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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 Number: 001-38381
_____________________________
EVOLUS, INC.
(Exact name of registrant as specified in its charter)
_____________________________
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Delaware |
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46-1385614 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification Number) |
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520 Newport Center Dr., Suite 1200
Newport Beach, California 92660
(949) 284-4555
(Address, including zip code, and telephone number, including area
code, of registrant’s principal executive offices)
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Securities registered pursuant to Section 12(b) of the
Act: |
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.00001 par value per share |
EOLS |
The Nasdaq Stock Market LLC |
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Securities registered pursuant to Section 12(g) of the
Act: |
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None |
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Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities
Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing
requirements for the past 90
days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to
be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405
of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit such
files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
☐ |
Accelerated filer |
☐ |
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Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
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Emerging growth company |
☒ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards pursuant to Section 13(a) of the Exchange Act.
☒
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 ☒
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 is a shell company
(as defined in Rule 12b-2 of the
Act). Yes ☐ No ☒
The aggregate market value of the registrant’s common stock held by
non-affiliates of the registrant as of the last business day of the
registrant’s most recently completed second fiscal quarter was
approximately $423.4 million, based on the closing price of
the registrant’s common stock on the Nasdaq Global Market of
$11.60 per share for such date.
As of March 3, 2023, 56,411,661 shares of the registrant’s
sole class of common stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Not applicable.
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EVOLUS, INC.
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TABLE OF CONTENTS
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Page |
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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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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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Item 16 |
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Special Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K, or Annual Report, contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as amended, or
the Exchange Act, that involve risks and uncertainties, including
statements regarding future events, our business, financial
condition, results of operations and prospects, our industry and
the regulatory environment in which we operate. Any statements
contained herein that are not statements of historical or current
facts are forward-looking statements. In some cases, you can
identify forward-looking statements by terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” “would” or the
negative of those terms, or other comparable terms intended to
identify statements about the future. The forward-looking
statements included herein are based on our current expectations,
assumptions, estimates and projections, which we believe to be
reasonable, and are subject to risks and uncertainties that could
cause actual results to differ materially from those expressed in
the forward-looking statements. These risks and uncertainties, all
of which are difficult or impossible to predict accurately and many
of which are beyond our control, include, but are not limited to,
those made below under “Summary of Risk Factors” and in Item 1A
Risk Factors in this Annual Report.
You should carefully consider these risks, as well as the
additional risks described in other documents we file with the SEC
in the future, including subsequent Annual Reports on Form 10-K and
Quarterly Reports on Form 10-Q, which may from time to time amend,
supplement or supersede the risks and uncertainties we disclose. We
also operate in a very competitive and rapidly changing
environment. New risks emerge from time to time and it is not
possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in, or implied by, any
forward-looking statements.
In light of the significant risks and uncertainties inherent in the
forward-looking statements included herein, the inclusion of such
information should not be regarded as a representation by us or any
other person that such results will be achieved, and readers are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date hereof. Except as
required by law, we undertake no obligation to revise the
forward-looking statements contained herein to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. You should read this Annual Report on Form
10-K and the other documents we file with the SEC with the
understanding that our actual future results, levels of activity,
performance and achievements may be materially different from what
we expect. We qualify all of our forward-looking statements by the
cautionary statements referenced above.
Summary of Risk Factors
An investment in our securities involves various risks and you are
urged to carefully consider the risks discussed under Item 1A “Risk
Factors,” in this Annual Report on Form 10-K prior to making an
investment in our securities. If any of the risks below or in Item
1A “Risk Factors” occurs, our business could be materially and
adversely affected. As more fully described in Item 1A “Risk
Factors”, the principal risks and uncertainties that may affect our
business, financial condition and results of operations include,
but are not limited to, the following:
•We
currently depend entirely on the successful commercialization of
our only product, Jeuveau®.
If we are unable to successfully market and sell
Jeuveau®,
we may not generate sufficient revenue to continue our
business.
•We
have a limited operating history and have incurred significant
losses since our inception and anticipate that we will continue to
incur losses for the foreseeable future. We have only one approved
product, which, together with our limited operating history, makes
it difficult to assess our future viability.
•We
may require additional financing to fund our future operations, and
a failure to obtain additional capital when so needed on acceptable
terms, or at all, could force us to delay, limit, reduce or
terminate our operations.
•If
we or our counterparties do not comply with the terms of our
settlement agreements with Medytox, Inc., or Medytox, we may face
litigation or lose our ability to market and sell
Jeuveau®,
which would materially and adversely affect our ability to carry
out our business and our financial condition and ability to
continue as a going concern.
•The
terms of the Settlement Agreement with Medytox will reduce our
profitability and may affect the extent of any discounts we may
offer to our customers.
•Our
business, financial condition and operations have been, and may in
the future be, adversely affected by the COVID-19 outbreak or other
similar outbreaks.
•We
rely on the license and supply agreement, as amended, with
Daewoong, which we refer to as the Daewoong Agreement, to provide
us with exclusive rights to distribute Jeuveau®
in certain territories. Any termination or loss of significant
rights, including exclusivity, under the Daewoong Agreement would
materially and adversely affect our development and
commercialization of Jeuveau®.
•Our
failure to successfully in-license, acquire, develop and market
additional product candidates or approved products would impair our
ability to grow our business.
•Jeuveau®
faces, and any of our future product candidates will face,
significant competition and our failure to effectively compete may
prevent us from achieving significant market penetration and
expansion.
•Jeuveau®
may fail to achieve the broad degree of physician adoption and use
or consumer demand necessary for commercial success.
•Our
ability to market Jeuveau®
is limited to use for the treatment of glabellar lines, and if we
want to expand the indications for which we market
Jeuveau®,
we will need to obtain additional regulatory approvals, which will
be expensive and may not be granted.
•Third
party claims of intellectual property infringement may prevent or
delay our commercialization efforts and interrupt our supply of
products.
•If
we or any of our current or future licensors, including Daewoong,
are unable to maintain, obtain or protect intellectual property
rights related to Jeuveau®
or any of our future product candidates, we may not be able to
compete effectively in our market.
•We
may need to increase the size of our organization, including our
sales and marketing capabilities in order to further market and
sell Jeuveau®
and we may experience difficulties in managing this
growth.
•We
rely on our digital technology and applications and our business
and operations would suffer in the event of computer system
failures or breach.
•We
are subject to extensive government regulation, and we may face
delays in or not obtain regulatory approval of our product
candidates and our compliance with ongoing regulatory requirements
may result in significant additional expense, limit or delay
regulatory approval or subject us to penalties if we fail to
comply.
Unless the context indicates otherwise, as used in this Annual
Report on Form 10-K, the terms “Evolus,” “company,” “we,” “us” and
“our” refer to Evolus, Inc., a Delaware corporation, and our
subsidiaries taken as a whole, unless otherwise noted.
EVOLUS™,
Jeuveau®,
Evolux®
are three of our trademarks that are used in this Annual Report on
Form 10-K. Jeuveau®
is the trade name in the United States for our approved product
with non-proprietary name, prabotulinumtoxinA-xvfs. The product has
different trade names outside of the United States, including
Nuceiva®
in Canada, Europe and Australia, but is referred to throughout this
Annual Report on Form 10-K as Jeuveau®.
This Annual Report on Form 10-K also includes trademarks, trade
names and service marks that are the property of other
organizations, such as BOTOX®
and BOTOX®
Cosmetic, which we refer to throughout this Annual Report on Form
10-K as BOTOX. Solely for convenience, trademarks and trade names
referred to in this Annual Report on Form 10-K may appear without
the ® and ™ symbols, but those references are not intended to
indicate that we will not assert, to the fullest extent under
applicable law, our rights, or that the applicable owner will not
assert its rights, to these trademarks and trade names. We do not
intend our use or display of other companies’ trade names or
trademarks to imply a relationship with, or endorsement or
sponsorship of us by, any other companies.
Website References
In this Annual Report on Form 10-K, we make references to our
website at www.evolus.com. References to our website through this
Form 10-K are provided for convenience only and the content on our
website does not constitute a part of, and shall not be deemed
incorporated by reference into, this Annual Report on Form
10-K.
Part I
Item 1. Business.
Overview
We are a performance beauty company with a customer-centric
approach to delivering breakthrough products in the self-pay
aesthetic market.
Our first commercial product is Jeuveau®,
which is a proprietary 900 kilodalton, or kDa, purified botulinum
toxin type A formulation indicated for the temporary improvement in
the appearance of moderate to severe glabellar lines, also known as
“frown lines,” in adults. Our primary market is the self-pay
aesthetic market, which includes medical products purchased by
physicians and other customers that are then sold to consumers or
used in procedures for aesthetic indications that are not
reimbursed by any third-party payor, such as Medicaid, Medicare or
commercial insurance. We believe we offer customers and consumers a
compelling value proposition with Jeuveau®.
Currently, BOTOX (onabotulinumtoxinA) is the neurotoxin market
leader, and prior to the approval of Jeuveau®,
was the only known 900 kDa botulinum toxin type A complex approved
in the United States. We believe aesthetic physicians generally
prefer the performance characteristics of the complete 900 kDa
neurotoxin complex and are accustomed to injecting this
formulation.
United States
In February 2019, we received the approval of our first product
Jeuveau®
(prabotulinumtoxinA-xvfs) from the U.S. Food and Drug
Administration, or FDA. In May 2019, we commercially launched
Jeuveau®
in the United States.
In November 2021, we announced the initiation of a Phase II
clinical trial designed to investigate a higher strength dose of
Jeuveau®
in the glabellar lines. We completed our patient enrollment in the
clinical study evaluating the “extra-strength” dose in the second
quarter of 2022 and the trial is expected to be completed in the
first half of 2023. If this indication is approved by the FDA after
our completion of all necessary clinical trials and regulatory
submissions (including a Phase III clinical trial), we will have
the opportunity to offer an extra-strength dosage option, which may
make Jeuveau®
the first multi-strength neurotoxin and give customers and
consumers increased treatment options.
International
In August 2018, we received approval from Health Canada for
the temporary improvement in the appearance of moderate to severe
glabellar lines in adult patients under 65 years of age. We
began marketing Jeuveau®
in Canada in October 2019 through our distribution partner, Clarion
Medical Technologies, Inc., or Clarion.
In September 2019, we received approval from the European
Commission, to market Jeuveau®
in all 27 European Union, or EU, member states plus the United
Kingdom, Iceland, Norway and Liechtenstein. In January 2021, we
received a positive decision from the European Commission to add
the 50 unit product to the existing approval obtained in September
2019. We commercially launched Jeuveau®
in Great Britain in September 2022, in Germany and Austria in
February 2023, and we are finalizing plans for entering additional
countries in Europe as part of a phased rollout.
In January 2023, we received approval from the Australian
Therapeutics Good Administration, or TGA, for regulatory approval
of our neurotoxin in Australia.
Our Market
Our primary market is self-pay aesthetic healthcare, which includes
medical products purchased by physicians that are then sold to
consumers or used in procedures for aesthetic indications that are
not reimbursed by any third-party payor, such as Medicaid, Medicare
or commercial insurance. By focusing on the self-pay medical
aesthetics market, we believe we are not exposed to reimbursement
risk associated with a reliance on payments from such third-party
payors, and we are subject to fewer regulations that place limits
on the types of marketing and other interactions we have with
physicians.
According to Medical Insight’s The Global Aesthetic Market Study,
within the self-pay aesthetic market, the global aesthetic
neurotoxin market is estimated to grow to approximately $6.4
billion in 2026 and the U.S. aesthetic neurotoxin market is
expected to grow to approximately $3.7 billion in 2026. According
to Clarivate Aesthetic Injectables Market Insights, the European
aesthetic neurotoxin market is expected to grow to approximately
$662 million in 2026.
We believe the growth in the medical aesthetics market is driven by
a number of factors, including:
•increased
use by millennials who are increasingly seeking medical aesthetic
treatments and utilizing neurotoxins as an entry point for
aesthetic procedures due to their minimally invasive
nature;
•an
aging population together with an increasing life expectancy, which
is resulting in more consumers with a desire for improved
appearance and well-being over a longer period of
time;
•rising
disposable income, with the U.S. Bureau of Economic Analysis
reporting that real disposable income in the United States
increased approximately 19% from December 2012 to December
2022;
•growing
awareness, utilization and acceptance of elective or minimally
invasive aesthetic procedures; and
•continued
innovation and improved accessibility to these treatments due to an
increase in the number of physicians who perform these
procedures.
Within the multiple age groups that receive aesthetic neurotoxin
treatments, we strategically focus our marketing efforts on the
millennial segment which is the largest cohort in the U.S.
population. In 2019 there were estimated to be approximately 73
million millennials, defined as individuals born between 1981 and
1996. We believe that approximately 1.7 million females between the
age of 30 and 39, which includes many individuals we define as
millennials, are considering neurotoxins in the next twelve
months.
Our Competitive Strengths
We offer physicians and consumers a compelling value proposition
because:
•Jeuveau®
offers the market the first known 900 kDa neurotoxin alternative to
BOTOX.
The manufacture of both Jeuveau®
and BOTOX starts with a 900 kDa complex, includes adding the
excipients human serum albumin, or HSA, and sodium chloride, and
finishes by vacuum drying. We believe Jeuveau®
is the only known neurotoxin product in the United States with a
900 kDa neurotoxin complex other than BOTOX. We also believe an
important component of competitiveness in the neurotoxin market
relates to the characteristics associated with the 900 kDa complex
and the potential of the accessory proteins to increase the
effectiveness of the active toxin portion of the
complex.
•Enhanced
level of physician-customer interaction through a self-pay,
aesthetic-only marketing strategy.
We have elected to specifically target the self-pay aesthetic
market. With a reduced regulatory burden compared to third-party
payor reimbursed therapeutic products, there is a number of
benefits that market participants in reimbursed markets are unable
to achieve, such as an enhanced level of interaction with our
physician-customers. Jeuveau®
is the only U.S. neurotoxin without a therapeutic indication. We
believe pursuing an aesthetic-only non-reimbursed product strategy
creates meaningful strategic advantages in the United States,
including pricing and marketing flexibility. We utilize this
flexibility to drive market adoption through programs such as
promotional events, co-branded marketing programs and pricing
strategies.
•We
offer a unique technology platform.
We provide a simple, personal and connected experience for
physicians utilizing our proprietary technology platform. We have
built and continue to improve our platform with the goal of
limiting friction and enhancing the overall experience for
physicians and ultimately consumers. We are modernizing the
customer engagement with our proprietary “Evolus Practice” app. We
not only leverage technology for operational efficiency, but more
importantly, to enhance a customer’s experience. We believe the
combination of a highly specialized sales force and our technology
platform is an effective and competitive model.
•Results
from our TRANSPARENCY global clinical program in more than 2,100
patients provides robust data to physicians evaluating the purchase
of Jeuveau®.
We believe the comprehensive TRANSPARENCY clinical data set,
including a head-to-head Phase III study comparing
Jeuveau®
and BOTOX, provides physicians with confidence in recommending
Jeuveau®
to their patients.
•Our
management team has significant experience and expertise in medical
aesthetics.
Our management team has extensive experience in self-pay healthcare
markets, in the development, market launch and commercialization of
major medical products, execution and integration of business
development transactions and understanding of the regulatory
environment of the healthcare markets. Key members of our
leadership team have also served in relevant senior leadership
positions with leading aesthetic companies.
Our Strategy
We launched Jeuveau®
in the United States with our own specialty sales organization now
consisting of over 100 positions between representatives,
management and other sales employees and in Canada through our
distribution partner, Clarion. We launched in Great Britain in
September 2022, in Germany and Austria in February 2023 and plan to
launch in additional European countries and Australia. We plan to
expand our product offerings over time through in-licensing,
partnerships and acquisitions and by launching our products
internationally. The key components of our strategy
are:
•Pursue
an aesthetic-only strategy to enhance marketing and pricing
flexibility along with improving transparency for our
customers.
•Launch
directly or partner outside of the United States to reach and serve
physicians and consumers in those territories.
•Leverage
our differentiated digital platform to efficiently open new
accounts, personalize the purchasing process and efficiently deploy
marketing programs at scale, including co-branded
media.
•Establish
a leading medical aesthetics company with a diversified product
offering by in-licensing technology, developing partnerships and
potentially acquiring products.
Jeuveau®
Overview
Jeuveau®
is an injectable formulation of a 900 kDa botulinum toxin type A
complex designed to address the needs of the large and growing
facial aesthetics market.
Jeuveau®
contains a 900 kDa botulinum toxin type A complex produced by the
bacterium
Clostridium botulinum.
The active part of the neurotoxin is the 150 kDa component, and the
remaining 750 kDa of the complex is made up of accessory proteins
that we believe help with the function of the active portion of the
toxin. Jeuveau®
has the same mechanism of action as other type A botulinum toxins.
When injected intramuscularly at therapeutic doses, botulinum toxin
causes a chemical denervation of the muscle resulting in localized
reduction of muscle activity. Botulinum toxin type A specifically
blocks peripheral acetylcholine release at presynaptic cholinergic
nerve terminals by cleaving SNAP-25, a protein integral to the
successful docking and release of acetylcholine from vesicles
situated within the nerve endings leading to denervation and
relaxation of the muscle.
TRANSPARENCY: Evolus Clinical Development for Glabellar
Lines
TRANSPARENCY was a comprehensive five-study clinical development
program for Jeuveau®
and was used to meet the regulatory requirements for a Biologics
License Application, or BLA, in the United States, a Marketing
Authorisation Application, or MAA, in the EU, and a New Drug
Submission, or NDS, in Canada, for the treatment of moderate to
severe glabellar lines. The TRANSPARENCY program, which was
developed in consultation with the FDA, Canadian, and European
regulatory bodies, included three multicenter, randomized,
double-blinded, controlled, single dose Phase III studies titled
EV-001, EV-002 and EVB-003. Treatment of the Glabellar lines was
based on a 4-point photonumeric Glabellar Line Scale, or GLS, where
0=no lines, 1=mild lines, 2=moderate lines and 3=severe
lines.
U.S. Phase III Clinical Trials
–
Composite End Point Versus Placebo
The two identical U.S. Phase III studies, EV-001 and EV-002 (the
“U.S. Phase III Studies”), enrolled a combined 654 adults who had
moderate to severe glabellar lines at maximum frown. Subjects were
randomly assigned in a 3:1 ratio to receive a single treatment of
either Jeuveau®
or placebo. The primary efficacy endpoint was defined as the
proportion of subjects classified as responders on Day 30. A
subject was considered a responder only if both the investigator
and the subject independently agreed that there was a 2 point
improvement or greater on the GLS from Day 0 to Day 30 at maximum
frown. This type of endpoint where both the investigator and
subject must agree is known as a composite endpoint.
Both of the U.S. Phase III studies met the primary endpoint of
superiority over placebo. The percentages of responders in the
intent to treat population were:
•EV-001:
1.2% placebo, 67.5% Jeuveau®,
with an absolute difference between the groups of 66.3%, 95% CI
(59.0, 72.4)
•EV-002:
1.3% placebo, 70.4% Jeuveau®,
with an absolute difference between the groups of 69.1%, 95% CI
(61.5, 75.1)
EU Phase III Clinical Trials – Head-to-Head Comparison of
Jeuveau®,
Botox and Placebo
The EVB-003 study was the third Phase III safety and efficacy study
in the TRANSPARENCY Program and compared the efficacy of
Jeuveau®,
Botox and Placebo. The study was conducted in Europe and Canada and
enrolled 540 adults who (i) the investigator assessed to have
moderate to severe glabellar lines and (ii) who felt their
glabellar lines had an important psychological impact, such as on
their mood, anxiety or depressive symptoms. Subjects were randomly
assigned in a 5:5:1 ratio to receive a single treatment of 20 units
of Jeuveau®,
20 units of BOTOX or placebo.
The primary efficacy endpoint was defined as the proportion of
subjects classified as responders on Day 30. A responder was a
subject with a GLS score of 0 or 1, as assessed by the investigator
at maximum frown. The primary analysis of the primary efficacy
endpoint in the EVB-003 study showed the superiority of
Jeuveau®
over placebo, and established non-inferiority of
Jeuveau®
to BOTOX. The percentages of responders for the primary efficacy
endpoint were:
•4.2%
in the placebo group, 95% CI (0.0, 9.8);
•82.8%
in the BOTOX group, 95% CI (78.1, 87.5); and
•87.2%
in the Jeuveau®
group, 95% CI (83.0, 91.5).
A confidence interval, or CI, is a range of values in which,
statistically, there is a specified level of confidence where the
result lies. As an example, in the results above for this Phase III
study, the results indicate that there is a 95% level of confidence
that the responder rate for placebo was between 0.0% and 9.8%,
which we express as: 95% CI (0.0, 9.8).
The absolute differences between the treatment groups
were:
•83.1%
between Jeuveau®
and placebo groups, 95% CI (70.3, 89.4), (p<0.001), indicating
Jeuveau®
was superior to placebo; and
•4.4%
between Jeuveau®
and BOTOX groups, 95% CI (-1.9, 10.8), with non‑inferiority of
Jeuveau®
versus BOTOX concluded based on the lower bound of the 95% CI for
the absolute difference exceeding -10.0%.
|
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EU Phase III Primary Endpoint - Responder Rates at Maximum Frown on
Day 30 (GLS = 0 or 1) by Investigator Assessment |
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EU Phase III Primary Endpoint - Non-Inferiority, at Maximum Frown
on Day 30 by Investigator Assessment |
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EU and Canadian Phase III Trial - Adverse Event Rate
Summary
EU and Canadian Phase III Trial - Select Secondary
Endpoints
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*P-Value Placebo vs Jeuveau®
<0.001
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TRANSPARENCY Safety Evaluations
Safety was studied across all five studies that made up the
TRANSPARENCY Clinical Program. Jeuveau®
was relatively well tolerated with no drug related serious adverse
events, or SAEs. Most adverse events were mild and the labeling
information for Jeuveau®
lists the most common adverse reactions as headache (9.3%), eyelid
ptosis (2.0%), upper respiratory tract infections (3%) and increase
white blood cell count (1%).
Pipeline
Phase II “Extra-Strength” Clinical Trial
In November 2021, we announced the initiation of a Phase II
clinical trial designed to investigate a higher strength dose of
Jeuveau®
in the glabellar lines. This planned glabellar line study is a
controlled, randomized, prospective, double blind, three-arm trial
following patients out to a maximum of 12 months. Three-arms will
be enrolled: the currently approved 20 units of BOTOX and 20 units
of Jeuveau®
compared to 40 units of “extra-strength” Jeuveau®.
In January 2023, we announced positive interim results from the
Phase II clinical trial. The interim data analysis of the
“extra-strength” formulation of Jeuveau®
demonstrated a median duration of at least 26 weeks based on the
time for patients to return to their original glabellar line scale
score (baseline) and the duration of at least one point improvement
on the same scale. The safety results included 33 adverse events,
88% of which rated as mild and 12% of which rated at moderate.
There were no severe or serious adverse events observed in the
safety results. The trial is expected to be completed in the first
half of 2023, and final results will be presented in the second
half of 2023.
Manufacturing
Daewoong Pharmaceuticals Co. Ltd., or Daewoong, manufactures and
supplies Jeuveau®
to us. Daewoong has over 70 years of experience manufacturing
pharmaceutical products and is one of the largest pharmaceutical
companies in South Korea. Daewoong constructed a facility in South
Korea where Jeuveau®
is produced. We believe this facility will be sufficient to meet
demand for Jeuveau®
for the foreseeable future. The FDA conducted a current Good
Manufacturing Practice, or cGMP, and pre-approval inspection of the
facility in November 2017 in connection with our BLA for
Jeuveau®.
The UK Medicines
and Healthcare Products Regulatory Agency, or MHRA, also completed
an inspection of the manufacturing facility in February 2018 in
connection with our Marketing Authorisation Application, or MAA.
The U.S. FDA approval of Jeuveau®
in February 2019 included approval to manufacture
Jeuveau®
at Daewoong’s facility.
Daewoong License and Supply Agreement
In 2013, we entered into the Daewoong Agreement, which has been
amended from time to time, pursuant to which Daewoong agreed to
manufacture and supply Jeuveau®
and grant us an exclusive license to import, distribute, promote,
market, develop, offer for sale and otherwise commercialize and
exploit Jeuveau®
for aesthetic indications in the United States, EU, United Kingdom,
members of the European Economic Area, Switzerland, Canada,
Australia, certain members of the Commonwealth of Independent
States, or CIS, and South Africa, as well as co-exclusive
distribution rights with Daewoong in Japan. Under the Daewoong
Agreement, we are required to make certain minimum annual purchases
in order to maintain the exclusivity of the license. If we fail to
meet these purchase requirements, Daewoong may, at its option,
convert the exclusive license for such covered territory to a
non-exclusive license. These minimum purchase obligations are
contingent upon the occurrence of future events, including receipt
of governmental approvals and our future market share in various
jurisdictions. Under the Daewoong Agreement, Daewoong is
responsible for all costs related to the manufacturing of
Jeuveau®,
including costs related to the operation and upkeep of its
manufacturing facility, and we are responsible for all costs
related to obtaining regulatory approval, including clinical
expenses, and commercialization of Jeuveau®.
The initial term of the Daewoong Agreement expires September 30,
2023, and automatically renews for unlimited additional three-year
terms if we meet certain performance requirements. We expect to
meet these performance requirements. The Daewoong Agreement will
terminate (A) upon written notice by either us or Daewoong upon a
continuing default that remains uncured within 90 days (or 30 days
for a payment default) by the other party, or (B) without notice
upon the bankruptcy or insolvency of our company.
Under the Daewoong Agreement, we are the sole owner of any
marketing authorization and clinical trial results we pursue in a
covered territory. However, if we do not renew the Daewoong
Agreement or upon termination of the Daewoong Agreement due to a
breach by us, we are obligated to transfer our rights to
Daewoong.
Impact of Settlement Agreements
In February 2021, we settled litigation claims related to a
complaint against us filed by Allergan, Inc. and Allergan Limited
(together, “Allergan”) and Medytox, Inc. (“Medytox”) in the U.S.
International Trade Commission related to
Jeuveau®
(the “ITC Action”) and certain related matters by entering into a
Settlement and License Agreement with Medytox and Allergan, which
we refer to as the U.S. Settlement Agreement, and another
Settlement and License Agreement with Medytox, which we refer to as
the Medytox Settlement Agreement. We refer to the U.S. Settlement
Agreement and the Medytox Settlement Agreement collectively as the
Medytox/Allergan Settlement Agreements.
We have completed all obligations to Allergan and the majority of
our obligations to Medytox under the Medytox/Allergan Settlement
Agreements. These completed obligations consisted of
(i) cash payments of
$35.0 million
in multiple payments to Allergan and Medytox, of which we
paid
$15.0 million
in the third quarter of 2021,
$15.0 million
in the first quarter of 2022, and
$5.0 million
in the first quarter of 2023, (ii) royalty payments to Allergan and
Medytox on the sale of Jeuveau®,
based on a certain dollar amount per vial sold of Licensed Products
by or on our behalf in the United States, from December 16, 2020
through September 16, 2022, (iii) royalty payments to Medytox, from
December 16, 2020 to September 16, 2022, of a low-double digit
percentage of net sales of Jeuveau®
sold by us or on our behalf in territories we have licensed outside
the United States, and (iv) the issuance of 6,762,652 shares of our
common stock to Medytox.
Going forward, our remaining obligation will be to pay Medytox a
mid-single digit royalty percentage on net sales of
Jeuveau®
in the United States and all territories we have licensed outside
the United States through September 16, 2032.
Competition
Our primary competitors are companies offering injectable dose
forms of botulinum toxin. There are only five approved injectable
botulinum toxin type A neurotoxins in the United States, including
Jeuveau®.
There are also other injectable botulinum toxin type A products
being developed for the U.S. market. We believe the primary
competing products in this market include BOTOX, Dysport, Xeomin
and Daxxify:
•BOTOX,
marketed by Allergan, received FDA approval in 2002 for glabellar
lines. Allergan (now AbbVie) was the first company to market
neurotoxins for aesthetic purposes.
•Dysport,
marketed by Galderma S.A., or Galderma, received FDA approval in
2009 for glabellar lines.
•Xeomin,
marketed by Merz Pharma GmbH & Co., or Merz, received FDA
approval in 2011 for glabellar lines.
•Daxxify,
marketed by Revance Therapeutics, Inc., or Revance, received FDA
approval in late 2022 for glabellar lines.
