will be able to
obtain the regulatory approvals, licenses and permits required for
both the export of cannabis from Canada and the import of cannabis
into Israel.
Our acquisition strategy may not be successful, and we have in the
past, and may in the future, need to write down the goodwill and
indefinite-lived intangible assets recognized upon the
acquisitions.
In the second quarter of 2021, we wrote off all of the goodwill and
substantially all of the indefinite-lived intangible assets
recognized upon the acquisition of Redwood. Acquisitions of
companies, or equity interests of companies operating in new
markets, such as the U.S. hemp market in the U.S., are risky and
speculative and may not produce the anticipated revenues and
profits.
Our acquisition of the PharmaCann Option (the “PharmaCann
Investment”) presents significant risks. See “Risk Factors –
Risks Relating to Our Growth Strategy – Our U.S. strategy in part
depends on the success of the PharmaCann Investment and there is no
guarantee that we will exercise the PharmaCann Option in the near
term, or at all, and, even if exercised, that the PharmaCann
Investment will achieve the expected benefits of the
transaction.”
We have had two restatements and seven material weaknesses in our
internal control over financial reporting over the last four years,
and one material weakness remains unremediated at December 31,
2022. We had a material weakness in our control environment, and in
2021 and 2022, we experienced significant turnover, both voluntary
and involuntary, in our accounting and financial reporting
functions. If we are unable to remediate our existing material
weakness and create an appropriate control environment, our
business, results of operations, financial condition, cash flows
and reputation will be adversely affected.
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting (as defined in
Rule 13a-15(f) under the Exchange Act) and for evaluating and
reporting on the effectiveness of our system of internal control.
Effective internal control is necessary for us to provide timely,
reliable and accurate financial reports, identify and proactively
correct any deficiencies, material weaknesses or fraud and meet our
reporting obligations. We had two restatements and
seven material weaknesses in the last four years, have
one material weakness existing as of December 31, 2022, and
have had significant turnover, both voluntary and involuntary, in
our accounting and financial reporting functions. Moreover, we had
a material weakness in our control environment. Remediation efforts
have placed, and will continue to place, a significant burden on
management and add increased pressure on our financial reporting
resources and processes. The accuracy of our financial reporting
and our ability to timely file with the SEC and the applicable
securities regulatory authorities in Canada have in the past been,
and may in the future be, adversely impacted if we are unable to
successfully remediate material weaknesses in a timely manner, or
if any additional material weaknesses in our internal control over
financial reporting are identified. In addition, if our remedial
efforts are insufficient, or if additional material weaknesses or
significant deficiencies in our internal control occur in the
future, we could be required to restate our financial statements
again, which could materially and adversely affect our business,
results of operations and financial condition, restrict our ability
to access the capital markets, require us to expend significant
resources to correct the material weaknesses or deficiencies,
subject us to regulatory investigations and penalties, harm our
reputation, cause a decline in investor confidence or otherwise
cause a decline in our stock price.
We are subject to civil litigation relating to the restatements and
we cannot predict the outcome of this litigation, but we have
incurred and expect to continue to incur significant costs and
expenses in defending against this civil litigation. For more
information on this civil litigation and proceedings, see Part 1,
Item 3, Legal Proceedings, of this Annual Report.
We are subject to disabilities as a result of our settlement with
the SEC that may expose us to increased future litigation and
adversely affect our ability to raise capital.
As of the date of our settlement with the SEC (the “SEC Order”),
October 24, 2022, and for a period of three years thereafter, we
are unable to rely on the safe harbor provisions regarding
forward-looking statements provided by the Securities Act and the
Exchange Act. Our inability to rely on these safe harbor provisions
may expose us to increased future litigation in connection with
forward-looking statements in our public disclosures.
Further, as of the date of the SEC Order, we have lost our status
as a “well-known seasoned issuer” for a period of three years,
which places limitations on the manner in which we can market our
securities to the public, and we are unable to rely on the private
offering exemptions provided by Regulations A and D under the
Securities Act for a period of five years, which could impair our
ability to raise additional capital in the private market quickly
in response to changing requirements and market
conditions.
There can be no assurance that our current and future strategic
alliances or expansions of scope of existing relationships will
have a beneficial impact on our business, financial condition and
results of operations.
We currently have, and may in the future enter into additional,
strategic alliances with third parties that we believe will
complement or augment our existing business. Our ability to
complete strategic alliances is dependent upon, and may be limited
by, the availability of suitable candidates and capital. In
addition, strategic alliances could present unforeseen integration
obstacles or costs, may not enhance our business and may involve
risks that could adversely affect us, including significant amounts
of management time that may be diverted from operations in order to
pursue and complete such transactions or maintain such strategic
alliances. Future strategic alliances could result in the
incurrence of debt, costs and contingent liabilities, and there can
be no assurance that future strategic alliances will achieve, or
that our existing strategic alliances will continue to achieve, the
expected benefits to our business or that we will be able to
consummate future strategic alliances on satisfactory terms, or at
all. Any of the foregoing could have a material adverse effect on
our business, financial condition and results of
operations.
In the case of the Ginkgo Strategic Partnership, we have and will
continue to obtain, pursuant to the Ginkgo Collaboration Agreement,
the exclusive right to use and commercialize the key patented
intellectual property related to the production of the target
cannabinoids globally (referred to herein as the “Ginkgo exclusive
licenses”). There can be no assurance that Ginkgo will be able to
develop microorganisms that we will be able to commercialize or to
obtain patents relating to production of the target cannabinoids,
or that third parties will not develop similar microorganisms or
obtain patents that may restrict our ability to commercialize the
microorganisms developed by Ginkgo, and, as a result, there can be
no assurance that we will be able to realize the expected benefits
of the Ginkgo Strategic Partnership. Additionally, we have
determined, and may determine in the future, that the production of
certain cannabinoids is not economically feasible and in our best
interests and we have abandoned, and may abandon in the future, the
production efforts of Ginkgo with respect to certain target
cannabinoids. Even if we are able to commercialize cultured
cannabinoids, we may not be able to generate satisfactory returns
on them or on the products that incorporate them, and there may not
be demand for such cultured cannabinoid products.
In addition, pursuant to the Ginkgo Collaboration Agreement, if we
undergo a change of control that is approved by the Board, Ginkgo
may elect to receive cash payments, which, given the number of
Equity Milestone Events (as defined in the Ginkgo Collaboration
Agreement) that have occurred to date, could total up to $17
million, in lieu of the common shares that would otherwise become
issuable in connection with any Equity Milestone Events achieved
following such election (the “Milestone Cash Election”). If we
undergo a change in control that has not been approved by the
Board, then Ginkgo will have the ability to terminate the Ginkgo
Collaboration Agreement immediately, in which case, among other
things: (i) all rights or licenses granted to us by Ginkgo under
the Ginkgo Collaboration Agreement will terminate; (ii) certain
expenses and costs incurred by Ginkgo will be accelerated and
become due and payable by us; (iii) the then-outstanding and unpaid
portion of all cash payments from us to Ginkgo for the achievement
of R&D milestones by Ginkgo shall be due immediately as if all
R&D milestones had been achieved; and (iv) a lump sum cash
payment equal to the aggregate of all Milestone Cash Election
amounts in respect of which the relevant Equity Milestone Events
have not yet been achieved will be immediately due and payable by
us. In addition, should Ginkgo terminate the Ginkgo Collaboration
Agreement upon a change of control, we will no longer be able to
use or commercialize the key patented intellectual property related
to the production of the target cannabinoids, which could have a
material adverse effect on our business, financial condition and
results of operations. See
“Description
of Business - Research and Development Activities and Intellectual
Property.”
As additional equity milestones occur under the Ginkgo
Collaboration Agreement, we are required by accounting rules to
conduct an impairment analysis related to the new Ginkgo exclusive
licenses. These analyses have resulted in impairment charges in the
past and may do so in the future as additional equity milestones
are achieved. For a discussion of our most recent impairments of
the Ginkgo exclusive licenses, see Note 6 “Goodwill
and Intangible Assets, net”
to the consolidated financial statements in the Item 8 of this
Annual Report.
We may not successfully execute our production capacity
strategy.
We may not be successful in executing our strategy to expand
production capacity at certain of our facilities and joint ventures
and wind-down of cultivation and certain production activities at
the Peace Naturals Campus. Continuing and expanding operations at
our facilities and joint ventures will be subject to obtaining and
maintaining the appropriate licenses from the relevant regulatory
agencies in those jurisdictions. In particular, continuing and
expanding operations at Cronos GrowCo’s production facilities will
be subject to obtaining and maintaining the appropriate licenses
from Health Canada. Construction delays or cost over-runs in
respect of such operations, howsoever caused, could have a material
adverse effect on our business, financial condition and results of
operations. Moreover, with the change in the nature of operations
at the Peace Naturals Campus, the continued operations of the
Cronos GrowCo production facilities will be more important to us.
Once cultivation and certain production activities at the Peace
Naturals Campus have ceased, these production facilities will be
our principal source of raw materials.
In addition, we may not be successful in obtaining the necessary
approvals required to export or import our products to or from the
jurisdictions in which we or our joint ventures operate. If we are
unable to secure necessary production licenses in respect of our
facilities and those of our joint ventures, the expectations of
management with respect to the increased future cultivation and
growing capacity may not be borne out, which could have a material
adverse effect on our business, financial condition and results of
operations.
There can be no assurance that the Realignment and the change in
the nature of operations at the Peace Naturals Campus will have a
beneficial impact on our business, financial condition and results
of operations. The timing, costs and benefits of the Realignment
and the change in the nature of operations at the Peace Naturals
Campus cannot be guaranteed.
In the first quarter of 2022, we announced our Realignment to
centralize functions under common leadership to increase efficient
distribution of resources, improve strategic alignment and
eliminate duplication of roles and costs; evaluate our global
supply chain and perform product reviews and pricing and
distribution optimization in order to reduce fixed expenses and
reduce complexity; and implement an operating expense target to
optimize cash deployment for activities such as margin accretive
innovation and U.S. adult-use cannabis market entry in the future.
Additionally, we announced a plan to leverage our strategic
partnerships to improve supply chain efficiencies and reduce
manufacturing overhead by partially exiting the Peace Naturals
Campus.
In the first quarter of 2023, we announced a shift in our strategic
plans for the Realignment. Our intent is to retain select
components of our operations at the Peace Naturals Campus, namely
distribution and warehousing, certain R&D activities and
manufacturing of certain of our proprietary innovation
products.
There can be no assurance that these initiatives will achieve the
expected benefits to our business or reduce costs or grow our
revenue as intended and, if achieved at all, the timing thereof.
The execution and implementation of these initiatives involve risk,
including that significant amounts of management’s time and Company
resources could be diverted from our core operations in order to
complete such initiatives. In addition, these initiatives could
present unforeseen obstacles, lead to operating inefficiencies and
negatively disrupt our corporate culture, which could lead to
further employee attrition, any of which would have a material
adverse effect on our business, financial condition and results of
operations. We have and will continue to incur costs to implement
these initiatives, and we could be subject to litigation risks and
expenses. Our projected costs and expenses to change the nature of
our operations at the Peace Naturals Campus may turn out to be too
low by a material amount.
The industries and markets in which we operate are relatively new,
and these industries and markets may not continue to exist or grow
as anticipated or we may ultimately be unable to succeed in these
industries and markets.
The cannabis and U.S. hemp industries and markets in which we
operate are relatively new, can be highly speculative, are rapidly
expanding and may ultimately not be successful. In addition to
being subject to general business risks, we need to continue to
build brand awareness in these industries and markets through
significant investments in our strategy, our production capacity,
quality assurance and compliance with regulations. These activities
may not promote our brand and products as effectively as intended,
or at all. Competitive conditions and consumer tastes, as
applicable, and spending patterns in these new industries and
markets are relatively unknown and may have unique circumstances
that differ from existing industries and markets. We are subject to
all of the business risks associated with a new business in a niche
market, including risks of unforeseen capital requirements, failure
of widespread market acceptance of our products, failure to
establish business relationships and competitive disadvantages
against larger and more established competitors.
Accordingly, there are no assurances that these industries and
markets will continue to exist or grow as currently estimated or
anticipated, or function and evolve in a manner consistent with
management’s expectations and assumptions, and a failure to do so
could have a material adverse effect on our business, financial
condition and results of operations.
We may not be able to supply the provincial purchasers in various
provinces and territories of Canada with our products in the
quantities or prices anticipated, or at all.
We have entered into various supply arrangements for cannabis
products with various provincial purchasers and have secured
listings with various private retailers in those provinces. We have
entered into such supply arrangements with all provinces in Canada
and the Yukon territory (where the relevant provincial body is the
sole wholesale distributor of cannabis products in the province)
and with private retailers in Saskatchewan. Our supply arrangements
with provincial and territorial purchasers, each of which we
understand to be substantially similar in all material respects
with the supply arrangements entered into with the other license
holders in the Canadian cannabis industry, do not contain any
binding minimum purchase obligations on the part of the relevant
provincial purchaser.
We expect purchase orders to be primarily driven by end-consumer
demand for our products and the relevant provincial or territorial
purchaser supply at the relevant time. Accordingly, we cannot
predict the quantities of our products that will be purchased by
the provincial and territorial purchasers, or if our products will
be purchased at all. Provincial and territorial purchasers may
change the terms of the supply agreements at any time during the
supply relationship including pricing, have broad rights of return
of products and are under no obligation to purchase our products or
maintain any listings of our products for sale. As a result,
provincial and territorial purchasers have a significant amount of
control over the terms of the supply arrangements.
The effect of the legalization of adult-use cannabis in Canada on
the medical cannabis market in Canada is still uncertain, and it
may have a significant negative effect upon our medical cannabis
business if consumers decide to purchase products available in the
adult-use market instead of purchasing our medical-use
products.
The Cannabis Act allows individuals over the age of 18 to legally
purchase, process and cultivate limited amounts of cannabis for
adult-use in Canada, subject to provincial and territorial age
restrictions which may increase the age of purchase in the province
or territory. As a result, individuals who rely upon the medical
cannabis market to supply their medical cannabis and cannabis-based
products may cease this reliance, and instead turn to the adult-use
cannabis market to supply their cannabis and cannabis-based
products. Factors that will influence this decision include the
price of medical cannabis products in relation to similar adult-use
cannabis products, the amount of active ingredients in medical
cannabis products in relation to similar adult-use cannabis
products, the types of cannabis products available to adult users
and limitations on access to adult-use cannabis products imposed by
the regulations under the Cannabis Act and the legislation
governing the distribution and sale of cannabis that has been
enacted by the individual provinces and territories of
Canada.
The impact of the legalization of adult-use cannabis in Canada on
the medical cannabis market is uncertain, and while we cannot
predict its impact on our sales and revenue prospects, it may be
adverse.
The adult-use cannabis market in Canada has in the past been and
may in the future become oversupplied following the implementation
of the Cannabis Act and the related legalization of cannabis for
adult-use.
As a result of the implementation of the Cannabis Act and the
legalization of adult cannabis use, numerous additional cannabis
producers have and may continue to enter the Canadian adult-use
market. We and such other cannabis producers have in the past
produced and may in the future produce more cannabis than is needed
to satisfy the collective demand of the Canadian medical and
adult-use markets, and we may be unable to export that over-supply
into other markets. As a result, the available supply of cannabis
could exceed demand, which has in the past, and may in the future,
result in significant inventory write downs.
We may be unsuccessful in competing in the legal adult-use cannabis
market in Canada.
We face competition from existing license holders licensed under
the Cannabis Act. Certain of these competitors may have
significantly greater financial, production, marketing, R&D and
technical and human resources than we do. As a result, our
competitors may be more successful than us in gaining market share
in the adult-use cannabis industry in Canada. Our commercial
opportunity in the adult-use market could be reduced or eliminated
if our competitors produce and commercialize products for the
adult-use market that, among other things, are safer, more
effective, more convenient or less expensive than the products that
we may produce, have greater sales, marketing and distribution
support than our products, enjoy enhanced timing of market
introduction and perceived effectiveness advantages over our
products and receive more favorable publicity than our products. If
our adult-use products do not achieve an adequate level of
acceptance by the adult-use market, we may not generate sufficient
revenue from these products, and our adult-use business may not
become profitable.
We are subject to liability arising from any fraudulent or illegal
activity by our employees, contractors and
consultants.
We are exposed to the risk that our employees, independent
contractors and consultants may engage in fraudulent or other
illegal activity. Misconduct by these parties could include
intentional, reckless and/or negligent conduct or disclosure of
unauthorized activities to us that violates: (i) applicable laws
and regulations; (ii) manufacturing standards; (iii) federal and
provincial healthcare fraud and abuse of federal, state and
provincial laws and regulations; or (iv) laws and regulations that
require the true, complete and accurate reporting of financial
information or data. It is not always possible for us to identify
and deter misconduct by our employees and other third parties, and
the precautions taken by us to detect and prevent this activity may
not be effective in controlling unknown or unmanaged risks or
losses or in protecting us from governmental investigations or
other actions or lawsuits stemming from a failure to comply with
such laws or regulations. If any such actions are brought against
us, and we are not successful in defending them, those actions
could have a significant impact on our business, including the
imposition of civil, criminal and administrative penalties,
damages, monetary fines, contractual damages, reputational harm,
diminished profits and future earnings, loss or suspension of
licenses and the curtailment of our operations, any of which could
have a material adverse effect on our business, financial condition
and results of operations.
Some jurisdictions may never develop markets for cannabis and U.S.
hemp.
Many jurisdictions place restrictions on or prohibit commercial
activities involving cannabis and U.S. hemp. Such restrictions or
prohibitions may make it impossible or impractical for us to enter
or expand our operations in such jurisdictions unless there is a
change in law or regulation. For example, U.S. Schedule I cannabis
remains illegal under U.S. federal law and may never become legal
under U.S. federal law.
Our U.S. strategy in part depends on the success of the PharmaCann
Investment and there is no guarantee that we will exercise the
PharmaCann Option in the near term, or at all, and, even if
exercised, that the PharmaCann Investment will achieve the expected
benefits of the transaction.
Our ability to exercise the PharmaCann Option will depend on the
satisfaction of several conditions, including U.S. federal cannabis
legalization. In addition, our ability to exercise the PharmaCann
Option is subject to the receipt of any required regulatory
approvals, including in the states where PharmaCann operates that
may be required upon exercise, as well as Altria’s approval under
the Investor Rights Agreement. These conditions are outside of our
control and therefore there can be no certainty that the PharmaCann
Option will be exercised in the near term, or at all. If the
PharmaCann Option is not exercised, we will not receive the
benefits of the contemplated commercial arrangements between us and
PharmaCann.
In addition, the regulatory approval processes in connection with
the exercise of any PharmaCann Option may take a prolonged period
of time to complete, which could significantly delay our ability to
exercise the PharmaCann Option and realize the benefits of the
PharmaCann Investment, or result in our not being able to exercise
all or part of the PharmaCann Option. Furthermore, in connection
with obtaining approvals from or otherwise satisfying the requests
of the state regulators or applicable laws, we may be required to
divest all or a portion of the PharmaCann Option, or if after the
exercise of the PharmaCann Option, our shares of
PharmaCann.
Even if we are able to and do exercise the PharmaCann Option, the
intended benefits of the PharmaCann Investment may not be realized.
We cannot assure you that the PharmaCann Investment will be
accretive to us in the near term or at all. For example, if entered
into, the commercial arrangements between us and PharmaCann may not
be successful or beneficial to us. Furthermore, if we fail to
realize the intended benefits of the PharmaCann Investment, our
stock price could decline to the extent that the market price
anticipates those benefits.
We are entitled to certain limited governance rights with respect
to PharmaCann, including limited information rights and board
observer rights. Therefore, we will have little to no ability to
influence the strategy and material decisions of PharmaCann’s
business. Furthermore, until such time as we exercise the
PharmaCann Option, we will not have the ability to vote on matters
requiring the vote of PharmaCann’s shareholders and, until the
exercise of the PharmaCann Option, will not have the right to
appoint directors to the PharmaCann board of directors. Even after
exercising the PharmaCann Option, we are entitled to appoint a
director of PharmaCann’s board only if we own at least 10% of the
outstanding capital stock of PharmaCann, and in any event may
appoint no more than two directors. In addition, we are subject to
certain standstill restrictions, both prior to and after the
exercise of the PharmaCann Option, which restrictions further limit
our ability to influence decisions of PharmaCann.
Although we are entitled to certain anti-dilution protections with
respect to our investment in PharmaCann, such protections are
subject to various conditions, and our potential ownership in
PharmaCann may be significantly diluted by, among other things,
future issuances of PharmaCann securities or acquisition activity
in which PharmaCann uses its equity as consideration. On February
28, 2022, PharmaCann closed the previously announced LivWell
Transaction. As a result of the LivWell Transaction, the Company’s
ownership percentage in PharmaCann on a fully diluted basis
decreased to approximately 6.4%. As of December 31, 2022, the
Company’s ownership percentage in PharmaCann on a fully diluted
basis was approximately 6.3%. Under the terms of our investment in
PharmaCann, Cronos’ rights to nominate an observer or a director to
the PharmaCann board of directors could be lost if our ownership
drops below 6% on a fully diluted basis and we sell or transfer all
or any portion of the PharmaCann Option (subject to certain
exceptions). As a result, further dilution could adversely affect
our rights under the PharmaCann Option. Any other equity event
could be significantly dilutive to our ownership in PharmaCann and
may adversely impact the potential benefits we may realize from the
PharmaCann Investment.
We must rely largely on our own market research to forecast sales
and market demand and market prices may differ from our
forecasts.
We must rely largely on our own market research and internal data
to forecast sales as detailed market data is not generally
obtainable from other sources at this early stage of the cannabis
or U.S. hemp industries. If our sales forecasts and our
expectations regarding market conditions, including prices,
influence capital expenditure levels, inventory levels, production
and supply chain capacity and operating expenses, prove to be
inaccurate, this could have a material adverse effect on our
business, financial condition and results of operations. For
example, our forecasts for product demand and market conditions
were impacted by a decline in market prices for cannabis products
in the Canadian market, which contributed to our inventory
write-down in the second and fourth quarters of 2020.
We could have difficulty integrating the operations of businesses
that we have acquired and will acquire.
The success of our acquisitions depends upon our ability to
integrate any businesses that we acquire. The integration of
acquired business operations could disrupt our business by causing
unforeseen operating difficulties, diverting management’s attention
from day-to-day operations and requiring significant financial
resources that would otherwise be used for the ongoing development
of our business. The difficulties of integrations could be
increased by the necessity of coordinating geographically dispersed
organizations, coordinating personnel with disparate business
backgrounds, managing different corporate cultures, or discovering
previously unknown liabilities. In addition, we could be unable to
retain key employees or customers of the acquired businesses. We
could face integration issues including those related to
operations, internal control and information systems and
operational functions of the acquired companies and we also could
fail to realize cost efficiencies or synergies that we anticipated
when selecting our acquisition candidates or these acquisitions
could fail to compete successfully. Any of these items could
adversely affect our business, financial condition and results of
operations. For more information on the risks associated with
acquisitions, see “Risk
Factors
–
Risks Relating to Our Growth Strategy – Our acquisition strategy
may not be successful and we have in the past, and may in the
future, need to write down the goodwill and indefinite-lived
intangible assets recognized upon the
acquisitions.”
We have been and may in the future be required to write down
intangible assets, including goodwill, due to impairment, which
could have a material adverse effect on our results of operations
or financial position.