Additionally, Hugel Inc., has submitted a BLA to the FDA for an
injectable botulinum toxin type A neurotoxin. If the Hugel BLA is
approved, we expect the competition in the U.S. injectable
botulinum toxin market to further increase. Most of our primary
competitors are also approved to sell injectable botulinum toxin
type A neurotoxins in Europe and other markets that we may
enter.
In addition to the companies commercializing and developing
neurotoxins, there are other products and treatments that may
indirectly compete with Jeuveau®,
such as dermal fillers, laser treatments, brow lifts, chemical
peels, fat injections and removal and cold therapy. We compete with
various companies that have products in these medical aesthetic
categories. Among these companies are Allergan (now AbbVie),
Sanofi, Revance, Sun Pharma, Valeant Pharmaceuticals International,
Inc., or Valeant, Mentor Worldwide LLC, a division of Johnson &
Johnson, Merz, Galderma, and Skinceuticals, a division of L’Oreal
SA. In addition, we are aware of other companies also developing
and/or marketing products in one or more of our target markets,
including competing injectable botulinum toxin type A formulations
that are in various phases of development in North America for the
treatment of glabellar lines.
Seasonality
Historically, given the limited history of the commercialization of
Jeuveau®,
the impact of the COVID-19 outbreak and the impact of the ITC
remedial orders, we have not observed significant seasonality in
our net revenues up to the second half of 2022. However, we are
aware that historically the aesthetic neurotoxin market generally
experiences higher revenue in the second and fourth calendar
quarters as compared to the first and third calendar
quarters.
Government Regulation in the United States
We operate in a highly regulated industry that is subject to
significant federal, state, local and foreign regulation. Our
business has been, and will continue to be, subject to a variety of
laws including the Federal Food Drug and Cosmetic Act, or FFDCA,
and the Public Health Service Act, or the PHS Act, among others.
Biologics and medical devices are subject to regulation under the
FFDCA and PHS Act.
In the United States, cosmetics, dietary supplements,
biopharmaceutical products and medical devices are subject to
extensive regulation by the FDA. The FFDCA, PHS Act, and other
federal and state statutes and regulations, govern, among other
things, the research, development, testing, manufacture, storage,
recordkeeping, regulatory approval, license or clearance, labeling,
promotion and marketing, distribution, post-approval monitoring and
reporting, sampling, and import and export of these products.
Failure to comply with applicable U.S. requirements may subject a
company to a variety of administrative or judicial sanctions, such
as FDA refusal to approve pending license or marketing
applications, warning letters and other enforcement actions,
product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, fines, civil penalties and
criminal prosecution.
FDA Marketing Approval
The process required by the FDA before a biological product may be
marketed in the United States generally involves the
following:
•completion
of nonclinical laboratory tests and animal studies according to
good laboratory practices, or GLPs, and applicable requirements for
the humane use of laboratory animals or other applicable
regulations;
•submission
to the FDA of an investigative new drug application, or IND, which
must become effective before human clinical trials may
begin;
•performance
of adequate and well-controlled human clinical trials to establish
the safety and efficacy of the proposed biological product for its
intended use, according to the FDA’s regulations, commonly referred
to as good clinical practices, or GCPs, and any additional
requirements including those for the protection of human research
subjects and their health and other personal
information;
•submission
to the FDA of a BLA for marketing approval that includes
substantive evidence of safety;
•purity
and potency from results of nonclinical testing and clinical
trials;
•satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities where the biological product is produced to assess
compliance with cGMP, to assure that the facilities, methods and
controls are adequate to preserve the biological product’s
identity, strength, quality and purity and, if applicable, the
FDA’s current good tissue practices for the use of human cellular
and tissue products;
•potential
FDA audits of the nonclinical study and clinical trial sites that
generated the data in support of the BLA; and
•FDA
review and approval of the BLA.
Post-Approval Requirements
Once a BLA is approved, a product is subject to certain
post-approval requirements. For instance, the FDA closely regulates
the post-approval marketing and promotion of biologics, including
standards and regulations, off-label promotion, industry-sponsored
scientific and educational activities and promotional activities
involving the internet. Biologics may be marketed only for the
approved indications and in accordance with the provisions of the
approved labeling. Adverse event reporting and submission of
periodic reports is required following FDA approval of a BLA. The
FDA also may require post-marketing testing, known as Phase IV
testing, Risk Evaluation and Mitigation Strategies, or REMS, and
surveillance to monitor the effects of an approved product or place
conditions on an approval that could restrict the distribution or
use of the product. In addition, quality control as well as product
manufacturing, packaging and labeling procedures must continue to
conform to cGMP after approval. Manufacturers and certain of their
subcontractors are required to register their establishments with
the FDA and certain state agencies, and are subject to periodic
unannounced inspections by the FDA during which the agency inspects
manufacturing facilities to assess compliance with applicable
regulations such as cGMP and the Quality System Regulation.
Accordingly, manufacturers must continue to expend time, money and
effort in the areas of production and quality control to maintain
compliance with cGMP. Regulatory authorities may withdraw product
approvals or request product recalls if a company fails to comply
with regulatory standards, if it encounters problems following
initial marketing, or if previously unrecognized problems are
subsequently discovered.
Other Regulation of the Healthcare Industry
While we do not currently have plans for our neurotoxin product to
be covered by insurance or government reimbursement programs, if we
were to offer reimbursable products, we could be subject to federal
laws and regulations covering reimbursable products, such as the
Anti-Kickback Statute, Stark Law and Physician Payment Sunshine
Act. These laws that may affect our ability to operate include, but
are not limited to:
•The
Anti-Kickback Statute, which prohibit persons from knowingly and
willfully soliciting, offering, receiving or providing
remuneration, directly or indirectly, in cash or in kind, to induce
either the referral of an individual, or furnishing or arranging
for a good or service, for which payment may be made under a
federal healthcare program;
•The
Federal False Claims Act which imposes civil and criminal liability
on individuals and entities who submit, or cause to be submitted,
false or fraudulent claims for payment to the
government;
•The
Federal Civil Monetary Penalties Law, which prohibits, among other
things, offering or transferring remuneration to a federal
healthcare beneficiary that a person knows or should know is likely
to influence the beneficiary’s decision to order or receive items
or services reimbursable by the government from a particular
provider or supplier;
•The
Foreign Corrupt Practices Act (“FCPA”), which prohibits certain
payments made to foreign government officials;
•The
Federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, which created new federal criminal statutes that
prohibit knowingly and willfully executing, or attempting to
execute, a scheme to defraud or to obtain, by means of false or
fraudulent pretenses, representations, or promises, any of the
money or property owned by, or under the custody or control of, any
healthcare benefit program, including private third-party payors
and knowingly and willfully falsifying, concealing or covering up
by trick, scheme or device a material fact or making
any materially false, fictitious or fraudulent statement in
connection with the delivery of or payment for healthcare benefits,
items or services relating to healthcare matters;
•The
Federal Physician Payments Sunshine Act, and its implementing
regulations, which require that certain manufacturers of drugs,
medical devices, biologics, and medical supplies for which payment
is available under Medicare, Medicaid, or the Children’s Health
Insurance Program (with certain exceptions) to report to the CMS
information related to certain payments or other transfers of value
made or distributed to physicians, which is defined broadly to
include other healthcare providers, teaching hospitals, and
ownership and investment interests held by physicians and their
immediate family members; and
•State
and foreign law equivalents of the foregoing and state laws
regarding pharmaceutical company marketing compliance, reporting
and disclosure obligations.
If our operations are found to be in violation of any of these
laws, regulations, rules or policies or any other law or
governmental regulation, or if interpretations of the foregoing
change, we may be subject to civil and criminal penalties, damages,
fines and the curtailment or restructuring of our
operations.
Government Regulation in Europe
In the European Economic Area, or EEA (which is composed of the 27
Member States of the EU plus Norway, Iceland and Liechtenstein),
medicinal products can only be commercialized after obtaining a
Marketing Authorization, or MA.
There are two types of MAs:
•The
Community MA, which is issued by the European Commission through
the Centralized Procedure, based on the opinion of the Committee
for Medicinal Products for Human Use, or CHMP, of the EMA and which
is valid throughout the entire territory of the EEA. The
Centralized Procedure is mandatory for certain types of products,
such as biotechnology medicinal products, orphan medicinal
products, and medicinal products indicated for the treatment of
AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune
and viral diseases. The Centralized Procedure is optional for
products containing a new active substance not yet authorized in
the EEA, or for products that constitute a significant therapeutic,
scientific or technical innovation or which are in the interest of
public health in the EU.
•National
MAs, which are issued by the competent authorities of the Member
States of the EEA and only cover their respective territory, are
available for products not falling within the mandatory scope of
the Centralized Procedure.
Because we are a biotechnology medicinal products company, we are
eligible for a Community MA under the Centralized
Procedure.
Under the above described procedures, before granting the MA, the
EMA or the competent authorities of the Member States of the EEA
make an assessment of the risk-benefit balance of the product on
the basis of scientific criteria concerning its quality, safety and
efficacy.
Regulation Outside of the United States and Europe
In addition to regulations in the United States and EU, we may be
subject to a variety of regulations in other jurisdictions
governing manufacturing, clinical trials, commercial sales and
distribution of our future products. Whether or not we obtain FDA
approval or MA approval for a product candidate, we must obtain
approval of the product by the comparable regulatory authorities of
foreign countries before commencing clinical trials or marketing in
those countries. The approval process varies from country to
country, and the time may be longer or shorter than that required
for FDA approval or MA approval. The requirements governing the
conduct of clinical trials, product licensing, pricing and
reimbursement vary greatly from country to country.
Data Privacy and Security Laws and Regulations
We are also subject to data privacy and security regulation by the
federal government, states and non-U.S. jurisdictions in which we
conduct our business. For example, HIPAA, as amended by the Health
Information Technology and Clinical Health Act, or HITECH, and its
implementing regulations, imposes certain requirements relating to
the privacy, security and transmission of individually identifiable
health information. Among other things, HITECH makes HIPAA’s
privacy and security standards directly applicable to “business
associates,” those independent contractors or agents of covered
entities that
create, receive, maintain, transmit or obtain protected health
information in connection with providing a service on behalf of a
covered entity. HITECH also increased the civil and criminal
penalties that may be imposed against covered entities, business
associates and possibly other persons, and gave state attorneys
general new authority to file civil actions for damages or
injunctions in federal courts to enforce the federal HIPAA laws and
seek attorney’s fees and costs associated with pursuing federal
civil actions. In addition, state and non-U.S. laws, including the
General Data Protection Regulation adopted by the EU, govern the
privacy and security of health and other personal information in
certain circumstances, many of which differ from each other in
significant ways and may not have the same effect, thus
complicating compliance efforts.
There are numerous other laws and legislative and regulatory
initiatives at the federal and state levels addressing privacy and
security concerns. We also remain subject to federal or state
privacy-related laws that are more restrictive than the privacy
regulations issued under HIPAA. These laws vary and could impose
additional penalties. For example, the Federal Trade Commission
uses its consumer protection authority to initiate enforcement
actions in response to alleged privacy and data security
violations. Further, certain states have proposed or enacted
legislation that will create new data privacy and security
obligations for certain entities, such as the California Consumer
Privacy Act, or CCPA, which came into effect January 1, 2020 and
was recently amended and expanded by the California Privacy Rights
Act, or the CRPA, passed on November 3, 2020. The CCPA and CPRA,
among other things, create new data privacy obligations for covered
companies and provides new privacy rights to California residents,
including the right to opt out of certain disclosures of their
information. The CCPA also created a private right of action with
statutory damages for certain data breaches, thereby potentially
increasing risks associated with a data breach. It remains unclear
what, if any, additional modifications will be made to the CPRA by
the California legislature or how it will be interpreted.
Therefore, the effects of the CCPA and CPRA are significant and
will likely require us to modify our data processing practices and
may cause us to incur substantial costs and expenses to comply,
particularly given our base of operations in
California.
Environmental Regulation
We are subject to numerous foreign, federal, state, and local
environmental, health and safety laws and regulations relating to,
among other matters, safe working conditions, manufacturing
practices, fire hazard control, product stewardship and end-of-life
handling or disposition of products, and environmental protection,
including those governing the generation, storage, handling, use,
transportation and disposal of hazardous or potentially hazardous
substances and biological materials. We believe that we have been
and remain in substantial compliance with all applicable
environmental laws and regulations and that we currently have no
liabilities under such environmental requirements that could
reasonably be expected to materially harm our business, results of
operations or financial condition.
Human Capital Resources
As of December 31, 2022, we had 215 employees, all of whom
were full-time in the United States and United Kingdom, and 70% of
our full-time employees were women. None of our employees are
represented by labor unions or covered by collective bargaining
agreements, and we have never experienced any work stoppage. We
believe we have good relations with our employees.
Attracting and Developing Talent
We believe that our employees are our greatest asset, and our
future success largely depends upon our continued ability to
attract and retain high caliber talent. Talent management is
critical to our ability to execute our long-term growth strategy.
To facilitate talent attraction and retention, we strive to make
our company a rewarding workplace. We provide opportunities for our
employees to grow and develop in their careers, through
professional development, leadership coaching, formal and informal
training opportunities, and an annual performance review process to
encourage ongoing growth and development. These opportunities are
supported by strong total rewards packages, and by programs that
build connections among our employees.
Compensation and Benefits
We are committed to a Total Rewards strategy that complements our
mission, culture, and business objectives. Our goal is to provide
competitive compensation and benefit programs that drive a high
level of employee satisfaction and allow us to attract and retain
the best and brightest talent. We want employees to feel at their
best and be at their best so they can make a profound impact on our
culture, community and business results. Compensation and benefits
are two of the main pillars of our total rewards package. We
provide total cash compensation (base pay and bonus/commission)
that is highly competitive in the labor markets in which we compete
for talent. We also ensure that pay is internally equitable by
differentiating rewards based on employee performance and impact to
the company. This empowers employees to take ownership over their
career
and development trajectory. Long-term incentives in the form of
equity (Stock Options and RSUs) provide a sense of ownership in the
company’s long-term success and help retain talent that can make a
difference. We also provide a robust and highly competitive
benefits package to ensure employees’ personal and family needs are
met whether it’s health (medical/dental/vision), wealth and
retirement (401k with competitive employer match), or well-being
(flexible PTO, paid leave, wellness coaching). We want employees to
know that we are investing in their success so they can bring the
best version of themselves each day.
Health, Safety and Wellness
We are committed to the health, safety and wellness of our
employees. We provide our employees with access to a variety of
health and wellness programs, including programs that support
physical and mental health and well-being by providing tools,
resources, and coaching to help them improve or maintain a healthy
lifestyle. We maintain a healthy workplace by encouraging employees
to work remotely if feeling ill, and by maintaining many of the
changes implemented in response to COVID-19 including our hybrid
work schedule, access to tests and sanitary supplies.
Inclusion and Belonging
We promote an inclusive culture that values equity, opportunity,
and respect. In 2019, we formed an employee-led Culture &
Belonging Council. This council has a vision to create and foster a
culture that reflects diversity and inclusion so that each of our
employees has a sense of belonging as their authentic, unique
selves. In support of our inclusive culture, we provide a variety
of diversity, equity, and inclusion trainings, including
unconscious bias training for employees and managers to strengthen
employee awareness and strive to recruit a diverse talent pool
across all levels of the organization. We are an equal opportunity
employer and believe that diverse and differentiated views
contribute to making us a better organization. It is our conscious
effort to support and promote equal opportunity for all our
employees within the workplace.
Our company has been built on the belief and commitment of evolving
together. This applies not only to our employees and customers, but
also to the communities in which we operate. We offer paid
volunteer time off to our employees and encourage our team of
employees to become involved in their communities, lending their
voluntary support to programs that positively impact the quality of
life within these communities. We value the impact of ongoing
volunteer opportunities with community partners Orangewood
Foundation, Samueli Academy and the Jesse Rees
Foundation.
Corporate Information
Our principal executive offices are located at 520 Newport
Center Drive, Suite 1200, Newport Beach, California 92660, and
our telephone number is (949) 284-4555. Our website address is
www.evolus.com. We do not incorporate the information on or
accessible through our website into this Annual Report on Form
10-K, and you should not consider any information on, or that can
be accessed through, our website a part of this Annual Report on
Form 10-K or any other filing we make with the SEC. We are an
emerging growth company under the Jumpstart Our Business Startups
Act of 2012 and also a smaller reporting company, and therefore we
are subject to reduced public company reporting
requirements.
Available Information
We make available, free of charge, on our website at www.evolus.com
our annual reports on Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K and any amendments to such reports, as
soon as reasonably practicable after such reports are
electronically filed with, or furnished to, the SEC. All such
reports are also available free of charge via EDGAR through the SEC
website at www.sec.gov. We do not incorporate the information
on or accessible through these websites into this Annual Report on
Form 10-K, and you should not consider any information on, or that
can be accessed through, these websites a part of this Annual
Report on Form 10-K or any other filing we make with the
SEC.
Item 1A. Risk Factors.
An investment in our company involves a high degree of risk. You
should carefully consider the risks and uncertainties described
below, together with all the other information in this Annual
Report on Form 10-K, including Item 7“Management’s Discussion and
Analysis of Financial Condition and Results of Operations” and the
consolidated financial statements and the notes thereto included in
Item 8 “Financial Statements and Supplementary Data.” If any of the
following risks actually occurs, our business, reputation,
financial condition, results of operations, revenue, and future
prospects could be seriously harmed. The risks and uncertainties
described below are not the only ones we face. Additional risks and
uncertainties that we are unaware of, or that we currently believe
are not material, may also become important factors that adversely
affect our business. Unless otherwise indicated, references to our
business being seriously harmed in these risk factors will include
harm to our business, reputation, financial condition, results of
operations, revenue and future prospects. In that event, the market
price of our common stock could decline, and you could lose part or
all of your investment.
Risks Related to Our Business and Strategy
We currently depend entirely on the successful commercialization of
our only product, Jeuveau®.
If we are unable to successfully market and sell
Jeuveau®,
we may not generate sufficient revenue to continue our
business.
We currently have only one product, Jeuveau®,
and our business presently depends entirely on our ability to
successfully market and sell it in a timely manner. While the
product was commercially launched in the United States in May 2019,
through a distribution partner in Canada in October 2019, in Great
Britain in September 2022, and in Germany and Austria in February
2023, we have a limited history of generating revenue for
Jeuveau®.
Our near-term prospects, including our ability to generate revenue,
as well as our future growth, depend entirely on the successful
commercialization of Jeuveau®.
The commercial success of Jeuveau®
will depend on a number of factors, including our ability to
successfully commercialize Jeuveau®,
whether alone or in collaboration with others, including our
ability to hire, retain and train sales representatives in the
United States. Our ability to market and sell
Jeuveau®
is also dependent on the willingness of consumers to pay for
Jeuveau®
relative to other discretionary items, especially during
economically challenging times. Additional factors necessary for
the successful commercialization of Jeuveau®
include the availability, perceived advantages, relative cost,
relative safety of Jeuveau®
and relative efficacy of competing products, the timing of new
product introductions by us or our competitors, and the sales and
marketing tactics of our competitors, including bundling of
multiple products, in response to our launch of
Jeuveau®.
Each of these factors may vary on a country by country basis as we
expand our operations.
If we do not achieve one or more of these factors, many of which
are beyond our control, in a timely manner or at all, we could
experience significant issues commercializing
Jeuveau®.
Further, we may never be able to successfully market and sell
Jeuveau®
or any future product candidates. In addition, our experience as a
commercial company is limited. Accordingly, we may not be able to
generate sufficient revenue through the sale of
Jeuveau®
or any future product candidates to continue our
business.
We have a limited operating history and have incurred significant
losses since our inception and anticipate that we may incur losses
in the future. We have only one product and limited commercial
sales, which, together with our limited operating history, makes it
difficult to assess our future viability.
We are a performance beauty company with a limited operating
history. To date, we have invested substantially all of our efforts
and financial resources in the clinical development, regulatory
approval, and commercial launch of Jeuveau®,
which is currently our only product. We began selling
Jeuveau®
in the United States in May 2019, through a distribution partner in
Canada in October 2019, in Great Britain in September 2022 and in
Germany and Austria in February 2023 and have a limited history of
generating revenue. We have incurred losses in each year since our
inception in 2012. We have a limited operating history upon which
you can evaluate our business and prospects. Consequently, any
predictions about our future success, performance or viability may
not be as accurate as they could be if we had a longer operating
history or greater experience commercializing a product. In
addition, we have limited experience and have not yet demonstrated
an ability to successfully overcome many of the risks and
uncertainties frequently encountered by companies in the medical
aesthetics field. We continue to incur significant expenses related
to the commercialization of Jeuveau®.
We have recorded net losses of $74.4 million and $46.8 million for
the years ended December 31, 2022 and 2021, respectively, and
had an accumulated deficit as of December 31, 2022 of $497.3
million. Our ability to achieve revenue and profitability is
dependent on our ability to successfully market and sell
Jeuveau®.
Even if we achieve profitability in the future, we may not be able
to sustain profitability in subsequent periods. Our prior losses,
combined with expected future losses, may adversely affect the
market price of our common stock and, if needed, our ability to
raise capital to continue operations.
We may require additional financing to fund our future operations,
and a failure to obtain additional capital when so needed on
acceptable terms, or at all, could force us to delay, limit, reduce
or terminate our operations.
We have utilized substantial amounts of cash since our inception in
order to conduct clinical development to support regulatory
approval and launch of Jeuveau®
in the United States, Europe, Canada, and Australia. We expect that
we will continue to expend substantial resources for the
foreseeable future in order to continue to market and sell
Jeuveau®
and for the clinical development of any additional product
candidates we may choose to pursue. While we believe that we
currently have adequate capital resources, which consist of cash
and cash equivalents and cash generated from operations, to operate
our business until our business generates profits and positive cash
flow, this belief is based upon certain financial assumptions
including net revenue, gross margin, working capital and expense
assumptions. If these assumptions are incorrect, or if we
experience other risks or uncertainties set forth in this Annual
Report on Form 10-K, we may require additional capital to operate
our business.
We expect to expend resources furthering the development and
continuation of our marketing programs and commercialization
infrastructure in connection with commercializing
Jeuveau®
within and outside of the United States. In the long term, our
expenditures will include costs associated with the continued
commercialization of Jeuveau®,
research and development, approval and commercialization of
products and any of our future product candidates, including our
proposed higher strength dose of Jeuveau®,
such as research and development, conducting preclinical studies
and clinical trials and manufacturing and supplying as well as
marketing and selling any products approved for sale. Because the
commercialization expenditures needed to meet our sales objectives
are highly uncertain, we cannot reasonably estimate the actual
amounts necessary to successfully market and sell
Jeuveau®.
We may in the future, also, acquire other companies or products
which may be costly and which may require additional capital to
operate. In addition, other unanticipated costs may arise.
Accordingly, our actual cash needs may exceed our
expectations.
If we were to raise additional capital through marketing and
distribution arrangements or other collaborations, strategic
alliances or licensing arrangements with third parties, we may have
to relinquish certain valuable rights to our product candidates,
technologies, future revenue streams or research programs or grant
licenses on terms that may not be favorable to us. If we raise
additional capital through public or private equity offerings or
offerings of securities convertible into our equity, the ownership
interest of our existing stockholders will be diluted and the terms
of any such securities may have a preference over our common stock.
Debt financing, receivables financing and royalty financing may
also be coupled with an equity component, such as warrants to
purchase our capital stock, which could also result in dilution of
our existing stockholders’ ownership, and such dilution may be
material. Additionally, if we raise additional capital through debt
financing, we will have increased fixed payment obligations and may
be subject to covenants limiting or restricting our ability to take
specific actions, such as incurring additional debt or making
capital expenditures to meet specified financial ratios, and other
operational restrictions, any of which could restrict our ability
to market and sell Jeuveau®
or any future product candidates or operate as a business and may
result in liens being placed on our assets. If we were to default
on any of our indebtedness, we could lose such assets.
In addition, the global economy, including the financial and credit
markets, has recently experienced significant volatility and
disruptions, including severely diminished liquidity and credit
availability and rising interest rates. In the event we are unable
to raise sufficient capital to fund our commercialization efforts
to achieve specified minimum sales targets under the Daewoong
Agreement, we will lose exclusivity of the license that we have
been granted under the Daewoong Agreement. In addition, if we are
unable to raise additional capital when required or on acceptable
terms, we will be required to take actions to address our liquidity
needs which may include the following: significantly reduce
operating expenses and delay, reduce the scope of or discontinue
some of our development programs, commercialization efforts or
other aspects of our business plan, out-license intellectual
property rights to our product candidates and sell unsecured
assets, or a combination of the above. As a result, our ability to
achieve profitability or to respond to competitive pressures would
be significantly limited and may have a material adverse effect on
our business, results of operations, financial condition and/or our
ability to fund our scheduled obligations on a timely basis or at
all.
If we or our counterparties do not comply with the terms of our
settlement agreement with Medytox, we may face litigation or lose
our ability to market and sell Jeuveau®,
which would materially and adversely affect our ability to carry
out our business and our financial condition and ability to
continue as a going concern.
Effective February 18, 2021, we entered into a Settlement and
License Agreement with Medytox which we refer to as the Medytox
Settlement Agreement.
Under the Medytox Settlement Agreement we obtained (i) a license to
commercialize, manufacture and to have manufactured for us certain
products identified in the Medytox Settlement Agreements, including
Jeuveau®
(the “Licensed Products”), in the United States and other
territories where we license Jeuveau®,
(ii) the dismissal of outstanding litigation against us, including
the ITC Action, a rescission of the related remedial orders, and
the dismissal of a civil case in the Superior Court of California
against us, which we refer to together with any claims (including
claims brought in Korean courts) with a common nexus of fact as the
Medytox/Allergan Actions, and (iii) releases of claims against us
for the Medytox/Allergan Actions. Going forward we are obligated to
pay to Medytox a mid-single digit royalty percentage on net sales
of Jeuveau®
in the United States and all territories we have licensed outside
the United States until September 16, 2032. In addition, under the
Medytox Settlement Agreement we made certain representations and
warranties and agreed to certain customary positive and negative
covenants.
In the event we fail to comply with the terms of the Medytox
Settlement Agreement, subject to applicable cure periods, Medytox
would have the ability to terminate the Medytox Settlement
Agreement and thereby cancel the licenses granted to us and
re-institute litigation against us. Any litigation may result in
remedies against our products, resulting in either an injunction
prohibiting our sales, or with respect to our sales, an obligation
on our part to pay royalties and/or other forms of compensation to
third parties, any of which would materially and adversely affect
our ability to generate revenue from Jeuveau®,
to carry out our business, and to continue as a going
concern.
Additionally, if Medytox fails to comply with the terms of the
Medytox Settlement Agreement and comply with the covenants and
agreements under the Medytox Settlement Agreement, it could
materially and adversely affect our ability to generate revenue
from Jeuveau®,
to carry out our business, and to continue as a going concern. For
example, as required by the Medytox Settlement Agreement, in
February 2021 Medytox filed a document with the Korean court that
its litigation with Daewoong would not affect Evolus’ right to have
Jeuveau®
manufactured by Daewoong or exported to Evolus. If Medytox were to
breach the Medytox Settlement Agreement and rescind this filing and
the Korean court issued a ruling against Daewoong, our supply of
Jeuveau®
could be hindered. We would also be required to engage in costly
and time-consuming litigation in order to enforce our rights under
the Medytox Settlement Agreement.
The terms of the Medytox Settlement Agreement will reduce our
profitability until the royalty obligations expire, and may affect
the extent of any discounts we may offer to our
customers.
As a result of the royalty payments that we are required to pay
under the Medytox Settlement Agreement, our profitability has and
will be adversely impacted for the period that we are required to
pay royalties. We may be able to offset a portion of the loss of
profitability by decreasing any discount to customers on
Jeuveau®
as compared to discounts we provided to customers prior to the
Medytox Settlement Agreement. If we reduce discounts for any
customers, their volume of purchases may decrease which would have
a material and adverse effect on our business and results of
operations.
We are subject to risks associated with a public health crisis,
including the COVID-19 pandemic and other outbreaks of contagious
diseases.
We are subject to risks associated with public health crises,
including relating to the COVID-19 pandemic. The COVID-19 pandemic
had, and may continue to have, a material adverse effects on our
business, financial condition, results of operations and cash
flows. Other public health crises, including any future outbreaks
of contagious diseases, could have a similar material adverse
effect on our business. Financial and operational impacts that we
experienced in connection with the COVID-19 pandemic, and may
experience as a result of future COVID-19 outbreaks or other public
health crises, include:
•a
decline in the rates of elective procedures;
•difficulties
in enrolling patients in clinical programs;
•changes
in the availability of our key personnel;
•temporary
closures of our facilities or the facilities of our business
partners, customers, third party service providers or other
vendors;
•interruptions
to our supply chain and distribution channels; and
•downstream
economic effects, including disruptions capital or financial
markets, increased inflation and rising interest
rates.
Depending on the severity of the financial and operational impacts,
our business, financial condition, and results of operations may be
materially adversely impacted. The extent to which any future
public health crises may impact our business, results of
operations, and financial condition depends on many factors which
are highly uncertain and are difficult to predict. These factors
include, but are not limited to, the duration and spread of any
outbreak, its severity, the actions to contain or address the
impact of the outbreak, the timing, distribution, and efficacy of
vaccines and other treatments, United States and foreign government
actions to respond to possible reductions in global economic
activity, and how quickly and to what extent normal economic and
operating conditions can resume.
Unfavorable global economic conditions could adversely affect our
business, financial condition or results of
operations.
Because we do not expect Jeuveau®
for the treatment of glabellar lines to be reimbursed by any
government or third-party payor, our only product is and will
continue to be paid for directly by the consumer. Demand for
Jeuveau®
is accordingly tied to the discretionary spending levels of our
targeted consumer population. A severe or prolonged economic
downturn or inflation in consumer prices, as we are currently
experiencing, could result in a variety of risks to our business,
including a decline in the discretionary spending of our target
consumer population, which could lead to a weakened demand for
Jeuveau®
or any future product candidates. A severe or prolonged economic
downturn may also affect our ability to raise additional capital
when needed on acceptable terms, if at all. A weak or declining
economy could also strain our suppliers, possibly resulting in
supply disruption, or cause our customers to delay making payments
for our products. Inflation in the markets we serve could similarly
impact our revenues, as consumer spending power could decline. Any
of the foregoing could harm our business.
In addition, our business strategy was developed based on a number
of important assumptions about the self-pay healthcare market. For
example, we believe that the number of self-pay healthcare
procedures will increase in the future. However, these trends are
uncertain and limited sources exist to obtain reliable market data.
Therefore, sales of Jeuveau®
or any of our future product candidates could differ materially
from our projections if our assumptions are incorrect.
Jeuveau®
faces, and any of our future product candidates will face,
significant competition and our failure to effectively compete may
prevent us from achieving significant market penetration and
expansion.
Jeuveau®
is approved for use in facial aesthetic medicine. The facial
aesthetic market is highly competitive and dynamic and is
characterized by rapid and substantial technological development
and product innovations. We have received regulatory approval of
Jeuveau®
for the treatment of glabellar lines and launched commercially in
the United States, Great Britain, Germany and Austria and through a
distribution partner in Canada. We anticipate that
Jeuveau®
will face significant competition from other facial aesthetic
products, such as other injectable and topical botulinum toxins and
dermal fillers. Jeuveau®
may also compete with unapproved and off-label treatments. Many of
our potential competitors, including Allergan, and now AbbVie Inc.,
which acquired Allergan, who first launched BOTOX for cosmetic uses
in 2002 and has since maintained the highest market share position
in the aesthetic neurotoxin market with its BOTOX product, are
large, experienced companies that enjoy significant competitive
advantages, such as substantially greater financial resources
enabling them to, among other things, market and discount
aggressively. Competitors may also have greater brand recognition
for their products, larger sales forces and larger aesthetic
product portfolios allowing the companies to bundle products to
provide customers more choices and to further discount their
products. Additionally, our competitors have greater existing
market share in the aesthetic neurotoxin product market and
long-standing customer loyalty programs and sales contracts with
large customers which creates established business and financial
relationships with customers, aesthetic societies and
universities.
These competitors may also try to compete with
Jeuveau®
on price both directly, through rebates and promotional programs to
high volume physicians and coupons to consumers, and indirectly,
through attractive product bundling with complimentary products,
such as dermal fillers that offer convenience and an effectively
lower price compared to the total price of purchasing each product
separately. These companies may also seek to compete based on their
longer operating history. Larger companies may be better
capitalized than us and, accordingly, are able to offer greater
customer loyalty benefits to encourage repeat use of their products
and finance a sustained global advertising campaign to compete with
our
commercialization efforts at launch. A number of our larger
competitors also have access to a significant number of studies and
publications that they could use to compete with us.
In the long term, we expect to expand our focus to the broader
self-pay healthcare market. Competitors and other parties may seek
to impact regulatory approval of our future product applications
through the filing of citizen petitions or other similar documents,
which could require costly and time-consuming responses to the
regulatory agencies. Larger competitors could seek to prevent or
delay our commercialization efforts via costly litigation which can
be lengthy and expensive and serve to distract our management
team’s attention. We could face competition from other sources as
well, including academic institutions, governmental agencies and
public and private research institutions. In addition, we are aware
of other companies also developing and/or marketing products in one
or more of our target markets, including competing injectable
botulinum toxin type A formulations that are currently in Phase III
clinical development in North America for the treatment of
glabellar lines. For example, Revance Therapeutics, Inc. obtained
approval for an injectable botulinum toxin type A neurotoxin on
September 8, 2022, called “Daxxify.” Additionally, Hugel Inc.,
submitted a BLA to the FDA for an injectable botulinum toxin type A
neurotoxin and received a Complete Response Letter from the FDA in
March 2022. With the approval of Revance Therapeutic’s BLA and the
potential approval of Hugel, Inc.’s BLA, we expect the competition
in the U.S. injectable botulinum toxin market to further increase.
We would face similar risks with respect to any future product
candidates that we may seek to develop or commercialize in the
broader self-pay healthcare market. Successful competitors in that
market have the ability to effectively discover, obtain patents,
develop, test and obtain regulatory approvals for products, as well
as the ability to effectively commercialize, market and promote
approved products, including communicating the effectiveness,
safety and value of products to actual and prospective customers
and medical staff.
Our strategy of competing in the aesthetic neurotoxin market is
dependent on the marketing and pricing flexibility that we believe
is afforded to a company with a portfolio limited to self-pay
healthcare, comprised of products and procedures that are not
reimbursed by third-party payors. In the event that regulations
applicable to reimbursed products are changed to apply to self-pay
healthcare products, we would no longer have this flexibility and
we may not be able to compete as effectively with our competitors
which may have a material effect on our business, financial
condition and results of operations. Additionally, as a result of
the royalty payments that we are required to pay under the Medytox
Settlement Agreement, we may not be able to discount
Jeuveau®
to the extent that we previously provided discounts to customers
without impacting our gross profit margins. If we increase prices
for any customers, their volume of purchases may decrease which
would have a material and adverse effect on our business and
results of operations.
In addition, competitors may develop new technologies within the
aesthetic market that may be superior in safety and efficacy to
Jeuveau®
or offer alternatives to the use of toxins, including surgical and
radio frequency techniques. To compete successfully in the
aesthetic market, we will have to demonstrate that
Jeuveau®
is at least as safe and effective as current products sold by our
competitors. Competition in the aesthetic market could result in
price-cutting and reduced profit margins, any of which would harm
our business, financial condition and results of
operations.
Due to less stringent regulatory requirements, there are many more
aesthetic products and procedures available for use in
international markets than are approved for use in the United
States. There are also fewer limitations on the claims that our
competitors in international markets can make about the
effectiveness of their products and the manner in which they can
market them. As a result, we expect to face more competition in
these markets than in the United States.
Our commercial opportunity could also be reduced or eliminated if
our competitors develop and commercialize products that are safer,
are more effective, have fewer or less severe side effects, are
more convenient or are less expensive than
Jeuveau®
or any other product that we may develop. Our competitors also may
obtain FDA or other regulatory approval for these products more
rapidly than we may obtain approval for our products, which could
result in our competitors establishing a strong market position
before we are able to enter the market, which may create additional
barriers to successfully commercializing Jeuveau®
and any future product candidates and attracting physician and
consumer demand.
Jeuveau®
may fail to achieve the broad degree of physician adoption and use
or consumer demand necessary for continued commercial
success.
Jeuveau®
may fail to gain sufficient market acceptance by physicians,
consumers and others in the medical aesthetics community to
continue to grow our net revenues. The continued commercial success
of Jeuveau®
and any future product candidates, including a proposed higher
strength dose of Jeuveau®,
will depend significantly on the broad adoption and use of the
resulting product by physicians for approved indications,
including, in the case of Jeuveau®,
the treatment of glabellar lines and other aesthetic indications
that we may seek to pursue. We are aware that other companies are
seeking to develop alternative products and treatments, any of
which could impact the demand for Jeuveau®.
The degree and rate of physician adoption of
Jeuveau®
and any future product candidates depend on a number of factors,
including the cost, profitability to our customers, consumer
demand, characteristics and effectiveness of the product. Our
success will also depend our ability to create compelling marketing
programs, training of our customers and ability to overcome any
biases physicians or consumers may have toward the use, safety and
efficacy of existing products over Jeuveau®.
Moreover, our competitors may utilize negative selling efforts or
offer more compelling marketing or discounting programs than we are
able to offer, including by bundling multiple aesthetic products to
provide a more comprehensive offering than we can as
Jeuveau®
is currently our sole product.
In addition, in its clinical trials, Jeuveau®
was clinically tested and compared to BOTOX.
Jeuveau®
is the only known neurotoxin product in the United States with a
900 kDa complex other than BOTOX. We believe that aesthetic
physicians’ familiarity with the 900 kDa complex’s handling,
preparation and dosing will more easily facilitate incorporation of
Jeuveau®
into their practices. However, the ease of integration of
Jeuveau®
into a physician’s practice may not be as seamless as we
anticipate.
With respect to consumer demand, the treatment of glabellar lines
with Jeuveau®
is an elective procedure, the cost of which must be borne by the
consumer, and we do not expect costs related to the treatment to be
reimbursable through any third-party payor, such as Medicaid,
Medicare or commercial insurance. The decision by a consumer to
undergo treatment with Jeuveau®
for the treatment of glabellar lines or other aesthetic indications
that we may pursue may be influenced by a number of factors,
including the cost, efficacy, safety, perception, marketing
programs for, and physician recommendations of
Jeuveau®
versus competitive products or procedures. Moreover, consumer
demand may fluctuate over time as a result of consumer sentiment
about the benefits and risks of aesthetic procedures generally and
Jeuveau®
in particular, changes in demographics and social trends, rising
inflation and general consumer confidence and consumer
discretionary spending, which may be impacted by the COVID-19
outbreak, economic and political conditions.
If Jeuveau®
or any future product candidates fail to achieve the broad degree
of physician adoption necessary for commercial success or the
requisite consumer demand, our operating results and financial
condition will be adversely affected, which may delay, prevent or
limit our ability to generate revenue and continue our
business.
Our ability to market Jeuveau®
is limited to use for the treatment of glabellar lines, and if we
want to expand the indications for which we market
Jeuveau®,
we will need to obtain additional regulatory approvals, which will
be expensive and may not be granted.
We have received regulatory approval for Jeuveau®
in the United States for the treatment of moderate to severe
glabellar lines. The terms of that approval restrict our ability to
market or advertise Jeuveau®
for other indications, which could limit physician and consumer
adoption. Under the U.S. Federal Food Drug and Cosmetic Act, we may
generally only market Jeuveau®
for approved indications. Many of our competitors have received
approval of multiple aesthetic and therapeutic indications for
their neurotoxin products and may be able to market such products
for use in a way we cannot. For example, we are aware that one of
our competitors, Allergan (now AbbVie), has obtained and plans to
obtain additional indications for its neurotoxin product within
medical aesthetics and, therefore, is able to market its product
across a greater number of indications than
Jeuveau®.
If we are unable to obtain approval for indications in addition to
our approval for glabellar lines, our marketing efforts for
Jeuveau®
will be severely limited. As a result, we may not generate
physician and consumer demand or approval of
Jeuveau®.
We rely on our digital technology and applications and our business
and operations would suffer in the event of computer system
failures or breach.
We are reliant on our digital technology, including our Evolus
Practice App, which allows customers to open a new account, order
Jeuveau®,
pay invoices and engage with our customer experience team and
medical affairs representatives. In the event that our digital
technology is unable to function in the manner it was designed or
at all, we would experience difficulty processing customer orders
and requests in a timely manner or at all which would have a
material adverse effect on our business, results of operations and
financial condition.
The systems underlying our digital technology may not be adequately
designed or may not operate with the reliability and redundancy
necessary to avoid performance delays or outages that could be
harmful to our business. If our digital technology is unavailable
when customers attempt to access them, or if they do not load as
quickly as expected, users may not use our technology as often in
the future, or at all, and our ability to sell
Jeuveau®
through a more limited sales force may be disrupted and we may not
realize the efficiencies of leveraging our digital technology, any
of which could adversely affect our business and financial
performance. As the number of users of our digital technology
continues to grow we will need an increasing amount of technical
infrastructure, including network capacity and computing power, to
continue to satisfy our
needs. It is possible that we may fail to continue to effectively
scale and grow our technical infrastructure to accommodate these
increased demands, which may adversely affect our customers’
experience with our digital technology which may decrease our
revenue and harm our results of operations.
Despite the implementation of security measures, our internal
computer systems, and those of third parties on which we rely, are
vulnerable to disruption or damage from computer viruses, malware,
natural disasters, terrorism, war, telecommunication and electrical
failures, cyberattacks or cyber intrusions, insider threats,
persons who access our systems in an unauthorized manner, or
inadvertent misconfiguration of our systems. The risk of a security
incident or system disruption, particularly through cyberattacks or
cyber intrusions, including by computer hackers, foreign
governments and cybercriminals, has generally increased as the
number, intensity and sophistication of attempted attacks and
intrusions from around the world have increased. Interruptions in
our operations caused by such an event could result in a material
disruption of our current or future product development programs.
The costs to us to mitigate network security problems, bugs,
viruses, worms, malicious software programs and security
vulnerabilities could be significant, and while we have implemented
security measures to protect our data security and information
technology systems, our efforts to address these problems may not
be successful, and these problems could result in unexpected
interruptions, delays, cessation of service, government files or
penalties and other harm to our business and our competitive
position. Interruptions in our operations caused by such an event
could also result in a material disruption in our relationship with
our customers. For example, if our Evolus Practice App were
rendered inoperable, we would have to process orders by telephone
or otherwise which may result in slower processing times and harm
to our reputation.
Moreover, a computer security incident that affects our systems or
results in the unauthorized access to financial information,
personally identifiable information (PII), customer information or
data, including credit card transaction data or other sensitive
information, could materially damage our reputation. In addition,
such a security incident may require notification to governmental
agencies, the media or individuals pursuant to various
international, federal and state privacy and security laws,
including the General Data Protection Regulation (GDPR), the Health
Insurance Portability and Accountability Act of 1996, as amended by
the Health Information Technology for Clinical Health Act of 2009,
and its implementing rules and regulations, as well as regulations
promulgated by the Federal Trade Commission and state breach
notification laws. Additionally, the regulatory environment
governing information, security and privacy laws is increasingly
demanding and continues to evolve and a number of states have
adopted laws and regulations that may affect our privacy and data
security practices regarding the use, disclosure and protection of
PII. For example, the California Consumer Privacy Act, among other
things, has created new individual privacy rights and imposes
increased obligations on companies handling PII. In the event of a
security incident, we would also be exposed to the risk of
litigation and potential liability, which could materially
adversely affect our business, results of operations and financial
condition. Our liability insurance may not be sufficient in type or
amount to cover us against claims related to security breaches,
cyberattacks and other related security incidents.
Jeuveau®
or any other product candidate for which we seek approval as a
biologic may face competition sooner than anticipated.
With the enactment of the Biologics Price Competition and
Innovation Act of 2009, or the BPCI Act, as part of the Patient
Protection and Affordable Care Act, an abbreviated pathway for the
approval of biosimilar or interchangeable biological products was
created. The abbreviated regulatory pathway establishes legal
authority for the FDA to review and approve biosimilar biologics.
Under the BPCI Act, an application for a biosimilar product cannot
be approved by the FDA until twelve years after the original
branded product was approved under a Biologics License Application,
or BLA. The law is complex and is still being interpreted and
implemented by the FDA. For example, one company has filed a
Citizen Petition requesting that the FDA not apply the BPCI Act to
pre-enactment BLAs. As a result, its ultimate impact,
implementation and meaning are subject to uncertainty. While it is
uncertain when such processes intended to implement the BPCI Act
may be fully adopted by the FDA, any such processes could have a
material adverse effect on the future commercial prospects for our
biological products.
We believe that Jeuveau®
should qualify for the twelve-year period of exclusivity. However,
there is a risk that this exclusivity could be shortened due to
congressional action or otherwise, or that the FDA will not
consider any of our product candidates to be a reference product
for competing products, potentially creating the opportunity for
competition sooner than anticipated. Moreover, the extent to which
a biosimilar product, once approved, will be substituted for any
one of our reference products in a way that is similar to
traditional generic substitution for non-biological products is not
yet clear and will depend on a number of marketplace and regulatory
factors that are still developing.
If we are found to have improperly promoted off-label uses, or if
physicians misuse our products or use our products off-label, we
may become subject to prohibitions on the sale or marketing of our
products, significant fines, penalties, sanctions, or product
liability claims, and our image and reputation within the industry
and marketplace could be harmed.
The FDA and other regulatory agencies strictly regulate the
marketing and promotional claims that are made about pharmaceutical
products, such as Jeuveau®.
In particular, a product may not be promoted for uses or
indications that are not approved by the FDA or other similar
regulatory authorities as reflected in the product’s approved
labeling. Physicians could use Jeuveau®
on their patients in a manner that is inconsistent with the
approved label of the treatment of moderate to severe glabellar
lines, potentially including for the treatment of other aesthetic
or therapeutic indications. If we are found to have promoted such
off-label uses, we may receive warning letters from and be subject
to other enforcement actions by the FDA, the European Medicines
Agency, or EMA, and other regulatory agencies, and become subject
to significant liability, which would materially harm our business.
The federal government has levied large civil and criminal fines
against companies for alleged improper promotion and has enjoined
several companies from engaging in off-label promotion. If we
become the target of such an investigation or prosecution based on
our marketing and promotional practices, we could face similar
sanctions, which would materially harm our business. In addition,
management’s attention could be diverted from our business
operations, significant legal expenses could be incurred, and our
reputation could be damaged. The FDA has also required that
companies enter into consent decrees or permanent injunctions under
which specified promotional conduct is changed or curtailed in
order to resolve FDA enforcement actions. If we are deemed by the
FDA to have engaged in the promotion of our products for off-label
use, we could be subject to FDA prohibitions or other restrictions
on the sale or marketing of our products and other operations or
significant fines and penalties, and the imposition of these
sanctions could also affect our reputation and position within the
industry. In addition, regulatory authorities outside the United
States may impose similar fines, penalties or
sanctions.
Physicians may also misuse Jeuveau®
or any future product candidates or use improper techniques,
potentially leading to adverse results, side effects or injury,
which may lead to product liability claims. If
Jeuveau®
or any future product candidates are misused or used with improper
techniques or are determined to cause or contribute to consumer
harm, we may become subject to costly litigation by our customers
or their patients. Product liability claims could divert
management’s attention from our core business, be expensive to
defend, result in sizable damage awards against us that may not be
covered by insurance and subject us to negative publicity resulting
in reduced sales of our products. Furthermore, the use of
Jeuveau®
or any future product candidates for indications other than those
cleared by the FDA may not effectively treat such conditions, which
could harm our reputation in the marketplace among physicians and
consumers. Any of these events could harm our business and results
of operations and cause our stock price to decline.
Jeuveau®
or any of our future product candidates may cause serious or
undesirable side effects or possess other unexpected properties
that could delay or prevent their regulatory approval, limit the
commercial profile of approved labeling, result in post-approval
regulatory action or in product liability lawsuits.
Unforeseen side effects from Jeuveau®
or our future product candidates could arise either during clinical
development or after marketing such product. Undesirable side
effects caused by product candidates could cause us or regulatory
authorities to interrupt, modify, delay or halt clinical trials and
could result in a more restrictive label or the delay or denial of
regulatory approval by the FDA, the EMA or similar regulatory
authorities. Results of clinical trials could reveal a high and
unacceptable severity and prevalence of side effects. In such an
event, trials could be suspended or terminated and the FDA, the EMA
or similar regulatory authorities could order us to cease further
development of or deny approval of product candidates for any or
all targeted indications. The drug-related side effects could
affect patient recruitment or the ability of enrolled patients to
complete the trial or result in product liability claims. Any of
these occurrences may harm our business, financial condition,
operating results and prospects.
Additionally, if we or others identify undesirable side effects, or
other previously unknown problems, caused by
Jeuveau®,
or any of our future product candidates, after obtaining regulatory
approval in the United States or other jurisdictions, a number of
potentially negative consequences could result, including
regulatory authorities withdrawing approval or limiting the
marketing of our products, requiring a recall of the product,
requiring additional warnings on our product labeling or medication
guides or instituting Risk Evaluation and Mitigation Strategies, or
REMS. In order to mitigate these risks, regulatory authorities may
require additional costly clinical trials or costly post-marketing
testing and surveillance to monitor the safety or efficacy of the
product. As a result of any of these actions our sales of the
product may decrease significantly, we may be required to expend
material amounts to comply with any requirements of the regulatory
authorities, we could be sued in a product liability lawsuit and
held liable for harm caused to patients, and our brand and
reputation may suffer.
We face an inherent risk of product liability as a result of the
commercialization of Jeuveau®
and any of our future product
candidates. For example, we may be sued if any product we develop
allegedly causes injury or is found to be otherwise unsuitable
during product testing, manufacturing, marketing or sale. Any such
product liability claims may include allegations of defects in
manufacturing, defects in design, a failure to warn of dangers
inherent in the product, negligence, strict liability and a breach
of warranties. Claims could also be asserted against us under state
consumer protection acts. If we cannot successfully defend
ourselves against product liability claims, we may incur
substantial liabilities or be required to limit commercialization
of our products. Even a successful defense would require
significant financial and management resources and result in
decreased demand for Jeuveau®
or any future product candidates or products we may develop,
termination of clinical trial sites or entire trial programs,
injury to our reputation and significant negative media attention,
withdrawal of clinical trial participants or cancellation of
clinical trials and significant costs and diversion management’s
time to defend the related litigation.
Our inability to obtain and maintain sufficient product liability
insurance at an acceptable cost and scope of coverage to protect
against potential product liability claims could prevent or inhibit
the commercialization of Jeuveau®
or any future products that we develop. We currently carry product
liability insurance covering our clinical trials. Although we
maintain such insurance, any claim that may be brought against us
could result in a court judgment or settlement in an amount that is
not covered, in whole or in part, by our insurance or that is in
excess of the limits of our insurance coverage. Our insurance
policies also have various exclusions and deductibles, and we may
be subject to a product liability claim for which we have no
coverage. We will have to pay any amounts awarded by a court or
negotiated in a settlement that exceed our coverage limitations or
that are not covered by our insurance, and we may not have, or be
able to obtain, sufficient capital to pay such amounts. Moreover,
in the future, we may not be able to maintain insurance coverage at
a reasonable cost or in sufficient amounts to protect us against
losses.
Any of the above events could prevent us from achieving or
maintaining market acceptance of the affected product, negatively
impact our revenues and could substantially increase the costs of
commercializing our products. The demand for
Jeuveau®
could also be negatively impacted by any adverse effects of a
competitor’s product or treatment.
Our failure to successfully in-license, acquire, develop and market
additional product candidates or approved products would impair our
ability to grow our business.
Although most of our effort is focused on the commercialization of
Jeuveau®,
a key element of our long-term strategy is to in-license, acquire,
develop, market and commercialize a portfolio of products to serve
the self-pay aesthetic market. Jeuveau®
is currently our sole product. Our competitors are currently able
to bundle multiple aesthetic products to provide a more
comprehensive offering than we can as a single product company.
Because our internal research and development capabilities are
limited, we may be dependent upon pharmaceutical and other
companies, academic scientists and other researchers to sell or
license products or technology to us. The success of this strategy
depends partly upon our ability to identify and select promising
aesthetic product candidates and products, negotiate licensing or
acquisition agreements with their current owners and finance these
arrangements.
The process of proposing, negotiating and implementing a license or
acquisition of a product candidate or approved product is lengthy
and complex. Other companies, including some with substantially
greater financial, marketing, sales and other resources, may
compete with us for the license or acquisition of product
candidates and approved products. We have limited resources to
identify and execute the acquisition or in-licensing of third-party
products, businesses and technologies and integrate them into our
current infrastructure. Moreover, we may devote resources to
potential acquisitions or licensing opportunities that are never
completed, or we may fail to realize the anticipated benefits of
such efforts. We may not be able to acquire the rights to
additional product candidates on terms that we find acceptable, or
at all.
Further, any product candidates that we acquire may require
additional development efforts prior to commercial sale, including
preclinical or clinical testing and approval by the FDA, the EMA
and other similar regulatory authorities. All product candidates
are prone to risks of failure during product development, including
the possibility that a product candidate will not be shown to be
sufficiently safe and effective for approval by regulatory
authorities. In addition, any approved products that we acquire may
not be manufactured or sold profitably or achieve market
acceptance.
We may need to increase the size of our organization, including our
sales and marketing capabilities, in order to further market and
sell Jeuveau®
and we may experience difficulties in managing this
growth.
As of December 31, 2022, we had 215 employees, all of whom
were full-time employees. Our management and personnel, systems and
facilities currently in place may not be adequate to support future
growth. Our need to effectively execute our growth strategy
requires that we identify, recruit, retain, incentivize and
integrate any additional employees to effectively manage any future
clinical trials, manage our internal development efforts
effectively while carrying out our contractual
obligations to third parties, and continue to improve our
operational, financial and management controls, reporting systems
and procedures.
We face risks in building and managing a sales organization whether
internally or by utilizing third parties, including our ability to
retain and incentivize qualified individuals, provide adequate
training to sales and marketing personnel, generate sufficient
sales leads, effectively manage a geographically dispersed sales
and marketing team, adequately provide complementary products to be
offered by sales personnel, which may otherwise put us at a
competitive disadvantage relative to companies with more extensive
product lines, and handle any unforeseen costs and expenses. Any
failure or delay in the development of our internal sales,
marketing and distribution capabilities would adversely impact the
commercialization of these products.
Due to our limited financial resources and our limited experience
in managing a company with such anticipated growth, we may not be
able to effectively manage the expansion of our operations or
recruit and train additional qualified personnel. The physical
expansion of our operations may lead to significant costs and may
divert our management and business development resources. Any
inability to manage growth could delay the execution of our
development and strategic objectives or disrupt our
operations.
Our business may be materially adversely affected by the impact of
the ongoing military conflict between Russia and Ukraine on the
global economy and capital markets and other geopolitical tensions
may also adversely affect our business.
U.S. and global markets are experiencing volatility and disruption
following the escalation of geopolitical tensions and the ongoing
military conflict between Russia and Ukraine. Although the length
and impact of the ongoing military conflict is highly
unpredictable, the conflict in Ukraine has led to market
disruptions, including significant volatility in commodity prices,
credit and capital markets, as well as supply chain interruptions,
which could continue.
Additionally, the recent military conflict in Ukraine has led to
the imposition of sanctions and other penalties by the U.S., EU and
other countries against Russia. Russian military actions and the
resulting sanctions have adversely affected the global economy and
financial markets and could lead to further instability and lack of
liquidity in capital markets, which could make it more difficult
for us to obtain additional funds at terms favorable to us, or at
all.
Although our business has not been materially impacted by the
ongoing military conflict between Russia and Ukraine, it is
impossible to predict the extent to which our operations, or those
of our suppliers and manufacturers, 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
could be substantial.
Our international operations will expose us to risks, and failure
to manage these risks may adversely affect our operating results
and financial condition.
We currently have operations in the United States, Canada, and
Europe, having launched in Great Britain in the third quarter of
2022 and in Germany and Austria in February 2023. International
operations are subject to a number of inherent risks, and our
future results could be adversely affected by a number of factors,
including differences in demand for our products due to local
requirements or preferences, the difficulty of hiring and managing
employees with cultural and geographic differences and the costs of
complying with differing regulatory requirements. Additionally, we
may experience difficulties and increased costs due to differences
in laws related to enforcing contracts, protecting intellectual
property, taxes, tariffs and export regulations. The current
conflict between Ukraine and Russia may also impact European
economies and consumer discretionary spending negatively. We do not
have significant international operations in Russia, Ukraine, or
the surrounding regions that have been impacted by the conflict
directly.