The Company has been and may in the future be required to write
down intangible assets, including goodwill, due to impairment,
which would reduce earnings. Indefinite-lived intangible assets are
reviewed annually or more frequently when events or changes in
circumstances indicate that the fair value of the indefinite-lived
intangible assets have been reduced to less than their carrying
amount. We periodically calculate the fair value of our reporting
units and intangible assets to test for impairment. This
calculation may be affected by several factors, including general
economic conditions, regulatory developments, changes in category
growth rates as a result of changing adult consumer preferences,
success of planned new product introductions, and competitive
activity. Certain events can also trigger an immediate review of
goodwill and intangible assets. If the carrying amount of our
reporting unit and other intangible assets exceed their fair value,
the goodwill and other intangible assets are considered impaired,
which would result in impairment losses and could have a material
adverse effect on our consolidated financial position or results of
operations. We cannot provide any assurance that the U.S. segment
will successfully execute its business plans and
strategies.
For a discussion of previous write downs of indefinite-lived
intangible assets and goodwill, see Note 6 “Goodwill and Intangible
Assets, net” to the consolidated financial statements in Item 8 of
this Annual Report.
Risks Relating to Our Products
There is limited long-term data with respect to the efficacy and
side effects of cannabis, U.S. hemp and cannabinoids, and future
clinical research studies on the effects of cannabis, U.S. hemp and
cannabinoids may lead to conclusions that dispute or conflict with
our understanding and belief regarding their benefits, viability,
safety, efficacy, dosing and social acceptance.
Research in Canada, the U.S. and internationally regarding the
benefits, viability, safety, efficacy, dosing and social acceptance
of cannabis, U.S. hemp or isolated cannabinoids (such as CBD and
THC) in dietary supplements, food, or cosmetic products remains in
early stages. There have been relatively few clinical trials on the
potential benefits of cannabis, U.S. hemp or isolated cannabinoids
and there is limited long-term data with respect to potential
benefits, effects and/or interaction of these substances with human
or animal biochemistry. As a result, our products could have
unexpected side effects or safety concerns, the discovery of which
could lead to civil litigation, regulatory actions and even
possibly criminal enforcement actions. In addition, if the products
we sell do not or are not perceived to have the effects intended by
the end user, this could have a material adverse effect on our
business, financial condition and results of
operations.
The statements made by the Company, including in this Annual
Report, concerning the potential benefits of cannabis, U.S. hemp
and isolated cannabinoids are based on published articles and
reports and therefore are subject to the experimental parameters,
qualifications and limitations in such studies that have been
completed. Although we believe that the existing public scientific
literature generally supports our beliefs regarding the benefits,
viability, safety, efficacy, dosing and social acceptance of
cannabis, U.S. hemp and cannabinoids, future research and clinical
trials may cast doubt or disprove such beliefs, or could raise or
heighten concerns regarding, and perceptions relating to, cannabis,
U.S. hemp and cannabinoids, which could have a material adverse
effect on the demand for our products with the potential to lead to
a material adverse effect on our business, financial condition and
results of operations. Given these risks, uncertainties and
assumptions, undue reliance should not be placed on such
literature. In particular, the FDA has raised several questions
regarding the safety of CBD and other cannabinoids and gaps in the
public scientific literature supporting the use of CBD and other
cannabinoids by the general population.
Clinical trials of cannabis-based medical products and treatments
are novel terrain with very limited or non-existent history, and
any trials may not result in commercially viable products and
treatments.
Clinical trials are expensive, time consuming and difficult to
design and implement. Regulatory authorities may suspend, delay or
terminate any clinical trials we commence at any time, may require
us, for various reasons, to conduct additional clinical trials, or
may require a particular clinical trial to continue for a longer
duration than originally planned. Clinical trials face many risks,
including, among others:
•lack
of effectiveness of any formulation or delivery system during
clinical trials;
•discovery
of serious or unexpected toxicities or side effects experienced by
trial participants or other safety issues;
•slower
than expected subject recruitment and enrollment rates in clinical
trials;
•delays
or inability in manufacturing or in obtaining sufficient quantities
of materials for use in clinical trials due to regulatory and
manufacturing constraints;
•delays
in obtaining regulatory authorization to commence a trial,
including licenses required for obtaining and using cannabis, U.S.
hemp or isolated cannabinoids for research, either before or after
a trial is commenced;
•unfavorable
results from ongoing pre-clinical studies and clinical
trials;
•trial
participants or investigators failing to comply with study
protocols;
•trial
participants failing to return for post-treatment follow-up at the
expected rate;
•sites
participating in an ongoing clinical study withdraw, requiring us
to engage new sites; and
•third
party clinical investigators declining to participate in our
clinical studies, not performing the clinical studies on the
anticipated schedule, or acting in ways inconsistent with the
established investigator agreement, clinical study protocol or good
clinical practices.
Any of the foregoing could cause our products or treatments not to
be commercially viable, which could have a material adverse effect
on our business, financial condition and results of
operations.
The controversy surrounding vaporizers and vaporizer products may
materially and adversely affect the market for vaporizer products
and expose us to litigation and additional regulation.
There have been a number of highly publicized cases involving lung
and other illnesses and deaths that appear to be related to
vaporizer devices and/or products used in such devices (such as
vaporizer liquids). The focus is currently on the vaporizer
devices, the manner in which the devices were used and the related
vaporizer device products – THC, nicotine, other substances in
vaporizer liquids, possibly adulterated products and other illegal
unlicensed cannabis vaporizer products. Some states, provinces,
territories and municipalities in the U.S. and Canada have already
taken steps to prohibit the sale or distribution of vaporizers,
restrict the sale and distribution of such products or impose
restrictions on flavors, substances and concentration of substances
used, or use of such vaporizers. This trend may continue,
accelerate and expand.
Cannabis vaporizers in Canada are regulated under the Cannabis Act,
Cannabis Regulations and other laws and regulations of general
application. Although this legislation sets rules and standards for
the manufacture, composition, packaging, and marketing of cannabis
vaporizer products, these rules and standards predate the spate of
vaporizer-related health issues that have recently arisen in the
U.S. These issues and accompanying negative public sentiment may
prompt Health Canada or individual provinces/territories or
municipalities to decide to further limit or defer the industry’s
ability to sell cannabis vaporizer products, and may also diminish
consumer demand for such products. Currently, Québec and Prince
Edward Island do not allow the sale of cannabis vaporizers in their
respective jurisdictions and Health Canada is seeking to limit the
flavors of inhaled cannabis extracts. In June 2021, Health Canada
opened a consultation into the use of flavors in inhaled cannabis
extracts as it claims that the availability of flavors is one of
the factors that contributes to the increase in cannabis vaping in
youth and young adults. As part of this consultation, Health Canada
released proposed regulations that contemplate restricting the
production, sale, promotion, packaging and labelling of inhaled
cannabis extracts from having a flavor, other than the flavor of
cannabis. The proposed amendments would apply equally to inhaled
cannabis extracts sold for medical and non-medical purposes. The
proposed amendments were pre-published in June 2021 and the
consultation period closed in September 2021. No expected in-force
date has been publicly announced.
There can be no assurance that the jurisdictions in which we
operate will allow the sale of cannabis vaporizers in the future,
that other jurisdictions will not prohibit the sale of cannabis
vaporizers, that we will be able to meet any additional compliance
requirements or regulatory restrictions, or that we will remain
competitive in face of unexpected changes in market
conditions.
An extension of this controversy to non-nicotine vaporizer devices
and other product formats could materially and adversely affect our
business, financial condition, operating results, liquidity, cash
flow and operational performance. In February 2020, the U.S.
Centers for Disease Control reported that federal and state
agencies were investigating an outbreak of over 2,807 lung injury
cases associated with the use of vaporizer products, including
non-nicotine containing products. Litigation pertaining to
vaporizer products is ongoing and that litigation could potentially
expand to include our products, which would materially and
adversely affect our business, financial condition, operating
results, liquidity, cash flow and operational
performance.
Future research may lead to findings that vaporizers, electronic
cigarettes and related products are not safe for their intended
use.
Vaporizers, electronic cigarettes and related products were
recently developed and therefore the scientific or medical
communities have had a limited period of time to study the
long-term health effects of their use. Currently, there is limited
scientific or medical data on the safety of such products for their
intended use and the medical community is still studying the health
effects of the use of such products, including the long-term health
effects. If a consensus were to develop among the scientific or
medical community that the use of any or all of these products pose
long-term health risks, market demand for these products and their
use could materially decline. Such a development could also lead to
litigation, reputational harm and significant regulation. Loss of
demand for our products, product liability claims and increased
regulation stemming from unfavorable scientific studies on
vaporizer products could have a material adverse effect on our
business, financial condition, operating results, liquidity, cash
flow and operational performance.
We, or the cannabis and U.S. hemp industries more generally, may
receive unfavorable publicity or become subject to negative
consumer perception.
We believe the cannabis and U.S. hemp industries are highly
dependent upon broad social acceptance and consumer perception
regarding the safety, efficacy and quality of the cannabis and U.S.
hemp products, as well as consumer views concerning regulatory
compliance. Consumer perception of our products can be
significantly influenced by scientific research or findings,
regulatory investigations, litigation, media attention, market
rumors or speculation and other publicity regarding the consumption
or effects thereof of cannabis and U.S. hemp products. There can be
no assurance that future scientific research, findings, regulatory
proceedings, litigation, media attention or other research findings
or publicity will be favorable to the cannabis or U.S. hemp markets
or any particular product, or consistent with earlier publicity.
Future research reports, findings, regulatory proceedings,
litigation, media attention or other publicity that are perceived
as less favorable than, or that question, earlier research reports,
findings or publicity could have a material adverse effect on the
demand for our products and our business, financial condition and
results of operations. Our dependence upon consumer perceptions
means that adverse scientific research reports, findings,
regulatory proceedings, litigation, media attention or other
publicity, whether or not accurate or with merit, could have a
material adverse effect on the demand for products, and our
business, results of operations, financial condition and cash
flows. Further, adverse publicity reports or other media attention
regarding the safety, efficacy and quality of U.S. hemp or cannabis
in general, or our products specifically, or associating the
consumption or use of U.S. hemp or cannabis with illness or other
negative effects or events, could have such a material adverse
effect. Such adverse publicity reports or other media attention
could arise even if the adverse effects associated with such
products resulted from consumers’ failure to consume such products
legally, appropriately or as directed.
The increased usage of social media and other web-based tools used
to generate, publish and discuss user-generated content and to
connect with other users has made it increasingly easier for
individuals and groups to communicate and share opinions and views,
whether or not true, on our operations and activities and the U.S.
hemp and cannabis industries in general, whether true or not.
Social media permits user-generated content to be distributed to a
broad audience which can respond or react, in near real time, with
comments that are often not filtered or checked for accuracy. In
many cases, we do not have the ability to filter such comments or
verify their accuracy. Accordingly, the speed with which negative
publicity (whether true or not) can be disseminated has increased
dramatically with the expansion of social media. The dissemination
of negative or inaccurate posts, comments or other user-generated
content about us on social media (including those published by
third-parties) could damage our brand, image and reputation or how
the U.S. hemp or cannabis industries are perceived generally, which
could have a detrimental impact on the market for our products and
thus on our business, financial condition and results of
operations.
Certain businesses may have strong economic opposition to the U.S.
hemp or cannabis industries. Lobbying by such groups, and any
resulting inroads they might make in halting or rolling back the
U.S. hemp and cannabis movements, could affect how the U.S. hemp or
cannabis industries are perceived by others and could have a
detrimental impact on the market for our products and thus on our
business, financial condition and results of
operations.
The parties with which we do business, may perceive that they are
exposed to reputational risk as a result of our cannabis or U.S.
hemp business activities. Failure to establish or maintain business
relationships could have a material adverse effect on our business,
financial condition and results of operations. Any third party
service provider or supplier could suspend or withdraw its services
to us or require increased fees or compensation if it perceives
that the potential risks exceed the potential benefits to such
services. For example, we face challenges making U.S. dollar wire
transfers or engaging any third party service provider or supplier
with a substantial presence where cannabis is not federally legal
(including the U.S.). In these circumstances, while we believe that
such services can be procured from other institutions, we may in
the future have difficulty maintaining existing, or securing new,
bank accounts or clearing services, service providers or other
vendors or we may be forced to pay increased fees or compensation
for such services.
Although we take care in protecting our image and reputation, we do
not ultimately have control over how we or the U.S. hemp or
cannabis industries are perceived by others. Reputation loss may
result in decreased investor confidence, increased challenges in
developing and maintaining community relations and an impediment to
our overall ability to advance our business strategy and realize on
our growth prospects, thereby having a material adverse impact on
our business, financial condition and results of
operations.
We may be subject to litigation in the ordinary course of our
marketing, distribution and sale of our products.
We are subject to litigation, claims and other legal and regulatory
proceedings from time to time in the ordinary course of our
manufacturing, marketing, distribution and sale of our products,
some of which may adversely affect our business, financial
condition and results of operations. Several companies in the U.S.
hemp-derived CBD industry, including the Company, have become party
to an increasing number of purported class actions lawsuits
relating to their food and dietary supplement products containing
U.S. hemp-derived CBD. While one such case against the Company was
dismissed, similar class actions may be filed against us again, and
the plaintiffs in such class action lawsuits, as well as in other
lawsuits against us, may seek very large or indeterminate amounts,
including punitive damages, which may remain unknown for
substantial periods of time. Should any litigation in which we
become involved be determined against us, such a decision could
adversely affect our ability to continue operating, adversely
affect the market price for our common shares and require the use
of significant resources. Even to the extent we ultimately prevail
in litigation, litigation can consume and redirect significant
resources. Litigation may also create a negative perception of our
brands, which could have an adverse effect on our business,
financial condition and results of operations. See Part I, Item
3,
Legal Proceedings,
of this Annual Report for a discussion of our legal
proceedings.
We may be subject to product liability claims.
As a manufacturer and distributor of products designed to be
ingested by humans, we face an inherent risk of exposure to product
liability claims, regulatory action and litigation if our products
are alleged to have caused significant loss or injury. In addition,
the manufacture and sale of cannabis and U.S. hemp products involve
the risk of injury to consumers due to tampering by unauthorized
third parties or product contamination. Previously unknown adverse
reactions resulting from human consumption of cannabis or U.S. hemp
products alone or in combination with other medications or
substances could occur as described above under
“—
There is limited long-term data with respect to the efficacy and
side effects of cannabis, U.S. hemp and cannabinoids and future
clinical research studies on the effects of cannabis, U.S. hemp and
cannabinoids may lead to conclusions that dispute or conflict with
our understanding and belief regarding their benefits, viability,
safety, efficacy, dosing and social acceptance.”
We have been, and may in the future be, subject to product
liability claims that include, among others, our products caused
injury or illness, incorrect labeling, inadequate instructions for
use or inadequate warnings concerning possible side effects or
interactions with other substances. A product liability claim or
regulatory action against us could result in increased costs, could
adversely affect our reputation with our consumers generally, and
could have a material adverse effect on our business, financial
condition and results of operations. See Part I, Item 3,
Legal Proceedings,
of this Annual Report for a discussion on our legal
proceedings.
There can be no assurances that we will be able to obtain or
maintain product liability insurance on acceptable terms or with
adequate coverage against potential liabilities. Such insurance is
expensive and may not be available in the future on acceptable
terms, or at all. The inability to obtain sufficient insurance
coverage on reasonable terms or to otherwise protect against
potential product liability claims could prevent or inhibit the
commercialization of products.
Our products have in the past and may in the future be subject to
recalls.
Manufacturers and distributors of products are sometimes subject to
the recall or return of their products for a variety of reasons,
including, among other things, product defects, such as
contamination, unintended harmful side effects or interactions with
other substances, packaging safety and inadequate or inaccurate
labelling disclosure. Some of our products have been subject to
recalls in the past.
If one or more of our products are recalled for any reason, we
could be required to incur the unexpected expense of the recall and
any legal proceedings that might arise in connection with the
recall. We may lose a significant number of sales and may not be
able to replace those sales at an acceptable margin, or at all. In
addition, product recalls have in the past and may in the future
require significant management attention. Although we have detailed
procedures in place for testing finished products, there can be no
assurance that any quality, potency or contamination problems will
be detected in time to avoid unforeseen product recalls, regulatory
action or lawsuits. If one or more of our products were subject to
recall, the public perception of that product and us could be
harmed. A recall of one of our products could lead to decreased
demand for that product and our other products and could have a
material adverse effect on our business, financial condition and
results of operations. Additionally, product recalls may lead to
increased scrutiny of our operations by Health Canada, the FDA, the
California Department of Public Health (the “CDPH”), the DEA or
other regulatory agencies, requiring further management attention
and potential legal fees and other expenses. Furthermore, any
product recall affecting the cannabis or U.S. hemp industries more
broadly could lead consumers to lose confidence in the safety and
security of the products sold by participants in these industries
generally, which could have a material adverse effect on our
business, financial condition and results of
operations.
We rely on third party testing and analytical methods which are
validated but still being standardized.
For certain of our cannabis and U.S. hemp products, testing for
cannabinoid levels, heavy metals and pesticides (among other
things) is performed by independent third-party testing
laboratories. Testing methods and analytical assays for
cannabinoids and levels of detection vary among different testing
laboratories in different jurisdictions. There is currently no
industry consensus on standards for testing methods or an industry
accepted compendium of analytical assays or standard levels of
detection. The detected and reported cannabinoid content in our
cannabis and U.S. hemp products therefore can differ depending on
the laboratory and testing methods (analytical assays) used.
Variations in reported cannabinoid content will likely continue
until the relevant regulatory agencies and independent
certification bodies (e.g., ISO, USP) collaborate to develop,
publish and implement standardized analytical assays and levels of
detection for cannabis, U.S. hemp, cannabinoids and their
derivative products. Until such standardized analytical assays and
levels of detection are developed, the existing differences could
cause confusion with our consumers which could lead to a negative
perception of us and our products, increase the risk of litigation
regarding cannabinoid content and regulatory enforcement action and
could make it more difficult for us to comply with regulatory
requirements regarding contents of ingredients and packaging and
labeling. For example, on June 16, 2020, an alleged consumer filed
a Statement of Claim, which has since been dismissed as against the
Company, on behalf of a class in the Court of King’s Bench of
Alberta in Alberta, Canada, against the Company and other Canadian
cannabis manufacturers and distributors alleging claims related to
the defendants’ advertised content of cannabinoids in cannabis
products for medicinal use on or after June 16, 2010 and cannabis
products for adult use on or after October 17, 2018. See Part I,
Item 3,
Legal Proceedings,
of this Annual Report.
The presence of trace amounts of THC in our U.S. hemp products may
cause adverse consequences to users of such products that will
expose us to the risk of litigation, liability and other
consequences.
Some of our products that are intended to primarily contain U.S.
hemp-derived CBD, or other U.S. hemp-derived cannabinoids, may
contain trace amounts of THC. THC is a controlled substance in many
jurisdictions, including under the federal laws of the U.S. Whether
or not ingestion of THC (at low levels or otherwise) is permitted
in a particular jurisdiction, there may be adverse consequences to
consumers of our U.S. hemp products who test positive for any
amounts of THC because of the presence of trace amounts of THC in
our U.S. hemp products. In addition, certain metabolic processes in
the body may negatively affect the results of drug tests. Positive
tests for THC may expose us to litigation from our consumers,
adversely affect our reputation, our ability to obtain or retain
customers and individuals’ participation in certain athletic or
other activities. A claim or regulatory action against us based on
such positive test results could materially and adversely affect
our business, financial condition, operating results, liquidity,
cash flow and operational performance.
We may not be able to successfully develop new products or find a
market for their sale.
The legal cannabis and U.S. hemp industries are in their early
stages of development and it is likely that we, and our
competitors, will seek to introduce new products, including
products that contain cannabinoids other than THC and CBD, in the
future. In attempting to keep pace with any new market
developments, we may need to spend significant amounts of capital
in order to successfully develop and generate revenues from new
products we introduce. In addition, we may be required to obtain
additional regulatory approvals from Health Canada, the FDA and/or
any other applicable regulatory authority, which may take
significant amounts of time. We may not be successful in developing
effective and safe new products, bringing such products to market
in time to be effectively commercialized, or obtaining any required
regulatory approvals, and, in the event we are successful, it is
possible that there may be little or no demand for the products we
develop (including products containing cannabinoids other than THC
and CBD with which consumers may not be familiar or have
significant reservations), which, together with any capital
expenditures made in the course of such product development and
regulatory approval processes, may have a material adverse effect
on our business, financial condition and results of
operations.
The Canadian excise duty framework may affect our
profitability.
Canada’s excise duty framework imposes an excise duty and various
regulatory-like restrictions on certain cannabis products sold in
Canada. We currently hold licenses issued by the Canada Revenue
Agency (“CRA”) required to comply with this excise framework. Any
change in the rates or application of excise duty to cannabis
products sold by us in Canada, and any restrictive interpretations
by the CRA or the courts of the provisions of the Excise Act, 2001
(which may be different than those contained in the Cannabis Act)
may affect our profitability and ability to compete in the
market.
Our business may be impacted as a result of increased rates of
inflation.
In the past year, the worldwide economy has experienced significant
inflation and inflationary pressures, including, in particular, on
wages. Increased inflation could reduce our purchasing power and
result in negative impacts on our ability to obtain goods and
services required for the operation of our business, to hire and
retain employees, or to pass on rising costs, including increased
employee costs, to our customers. To the extent that we are unable
to offset such inflation through higher prices of our products or
other cost savings, there could be a negative impact on our
operating margins, net income, cash flows and the trading price of
our common shares.
A period of sustained inflation across the markets in which we
operate could result in higher operating costs. Further rising
inflation may negatively impact our business, raise cost and reduce
profitability. Despite efforts we may take to reduce the impact of
inflation on our business across the markets in which we operate,
it could become increasingly difficult to effectively mitigate the
increases to our costs. In addition, the effects of inflation on
consumers’ budgets could result in the reduction of our customers’
spending habits. If we are unable to take actions to effectively
mitigate the effect of the resulting higher costs, our operating
margins could be negatively impacted.
Risks Relating to Production and Distribution of
Products
Our production facilities and those of our strategic joint
ventures, are integral to our operations, and any adverse changes
or developments affecting such facilities may impact our business,
financial condition and results of operations.
Our activities and resources are focused on various production and
manufacturing facilities including in the U.S. (for U.S. hemp
products), Canada and Israel. Some licenses are specific to those
facilities. Adverse changes or developments affecting our
facilities and the facilities of our joint venture partners,
including but not limited to a breach of security, an inability to
successfully grow cannabis plants or produce finished goods,
unanticipated cost overruns in growing or producing products, an
outbreak of a communicable illness (such as COVID-19) or a force
majeure event, could have a material and adverse effect on our
business, financial condition and results of operations. As we
proceed to wind-down cultivation and certain production activities
at the Peace Naturals Campus, the production and manufacturing
facilities that we continue to use will become increasingly
important to our business. Any breach of the security measures and
other facility requirements, including any failure to comply with
recommendations or requirements arising from inspections by
regulatory agencies, could also have an impact on our ability to
continue operating under our licenses or the prospect of renewing
our licenses or could result in a revocation of our
licenses.
We bear the responsibility for all of the costs of maintenance and
upkeep at our facilities and our operations and financial
performance may be adversely affected if our facilities are unable
to keep up with maintenance requirements.
We may experience breaches of security at our facilities or
fraudulent or unpermitted data access or other cybersecurity
breaches, which may cause our customers to lose confidence in our
security or data protection measures and may expose us to risks
related to breaches of applicable privacy and security laws and
regulations.
Given the nature of our products and the concentration of inventory
in our facilities, we are subject to a risk of theft. A security
breach at one of our facilities could expose us to additional
liability and to potentially costly litigation, increase expenses
and business disruptions relating to the resolution and future
prevention of these breaches and may deter potential customers from
choosing our products.
In addition, we collect and store personal information about our
customers and are responsible for protecting that information from
cybersecurity breaches. A cybersecurity breach may occur in a
variety of ways, including, without limitation, a procedural or
process failure, information technology malfunction, deliberate
unauthorized intrusion, computer virus, and direct or indirect
cyberattack or other electronic security breach. Theft of data for
competitive or fraudulent purposes, such as customer lists and
preferences and other consumer and employee personal information,
is an ongoing and growing risk. Any such theft or cybersecurity
breach may have a material adverse effect on our business,
financial condition and results of operations.
We are dependent upon information technology systems in the conduct
of our operations, and we collect, store and use certain data,
intellectual property, proprietary business information and certain
personal information of our employees and customers on our computer
systems. We have been, and expect to continue to be, subject to
various cyberattacks and phishing schemes. Additionally, we are
undertaking an effort to modernize our information technology
systems, which could expose us to additional risks relating to our
collection, storage and use of certain data on our
systems.
There have been many highly publicized attacks over the last
several years and we expect those to continue. Any fraudulent,
malicious or accidental breach of our systems could result in
unintended disclosure of, or unauthorized access to, third party,
customer, vendor, employee or other confidential information, which
could potentially result in additional costs and business
disruption to us, including without limitation, to repair or
replace damaged systems, enhance security or respond to
occurrences, lost sales, violations of data privacy, security or
other laws and regulations and subsequent penalties, fines,
regulatory action or litigation. We also rely on third
party-service providers for certain information technology systems,
such as payment processing, and any data security breach at a
third-party service provider could have similar effects. In
addition, media or other reports of perceived security
vulnerabilities to our systems or those of our third-party
suppliers, even if no breach has been attempted or occurred, could
adversely impact our brand and reputation, and customers could lose
confidence in our security measures and reliability, which would
harm our ability to retain customers and gain new ones. If any of
these were to occur, it could have a material adverse effect on our
business, financial position and results of
operations.
We are responsible for protecting employee and client health
information. In the U.S., for example, we must comply with
Americans with Disability Act requirements for confidential
employee medical records, including that they must be stored
separately from other personal records and access must be
restricted to those who need access. With respect to customer
health information,
there are a number of federal, state and provincial laws and
regulations
protecting the confidentiality of certain customer health
information, including customer records, and restricting the use
and disclosure of that protected information. The privacy rules
under the Personal Information Protection and Electronics Documents
Act (Canada) (“PIPEDA”) protect medical records and other personal
health information by limiting their use and disclosure of health
information to the minimum level reasonably necessary to accomplish
the intended purpose and apply to our operations globally. If we
were to be found to be in violation of the privacy or security
rules under PIPEDA or other applicable laws and regulations
protecting the confidentiality of client health information in
jurisdictions we operate in, we could be subject to sanctions and
civil or criminal penalties, which could increase our liabilities,
harm our reputation and have a material adverse effect on our
business, results of operations and financial
condition.
The jurisdictions in which we operate or which we may enter also
have data privacy and security laws and regulations that govern the
collection, use, disclosure, transfer, storage, disposal, and
protection of personal information (such as the California
Consumer Privacy Act (the “CCPA”) in California). In Canada, we may
be required to retain certain customer personal information for
prescribed periods of time pursuant to the Cannabis
Act.
Additionally, several states, including California, Colorado, and
Virginia, have passed laws and regulations, modeled on the E.U.
GDPR, that will significantly impact data privacy and security
requirements in the U.S.
The California Privacy Rights Act (“CPRA”) imposes broad new
requirements on companies covered
by the legislation. Under the CPRA, California consumers (i.e.,
California residents) will have new and expanded rights, and
businesses covered by the CPRA must disclose these rights to them.
These new rights include, but are not limited to, a right of
correction (i.e., the right to request that a business correct any
inaccurate personal information about them), a right to limit the
use and disclosure of “Sensitive Information” (a new category of
personal information defined by the CPRA), a right to access
information about automatic decision making used by the business,
and a right to data portability (i.e., that a business transfer
their personal information to another entity to the extent
technically feasible). Enhanced rights for California consumers
under the CPRA include, but are not limited to, expanded rights to
know and access their personal information, expanded rights to
delete their personal information, and an explicit requirement that
California consumers have the right to opt-out of the sharing, in
addition to the selling, of their personal information. Separately,
the CPRA will codify the following GDPR-inspired requirements: (i)
data minimization or the requirement that personal information
collected by businesses be reasonably necessary and proportionate
to achieve the purpose for which the personal information was
collected, (ii) purpose limitation or the requirement that
businesses only collect personal information for specific,
explicit, and legitimate disclosed purposes that are disclosed in
advance to California consumers, (iii) data retention limitations
for personal information predicated on the length of time the
business intends to retain each category of personal information,
and (iv) reasonable data security requirements. Lastly, the CPRA
provides for an expanded private right of action in the context of
cybersecurity breaches and creates a designated privacy agency, the
California Privacy Protection Agency (“CPPA”), with authority to
implement and enforce the CCPA and CPRA.
While uncertain, the effects of the CCPA, the CPRA and other new
state laws and regulations, as well as analogous laws and
regulations in Canada (e.g., Bill 64 in Quebec), are potentially
significant and may require us to modify our data collection
or
processing practices and policies, incur substantial costs and
expenses to comply with these laws and regulations, and increase
our potential exposure to regulatory enforcement and/or
litigation.
The interpretation and enforcement of such laws and regulations are
uncertain and subject to change and may require substantial costs
to monitor and implement compliance. Failure to comply with data
privacy and protection laws and regulations could result in
government enforcement actions (which could include substantial
civil and/or criminal penalties), litigation, business disruption,
the diversion of management’s attention and/or adverse publicity
and could negatively affect our business, results of operations and
financial condition.
Our cannabis cultivation and U.S. hemp operations are subject to
risks inherent in an agricultural business.
Our business and that of our joint venture partners involves the
growing of cannabis, an agricultural product, in certain
jurisdictions where that activity is permitted. As such, the
business is subject to the risks inherent in the agricultural
business, such as insects, plant diseases and similar agricultural
risks that may create crop failures and supply interruptions for
our customers. Although our current operational production
facilities, and those of our joint venture partners, grow products
indoors (including in greenhouses) under climate-controlled
conditions and we and our joint venture partners carefully monitor
the growing conditions with trained personnel, there can be no
assurance that natural elements will not have a material adverse
effect on the production of our products. To the extent we rely on
third parties or our joint venture partners to grow cannabis that
we intend to commercialize, we are exposed to similar risks and
there can be no assurance that such risks will not have a similarly
material adverse effect on the production of our
products.
Our business also involves products containing U.S. hemp. U.S. hemp
is typically harvested in or around the month of October. U.S. hemp
plants can be vulnerable to various pathogens including bacteria,
fungi, viruses and other miscellaneous pathogens. Such instances
often lead to reduced crop quality, stunted growth and/or death of
the plant. Moreover, U.S. hemp is “phytoremediative” (meaning that
it may extract toxins or other undesirable chemicals or compounds
from the ground in which it is planted). Various regulatory
agencies have established maximum limits for pathogens, toxins,
chemicals and other compounds that may be present in agricultural
materials. If U.S. hemp used in our products is found to have
levels of pathogens, toxins, chemicals or other undesirable
compounds that exceed limits permitted by applicable law, it may
have to be destroyed. Should the U.S. hemp used in our products be
lost due to pathogens, toxins, chemicals or other undesirable
compounds, or if we or our suppliers are otherwise unable to obtain
U.S. hemp for use in our products on an ongoing basis, it may have
a material and adverse effect on our business, financial condition,
operating results, liquidity, cash flow and operational
performance.
The inability of our suppliers to meet their financial or
contractual obligations to us may result in disruption to our
supply chain and could result in financial losses.
We face exposure to our third party U.S. hemp and cannabis
suppliers that may face financial difficulties which would impact
our supply of U.S. hemp and cannabis products. For example, supply
chains throughout the world have been negatively impacted by
COVID-19 and this has increased the costs of products and shipping.
We have in the past, and may in the future, have disruptions in our
supply chain.
We rely on third party distributors to distribute our products, and
those distributors may not perform their obligations.
We rely on third party distributors and other courier services, and
may in the future rely on other third parties, to distribute our
products. If these distributors do not successfully carry out their
contractual obligations or terminate or suspend their contractual
arrangements with us, if there is a delay or interruption in the
distribution of our products or if these third parties damage our
products, it could negatively impact our revenue and may require
significant management attention. In addition, any damage to our
products due to acts or omissions of our third party distributors,
such as product spoilage or improper storage or handling, could
expose us to potential product liability, damage our reputation and
the reputation of our products or brands or otherwise harm our
business.
Risks Relating to Intellectual Property
We are subject to risks related to the protection and enforcement
of our intellectual property rights, and we may be unable to
protect or enforce our intellectual property rights.
The ownership and protection of our intellectual property rights is
a significant aspect of our future success. Currently we rely on
trade secrets, technical know-how, proprietary information,
trademarks, copyrights, designs and certain patent filings to
maintain our competitive position. We try to protect our
intellectual property by strategically seeking and obtaining
registered protection where appropriate, developing and
implementing standard operating procedures to protect trade
secrets, technical know-how and proprietary information, and
entering into agreements with parties that have access to our
inventions, trade secrets, technical know-how and proprietary
information, such as our partners, collaborators, employees and
consultants, to protect confidentiality and ownership. We also seek
to preserve the integrity and confidentiality of our inventions,
trade secrets, technical know-how and proprietary information by
maintaining physical security of our premises and physical and
electronic security of our information technology systems, and we
seek to protect our trademarks and the goodwill associated
therewith by monitoring and enforcing against unauthorized use of
our trademarks.
It is possible that we will inadvertently disclose or otherwise
fail or be unable to protect our inventions, trade secrets,
technical know-how or proprietary information, or will fail to
identify our inventions or trademarks as patentable or registrable
intellectual property, or fail to obtain patent or registered
trademark protection therefor. Any such disclosure or failure could
have a material adverse effect on our business.
We may be unable to protect our inventions, trade secrets, and
other intellectual property from discovery or unauthorized
use.
In relation to our agreements with parties that have access to our
intellectual property, any of these parties may breach their
obligations to us, and we may not have adequate remedies for such
breach. In relation to our security measures, such security
measures may be breached and we may not have adequate remedies for
such breach. In addition, our intellectual property that has not
yet been applied for or registered may otherwise become known to,
or be independently developed by, competitors, or may already be
the subject of applications for intellectual property registrations
filed by our competitors, which may have a material adverse effect
on our business, financial condition and results of
operations.
We cannot provide any assurances that our inventions, trade
secrets, technical know-how and other proprietary information will
not be disclosed in violation of agreements, or that competitors
will not otherwise gain access to our intellectual property or
independently develop and file applications for intellectual
property rights in a manner that adversely impacts our intellectual
property rights. Unauthorized parties may attempt to replicate or
otherwise obtain and use our inventions, trade secrets, technical
know-how and proprietary information. Policing the unauthorized use
of our current or future intellectual property rights is difficult,
expensive, time-consuming and unpredictable, as is enforcing these
rights against unauthorized use by others. Identifying unauthorized
use of intellectual property rights is difficult. For example, we
may be unable to effectively monitor and evaluate the products
being distributed by our competitors, including parties such as
unlicensed dispensaries, and the processes used to produce such
products. If the steps taken to identify and protect our trade
secrets are inadequate, we may be unable to enforce our rights in
them against third parties.
Our intellectual property rights may be invalid or unenforceable
under applicable laws, and we may be unable to have issued or
registered, and unable to enforce, our intellectual property
rights.
The laws regarding intellectual property rights relating to
cannabis and cannabis-related products, and the positions of
intellectual property offices administering such laws, are
constantly evolving, and there is uncertainty regarding which
countries will permit the filing, prosecution, issuance,
registration and enforcement of intellectual property rights
relating to cannabis and cannabis-related products.
Specifically, we have sought trademark protection in many
countries, including Canada, the U.S. and others. Our ability to
obtain registered trademark protection for cannabis and
cannabis-related goods and services (including U.S. hemp and U.S.
hemp-related goods and services) may be limited in certain
countries outside of Canada, including the U.S., where registered
federal trademark protection is currently unavailable for
trademarks covering the sale of U.S. Schedule I cannabis products
or certain goods containing U.S. hemp-derived CBD (such as dietary
supplements and foods) until the FDA provides clearer guidance on
the regulation of such products, and including Europe, where laws
on the legality of cannabis use are not uniform, and trademarks
cannot be obtained for products that are “contrary to public policy
or accepted principles of morality.” Accordingly, our ability to
obtain intellectual property rights or enforce intellectual
property rights against third party uses of similar trademarks may
be limited in certain countries.
Moreover, in any infringement proceeding, some or all of our
current or future trademarks, patents or other intellectual
property rights or other proprietary know-how, or arrangements or
agreements seeking to protect the same for our benefit, may be
found invalid, unenforceable, anti-competitive or not infringed. An
adverse result in any litigation or defense proceedings could put
one or more of our current or future trademarks, patents or other
intellectual property rights at risk of being invalidated or
interpreted narrowly and could put existing intellectual property
applications at risk of not being issued. Any or all of these
events could materially and adversely affect our business,
financial condition and results of operations.
There is no guarantee that any patent or other intellectual
property applications that we file will result in registration or
any enforceable intellectual property rights or the breadth of any
such protection. Further, with respect to any patent applications
that we file, there is no assurance that we will find all
potentially relevant prior art relating to such applications, which
may prevent a patent from issuing from such application or
invalidate any patent that issues from such application. Even if
patents do successfully issue, and cover our products and
processes, third parties may challenge their validity,
enforceability or scope, which may result in such patents being
narrowed, found unenforceable or invalidated. Even if they are
unchallenged, any patent applications and future patents may not
adequately protect our intellectual property rights, provide
exclusivity for our products or processes or prevent others from
designing around any issued patent claims. Any of these outcomes
could impair our ability to prevent competition from third parties,
which could materially and adversely affect our business, financial
condition and results of operations.
We may be subject to allegations that we are in violation of
third-party intellectual property rights, and we may be found to
infringe third-party intellectual property rights, possibly without
the ability to obtain licenses necessary to use such third party
intellectual property rights.
Other parties may claim that our products infringe on their
intellectual property rights, including with respect to patents,
and our operation of our business, including our development,
manufacture and sale of our goods and services, may be found to
infringe third party intellectual property rights. There may be
third party patents or patent applications with claims to products
or processes related to the manufacture, use or sale of our
products and processes. There may be currently pending patent
applications, some of which may still be confidential, that may
later result in issued patents that our products or processes may
infringe. In addition, third parties may obtain patents in the
future and claim that use of our inventions, trade secrets,
technical know-how and proprietary information, or the manufacture,
use or sale of our products, infringes upon those patents. Third
parties may also claim that our use of our trademarks infringes
upon their trademark rights. Such claims, whether or not
meritorious, may result in the expenditure of significant financial
and managerial resources, legal fees, injunctions, temporary
restraining orders, other equitable relief, and/or require the
payment of damages, any or all of which may have an adverse impact
on our business, financial condition and results of operations. In
addition, we may need to obtain licenses from third parties who
allege that we have infringed on their purported rights, whether or
not such allegations have merit. Such licenses may not be available
on terms acceptable to us, and we may be unable to obtain any
licenses or other necessary or useful rights to such third-party
intellectual property.
Our germplasm relies heavily on intellectual property, and we may
be unable to protect, register or enforce our intellectual property
rights in germplasm, and may infringe third-party intellectual
property rights with respect to germplasm, possibly without the
ability to obtain licenses necessary to use such third-party
intellectual property rights.
Germplasm, including seeds, clones and cuttings, is the genetic
material used in new cannabis varieties and hybrids. We use
advanced breeding technologies to produce cannabis germplasm
(hybrids and varieties). We rely on parental varieties for the
success of our breeding program. Although we believe that the
parental germplasm is proprietary to us, we may need to obtain
licenses from third parties who may allege that we have
appropriated their germplasm or their rights to such germplasm,
whether or not such allegations have merit. Such licenses may not
be available on terms acceptable to us, and we may be unable to
obtain any licenses or other necessary or useful rights under third
party intellectual property. We may seek to protect our parental
germplasm, as appropriate, relying on intellectual property rights,
including rights related to inventions (patents and plant breeders’
rights), trade secrets, technical know-how, and proprietary
information. There is a risk that we will fail to protect such
germplasm or that we will fail to register rights in relation to
such germplasm.
We also seek to protect our parental germplasm, hybrids and
varieties from pests and diseases and enhance plant productivity
and fertility, and we research products to protect against crop
pests and fungus. There are several reasons why new product
concepts in these areas may be abandoned, including greater than
anticipated development costs, technical difficulties, regulatory
obstacles, competition, inability to prove the original concept,
lack of demand and the need to divert focus, from time to time, to
other initiatives. The processes of breeding, development and trait
integration are lengthy, and the germplasm we test may not be
selected for commercialization. The length of time and the risk
associated with breeding may affect our business. Our sales depend,
in part, on our germplasm. Commercial success frequently depends on
being the first company to the market, and many of our competitors
are also making considerable investments in similar new and
improved cannabis germplasm products. Consequently, there is no
assurance that we will successfully develop new cannabis germplasm
to the point of commercial viability in the markets we serve on a
timely basis.
Finally, we seek to protect our germplasm, hybrids and varieties
from accidental release, theft, misappropriation and sabotage by
maintaining physical security of our premises and through
contractual rights with our employees and certain of our suppliers,
independent contractors, consultants and licensees. However, such
security measures may be insufficient or breached, and our
employees, independent contractors, consultants and licensees may
engage in the inadvertent disclosure, theft, misappropriation or
sabotage. We may not have adequate remedies in the case of any such
security breach, inadvertent disclosure, theft, misappropriation or
sabotage.
We receive licenses to use some third-party intellectual property
rights; the failure of the owner of such intellectual property to
properly maintain or enforce the intellectual property underlying
such licenses, or our inability to obtain or maintain such
licenses, could have a material adverse effect on our business,
financial condition and performance.
We are party to licenses granted by third parties, including
through the Ginkgo Strategic Partnership, that give us rights to
use third party intellectual property that is necessary or useful
to our business. Our success will depend, in part, on the ability
of the applicable licensor to maintain and enforce its licensed
intellectual property against other third parties, particularly
intellectual property rights to which we have secured exclusive
rights. Without protection for the intellectual property we have
licensed, other companies might be able to offer substantially
similar products for sale or utilize substantially similar
processes or publicity and marketing rights, any of which could
have a material adverse effect on our business, financial condition
and results of operations. Our success will also depend, in part,
on our ability to obtain licenses to certain intellectual property
that we believe are necessary or useful for our business. Such
licenses may not be available on terms acceptable to us, or at all,
which could adversely affect our ability to commercialize our
products or services, as well as have a material adverse effect on
our business, financial condition and results of
operations.
Any of our licensors may allege that we have breached our license
agreements with those licensors, whether with or without merit, and
accordingly seek to terminate our applicable licenses. If
successful, this could result in our loss of the right to use
applicable licensed intellectual property, which could adversely
affect our ability to commercialize our products or services, as
well as have a material adverse effect on our business, financial
condition and results of operations.
The technologies, process and formulations we use may face
competition or become obsolete.
Rapidly changing markets, technology, emerging industry standards
and frequent introduction of new products characterize our
business. The introduction of new products embodying new
technologies, including new manufacturing processes or
formulations, and the emergence of new industry standards may
render our products obsolete, less competitive or less marketable.
The process of developing our products is complex and requires
significant continuing costs, development efforts and third-party
commitments, including licensees, researchers, and collaborators.
Our failure to develop new technologies and products and the
obsolescence of existing technologies or processes could adversely
affect our business, financial condition and results of operations.
We may be unable to anticipate changes in our potential customer
preferences or requirements that could make our existing
technology, processes or formulations obsolete. Our success will
depend, in part, on our ability to continue to enhance our existing
technologies, develop new technology that addresses the increasing
sophistication and varied views of the market, and respond to
technological advances and emerging industry standards and
practices on a timely and cost-effective basis. The development of
our proprietary technology, processes and formulations entails
significant technical and business risks. We may not be successful
in using our new technologies or exploiting our niche markets
effectively or adapting our business to evolving customer
requirements or preferences or emerging industry
standards.
Risks Relating to Entry into New Markets
Controlled substance and other legislation and treaties may
restrict or limit our ability to research, manufacture and develop
a commercial market for our products outside of the jurisdictions
in which we currently operate, and our expansion into such
jurisdictions is subject to risks.
Approximately 250 substances, including cannabis, are listed in the
Schedules annexed to the UN Single Convention on Narcotic Drugs
(New York, 1961), the Convention on Psychotropic Substances
(Vienna, 1971) and the Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances (introducing control on
precursors) (Vienna, 1988). The purpose of these listings is to
control and limit the use of these drugs according to a
classification of their therapeutic value, risk of abuse and health
dangers, and to minimize the diversion of precursor chemicals to
illegal drug manufacturers. The 1961 UN Single Convention on
Narcotic Drugs, as amended in 1972 classifies cannabis as a
Schedule I (“substances with addictive properties, presenting a
serious risk of abuse”) narcotic drug. In December 2020, the
Commission on Narcotic Drugs voted to remove cannabis from Schedule
IV (“the most dangerous substances, already listed in Schedule I,
which are particularly harmful and of extremely limited medical or
therapeutic value”). The 1971 UN Convention on Psychotropic
Substances classifies THC as a Schedule I psychotropic substance
(substances presenting a high risk of abuse, posing a particularly
serious threat to public health which are of very little or no
therapeutic value). Many countries are parties to these
conventions, which govern international trade and domestic control
of these substances, including cannabis. They may interpret and
implement their obligations in a way that creates legal obstacles
to our obtaining manufacturing and/or marketing approval for our
products in those countries. These countries may not be willing or
able to amend or otherwise modify their laws and regulations to
permit our products to be manufactured and/or marketed, and
achieving such amendments to the laws and regulations may take a
prolonged period of time. There can be no assurance that any market
for our products will develop in any jurisdiction in which we do
not currently have operations. We may face new or unexpected risks
or significantly increase our exposure to one or more existing risk
factors, including economic instability, political instability,
changes in laws and regulations and the effects of competition.
These factors may limit our capability to successfully expand our
operations into such jurisdictions and may have a material adverse
effect on our business, financial condition and results of
operations.
Investments and joint ventures outside of Canada and the U.S. are
subject to the risks normally associated with any conduct of
business in foreign countries, including varying degrees of
political, legal, regulatory and economic risk.
Much of our exposure to markets in jurisdictions outside of Canada
and the U.S. is through investments and joint ventures. These
investments and joint ventures are subject to the risks normally
associated with any conduct of business in foreign and/or emerging
countries including political risks; civil disturbance risks;
changes in laws, regulations or policies of particular countries,
including those relating to royalties, duties, imports, exports and
currency; the cancellation or renegotiation of contracts; the
imposition of royalties, net profits payments, tax increases or
other claims by government entities, including retroactive claims;
a disregard for due process and the rule of law by local courts;
the risk of expropriation and nationalization; delays in obtaining
or the inability to obtain necessary governmental permits or the
reimbursement of refundable tax from fiscal
authorities.