Our international operations will also subject us to risks related
to multiple, conflicting and changing laws and regulations such as
privacy regulations, including the GDPR, tax laws, export and
import restrictions, employment laws, immigration laws, labor laws,
regulatory requirements and other governmental approvals, permits
and licenses. Additionally, we will face heightened risk of unfair
or corrupt business practices in certain geographies and of
improper or fraudulent sales arrangements that may impact financial
results and result in restatements of, or irregularities in,
financial statements. These and other factors could harm our
ability to gain future revenue and, consequently, materially impact
our business, operating results and financial
condition.
Fluctuations in currency exchange rates may negatively affect our
financial condition and results of operations.
Exchange rate fluctuations may affect the costs that we incur in
our operations. The main currencies to which we are exposed to such
fluctuations are the British pound and the EU euro. The exchange
rates between these currencies and the U.S. dollar in recent years
have fluctuated significantly and may continue to do so in the
future. A depreciation of these currencies against the U.S. dollar
will decrease the U.S. dollar equivalent of the amounts derived
from foreign operations reported in our consolidated financial
statements, and an appreciation of these currencies will result in
a corresponding increase in such amounts. The cost of certain
items, such as raw materials, manufacturing, employee salaries and
transportation and freight, required by our operations may be
affected by changes in the value of the relevant currencies. To the
extent that we are required to pay for goods or services in foreign
currencies, the appreciation of such currencies against the U.S.
dollar will tend to negatively affect our business. There can be no
assurance that foreign currency fluctuations will not have a
material adverse effect on our business, financial condition and
results of operations.
If we fail to attract and keep senior management and key scientific
personnel, we may be unable to market and sell
Jeuveau®
successfully, or any future products we develop.
Our success depends in part on our continued ability to attract,
retain and motivate highly qualified management. We believe that
our future success is highly dependent upon the contributions of
our senior management, particularly David Moatazedi, our President,
Chief Executive Officer and member of our board of directors,
Sandra Beaver, our Chief Financial Officer, and Rui Avelar, our
Chief Medical Officer and Head of R&D, as well as other members
of our senior management team. The loss of services of any of these
individuals could delay or prevent the successful development of
our product pipeline, completion of our planned clinical trials or
the commercialization of Jeuveau®
or any future products we develop.
In addition, we could experience difficulties attracting and
retaining qualified employees in the future. For example,
competition for qualified personnel in the pharmaceuticals and
medical aesthetic field is intense due to the limited number of
individuals who possess the skills and experience required by our
industry. We may not be able to attract and retain quality
personnel on acceptable terms, or at all. In addition, to the
extent we hire personnel from competitors, we may be subject to
allegations that they have been improperly solicited or that they
have divulged proprietary or other confidential information or that
their former employers own their research output.
Our strategy of focusing exclusively on the self-pay healthcare
market may limit our ability to increase sales or achieve
profitability.
Our strategy is to focus exclusively on the self-pay healthcare
market. This focus may limit our ability to increase sales or
achieve profitability. For example, to maintain our business model,
we have chosen not to offer products or services available in the
broader healthcare market that are reimbursed by third-party payors
such as Medicare, Medicaid or commercial insurance. This eliminates
our ability to offer a substantial number of products and
indications for Jeuveau®.
For example, under the Daewoong Agreement our rights to market and
sell Jeuveau®
are limited to cosmetic indications. Daewoong has subsequently
licensed the rights to the therapeutic indications to a third
party. As a result, we do not have the ability to expand the
permitted uses of botulinum toxin products for therapeutic
indications.
Jeuveau®
is the only U.S. neurotoxin without a therapeutic indication,
although other companies may seek to develop a similar product in
the future. We believe pursuing an aesthetic-only non-reimbursed
product strategy allows for meaningful strategic advantages in the
United States, including pricing and marketing flexibility.
However, physicians may choose to not pass any cost benefits
received by them due to such pricing flexibility to their patients.
In addition, companies offering aesthetic products competitive to
Jeuveau®,
whether they pursue an aesthetic-only non-reimbursed product
strategy or not, may nonetheless try to compete with
Jeuveau®
on price both directly through rebates, promotional programs and
coupons and indirectly through attractive product bundling and
customer loyalty programs. Our business, financial results and
future prospects will be materially harmed if we cannot generate
sufficient consumer demand for Jeuveau®.
Our business involves the use of hazardous materials, and we and
our third-party manufacturer and supplier must comply with
environmental laws and regulations, which can be expensive and
restrict how we do business.
Our research and development and manufacturing activities in the
future may, and Daewoong’s manufacturing and supplying activities
presently do, involve the controlled storage, use and disposal of
hazardous materials, including botulinum toxin type A, a key
component of Jeuveau®,
and other hazardous compounds. We and Daewoong are subject to laws
and regulations governing the use, manufacture, storage, handling
and disposal of these hazardous materials. In some cases, these
hazardous materials and various wastes resulting from their use are
stored at Daewoong’s facilities pending their use and disposal. We
and Daewoong cannot eliminate the risk of contamination, which
could cause an interruption of Daewoong’s manufacturing processes,
our commercialization efforts, business operations and
environmental damage resulting in costly
clean-up and liabilities under applicable laws and regulations
governing the use, manufacture, storage, handling and disposal of
these materials and specified waste products. Although we believe
that the safety procedures utilized by Daewoong for handling and
disposing of these materials generally comply with the standards
prescribed by these laws and regulations, this may not eliminate
the risk of accidental contamination or injury from these
materials. In such an event, we may be held liable for any
resulting damages and such liability could exceed our resources,
and state or federal or other applicable authorities may curtail
our use of certain materials and interrupt our business operations.
Furthermore, environmental laws and regulations are complex, change
frequently and have tended to become more stringent.
We may use third-party collaborators to help us develop, validate
or commercialize any new products, and our ability to commercialize
such products could be impaired or delayed if these collaborations
are unsuccessful.
We may license or selectively pursue strategic collaborations for
the development, validation and commercialization of
Jeuveau®
and any future product candidates, such as the Collaboration
Agreement entered into in June 2022. In any third-party
collaboration, we would be dependent upon the success of the
collaborators in performing their responsibilities and their
continued cooperation. Our collaborators may not cooperate with us
or perform their obligations under our agreements with them. Our
collaborators may choose to pursue alternative technologies in
preference to those being developed in collaboration with us. The
development, validation and commercialization of our product
candidates will be delayed if collaborators fail to conduct their
responsibilities in a timely manner or in accordance with
applicable regulatory requirements or if they breach or terminate
their collaboration agreements with us. Disputes with our
collaborators could also impair our reputation or result in
development delays, decreased revenues and litigation
expenses.
In addition, we may face significant competition in seeking
appropriate collaborators. Whether we reach a definitive agreement
for a collaboration will depend, among other things, upon our
assessment of the collaborator’s resources and expertise, the terms
and conditions of the proposed collaboration and the proposed
collaborator’s evaluation of a number of factors. Those factors may
include the design or results of clinical trials, the likelihood of
approval by the FDA or similar regulatory authorities outside the
United States, the potential market for the subject product
candidate, the costs and complexities of manufacturing and
delivering such product candidate to consumers, the potential of
competing products, the existence of uncertainty with respect to
our ownership of technology, which can exist if there is a
challenge to such ownership without regard to the merits of the
challenge and industry and market conditions generally. The
collaborator may also consider alternative product candidates or
technologies for similar indications that may be available to
collaborate on and whether such a collaboration could be more
attractive than the one with us for our product candidate.
Collaborations are complex and time-consuming to negotiate and
document.
We may not be able to negotiate collaborations on a timely basis,
on acceptable terms, or at all. If we are unable to do so, we may
have to curtail the development of such product
candidate, reduce or delay its development program or one or more
of our other development programs, delay its potential
commercialization or reduce the scope of any sales or marketing
activities, or increase our expenditures and undertake development
or commercialization activities at our own expense. If we elect to
increase our expenditures to fund development or commercialization
activities on our own, we may need to obtain additional capital,
which may not be available to us on acceptable terms or at all. If
we do not have sufficient funds, we may not be able to further
develop our product
candidates or bring them to market and generate
revenue.
Our ability to use our net operating loss carryforwards and certain
other tax attributes may be limited.
We have incurred substantial losses during our history and we may
never achieve profitability. To the extent that we continue to
generate taxable losses, unused losses will carry forward to offset
future taxable income, if any, until such unused losses expire.
Under Section 382 of the Internal Revenue Code of 1986, as amended,
or the Code, if a corporation undergoes an “ownership change,”
generally defined as a greater than 50% change (by value) in its
equity ownership over a three-year period, the corporation’s
ability to use its pre-change net operating loss carryforwards, or
NOLs, and other pre-change tax attributes, such as research tax
credits, to offset its post-change income may be limited. As of
December 31, 2022, we had $318.8 million of federal NOLs and
$214.3 million of state NOLs available to offset our future taxable
income, if any. As of December 31, 2022, we had federal
research and development credit carryforwards of $2.9 million.
These federal and state NOLs and federal research and development
tax credit carryforwards expire at various dates beginning in 2034.
We may experience ownership changes in the future as a result of
subsequent shifts in our stock ownership. As a result, if we earn
net taxable income, our ability to use our pre-change NOLs to
offset U.S. federal taxable income may be subject to limitations,
which could potentially result in increased future tax liability to
us. In addition, at the state level, there may be periods during
which the use of NOLs is suspended or otherwise limited, which
could accelerate or permanently increase state taxes
owed.
The planned discontinuation of LIBOR could have an adverse impact
on operations.
As of December 31, 2022, we had $71.9 million of outstanding
indebtedness that bears interest at a floating rate using London
Interbank Offered Rate ("LIBOR") as the applicable reference rate.
LIBOR, the London interbank offered rate, is the interest rate
benchmark used as a reference rate on our variable rate debt,
including our Credit Facility. On March 5, 2021, LIBOR’s regulator,
the Financial Conduct Authority and administrator, ICE Benchmark
Administration, announced that the publication of one-week and
two-month USD LIBOR maturities and the non-USD LIBOR maturities
will cease immediately after December 31, 2021, with the
publication of overnight, one-, three-, six-, and 12-month USD
LIBOR ceasing immediately after June 30, 2023. On March 15, 2022,
the Adjustable Interest Rate (LIBOR) Act (the “LIBOR ACT”) was
signed into law. Under the LIBOR Act, the Board of Governors of the
Federal Reserve System is directed to select the Secured Overnight
Financing Rate (“SOFR”), published by the Federal Reserve Bank of
New York, as the replacement rate for contracts that reference
LIBOR as a benchmark rate and that do not contain either a
specified replacement rate or a replacement mechanism after USD
LIBOR ceases publication. In addition, recent New York state
legislation effectively codified the use of SOFR as the alternative
to LIBOR in the absence of another chosen replacement rate, which
may affect contracts governed by New York state law.
SOFR is calculated differently from LIBOR and the inherent
differences between LIBOR and SOFR or any other alternative
benchmark rate gives rise to many uncertainties, including the need
to amend existing debt instruments and the need to choose
alternative reference rates in new contracts. Furthermore,
uncertainty regarding whether or when SOFR or other alternative
reference rates will be widely accepted by lenders as the
replacement for LIBOR may impact the liquidity of the SOFR loan
market, and SOFR itself. Since the initial publication of SOFR,
daily changes in the rate have, on occasion, been more volatile
than daily changes in comparable benchmark or market rates, and
SOFR over time may bear little or no relation to the historical
actual or historical indicative data. It is possible that the
volatility of and uncertainty around SOFR as a LIBOR replacement
rate and the applicable credit adjustment would result in higher
borrowing costs for us, and would adversely affect our liquidity,
financial condition, and earnings. The consequences of these
developments with respect to LIBOR cannot be entirely predicted and
span multiple future periods but could result in an increase in the
cost of our variable rate debt which may negatively impact our
financial results.
Risks Related to Our Relationship with Daewoong
We rely on the license and supply agreement, the Daewoong
Agreement, with Daewoong to provide us exclusive rights to
distribute Jeuveau®
in certain territories. Any termination or loss of significant
rights, including exclusivity, under the Daewoong Agreement would
materially and adversely affect our development or
commercialization of Jeuveau®.
Pursuant to the Daewoong Agreement, as it has been amended from
time to time, we have secured an exclusive license from Daewoong, a
South Korean pharmaceutical manufacturer, to import, distribute,
promote, market, develop, offer for sale and otherwise
commercialize and exploit Jeuveau®
for aesthetic indications in the United States, EU, United Kingdom,
members of the European Economic Area, Switzerland, Canada,
Australia, certain members of the Commonwealth of Independent
States, and South Africa, as well as co-exclusive distribution
rights with Daewoong in Japan. The Daewoong Agreement imposes on us
obligations relating to exclusivity, territorial rights,
development, commercialization, funding, payment, diligence,
sublicensing, intellectual property protection and other matters.
We are obligated to conduct development activities, obtain
regulatory approval of Jeuveau®
and obtain from Daewoong all of our product supply requirements for
Jeuveau®.
In addition, under the Daewoong Agreement, we are required to
submit our commercialization plan to a joint steering committee, or
JSC, comprised of an equal number of development and commercial
representatives from Daewoong and us, for review and input.
Although the Daewoong Agreement provides us with final
decision-making power regarding the marketing, promotion, sale
and/or distribution of Jeuveau®,
any disagreement among the JSC would be referred to Daewoong’s and
our respective senior management for resolution if the JSC is
unable to reach a decision within thirty days, which may result in
a delay in our ability to implement our commercialization plan or
harm our working relationship with Daewoong. If we fail to achieve
minimum annual purchase targets of Jeuveau®
under the Daewoong Agreement, Daewoong may, at its sole option,
elect to convert the exclusive license to a non-exclusive license.
In light of the COVID-19 outbreak, any potential decline in
consumer discretionary spending and the potential loss of our
ability to discount the product to levels previously provided as a
result of the Medytox Settlement Agreement, it may become more
difficult for us to achieve the minimum annual purchase targets for
Jeuveau®
which may result in the license being converted to a non-exclusive
license.
The initial term of the Daewoong Agreement will expire on September
30, 2023 in any of the aforementioned territories. The Daewoong
Agreement will renew for unlimited additional three-year terms
after the expiration of the initial term, only if we meet certain
performance requirements during the initial term or preceding
renewal term, as applicable. We or Daewoong may terminate the
Daewoong Agreement if the other party breaches any of its duties or
obligations and such breach continues without cure for ninety days,
or thirty days in the case of a payment breach, or if we declare
bankruptcy or assign our business for the benefit of
creditors.
If we breach any material obligations, or use the intellectual
property licensed to us in an unauthorized manner, we may be
required to pay damages to Daewoong and Daewoong may have the right
to terminate our license. In addition, if any of the regulatory
milestones or other cash payments become due under the terms of the
Daewoong Agreement, we may not have sufficient funds available to
meet our obligations, which would allow Daewoong to terminate the
Daewoong Agreement. Any termination or loss of rights, including
exclusivity, under the Daewoong Agreement would materially and
adversely affect our ability to market and sell
Jeuveau®,
which in turn would have a material adverse effect on our business,
operating results and prospects. If we were to lose our rights
under the Daewoong Agreement, we believe it would be difficult for
us to find an alternative supplier of a botulinum toxin type A
complex. In addition, to the extent the alternative supplier has
not secured regulatory approvals in a jurisdiction, we would have
to expend significant resources to obtain regulatory approvals that
may never be obtained or require several years to obtain, which
could significantly delay commercialization. We may be unable to
raise additional capital to fund our operations during this
extended time on terms acceptable to us or at all. Additionally, if
we experience delays as a result of a dispute with Daewoong, the
demand for Jeuveau®
could be materially and adversely affected.
We currently rely solely on Daewoong to manufacture
Jeuveau®,
and as such, any production or other problems with Daewoong could
adversely affect us.
We depend solely upon Daewoong for the manufacturing of
Jeuveau®.
Although alternative sources of supply may exist, the number of
third-party suppliers with the necessary manufacturing and
regulatory expertise and facilities is limited, and it could be
expensive and take a significant amount of time to arrange for and
qualify alternative suppliers, which could have a material adverse
effect on our business. Suppliers of any new product candidate
would be required to qualify under applicable regulatory
requirements and would need to have sufficient rights under
applicable intellectual property laws to the method of
manufacturing the product candidate. Obtaining the necessary FDA
approvals or other qualifications under applicable regulatory
requirements and ensuring non-infringement of third-party
intellectual property rights could result in a significant
interruption of supply and could require the new manufacturer to
bear significant additional costs which may be passed on to
us.
In addition, our reliance on Daewoong entails additional risks,
including reliance on Daewoong for regulatory compliance and
quality assurance, the possible breach of the Daewoong Agreement by
Daewoong, and the possible termination or nonrenewal of the
Daewoong Agreement at a time that is costly or inconvenient for us.
Our failure, or the failure of Daewoong, to comply with applicable
regulations could result in sanctions being imposed on us,
including fines, injunctions, civil penalties, delays, suspension
or withdrawal of approvals, license revocation, seizures or recalls
of products, operating restrictions and criminal prosecutions, any
of which could significantly and adversely affect supplies of
Jeuveau®.
Our dependence on Daewoong also subjects us to all of the risks
related to Daewoong’s business, which are all generally beyond our
control. Daewoong’s ability to perform its obligations under the
Daewoong Agreement is dependent on Daewoong’s operational and
financial health, which could be negatively impacted by several
factors, including changes in the economic, political and
legislative conditions in South Korea and the broader region in
general and the ability of Daewoong to continue to successfully
attract customers and compete in its market. Furthermore,
Daewoong’s recently constructed manufacturing facility is
Daewoong’s only facility meeting FDA and EMA, current Good
Manufacturing Requirements, or cGMPs. Daewoong’s lack of
familiarity with, or inability to effectively operate, the facility
and produce products of consistent quality, may harm our ability to
compete in our market.
Additionally, although we are ultimately responsible for ensuring
compliance with regulatory requirements such as cGMPs, we are
dependent on Daewoong for day-to-day compliance with cGMP for
production of drug substance and finished products. Facilities used
by Daewoong to produce the drug substance and materials or finished
products for commercial sale must pass inspection and be approved
by the FDA and other relevant regulatory authorities. If the safety
of Jeuveau®
is compromised due to a failure to adhere to applicable laws or for
other reasons, we may not be able to successfully commercialize our
product and we may be held liable for injuries sustained as a
result. In addition, the manufacturing facilities of certain of our
suppliers are located outside of the United States. This may give
rise to difficulties in importing our product into the United
States or other countries as a result of, among other things,
regulatory agency approval requirements, taxes, tariffs, local
import requirements such as import duties or inspections,
incomplete or inaccurate import documentation or defective
packaging. Any of these factors could adversely impact our ability
to effectively market and sell Jeuveau®.
Any failure or refusal by Daewoong or any other third party to
supply Jeuveau®
or any other product candidates or products that we may develop
could delay, prevent or impair our clinical development or
commercialization efforts.
Moreover, Daewoong developed the manufacturing process for
Jeuveau®
and manufactures Jeuveau®
in a recently constructed facility located in South Korea. If this
facility were to be damaged, destroyed or otherwise unable to
operate or
comply with regulatory requirements, whether due to earthquakes,
fire, floods, hurricanes, storms, tornadoes, other natural
disasters, public health emergencies (such as the COVID-19
outbreak) employee malfeasance, terrorist acts, power outages or
otherwise, or if operations at the facility is disrupted for any
other reason, such an event could jeopardize Daewoong’s ability to
manufacture Jeuveau®
as promptly as we or our customers expect or possibly at all. If
Daewoong is unable to manufacture Jeuveau®
within a timeframe that meets our and our customers’ expectations,
our business, prospects, financial results and reputation could be
materially harmed. Any disaster recovery and business continuity
plans that we and Daewoong have in place or put in place may not be
adequate in the event of a serious disaster or similar event. We
may incur substantial expenses as a result of our or Daewoong’s
lack of disaster recovery and business continuity plans, or the
adequacy thereof, which could have a material adverse effect on our
business.
We forecast the demand for commercial quantities of our products,
and if our forecasts are inaccurate, we may experience delays in
shipments, increased inventory costs or inventory levels, and
reduced cash flow.
We purchase Jeuveau®
from Daewoong. Pursuant to the Daewoong Agreement, we submit
forecasts of anticipated product orders to Daewoong and may, from
time to time, submit purchase orders on the basis of these
forecasting requirements. Our limited historical experience may not
provide us with enough data to accurately predict future demand. In
addition, we expect Daewoong to manufacture its own product,
Nabota, a botulinum toxin formulation, from this facility for sale
in the South Korean market and other markets in which we do not
have exclusive rights. If our business significantly expands, our
demand for commercial products would increase and Daewoong may be
unable to meet our increased demand. In addition, our product will
have fixed future expiration dates. If we overestimate requirements
for Jeuveau®,
we will have excess inventory, which may have to be disposed of if
such inventory exceeds approved expiration dates, which would
result in lost revenues and increase our expenses. If we
underestimate requirements for Jeuveau®,
we may have inadequate inventory, which could interrupt, delay or
prevent delivery of our products to our customers. Any of these
occurrences would negatively affect our financial
performance.
Risks Related to Intellectual Property
Third-party claims of intellectual property infringement may
prevent or delay our commercialization efforts and interrupt our
supply of products.
Our commercial success depends in part on our avoiding infringement
of the proprietary rights of third parties. Competitors in the
field of dermatology, medical aesthetic and neurotoxins have
developed large portfolios of patents and patent applications in
fields relating to our business. In particular, there are patents
held by third parties that relate to the treatment with
neurotoxin-based products for the indication we are currently
marketing. There may also be patent applications that have been
filed but not published that, when issued as patents, could be
asserted against us. There is a substantial amount of litigation,
both within and outside the United States, involving patent and
other intellectual property rights in the technology, medical
device and pharmaceutical industries, including patent infringement
lawsuits, interferences, oppositions and inter-party reexamination
proceedings before the U.S. Patent and Trademark Office, or USPTO.
Numerous U.S. and foreign issued patents and pending patent
applications, which are owned by third parties, exist in the fields
in which we are developing Jeuveau®.
As the technology, medical device and pharmaceutical industries
expand and more patents are issued, the risk increases that our
product candidates may be subject to claims of infringement of the
patent rights of third parties.
Third parties may assert that we or any of our current or future
licensors, including Daewoong, are employing their proprietary
technology without authorization. There may be third-party patents
or patent applications with claims to materials, methods of
manufacture or methods for treatment related to the use or
manufacture of Jeuveau®
or any future product candidates. Because patent applications can
take many years to issue, there may be currently pending patent
applications that may later result in issued patents that
Jeuveau®
or any future product candidates may infringe. In addition, third
parties may obtain patents in the future and claim that use of our
technologies infringes upon these patents. If any third-party
patents were held by a court of competent jurisdiction to cover the
manufacturing process of Jeuveau®
or any future product candidates, the holders of any such patents
may be able to block our ability to commercialize such product
candidate unless we obtain a license under the applicable patents
or until such patents expire. Similarly, if any third-party patent
were held by a court of competent jurisdiction to cover aspects of
our methods of use, the holders of any such patent may be able to
block our ability to develop and commercialize the applicable
product candidate unless we obtain a license or until such patent
expires. In either case, such a license may not be available on
commercially reasonable terms or at all.
In addition to claims of patent infringement, third parties may
bring claims against us asserting misappropriation of proprietary
technology or other information in the development, manufacture and
commercialization of Jeuveau®
or any of our future product candidates. Defense of such a claim
would require dedicated time and resources, which time and
resources
could otherwise be used by us toward the maintenance of our own
intellectual property and the development and commercialization of
Jeuveau®
and any of our future product candidates or by any of our current
or future licensors for operational upkeep and manufacturing of our
products. For example, prior to entering into the Medytox
Settlement Agreement, we were a defendant in a lawsuit brought by
Medytox in the Superior Court of the State of California, or the
Medytox Litigation, and a respondent in an action filed by Allergan
and Medytox in the U.S. International Trade Commission, each
alleging, among other things, that Daewoong stole Medytox’s
botulinum toxin bacterial strain, or the BTX strain, that Daewoong
misappropriated certain trade secrets of Medytox, including the
process used to manufacture Jeuveau®
(which Medytox claims is similar to its biopharmaceutical drug,
Meditoxin) using the BTX strain, and that Daewoong thereby
interfered with Medytox’s plan to license Meditoxin to us, or the
Medytox Litigation. Each of the Medytox Litigation and the ITC
Action diverted the attention of our senior management and were
costly, in terms of legal costs and the ultimate payments and
royalties to be paid under the Medytox Settlement
Agreement.
Parties making claims against us or any of our current or future
licensors may request and obtain injunctive or other equitable
relief, which could effectively block our ability to further
develop and commercialize one or more of our product candidates.
Defense of these claims, regardless of their merit, would involve
substantial litigation expense and would be a substantial diversion
of employee resources from our business. In the event of a
successful claim of infringement, we or any of our current or
future licensors may have to pay substantial damages, including
treble damages and attorneys’ fees for willful infringement, obtain
one or more licenses from third parties which may not be
commercially or more available, pay royalties or redesign our
infringing products or manufacturing processes, which may be
impossible or require substantial time and monetary expenditure.
Furthermore, even in the absence of litigation, we may need to
obtain licenses from third parties to advance our research,
manufacture clinical trial supplies or allow commercialization of
Jeuveau®
or any future product candidates. We may fail to obtain any of
these licenses at a reasonable cost or on reasonable terms, if at
all. In that event, we would be unable to further develop and
commercialize one or more of our product candidates, which could
harm our business significantly. Similarly, third-party patents
could exist that might be enforced against our products, resulting
in either an injunction prohibiting our sales, or with respect to
our sales, an obligation on our part to pay royalties and/or other
forms of compensation to third parties.
If we or any of our current or future licensors, including
Daewoong, are unable to maintain, obtain or protect intellectual
property rights related to Jeuveau®
or any of our future product candidates, we may not be able to
compete effectively in our market.
We and our current licensor, Daewoong, currently rely upon a
combination of trademarks, trade secret protection, confidentiality
agreements and proprietary know-how. Botulinum toxin cannot be
patented, as it is produced by
Clostridium
botulinum,
a gram-positive, rod-shaped, anaerobic, spore-forming, motile
bacterium with the ability to produce the neurotoxin botulinum.
Only the manufacturing process for botulinum toxin can be patented,
for which Daewoong has obtained a U.S. patent. Our trade secrets
and other confidential proprietary information and those of our
licensors could be disclosed or competitors could otherwise gain
access to our trade secrets or independently develop substantially
equivalent information and techniques. Further, the laws of some
foreign countries do not protect proprietary rights to the same
extent or in the same manner as the laws of the United States. As a
result, we or any of our current or future licensors may encounter
significant problems in protecting and defending our or their
intellectual property both in the United States and
internationally. If we or any of our current or future licensors
are unable to prevent material disclosure of the non-patented
intellectual property related to Jeuveau®
to third parties, we may not be able to establish or maintain a
competitive advantage in our market, which could adversely affect
our business.
In addition to the protection afforded by trademarks,
confidentiality agreements and proprietary know-how, we may in the
future rely upon in-licensed patents for any future product
offerings. The strength of patents we may in-license in the
technology and healthcare fields involves complex legal and
scientific questions and can be uncertain. The patent applications
that we may in-license may fail to result in issued patents with
claims that cover any of our future product candidates in the
United States or in other foreign countries, and the issued patents
that we may in-license may be declared invalid or
unenforceable.
We are reliant on the ability of Daewoong, as the licensor of our
only product, and will be reliant on future licensors of any future
product candidates, to maintain their intellectual property and
protect their intellectual property against misappropriation,
infringement or other violation. We may not have primary control
over our future licensors’ patent prosecution activities.
Furthermore, we may not be allowed to comment on prosecution
strategies, and patent applications may be abandoned by the patent
owner without our knowledge or consent. With respect to patents
that are issued to our licensors, or patents that may be issued on
patent applications, third parties may challenge their validity,
enforceability or scope, which may result in such patents being
narrowed or invalidated. As a licensee, we are reliant on Daewoong
and our
future licensors to defend any third-party claims. Our licensors
may not defend or prosecute such actions as vigorously or in the
manner that we would have if entitled to do so, and we will be
subject to any judgment or settlement resulting from such actions.
Also, a third-party may challenge the validity of our in-licensing
transactions. Furthermore, even if they are unchallenged, any of
our future in-licensed patents and patent applications may not
adequately protect the licensors or our intellectual property or
prevent others from designing around their or our
claims.
We may become involved in lawsuits to protect or enforce our
intellectual property or the patents and other intellectual
property of our licensors, which could be expensive and
time-consuming.