Threats or instability in a country caused by political events
including elections, change in government, changes in personnel or
legislative bodies, foreign relations or military control present
serious political and social risk and instability causing
interruptions to the flow of business negotiations and influencing
relationships with government officials. Changes in policy or law
may have a material adverse effect on our business, financial
condition and results of operations. The risks include increased
“unpaid” state participation, higher energy costs, higher taxation
levels and potential expropriation.
Other risks include the potential for fraud and corruption by
suppliers or personnel or government officials which may implicate
us, compliance with applicable anti-corruption laws and
regulations, including the U.S. Foreign Corrupt Practices Act and
the Corruption of Foreign Public Officials Act (Canada), by virtue
of our or our joint ventures operating in jurisdictions that may be
vulnerable to the possibility of bribery, collusion, kickbacks,
theft, improper commissions, facilitation payments, conflicts of
interest and related party transactions and our or our joint
ventures’ possible failure to identify, manage and mitigate
instances of fraud, corruption or violations of our Code of
Business Conduct and Ethics and applicable regulatory
requirements.
There is also the risk of increased disclosure requirements;
currency fluctuations; restrictions on the ability of local
operating companies to hold Canadian dollars, U.S. dollars or other
foreign currencies in offshore bank accounts; import and export
restrictions; increased regulatory requirements and restrictions;
increased health-related regulations; limitations on the
repatriation of earnings or on our ability to assist in minimizing
our expatriate workforce’s exposure to double taxation in both the
home and host jurisdictions; and increased financing
costs.
These risks may limit or disrupt our joint ventures, strategic
alliances or investments, restrict the movement of funds, cause us
to have to expend more funds than previously expected or required
or result in the deprivation of contract rights or the taking of
property by nationalization or expropriation without fair
compensation, and may materially adversely affect our business,
financial position and/or results of operations. In addition, the
enforcement by us of our legal rights in foreign countries,
including rights to exploit our properties or utilize our permits
and licenses and contractual rights may not be recognized by the
court systems in such foreign countries or enforced in accordance
with the rule of law.
We currently do, and may in the future, invest in companies, or
engage in joint ventures, in countries with developing economies.
It is difficult to predict the future political, social and
economic direction of the countries in which we or our joint
ventures operate, and the impact government decisions may have on
our business. Any political or economic instability in the
countries in which we operate could have a material and adverse
effect on our business, financial condition and results of
operations.
Risks Relating to Regulation and Compliance
We operate in highly regulated sectors where the regulatory
environment is rapidly developing, and we may not always succeed in
complying fully with applicable regulatory requirements in all
jurisdictions where we carry on business.
Our business and activities are heavily regulated in all
jurisdictions where we carry on business. Our operations are
subject to various laws, regulations and guidelines by governmental
authorities (including, in Canada, Health Canada and other federal,
provincial and local regulatory agencies and, in the U.S., the FDA,
the USDA, CDPH, DEA, PTO and FTC and other federal and state
agencies) relating to the cultivation, manufacture, processing,
marketing, labeling, packaging, management, transportation,
distribution, import, export, storage, sale, pricing and disposal
of cannabis and U.S. hemp, and also including laws, regulations and
guidelines relating to health and safety, insurance coverage, the
conduct of operations and the protection of the environment
(including relating to emissions and discharges to water, air and
land, and the handling and disposal of hazardous and non-hazardous
materials and wastes). Our operations may also be affected in
varying degrees by government regulations with respect to, among
other things, price controls, import or export controls, controls
on currency remittance, increased income taxes, restrictions on
foreign investment and government policies rewarding contracts to
local competitors or requiring domestic producers or vendors to
purchase supplies from a particular jurisdiction. Laws, regulations
and guidelines, applied generally, grant government agencies and
self-regulatory bodies broad administrative discretion over our
activities, including the power to limit or restrict business
activities as well as impose additional disclosure requirements on
our products and services, as well as on our personnel (including
management and our board of directors).
Achievement of our business objectives is contingent, in part, upon
compliance with regulatory requirements enacted by these
governmental authorities and obtaining all necessary regulatory
approvals for the cultivation, production, processing storage,
transportation, distribution, sale, import and export, as
applicable, of our products. The cannabis and U.S. hemp industries
are still new, and in Canada in particular, the Cannabis Act is a
new regime that has no close precedent in Canadian law. Similarly,
the
regulatory regimes in the jurisdictions in which we and our joint
ventures operate outside of the U.S. and Canada are new and are
still being developed without close precedent in such
jurisdictions. The effect of relevant governmental authorities’
administration, application and enforcement of their respective
regulatory regimes and delays in obtaining, or failure to obtain,
necessary regulatory approvals may significantly delay or impact
the development of markets, products and sales initiatives and
could have a material adverse effect on our business, financial
condition and results of operations.
The regulatory environment for our products is rapidly developing,
and the need to build and maintain robust systems to comply with
different and changing regulations in multiple jurisdictions
increases the possibility that we may violate one or more
applicable requirements. While we endeavor to comply with all
relevant laws, regulations and guidelines, any failure to comply
with the regulatory requirements applicable to our operations could
subject us to negative consequences, including, but not limited to,
civil and criminal penalties, damages, fines, the curtailment or
restructuring of our operations, asset seizures, revocation or
imposition of additional conditions on licenses to operate our
business, the denial of regulatory applications (including, in the
U.S., by other regulatory regimes that rely on the positions of the
DEA and FDA in the application of their respective regimes), the
suspension or expulsion from a particular market or jurisdiction of
our key personnel, or the imposition of additional or more
stringent inspection, testing and reporting requirements, any of
which could materially adversely affect our business, financial
condition and results of operations. Additionally, scheduled or
unscheduled inspections of our facilities or facilities of our
joint ventures or third-party suppliers by applicable regulatory
agencies could result in adverse findings that could require
significant remediation efforts and/or temporary or permanent
shutdown of our facilities or those of our joint ventures or
third-party suppliers. In the U.S., failure to comply with FDA
requirements (and analogous state agencies) may result in, among
other things, injunctions, product withdrawals, recalls, product
seizures, fines and criminal prosecutions. The outcome of any
regulatory or agency proceedings, investigations, inspections,
audits, and other contingencies could harm our reputation, require
us to take, or refrain from taking, actions that could harm our
operations or require us to pay substantial amounts of money,
harming our results of operations, financial condition and cash
flows. There can be no assurance that any pending or future
regulatory or agency proceedings, investigations, inspections and
audits will not result in substantial costs or a diversion of
management’s attention and resources, negatively impact our future
growth plans and opportunities or have a material adverse impact on
our business, financial condition and results of
operations.
If the Company’s U.S. hemp business activities are found to be in
violation of any of U.S. federal, state or local laws or any other
governmental regulations, in addition to the items described
above:
•the
Company may be subject to “Warning Letters,” fines, penalties,
administrative sanctions, settlements, injunctions, product recalls
and/or other enforcement actions arising from civil, administrative
or other proceedings initiated that could adversely affect the
Company’s business, financial condition, operating results,
liquidity, cash flow and operational performance;
•the
profits or revenues derived therefrom could be subject to
anti-money laundering statutes, including the Money Laundering
Control Act, which could result in significant disruption to our
U.S. hemp business operations and involve significant costs,
expenses or other penalties; and
•the
Company’s suppliers, service providers and distributors may elect,
at any time, to breach, terminate or otherwise cease to participate
in supply, service or distribution agreements, or other
relationships, on which the Company’s operations rely.
As it relates to U.S. Schedule I cannabis, in the U.S., despite
cannabis possession and use having been legalized at the state
level for medical use in many states and for adult-use in a number
of states, marijuana as defined by the CSA continues to be
categorized as a Schedule I controlled substance under the CSA and
subject to the Controlled Substances Import and Export Act
(“CSIEA”). Although we do not engage in any activities related to
marijuana as defined by the CSA in the U.S., violations of any U.S.
federal laws and regulations, including the CSA and the CSIEA,
whether intentional or inadvertent, could result in civil, criminal
and/or administrative enforcement actions, which could result in
fines, penalties, and other sanctions, including but not limited
to, cessation of business activities. Additionally, U.S. border
officials could deny entry into the U.S. to those employed at or
investing in legal and licensed non-U.S. cannabis companies and
such persons could face detention, denial of entry or lifetime bans
from the U.S. for their business associations with cannabis
businesses.
We and our joint ventures and strategic investments are reliant on
required licenses, authorizations, approvals and permits for our
ability to grow, process, store and sell cannabis, U.S. hemp and
cannabinoids which are subject to ongoing compliance, reporting and
renewal requirements, and we may also be required to obtain
additional licenses, authorizations, approvals and permits in
connection with our business.
Our ability to grow, process, store and sell cannabis in Canada is
dependent on our licenses from Health Canada, and in particular the
licenses currently held by Peace Naturals, Cronos Fermentation and
Cronos GrowCo. Failure to comply with the requirements of the
licenses or failure to maintain the licenses would have a material
adverse impact on our business, financial condition and results of
operations. Although we believe Peace Naturals, Cronos Fermentation
and Cronos GrowCo will meet the requirements of the Cannabis Act
for their licenses, there can be no guarantee that Health Canada
will extend or renew the licenses or, if they are extended or
renewed, that they will be extended or renewed on the same or
similar terms or that Health Canada will not revoke the licenses.
Should we fail to comply with requirements of the licenses, should
Health Canada not extend or renew the licenses, should they be
renewed on different terms (including not allowing for anticipated
capacity increases) or should the licenses be revoked or suspended,
our business, financial condition and results of the operations
will be materially adversely affected. To the extent we apply for
any additional licenses from Health Canada, there can be no
assurance that such licenses will be granted or, if granted, that
they will be granted on commercially reasonable terms or within the
time period we expect, which could have a material adverse effect
on our business, financial condition and results of
operations.
Our ability to grow, process, store and sell cannabis in Israel is
dependent on maintaining our cannabis cultivation, production and
distribution licenses and our ability to export products to, or
import products from, Cronos Israel is also dependent on obtaining
the relevant permits. Cronos GrowCo’s ability to grow, process,
store and sell cannabis at its production facility depends on
obtaining and maintaining the appropriate licenses from Health
Canada. Should we or our joint ventures fail to comply with the
requirements of the licenses, or should they not be extended or
renewed by the applicable regulatory authorities, or should they be
renewed on different terms (including not allowing for anticipated
capacity increases) or should the licenses be revoked, the
business, financial condition and results of our and our joint
ventures’ operations will be materially adversely affected. There
is no assurance that we or our joint ventures will be able to
obtain necessary permits or licenses on commercially reasonable
terms or within expected time periods, if at all. Moreover, the
change in the nature of operations at the Peace Naturals Campus
will increase the importance of the licenses of Cronos GrowCo for
our business and operations.
In addition, Ginkgo’s ability to conduct certain R&D activities
in the U.S. under the Ginkgo Collaboration Agreement is conditional
on Ginkgo continuing to maintain all necessary licenses, permits
and approvals required for Ginkgo to perform such R&D
activities. There are no assurances that Ginkgo will be able to
maintain required licenses, permits and approvals and, to the
extent such licenses, permits and approvals are not maintained, we
may not realize the expected benefits of the Ginkgo Strategic
Partnership.
We have obtained a processed food registration from CDPH and may
also be required to obtain and maintain certain permits, licenses
and approvals in the jurisdictions where we source, process, or
sell products derived from U.S. hemp. We may be unable to obtain or
maintain any necessary licenses, permits or approvals. Additional
government licenses are currently, and in the future, may be,
required in connection with our operations, in addition to other
unknown permits and approvals which may be required. To the extent
such permits, and approvals are required and not obtained, we may
be prevented from operating and/or expanding our business, which
could have a material adverse effect on our business, financial
condition and results of operations.
Changes in the laws, regulations and guidelines governing cannabis
and U.S. hemp may adversely impact our business.
Our current operations are subject to various laws, regulations and
guidelines promulgated by governmental authorities (including, in
Canada, Health Canada and other federal, provincial and local
regulatory agencies and, in the U.S., the FDA, the USDA, CDPH, DEA,
FTC and PTO and other federal and state agencies) relating to the
cultivation, processing, marketing, acquisition, manufacture,
packaging/labeling, management, transportation, distribution,
import, export, storage, sale and disposal of cannabis or U.S. hemp
but also including laws and regulations relating to health and
safety, the conduct of operations and the protection of the
environment. Additionally, our growth strategy continues to evolve
as regulations governing the cannabis industry in the jurisdictions
other than Canada and the U.S. in which we and our joint ventures
operate become more fully developed. Interpretation of these laws,
rules and regulations and their application to our operations and
those of our joint ventures is ongoing. No assurance can be given
that new laws, regulations and guidelines will not be enacted or
that existing laws, regulations and guidelines will not be amended,
repealed or interpreted or applied in a manner which could require
extensive changes to our operations, increase compliance costs,
give rise to material liabilities or a revocation of our licenses
and other permits, restrict the growth opportunities that we
currently anticipate or otherwise limit or curtail our operations.
For example, the Cannabis Act requires the Canadian federal
government to conduct a review of the Cannabis Act after three
years, which commenced in September 2022. The scope of this
statutory review includes, among other things, consideration of (i)
the administration and operation of the Cannabis Act, (ii) the
impact of the Cannabis Act on public health, (iii) the health and
consumption habits of young persons, (iv) the impact of cannabis on
Indigenous persons and communities and (v) the impact of
cultivation of cannabis plants in a dwelling-house. This report
resulting from the statutory review may recommend and/or lead to
the amendment, removal or addition of provisions in or to the
Cannabis Act which could adversely affect our business. Amendments
to current laws, regulations and guidelines governing the
production, sale and use of cannabis and cannabis-based products,
more stringent implementation or enforcement thereof or other
unanticipated events, including changes in political regimes or
political instability, currency controls, fluctuations in currency
exchange rates and rates of inflation, labor unrest, changes in
taxation laws, regulations and policies, restrictions on foreign
exchange and repatriation, governmental regulations relating to
foreign investment and the cannabis business more generally, and
changes in attitudes toward cannabis, are beyond our control and
could require extensive changes to our operations, which in turn
may result in a material adverse effect on our business, financial
condition and results of operations.
While the production of cannabis in Canada, among other things, is
under the regulatory oversight of the federal government of Canada,
the distribution and retail sale of adult-use cannabis in Canada
falls within the jurisdiction of the provincial and territorial
governments. The impact of the legislation regulating adult-use
cannabis passed in the provinces and territories on the cannabis
industry and our business plans and operations is uncertain.
Provinces and territories have announced certain restrictions that
are more stringent than the federal rules or regulations such as
retail sale and marketing restrictions, bans on certain types of
cannabis products, raising minimum age of purchase and flavor
restrictions. For example, Québec and Prince Edward Island do not
currently permit sales of cannabis vaporizers, and Québec limits
the sale of other high THC non-edible cannabis products. In
addition, the distribution and retail channels and applicable rules
and regulations in the provinces continue to evolve, and our
ability to distribute and retail cannabis products in Canada is
dependent on the ability of the provinces and territories of Canada
to establish licensed retail networks and outlets. There is no
guarantee that the applicable legislation regulating the
distribution and sale of cannabis for adult-use purposes will allow
for the growth opportunities we currently anticipate and may result
in a material adverse effect on our business, financial condition
and results of operations.
Furthermore, additional countries continue to pass laws with
respect to the production and distribution of cannabis in some form
or another. We have subsidiaries, investments, joint ventures and
strategic alliances in place outside of the U.S. and Canada, which
may be affected if more countries legalize cannabis. Increased
international competition and limitations placed on us by Canadian
regulations might lower the demand for our products on a global
scale. We also face competition in each jurisdiction outside of the
U.S. and Canada where we have subsidiaries, investments, joint
ventures and strategic alliances with local companies that have
more experience, more in-depth knowledge of local markets or
applicable laws, regulations and guidelines or longer operating
histories in such jurisdictions.
We are subject to certain restrictions of the TSX and Nasdaq, which
may constrain our ability to expand our business
internationally.
Our common shares are listed on the TSX and Nasdaq. We must comply
with the TSX and Nasdaq requirements or guidelines when conducting
business.
On October 16, 2017, the TSX provided clarity regarding the
application of Section 306 (Minimum Listing Requirements), Section
325 (Management) and Part VII (Halting of Trading, Suspension and
Delisting of Securities) of the TSX Company Manual (collectively,
the “Requirements”) to TSX-listed issuers with business activities
in the cannabis sector. In TSX Staff Notice 2017- 0009, the TSX
notes that issuers with ongoing business activities that violate
U.S. federal law regarding U.S. Schedule I cannabis are not in
compliance with the Requirements. The TSX reminded issuers that,
among other things, should the TSX find that a listed issuer is
engaging in activities contrary to the Requirements, the TSX has
the discretion to initiate a delisting review. Although we do not
conduct any operations in the U.S. with respect to U.S. Schedule I
cannabis, failure to comply with the Requirements could result in a
delisting of our common shares from the TSX or the denial of an
application for certain approvals, such as to have additional
securities listed on the TSX, which could have a material adverse
effect on the trading price of our common shares and have a
material adverse effect on our business, financial condition and
results of operations.
While Nasdaq has not issued official rules specific to the cannabis
or U.S. hemp industry, stock exchanges in the U.S., including
Nasdaq, have historically refused to list certain U.S. Schedule I
cannabis related businesses, including U.S. Schedule I cannabis
retailers, that operate primarily in the U.S. Failure to comply
with any requirements imposed by Nasdaq could result in the
delisting of our common shares from Nasdaq or denial of any
application to have additional securities listed on Nasdaq which
could have a material adverse effect on the trading price of our
common shares.
We are constrained by law in our ability to market and advertise
our products.
Our marketing and advertising are subject to regulation by various
regulatory bodies in the jurisdictions we operate. In Canada, the
development of our business and related results of operations may
be hindered by applicable regulatory restrictions on sales and
marketing activities. For example, the regulatory environment in
Canada limits our ability to compete for market share in a manner
similar to other industries. Furthermore, the applicable regulatory
restrictions on sales and marketing activities are not always
clear, may be subject to interpretation and have in the past, and
may in the future, be interpreted or applied inconsistently by the
applicable Canadian regulatory agencies, which have broad
interpretative and enforcement discretion with respect to such
activities. This may result in such restrictions on sales and
marketing activities being interpreted unfavorably by a regulatory
agency against some market participants, including us, but not
others. Furthermore, if our competitors fail to comply with
applicable laws relating to sales and marketing activities with
which we comply, and regulatory agencies delay or do not take
enforcement action against such competitors, or take sporadic
enforcement action, our ability to compete for market share and our
sales and results of operations could be adversely affected. If we
are unable to effectively market our products and compete for
market share in Canada, or if the costs of compliance with
government legislation and regulation cannot be absorbed through
increased selling prices for our products, our sales and results of
operations could be adversely affected. See “Business
–Regulatory Framework in Canada.”
In the U.S., our advertising is subject to regulation by the FTC
under the Federal Trade Commission Act
as well as the FDA under the FFDCA, including as amended by the
Dietary Supplement Health and Education Act of 1994, and by state
agencies under analogous and similar state and local laws and
regulations. In recent years, the FTC, the FDA and state agencies
have initiated numerous investigations of food and dietary
supplement products both because of their CBD and/or cannabinoid
content and based on allegedly deceptive or misleading marketing
claims and have, on occasion, issued “Warning Letters” or
instituted enforcement actions due to such claims. Some U.S. states
also permit content, advertising and labeling laws and regulations
to be enforced by state attorneys general, who may seek civil and
criminal penalties, relief for consumers, class action
certifications, class wide damages and recalls of products sold by
us. There has also been an increase in private litigation that
seeks, among other things, relief for consumers, class action
certifications, class wide damages and recalls of products. We have
been subject to such litigation and may be subject to additional
private class action litigation. Any actions against us by
governmental authorities or private litigants could have a material
and adverse effect on our business, financial condition, operating
results, liquidity, cash flow and operational
performance.
Risks Related to U.S. Regulation and Compliance
We are subject to uncertainty regarding the legal and regulatory
status of U.S. hemp, including with respect to U.S. federal and
state implementation of the 2018 Farm Bill and related laws and
regulations, including the FFDCA, and the interpretation or
application of, or changes to, such laws and regulations may have
material and adverse effects on our business, financial condition,
operating results, liquidity, cash flow and operational
performance.
On December 20, 2018, the 2018 Farm Bill was signed into law. The
2018 Farm Bill, among other things, removes “hemp” (which we refer
to as “U.S. hemp” in this Annual Report, defined as the plant
Cannabis sativa L. and any part of that plant, including the seeds
thereof and all derivatives, extracts, cannabinoids, isomers,
acids, salts, and salts of isomers, whether growing or not, with a
THC concentration of not more than 0.3% on a dry weight basis and
its derivatives) from the U.S. federal Controlled Substances Act
and amends the Agricultural Marketing Act of 1946 to permit the
production and sale of U.S. hemp in the U.S. The 2018 Farm Bill
tasked the USDA with promulgating regulations in relation to the
cultivation and production of U.S. hemp. The 2018 Farm Bill also
directed the USDA to promulgate federal regulations that would
apply to the production of U.S. hemp in every state which does not
put forth a state U.S. hemp plan for approval by the USDA, for
which the USDA has issued final rules. Beginning in January 2024,
the USDA will require hemp producers to use a laboratory that is
registered with the DEA for analytical testing of hemp plants. The
USDA rules also include provisions for producers to dispose of or
remediate violative hemp plants without the use of a DEA-registered
reverse distributor or law enforcement. Various states have applied
and are in the process of applying to the USDA for approval of
their U.S. hemp production regulations which impose different
levels of regulation and costs on the production of U.S. hemp, and
many such state plans have been approved by the USDA. The 2018 Farm
Bill provides that its provisions do not preempt or limit state
laws that regulate the production of U.S. hemp. Accordingly, some
states may choose to restrict or prohibit some or all U.S. hemp
production or sales within the state, and variances in states’ laws
and regulations on U.S. hemp are likely to persist. Further, each
state has discretion to develop and implement its own laws and
regulations governing the manufacturing, marketing, labeling, and
sale of U.S. hemp products, which has created a patchwork of
different regulatory schemes applicable to such
products.
The FDA or particular states may ultimately prohibit the sale of
some or all dietary supplements or conventional foods containing
U.S. hemp and U.S. hemp-derived ingredients, including CBD and
other cannabinoids, and we may be required to submit a New Dietary
Ingredient notification to the FDA, which may not be accepted
without objection.
Under the 2018 Farm Bill, the FDA has retained authority over the
FFDCA-regulated products (e.g., drugs (human and animal), food
(human and animal), dietary supplements and cosmetics) containing
U.S. hemp and U.S. hemp-derived ingredients, including CBD. The FDA
has consistently taken the position that CBD, whether derived from
U.S. hemp or U.S. Schedule I cannabis, is prohibited from use as an
ingredient in food and dietary supplements. This stems from its
interpretation of the exclusionary clauses in the FFDCA because CBD
is the active ingredient in a drug that has been approved as a
prescription drug and is the subject of substantial clinical
investigations as a drug, which have been made public. The
exclusionary clauses under the FFDCA provide that a substance that
has been approved or has been subject to substantial clinical
investigations as a drug may not be used in a food or dietary
supplement, unless the substance was first marketed in a food or
dietary supplement prior to the initiation of substantial clinical
investigations of the substance as a drug.
To date, the FDA has not issued regulations that elaborate on the
exclusionary clauses, and the FDA has not taken any enforcement
action in the courts asserting a violation of the exclusionary
clauses due to the marketing of U.S. hemp, U.S. hemp extracts, CBD
or other cannabinoids. Additionally, on January 26, 2023, the FDA
stated its views publicly that a new regulatory pathway for CBD is
needed and it is prepared to work with Congress to create such a
pathway. To date, the FDA has issued several “Warning Letters” to
companies unlawfully marketing CBD products. In many of these
cases, the manufacturer made unsubstantiated claims about the
product being able to treat medical conditions (e.g., cancer,
Alzheimer’s disease, opioid withdrawal, anxiety and COVID-19) and
had not obtained drug approvals. Some of these letters were
co-signed with the FTC and cited the companies for making claims
about the efficacy of CBD or other ingredients which were not
substantiated by competent and reliable scientific evidence. In
December 2020, the FTC announced it had entered into settlement
agreements with six companies marketing CBD products including
oils, gummies, creams, and others with deceptive health claims
about serious health conditions. The settlements included monetary
penalties ranging from $20,000 to $85,000. The FTC announced
another CBD enforcement action and settlement in May 2021, ordering
more than $30,000 in consumer redress. The FDA has also issued a
“Warning Letter” to at least one dietary supplement manufacturer
for a number of violations observed during an inspection, including
manufacturing CBD supplements in a licensed facility. In November
2022, the FDA issued “Warning Letters” to five additional companies
selling CBD-products in forms that the FDA asserted are appealing
to children, including gummies, hard candies and cookies. These
letters also outlined additional violations of the FFDCA including
that several of the companies made claims that CBD-containing
products cure, mitigate, treat or prevent various diseases or were
added to animal foods.
Until the FDA formally adopts regulations with respect to CBD or
other U.S. hemp-derived cannabinoid products or announces an
official position with respect to CBD or other U.S. hemp-derived
cannabinoid products, there is a risk that the FDA could take
enforcement action (e.g., a “Warning Letter,” seizure, or
injunction) against the Company in respect of its U.S. hemp-derived
products sold in the U.S.
Moreover, states have retained regulatory authority through their
own analogues to the FFDCA, and the states may diverge from the
federal treatment of the use of U.S. hemp as, or in, food, dietary
supplements or cosmetic products. The FDA or applicable states
(under their CSA or FFDCA analogues) may ultimately not permit the
sale of non-pharmaceutical products containing U.S. hemp-derived
ingredients, including CBD and other cannabinoids, which would have
a material adverse impact on our business, financial condition and
results of operations.
Even if the exclusionary clause issue discussed above is resolved
in a manner favorable to us, we could be required to submit a NDIN
to the FDA with respect to U.S. hemp-derived ingredients, including
CBD and other cannabinoids we intend to include in our products,
used in dietary supplement products. This could depend on whether
we can establish that a particular ingredient was marketed as a
dietary ingredient in a dietary supplement prior to October 15,
1994 or is otherwise currently in the food supply in the same
chemical form as used in our dietary supplement products. If the
FDA objects to our NDIN, this could prevent us from producing,
marketing and selling ingestible U.S. hemp products which would
have a material adverse impact on our business, financial condition
and results of operations. Such an NDIN submitted by one of our
competitors was objected to by the FDA in August 2021.
The FDA or particular U.S. states may seek to regulate our cosmetic
products containing U.S. hemp-derived ingredients, including CBD
and other cannabinoids, as drugs, medical devices, or drug-device
combination products.
The FDA may seek to regulate our cosmetic products containing U.S.
hemp-derived ingredients, including CBD and other cannabinoids,
under its authorities for medical products (i.e., drugs, medical
devices, or drug-device combination products). Specifically, the
agency could assert that our lotions, oils, balms and creams are
intended for use in diagnosing, treating, mitigating or preventing
disease or for use in affecting the structure or any function of
the body. In making classification decisions, the agency considers
a wide variety of factors to determine a product’s intended use;
indeed, the FDA has sometimes asserted that a product qualifies as
a drug based solely on the presence of an ingredient widely
understood to have drug effects, even in the absence of express
claims about them. Though we do not market our lotions, oils, balms
and creams as drugs for use in the treatment of diseases or their
symptoms, the FDA could still assert that the products are intended
for use as drugs, including based on the understood or presumed
physical effects of topically administered cannabinoids. Thus, we
may not have the ability to successfully respond to such
allegations simply by modifying labeling or advertising claims.
Ultimately, if the FDA asserts one of its medical product
authorities over our lotion, oil, balm and cream products, and we
cannot or elect not to comply with the onerous regulatory
requirements applicable to the asserted medical product category
(e.g., drug), we could be prevented from producing, marketing and
selling cosmetic products containing U.S. hemp-derived ingredients,
including CBD or other cannabinoids. In addition, states may
similarly seek to regulate our cosmetic products containing U.S.
hemp-derived ingredients, including CBD and other cannabinoids, as
medical products (i.e., drugs, medical devices, or drug-device
combination products) under state analogues to the FFDCA or
otherwise. States have also considered and established additional
restrictions on, or requirements for, the marketing of cosmetic
products containing U.S. hemp-derived ingredients. If states assert
their medical product authorities over our cosmetic products
containing U.S. hemp-derived ingredients, including CBD or other
cannabinoids, in a manner that we cannot address simply by
modifying labeling or advertising claims, and we cannot or elect
not to comply with the onerous regulatory requirements applicable
to the asserted medical product category (e.g., drug), we could be
prevented from producing, marketing and selling cosmetic products
containing U.S. hemp-derived ingredients, including CBD and other
cannabinoids. Likewise, if states enforce or adopt regulatory
interpretations or restrictions that limit our ability to market
our cosmetic products containing U.S. hemp-derived ingredients,
including CBD and other cannabinoids, in such states, it could
materially and adversely affect our business, financial condition,
operating results, liquidity, cash flow and operational
performance.
Recent U.S. legislation granting the FDA additional authority to
regulate cosmetics products imposes additional requirements
relating to the manufacture, labeling, safety reporting,
recordkeeping, and other aspects of cosmetics products.
Compliance with these additional requirements will be complex and
we may need significant additional resources to comply with these
new requirements.
On December 29, 2022, President Biden signed into law the
Modernization of Cosmetics Regulation Act of 2022, which
significantly expands FDA’s enforcement authorities over cosmetics
products and imposes new obligations on the cosmetics industry,
including requirements relating to GMP, labeling, safety
substantiation, facility registration and product listing with the
FDA, adverse event reporting and recordkeeping, among
others.
Under the new legislation, the FDA is required over the next
several years to issue additional regulations and reports to
clarify requirements. Most enforcement of requirements under the
new legislation will not go into effect until a year or later from
the date of enactment; however, we expect that regulation of our
cosmetic products in the U.S. will become increasingly complex, and
compliance with regulatory requirements may take significant
additional resources.
The DEA could take enforcement action against us or other
participants in the U.S. hemp industry.
There is substantial uncertainty concerning the legal status of
U.S. hemp and U.S. hemp products containing U.S. hemp-derived
ingredients, including CBD and other cannabinoids. The status of
products derived from the cannabis or hemp plant, under both
federal and state law can depend on the THC content of the plant or
derivative (including whether the plant meets the statutory
definition of “industrial hemp” or “hemp”), the part of the plant
from which an individual or entity produces the derivative
(including whether the plant meets the statutory definition of
“marihuana” under the CSA), the THC concentration during the
manufacturing process, whether the cultivator, processor,
manufacturer or product marketer engages in cannabis-related
activities for research versus purely commercial purposes, as well
as the form and intended use of the product. The mere presence of a
cannabinoid (such as CBD) is not dispositive as to whether the
product is legal or illegal. Under U.S. federal law, products
containing CBD may be unlawful if derived from U.S. Schedule I
cannabis (including hemp with a concentration greater than 0.3% THC
on a dry weight basis), or if derived from U.S. hemp grown outside
the parameters of an approved U.S. hemp pilot program or U.S. hemp
cultivated in violation of the 2018 Farm Bill. Even after enactment
of the 2018 Farm Bill, the DEA may not treat all products
containing U.S. hemp-derived ingredients, including CBD and other
cannabinoids, as exempt from the CSA. In September 2020, the DEA
issued an interim final rule that purported to align the DEA’s
regulations with the statutory changes to the CSA made effective by
the 2018 Farm Bill. The DEA received a number of comments objecting
to the interim final rule, and the interim final rule has been the
subject of litigation. However, the litigation was dismissed by the
D.C. Circuit Court in June 2022. If the DEA takes action against us
or other participants in the U.S. hemp industry, this could have a
material and adverse effect on our business, financial condition,
operating results, liquidity, cash flow and operational
performance.
There is continuing uncertainty regarding the FDA’s potential
position on CBG and other cannabinoids.
CBG is a cannabinoid that can be lawfully derived from U.S. hemp
and the Company has begun and plans to continue developing products
with CBG and other rare cannabinoids (i.e., cannabinoids other than
THC and CBD). The 2018 Farm Bill preserved the FDA’s authority over
U.S. hemp-derived consumer products and to date, the FDA has
provided no guidance as to how cannabinoids other than CBD will be
regulated under the FFDCA. Future regulatory changes or enforcement
actions by the FDA, with respect to CBG or other U.S. hemp-derived
cannabinoids, could have a materially adverse impact on our
business, financial condition, results of operations or
prospects.
Risks Relating to Competition
The markets in which we operate are increasingly competitive, and
we may compete for market share with other companies, both
domestically and internationally, that may have longer operating
histories and more financial resources, manufacturing and marketing
experience than us.
The markets for cannabis and U.S. hemp are competitive and evolving
and we face strong competition from both existing and emerging
companies that offer similar products. Some of our current and
potential competitors may have longer operating histories, greater
financial, marketing and other resources and larger customer bases
than we have. In addition, there is potential that the cannabis and
U.S. hemp industries will undergo consolidation, creating larger
companies with financial resources, manufacturing and marketing
capabilities and product offerings that are greater than ours. As a
result of this competition, we may be unable to maintain our
operations or develop them as currently proposed on terms we
consider acceptable, or at all. Increased competition by larger,
better-financed competitors with geographic advantages could
materially and adversely affect our business, financial condition
and results of operations.
Given the rapid changes affecting global, national and regional
economies generally, and the U.S. hemp industry in particular, we
may not be able to create and maintain a competitive advantage in
the marketplace. Our success will depend on our ability to respond
to, among other things, changes in the economy, regulatory
conditions, market conditions and competitive pressures. Any
failure by us to anticipate or respond adequately to such changes
could have a material and adverse effect on our business, financial
condition, operating results, liquidity, cash flow and operational
performance.
In Canada, the number of licenses granted by Health Canada could
also have an impact on our operations. We expect to face additional
competition from new market entrants that are granted licenses
under the Cannabis Act or existing license holders which are not
yet active in the industry. If a significant number of new licenses
are granted by Health Canada in the near term, we may experience
increased competition for market share and may experience downward
price pressure on our products as new entrants increase production.
If the number of users of cannabis in Canada increases, the demand
for products will increase and we expect that competition will
become more intense, as current and future competitors begin to
offer an increasing number of diversified products. To remain
competitive, we will require a continued high level of investment
in R&D, sales and customer support. We may not have sufficient
resources to maintain R&D, sales and customer support efforts
on a competitive basis which could have a material adverse effect
on our business, financial condition and results of operations.
Furthermore, the Canadian federal authorization of home
cultivation, outdoor grow, and the easing of other barriers to
entry to the Canadian adult-use cannabis market, could materially
and adversely affect our business, financial condition and results
of operations.
In the U.S., the number of competitors in the U.S. hemp industry
has increased significantly in recent years and is expected to
continue to increase, which could negatively impact our market
share and demand for our products. Additionally, if the U.S. takes
steps to legalize U.S. Schedule I cannabis, the impact of such a
development could result in new entrants into the market and
increased levels of competition.
We face competition from the illegal cannabis market.
We face competition from illegal market operators that are
unlicensed and unregulated. As these illegal market participants do
not comply with the regulations governing the cannabis industry,
their operations may also have significantly lower costs and they
may be able to sell products with significantly higher cannabinoid
potencies or which include ingredients that are prohibited by law.
The perpetuation of the illegal market for cannabis may have a
material adverse effect on our business, results of operations,
financial condition as well as the perception of cannabis
use.
We have been and may in the future be required to write down
inventory due to downward pressure on market prices, which could
have a material adverse effect on our results of operations or
financial position.
At the end of each reporting period, management performs an
assessment of inventory obsolescence, prices and demand to measure
inventory at the lower of cost and net realizable value. Net
realizable value is defined as the estimated selling price in the
ordinary course of business, less reasonably predictable costs of
completion, disposal and transportation. We also consider factors
such as slow-moving or non-marketable products in our determination
of obsolescence. As a result of this assessment, inventory
write-downs may occur from period to period. Due to continued
pricing pressures in the Canadian marketplace, we may incur further
inventory write-downs in the future.
We have had a series of inventory write-downs due to price
compression in the cannabis market. We expect these write-downs to
continue as pricing pressures remain elevated. These inventory
write-downs have in the past and may in the future materially
adversely affect our results of operations and financial
position.
We may be unable to attract or retain skilled labor and personnel
with experience in the cannabis or U.S. hemp sector and may be
unable to attract, develop and retain additional employees required
for our operations and future developments.
We may be unable to attract or retain employees with sufficient
experience in the cannabis or U.S. hemp industry, and may prove
unable to attract, develop and retain additional employees required
for our development and future success.
Our success is currently largely dependent on the performance of
our skilled employees. Our future success depends on our continuing
ability to attract, develop, motivate and retain highly qualified
and skilled employees. Qualified individuals are in high demand,
and we may incur significant costs to attract and retain them. In
2022, we announced a Realignment to, among other things, centralize
functions under common leadership to increase efficient
distribution of resources, optimize collaboration and strategic
alignment and eliminate duplication of roles and costs, including a
reduction in headcount impacting a number of employees. The
Realignment could lead to increased attrition amongst those
employees who were not directly affected by the reduction in
headcount, and we may not be successful at retaining such employees
or attracting new employees, which may have a material adverse
effect on our business, results of operations and financial
condition.
Further, certain shareholders, directors, officers and employees in
our Canadian operations may require security clearance from Health
Canada or require analogous clearance by various provincial
agencies. Under the Cannabis Act, a security clearance cannot be
valid for more than five years and must be renewed before the
expiry of a current security clearance. There is no assurance that
any of our existing personnel who presently or may in the future
require a security clearance will be able to obtain or renew such
clearances or that new personnel who require a security clearance
will be able to obtain one. A failure by any of our existing
personnel to maintain or renew his or her security clearance may
impair our business operations. In addition, if an employee with
security clearance leaves and we are unable to find a suitable
replacement who has a security clearance required by the Cannabis
Act in a timely manner, or at all, there could occur a material
adverse effect on our business operations. Similar risks and
potential effects apply to analogous security clearances required
by various provincial agencies.
Risks Relating to the Altria Investment
Altria has significant influence over us following closing of the
Altria Investment.
Altria is our single largest shareholder. As of December 31, 2022,
Altria beneficially owned approximately 41% of our issued and
outstanding common shares (calculated on a non-diluted basis). In
light of such ownership, Altria is in a position to exercise
significant influence over matters affecting shareholders or
requiring shareholder approval, including the election of the
Board, amendments to our articles and the determination of
significant corporate actions. In addition, pursuant to the
Investor Rights Agreement, Altria has certain rights, including the
right to nominate a specified number of directors to the Board,
approval rights over certain Company actions and pre-emptive and
top-up rights entitling Altria to maintain its pro rata beneficial
ownership in us. Further, as of the date hereof, four of the seven
directors on the Board are Altria Nominees. For more information,
see “Business
-Altria Strategic Investment – Investor Rights
Agreement.”
Accordingly, Altria currently has significant influence over us.
There can be no assurance that Altria’s interests will align with
our interests or the interests of other shareholders. In addition,
such influence could limit the price that an acquirer might be
willing to pay in the future for our common shares and it may have
the effect of delaying or preventing a change of control of us,
such as a merger or take-over.
We have discretion in the use of net proceeds from the Altria
Investment and may not use them effectively.
Under the Subscription Agreement, we have discretion in the use of
net proceeds from the Altria Investment, subject to our obligation
to consult with Altria, in certain circumstances, seek the approval
of Altria (such approval not to be unreasonably conditioned,
withheld or delayed) and certain other limitations regarding the
use of net proceeds set forth in the Subscription Agreement.
Accordingly, shareholders may not agree with the manner in which
management chooses to allocate and spend the net proceeds. Our
failure to apply the funds effectively could have a material
adverse effect on our business, financial condition and results of
operations.
We have cash on hand, including short-term investments, of
approximately $878 million as of December 31, 2022. There can
be no assurance that we will be able to deploy the available cash
in an effective manner that is accretive to us, or at all. Until
such time as we are able to deploy the cash available to us, we
anticipate holding the net proceeds as cash balances in our bank
accounts, investing in certificates of deposit and other
instruments issued by banks or obligations of or guaranteed by the
Government of Canada or any province thereof, or investing in U.S.
Treasury securities or other obligations issued or guaranteed by
the U.S. Government, its agencies or instrumentalities. Based on
the level of current interest rates, we will not earn any material
revenue from such invested cash.
We may not realize the benefits of our strategic partnership with
Altria, which could have an adverse effect on our business,
financial condition and results of operations.
We believe that the strategic partnership between us and Altria
provides us with additional financial resources, product
development and commercialization capabilities, and deep regulatory
expertise to better position us to compete, scale and lead the
rapidly growing global cannabis industry. We believe that the
growth opportunities for us are significant and could extend across
the globe as new markets open. With Altria’s resources, we expect
to be even better positioned to support cannabinoid innovation,
create differentiated products and brands across medical and
adult-use categories and expand our global footprint and growing
production capacity. Nevertheless, a number of risks and
uncertainties are associated with the expansion into such markets
and the pursuit of these other growth opportunities. The successful
implementation of the Altria Investment is critical to our growth
and capital position. The failure to successfully implement or reap
the anticipated benefits of Altria’s resources and expertise to
realize growth and expansion opportunities could have a material
adverse effect on our business, financial condition and results of
operations.
Altria’s significant interest in us may impact the liquidity of our
common shares.
Our common shares may be less liquid and trade at a discount
relative to the trading that could occur in circumstances where
Altria did not have the ability to significantly influence or
determine matters affecting us. Additionally, Altria’s significant
voting interest in us may discourage transactions involving a
change of control of us, including transactions in which an
investor, as a shareholder, might otherwise receive a premium for
its common shares over the then-current market price.
Future sales of our common shares by Altria could cause the market
price for our common shares to fall.
Sales of a substantial number of our common shares by Altria could
occur at any time. Such sales, or the market perception of such
sales, could significantly reduce the market price of our common
shares. We cannot predict the effect, if any, that future public
sales of our common shares beneficially owned by Altria or the
availability of these common shares for sale will have on the
market price of our common shares. If the market price of our
common shares were to drop as a result, this might impede our
ability to raise additional capital and might cause a significant
decline in the value of the investments of our other
shareholders.
The intentions of Altria regarding its long-term economic ownership
of our common shares are subject to change as a result of changes
in the circumstances of Altria or its affiliates, changes in our
management and operation and changes in laws and regulations,
market conditions and our financial performance.
Conflicts of interest may arise between us and our directors and
officers, including as a result of the continuing involvement of
certain of our directors with Altria and its
affiliates.
We may be subject to various potential conflicts of interest
because of the fact that some of our directors and officers may be
engaged in a range of business activities, or have relationships
with or are employed by Altria. One of our directors, Jason Adler,
is the co-founder and Managing Member of Gotham Green Partners, a
private equity firm focused primarily on early-stage investing in
companies in the cannabis industry, and Michael Gorenstein, our
Chairman, President, and Chief Executive Officer, is a co-founder
and non-managing Member of Gotham Green Partners. Three of our
directors, Jody Begley, Murray Garnick and Heather Newman, are
employed by Altria as Executive Vice President and Chief Operating
Officer, Executive Vice President and General Counsel, and Senior
Vice President, Corporate Strategy, respectively. As a result of
these relationships, conflicts of interests may arise between us
and them, as described below.
We may also become involved in other transactions that are
inconsistent or conflict with the interests of our directors and
officers, and/or our directors and officers may have interests in
persons, firms, institutions, corporations or transactions that are
inconsistent or in conflict with our interests and those of our
shareholders. In addition, from time to time, Gotham Green Partners
or Altria may be competing with us for available investment
opportunities. Conflicts of interest, if any, will be subject to
the procedures and remedies provided under applicable laws and
regulations. In particular, in the event that such a conflict of
interest arises at a meeting of our directors, a director who has
such a conflict will abstain from voting for or against the
approval of the transaction and may recuse himself or herself from
any related discussion or deliberation. In accordance with
applicable laws and regulations, our directors are required to act
honestly, in good faith and in our best interests.
Risks Relating to Our Common Shares
It is not anticipated that any dividend will be paid to holders of
our common shares for the foreseeable future.
No dividends on our common shares have been paid to date. We
currently intend to retain future earnings, if any, for future
operation and expansion. Any decision to declare and pay dividends
in the future will be made at the discretion of the Board and will
depend on, among other things, financial results, cash
requirements, contractual restrictions and other factors that the
Board may deem relevant. Any changes to our policy with respect to
the declaration and payment of any dividends requires Altria’s
approval. As a result, investors may not receive any return on an
investment in our common shares unless they sell their shares for a
price greater than that which such investors paid for
them.
The market price for our common shares may be volatile and subject
to fluctuation in response to numerous factors, many of which are
beyond our control.
The market price for our common shares may be volatile and subject
to wide fluctuations in response to many factors,
including:
•actual
or anticipated fluctuations in our results of
operations;
•changes
in estimates of our future results of operations by us or
securities research analysts;
•changes
in the economic performance or market valuations of other companies
that investors deem comparable to us;
•additions
or departures of our executive officers and other key
personnel;
•our
restating financial results twice in the last four
years;
•sales
of additional common shares or the perception in the market that
such sales might occur;
•significant
acquisitions or business combinations, strategic partnerships,
investments, joint ventures or capital commitments by or involving
us or our competitors;
•increases
in speculative trading activity by investors targeting publicly
traded cannabis companies, which can further contribute to the
volatility of the market price for our common shares if aggregate
short exposure exceeds the number of our common shares available
for purchase;
•news
reports relating to trends, concerns or competitive developments,
regulatory changes or enforcement actions and other related issues
in our industry or target markets;
•the
prospect of actual or perceived future changes to the legal and
regulatory regimes that govern our products and our
industries;
•investors’
general perception of us and the public’s reaction to our press
releases, our other public announcements and our filings with the
SEC and Canadian securities regulators;
•our
failure to timely file our public filings with the SEC and Canadian
securities regulators;
•our
failure to comply with the Nasdaq and TSX rules and potential
trading halts or delisting notices;
•reports
by industry analysts, investor perceptions, and market rumors or
speculation; and
•negative
announcements by our customers, competitors or suppliers regarding
their own performance.
For example, reports by industry analysts, investor perceptions,
market rumors or speculation could trigger a sell-off in our common
shares. Any sales of substantial numbers of our common shares in
the public market or the perception that such sales might occur may
cause the market price of our common shares to decline. In
addition, to the extent that other large companies within our
industries experience declines in their stock price, the price of
our common shares may decline as well. Moreover, if the market
price of our common shares drops significantly, shareholders may
institute securities class action lawsuits against us. Lawsuits
against us could cause us to incur substantial costs and could
divert the time and attention of our management and other
resources.