Competitors may infringe our intellectual property, including any
future patents we may acquire, or the patents and other
intellectual property of our licensors, including Daewoong. As a
result, we or any of our current or future licensors may be
required to file infringement claims to stop third-party
infringement or unauthorized use. This can be expensive,
particularly for a company of our size, and time-consuming. In
addition, in an infringement proceeding, a court may decide that a
patent of ours or any of our current or future licensors is not
valid or is unenforceable, or may refuse to stop the other party
from using the technology at issue on the grounds that our patent
claims do not cover its technology or that the factors necessary to
grant an injunction against an infringer are not
satisfied.
An adverse determination of any litigation or other proceedings
could put one or more of such patents at risk of being invalidated
or interpreted narrowly. Interference, derivation or other
proceedings brought at the USPTO may be necessary to determine the
priority or patentability of inventions with respect to any of our
future patent applications or those of our licensors or
collaborators. Litigation or USPTO proceedings brought by us or any
of our current or future licensors may fail or may be invoked
against us or our licensors by third parties. Even if we are
successful, domestic or foreign litigation or USPTO or foreign
patent office proceedings may result in substantial costs and
distraction to our management or the management of any of our
current or future licensors, including Daewoong. We may not be
able, alone or with any of our current or future licensors or
collaborators, to prevent misappropriation of our proprietary
rights, particularly in countries where the laws may not protect
such rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery
required in connection with intellectual property litigation or
other proceedings, there is a risk that some of our confidential
information could be compromised by disclosure during this type of
litigation or proceedings. In addition, during the course of this
kind of litigation or proceedings, there could be public
announcements of the results of hearings, motions or other interim
proceedings or developments or public access to related documents.
If investors perceive these results to be negative, the market
price for our common stock could be significantly
harmed.
Most of our competitors are larger than we are and have
substantially greater resources. They are, therefore, likely to be
able to sustain the costs of complex patent litigation longer than
we could. Accordingly, despite our efforts, we may not be able to
prevent third parties from infringing upon or misappropriating our
intellectual property. In addition, the uncertainties associated
with litigation could compromise our ability to raise the funds
necessary to continue our clinical trials, continue our internal
research programs, or in-license needed technology or other product
candidates. There could also be public announcements of the results
of the hearing, motions, or other interim proceedings or
developments. If securities analysts or investors perceive those
results to be negative, it could cause the price of shares of our
common stock to decline.
We may not be able to protect our intellectual property rights
throughout the world.
Filing, prosecuting and defending patents on product candidates in
all countries throughout the world would be prohibitively
expensive, and our intellectual property rights in some countries
outside the United States can be less extensive than those in the
United States. In addition, the laws of some foreign countries do
not protect intellectual property rights to the same extent as
federal and state laws in the United States and in some cases may
even force us to grant a compulsory license to competitors or other
third parties. Consequently, we may not be able to prevent third
parties from using our inventions in all countries outside the
United States or from selling or importing products made using our
inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have
not obtained patent protection to develop their own products and
further, may export otherwise infringing products to territories
where we have patent protection, but enforcement is not as strong
as that in the United States. These products may compete with our
products and our patents or other intellectual property rights may
not be effective or sufficient to prevent them from
competing.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in foreign
jurisdictions. The legal systems of certain countries, particularly
certain developing countries, do not favor the enforcement of
patents and other intellectual property protection, particularly
those relating to biopharmaceuticals, which could make
it
difficult for us to stop the infringement of our patents or
marketing of competing products in violation of our proprietary
rights generally. Proceedings to enforce our patent rights in
foreign jurisdictions could result in substantial costs and divert
our efforts and attention from other aspects of our business, could
put our patents at risk of being invalidated or interpreted
narrowly and our patent applications at risk of not issuing and
could provoke third parties to assert claims against us. We may not
prevail in any lawsuits that we initiate, and the damages or other
remedies awarded, if any, may not be commercially meaningful.
Accordingly, our efforts to enforce our intellectual property
rights around the world may be inadequate to obtain a significant
commercial advantage from the intellectual property that we develop
or license.
In addition, our ability to protect and enforce our intellectual
property rights may be adversely affected by unforeseen changes in
domestic and foreign intellectual property laws.
If we are unable to protect the confidentiality of our trade
secrets, our business and competitive position would be
harmed.
In addition to seeking patents for our product candidates, we also
rely on trade secrets, including unpatented know-how, technology
and other proprietary information, to maintain our competitive
position.
We seek to protect our trade secrets, in part, by entering into
non-disclosure and confidentiality agreements with parties who have
access to them, such as our employees, collaborators, consultants,
advisors and other third parties. We expect to enter into
confidentiality and invention assignment agreements with our
employees and consultants. Despite these efforts, any of these
parties may breach the agreements and disclose our proprietary
information, including our trade secrets, and we may not be able to
obtain adequate remedies for such breaches. Enforcing a claim that
a party illegally disclosed or misappropriated a trade secret is
difficult, expensive and time-consuming, and the outcome is
unpredictable. In addition, some courts within and outside the
United States are less willing or unwilling to protect trade
secrets. If any of our trade secrets were to be lawfully obtained
or independently developed by a competitor, we would have no right
to prevent them, or those to whom they communicate it, from using
that technology or information to compete with us. If any of our
trade secrets were to be disclosed to or independently developed by
a competitor, our competitive position would be
harmed.
We may be subject to claims that our employees, consultants or
independent contractors have wrongfully used or disclosed
confidential information of third parties.
We employ individuals who were previously employed at other
pharmaceutical or medical aesthetic companies. We may be subject to
claims that we or our employees, consultants or independent
contractors have inadvertently or otherwise used or disclosed
confidential information of our employees’ former employers or
other third parties. We may also be subject to claims that former
employers or other third parties have an ownership interest in our
patents. Litigation may be necessary to defend against these
claims. We may not be successful in defending these claims, and
even if we are successful, litigation could result in substantial
cost and be a distraction to our management and other employees.
Any litigation or the threat thereof may adversely affect our
ability to hire employees. A loss of key personnel or their work
product could diminish or prevent our ability to commercialize
product candidates, which could have an adverse effect on our
business, results of operations and financial
condition.
We may need to license intellectual property from third parties,
and such licenses may not be available or may not be available on
commercially reasonable terms.
A third party may hold intellectual property, including patent
rights that are important or necessary to the development of our
future product candidates. It may be necessary for us to use the
patented or proprietary technology of third parties to
commercialize our product candidates, in which case we would be
required to obtain a license from these third parties on
commercially reasonable terms, or our business could be harmed,
possibly materially.
If our trademarks and trade names are not adequately protected,
then we may not be able to build name recognition in our markets of
interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks. We may not be able to
protect our rights to these trademarks and trade names, which we
need to build name recognition by potential partners or customers
in our markets of interest. Over the long term, if we are unable to
establish name recognition based on our trademarks and trade names,
then we may not be able to compete effectively, and our business
may be adversely affected.
Third parties may assert that we are using trademarks or trade
names that are confusingly similar to their marks. If any third
party were able to establish that our trademarks or trade names
were infringing their marks, that third party may be able
to
block our ability to use the infringing trademark or trade name. In
addition, if a third party were to bring such a claim, we would be
required to dedicate time and resources to fight the claim, which
time and resources could otherwise be used toward the maintenance
of our own intellectual property.
Parties making claims against us may request and obtain injunctive
or other equitable relief, which could prevent our ability to use
the subject trademarks or trade names. Defense of these claims,
regardless of their merit, would involve substantial litigation
expense and would be a substantial diversion of employee resources
from our business. In the event of a successful claim of
infringement against us, we may have to pay substantial damages,
including treble damages and attorneys’ fees for willful
infringement. We may be required to re-brand one or more of our
products, product candidates, or services offered under the
infringing trademark or trade name, which may require substantial
time and monetary expenditure. Third parties could claim senior
rights in marks which might be enforced against our use of
trademarks or trade names, resulting in either an injunction
prohibiting our sales under those trademarks or trade
names.
Risks Related to Government Regulation
Our business and products are subject to extensive government
regulation.
We are subject to extensive, complex, costly and evolving
regulation by federal and state governmental authorities in the
United States, the EU, Canada and other countries, principally by
the FDA, the U.S. Drug Enforcement Administration, the Centers for
Disease Control and Prevention, the EMA and other similar
regulatory authorities. Daewoong is also subject to extensive
regulation by the FDA and the South Korean regulatory authorities
as well as other regulatory authorities. Our failure to comply with
all applicable regulatory requirements, or Daewoong’s failure to
comply with applicable regulatory requirements, including those
promulgated under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and the Controlled Substances Act, may
subject us to operating restrictions and criminal prosecution,
monetary penalties and other enforcement or administrative actions,
including, sanctions, warnings, product seizures, recalls, fines,
injunctions, suspension, revocation of approvals, or exclusion from
future participation in the Medicare and Medicaid
programs.
Following regulatory approval, we, and our direct and indirect
suppliers, including Daewoong, remain subject to the periodic
inspection of our plants and facilities, review of production
processes, and testing of our products to confirm that we are in
compliance with all applicable regulations. Adverse findings during
regulatory inspections may result in requirements that we implement
REMS programs, requirements that we complete government mandated
clinical trials, and government enforcement actions including those
relating to labeling, advertising, marketing and promotion, as well
as regulations governing manufacturing controls.
If we experience delays in obtaining approval or if we fail to
obtain approval of our product candidates, the commercial prospects
for our product candidates may be harmed and our ability to
generate revenue will be materially impaired.
We may not obtain regulatory approval for the commercialization of
any future product candidates.
The research, testing, manufacturing, labeling, approval, selling,
import, export, marketing and distribution of drug and biologic
products are subject to extensive regulation by the FDA and other
regulatory authorities in the United States and other countries,
with regulations differing from country to country. If we, our
products or the manufacturing facilities for our products fail to
comply with applicable regulatory requirements, a regulatory agency
may:
•impose
restrictions on the marketing or manufacturing of the product,
suspend or withdraw product approvals or revoke necessary
licenses;
•issue
warning letters, show cause notices or untitled letters describing
alleged violations, which may be publicly available;
•mandate
modifications to promotional materials or require us to provide
corrective information to healthcare practitioners;
•require
us to enter into a consent decree, which can include imposition of
various fines, reimbursements for inspection costs, required due
dates for specific actions and penalties for
noncompliance;
•commence
criminal investigations and prosecutions;
•impose
injunctions;
•impose
other civil or criminal penalties;
•suspend
any ongoing clinical trials;
•delay
or refuse to approve pending applications or supplements to
approved applications filed by us;
•refuse
to permit drugs or active ingredients to be imported or
exported;
•suspend
or impose restrictions on operations, including costly new
manufacturing requirements; or
•seize
or detain products or require us to initiate a product
recall.
Any of the foregoing could materially harm our business and
reputation. Prior to obtaining approval to commercialize a product
candidate in the United States or abroad, we or our collaborators
must demonstrate with substantial evidence from well-controlled
clinical trials, and to the satisfaction of the FDA, the EMA or
other similar foreign regulatory authorities, that such product
candidates are safe and effective for their intended uses. Results
from preclinical studies and clinical trials can be interpreted in
different ways. Even if we and our collaborators believe the
preclinical or clinical data for our product candidates are
promising, such data may not be sufficient to support approval by
the FDA, the EMA and other similar regulatory authorities.
Administering product candidates to humans may produce undesirable
side effects, which could interrupt, delay or halt clinical trials
and result in the FDA, the EMA or other similar regulatory
authorities delaying or denying approval of a product candidate for
any or all targeted indications.
Regulatory approval of a BLA or BLA supplement, marketing
authorization application, or MAA, or other product approval is not
guaranteed, and the approval process is expensive and may take
several years. The FDA, the EMA and other regulatory authorities
have substantial discretion in the approval process. Despite the
time and expense expended, failure can occur at any stage, and we
could encounter problems that cause us to abandon, modify or repeat
clinical trials, or perform additional preclinical studies and
clinical trials. The number of preclinical studies and clinical
trials that will be required for the FDA, the EMA or other
regulatory approval varies depending on the product candidate, the
disease or condition that the product candidate is designed to
address and the regulations applicable to any particular product
candidate. The FDA, the EMA and other regulatory authorities can
delay, limit or deny approval of a product candidate for many
reasons, including the following:
•a
product candidate may not be deemed safe, effective, pure or
potent;
•the
data from preclinical studies and clinical trials may not be deemed
sufficient;
•the
FDA or other regulatory authorities might not approve our
third-party manufacturers’ processes or facilities;
•deficiencies
in the formulation, quality control, labeling, or specifications of
a product candidate or in response to citizen petitions or similar
documents filed in connection with the product
candidate;
•general
requirements intended to address risks associated with a class of
drugs, such as a new REMS requirement for neurotoxins;
•the
enactment of new laws or promulgation of new regulations that
change the approval requirements; or
•the
FDA or other regulatory authorities may change their approval
policies or adopt new regulations.
If any future product candidates fail to demonstrate safety and
efficacy in clinical trials or do not gain approval, our business
and results of operations will be materially and adversely
harmed.
We are subject to ongoing regulatory obligations and continued
regulatory review, which may result in significant additional
expense, limit or delay regulatory approval and subject us to
penalties if we fail to comply with applicable regulatory
requirements.
Jeuveau®
and any other approved products are subject to continual regulatory
review by the FDA, the EMA and other similar regulatory
authorities.
Any regulatory approvals that we or our collaborators receive for
any future product candidates may also be subject to limitations on
the approved indications for which the product may be marketed or
to the conditions of approval, or contain requirements for
potentially costly post-marketing testing, including Phase IV
clinical trials, and surveillance to monitor the safety and
efficacy of the product. In addition, the manufacturing processes,
labeling, packaging, distribution, adverse event reporting,
storage, advertising, promotion and recordkeeping for
Jeuveau®
and any other future product candidates will be subject to
extensive and ongoing regulatory requirements. These requirements
include submissions of safety and other post-marketing information
and reports, registration, as well as continued compliance with
cGMP requirements and compliance with good clinical practice, or
GCP, requirements, for any clinical trials that we conduct
post-approval. Later discovery of previously unknown problems with
Jeuveau®
or any future product candidates, including adverse events of
unanticipated severity or frequency, or with our third-party
manufacturers or manufacturing processes, or failure to comply with
regulatory requirements, may result in, among other things:
restrictions on the marketing or manufacturing of the product,
withdrawal of the product from the market, or voluntary or
mandatory product recalls; fines, warning letters or holds on
clinical trials; refusal by the FDA, the EMA or other similar
regulatory authorities to approve pending applications or
supplements to approved applications filed by us or our strategic
collaborators or suspension or revocation of product license
approvals; product seizure or detention or refusal to permit the
import or export of products; and injunctions or the imposition of
civil or criminal penalties.
Our ongoing regulatory requirements may also change from time to
time, potentially harming or making costlier our commercialization
efforts. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if
we are not able to maintain regulatory compliance, we may lose any
marketing approval that we may have obtained and we may not achieve
or sustain profitability, which would adversely affect our
business.
If we fail to obtain regulatory approvals in foreign jurisdictions
for Jeuveau®
or any future product candidates, we will be unable to market our
products outside of the United States.
In addition to regulations in the United States, we are and will be
subject to a variety of foreign regulations governing
manufacturing, clinical trials, commercial sales and distribution
of our future products. Whether or not we obtain FDA approval for a
product candidate, we must obtain approval of the product by the
comparable regulatory authorities of foreign countries before
commencing clinical trials or marketing in those countries. The
approval procedures vary among countries and can involve additional
clinical testing, and the time required to obtain approval may
differ from that required to obtain FDA approval. Clinical trials
conducted in one country may not be accepted by regulatory
authorities in other countries. Approval by the FDA does not ensure
approval by regulatory authorities in other countries, and approval
by one or more foreign regulatory authorities does not ensure
approval by regulatory authorities in other foreign countries or by
the FDA. The foreign regulatory approval process may include all of
the risks associated with obtaining FDA approval. We may not be
able to file for regulatory approvals or to do so on a timely
basis, and even if we do file, we may not receive necessary
approvals to commercialize our products in markets outside of the
United States.
Jeuveau®
or any future products may cause or contribute to adverse medical
events that we are required to report to regulatory agencies and if
we fail to do so, we could be subject to sanctions that would
materially harm our business.
Some participants in our clinical trials have reported adverse
events after being treated with Jeuveau®.
If we are successful in commercializing Jeuveau®
or any other product candidate, the FDA and other regulatory agency
regulations require that we report certain information about
adverse medical events if those products may have caused or
contributed to those adverse events. The timing of our obligation
to report would be triggered by the date we become aware of the
adverse event as well as the nature of the event. We may fail to
report adverse events that we become aware of within the prescribed
timeframe. We may also fail to appreciate that we have become aware
of a reportable adverse event, especially if it is not reported to
us as an adverse event or if it is an adverse event that is
unexpected or removed in time from the use of our products. If we
fail to comply with our reporting obligations, the FDA, the EMA or
other similar regulatory authorities could take action including
criminal prosecution, the imposition of civil monetary penalties,
seizure of our products, or delay in approval or clearance of
future products.
We may in the future be subject to various U.S. federal and state
laws pertaining to health care fraud and abuse, including
anti-kickback, self-referral, false claims and fraud laws, and any
violations by us of such laws could result in fines or other
penalties.
While we do not expect that Jeuveau®
will subject us to the various U.S. federal and most state laws
intended to prevent health care fraud and abuse, we may in the
future become subject to such laws. The Anti-Kickback Statute
prohibits the offer, receipt, or payment of remuneration in
exchange for or to induce the referral of patients or the use of
products or services that
would be paid for in whole or part by Medicare, Medicaid or other
federal health care programs. Remuneration has been broadly defined
to include anything of value, including cash, improper discounts,
and free or reduced price items and services. Many states have
similar laws that apply to their state health care programs as well
as private payors. Violations of anti-kickback and other applicable
laws can result in exclusion from federal health care programs and
substantial civil and criminal penalties.
The federal False Claims Act, or FCA, imposes liability on persons
who, among other things, present or cause to be presented false or
fraudulent claims for payment by a federal health care program. The
FCA has been used to prosecute persons submitting claims for
payment that are inaccurate or fraudulent, that are for services
not provided as claimed, or for services that are not medically
necessary. The FCA includes a whistleblower provision that allows
individuals to bring actions on behalf of the federal government
and share a portion of the recovery of successful claims. Some
state law equivalents of the above federal laws, such as the
Anti-Kickback Statute and FCA, apply to items or services
regardless of whether the good or service was reimbursed by a
government program, so called all-payor laws. These all-payor laws
could apply to our sales and marketing activities even if the
Anti-Kickback Statute and FCA laws are inapplicable.
If our marketing or other arrangements were determined to violate
anti-kickback or related laws, including the FCA or an all-payor
law, then we could be subject to penalties, including
administrative, civil and criminal penalties, damages, fines,
disgorgement, the exclusion from participation in federal and state
healthcare programs, individual imprisonment or the curtailment or
restructuring of our operations, any of which could materially and
adversely affect our ability to operate our business and our
financial results.
State and federal authorities have aggressively targeted
pharmaceutical companies for alleged violations of these anti-fraud
statutes, based on improper research or consulting contracts with
doctors, certain marketing arrangements with pharmacies and other
healthcare providers that rely on volume-based pricing, off-label
marketing schemes, and other improper promotional practices.
Companies targeted in such prosecutions have paid substantial
fines, have been ordered to implement extensive corrective action
plans, and have in many cases become subject to consent decrees
severely restricting the manner in which they conduct their
business, among other consequences. Additionally, federal and state
regulators have brought criminal actions against individual
employees responsible for alleged violations. If we become the
target of such an investigation or prosecution based on our
contractual relationships with providers or institutions, or our
marketing and promotional practices, we could face similar
sanctions, which would materially harm our business.
Also, the FCPA and similar worldwide anti-bribery laws generally
prohibit companies and their intermediaries from making improper
payments to non-U.S. officials for the purpose of obtaining or
retaining business. Our internal control policies and procedures
may not protect us from reckless or negligent acts committed by our
employees, future distributors, partners, collaborators or agents.
Violations of these laws, or allegations of such violations, could
result in fines, penalties or prosecution and have a negative
impact on our business, results of operations and
reputation.
Legislative or regulatory healthcare reforms in the United States
and other countries may make it more difficult and costly for us to
obtain regulatory clearance or approval of any future product
candidates and to produce, market, and distribute our products
after clearance or approval is obtained.
From time to time, legislation is drafted and introduced in the
U.S. Congress or other countries that could significantly change
the statutory provisions governing the regulatory clearance or
approval, manufacture, and marketing of regulated products or the
reimbursement thereof. In addition, regulations and guidance are
often revised or reinterpreted by the FDA and other regulatory
authorities in ways that may significantly affect our business and
our products. Any new regulations or revisions or reinterpretations
of existing regulations may impose additional costs or lengthen
review times of any future product candidates. Such changes could,
among other things, require changes to manufacturing or marketing
methods, changes to product labeling or promotional materials,
recall, replacement, or discontinuance of one or more of our
products; and additional recordkeeping.
Each of these would likely entail substantial time and cost and
could materially harm our business and our financial results. In
addition, delays in receipt of or failure to receive regulatory
clearances or approvals for any future products would harm our
business, financial condition and results of
operations.
Risks Related to Our Common Stock
Medytox, Alphaeon 1, LLC and Daewoong each own a significant
portion of our common stock and may exert significant control over
our business.
We had 56,260,570 shares of common stock issued and outstanding as
of December 31, 2022. As of December 31, 2022, Medytox
owned 13.0% of our outstanding shares of common stock, Alphaeon 1,
LLC owned 10.8% of our outstanding shares of common stock, and
Daewoong owned 5.6% of our outstanding shares of common
stock.
This concentrated ownership position may provide any one of
Medytox, Alphaeon 1, LLC or Daewoong with influence in determining
the outcome of corporate actions requiring stockholder approval,
including the election and removal of directors. The significant
stock ownership by Medytox, Alphaeon 1, LLC and Daewoong may also
discourage transactions involving a change-of-control of our
company, including transactions in which you as a holder of our
common stock might otherwise receive a premium for your
shares.
Securities class action and derivative lawsuits have been filed
against us and certain of our officers and directors, which could
result in substantial costs and could divert management
attention.
As disclosed in Part I, Item 3 “Legal Proceedings,” we and certain
of our officers have been named as defendants in a securities class
action lawsuit and we are a nominal defendant in derivative
lawsuits filed against certain of our officers and directors. We
maintain director and officer’s insurance coverage and continue to
engage in vigorous defense of such litigation. If we are not
successful in our defense of such litigation, we could be forced to
make significant payments to or other settlements with our
stockholders and their lawyers outside of our insurance coverage,
and such payments or settlement arrangements could have a material
adverse effect on our business, operating results or financial
condition. We may also be the target of this type of litigation in
the future, as companies that have experienced volatility in the
market price of their stock have been subject to securities act
litigation.
Even if the claims asserted in these lawsuits are not successful,
the litigation could result in substantial costs and significant
adverse impact on our reputation and divert management’s attention
and resources, which could have a material adverse effect on our
business, operating results or financial condition.
The trading price of our common stock has been volatile, and
purchasers of our common stock could incur substantial
losses.
Our stock price is volatile. For example, the closing price of our
common stock during the year ended December 31, 2022 has ranged
from a low of $5.22 to a high of $13.94. The stock market in
general and the market for earlier-stage pharmaceutical and medical
aesthetic companies in particular have experienced extreme
volatility that has often been unrelated to the operating
performance of particular companies. The market price for our
common stock may be influenced by many factors, some of which are
beyond our control, including:
•changes
in financial estimates or guidance, including our ability to meet
our future revenue and operating profit or loss estimates or
guidance;
•the
public’s reaction to our earnings releases, other public
announcements and filings with the SEC or those of companies that
are perceived to be similar to us;
•variations
in our financial results or those of companies that are perceived
to be similar to us;
•any
termination or loss of rights under the Daewoong
Agreement;
•the
FDA or other U.S. or foreign regulatory or legal actions or changes
affecting us or our industry;
•adverse
developments concerning our manufacturer or any future strategic
partnerships;
•adverse
developments affecting our compliance with the Medytox Settlement
Agreement;
•adverse
developments concerning litigation pending against us;
•introductions
and announcements of new technologies and products by us, any
commercialization partners or our competitors, and the timing of
these introductions and announcements;
•success
or failure of competitive products or medical aesthetic products
generally;
•announcements
of results of clinical trials or regulatory approval or disapproval
of product candidates;
•unanticipated
safety concerns related to the use of Jeuveau®
or any of our future products;
•changes
in the structure of healthcare payment systems;
•announcements
by us or our competitors of significant acquisitions, licenses,
strategic partnerships, new product approvals and introductions,
joint ventures or capital commitments;
•overall
financial market conditions for the pharmaceutical and
biopharmaceutical sectors and issuance of securities analysts’
reports or recommendations;
•rumors
and market speculation involving us or other companies in our
industry;
•short
selling of our common stock or the publication of opinions
regarding our business prospects in a manner that is designed to
create negative market momentum;
•sales
of substantial amounts of our stock by Medytox, Alphaeon 1, LLC,
Daewoong or other significant stockholders or our insiders, or the
expectation that such sales might occur;
•news
reports relating to trends, concerns and other issues in medical
aesthetics market or the pharmaceutical or biopharmaceutical
industry;
•operating
and stock performance of other companies that investors deem
comparable to us and overall performance of the equity
markets;
•additions
or departures of key personnel, including our Chief Executive
Officer, Chief Financial Officer, and Chief Medical
Officer;
•intellectual
property, product liability or other litigation against us, our
manufacturer or other parties on which we rely or litigation
against our general industry;
•changes
in our capital structure, such as future issuances of securities
and the incurrence of additional debt;
•changes
in accounting standards, policies, guidelines, interpretations or
principles;
•economic
conditions in the markets in which we operate, including those
related to COVID-19 and the Russian-Ukrainian conflict;
and
•other
factors described in this “Risk Factors” section.
In addition, the stock market in general, and the market for
pharmaceutical, biotechnology and medical aesthetics companies in
particular, have experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating
performance of those companies. Broad market and industry factors
may affect the market price of our common stock, regardless of our
actual operating performance. In the past, following periods of
volatility in the overall market and the market prices of a
particular company’s securities, securities class action litigation
has often been instituted against that company. We may become the
target of this type of litigation in the future. Securities
litigation, if instituted against us, could result in substantial
costs and divert our management’s attention and resources from our
business.
Future sales of our common stock by us, Medytox, Alphaeon 1, LLC,
Daewoong or others, or the perception that such sales may occur,
could depress the market price of our common stock.
Sales by us of a substantial number of shares of our common stock
in the public market, or the perception that these sales might
occur, could significantly reduce the market price of our common
stock and could impair our ability to raise capital through the
sale of additional equity securities.
Additionally, as discussed above, each of Medytox, Alphaeon 1, LLC
and Daewoong owns a significant portion of our outstanding shares
of common stock. Subject to the restrictions described in the
paragraph below, future sales of these shares in the public market
will be subject to certain contractual limitations in the case of
shares of our common stock owned by Medytox and the volume and
other restrictions of Rule 144 under the Securities Act for so long
as Medytox, Alphaeon 1,
LLC or Daewoong are deemed to be our affiliate, unless the shares
to be sold are registered with the SEC. Additionally, the shares of
common stock held by Medytox are subject to contractual
restrictions on transfer that, subject to certain limited
exceptions such as transfers to affiliates prohibit Medytox from
transferring more than 25% of the shares it holds prior to
September 16, 2023, more than 50% of the shares it holds prior to
September 16, 2024 and more than 75% of the shares it holds prior
to September 16, 2025, with such contractual restrictions
terminating on September 16, 2025. The sale by Medytox, Alphaeon 1,
LLC or Daewoong of a substantial number of shares of our common
stock, or a perception that such sales could occur, could
significantly reduce the market price of our common stock. For
example, in September 2021, Alphaeon 1, LLC sold 2,597,475 shares
of our common stock.
We have filed a registration statement with the SEC covering shares
of our common stock available for future issuance under
our 2017 Omnibus Incentive Plan and may file future
registration statements covering shares of our common stock for
future issuance under any future plans. Upon effectiveness of such
registration statements, any shares subsequently issued under such
plans will be eligible for sale in the public market, except to the
extent that they are restricted by the contractual arrangements
discussed above and subject to compliance with Rule 144 in the case
of our affiliates. Sales of a large number of the shares issued
under these plans in the public market, or a perception that such
sales could occur, could significantly reduce the market price of
our common stock.
Anti-takeover provisions in our certificate of incorporation and
bylaws, as well as Delaware law, could discourage a
takeover.