Securities markets continue to experience significant price and
volume fluctuations that have, in some cases, been unrelated to the
operating performance, underlying asset values or prospects of
public companies. Accordingly, the market price of our common
shares may decline even if our results of operations, underlying
asset values or prospects have not changed. In addition, certain
institutional investors may base their investment decisions on
consideration of our environmental, governance, diversity and
social practices and performance against such institutions’
respective investment guidelines and criteria, and failure to meet
such criteria may result in limited or no investment in our common
shares by those institutions, which could adversely affect the
trading price of our common shares. There can be no assurance that
continuing fluctuations in price and volume will not occur. If such
increased levels of volatility and market turmoil continue, the
trading price of the common shares may be adversely
affected.
Securities class action litigation often has been brought against
companies following periods of volatility in the market price of
their securities. We have been the target of such litigation and
may in the future be the target of similar litigation. Regardless
of merit, such litigation could result in substantial costs and
damages and divert management’s attention and resources, which
could adversely affect our business. Any adverse determination in
litigation against us could also subject us to significant
liabilities.
We may require additional capital in the future or be required to
issue common shares pursuant to certain of our agreements, which
may dilute holders of our securities.
We may be required to issue additional common shares pursuant to
the Ginkgo Collaboration Agreement. Pursuant to the Ginkgo
Collaboration Agreement, upon Ginkgo’s demonstration that the
microorganisms they develop are capable of producing certain target
cannabinoids above a minimum productivity level, we will issue to
Ginkgo up to approximately 14.7 million common shares in the
aggregate. To date, we have issued approximately 7.1 million
common shares to Ginkgo in respect of certain Equity Milestone
Events that have occurred. Additional tranches of common shares
will be issued if and when additional Equity Milestone Events are
reached. The issuance of such common shares, if any, would dilute
holders of our common shares. In addition, Altria has pre-emptive
rights to subscribe for additional common shares in us following
any issuances we make to Ginkgo pursuant to the Ginkgo
Collaboration Agreement, and the issuance of such common shares, if
any, would further dilute holders of our common
shares.
Holders of common shares will have no pre-emptive rights in
connection with such further issuances. Our Board has the
discretion to determine if an issuance of common shares is
warranted, the price at which such issuance is effected and the
other terms of issue of common shares. Any additional capital
raised through the sale of equity will dilute the percentage of
ownership of holders of our common shares. Capital raised through
debt financing would require us to make periodic interest payments
and may impose restrictive covenants on the conduct of our
business.
A substantial number of our securities are owned by a limited
number of existing shareholders.
Our management, directors and employees own a substantial number of
our outstanding common shares (on a fully diluted basis). In
addition, as of December 31, 2022, Altria beneficially owned
approximately 41% of our outstanding common shares (calculated on a
non-diluted basis). As such, our management, directors and
employees, as a group, and Altria each are in a position to
exercise significant influence over matters requiring shareholder
approval, including the election of directors and the determination
of significant corporate actions. In addition, these shareholders
could delay or prevent a change in control that could otherwise be
beneficial to holders of common shares.
Investors in the U.S. may have difficulty bringing actions and
enforcing judgments against us and others based on securities law
civil liability provisions.
We are incorporated under the laws of the Province of British
Columbia and our head office is located in the Province of Ontario.
Some of our directors and officers and some of the experts named in
this Annual Report are residents of Canada or otherwise reside
outside of the U.S., and a substantial portion of their assets and
our assets are located outside the U.S. Consequently, it may be
difficult for investors in the U.S. to bring an action against such
directors, officers or experts or to enforce against those persons
or us a judgment obtained in a U.S. court predicated upon the civil
liability provisions of U.S. federal securities laws or other laws
of the U.S. In addition, while statutory provisions exist in
British Columbia for derivative actions to be brought in certain
circumstances, the circumstances in which a derivative action may
be brought, and the procedures and defenses that may be available
in respect of any such action, may be different than those of
shareholders of a company incorporated in the U.S.
If we are a passive foreign investment company for U.S. federal
income tax purposes in any year, certain adverse tax rules could
apply to U.S. holders of our common shares.
We will be classified as a passive foreign investment company
(“PFIC”) for any taxable year for U.S. federal income tax purposes
if for a taxable year, (i) 75% or more of our gross income is
passive income, or (ii) 50% or more of the value of our assets
either produce passive income or are held for the production of
passive income, based on the quarterly average of the fair market
value of such assets. The determination of PFIC status depends on
interpretive rules and computational conventions that are often
unclear. In particular, in making our determination, we are relying
on the application of certain “look-through” rules, taking into
account certain intercompany items. There is, however, no direct
legal authority applying these look-through rules to our particular
situation (including to what extent, they apply to intercompany
items). Likewise, in light of the volatility of our common share
price, we intend to take the position that the spot trading price
of our stock at each quarter end, as adjusted by liabilities, does
not dictate the determination of the fair market value of our
assets. Based on current business plans and financial expectations,
an independent valuation report in respect of our assets, and the
application of certain look-through rules (including the taking
into account of certain intercompany items), we do not expect to be
a PFIC for the taxable year ending December 31, 2023. However, PFIC
status is determined annually and depends upon the composition of
our gross income and assets, both of which are subject to change.
Moreover, there can be no assurance that the Internal Revenue
Service (“IRS”) or a court will agree with our interpretation of
fair market value or its computation, or with our interpretation of
the PFIC rules (including the “look-through” rules and the scope of
their application, including in respect of intercompany items).
Therefore, there can be no assurance as to our PFIC status for the
current taxable year or for future taxable years, nor any assurance
that the IRS or a court will agree with our determination of our
PFIC status.
If securities or industry analysts do not publish research, or
publish inaccurate or unfavorable research about our business, our
share price and trading volume could decline.
The trading market for our common shares depends, in part, on the
research and reports that securities or industry analysts publish
about us or our business. If one or more of the analysts who cover
us downgrade our common shares or publish inaccurate or unfavorable
research about our business, the trading price of our common shares
would likely decline. In addition, if our results of operations
fail to meet the forecasts of analysts, the trading price of our
common shares would likely decline. If one or more of these
analysts cease coverage of us or fail to publish reports on us
regularly, demand for our common shares could decrease, which might
cause our trading price and trading volume to decline.
General Risks
We are dependent on our senior management.
Our success is dependent upon the ability, expertise, judgment,
discretion and good faith of our senior management. While
employment agreements are customarily used as a primary method of
retaining the services of key employees, these agreements cannot
assure the continued services of our senior management team.
Qualified individuals are in high demand, and we may incur
significant costs to attract and retain them. The loss of the
services of a member of senior management, or an inability to
attract other suitably qualified persons when needed, could have a
material adverse effect on our ability to execute on our business
plan and strategy, and we may be unable to find adequate
replacements on a timely basis, or at all. We do not maintain
key-person insurance on the lives of any of our officers or
employees.
We will seek to maintain adequate insurance coverage in respect of
the risks we face; however, insurance premiums for such insurance
may not continue to be commercially justifiable, and there may be
coverage limitations and other exclusions which may not be
sufficient to cover our potential liabilities.
We have insurance to protect our assets, operations and employees.
While we believe our insurance coverage addresses all material
risks to which we are exposed in our current state of operations,
such insurance is subject to deductibles, coverage limits and
exclusions and may not be available or adequate for the risks and
hazards to which we are exposed. For example, certain wholesalers,
distributors, retailers and other service providers may require
suppliers of U.S. hemp products to provide an indemnification from
liability in connection with such products, which may not be
covered by insurance. In addition, no assurance can be given that
such insurance will be adequate to cover our liabilities or will be
generally available in the future or, if available, that premiums
and deductibles will be commercially justifiable. If we were to
incur substantial liability claims and such damages were not
covered by insurance or were in excess of policy limits, or if we
were to incur such liability at a time when we are not able to
obtain liability insurance, there could be a material adverse
effect on our business, financial condition and results of
operations. Furthermore, our insurers have in the past and may in
the future deny us coverage, whether or not such denial is with
merit, and we have in the past and may in the future need to
commence litigation against such insurers, which could be time
consuming and expensive and divert significant management
resources, with no assurance that we will be successful in any
resulting proceedings.
Tax and accounting requirements may be interpreted or changed in
ways that are complex and not necessarily anticipated by us, and we
may face difficulty or be unable to implement and/or comply with
any such interpretations or changes.
We are subject to numerous tax and accounting requirements, and
changes in existing accounting or taxation rules or practices, or
varying interpretations of current rules or practices, could have a
significant adverse effect on our financial results, the manner in
which we conduct our business or the marketability of any of our
products. In many countries, including the U.S., we are subject to
transfer pricing and other tax regulations designed to ensure that
appropriate levels of income are reported as earned and are taxed
accordingly. Although we believe that we are in substantial
compliance with all applicable regulations and restrictions, we are
subject to the risk that governmental authorities could audit our
transfer pricing and related practices and assert that additional
taxes are owed or that various jurisdictions could assert that we
should file tax returns in jurisdictions where we do not file and
subject us to additional tax. In the future, the geographic scope
of our business may expand, and such expansion will require us to
comply with the tax laws and regulations of additional
jurisdictions. Requirements as to taxation vary substantially among
jurisdictions. Complying with the tax laws and regulations of these
jurisdictions can be time consuming and expensive and could
potentially subject us to penalties and fees in the future if we
failed to comply. In the event that we failed to comply with
applicable tax laws and regulations, this could have a material
adverse effect on our business, financial condition and results of
operations.
Our business and results of operations have been adversely affected
and will likely continue to be materially adversely impacted by the
coronavirus pandemic (COVID-19).
The COVID-19 pandemic has in the past, and could in the future,
severely restrict the level of economic activity around the world
and in all countries in which we or our affiliates, investments and
joint ventures operate (including the U.S., Canada, and Israel). In
response to the COVID-19 pandemic the governments of many
countries, states, provinces, municipalities, and other geographic
regions took preventative or protective actions, such as imposing
restrictions on travel and business operations, ordering temporary
closures of businesses and advising or requiring individuals to
limit or forego their time outside of their homes. Although many
preventative or protective actions have been eased or lifted in
varying degrees by different governments of various countries,
states and municipalities, the situation remains dynamic and
subject to rapid and possibly material changes. Notwithstanding
widespread
vaccine availability within Canada, the U.S. and Israel, the
emergence of COVID-19 variants and slowing vaccination rates in
certain localities have resulted in increased infection rates and
has caused, and may continue to cause, several jurisdictions to
reinstitute certain COVID-19 restrictions. Additional waves of
increased COVID-19 infections as well as COVID-19 related
restrictions imposed by various governmental authorities
(including, for example, requirements to show proof of
vaccination), could negatively impact our supply chain, as well as
traffic and sales volume for retailers offering the Company’s
products, which in turn could have an adverse effect on our
business, financial condition and results of
operations.
Further effects of the COVID-19 pandemic and any emerging COVID-19
variants could include closures of our or our joint ventures’
facilities or the facilities of our suppliers and other vendors in
our supply chain and other preventive and protective measures in
our supply chain. If the pandemic persists, including if and when
new variants of the virus emerge, closures or other restrictions on
the conduct of business operations of our joint ventures, third
party manufacturers, suppliers or vendors could disrupt our supply
chain. We have experienced minor delays in shipping and the
increased global demand on shipping and transport services, in
addition to customs and border control policies put in place in
response to COVID-19 that require shipments to undergo quarantine
periods, may cause us to experience delays or increased costs in
the future which could impact our ability to obtain materials or
deliver our products in a timely manner, could otherwise disrupt
our operations and could have an adverse effect on our business,
financial condition and results of operations.
The global impact of the COVID-19 pandemic continues to evolve, and
the extent of its effect on our operational and financial
performance will depend on future developments, which are highly
uncertain, including the duration, scope and severity of the
pandemic, the development and availability of effective treatments
and vaccines, further actions taken by governments and other third
parties to contain or mitigate its impact, the direct and indirect
economic effects of the pandemic and related containment measures,
and new information that will emerge concerning the severity and
impact of COVID-19 and new variants of the virus, among others.
Even after the COVID-19 pandemic subsides, our businesses could
also be negatively impacted should the effects of the COVID-19
pandemic lead to changes in consumer behavior, including as a
result of a decline in the level of vaping or demand for inhalable
products in light of certain recent published articles and studies
on the potential increased susceptibility of individuals who smoke
or vaporize nicotine or cannabis to COVID-19, in light of changes
in consumer behavior such as reduced spending on certain product
formats historically used in shared experiences such as pre-rolls
or in reductions in discretionary spending.
Natural disasters, unusual weather, pandemic outbreaks, boycotts
and geo-political events or acts of terrorism could adversely
affect our operations and financial results.
The occurrence of one or more natural disasters, such as
hurricanes, floods and earthquakes, unusually adverse weather,
pandemic outbreaks, such as the COVID-19 virus, influenza and other
highly communicable diseases or viruses, boycotts and geo-political
events, such as civil unrest in countries in which our or our joint
ventures’ operations are located and acts of terrorism, or similar
disruptions could adversely affect our business, financial
condition and results of operations. These events could result in
physical damage to one or more of our or our joint ventures’
properties, increases in fuel or other energy prices, the temporary
or permanent closure of one or more of our or our joint ventures’
facilities, the temporary lack of an adequate workforce in a
market, the temporary or long-term disruption in the supply of
products from suppliers, the temporary disruption in the transport
of goods, delay in the delivery of goods to our or our joint
ventures’ facilities, and disruption to our information systems.
Such events could also negatively impact consumer sentiment, reduce
demand for consumer products like ours and cause general economic
slowdown.
Our business is subject to evolving corporate governance and public
disclosure regulations and expectations, including with respect to
environmental, social and governance matters, that could expose us
to numerous risks.
We are subject to changing rules and regulations promulgated by a
number of governmental and self-regulatory organizations, including
the SEC, Nasdaq and the Financial Accounting Standards Board. These
rules and regulations continue to evolve in scope and complexity.
In addition, increasingly regulators, customers, investors,
employees and other stakeholders are focusing on environmental,
social and governance (“ESG”) matters and related disclosures.
These changing rules, regulations and stakeholder expectations have
resulted in, and are likely to continue to result in, increased
general and administrative expenses and increased management time
and attention spent complying with or meeting such regulations and
expectations. For example, developing and acting on initiatives
within the scope of ESG, and
collecting, measuring and reporting ESG related information and
metrics can be costly, difficult and time consuming and is subject
to evolving reporting standards, including the SEC’s recently
proposed climate-related reporting requirements, and similar
proposals by other international regulatory bodies. We may also
communicate certain initiatives and goals, regarding environmental
matters, diversity, responsible sourcing and social investments and
other ESG related matters, in our SEC filings or in other public
disclosures. These initiatives and goals within the scope of ESG
could be difficult and expensive to implement, the technologies
needed to implement them may not be cost effective and may not
advance at a sufficient pace, and we could be criticized for the
accuracy, adequacy or completeness of the disclosure. Further,
statements about our ESG related initiatives and goals, and
progress against those goals, may be based on standards for
measuring progress that are still developing, internal controls and
processes that continue to evolve, and assumptions that are subject
to change in the future. In addition, we could be criticized for
the scope or nature of such initiatives or goals, or for any
revisions to these goals. If our ESG-related data, processes and
reporting are incomplete or inaccurate, or if we fail to achieve
progress with respect to our initiatives or goals within the scope
of ESG on a timely basis, or at all, our reputation, business,
financial performance and growth could be adversely
affected.
Climate change may disrupt our business and our efforts to address
concerns relating to climate change could result in damage to our
reputation.
Our business and that of our joint venture partners involves the
growing of cannabis, an agricultural product, and adverse weather
conditions have historically caused volatility in the agricultural
industry and consequently in operating results by causing crop
failures or significantly reduced harvests, which may negatively
affect the supply and pricing of agricultural commodities, such as
cannabis. Additionally, the potential physical impacts of climate
change are uncertain and may vary by region. These potential
effects could include changes in rainfall patterns, water
shortages, changing sea levels, changing storm patterns and
intensities, and changing temperature levels that could adversely
impact our costs and business operations, the location, costs, and
competitiveness of cannabis production and related storage and
processing facilities and the supply of cannabis.
We are also exposed to risks resulting from changes in public
policy, laws and regulations, or market and public perceptions and
preferences in connection with the transition to a less
carbon-dependent economy. These changes could adversely affect our
business, results of operations and reputation.
Our financial performance is subject to risks of foreign exchange
rate fluctuation, which could result in foreign exchange
losses.
We may be exposed to fluctuations of the U.S. dollar against
certain other currencies, particularly the Canadian dollar, because
we publish our financial statements in U.S. dollars, while a
significant portion of our assets, liabilities, revenues and costs
are or will be denominated in other currencies. Exchange rates for
currencies of the countries in which we operate may fluctuate in
relation to the U.S. dollar, and such fluctuations may have a
material adverse effect on our earnings or assets when translating
foreign currency into U.S. dollars.
Our business, financial condition, results of operations and cash
flows could be adversely affected by disruptions in the global
economy caused by the ongoing conflict between Russia and
Ukraine.
The global economy has been negatively impacted by the military
conflict between Russia and Ukraine. Furthermore, governments in
the U.S., Canada, United Kingdom, and European Union have each
imposed export controls on certain products and financial and
economic sanctions on certain industry sectors and parties in
Russia. Although we do not have any customers or direct supplier
relationships in Russia or Ukraine, businesses in the United States
and globally have experienced shortages in materials and increased
costs for transportation, energy, and raw material due in part to
the negative impact of the Russia-Ukraine military conflict on the
global economy. Further escalation of geopolitical tensions related
to the military conflict, including increased trade barriers or
restrictions on global trade, could result in, among other things,
cyberattacks, supply disruptions, lower consumer demand, and
changes to foreign exchange rates and financial markets, any of
which may adversely affect our business, financial condition,
results of operations and cash flows.
We are continuing to monitor the situation in Ukraine and globally
and assessing its potential impact on our business. Although our
business has not been, to the date of this Annual Report,
materially impacted by the ongoing military conflict in Ukraine, it
is impossible to predict the extent to which our operations, or
those of our suppliers and vendors, will be impacted in the short
and long term, or the ways in which the conflict may impact our
business. The extent and duration of the military action, sanctions
and resulting market disruptions are impossible to predict, but may
be substantial. In addition, the effects of the ongoing conflict
could heighten any of our known risks described above.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
None.
ITEM 2. PROPERTIES.
Our executive offices are located in Toronto, Ontario in Canada,
where we lease office space. As of December 31, 2022, our Rest of
World segment owned various manufacturing facilities in the
Canadian provinces of Manitoba and Ontario, and in Hadera, Israel.
As of December 31, 2022, our United States segment leased office
space and manufacturing facilities in Los Angeles, California.
Management believes that our existing facilities are adequate to
meet our current requirements and, to the extent that our
facilities are leased, comparable space is readily
available.
ITEM 3. LEGAL PROCEEDINGS.
The Company is subject to various legal proceedings in the ordinary
course of its business and in connection with its marketing,
distribution and sale of its products. Many of these legal
proceedings are in the early stages of litigation and seek damages
that are unspecified or not quantified. Although the outcome of
these matters cannot be predicted with certainty, the Company does
not believe
these legal proceedings, individually or in the aggregate, will
have a material adverse effect on its consolidated financial
condition but could be material to its results of operations for
any particular reporting period depending, in part, on its results
for that period.
Class action complaints relating to restatement of 2019 interim
financial statements
On March 11 and 12, 2020, two alleged shareholders of the Company
separately filed two putative class action complaints in the U.S.
District Court for the Eastern District of New York against the
Company and its former Chief Executive Officer (now Executive
Chairman) and now former Chief Financial Officer. The court has
consolidated the cases, and the consolidated amended complaint
alleges violations of Section 10(b) of the Exchange Act and Rule
10b-5 promulgated thereunder against all defendants, and Section
20(a) of the Exchange Act against the individual defendants. The
consolidated amended complaint generally alleges that certain of
the Company’s prior public statements about revenues and internal
controls were incorrect based on the Company’s disclosures relating
to the Audit Committee of the Board’s review of the appropriateness
of revenue recognized in connection with certain bulk resin
purchases and sales of products through the wholesale channel. The
consolidated amended complaint does not quantify a damage request.
Defendants moved to dismiss on February 8, 2021.
On June 3, 2020, an alleged shareholder filed a Statement of Claim,
as amended on August 12, 2020, in the Ontario Superior Court of
Justice in Toronto, Ontario, Canada, seeking, among other things,
an order certifying the action as a class action on behalf of a
putative class of shareholders and damages of an unspecified
amount. The Amended Statement of Claim names (i) the Company, (ii)
its former Chief Executive Officer (now Executive Chairman), (iii)
now former Chief Financial Officer, (iv) former Chief Financial
Officer and Chief Commercial Officer, and (v) current and former
members of the Board as defendants and alleges breaches of the
Ontario Securities Act, oppression under the Ontario Business
Corporations Act and common law misrepresentation. The Amended
Statement of Claim generally alleges that certain of the Company’s
prior public statements about revenues and internal controls were
misrepresentations based on the Company’s March 2, 2020 disclosure
that the Audit Committee of the Board was conducting a review of
the appropriateness of revenue recognized in connection with
certain bulk resin purchases and sales of products through the
wholesale channel, and the Company’s subsequent restatement. The
Amended Statement of Claim does not quantify a damage request. On
June 28, 2021, the Court dismissed motions brought by the plaintiff
for leave to commence a claim for misrepresentation under the
Ontario Securities Act and for certification of the action as a
class action. The plaintiff has appealed the Court’s dismissal of
the motions only with respect to the Company, the former Chief
Executive Officer (now Executive Chairman), and the now former
Chief Financial Officer; the remaining defendants were dismissed
from the matter with prejudice and the Company and all individual
defendants agreed not to seek costs from plaintiff in connection
with the dismissal of the motions.
On September 26, 2022, the Court of Appeal for Ontario reversed the
Superior Court’s dismissal of the leave and certification motions,
granted the plaintiff leave to proceed to bring a claim for
misrepresentation under the Ontario Securities Act, and remitted
the certification motion back to the Superior Court.
Regulatory reviews relating to restatement
The Company previously responded to requests for information from
various regulatory authorities relating to its previously disclosed
restatement of its financial statements for the first three
quarters of 2019 as well as the previously disclosed restatement of
the second quarter of 2021 interim financial statements
(collectively, the “Restatements”). On October 24, 2022, the
Company announced settlements with those regulatory authorities as
follows:
SEC Settlement
On October 24, 2022, the SEC issued an Order Instituting
Cease-and-Desist Proceedings Pursuant to Section 8(a) of the
Securities Act of 1933 (the “Securities Act”) and Section 21(c) of
the Exchange Act, Making Findings, and Imposing a Cease-and-Desist
Order (the “Settlement Order”) resolving the
Restatements.
The Company agreed to settle with the SEC, without admitting or
denying the allegations described in the Settlement Order. The
Settlement Order fully and finally disposes of the investigation of
the Company by the SEC into the Restatements without the payment of
any civil penalty or other amount.
The Settlement Order required the Company to cease and desist from
committing or causing any violations and any future violations of
Section 17(a) of the Securities Act, Sections 10(b), 13(a),
13(b)(2)(B) of the Exchange Act and Rules 10b-5, 13a-13, 13a-15(a),
13a-16 and 12b-20 thereunder. Additionally, the Company agreed to
certain undertakings, which include, among other things, retaining
a qualified independent consultant (the “Consultant”) to engage in
a review of, and make recommendations with respect to, certain of
the Company’s internal accounting controls and internal control
over financing reporting.
As a result of the Settlement Order, the Company (i) lost its
status as a well-known seasoned issuer for a period of three years,
(ii) is unable to rely on the private offering exemptions provided
by Regulations A and D under the Securities Act for a period of
five years and (iii) is unable to rely on the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995 for a period of three years.
Ontario Securities Commission Settlement
On October 24, 2022, the Ontario Capital Markets Tribunal approved
a settlement agreement (the “Settlement Agreement”) between the
Company and the staff of the Ontario Securities Commission (“OSC”),
resolving the Restatements.
Pursuant to the terms of the Settlement Agreement, which fully and
finally disposes the investigation of the Company by the OSC,
Cronos agreed to pay a total of C$1.34 million to fully settle the
matter, and acknowledged that it had failed to comply with the
requirement under Section 77 of the Securities Act (Ontario) to
file interim financial reports in the manner set out therein and
had acted in a manner contrary to the public interest.
Additionally, the Company agreed to retain the Consultant to engage
in a review of, and make recommendations with respect to, certain
of the Company’s internal accounting controls and internal control
over financing reporting, on substantially the same terms as were
required by the SEC pursuant the Settlement Order.
Litigation relating to marketing, distribution and sale of
products
On June 16, 2020, an alleged consumer filed a Statement of Claim on
behalf of a class in the Court of King’s Bench of Alberta in
Alberta, Canada, against the Company and other Canadian cannabis
manufacturers and/or distributors. On December 4, 2020, a Third
Amended Statement of Claim was filed, which added a second alleged
consumer. The Third Amended Statement of Claim alleges claims
related to the defendants’ advertised content of cannabinoids in
cannabis products for medicinal use on or after June 16, 2010 and
cannabis products for adult use on or after October 17, 2018. The
Third Amended Statement of Claim seeks a total of C$500 million for
breach of contract, compensatory damages, and unjust enrichment or
such other amount as may be proven in trial and C$5 million in
punitive damages against each defendant, including the Company. The
Third Amended Statement of Claim also seeks interest and costs
associated with the action. The Company has not responded to the
Third Amended Statement of the Claim. On January 31, 2022, upon
consent of the Company and the plaintiffs, the court dismissed the
case in its entirety as to the Company.
A number of claims, including purported class actions, have been
brought in the U.S. against companies engaged in the U.S. hemp
business alleging, among other things, violations of state consumer
protection, health and advertising laws. On April 8, 2020, a
putative class action complaint was filed in the U.S. District
Court for the Central District of California against Redwood,
alleging violations of California’s Unfair Competition Law, False
Advertising Law, Consumers Legal Remedies Act, and breaches of the
California Commercial Code for breach of express warranties and
implied warranty of merchantability with respect to Redwood’s
marketing and sale of U.S. hemp products. The complaint did not
quantify a damage request. On April 10, 2020, the class action
complaint was dismissed for certain pleading deficiencies and the
plaintiff was granted leave until April 24, 2020 to amend the
complaint to establish federal subject matter jurisdiction. On
April 28, 2020, the action was dismissed without prejudice for
failure to prosecute and for failure to comply with a court order.
As of the date of this Annual Report, the plaintiff has not refiled
the complaint.
We expect litigation and regulatory proceedings relating to the
marketing, distribution and sale of our products to
increase.
ITEM 4. MINE SAFETY DISCLOSURE.
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Our common shares are traded on Nasdaq and the TSX under the symbol
“CRON.”
Holders
As of February 24, 2023, there were approximately 107 holders
of record of our common shares. This number of holders of record
does not represent the actual number of beneficial owners of our
common shares because shares are frequently held in “street name”
by securities dealers and others for the benefit of individual
owners who have the right to vote their shares.
Dividends
As of the date of this Annual Report, we have not declared any
dividends or made any distributions on our common shares.
Furthermore, we have no current intention to declare dividends on
our common shares in the foreseeable future. Any decision to pay
dividends on our common shares in the future will be at the
discretion of the Board and will depend on, among other things, our
results of operations, current and anticipated cash requirements
and surplus, financial condition, any future contractual
restrictions and financing agreement covenants, our ability to meet
solvency tests imposed by corporate law and other factors that the
Board may deem relevant.
Securities Authorized for Issuance under Equity Compensation
Plans
Information concerning securities authorized for issuance under
equity compensation plans will be set forth in the Company’s
definitive proxy statement for its 2023 Annual Meeting of
Shareholders or an amendment to this Annual Report to be filed
within 120 days of our fiscal year end.
Purchases of Equity Securities by the Issuer and Affiliated
Persons
None.
Recent Sales of Unregistered Securities
None.
Performance Graph
The following performance graph compares the cumulative total
shareholder return of our common shares as listed on Nasdaq with
the cumulative total return of the S&P 500 Index and a
market-weighted index of publicly traded peers over the 58-month
period beginning on February 27, 2018 and ending on December 31,
2022. The new peer group includes Aurora Cannabis Inc., Canopy
Growth Corporation, Green Thumb Industries, Inc., HEXO Corporation,
Organigram Holdings Inc., Tilray Inc., and Trulieve Cannabis Corp.,
(the “New Peer Group”). The graph assumes that $100 is invested in
each of our common shares, the S&P 500 Index, and the indices
of publicly traded peers on February 27, 2018 and that all
dividends, if applicable, were reinvested. Past performance may not
be indicative of future performance.
The old peer group included Aurora Cannabis Inc., Canopy Growth
Corporation, Green Thumb Industries, Inc., HEXO Corporation,
iAnthus Capital Holdings Inc., Organigram Holdings Inc., and Tilray
Inc. (the “Old Peer Group”). iAnthus Capital Holdings Inc. was
removed from the New Peer Group and replaced with Trulieve Cannabis
Corp. to better align the New Peer Group, as iAnthus Capital
Holdings Inc.’s share price has fallen to a nominal
value.

|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date |
Cronos Group Inc. |
S&P 500 |
Old Peer Group |
New Peer Group |
February 27, 2018 |
$ |
100.00 |
|
$ |
100.00 |
|
$ |
100.00 |
|
$ |
100.00 |
|
March 31, 2018 |
$ |
88.32 |
|
$ |
97.46 |
|
$ |
111.22 |
|
$ |
114.36 |
|
June 30, 2018 |
$ |
85.56 |
|
$ |
100.81 |
|
$ |
121.53 |
|
$ |
136.42 |
|
September 30, 2018 |
$ |
145.93 |
|
$ |
108.58 |
|
$ |
190.41 |
|
$ |
217.76 |
|
December 31, 2018 |
$ |
136.35 |
|
$ |
93.90 |
|
$ |
98.39 |
|
$ |
115.61 |
|
March 31, 2019 |
$ |
241.86 |
|
$ |
106.71 |
|
$ |
145.34 |
|
$ |
187.52 |
|
June 30, 2019 |
$ |
209.71 |
|
$ |
111.31 |
|
$ |
124.13 |
|
$ |
155.63 |
|
September 30, 2019 |
$ |
118.77 |
|
$ |
113.20 |
|
$ |
70.99 |
|
$ |
101.19 |
|
December 31, 2019 |
$ |
100.66 |
|
$ |
123.46 |
|
$ |
55.09 |
|
$ |
60.79 |
|
March 31, 2020 |
$ |
74.41 |
|
$ |
99.27 |
|
$ |
32.45 |
|
$ |
36.12 |
|
June 30, 2020 |
$ |
78.87 |
|
$ |
119.66 |
|
$ |
37.99 |
|
$ |
39.30 |
|
September 30, 2020 |
$ |
65.75 |
|
$ |
130.35 |
|
$ |
33.33 |
|
$ |
35.71 |
|
December 31, 2020 |
$ |
91.08 |
|
$ |
146.18 |
|
$ |
58.43 |
|
$ |
57.65 |
|
March 31, 2021 |
$ |
124.15 |
|
$ |
155.21 |
|
$ |
80.99 |
|
$ |
85.50 |
|
June 30, 2021 |
$ |
112.86 |
|
$ |
168.47 |
|
$ |
70.52 |
|
$ |
74.35 |
|
September 30, 2021 |
$ |
74.28 |
|
$ |
169.46 |
|
$ |
47.25 |
|
$ |
42.72 |
|
December 31, 2021 |
$ |
51.44 |
|
$ |
188.14 |
|
$ |
32.67 |
|
$ |
28.17 |
|
March 31, 2022 |
$ |
51.05 |
|
$ |
179.49 |
|
$ |
29.70 |
|
$ |
36.89 |
|
June 30, 2022 |
$ |
37.01 |
|
$ |
150.59 |
|
$ |
11.66 |
|
$ |
15.59 |
|
September 30, 2022 |
$ |
37.01 |
|
$ |
143.24 |
|
$ |
11.13 |
|
$ |
14.14 |
|
December 31, 2022 |
$ |
33.33 |
|
$ |
154.07 |
|
$ |
9.00 |
|
$ |
11.88 |
|
*$100 invested on 2/27/18 in stock or 2/28/18 in index, including
reinvestment of dividends. Fiscal year ending December 31.
Copyright© 2022 Standard & Poor’s, a division of S&P
Global. All rights reserved.
ITEM 6. RESERVED
Not applicable.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Management’s discussion and analysis of financial condition and
results of operations is provided as a supplement to, and should be
read in conjunction with, the consolidated financial statements and
related notes, which are included in Item 8 of this Annual Report
on Form 10-K (this “Annual Report”), to enhance the understanding
of our operations and our present business
environment.
This discussion contains Forward-Looking Statements that involve
risks and uncertainties.
For more information about our operations and the risks facing our
business, see Item 1 “Business”
and Item 1A “Risk
Factors”,
respectively, of this Annual Report.
Business Overview
Cronos is an innovative global cannabinoid company committed to
building disruptive intellectual property by advancing cannabis
research, technology and product development. With a passion to
responsibly elevate the consumer experience, Cronos is building an
iconic brand portfolio. Cronos’ diverse international brand
portfolio includes Spinach®,
PEACE NATURALS®
and Lord Jones®.
Unless otherwise noted or the context indicates otherwise,
references in this Annual Report to the “Company”, “Cronos”, “we”,
“us” and “our” refer to Cronos Group Inc., its direct and indirect
wholly owned subsidiaries and, if applicable, its joint ventures
and investments accounted for by the equity method; the term
“cannabis” means the plant of any species or subspecies of
genus
Cannabis
and any part of that plant, including all derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers; the term
“U.S. hemp” has the meaning given to term “hemp” in the U.S.
Agricultural Improvement Act of 2018, including hemp-derived
cannabidiol (“CBD”).
Strategy
Cronos seeks to create value for shareholders by focusing on four
core strategic priorities:
•growing
a portfolio of iconic brands that responsibly elevate the consumer
experience;
•developing
a diversified global sales and distribution network;
•establishing
an efficient global supply chain; and
•creating
and monetizing disruptive intellectual property.
Business Segments
We report through two segments: “United States” (the “U.S.
segment”) and “Rest of World” (the “ROW segment”). These two
segments represent the geographic regions in which we operate and
the different product offerings within each geographic
region.
The U.S. segment manufactures, markets and distributes U.S.
hemp-derived products through e-commerce, retail and hospitality
partner channels in the United States under the Lord
Jones®
brand.
The ROW segment is involved in the cultivation, manufacturing, and
marketing of cannabis products for the medical and adult-use
markets. In Canada, Cronos operates two wholly owned license
holders under the Cannabis Act (Canada) (the “Cannabis Act”), Peace
Naturals Project Inc. (“Peace Naturals”), which has production
facilities near Stayner, Ontario (the “Peace Naturals Campus”), and
Thanos Holdings Ltd., known as Cronos Fermentation (“Cronos
Fermentation”), which has a production facility in Winnipeg,
Manitoba. In Israel, the Company operates under the IMC-GAP,
IMC-GMP and IMC-GDP certifications required for the cultivation,
production and marketing of dried flower, pre-rolls and oils in the
Israeli medical market. Cronos has established two strategic joint
ventures in Canada and Israel. Additionally, as of
December 31, 2022, Cronos held approximately 10% of the issued
capital of Vitura Health Limited (“Vitura”), formerly known as
Cronos Australia Limited, which is listed on the Australian
Securities Exchange under the trading symbol “VIT” and
approximately 13.7% of the issued capital of Natuera.
Recent Developments
COVID-19
In December 2019, an outbreak of a novel strain of coronavirus,
COVID-19, was identified in Wuhan, China. Since then, COVID-19 has
spread across the globe, including the U.S., Canada and Israel, and
other countries in which Cronos or its affiliates operate, and was
recognized as a pandemic by the World Health Organization. The
COVID-19 pandemic resulted in a sharp contraction in many areas of
the global economy and increased volatility and uncertainty in the
capital markets. In response to the pandemic, the governments of
many countries, provinces, states, municipalities, and other
geographic regions took preventative or protective actions,
including closures of certain businesses, mandatory quarantines,
limits on individuals’ time outside of their homes, travel
restrictions and social distancing or other preventative measures.
Such measures have been eased or lifted in varying degrees by
different governments of various countries, states and
municipalities since implementation in 2020, but the continued
spread of COVID-19 and increased infection rates has caused, and
may continue to cause, some jurisdictions to roll back reopening
plans that had been underway and re-impose quarantines, border
closures, closure of certain businesses and stay-at-home
orders.
The COVID-19 pandemic continues to impact the global economy and,
specifically, the U.S., Canada, Israel, and the other countries in
which Cronos or its affiliates operate. We continue to closely
monitor and respond, where possible, to the ongoing COVID-19
pandemic. As the global situation continues to change rapidly,
ensuring the health and safety of our employees remains one of our
top priorities.
In the U.S., numerous states have continued to remove their
COVID-19 related restrictions. This has resulted in the re-opening
of, and increased occupancy capacities in, retail outlets,
including those that sell our products. Any reinstatement of
restrictions on the operations of retail outlets could negatively
impact our short-term results of operations in the U.S.
Additionally, in the U.S., there have been a number of supply chain
challenges, such as container ships facing delays due to congestion
in ports, impacting many industries, including the industries in
which we operate. Although we have not yet seen a significant
impact from supply chain disruptions, we continue to monitor our
supply chain closely.
In Canada, COVID-19 restrictions began gradually easing at the end
of June 2021 as the vaccination rate increased. The lockdown
measures taken in the first six months of 2021 to slow infection
rates negatively impacted our short-term revenue growth in Canada
in 2021. The increase in cases related to the Omicron variant of
COVID-19 beginning in December 2021 caused the reinstatement of
some restrictions on non-essential retail stores in some provinces,
including Quebec, in early 2022; however, those restrictions have
eased in most other provinces. Each province is responsible for
implementing re-opening plans and certain provinces, including
Ontario, are progressing through phases of re-opening which may
permit continued increases to the allowance of in-person shopping,
typically in the form of percentage of store capacity. All
provinces have some form of cannabis retail open to consumers, and
most provinces have lifted the requirement that retail shoppers
show proof of vaccination before entering retail stores. The
potential for recurring retail restrictions is ongoing, which could
negatively impact our results of operations.
In Israel, most COVID-19 restrictions have been removed as
vaccination rates have increased. Occupancy limitations in retail
outlets have been removed, including those that sell our products.
We do not expect the remaining COVID-19 restrictions to have a
material impact on our short-term revenue growth in
Israel.
Collectively, the effects of the COVID-19 pandemic have adversely
affected our results of operations and, if the effects continue
unabated, could continue to do so as long as measures to combat the
COVID-19 pandemic remain in effect or supply chains continue to be
challenged. At this time, neither the duration nor scope of the
disruption can be predicted; therefore, the ultimate impact to our
business cannot be reasonably estimated, but such impact could
materially adversely affect our business, financial condition and
results of operations.
Despite the impacts of the COVID-19 pandemic, we believe that our
significant cash on hand and short-term investments will be
adequate to meet liquidity and capital requirements for at least
the next twelve months.
2022 Business Highlights
Spinach®
Branded Product Portfolio Expansion in Canada
Throughout 2022, the Company expanded its
Spinach®
gummies portfolio under both SOURZ by Spinach®
and Spinach FEELZ™, with the following new products:
•April
2022: SOURZ by Spinach®
Cherry Lime (Hybrid), 10mg of THC per pack
•July
2022: Spinach FEELZ™ DEEP DREAMZ CBN, 10mg of THC and 5mg of CBN
per pack
•October
2022: SOURZ by Spinach®
Tropical Triple Berry 2:1 CBD:THC, 20mg of CBD and 10mg of THC per
pack
•December
2022: Spinach FEELZ™ 1:3 THC+CBC Mango Lime, 10mg of THC and 30mg
of CBC per pack
In 2022, Cronos was also focused on renovating both its vape and
pre-roll offerings and launched the products below in those
categories in 2022:
Vape:
•August
2022: Spinach FEELZ™ Deep Dreamz Blackberry Kush (7:1 THC|CBN)
1-gram vape
•May
2022: Spinach®
Cosmic Green Apple and Polar Mint Vortex (800 mg/g THC) 1-gram
vapes
In November, 2022, Cronos launched two infused pre-rolls in Canada.
The first, Fully Charged Atomic GMO, was launched under the
Spinach®
brand and is offered in a 5-pack with 0.5 grams per pre-roll.
Second, Cronos launched Tropical Diesel CBG, a 3-pack of CBG
infused pre-rolls with 0.5 grams per pre-roll under the Spinach
FEELZ™ sub-brand.
Intellectual property initiatives
In 2022, we continued to progress our fermentation initiative in
partnership with Ginkgo. We achieved equity milestones for the
following cannabinoids in 2022:
•June
2022: tetrahydrocannabivaric acid (“THCVA”)
•November
2022: cannabichromenic acid (“CBCA”)
•December
2022: cannabichromevarinic acid (“CBCVA”)
Strategic and Organizational Update
In February 2023, the Company announced a shift in its strategic
plans for the Realignment, with the intent to retain select
components of its operations at the Peace Naturals Campus, namely
distribution and warehousing, certain research and development
activities and manufacturing of certain of the Company’s
proprietary innovation products.
Appointments
In March 2022, the Board of Directors appointed Cronos’s founder,
Mike Gorenstein, as Chairman, President and Chief Executive
Officer. Mr. Gorenstein previously served as Chairman, President
and Chief Executive Officer of Cronos until September 2020, when he
transitioned to the Executive Chairman role.
In April 2022, the Company appointed Terry Doucet as Senior Vice
President, Legal, Regulatory Affairs and Corporate Secretary, after
serving in an interim capacity since December 2021. Mr. Doucet has
been with Cronos since 2018 and has guided Cronos through
significant growth over the last few years, including the build-out
of the Company’s Legal and Regulatory Affairs teams, the Altria
Investment, the Ginkgo Strategic Partnership, the PharmaCann Option
and various product commercialization initiatives.
In August 2022, the Company appointed Arye Weigensberg as Senior
Vice President, Head of Research & Development, after serving
in an interim capacity since November 2021. Prior to serving as
interim Head of Research and Development, Mr. Weigensberg was the
General Manager and Vice President of Research and Technology at
Cronos Research Labs. Before joining the Company, Mr. Weigensberg
was the CEO of Altria Israel Ltd (an Altria research and
development hub). Since joining Cronos, Mr. Weigensberg has played
a foundational role developing the scope of our rare cannabinoid
work, while advancing our research capabilities to forge new
strategies for differentiated cannabis products.
In October 2022, Jeff Jacobson was appointed Chief Growth Officer.
Mr. Jacobson previously served as the Company’s Senior Vice
President, Head of Growth (North America). Mr. Jacobson has been
with Cronos since December 2016 and was a co-founder of Peace
Naturals Project Inc. Mr. Jacobson’s expertise and experience in
licensing and compliance, new business development, project
management and resource management assist Cronos in developing and
penetrating domestic and international markets.
In November 2022, the Company appointed James Holm as Chief
Financial Officer after nearly two decades of finance and
accounting experience at leading companies across industries. He
most recently served as the Global Vice President of Finance
Transformation at Vertiv, a global provider of critical digital
infrastructure and continuity solutions, where he led the company’s
centralization, standardization and optimization to a Global Shared
Service hub for finance processes. Before joining Vertiv, Mr. Holm
served as Finance Leader, Finance Solutions & Process
Transformation Organization at Worldpay, one of the largest global
payment processors. There he drove financial reporting accuracy,
capabilities and enhancements across the company. Earlier in his
career, he held multiple positions of increasing seniority in the
finance department during his eight-year tenure at Procter and
Gamble.
2021 Compared to 2020
Results of Operations
For a discussion of our 2021 results of operations compared to
2020, see Part II, Item 7 “Management’s Discussion and Analysis of
Financial Condition and Results of Operations,” in our Annual
Report on Form 10-K for the year ended December 31,
2021.
Cash Flows
For a discussion of our 2021 cash flows compared to 2020, see Part
II, Item 7 “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” in our Annual Report on Form
10-K for the year ended December 31, 2021.
Foreign currency exchange rates
All currency amounts in this Annual Report are stated in U.S.
dollars, which is our reporting currency, unless otherwise noted.
All references to “dollars” or “$” are to U.S. dollars. The assets
and liabilities of our foreign operations are translated into
dollars at the exchange rate in effect as of December 31, 2022
and December 31, 2021, as reported on Bloomberg. Transactions
affecting the shareholders’ equity (deficit) are translated at
historical foreign exchange rates. The consolidated statements of
net income (loss) and comprehensive income (loss) and consolidated
statements of cash flows of our foreign operations are translated
into dollars by applying the average foreign exchange rate in
effect for the years ended December 31, 2022,
December 31, 2021, and December 31, 2020, as reported on
Bloomberg.
The exchange rates used to translate from Canadian dollars (“C$”)
to dollars are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Exchange rates are shown as C$ per $) |
Year ended December 31, |
|
2022 |
|
2021 |
|
2020 |
Average rate |
1.3017 |
|
1.2541 |
|
1.3411 |
Spot rate |
1.3554 |
|
1.2746 |
|
1.2751 |
Consolidated Results of Operations
The tables below set forth our consolidated results of operations,
expressed in thousands of U.S. dollars for the periods presented.
Our consolidated financial results for these periods are not
necessarily indicative of the consolidated financial results that
we will achieve in future periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
2022 |
|
2021 |
Net revenue before excise taxes |
$ |
114,456 |
|
$ |
89,486 |
Excise taxes |
(22,552) |
|
(15,051) |
Net revenue |
91,904 |
|
74,435 |
Cost of sales |
79,935 |
|
80,008 |
Inventory write-down |
— |
|
11,961 |
Gross profit |
11,969 |
|
(17,534) |
Operating expenses: |
|
|
|
Sales and marketing |
22,282 |
|
44,937 |
Research and development |
13,381 |
|
23,331 |
General and administrative |
71,178 |
|
96,482 |
Restructuring costs |
5,333 |
|
— |
Share-based compensation |
15,115 |
|
10,151 |
Depreciation and amortization |
6,025 |
|
4,484 |
Impairment loss on goodwill and indefinite-lived intangible
assets |
— |
|
236,056 |
Impairment loss on long-lived assets |
3,493 |
|
127,619 |
Total operating expenses |
136,807 |
|
543,060 |
Operating loss |
(124,838) |
|
(560,594) |
Other income (expense) |
(9,721) |
|
163,459 |
Income tax benefit (expense) |
(34,175) |
|
431 |
Loss from discontinued operations |
— |
|
(500) |
Net loss |
(168,734) |
|
(397,204) |
Net loss attributable to non-controlling interest |
— |
|
(1,097) |
Net loss attributable to Cronos Group |
$ |
(168,734) |
|
$ |
(396,107) |
Summary of select financial results
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
|
2022 |
|
2021 |
|
$ |
|
% |
Net revenue |
$ |
91,904 |
|
|
$ |
74,435 |
|
|
$ |
17,469 |
|
|
23 |
% |
Cost of sales |
79,935 |
|
|
80,008 |
|
|
(73) |
|
|
— |
% |
Inventory write-down |
— |
|
|
11,961 |
|
|
(11,961) |
|
|
(100) |
% |
Gross profit |
11,969 |
|
|
(17,534) |
|
|
29,503 |
|
|
168 |
% |
Gross margin(i)
|
13 |
% |
|
(24) |
% |
|
N/A |
|
37 |
pp |
(i)Gross
margin is defined as gross profit divided by net
revenue.