Our certificate of incorporation, bylaws and Delaware law contain
provisions that might enable our management to resist a takeover
and might make it more difficult for an investor to acquire a
substantial block of our common stock. These include the following
provisions:
•permit
our board of directors to issue shares of preferred stock, with any
rights, preferences and privileges as they may designate, without
stockholder approval, which could be used to dilute the ownership
of a hostile bidder significantly;
•provide
that the authorized number of directors may be changed only by
resolution of our board of directors and that a director may only
be removed for cause by the affirmative vote of the holders of at
least 66 2/3% of our voting stock;
•provide
that all vacancies, including newly created directorships, may,
except as otherwise required by law, be filled by the affirmative
vote of a majority of directors then in office, even if less than a
quorum;
•divide
our board of directors into three classes, with each class serving
staggered three-year terms, which may delay the ability of
stockholders to change the membership of a majority of our board of
directors;
•require
that any action to be taken by our stockholders must be effected at
a duly called annual or special meeting of stockholders and not be
taken by written consent;
•provide
that stockholders seeking to present proposals before a meeting of
stockholders or to nominate candidates for election as directors at
a meeting of stockholders must provide notice in writing in a
timely manner and also specify requirements as to the form and
content of a stockholder’s notice, which may discourage or deter a
potential acquiror from conducting a solicitation of proxies to
elect the acquiror’s own slate of directors or otherwise attempting
to obtain control of our company;
•prohibit
cumulative voting in the election of directors, which limits the
ability of minority stockholders to elect director candidates;
and
•provide
that special meetings of our stockholders may be called only by the
chairman of the board, our Chief Executive Officer or by our board
of directors pursuant to a resolution adopted by a majority of the
total number of authorized directors, which may delay the ability
of our stockholders to force consideration by our company of a
take-over proposal or to take certain corporate actions, including
the removal of directors.
These provisions may frustrate or prevent any attempts by our
stockholders to replace or remove our current management by making
it more difficult for stockholders to replace members of our board
of directors, which is responsible for appointing the members of
our management. In addition, we are subject to Section 203 of the
General Corporation Law of the State of Delaware, or the DGCL,
which generally prohibits a Delaware corporation from engaging in
any of a broad range of business
combinations with an interested stockholder who owns in excess of
15% of our outstanding voting stock from merging or combining with
us for a period of three years after the date of the transaction in
which the person acquired in excess of 15% of our outstanding
voting stock, unless the merger or combination is approved in a
prescribed manner. This provision could have the effect of delaying
or preventing a change-of-control, whether or not it is desired by
or beneficial to our stockholders. Further, other provisions of
Delaware law may also discourage, delay or prevent someone from
acquiring us or merging with us.
Our certificate of incorporation designates the Court of Chancery
of the State of Delaware as the sole and exclusive
forum for certain types of actions and proceedings that may be
initiated by our stockholders, which could limit our stockholders’
ability to obtain a favorable judicial forum for disputes with us
or our directors, officers, employees or agents.
Our certificate of incorporation provides that, unless we consent
in writing to an alternative forum, the Court of Chancery of the
State of Delaware will be the sole and exclusive
forum for all “internal corporate claims.” “Internal corporate
claims” are claims that are based upon a violation of a duty by a
current or former director, officer or stockholder in such
capacity, or as to which Title 8 of the DGCL confers jurisdiction
upon the Court of Chancery of the State of Delaware, or the Court
of Chancery, in each case subject to the Court of Chancery having
personal jurisdiction over the indispensable parties named as
defendants and the claim not being one which is vested in the
exclusive jurisdiction of a court or forum other than the Court of
Chancery, or for which the Court of Chancery does not have subject
matter jurisdiction. For example, this choice of forum provision
would not apply to claims brought pursuant to the Exchange Act or
the Securities Act of 1933, as amended, or any other claim for
which the federal courts have exclusive jurisdiction. Any person
purchasing or otherwise acquiring any interest in any shares of our
capital stock shall be deemed to have notice of and to have
consented to this provision of our certificate of incorporation.
The choice of forum provision in our certificate of incorporation
will not relieve us of our duties to comply with the federal
securities laws and the rules and regulations thereunder, and our
stockholders will not be deemed to have waived our compliance with
these laws, rules and regulations.
This choice of forum provision may limit our stockholders’ ability
to bring a claim in a judicial forum that they find favorable for
disputes with us or our directors, officers, employees or agents,
which may discourage such lawsuits against us and our directors,
officers, employees and agents even though an action, if
successful, might benefit our stockholders. Stockholders who do
bring a claim in the Court of Chancery could face additional
litigation costs in pursuing any such claim, particularly if they
do not reside in or near Delaware. The Court of Chancery may also
reach different judgments or results than would other courts,
including courts where a stockholder considering an action may be
located or would otherwise choose to bring the action, and such
judgments or results may be more favorable to us than to our
stockholders. Alternatively, if a court were to find this provision
of our certificate of incorporation inapplicable to, or
unenforceable in respect of, one or more of the specified types of
actions or proceedings, we may incur additional costs associated
with resolving such matters in other jurisdictions, which could
have a material adverse effect on our business, financial condition
or results of operations.
Claims for indemnification by our directors and officers may reduce
our available funds to satisfy successful third-party claims
against us and may reduce the amount of money available to
us.
Our certificate of incorporation and bylaws provide that we can
indemnify our directors and officers, in each case to the fullest
extent permitted by Delaware law. Separate indemnity agreements
have been issued with each director and executive
officer.
In addition, as permitted by Section 145 of the DGCL, our bylaws
and our indemnification agreements that we have entered into with
our directors and officers, among other things provide
that:
•We
have indemnified our directors and officers for serving us in those
capacities, or for serving as a director, officer, employee or
agent of other business enterprises at our request, to the fullest
extent permitted by Delaware law. Delaware law provides that we may
indemnify such person if such person acted in good faith and in a
manner such person reasonably believed to be in or not opposed to
our best interest and, with respect to any criminal proceeding, had
no reasonable cause to believe such person’s conduct was
unlawful.
•We
may, in our discretion, indemnify employees and agents in those
circumstances where indemnification is permitted by applicable
law.
•We
will be required to advance expenses, as incurred, to our directors
and officers in connection with defending a proceeding, except that
such directors or officers shall undertake to repay such advances
if it is ultimately determined that such person is not entitled to
indemnification.
•The
rights conferred in our bylaws will not be exclusive. We may not
retroactively amend our bylaw provisions to reduce our
indemnification obligations to directors, officers, employees and
agents.
As a result, claims for indemnification by our directors and
officers may reduce our available funds to satisfy successful
third-party claims against us and may reduce the amount of money
available to us.
We are an “emerging growth company,” and the reduced reporting
requirements available to emerging growth companies could make our
common stock less attractive to investors.
We qualify as an “emerging growth company,” as defined in the JOBS
Act. For as long as we remain an emerging growth company, we may
take advantage of certain exemptions from various reporting
requirements that are applicable to other public companies. These
provisions include, but are not limited to:
•being
permitted to have only two years of audited financial statements
and only two years of related selected financial data and
management’s discussion and analysis of financial condition and
results of operations disclosure;
•an
exemption from compliance with the auditor attestation requirement
in the assessment of our internal control over financial reporting
pursuant to the Sarbanes-Oxley Act;
•reduced
disclosure about executive compensation arrangements in our
periodic reports, registration statements and proxy statements;
and
•exemptions
from the requirements to seek non-binding advisory votes on
executive compensation or golden parachute
arrangements.
To the extent we take advantage of any of these exemptions, the
information that we provide stockholders may be different than what
is available with respect to other public companies. Investors may
find our common stock less attractive because we will rely on these
exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our
common stock and our stock price may be more volatile.
Even after we no longer qualify as an emerging growth company, we
may still qualify as a “smaller reporting company” which would
allow us to take advantage of many of the same exemptions from
disclosure requirements, including exemption from compliance with
the auditor attestation requirements of Section 404(b) as long as
we do not otherwise also qualify as an “accelerated filer” or
“large accelerated filer” for SEC reporting purposes and reduced
disclosure obligations regarding executive compensation in our
periodic reports and proxy statements. Investors could find our
common stock less attractive because we may rely on these
exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our
common stock and our trading price may be more
volatile.
General Risk Factors
Our business could be negatively affected as a result of actions of
activist stockholders, and such activism could impact the trading
value of our securities.
Stockholders may, from time to time, engage in proxy solicitations
or advance stockholder proposals, or otherwise attempt to effect
changes and assert influence on our board of directors and
management. Activist campaigns that contest or conflict with our
strategic direction or seek changes in the composition of our board
of directors could have an adverse effect on our operating results
and financial condition. A proxy contest would require us to incur
significant legal and advisory fees, proxy solicitation expenses
and administrative and associated costs and require significant
time and attention by our board of directors and management,
diverting their attention from the pursuit of our business
strategy. Any perceived uncertainties as to our future direction
and control, our ability to execute on our strategy, or changes to
the composition of our board of directors or senior management team
arising from a proxy contest could lead to the perception of a
change in the direction of our business or instability which may
result in the loss of potential business opportunities, make it
more difficult to pursue our strategic initiatives, or limit our
ability to attract and retain qualified personnel and business
partners, any of which could adversely affect our business and
operating results. If individuals are ultimately elected to our
board of directors with a specific agenda, it may adversely affect
our ability to effectively implement our business strategy and
create additional value for our stockholders. We may choose to
initiate, or may become subject to, litigation as a result of the
proxy contest or matters arising from the proxy contest, which
would serve as a further distraction to our board of directors and
management and would require us to incur significant additional
costs. In addition, actions such as those described above could
cause
significant fluctuations in our stock price based upon temporary or
speculative market perceptions or other factors that do not
necessarily reflect the underlying fundamentals and prospects of
our business.
If securities or industry analysts publish unfavorable research
about our business or decrease the frequency or cease to provide
coverage of our company, our stock price and trading volume could
decline.
The trading market for our common stock depends in part on the
research and reports that equity research analysts publish about us
and our business. If one or more of the equity research analysts
who cover us downgrades our common stock or issues other
unfavorable commentary or research the price of our common stock
may decline. If one or more equity research analysts ceases
coverage of our company or fails to publish reports on us
regularly, demand for our common stock could decrease, which in
turn could cause the trading price or trading volume of our common
stock to decline.
We have not paid dividends in the past and do not expect to pay
dividends in the future, and any return on investment may be
limited to the value of our stock.
We have never paid cash dividends on our common stock and do not
anticipate paying cash dividends on our common stock in the
foreseeable future, and the payment of dividends is also restricted
under our credit facility. The payment of dividends on our common
stock will depend on our earnings, financial condition and other
business and economic factors affecting us at such time as our
board of directors may consider relevant. If we do not pay
dividends, capital appreciation, if any, of our common stock will
be your sole source of gain for the foreseeable
future.
The requirements of being a public company may strain our
resources, divert management’s attention and affect our ability to
attract and retain executive management and qualified board
members.
As a public company, we are subject to the reporting requirements
of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall
Street Reform and Consumer Protection Act, the Nasdaq Marketplace
Rules and other applicable securities rules and regulations.
Complying with these rules and regulations will increase our legal
and financial compliance costs, make some activities more
difficult, time-consuming or costly and increase demand on our
systems and resources, particularly after we are no longer an
“emerging growth company,” as defined in the JOBS Act. The Exchange
Act requires, among other things, that we file annual, quarterly
and current reports with respect to our business and operating
results. The Sarbanes-Oxley Act requires, among other things, that
we maintain effective disclosure controls and procedures and
internal control over financial reporting. In order to maintain
and, if required, improve our disclosure controls and procedures
and internal control over financial reporting to meet this
standard, significant resources and management oversight may be
required. As a result, management’s attention may be diverted from
other business concerns, which could adversely affect our business
and operating results. We may need to hire more employees in the
future or engage outside consultants to assist us in complying with
these requirements, which will increase our costs and
expenses.
In addition, changing laws, regulations and standards relating to
corporate governance and public disclosure are creating uncertainty
for public companies, increasing legal and financial compliance
costs and making some activities more time consuming. These laws,
regulations and standards are subject to varying interpretations,
in many cases due to their lack of specificity, and, as a result,
their application in practice may evolve over time as new guidance
is provided by regulatory and governing bodies. This could result
in continuing uncertainty regarding compliance matters and higher
costs necessitated by ongoing revisions to disclosure and
governance practices. We intend to invest resources to comply with
evolving laws, regulations and standards, and this investment may
result in increased selling, general and administrative expenses
and a diversion of our management’s time and attention from
revenue-generating activities to compliance activities. If our
efforts to comply with new laws, regulations and standards differ
from the activities intended by regulatory or governing bodies due
to ambiguities related to their application and practice,
regulatory authorities may initiate legal proceedings against us
and our business may be adversely affected.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Our corporate headquarters is located at 520 Newport Center Drive,
Suite 1200, Newport Beach, CA 92660, in a facility that we lease,
encompassing approximately 17,758 square feet of space. The lease
for this facility expires on January 31, 2025. We believe our
facilities are sufficient for our current needs. When our lease
expires, we may exercise our renewal option or look for additional
or alternate space for our operations, and we believe that suitable
additional or alternative space will be available in the future on
commercially reasonable terms.
Item 3. Legal Proceedings.
Securities Class Action Lawsuit
On October 16 and 28, 2020, two putative securities class action
complaints were filed in the U.S. District Court for the Southern
District of New York by Evolus shareholders Armin Malakouti and
Clinton Cox, respectively, naming us and certain of our officers as
defendants. The complaints assert violations of Sections 10(b) and
20(a) of the Securities Exchange Act of 1934 and Rule 10b-5
promulgated thereunder, claiming that the defendants made false and
materially misleading statements and failed to disclose material
adverse facts related to our acquisition of the right to sell
Jeuveau®, the complaint against us filed by Allergan and Medytox in
the U.S. International Trade Commission related to Jeuveau® (the
“ITC Action”), and risks related to the ITC Action. The complaints
assert a putative class period of February 1, 2019 to July 6, 2020.
The court consolidated the actions on November 13, 2020, under the
caption In re Evolus Inc. Securities Litigation, No. 1:20-cv-08647
(PGG). On September 17, 2021, the court appointed a lead plaintiff
and lead counsel. On November 17, 2021, the lead plaintiff filed an
amended class action complaint against us, three of our officers,
and Alphaeon Corporation, our former majority shareholder. On
January 18, 2022, we and the officer defendants served a motion to
dismiss the amended complaint. On February 10, 2022, Alphaeon
Corporation served its motion to dismiss the amended complaint.
Both motions were fully briefed on June 16, 2022. The outcome of
the legal proceeding is uncertain at this point. Based on
information available to us at present, management cannot
reasonably estimate a range of loss with respect to this
matter.
Shareholder Derivative Lawsuit
On November 27, 2020 and December 2, 2020, two putative Evolus
shareholders filed substantially similar shareholder derivative
actions in the U.S. District Court for the Southern District of New
York against certain of our officers and directors as defendants.
The complaints alleged substantially similar facts as those in the
Securities Class Action and assert claims for, among other things,
breach of fiduciary duty, waste of corporate assets, unjust
enrichment, and violations of Section 14(a) of the Exchange Act and
for contribution under Sections 10(b) and 21(D) of the Exchange
Act. On December 29, 2020, the plaintiffs filed a joint stipulation
to consolidate their actions and on February 5, 2021, the court
consolidated the action under the caption In re Evolus, Inc.
Derivative Litigation, No. 1:20-cv-09986-PPG, and adjourned
defendants’ time to move, answer or otherwise respond to the
complaints. On September 20, 2021, the court so-ordered the
parties’ stipulated stay of the consolidated derivative suit
pending the court’s decision on the defendants’ motion to dismiss
the Securities Class Action.
It is possible that additional suits will be filed, or additional
allegations will be made by stockholders, with respect to these
same or similar or other matters and also naming us and/or our
officers and directors as defendants. We believe that the
complaints are without merit and intends to vigorously defend
against it. However, the outcome of the legal proceeding is
uncertain at this point. Based on information available to us at
present, management cannot reasonably estimate a range of loss with
respect to this matter.
Books and Records Demand
On March 5, 2021, we received a letter from a putative stockholder
demanding inspection of specified categories of our books and
records under Section 220 of the Delaware General Corporations Law.
We were subsequently informed that the stockholder sold his shares
of our common stock. On October 13, 2021, we received a
substantially similar demand to inspect specified categories of our
books and records under Section 220 of the Delaware General
Corporations Law from another putative stockholder. The subject of
the demand is substantially similar to the allegations in the
putative securities class action and derivative complaints
described above. We responded to the demand in December 2021. The
outcome of this matter is uncertain at this point. Based on
information available to us at present, management cannot
reasonably estimate a range of loss with respect to this
matter.
Other Legal Matters
In addition to the legal proceedings set forth above, from time to
time, we may be subject to other legal proceedings and claims in
the ordinary course of business.
Item 4. Mine Safety
Disclosures.
Not applicable.
Part II
Item 5. Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities.
Market Information
Our common stock has been listed and traded on the Nasdaq under the
symbol “EOLS” since February 12, 2018.
Holders of Record
As of March 3, 2023, we had approximately 53 holders
of record of our common stock. This number does not include
beneficial owners whose shares were held in street name. The actual
number of holders of our common stock is greater than this number
of record holders and includes stockholders who are beneficial
owners, but whose shares are held in street name by brokers or held
by other nominees. This number of holders of record also does not
include stockholders whose shares may be held in trust by other
entities.
Dividend Policy
We have never declared or paid any cash dividends on our capital
stock and we do not currently intend to pay any cash dividends on
our capital stock for the foreseeable future. We currently intend
to retain all available funds and any future earnings to support
our operations and finance the growth and development of our
business. Any future determination related to our dividend policy
will be made at the discretion of our board of directors and will
depend upon, among other factors, our results of operations,
financial condition, capital requirements, tax considerations,
legal or contractual restrictions, business prospects, the
requirements of current or then-existing debt instruments, general
economic conditions and other factors our board of directors may
deem relevant. The payment of dividends is also restricted under
our credit facility.
Item 6. [Reserved].
Item 7. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
The following discussion contains management’s discussion and
analysis of our financial condition and consolidated results of
operations and should be read together with the historical
consolidated financial statements and the notes thereto included in
Item 8 “Consolidated Financial Statements and Supplementary Data”
and included elsewhere in this Annual Report on Form 10-K. This
discussion contains forward-looking statements that reflect our
plans, estimates and beliefs and involve numerous risks and
uncertainties, including but not limited to those described in the
Item 1A “Risk Factors” section of this Annual Report on Form 10-K.
Actual results may differ materially from those contained in any
forward-looking statements. You should carefully read “Special Note
Regarding Forward-Looking Statements” and Item 1A “Risk
Factors.”
Overview
We are a performance beauty company with a customer-centric
approach to delivering breakthrough products in the self-pay
aesthetic market. In February 2019, we received the approval of our
first product Jeuveau®
(prabotulinumtoxinA-xvfs) from the U.S. Food and Drug
Administration, or FDA. In May 2019, we commercially launched
Jeuveau®
in the United States.
Jeuveau®
is a proprietary 900 kDa purified botulinum toxin type A
formulation indicated for the temporary improvement in the
appearance of moderate to severe glabellar lines, also known as
“frown lines,” in adults. Our primary market is the self-pay
aesthetic market, which includes medical products purchased by
physicians and other customers that are then sold to consumers or
used in procedures for aesthetic indications that are not
reimbursed by any third-party payor, such as Medicaid, Medicare or
commercial insurance. We believe we offer customers and consumers a
compelling value proposition with Jeuveau®.
Currently, onabotulinumtoxinA (BOTOX) is the neurotoxin market
leader, and prior to the approval of Jeuveau®,
was the only known 900 kDa botulinum toxin type A complex approved
in the United States. We believe aesthetic physicians generally
prefer the performance characteristics of the complete 900 kDa
neurotoxin complex and are accustomed to injecting this
formulation.
In August 2018, we received approval from Health Canada for
the temporary improvement in the appearance of moderate to severe
glabellar lines in adult patients under 65 years of age. We
began marketing Jeuveau®
in Canada in October 2019 through our distribution partner Clarion
Medical Technologies, Inc., or Clarion. In September 2019, we also
received approval from the European Commission, to market the
product in all 27 European Union, or EU, member states plus the
United Kingdom, Iceland, Norway and Liechtenstein. In January 2021,
we received a positive decision from the European Commission to add
the 50 unit product to the approval obtained in September 2019. We
launched Jeuveau®
in Great Britain in September 2022, in Germany and Austria in
February 2023, and we are finalizing plans for entering additional
countries in Europe as part of a phase rollout. In January 2023, we
received approval from the Australian Therapeutics Good
Administration, or TGA, for regulatory approval of our neurotoxin
in Australia.
In November 2021, we announced the initiation of a Phase II
clinical trial designed to investigate a higher strength dose of
Jeuveau®
in the frown lines. We completed our patient enrollment in the
clinical study evaluating the “extra-strength” dose in the second
quarter of 2022. This program provides us with the opportunity to
offer the first multi-strength neurotoxin, giving customers and
consumers increased treatment options. In January 2023, we
announced positive interim results from the Phase II clinical
trial. The interim data showed that the “extra-strength”
formulation of Jeuveau®
appeared to be generally safe and well-tolerated and demonstrated a
median duration of at least 26 weeks based on the time for patients
to return to baseline after treatment. The trial is expected to be
completed in the first half of 2023, and final results will be
presented in the second half of 2023.
Impact of Settlement Agreements
In February 2021, we settled litigation claims related to a
complaint against us filed by Allergan, Inc. and Allergan Limited
(together, “Allergan”) and Medytox, Inc. (“Medytox”) in the U.S.
International Trade Commission related to
Jeuveau®
(the “ITC Action”) and certain related matters by entering into a
Settlement and License Agreement with Medytox and Allergan, which
we refer to as the U.S. Settlement Agreement, and another
Settlement and License Agreement with Medytox which we refer to as
the Medytox Settlement Agreement. We refer to the U.S. Settlement
Agreement and the ROW Settlement Agreement collectively as the
Medytox/Allergan Settlement Agreements.
We have completed all obligations to Allergan and the majority of
our obligations to Medytox under the Medytox/Allergan Settlement
Agreements. These completed obligations consisted of
(i) cash payments of
$35.0 million
in multiple payments to Allergan and Medytox, of which we paid each
of the first payment of
$15.0 million
in the third quarter of 2021, the second payment of
$15.0 million
in the first quarter of 2022, and the final payment of
$5.0 million
in the first quarter of 2023, (ii) payment to Allergan and Medytox
of certain royalties on the sale of Jeuveau®,
based on a certain dollar amount per vial sold
of Licensed Products by or on our behalf in the United States, from
December 16, 2020 through September 16, 2022, (iii) payment to
Medytox, from December 16, 2020 to September 16, 2022, of a
low-double digit royalty on net sales of Jeuveau®
sold by us or on our behalf in territories we have licensed outside
the United States, and (iv) the issuance of 6,762,652 shares of our
common stock to Medytox.
Going forward, our remaining obligation will be to pay Medytox a
mid-single digit royalty percentage on net sales of
Jeuveau®
in the United States and all territories we have licensed outside
the United States through September 16, 2032.
In addition, in March 2021, we entered into a Confidential
Settlement and Release Agreement and certain related agreements
with Daewoong Pharmaceutical Co. Ltd. (“Daewoong”), which we refer
to as the Daewoong Settlement Agreement, under which Daewoong paid
us $25.5 million in April 2021, cancelled all remaining milestone
payments up to $10.5 million in aggregate under the Daewoong
Settlement Agreement and reimbursed us certain amounts (calculated
on a dollar amount per vials sold basis in the United States) for
sales of certain products with respect to which we are required to
pay Medytox and Allergan royalties pursuant to the U.S. Settlement
Agreement. See
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for additional details on the litigation settlement
agreements.
As a result of the royalty payments that we are required to pay
under the Medytox Settlement Agreements, our cost of sales and
gross profit margin have been negatively impacted and will continue
to be negatively impacted to a marginal extent from September 2022
to September 2032.
The Pharmakon Term Loans
On December 14, 2021, we entered into a loan agreement with BPCR
Limited Partnership, BioPharma Credit Investments V (Master) LP,
and Biopharma Credit PLC (collectively, “Pharmakon”). Pursuant to
the terms of the agreement, Pharmakon agreed to make term loans to
us in two tranches (“Pharmakon Term Loans”). The first tranche of
$75.0 million was funded on December 29, 2021. On December 5, 2022,
we entered into a Second Amendment to the loan agreement to extend
our option to draw down the second tranche of $50.0 million
until December 31, 2023. In exchange for the extension, we paid an
amendment fee of $0.5 million to Pharmakon. The second tranche of
$50.0 million may be drawn at our election no later than
December 31, 2023, subject to the terms and conditions of the
Pharmakon Term Loans. As of March 8, 2023, we have not drawn
the second tranche. The Pharmakon Term Loans will mature on the
six-year anniversary of the closing date of the first tranche. See
“—Liquidity and Capital Resources—The Pharmakon Term Loans” for
further information.
Contingent Royalties and Notes Payable to Evolus
Founders
We are obligated to make quarterly future payments to the founders
of Evolus, which we refer to as the Evolus Founders, of a low
single digit percentage of net sales of Jeuveau®.
These obligations terminate at the end of the second quarter of
2029. The fair value of the obligations are valued quarterly and
are referred to in our consolidated financial statements as the
contingent royalty obligation. In November 2021, we also paid $20.0
million to satisfy in full a promissory note that matured in
November 2021.
Market Trends and Uncertainties
The global economy, including the financial and credit markets, has
recently experienced extreme volatility and disruptions, including
the COVID-19 pandemic, increases in inflation rates, rising
interest rates, severely diminished liquidity and credit
availability, declines in consumer confidence, declines in economic
growth, and uncertainty about economic stability. We anticipate
that the fiscal 2023 will continue to reflect a dynamic
macroeconomic environment. We expect elevated levels of cost
inflation to continue, potentially impacting consumer discretionary
spending for aesthetic medical procedures. Markets experiencing
uncertainty could have substantial high rates of inflation. We
cannot reasonably estimate the financial impact of increased
inflation on our financial condition, results of operations or cash
flows in the future.
Management’s Use of Adjusted Gross Profit Margin
Adjusted gross profit and adjusted gross profit margin are not
required by, nor presented in accordance with United States
generally accepted accounting principles, or GAAP. Adjusted gross
profit is defined as total net revenues less product cost of sales,
excluding the one-time settlement payment from Daewoong in 2021 and
amortization of an intangible asset. Adjusted gross profit margin
is calculated as adjusted gross profit divided by total net
revenues. Management believes that adjusted gross profit margin is
an important measure for investors because management uses adjusted
gross profit margin as a key performance indicator to evaluate the
profitability of sales without giving effect to costs that are not
core to our cost of sales, such as the settlement payment from
Daewoong and the amortization of an intangible asset. Adjusted
gross profit margin
should not be considered a measure of financial performance under
GAAP, and the items excluded from adjusted gross profit margin
should not be considered in isolation or as alternatives to
financial statement data presented in the
consolidated
financial statements as an indicator of financial performance or
liquidity. As adjusted gross profit margin is not a measurement
determined in accordance with GAAP and is therefore susceptible to
varying methods of calculation, this metric, as presented, has
limitations as an analytical tool and may not be comparable to
other similarly titled measures of other companies.