Net revenue
For 2022, we reported consolidated net revenue of $91.9 million,
representing a $17.5 million increase from 2021. This change was
primarily due to higher cannabis flower sales in the Israeli
medical market and higher cannabis extract sales in the Canadian
adult-use market, partially offset by a reduction in revenue in the
U.S. segment, lower cannabis flower sales in the Canadian adult-use
market driven by an unfavorable price/mix shift and the impact of
the weakening Canadian dollar against the U.S. dollar during
2022.
Cost of sales
For 2022, we reported consolidated cost of sales of $79.9 million,
essentially flat with 2021, despite a 23% increase in net revenue.
This was primarily due to lower cannabis biomass costs, lower sales
volumes in the U.S. segment and the impact of the weakening
Canadian dollar against the U.S. dollar during the period,
partially offset by higher sales volumes in the ROW segment and
lower fixed cost absorption due to the timing of the wind-down of
cultivation and certain production activities associated with the
change in the nature of operations at the Peace Naturals
Campus.
Inventory write-downs
For 2021, we reported inventory write-downs of $12.0 million,
primarily related to cannabis strains and potency levels that were
no longer in-line with consumer preferences in the Canadian market
and adjustments for obsolete inventory in Canada. We reported no
inventory write-downs for 2022.
Gross profit
For 2022, we reported consolidated gross profit of $12.0 million,
representing a $29.5 million improvement from 2021. The improvement
in gross profit is primarily due to increased revenue in the ROW
segment driven mainly by a favorable mix of cannabis extract
products, which carry a higher gross profit and gross margin than
other product categories, higher sales of cannabis flower in
Israel, the absence of inventory write-downs in 2022, and lower
cannabis biomass costs, partially offset by lower revenue in the
U.S. segment and lower fixed cost absorption due to the timing of
the wind-down of cultivation and certain production activities
associated with the change in the nature of operations at the Peace
Naturals Campus.
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
|
2022 |
|
2021 |
|
$ |
|
% |
Sales and marketing |
$ |
22,282 |
|
|
$ |
44,937 |
|
|
$ |
(22,655) |
|
|
(50) |
% |
Research and development |
13,381 |
|
|
23,331 |
|
|
(9,950) |
|
|
(43) |
% |
General and administrative |
71,178 |
|
|
96,482 |
|
|
(25,304) |
|
|
(26) |
% |
Restructuring costs |
5,333 |
|
|
— |
|
|
5,333 |
|
|
100 |
% |
Share-based compensation |
15,115 |
|
|
10,151 |
|
|
4,964 |
|
|
49 |
% |
Depreciation and amortization |
6,025 |
|
|
4,484 |
|
|
1,541 |
|
|
34 |
% |
Impairment loss on goodwill and indefinite-lived intangible
assets |
— |
|
|
236,056 |
|
|
(236,056) |
|
|
(100) |
% |
Impairment loss on long-lived assets |
3,493 |
|
|
127,619 |
|
|
(124,126) |
|
|
(97) |
% |
Operating expenses |
$ |
136,807 |
|
|
$ |
543,060 |
|
|
$ |
(406,253) |
|
|
(75) |
% |
Sales and marketing
For 2022, we reported sales and marketing expenses of $22.3
million, representing a decrease of $22.7 million from 2021. The
decrease was primarily due to lower advertising and marketing spend
and lower personnel-related costs in the U.S. segment as a result
of the Realignment.
Research and development
For 2022, we reported research and development expenses of $13.4
million, representing a decrease of $10.0 million from 2021. This
decrease was primarily due to lower costs associated with the
Ginkgo Collaboration Agreement and cancellation of beauty-focused
product development spending in the U.S. segment.
General and administrative
For 2022, we reported general and administrative expenses of $71.2
million, representing a decrease of $25.3 million from 2021. The
decrease was primarily due to lower expected credit losses on our
loans to joint venture partners when compared to 2021, lower legal
and advisory fees associated with strategic initiatives and lower
personnel-related costs associated with the
Realignment.
Restructuring costs
For 2022, we reported restructuring costs of $5.3 million, compared
to no restructuring costs in 2021. The restructuring costs in 2022
were related to Realignment activities. For further information,
see Note 16 “Restructuring”
to the consolidated financial statements in Item 8 of this Annual
Report.
Share-based compensation
For 2022, we reported share-based compensation expenses of $15.1
million, representing an increase of $5.0 million from 2021. The
increase was primarily due to the acceleration of expense on equity
awards granted to certain executive employees in connection with
their separation from the Company as well as the approval for grant
of previously held-back equity awards granted to certain executives
in connection with the SEC and OSC settlements. For further
information, see Note 10 “Share-based
Compensation”
to the consolidated financial statements in Item 8 of this Annual
Report.
Depreciation and amortization
For 2022, depreciation and amortization expenses were $6.0 million,
representing an increase of $1.5 million from 2021. The increase
was primarily due to higher amortization on our Ginkgo exclusive
license intangible assets.
Impairment loss on goodwill and indefinite-lived intangible
assets
For 2021, we reported impairment loss on goodwill and intangible
assets of $236.1 million due to impairment charges on the goodwill
associated with our U.S. reporting unit and impairment on our Lord
Jones®
brand. For 2022, we reported no such impairment losses. For further
information, see Note 6 “Goodwill
and Intangible Assets, net”
to the consolidated financial statements in Item 8 of this Annual
Report.
Impairment loss on long-lived assets
During 2022, we recorded impairment charges of $3.5 million related
to the right-of-use lease asset and leasehold improvements
associated with our corporate headquarters in Toronto, Ontario,
Canada, which the Company plans to sublease. For 2021, we recorded
an impairment charge of $119.9 million on long-lived assets related
to the previously announced planned exit from the Peace Naturals
Campus. Additionally, in 2021, we recorded impairment charges of
$4.8 million related to our Ginkgo exclusive licenses for
cannabigerolic acid (“CBGA”) and cannabigerovarinic acid (“CBGVA”)
for the difference between the fair value of the licenses and the
consideration paid. Furthermore, in 2021, our U.S. segment recorded
impairment charges of $1.2 million on property, plant, and
equipment where the carrying value of those assets was not
recoverable and a $1.7 million impairment charge related to ceasing
use of certain leased premise and the derecognition of the
associated right-of-use asset. See Note 5 “Property,
plant and equipment, net”
Note 6, “Goodwill
and Intangible Assets, net”
and Note 7 “Leases”
to the consolidated financial statements in Item 8 of this Annual
Report for additional information.
Total other income, income tax benefit (expense) and loss from
discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change(i)
|
|
2022 |
|
2021 |
|
$ |
|
% |
Interest income, net |
$ |
22,537 |
|
|
$ |
9,071 |
|
|
$ |
13,466 |
|
|
148 |
% |
Gain on revaluation of derivative liabilities |
14,060 |
|
|
151,360 |
|
|
(137,300) |
|
|
(91) |
% |
Impairment loss on other investments |
(61,392) |
|
|
— |
|
|
(61,392) |
|
|
N/M |
Share of income (loss) from equity method investments |
3,114 |
|
|
(6,313) |
|
|
9,427 |
|
|
149 |
% |
Gain on revaluation of financial instruments |
14,739 |
|
|
8,611 |
|
|
6,128 |
|
|
71 |
% |
Foreign currency transaction loss |
(2,286) |
|
|
— |
|
|
(2,286) |
|
|
N/M |
Other, net |
(493) |
|
|
730 |
|
|
(1,223) |
|
|
(168) |
% |
Total other income |
(9,721) |
|
|
163,459 |
|
|
(173,180) |
|
|
(106) |
% |
Income tax benefit (expense) |
(34,175) |
|
|
431 |
|
|
(34,606) |
|
|
N/M |
Loss from discontinued operations |
— |
|
|
(500) |
|
|
500 |
|
|
(100) |
% |
Net loss |
$ |
(168,734) |
|
|
$ |
(397,204) |
|
|
$ |
228,470 |
|
|
58 |
% |
(i)“N/M”
is defined as not meaningful.
Interest income, net
For 2022, we reported interest income, net of $22.5 million,
representing an increase of $13.5 million from 2021 primarily due
to higher short-term investment balances and higher interest rates
in 2022 when compared to 2021.
Gain on revaluation of derivative liabilities
For 2022, we reported a gain on revaluation of derivative
liabilities of $14.1 million, representing a decrease of $137.3
million from 2021 primarily due to the greater impact on the
derivative liabilities in 2021 from the decreased estimated term of
the derivative instruments and the decreased price of Cronos common
shares.
Impairment loss on other investments
For 2022, impairment loss on other investments was $61.4 million,
driven by impairment charges recorded on our PharmaCann Option for
the difference between its estimated fair value and its carrying
amount. There were no such impairment losses on other investments
during 2021. For more information, see Note 3 “Investments”
to the consolidated financial statements in Item 8 of this Annual
Report for additional information.
Share of income (loss) from equity method investments
For 2022, we reported share of income from equity method
investments of $3.1 million, representing an increase of $9.4
million from 2021. The change was primarily due to improved results
from our equity method investment in Cronos GrowCo.
Gain (loss) on revaluation of financial instruments
For 2022, we reported a gain on revaluation of financial
instruments of $14.7 million, representing an increase of $6.1
million from 2021. The increase was due to the change in fair value
of our investment in Vitura. See Note 3 “Investments”
to the consolidated financial statements in Item 8 of this Annual
Report for additional information.
Foreign currency transaction loss
For 2022, foreign currency transaction loss was $2.3 million, which
related to certain foreign currency-denominated intercompany loans
anticipated to be settled in the foreseeable future. There were no
such foreign currency transaction gains or losses during
2021.
Other, net
For 2022, other, net was a loss of $0.5 million, compared to income
of $0.7 million in 2021. The change was primarily due to loss on
disposal of assets associated with the Realignment, partially
offset by $0.4 million of dividend income from our Vitura
investment during 2022.
Income tax benefit (expense)
For 2022, we reported income tax expense of $34.2 million, compared
to an income tax benefit of $0.4 million in 2021. The change was
due primarily to a capital gain for tax purposes of $479.8 million,
which resulted in an income tax liability of $34.2 million, related
to the irrevocable relinquishment by Altria of the Warrant on
December 16, 2022.
Loss from discontinued operations
For 2021, we reported loss from discontinued operations of $0.5
million. There was no such loss from discontinued operations in
2022.
Results of Operations by Business Segment: 2022 compared with
2021
The tables below set forth our consolidated results of operations
by our two business segments: the ROW segment and the U.S. segment,
expressed in U.S. dollars and in thousands for the periods
presented. Our consolidated financial results for these periods are
not necessarily indicative of the consolidated financial results
that we will achieve in future periods. Certain totals in the
tables below will not sum to exactly 100% due to
rounding.
Summary of financial results
–
ROW
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
|
2022 |
|
2021 |
|
$ |
|
% |
Net revenue |
$ |
86,749 |
|
|
$ |
64,561 |
|
|
$ |
22,188 |
|
|
34 |
% |
Cost of sales |
71,313 |
|
|
70,193 |
|
|
1,120 |
|
|
2 |
% |
Inventory write-down |
— |
|
|
11,961 |
|
|
(11,961) |
|
|
(100) |
% |
Gross profit |
15,436 |
|
|
(17,593) |
|
|
33,029 |
|
|
188 |
% |
Gross margin |
18 |
% |
|
(27) |
% |
|
N/A |
|
45 |
pp |
Net revenue
–
ROW
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
|
2022 |
|
2021 |
|
$ |
|
% |
Cannabis flower |
$ |
63,593 |
|
|
$ |
55,194 |
|
|
$ |
8,399 |
|
|
15 |
% |
Cannabis extracts |
22,522 |
|
|
8,807 |
|
|
13,715 |
|
|
156 |
% |
Other |
634 |
|
|
560 |
|
|
74 |
|
|
13 |
% |
Net revenue |
$ |
86,749 |
|
|
$ |
64,561 |
|
|
$ |
22,188 |
|
|
34 |
% |
For 2022, the ROW segment reported net revenue of $86.7 million,
representing an increase of $22.2 million from 2021. This increase
was primarily due to higher cannabis extract sales in the Canadian
adult-use market and higher cannabis flower sales in the Israeli
medical market, partially offset by lower cannabis flower sales in
the Canadian adult-use market driven by an unfavorable price/mix
shift and the impact of the weakening Canadian dollar against the
U.S. dollar during 2022.
Cost of sales - ROW
For 2022, the ROW segment reported a year-over-year increase in
cost of sales of 2%, while net revenue increased 34%. This increase
was primarily due to higher sales volumes and lower fixed cost
absorption due to the timing of the wind-down of cultivation and
certain production activities associated with the change in the
nature of operations at the Peace Naturals Campus, partially offset
by lower cannabis biomass costs and the impact of the weakening
Canadian dollar against the U.S. dollar during 2022.
Inventory write-downs - ROW
We reported no inventory write-downs for 2022. For 2021, we
reported inventory write-downs of $12.0 million, primarily related
to cannabis strains and potency levels that were no longer in-line
with consumer preferences in the Canadian market and adjustments
for obsolete inventory in Canada.
Gross profit - ROW
For 2022, the ROW segment reported gross profit of $15.4 million,
representing an increase of $33.0 million from 2021. The
improvement in gross profit is primarily due to increased revenue
driven mainly by a favorable mix of cannabis extract products,
which carry a higher gross profit and gross margin than other
product categories, sales of cannabis flower in Israel, the absence
of inventory write-downs in 2022, and lower cannabis biomass costs,
partially offset by lower fixed cost absorption due to the timing
of the wind-down of cultivation and certain production activities
at the Peace Naturals Campus.
Summary of financial results
–
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
|
2022 |
|
2021 |
|
$ |
|
% |
Net revenue |
$ |
5,155 |
|
|
$ |
9,874 |
|
|
$ |
(4,719) |
|
|
(48) |
% |
Cost of sales |
8,622 |
|
|
9,815 |
|
|
(1,193) |
|
|
(12) |
% |
|
|
|
|
|
|
|
|
Gross profit |
$ |
(3,467) |
|
|
$ |
59 |
|
|
$ |
(3,526) |
|
|
N/M |
Gross margin |
(67) |
% |
|
1 |
% |
|
N/A |
|
(68) |
pp |
Net revenue
–
U.S.
For 2022, the U.S. segment reported net revenue of $5.2 million,
representing a decrease of $4.7 million from 2021. The decrease in
sales was driven by the decision to exit the adult beauty business,
a decrease in promotional spending and SKU rationalization efforts
as the Company implements the Realignment in the U.S.
segment.
Cost of sales
–
U.S.
For 2022, the U.S. segment reported cost of sales of $8.6 million,
representing a decrease of $1.2 million from 2021. This decrease
was primarily due to lower sales volumes due to the decision to
exit the adult beauty business, partially offset by higher
inventory reserves associated with discontinued
products.
Gross profit
–
U.S.
For 2022, the U.S. segment reported negative gross profit of $3.5
million, representing a decrease in gross profit of $3.5 million
from 2021. This decrease was primarily due to the decision to exit
the adult beauty business and higher inventory reserves associated
with discontinued products.
Non-GAAP Measures
Cronos reports its financial results in accordance with Generally
Accepted Accounting Principles in the United States (“U.S. GAAP”).
This Annual Report refers to measures not recognized under U.S.
GAAP (“non-GAAP measures”). These non-GAAP measures do not have a
standardized meaning prescribed by U.S. GAAP and are therefore
unlikely to be comparable to similar measures presented by other
companies. Rather, these non-GAAP measures are provided as a
supplement to corresponding U.S. GAAP measures to provide
additional information regarding our results of operations from
management’s perspective. Accordingly, non-GAAP measures should not
be considered a substitute for, or superior to, the financial
information prepared and presented in accordance with U.S. GAAP.
All non-GAAP measures presented in this Annual Report are
reconciled to their closest reported GAAP measure. Reconciliations
of historical adjusted financial measures to corresponding U.S.
GAAP measures are provided below.
Adjusted EBITDA
Management reviews Adjusted EBITDA, a non-GAAP measure which
excludes non-cash items or items that do not reflect management’s
assessment of ongoing business performance of our operating
segments. Management defines Adjusted EBITDA as net income (loss)
before interest, tax expense (benefit), depreciation and
amortization adjusted for: share of income (loss) from equity
method investments; impairment loss on goodwill and intangible
assets; impairment loss on long-lived assets; (gain) loss on
revaluation of derivative liabilities; (gain) loss on revaluation
of financial instruments; transaction costs related to strategic
projects; impairment loss on other investments; foreign currency
transaction loss; other, net; loss from discontinued operations;
restructuring costs; share-based compensation; and financial
statement review costs and reserves related to the restatements of
our 2019 and 2021 interim financial statements (the
“Restatements”), including the costs related to the settlement of
the SEC’s and the OSC’s investigations of the Restatements and
legal costs defending shareholder class action complaints brought
against us as a result of the 2019 restatement (see Part I, Item 3,
Legal Proceedings, of this Annual Report for a discussion of the
settlement of the SEC’s and OSC’s regulatory reviews relating to
the Restatements and shareholder class action complaints relating
to the restatement of the 2019 interim financial
statements).
Management believes that Adjusted EBITDA provides the most useful
insight into underlying business trends and results and provides a
more meaningful comparison of year-over-year results. Management
uses Adjusted EBITDA for planning, forecasting and evaluating
business and financial performance, including allocating resources
and evaluating results relative to employee compensation
targets.
Adjusted EBITDA is reconciled to net income (loss) as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of U.S. dollars) |
Year ended December 31, 2022 |
|
US |
|
ROW |
|
Corporate |
|
Total |
Net loss |
$ |
(84,194) |
|
|
$ |
(54,129) |
|
|
$ |
(30,411) |
|
|
$ |
(168,734) |
|
Interest income, net |
(4,518) |
|
|
(18,019) |
|
|
— |
|
|
(22,537) |
|
Income tax expense |
— |
|
|
34,175 |
|
|
— |
|
|
34,175 |
|
Depreciation and amortization |
1,485 |
|
|
11,637 |
|
|
— |
|
|
13,122 |
|
EBITDA |
(87,227) |
|
|
(26,336) |
|
|
(30,411) |
|
|
(143,974) |
|
Share of income from equity accounted investments |
— |
|
|
(3,114) |
|
|
— |
|
|
(3,114) |
|
|
|
|
|
|
|
|
|
Impairment loss on long-lived assets(ii)
|
— |
|
|
3,493 |
|
|
— |
|
|
3,493 |
|
Gain on revaluation of derivative liabilities(iii)
|
— |
|
|
(14,060) |
|
|
— |
|
|
(14,060) |
|
Gain on revaluation of financial instruments(iv)
|
— |
|
|
(14,739) |
|
|
— |
|
|
(14,739) |
|
|
|
|
|
|
|
|
|
Impairment loss on other investments(vi)
|
61,392 |
|
|
— |
|
|
— |
|
|
61,392 |
|
Foreign currency transaction loss |
— |
|
|
2,286 |
|
|
— |
|
|
2,286 |
|
Other, net(vii)
|
169 |
|
|
324 |
|
|
— |
|
|
493 |
|
|
|
|
|
|
|
|
|
Restructuring costs(ix)
|
1,788 |
|
|
3,545 |
|
|
— |
|
|
5,333 |
|
Share-based compensation(x)
|
3,744 |
|
|
11,371 |
|
|
— |
|
|
15,115 |
|
Financial statement review costs(xi)
|
— |
|
|
— |
|
|
7,167 |
|
|
7,167 |
|
Adjusted EBITDA |
$ |
(20,134) |
|
|
$ |
(37,230) |
|
|
$ |
(23,244) |
|
|
$ |
(80,608) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of U.S. dollars) |
Year ended December 31, 2021 |
|
US |
|
ROW |
|
Corporate |
|
Total |
Net loss |
$ |
(283,883) |
|
|
$ |
(81,811) |
|
|
$ |
(31,510) |
|
|
$ |
(397,204) |
|
Interest income, net |
(40) |
|
|
(9,031) |
|
|
— |
|
|
(9,071) |
|
Income tax benefit |
(89) |
|
|
(342) |
|
|
— |
|
|
(431) |
|
Depreciation and amortization |
917 |
|
|
14,485 |
|
|
— |
|
|
15,402 |
|
EBITDA |
(283,095) |
|
|
(76,699) |
|
|
(31,510) |
|
|
(391,304) |
|
Share of loss from equity method investments |
— |
|
|
6,313 |
|
|
— |
|
|
6,313 |
|
Impairment loss on goodwill and indefinite-lived intangible
assets(i)
|
236,019 |
|
|
37 |
|
|
— |
|
|
236,056 |
|
Impairment loss on long-lived assets(ii)
|
2,955 |
|
|
124,664 |
|
|
— |
|
|
127,619 |
|
Gain on revaluation of derivative liabilities(iii)
|
— |
|
|
(151,360) |
|
|
— |
|
|
(151,360) |
|
Gain on revaluation of financial instruments(iv)
|
— |
|
|
(8,611) |
|
|
— |
|
|
(8,611) |
|
Transaction costs(v)
|
— |
|
|
— |
|
|
3,801 |
|
|
3,801 |
|
|
|
|
|
|
|
|
|
Other, net(vii)
|
3 |
|
|
(733) |
|
|
— |
|
|
(730) |
|
Loss from discontinued operations(viii)
|
— |
|
|
500 |
|
|
— |
|
|
500 |
|
Share-based compensation(x)
|
3,401 |
|
|
6,750 |
|
|
— |
|
|
10,151 |
|
Financial statement review costs(xi)
|
— |
|
|
— |
|
|
7,102 |
|
|
7,102 |
|
Adjusted EBITDA |
$ |
(40,717) |
|
|
$ |
(99,139) |
|
|
$ |
(20,607) |
|
|
$ |
(160,463) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of U.S. dollars) |
Year ended December 31, 2020 |
|
US |
|
ROW |
|
Corporate |
|
Total |
Net income (loss) |
$ |
(77,368) |
|
|
$ |
32,671 |
|
|
$ |
(30,573) |
|
|
$ |
(75,270) |
|
Interest expense (income), net |
18 |
|
|
(18,433) |
|
|
— |
|
|
(18,415) |
|
Income tax expense |
323 |
|
|
1,024 |
|
|
— |
|
|
1,347 |
|
Depreciation and amortization |
234 |
|
|
6,811 |
|
|
— |
|
|
7,045 |
|
EBITDA |
(76,793) |
|
|
22,073 |
|
|
(30,573) |
|
|
(85,293) |
|
Share of loss from equity accounted investments |
— |
|
|
4,510 |
|
|
— |
|
|
4,510 |
|
Impairment loss on goodwill and indefinite-lived intangible
assets(i)
|
40,000 |
|
|
— |
|
|
— |
|
|
|