The following are reconciliations of adjusted gross profit to gross
profit, the most directly comparable to GAAP measure, and adjusted
gross profit margin to gross profit margin, the most directly
comparable GAAP measure:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31, |
(in millions) |
2022 |
|
2021 |
Total net revenues |
$ |
148.6 |
|
|
$ |
99.7 |
|
Cost of sales: |
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
55.9 |
|
|
43.5 |
|
Settlement payment from Daewoong |
— |
|
|
(25.5) |
|
Amortization of distribution right intangible asset |
3.0 |
|
|
2.9 |
|
Total cost of sales |
58.9 |
|
|
20.9 |
|
Gross profit |
89.8 |
|
|
78.7 |
|
Gross profit margin |
60.4 |
% |
|
79.0 |
% |
Add: Settlement payment from Daewoong |
— |
|
|
(25.5) |
|
Add: Amortization of distribution right intangible
asset |
3.0 |
|
|
2.9 |
|
Adjusted gross profit |
$ |
92.7 |
|
|
$ |
56.1 |
|
Adjusted gross profit margin |
62.4 |
% |
|
56.3 |
% |
Results of Operations
Comparison of the Years Ended December 31, 2022 and
2021
The following table summarizes our results of operations for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
(in millions) |
2022 |
|
2021 |
|
|
Revenue: |
|
|
|
|
|
Product revenue, net |
$ |
146.6 |
|
|
$ |
99.0 |
|
|
|
Service revenue |
2.0 |
|
|
0.7 |
|
|
|
Total net revenues |
148.6 |
|
|
99.7 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
55.9 |
|
|
43.5 |
|
|
|
Settlement payment from Daewoong |
— |
|
|
(25.5) |
|
|
|
Selling, general and administrative |
141.8 |
|
|
112.1 |
|
|
|
Research and development |
4.7 |
|
|
2.1 |
|
|
|
In-process research and development |
2.0 |
|
|
— |
|
|
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
5.8 |
|
|
6.3 |
|
|
|
Depreciation and amortization |
3.7 |
|
|
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
213.9 |
|
|
144.1 |
|
|
|
Loss from operations |
(65.3) |
|
|
(44.4) |
|
|
|
Non-operating expense, net |
(9.0) |
|
|
(1.4) |
|
|
|
Loss from extinguishment of debts, net |
— |
|
|
(1.0) |
|
|
|
Loss before income taxes: |
(74.3) |
|
|
(46.8) |
|
|
|
Income tax expense |
0.1 |
|
|
0.0 |
|
|
|
Net loss |
$ |
(74.4) |
|
|
$ |
(46.8) |
|
|
|
Unrealized loss, net of tax |
(0.3) |
|
|
— |
|
|
|
Comprehensive loss |
$ |
(74.7) |
|
|
$ |
(46.8) |
|
|
|
Net Revenues
We currently operate in one reportable segment, and all of our net
revenues are derived from sales of Jeuveau®.
Net revenues consist of revenues, net of adjustments primarily for
customer rebates, rewards related to the consumer loyalty program
and co-branded marketing programs. Revenues are recognized when the
control of the promised goods is transferred to the customer in an
amount that reflects the consideration allocated to the related
performance obligations and to which we expect to be entitled in
exchange for those products or services.
Net revenues of Jeuveau®
sales increased by $48.9 million, or 49.1%, to $148.6 million for
the year ended December 31, 2022 from $99.7 million for the year
ended December 31, 2021, primarily due to higher sales volumes. We
anticipate our continued sales growth will depend on our ability to
grow our customer base and increase purchases by our current
customers in the competitive medical aesthetic market.
Cost of Sales
Product Cost of Sales
Product cost of
sales, excluding amortization of intangible assets,
primarily consisted of the cost of inventory purchased from
Daewoong. In addition, during the period from December 2020 to
September 2022, product cost of sales, excluding amortization of
intangible assets, also included certain royalties on the sale of
Jeuveau®
payable to Medytox and Allergan pursuant to the Medytox/Allergan
Settlement Agreements, partially offset by reimbursement receivable
from Daewoong pursuant to the Daewoong Arrangement with respect to
such royalties. Our royalty obligations to Allergan concluded
on
September 16, 2022, and beginning on September 17, 2022, our
royalty obligations to Medytox were reduced to a mid-single digit
percentage of net revenue for ten years thereafter.
Product cost of sales, excluding amortization of intangible assets,
increased by
$12.4 million, or 28.4%,
to $55.9
million for the year
ended December 31, 2022 from
$43.5 million
from the
year ended December 31, 2021
primarily due to higher sales volume. We anticipate that our
product cost of sales will fluctuate in line with changes in
revenues.
Settlement Payment from Daewoong
In the first quarter of 2021, we recorded a one-time settlement
receipt of $25.5 million from Daewoong in connection with the
Daewoong Settlement Agreement.
Gross Profit Margin
Our gross profit margin was 60.4% and 79.0% for the years ended
December 31, 2022 and 2021, respectively. Our adjusted gross profit
margin, calculated as total net revenues less product cost of
sales, excluding amortization of intangible assets and the one-time
settlement payments from Daewoong, as a percentage of total net
revenues was 62.4% and 56.3% for the years ended
December 31, 2022 and 2021, respectively. Our gross profit margin
and adjusted gross profit margin were impacted negatively and
materially through September 2022, offset by payments we receive
under the Daewoong Arrangement, by our payments under the
Medytox/Allergan Settlement Agreements. Our gross profit margin and
adjusted gross profit margin will continue to be negatively
impacted to a lesser extent from September 2022 to September 2032
as we pay royalty obligations to Medytox at a mid-single digit
percentage of net revenue. We also anticipate our gross profit
margin and adjusted gross profit margin will fluctuate as we
implement various marketing programs that may affect the average
selling price for Jeuveau®
and as we expand internationally.
Selling, General and Administrative
Selling, general and administrative expenses increased
by $29.8 million, or 26.6%, to $141.8
million for the year ended December 31,
2022 from $112.1 million for the year ended
December 31, 2021, primarily resulting from increased personnel
costs and increased commercial activities. Selling, general and
administrative expenses may fluctuate in the future primarily due
to potential changes in marketing strategies and future launches
internationally.
Research and Development
Research and development expenses increased by $2.7
million, or 129.7%, to $4.7 million for
the year ended December 31, 2022 from $2.1
million for the year ended December 31, 2021. The
increase was primarily attributable to increasing our clinical
operations and research and development expenses related to the
Phase II “extra-strength” clinical trial. We expect our research
and development expenses to continue to increase if and when we
seek to develop further product candidates and as we pursue
regulatory approvals in other jurisdictions.
In-process Research and Development
In the second quarter of 2022, we recorded an upfront payment of
$2.0 million in connection with the License and Research
Collaboration Agreement (the “Collaboration Agreement”) we entered
into in June 2022 with a 3D printing company with biomaterial
capabilities. See
Note 2.
Basis of Presentation and Summary of Significant Accounting
Policies
for additional information.
Revaluation of Contingent Royalty Obligation Payable to Evolus
Founders
The change in the fair value of the contingent royalty obligation
payable to Evolus Founders is recorded in operating expenses in
each reporting period. During the years ended December 31,
2022 and 2021, the revaluation charge of $5.8
million and $6.3 million, respectively, were primarily
driven by changes in management assumptions relating to revenue
forecasts, the discount rate used
and the timing
of cash flows.
Depreciation and Amortization
Depreciation and amortization decreased by $1.9 million, or
33.8%, to $3.7 million for the year ended
December 31, 2022 from $5.6 million for the year ended
December 31, 2021 due to the decrease in amortization of the
internal-use software.
Non-Operating Expense, Net
Non-operating expenses, net, increased by $7.6 million, or
544.2%, to $9.0 million for the year ended
December 31, 2022 from $1.4 million for the year
ended December 31, 2021, primarily due to higher interest expense
for the Pharmakon Term Loans. The interest on the Pharmakon Term
Loans is based on a variable interest rate, which we expect will
continue to result in higher interest expense in the current
interest rate environment.
Loss from Extinguishment of Debts, Net
Loss from extinguishment of debts, net includes a $1.9 million loss
from payoff of long-term debt with Oxford Finance, LLC in January
2021, partially offset by a $1.0 million gain from the conversion
of the Daewoong Convertible Note in March 2021.
Income Taxes Expense
Income tax expense was de minimis for the year ended
December 31, 2022 and 2021.
Liquidity and Capital Resources
As of December 31, 2022, we had cash and cash equivalents of
$53.9 million, positive working capital of $54.3 million and
stockholders’ equity of $18.5 million.
We have a limited history of generating revenues and began shipping
Jeuveau®
in May 2019. Since inception, we have incurred recurring net
operating losses and as of December 31, 2022, we had an
accumulated deficit of $497.3 million. We incurred net losses of
$74.4 million and $46.8 million in the years ended December 31,
2022 and 2021, respectively. We used net cash of $84.9 million and
$33.4 million in operating activities for the twelve months ended
December 31, 2022 and 2021, respectively. We expect to continue to
incur significant expenses for the foreseeable future as we
increase marketing efforts for Jeuveau®
in the U.S., Europe, and Australia and maintain our regulatory
approvals.
Impact of Inflation
The markets in which we operate are currently experiencing
increased inflation. While we do not believe that inflation has had
a material impact on our business, revenues or operating results
during the periods presented, a prolonged inflationary environment
could increase our cash required for operations and impact our
liquidity position.
The Pharmakon Term Loans
On December 14, 2021, we entered into a loan agreement with
Pharmakon. Pursuant to the terms of the agreement, Pharmakon agreed
to make term loans to us in two tranches. The first tranche of
$75.0 million was funded on December 29, 2021. We received net
proceeds of approximately $68.7 million from Pharmakon, after
issuance costs and debt discounts. On December 5, 2022, we entered
into a Second Amendment to the loan agreement to extend our option
to draw down the second tranche of $50.0 million until
December 31, 2023. The second tranche of $50.0 million may be
drawn at our election no later than December 31, 2023. As of
March 8, 2023, we have not drawn the second tranche. We shall
make 12 equal quarterly payments of principal on the outstanding
Pharmakon Term Loans commencing in March 2025 and continuing
through the maturity date. The Pharmakon Term Loans will mature on
the sixth year anniversary of the closing date of the first
tranche. The term loan bears an annual interest rate equal to the
U.S. Dollar LIBOR rate (subject to a LIBOR rate floor of 1.0%) plus
8.5%, and matures in December 2027. The proceeds of the Pharmakon
Term Loans are used to fund our general corporate and working
capital requirements.
Contingent Royalties and Promissory Note Payable to the Evolus
Founders
We are obligated to make quarterly royalty payments of a low single
digit percentage of net sales of Jeuveau®
to the Evolus Founders. These obligations terminate at the end of
the second quarter of 2029. The fair value of the obligations is
valued quarterly and is referred to in our consolidated financial
statements as the contingent royalty obligation. In November 2021,
we also paid $20.0 million to satisfy in full a promissory note
that matured in November 2021.
As of December 31, 2022 and 2021, we recorded an aggregate
balance of $46.3 million and $44.7 million, respectively, on our
consolidated balance sheets for the royalty payment
obligation.
Daewoong Convertible Note
On July 6, 2020, pursuant to a Convertible Promissory Note Purchase
Agreement with Daewoong, we issued to Daewoong a Convertible
Promissory Note for the principal amount of $40.0 million, which we
refer to as the Daewoong Convertible Note, which was funded on July
30, 2020. On March 23, 2021, the outstanding principal
balance, together with all accrued and unpaid interest thereon, in
the amount of $40.8 million was converted, at the conversion price
of $13.00 per share, into the right to receive 3,136,869 shares of
our common stock under the Conversion Agreement.
Litigation Settlement
As described in “—Overview—Impact
of Settlement Agreements,”
on February 18, 2021, upon entering into the Medytox/Allergan
Settlement Agreements, we agreed to pay to Allergan and Medytox
$35.0 million in multiple payments over two years, of which we
paid $15.0 million in the third quarter of 2021 and $15.0 million
during the first quarter of 2022, with final payment of $5.0
million paid in the first quarter of 2023. We also issued 6,762,652
shares of common stock to Medytox. In addition, during the period
from December 16, 2020 through September 16, 2022, we agreed to pay
to Allergan and Medytox royalties on the sale of
Jeuveau®,
based on a certain dollar amount per vial sold in the United
States, and a low-double digit royalty on net sales of
Jeuveau®
sold in other Evolus territories. During the period from September
17, 2022 to September 16, 2032, we agreed to pay to Medytox a
mid-single digit royalty percentage on all net sales of
Jeuveau®.
The royalty payments are made quarterly.
As described in “—Overview—Impact
of Settlement Agreements,”
on March 23, 2021, upon entering the Daewoong Arrangement, Daewoong
paid us $25.5 million in April 2021, cancelled all remaining
milestone payments up to $10.5 million in aggregate under the
Daewoong Arrangement and agreed to reimburse us certain amounts
(calculated on a dollar amount per vials sold basis in the United
States) for sales of certain products with respect to which we are
required to pay Medytox and Allergan royalties pursuant to the U.S.
Settlement Agreement.
License and Supply Agreement
The Daewoong Agreement includes certain minimum annual purchases we
are required to make in order to maintain the exclusivity of the
license. We may, however, meet these minimum purchase obligations
by achieving certain market share in our licensed territories.
These potential minimum purchase obligations are contingent upon
the occurrence of future events, including receipt of governmental
approvals and our future market share in various
jurisdictions.
Operating Leases
Our corporate headquarters in Newport Beach, California is under a
five-year non-cancelable operating lease, which expires on January
31, 2025 with an option to extend the term for an
additional 60 months. Lease payments increase based on an
annual rent escalation clause that occurs on each February 1
anniversary. We may, under certain circumstances, terminate
the lease on the 36 months anniversary of the lease
commencement date by providing a written notice 12
months prior to such anniversary and paying a termination
fee equal to six months basic rent plus certain other
expenses.
Current and Future Capital Requirements
We believe that our current capital resources, which consist of
cash and cash equivalents, future cash generated from operations,
and cash available under the Pharmakon Term Loans, will be
sufficient to satisfy our cash requirements for at least the next
twelve months for working capital to support our daily operations
and meet commitments under our contractual obligations with third
parties, although we may need to access the debt and equity markets
or other sources of financing to satisfy our long-term cash
requirements as further discussed below.
We have based our projections of capital requirements on
assumptions that may prove to be incorrect and we may use all our
available capital resources, which consist of cash and cash
equivalents, cash generated from operations, and cash available
under the Pharmakon Term Loans, sooner than we expect. Our cash
requirements depend on numerous factors, including but not limited
to the impact of any potential disruptions to our supply chain,
inflation or other economic conditions, and other long-term
commitments and contingencies. Because of the numerous risks and
uncertainties associated with research, development and
commercialization of our products, we are unable to estimate the
exact amount of our operating capital requirements. In such case,
we may be required to raise additional capital to fund future
operations through the incurrence of debt, the entry into licensing
or collaboration agreements with partners, sale of equity
securities, grants or other sources of financing. However, there
can be no assurance such financing or other alternatives will be
available to us on acceptable terms, or at all. The global economy,
including the financial and credit markets, has recently
experienced significant volatility
and disruptions, including severely diminished liquidity and credit
availability and rising interest rates. These conditions may
adversely impact our ability to raise additional capital on
acceptable terms, or at all.
Our future funding requirements will depend on many factors,
including, but not limited to:
•the
rate of revenue growth for Jeuveau®
in the United States and success of planned international
launches;
•our
ability to forecast demand for our products, scale our supply to
meet that demand and manage working capital
effectively;
•corporate
development activities including the purchase, license, or other
acquisition of products and services to add to our product or
service offerings
•the
number, characteristics, and development stage of any future
product candidates we may develop or acquire;
•the
timing and costs of any ongoing or future clinical programs we may
conduct;
•the
cost of manufacturing our product or any future product candidates
and any products we successfully commercialize, including costs
associated with our supply chain;
•the
timing and amounts of the royalty and other payments payable in
connection with the Medytox Settlement Agreement;
•the
amounts of the royalty payable to the Evolus Founders;
•the
cost of commercialization activities for Jeuveau®
or any future product candidates are approved or cleared for sale,
including marketing, sales and distribution costs;
•the
cost of maintaining a sales force, the productivity of that sales
force, the market acceptance of our products and the actions and
product introductions of our competitors;
•our
ability to establish and maintain strategic collaborations,
licensing or other arrangements and the financial terms of any such
agreements that we may enter into;
•any
product liability or other lawsuits related to our
products;
•the
cost of any current litigation, including our ongoing securities
class action lawsuit and shareholder derivative
lawsuit;
•the
expenses needed to attract and retain skilled
personnel;
•the
costs associated with being a public company;
•the
costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing intellectual property and any other future
intellectual litigation we may be involved in; and
•the
timing, receipt and amount of sales of any future approved or
cleared products, if any.
Cash Flows
The following table summarizes our cash flows for the periods
indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
|
2022 |
|
2021 |
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
Net cash (used in) provided by: |
|
|
|
|
|
|
|
Operating activities
|
$ |
(84.9) |
|
|
$ |
(33.4) |
|
|
|
|
|
Investing activities
|
(2.9) |
|
|
4.0 |
|
|
|
|
|
Financing activities
|
(4.1) |
|
|
73.1 |
|
|
|
|
|
Effect of exchange rates on cash |
(0.3) |
|
|
— |
|
|
|
|
|
Change in cash and cash equivalents
|
(92.3) |
|
|
43.7 |
|
|
|
|
|
Cash and cash equivalents, beginning of period
|
146.3 |
|
|
102.6 |
|
|
|
|
|
Cash and cash equivalents, end of period
|
$ |
53.9 |
|
|
$ |
146.3 |
|
|
|
|
|
Operating Activities
For the year ended December 31, 2022, operating activities used
$84.9 million of cash, which primarily resulted from our net loss
of $74.4 million, as adjusted for certain non-cash charges
including $10.8 million of stock-based compensation expense, $1.6
million of provision of allowance for doubtful accounts, $1.1
million of amortization of debt discount and issuance costs, $3.7
million of depreciation and amortization and $5.8 million in
revaluation of our contingent royalty obligation. In addition, net
operating assets and liabilities changed by $34.3 million primarily
driven by $15.0 million of accrued litigation settlement expenses
and various timing of inventory purchases and payments, collections
from customers and payments to vendors.
For the year ended December 31, 2021, operating activities used
$33.4 million of cash, which primarily resulted from our net loss
of $46.8 million as adjusted for certain non-cash charges including
$9.6 million of stock-based compensation expense, $0.6 million of
provision of allowance for doubtful accounts, $0.9 million of
amortization of debt discount and issuance costs, $5.6 million of
depreciation and amortization and $6.3 million in revaluation of
our contingent royalty obligation. In addition, net operating
assets and liabilities changed by $11.5 million primarily driven by
$15.0 million of accrued litigation settlement expenses and various
timing of inventory purchases and payments, collections from
customers and payments to vendors.
Investing Activities
Cash used in investing activities was $2.9 million for
the year ended December 31, 2022 compared to cash provided by
investing activities of $4.0 million for the year ended December
31, 2021. The change in cash used in investing activities was
attributable to maturities of short-term investments with no new
purchases during the year ended December 31, 2021.
Financing Activities
Cash used in financing activities was $4.1 million for
the year ended December 31, 2022, compared to $73.1 million of
cash provided by financing activities for the year ended December
31, 2021.
For the year ended December 31, 2022, cash used in financing
activities primarily resulted from the payment of contingent
royalty obligation to Evolus Founders of $4.2 million.
For the year ended December 31, 2021, cash provided by
financing activities resulted from the net proceeds from our
follow-on offering of $92.4 million, sales of $10.9 million of our
common shares under the ATM Program, and $72.0 million net proceeds
from long-term debt with Pharmakon, offset by the repayment of
long-term debt with Oxford of $76.3 million and repayment of the
promissory note payable to Evolus Founders of $20.0
million.
Indebtedness
See “—Liquidity
and Capital Resources”
for a description of our Pharmakon Term Loans.
Material Cash Requirements
Our material cash requirements from known contractual and other
obligations primarily consist of (i) principal and interest
payments related to our Pharmakon Term Loans (future interest
payments on our outstanding Pharmakon Term Loans total
approximately $33.8 million, with $9.3 million due within
twelve months), (ii) a final payment of $5.0 million related
to the Medytox/Allergan Settlement Agreements, which was paid in
February 2023, (iii) quarterly royalty payments to the Evolus
Founders of a low single digit percentage of net sales of
Jeuveau®
(these obligations terminate in the quarter after the 10-year
anniversary of the first commercial sale of
Jeuveau®
in the United States), (iv) quarterly royalty payments to Medytox
of a low-double digit royalty on net sales of
Jeuveau®
sold in the United States and other Evolus territories (during the
period from September 17, 2022 to September 16, 2032) and (v)
obligations under operating leases related to our office
spaces.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and
results of operations are based on our consolidated financial
statements, which have been prepared in accordance with GAAP. The
preparation of these consolidated financial statements requires us
to make estimates and assumptions that affect the reported amounts
of assets and liabilities and related disclosure of contingent
assets and liabilities, revenue and expenses at the date of the
consolidated financial statements as well as the expenses incurred
during the reporting period. Generally, we base our estimates on
historical experience and on various other assumptions in
accordance with GAAP that we believe to be reasonable under the
circumstances. Actual results may differ materially from these
estimates under different assumptions or conditions and such
differences could be material to the financial position and results
of operations. On an ongoing basis, we evaluate our estimates and
assumptions in light of changes in circumstances, facts and
experience.
While our significant accounting policies are more fully described
in the notes to our consolidated financial statements appearing
elsewhere in this Annual Report on Form 10-K, we believe the
following accounting policies to be most critical for fully
understanding and evaluating our financial condition and results of
operations, as these policies relate to the more significant areas
involving management’s judgments and estimates.
Revenue Recognition
We recognize revenue when control of the promised goods or services
is transferred to our customers, in an amount that reflects the
consideration to which we expect to be entitled in exchange for the
goods or services. In order to achieve that core principle, a
five-step approach is applied: (1) identify the contract with a
customer, (2) identify the performance obligations in the contract,
(3) determine the transaction price, (4) allocate the transaction
price to the performance obligations in the contract, and (5)
recognize revenue allocated to each performance obligation when (or
as) we satisfy the performance obligations. A performance
obligation is a promise in a contract to transfer a distinct good
or service to the customer, and is the unit of account for revenue
recognition.
We generate product revenue from the sale of
Jeuveau®
in the United States and Great Britain and service revenue from the
sale of Jeuveau®
through a distribution partner in Canada. For product revenue,
we recognize revenue when control
of Jeuveau® is
transferred to a customer upon receipt. For service revenue, we are
determined to be the agent in the distribution of
Jeuveau®
in Canada and record the sale as service revenue on a net
basis.
Product revenues are recorded net of sales-related adjustments,
wherever applicable, for the volume rebates, consumer loyalty
program and co-branded marketing programs.
Volume rebates are contractually offered to certain customers, and
the rebates payable to each customer are determined based on the
contract and quarterly purchase volumes, which are readily
available. The consumer loyalty program allows participating
customers to earn rewards for qualifying treatments to their
patients (i.e. consumers) using Jeuveau®
and redeem the rewards for Jeuveau®
in the future at no additional cost. The loyalty program represents
a customer option that provides a material right and, accordingly,
is a performance obligation. At the time Jeuveau®
product is sold to customers, the invoice price is allocated
between the product sold and the estimated material right reward,
or Reward, that the customer might redeem in the future. The
standalone selling price of the Reward is measured based on
historical sales data, estimated average selling price of
Jeuveau®
at the time of redemption, expected customer and consumer
participation rates in the loyalty program, and estimated number of
qualifying treatments to be performed by customers. We do not
believe there is a reasonable likelihood that there will be a
material change in the future estimates or assumptions we use to
establish the liability for the Reward. However, if the actual
customer and consumer participation rates and number of qualifying
treatments in any future periods materially differ from the
estimates, we may be exposed to adjustments that could be material.
The portion of invoice price allocated to the Reward is initially
recorded as deferred revenue, and when customers
redeem the Reward and the related product is delivered, the
deferred revenue is reversed and included in net revenues. Through
the co-branded marketing programs, eligible customers with a
certain level of Jeuveau®
purchases receive advertising co-branded with us. At the time
Jeuveau®
is sold to customers, the invoice price is allocated between the
product sold and the advertisement. The standalone selling price of
the advertisement is measured based on estimated market value of
similar advertisement adjusted for the customer’s portion of the
advertisement. The portion of invoice price allocated to the
advertisement is initially recorded as deferred revenue, and when
the advertisement airs, the deferred revenue is recognized in net
revenues at that time.
Accounts receivable are recorded at the invoiced amount and do not
bear interest. We assess the probability that we will collect the
entitled consideration in exchange for the goods sold, by
considering the customer’s ability and intention to pay when
consideration is due. On a recurring basis, we estimate the amounts
of receivables considered uncollectible to reflect an allowance for
doubtful accounts.
Contingent Royalty Obligation to the Evolus Founders
We determine the fair value of the contingent royalty obligation
payable to the Evolus Founders under the Amended Purchase Agreement
based on significant unobservable inputs using a discounted cash
flows method. Changes in the fair value of this contingent royalty
obligation are determined each period end and recorded in operating
expenses in the consolidated statements of operations and
comprehensive loss and in the current and non-current liabilities
in the consolidated balance sheets. The significant unobservable
input assumptions that can significantly change the fair value
includes (i) projected net revenues during the payment period, (ii)
the discount rate and (iii) the timing of payments. Significant
increases (decreases) in the discount rate would result in a
significantly lower (higher) fair value measurement, which could
materially impact the fair value reported on the consolidated
balance sheet.
Goodwill
Goodwill represents the excess of the purchase price over the fair
value of the net tangible and intangible assets acquired in a
business combination. We review goodwill for impairment annually
and whenever events or changes in circumstances indicate the
carrying amount of goodwill may not be recoverable. We perform an
annual qualitative assessment of goodwill in the fourth quarter
each calendar year to determine if any events or circumstances
exist, such as an adverse change in business climate or a decline
in the overall industry demand, that would indicate that it would
more likely than not reduce the fair value of a reporting unit
below its carrying amount, including goodwill. If events or
circumstances do not indicate that the fair value of a reporting
unit is below its carrying amount, then goodwill is not considered
to be impaired and no further testing is required. If further
testing is required, we perform a two-step process. The first step
involves comparing the fair value of our reporting unit to its
carrying value, including goodwill. If the carrying value of the
reporting unit exceeds its fair value, the second step of the test
is performed by comparing the carrying value of the goodwill in the
reporting unit to its implied fair value. An impairment charge is
recognized for the excess of the carrying value of goodwill over
its implied fair value. For the purpose of impairment testing, we
have determined that there is one reporting unit. There has been no
impairment of goodwill for any of the periods
presented.
Intangible Assets
Intangible assets are consisted of a definite-lived distribution
right of Jeuveau®
and capitalized internal-use software. The distribution right is
amortized over the period the asset is expected to contribute to
our future cash flows. We determined the pattern of this intangible
asset’s future cash flows could not be readily determined with a
high level of precision. As a result, the distribution right
intangible asset is being amortized on a straight-line basis over
the estimated useful life of 20 years.
We capitalize certain internal-use software costs associated with
the development of its mobile and web-based customer platforms.
These costs include personnel expenses and external costs that are
directly associated with the software projects. These costs are
included as intangible assets in the accompanying consolidated
balance sheets. The capitalized internal-use software costs are
amortized on a straight-line basis over the estimated useful life
of two years upon being placed in service.
We review long-term and identifiable definite-lived intangible
assets or asset groups for impairment when events or changes in
circumstances indicate that the carrying amount of an asset or
asset group may not be recoverable. If the sum of the expected
future undiscounted cash flows is less than the carrying amount of
the asset or an asset group, further impairment analysis is
performed. An impairment loss is measured as the amount by which
the carrying amount of the asset or asset groups exceeds the fair
value for assets to be held and used or fair value less cost to
sell for assets to be disposed of. We also review the useful lives
of its assets periodically to determine whether events and
circumstances warrant a revision to the
remaining useful life. Changes in the useful life are adjusted
prospectively by revising the remaining period over which the asset
is amortized. There was no material impairment of
long-lived assets for any periods presented.
Recently Issued and Adopted Accounting Pronouncements
We describe the recently issued accounting pronouncements that
apply to us in
Item 8. Consolidated Financial Statements and Supplementary Data
-
Note 2.
Basis of Presentation and Summary of Significant Accounting
Policies-Recent Accounting Pronouncements.
Item 7A. Quantitative and Qualitative Disclosure About Market
Risk.
Not applicable.
Item 8. Consolidated Financial
Statements and Supplementary Data.
Evolus, Inc.
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting
Firm
To the Stockholders and the Board of Directors of Evolus,
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of
Evolus, Inc. (the Company) as of December 31, 2022 and 2021, the
related consolidated statements of operations and comprehensive
loss,
stockholders’ equity (deficit) and cash flows for each of the two
years in the period ended December 31, 2022, and the related notes
(collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of
the Company at December 31, 2022 and 2021, and the results of its
operations and its cash flows for each of the two years in the
period ended December 31, 2022, in conformity with U.S. generally
accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on the
Company’s financial statements based on our audits. We are a public
accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be
independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of
the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the
PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error
or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial
reporting. As part of our audits we are required to obtain an
understanding of internal control over financial reporting but not
for the purpose of expressing an opinion on the effectiveness of
the Company's internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of
material misstatement of the financial statements, whether due to
error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis,
evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as
well as evaluating the overall presentation of the financial
statements. We believe that our audits provide a reasonable basis
for our opinion.
We have served as the Company’s auditor since 2017.
Irvine, California
March 8, 2023
Evolus, Inc.
Consolidated Balance Sheets
(in thousands, except par value and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
53,922 |
|
|
$ |
146,256 |
|
|
|
|
|
Accounts receivable, net |
22,448 |
|
|
14,657 |
|
Inventories |
18,852 |
|
|
1,762 |
|
Prepaid expenses |
3,902 |
|
|
5,082 |
|
Other current assets |
1,678 |
|
|
11,042 |
|
Total current assets |
100,802 |
|
|
178,799 |
|
Property and equipment, net |
2,616 |
|
|
1,371 |
|
Operating lease right-of-use assets |
1,947 |
|
|
2,722 |
|
Intangible assets, net |
48,597 |
|
|
50,625 |
|
Goodwill |
21,208 |
|
|
21,208 |
|
Other assets |
2,813 |
|
|
2,758 |
|
Total assets |
$ |
177,983 |
|
|
$ |
257,483 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities |
|
|
|
Accounts payable |
$ |
8,935 |
|
|
$ |
6,091 |
|
|
|
|
|
|
|
|
|
Accrued expenses |
24,794 |
|
|
29,993 |
|
Accrued litigation settlement |
5,000 |
|
|
15,000 |
|
Operating lease liabilities |
1,320 |
|
|
1,265 |
|
Contingent royalty obligation payable to Evolus
Founders |
6,460 |
|
|
5,314 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
46,509 |
|
|
57,663 |
|
Accrued litigation settlement |
— |
|
|
5,000 |
|
Operating lease liabilities |
1,224 |
|
|
2,256 |
|
Contingent royalty obligation payable to Evolus
Founders |
39,850 |
|
|
39,426 |
|
Term loan, net of discount and issuance costs |
71,879 |
|
|
71,222 |
|
|
|
|
|
Deferred tax liability |
22 |
|
|
40 |
|
Total liabilities |
159,484 |
|
|
175,607 |
|
Commitments and contingencies (Note 9) |
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Preferred Stock, $0.00001 par value; 10,000,000 shares authorized;
no shares issued and outstanding at December 31, 2022 and
December 31, 2021, respectively
|
— |
|
|
— |
|
Common Stock, $0.00001 par value; 100,000,000 shares authorized;
56,260,570 and 55,576,988
shares issued and outstanding at December 31, 2022 and
December 31, 2021, respectively
|
1 |
|
|
1 |
|
Additional paid-in capital |
516,129 |
|
|
504,757 |
|
Accumulated other comprehensive loss |
(337) |
|
|
— |
|
Accumulated deficit |
(497,294) |
|
|
(422,882) |
|
Total stockholders’ equity |
18,499 |
|
|
81,876 |
|
Total liabilities and stockholders’ equity |
$ |
177,983 |
|
|
$ |
257,483 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
|
|
|
Revenue: |
|
|
|
Product revenue, net |
$ |
146,592 |
|
|
$ |
98,971 |
|
Service revenue |
2,024 |
|
|
702 |
|
Total net revenues |
148,616 |
|
|
99,673 |
|
|
|
|
|
Operating expenses: |
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
55,887 |
|
|
43,534 |
|
Settlement payment from Daewoong |
— |
|
|
(25,500) |
|
Selling, general and administrative |
141,840 |
|
|
112,068 |
|
Research and development |
4,742 |
|
|
2,064 |
|
In-process research and development |
2,000 |
|
|
— |
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
5,755 |
|
|
6,290 |
|
Depreciation and amortization |
3,722 |
|
|
5,622 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
213,946 |
|
|
144,078 |
|
Loss from operations |
(65,330) |
|
|
(44,405) |
|
Other income (expense): |
|
|
|
Interest income |
119 |
|
|
1 |
|
Interest expense |
(9,097) |
|
|
(1,396) |
|
Loss from extinguishment of debts, net |
— |
|
|
(968) |
|
Other expense, net |
(9) |
|
|
— |
|
Loss before income taxes: |
(74,317) |
|
|
(46,768) |
|
Income tax expense |
95 |
|
|
42 |
|
Net loss |
$ |
(74,412) |
|
|
$ |
(46,810) |
|
Other comprehensive loss: |
|
|
|
Unrealized loss, net of tax |
(337) |
|
|
— |
|
|
|
|
|
Comprehensive loss |
$ |
(74,749) |
|
|
$ |
(46,810) |
|
Net loss per share, basic and diluted |
$ |
(1.33) |
|
|
$ |
(0.94) |
|
Weighted-average shares outstanding used to compute basic and
diluted net loss per share |
56,065,297 |
|
|
49,773,101 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Consolidated Statements of Stockholders’ Equity
(Deficit)
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid In Capital |
|
Accumulated
Other Comprehensive Loss |
|
Accumulated Deficit |
|
Total |
|
|
|
|
|
Shares |
|
Amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2020 |
|
|
|
|
33,749,228 |
|
|
$ |
1 |
|
|
$ |
303,113 |
|
|
$ |
— |
|
|
$ |
(376,072) |
|
|
$ |
(72,958) |
|
Issuance of common stock in connection with litigation
settlement |
|
|
|
|
6,762,652 |
|
|
— |
|
|
48,421 |
|
|
— |
|
|
— |
|
|
48,421 |
|
Issuance of common stock for conversion of convertible
note |
|
|
|
|
3,136,869 |
|
|
— |
|
|
39,808 |
|
|
— |
|
|
— |
|
|
39,808 |
|
Issuance of common stock upon follow-on offering, net of issuance
costs |
|
|
|
|
10,350,000 |
|
|
— |
|
|
92,212 |
|
|
— |
|
|
— |
|
|
92,212 |
|
Issuance of common stock under “at-the-market” (ATM)
program |
|
|
|
|
934,367 |
|
|
— |
|
|
10,910 |
|
|
— |
|
|
— |
|
|
10,910 |
|
Issuance of common stock in connection with the incentive equity
plan |
|
|
|
|
643,872 |
|
|
— |
|
|
655 |
|
|
— |
|
|
— |
|
|
655 |
|
Stock-based compensation expense |
|
|
|
|
— |
|
|
— |
|
|
9,638 |
|
|
— |
|
|
— |
|
|
9,638 |
|
Net loss |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(46,810) |
|
|
(46,810) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021 |
|
|
|
|
55,576,988 |
|
|
$ |
1 |
|
|
$ |
504,757 |
|
|
$ |
— |
|
|
$ |
(422,882) |
|
|
$ |
81,876 |
|
Issuance of common stock in connection with the incentive equity
plan |
|
|
|
|
683,582 |
|
|
— |
|
|
539 |
|
|
— |
|
|
— |
|
|
539 |
|
Stock-based compensation expense |
|
|
|
|
— |
|
|
— |
|
|
10,833 |
|
|
— |
|
|
— |
|
|
10,833 |
|
Net loss |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(74,412) |
|
|
(74,412) |
|
Other comprehensive loss |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
(337) |
|
|
— |
|
|
(337) |
|
Balance at December 31, 2022 |
|
|
|
|
56,260,570 |
|
|
$ |
1 |
|
|
$ |
516,129 |
|
|
$ |
(337) |
|
|
$ |
(497,294) |
|
|
$ |
18,499 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Consolidated Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Cash flows from operating activities |
|
|
|
Net loss |
$ |
(74,412) |
|
|
$ |
(46,810) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation and amortization |
3,722 |
|
|
5,622 |
|
Stock-based compensation |
10,833 |
|
|
9,576 |
|
Provision for bad debts |
1,598 |
|
|
589 |
|
Amortization of discount on short-term investments |
— |
|
|
272 |
|
Amortization of operating lease right-of-use assets |
775 |
|
|
692 |
|
Amortization of debt discount and issuance costs |
1,086 |
|
|
941 |
|
|
|
|
|
Deferred income taxes |
(18) |
|
|
15 |
|
Revaluation of contingent royalty obligation to Evolus
Founders |
5,755 |
|
|
6,290 |
|
Loss from extinguishment of debts |
— |
|
|
968 |
|
|
|
|
|
Changes in assets and liabilities: |
|
|
|
Inventories |
(10,688) |
|
|
(2,979) |
|
Accounts receivable |
(9,389) |
|
|
(5,566) |
|
Prepaid expenses |
1,180 |
|
|
(254) |
|
Other current assets |
4,854 |
|
|
(7,010) |
|
Accounts payable |
968 |
|
|
(787) |
|
Accrued expenses |
(5,199) |
|
|
20,891 |
|
Accrued litigation settlement |
(15,000) |
|
|
(15,000) |
|
Operating lease liabilities |
(977) |
|
|
(838) |
|
|
|
|
|
Net cash used in operating activities |
(84,912) |
|
|
(33,388) |
|
Cash flows from investing activities |
|
|
|
Purchases of property and equipment |
(1,618) |
|
|
(393) |
|
Additions to capitalized software |
(1,321) |
|
|
(577) |
|
|
|
|
|
Maturities of short-term investments |
— |
|
|
5,000 |
|
Net cash (used in) provided by investing activities |
(2,939) |
|
|
4,030 |
|
Cash flows from financing activities |
|
|
|
Repayment of long term debt |
— |
|
|
(76,323) |
|
Repayment of promissory note payable to Evolus Founders |
— |
|
|
(20,000) |
|
Payment of contingent royalty obligation to Evolus
Founders |
(4,185) |
|
|
(3,097) |
|
|
|
|
|
|
|
|
|
Proceeds from issuance of long-term debt, net of
discounts |
— |
|
|
71,958 |
|
Payments for debt issuance costs |
(500) |
|
|
(3,263) |
|
|
|
|
|
Proceeds from follow-on offering, net of underwriting
fees |
— |
|
|
92,426 |
|
Payments for offering costs |
— |
|
|
(214) |
|
Issuance of common stock in connection with incentive equity
plan |
539 |
|
|
655 |
|
Proceeds from ATM sales of shares |
— |
|
|
10,910 |
|
Net cash (used in) provided by financing activities |
(4,146) |
|
|
73,052 |
|
|
|
|
|
Effect of exchange rates on cash |
(337) |
|
|
— |
|
Change in cash and cash equivalents |
(92,334) |
|
|
43,694 |
|
Cash and cash equivalents, beginning of period |
146,256 |
|
|
102,562 |
|
Cash and cash equivalents, end of period |
$ |
53,922 |
|
|
$ |
146,256 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Consolidated Statements of Cash Flows (Continued)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Supplemental disclosure of cash flow information |
|
|
|
Cash paid for interest |
$ |
7,999 |
|
|
$ |
138 |
|
Cash paid for income taxes |
$ |
76 |
|
|
$ |
14 |
|
Non-cash investing and financing information |
|
|
|
Conversion of convertible note to equity |
$ |
— |
|
|
$ |
39,808 |
|
Issuance of common stock in exchange for litigation settlement
expense |
$ |
— |
|
|
$ |
48,421 |
|
Capitalized software recorded in accounts payable and accrued
expenses |
$ |
— |
|
|
$ |
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Note 1. Description of Business
Description of Business
Evolus, Inc., (“Evolus” or the “Company”) is a performance beauty
company focused on delivering products in the self-pay aesthetic
market. The Company received the approval of its first product
Jeuveau®
(prabotulinumtoxinA-xvfs) from the U.S. Food and Drug
Administration (the “FDA”) in February 2019. The product was also
approved by Health Canada in August 2018, the European Commission
(“EC”) in September 2019, and the Australian Therapeutics Good
Administration (“TGA”) in January 2023. Jeuveau®
is a proprietary 900 kDa purified botulinum toxin type A
formulation indicated for the temporary improvement in the
appearance of moderate to severe glabellar lines, also known as
“frown lines,” in adults. The Company commercially launched
Jeuveau®
in the United States in May 2019, in Canada through a distribution
partner in October 2019, in Great Britain in September 2022, and in
Germany and Austria in February 2023. The Company currently
generates all of its net revenues from Jeuveau®.
The Company is headquartered in Newport Beach,
California.
Liquidity and Financial Condition
The accompanying consolidated financial statements have been
prepared on a basis that assumes that the Company will continue as
a going concern, and do not include any adjustments that may result
from the outcome of this uncertainty. This basis of accounting
contemplates the recovery of the Company’s assets and the
satisfaction of the Company’s liabilities and commitments in the
normal course of business and does not include any adjustments to
reflect the possible future effects of the recoverability and
classification of recorded asset amounts or amounts and
classification of liabilities that might be necessary should the
Company be unable to continue as a going concern.
Since inception, the Company has incurred recurring net operating
losses and negative cash flows from operating activities and
management expects operating losses and negative cash flows to
continue for at least the next 12 months. The Company recorded net
loss of $74,412 for the twelve months ended December 31, 2022. The
Company used cash of $84,912 from operations during the twelve
months ended December 31, 2022, which included a lump sum
settlement payment of $15,000 to Medytox and Allergan. As of
December 31, 2022, the Company had $53,922 in cash and cash
equivalents as well as $50,000 available under its debt agreement
with Pharmakon, and an accumulated deficit of
$497,294.
In December 2021, the Company entered into a $125,000 Term Loan
agreement with BPCR Limited Partnership, BioPharma Credit
Investments V (Master) LP, and Biopharma Credit PLC (collectively,
“Pharmakon”). The first tranche of $75,000 was funded on December
29, 2021. The Company received net proceeds of $68,695 from
Pharmakon, after issuance costs and debt discounts in December
2021. On December 5, 2022, the Company entered into a Second
Amendment to the loan agreement to extend its option to draw down
the second tranche of $50,000 until December 31, 2023. In exchange
for the extension, the Company paid an amendment fee of $500 to
Pharmakon. The second tranche of $50,000 may be drawn at the
Company’s election no later than December 31, 2023, subject to the
terms and conditions of the loan agreement. As of March 8,
2023, the Company has not drawn the second tranche. The Pharmakon
Term Loans will mature on the six-year anniversary of the closing
date of the first tranche. See
Note 6. Term Loans
for additional information.
The Company believes that its current capital resources, which
consist of cash and cash equivalents, will be sufficient to fund
operations through at least the next twelve months from the date
the accompanying consolidated financial statements are issued based
on its expected cash needs. The Company may need to raise
additional capital to fund future operations through entering into
licensing or collaboration agreements with partners, grants or
other sources of financing. Sufficient funds may not be available
to the Company at all or on attractive terms when needed from
equity or debt financings. If the Company is unable to obtain
additional funding from these or other sources when needed, or to
the extent needed, it may be necessary to significantly reduce its
scope of operations to reduce the current rate of spending through
actions such as reductions in staff and delaying, scaling back, or
suspending certain research and development, sales and marketing
programs and other operational goals.
Note 2. Basis of Presentation and Summary of
Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been
prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”).
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Principles of Consolidation
The Company’s consolidated financial statements include the
Company’s accounts and those of the Company’s wholly-owned
subsidiaries, Evolus Pharma Limited, Evolus International Ltd. and
Evolus Pharma BV, and have been prepared in conformity with GAAP.
All intercompany transactions have been eliminated.
Use of Estimates
Management is required to make certain estimates and assumptions in
order to prepare consolidated financial statements in conformity
with GAAP. Such estimates and assumptions affect the reported
consolidated financial statements. These estimates include, but are
not limited to net revenues, allowance for doubtful accounts, fair
value measurements, inventory valuations, and stock-based
compensation, among others. Management bases estimates on
historical experience and on assumptions that management believes
are reasonable. The Company’s actual results could differ
materially from those estimates.
Risks and Uncertainties
The Company is party to an agreement (the “Daewoong Agreement”)
with Daewoong Pharmaceutical Co. Ltd. (“Daewoong”), pursuant to
which the Company received an exclusive distribution license to
Jeuveau®
from Daewoong for aesthetic indications in the United States,
European Union, United Kingdom, members of the European Economic
Area, Switzerland, Canada, Australia, certain members of the
Commonwealth of Independent States, and South Africa, as well as
co-exclusive distribution rights with Daewoong in Japan.
Jeuveau® is
manufactured by Daewoong in a facility in South Korea. The Company
also has the option to negotiate first with Daewoong to secure a
distribution license for any product that Daewoong directly or
indirectly develops or commercializes that is classified as an
injectable botulinum toxin (other than Jeuveau®)
in a territory covered by the Daewoong Agreement. The Company
relies on Daewoong, its exclusive and sole supplier, to manufacture
Jeuveau®.
Any termination or loss of significant rights, including
exclusivity, under the Daewoong Agreement would materially and
adversely affect the Company’s commercialization of
Jeuveau®.
See
Note 9. Commitments and Contingencies and
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for additional information.
The Company commercially launched Jeuveau® in
the United States in May 2019, in Canada through its distribution
partner in October 2019, in Great Britain in September 2022, and in
Germany and Austria in February 2023 and, as such, has a limited
history of sales. If any previously granted approval is retracted
or the Company is denied approval or approval is delayed by any
other regulators, it may have a material adverse impact on the
Company’s business and its consolidated financial
statements.
The Company is also subject to risks common to companies in the
pharmaceutical industry including, but not limited to, dependency
on the commercial success of Jeuveau®,
the Company’s sole commercial product, significant competition
within the medical aesthetics industry, its ability to maintain
regulatory approval of Jeuveau®,
third party litigation and challenges to its intellectual property,
uncertainty of broad adoption of its product by physicians and
patients, its ability to in-license, acquire or develop additional
product candidates and to obtain the necessary approvals for those
product candidates, and the need to scale manufacturing
capabilities over time.
Any disruption and volatility in the global capital markets caused
by other events, such as public health crises, increased inflation
and rising interest rates and the military conflict between Russia
and Ukraine, may increase the Company’s cost of capital and
adversely affect its ability to access financing when and on terms
that the Company desires. Any of these events could have a material
adverse effect on the Company’s business, financial condition,
results of operations and cash flows.
Segment Reporting
Operating segments are identified as components of an enterprise
about which separate discrete financial information is available
for evaluation by the chief operating decision-maker. The Company
has determined that it operates in a single operating and
reportable segment. The Company’s chief operating decision maker is
its Chief Executive Officer who manages operations and reviews the
financial information as a single operating segment for purposes of
allocating resources and evaluating its financial
performance.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a
concentration of credit risk consist of cash and cash equivalents,
short-term investments and accounts receivable. Substantially all
of the Company’s cash is held by financial institutions that
management believes are of high credit quality. Such deposits may,
at times, exceed federally insured limits. To date, the Company has
not experienced any losses associated with this credit risk and
continues to believe that this exposure is not significant. The
Company invests, or plans to soon invest, its excess cash, in line
with its investment policy, primarily in money market funds and
debt instruments of U.S. government agencies.
The Company’s accounts receivable is derived from customers located
principally in the United States. Concentrations of credit risk
with respect to trade receivables are limited due to the Company’s
credit evaluation process. The Company does not typically require
collateral from its customers. Credit losses historically have not
been material. The Company continuously monitors customer payments
and maintains an allowance for doubtful accounts based on its
assessment of various factors including historical experience, age
of the receivable balances, and other current economic conditions
or other factors that may affect customers’ ability to
pay.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and highly liquid
investments with remaining maturities at purchase of three months
or less that can be liquidated without prior notice or penalty.
Cash and cash equivalents may include deposits, money market funds
and debt securities. Amounts receivable from credit card issuers
are typically converted to cash within two to four days of the
original sales transaction and are considered to be cash
equivalents.
Short-Term Investments
Short-term investments consist of available-for-sale U.S. Treasury
securities with original maturities greater than three months and
remaining maturities of less than twelve months. These investments
are recorded at fair value based on quoted prices in active
markets, with unrealized gains and losses reported in other
comprehensive loss in the Company’s consolidated statements of
operations and comprehensive loss. Purchase premiums and discounts
are recognized in interest expense using the effective interest
method over the terms of the securities. Realized gains and losses
and declines in fair value that are deemed to be other than
temporary are reflected in the consolidated statements of
operations and comprehensive loss using the specific-identification
method.
The Company periodically reviews all available-for-sale securities
for other than temporary declines in fair value below the cost
basis whenever events or changes in circumstances indicate that the
carrying amount of an asset may not be recoverable. The Company
also evaluates whether it has plans or is required to sell
short-term investments before recovery of their amortized cost
bases. To date, the Company has not identified any other than
temporary declines in fair value of its short-term
investments.
Inventories
Inventories consist of finished goods held for sale and
distribution.
Cost is determined based on the estimated amount payable to the
Company’s supplier after accounting for any reimbursement
receivable pursuant to the Daewoong Settlement Agreement (as such
term is defined, and such agreement is discussed, in
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement),
using
the first-in, first-out method with prioritization of the items
with the earliest expiration dates. Inventory
valuation reserves are established based on a number of factors
including, but not limited to, finished goods not meeting product
specifications, product excess and obsolescence, or application of
the lower of cost or net realizable value concepts. The
determination of events requiring the establishment of inventory
valuation reserves, together with the calculation of the amount of
such reserves may require judgment. No material inventory valuation
reserves have been recorded for the periods presented. Adverse
changes in assumptions utilized in the Company’s inventory reserve
calculations could result in an increase to its inventory valuation
reserves.
Product cost of sales, excluding amortization of intangible assets,
consisted of the inventory cost, and, for periods on or after
December 16, 2020, included certain royalties on the sale of
Jeuveau®
payable to Medytox and Allergan pursuant to the Medytox/Allergan
Settlement Agreements (as such term is defined in
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement),
as partially offset by reimbursement receivable from Daewoong
pursuant to the Daewoong
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Settlement Agreement with respect to such royalties. In the year
ended December 31, 2021, the Company recorded a one-time settlement
payment of $25,500 from Daewoong in connection with the Daewoong
Settlement Agreement as part of cost of sales.
Fair Value of Financial Instruments
Fair value is defined as the exchange price that would be received
for an asset or an exit price paid to transfer a liability in an
orderly transaction between market participants in a principal
market on the measurement date.
The fair value hierarchy defines a three-tiered valuation hierarchy
for disclosure of fair value measurement is classified and
disclosed by the Company in one of the three categories as
follows:
•Level
1—Unadjusted quoted prices in active markets that are accessible at
the measurement date for identical, unrestricted assets or
liabilities;
•Level
2—Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities
in active markets; quoted prices in markets that are not active; or
other inputs that are observable, either directly or indirectly, or
can be corroborated by observable market data for substantially the
full term of the asset or liability; and
•Level
3—Prices or valuation techniques that require inputs that are
unobservable that are supported by little or no market activity and
that are significant to the fair value of the assets or
liabilities.
The categorization of a financial instrument within the valuation
hierarchy is based upon the lowest level of input that is
significant to the fair value measurement.
Property and Equipment
Property and equipment are stated at cost. Depreciation and
amortization are provided using the straight-line method over the
estimated useful lives of approximately five years. Leasehold
improvements are amortized over the shorter of the estimated useful
lives of the improvements or the term of the related
lease.
Goodwill
Goodwill represents the excess of the purchase price over the fair
value of the net tangible and intangible assets acquired in a
business combination. The Company assesses goodwill for impairment
annually and whenever events or changes in circumstances indicate
that the carrying amount of goodwill may not be recoverable. The
Company performs an annual qualitative assessment of its goodwill
in the fourth quarter of each calendar year to determine if any
events or circumstances exist, such as an adverse change in
business climate or a decline in the overall industry demand, that
would indicate that it would more likely than not reduce the fair
value of a reporting unit below its carrying amount, including
goodwill. If events or circumstances do not indicate that the fair
value of a reporting unit is below its carrying amount, then
goodwill is not considered to be impaired and no further testing is
required. If further testing is required, the Company performs a
two-step process. The first step involves comparing the fair value
of the Company’s reporting unit to its carrying value, including
goodwill. If the carrying value of the reporting unit exceeds its
fair value, the second step of the test is performed by comparing
the carrying value of the goodwill in the reporting unit to its
implied fair value. An impairment charge is recognized for the
excess of the carrying value of goodwill over its implied fair
value. For the purpose of impairment testing, the Company has
determined that it has one reporting unit. There was no impairment
of goodwill for any of the periods presented.
Intangible Assets
The distribution right intangible asset related to
Jeuveau®
is amortized over the period the asset is expected to contribute to
the future cash flows of the Company. The Company determined the
pattern of this intangible asset’s future cash flows could not be
readily determined with a high level of precision. As a result, the
distribution right intangible asset is being amortized on a
straight-line basis over the estimated useful life of 20
years.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The Company capitalizes certain internal-use software costs
associated with the development of its mobile and web-based
customer platforms. These costs include personnel expenses and
external costs that are directly associated with the software
projects. These costs are included as intangible assets in the
accompanying consolidated balance sheets. The capitalized
internal-use software costs are amortized on a straight-line basis
over the estimated useful life of two years upon being
placed in service.
The Company reviews long-term and identifiable definite-lived
intangible assets or asset groups for impairment when events or
changes in circumstances indicate that the carrying amount of an
asset or asset group may not be recoverable. If the sum of the
expected future undiscounted cash flows is less than the carrying
amount of the asset or an asset group, further impairment analysis
is performed. An impairment loss is measured as the amount by which
the carrying amount of the asset or asset groups exceeds the fair
value for assets to be held and used or fair value less cost to
sell for assets to be disposed of. The Company also reviews the
useful lives of its assets periodically to determine whether events
and circumstances warrant a revision to the remaining useful life.
Changes in the useful life are adjusted prospectively by revising
the remaining period over which the asset is amortized. There was
no material impairment of long-lived assets for any periods
presented.
Leases
At the inception of a contractual arrangement, the Company
determines whether the contract contains a lease by assessing
whether there is an identified asset and whether the contract
conveys the right to control the use of the identified asset in
exchange for consideration over a period of time. If both criteria
are met, upon lease commencement, the Company records a lease
liability which represents the Company’s obligation to make lease
payments arising from the lease, and a corresponding right-of-use
(“ROU”) asset which represents the Company’s right to use an
underlying asset during the lease term. Operating lease assets and
liabilities are included in ROU assets, current portion of
operating lease liabilities and noncurrent operating lease
liabilities in the accompanying consolidated balance
sheets.
Operating lease ROU assets and lease liabilities are initially
recognized based on the present value of the future minimum lease
payments over the lease term at commencement date calculated using
the Company’s incremental borrowing rate applicable to the
underlying asset unless the implicit rate is readily determinable.
Operating lease ROU assets also include any lease payments made at
or before lease commencement and exclude any lease incentives
received, if any. The Company determines the lease term as the
noncancelable period of the lease and may include options to extend
or terminate the lease when it is reasonably certain that the
Company will exercise such options. The Company’s leases do not
contain any residual value guarantees. Leases with a term of 12
months or less are not recognized on the consolidated balance
sheets. For operating leases, the Company recognized rent expense
on a straight-line basis over the lease term. There were no
significant finance leases as of December 31,
2022.
Contingent Royalty Obligation Payable to Evolus
Founders
The Company was acquired by Strathspey Crown Holdings Group, LLC
(“SCH”) in 2013 and subsequently by its subsidiary, Alphaeon
Corporation (“Alphaeon”), by means of a stock purchase agreement
(“Stock Purchase Agreement”) pursuant to which Alphaeon assumed
certain payment obligations related to the acquisition. On December
14, 2017, the Stock Purchase Agreement was amended (“Amended Stock
Purchase Agreement”), and, as a result, effective upon the closing
of the Company’s initial public offering in February 2018, the
Company assumed all of Alphaeon’s payment obligations under the
Amended Stock Purchase Agreement.
Payment obligations to the Evolus Founders consist of quarterly
royalty payments of a low single digit percentage of net sales of
Jeuveau®.
The obligations terminate in the quarter following the 10-year
anniversary of the first commercial sale of
Jeuveau® in
the United States. Under the Amended Stock Purchase Agreement, the
Company recorded the fair value of all revised payment obligations
owed to the Evolus Founders.
The Company determines the fair value of the contingent royalty
obligation payable at each reporting period end based on Level 3
inputs using a discounted cash flows method. Changes in the fair
value of the contingent royalty obligation payable are determined
at each reporting period end and recorded in operating expenses in
the accompanying consolidated statements of operations and
comprehensive loss and as a liability in the accompanying
consolidated balance sheets. In November 2021, the Company paid
$20,000 to satisfy in full a promissory note that matured in
November 2021.
Promissory Note Payable to the Evolus Founders
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
On February 12, 2018, the Company recognized a promissory note
payable at present value using a discount rate for similar rated
debt securities. Discount amortization related to the promissory
note is recorded in interest expense in the accompanying
consolidated statements of operations and comprehensive loss with a
corresponding increase to the liabilities in the accompanying
consolidated balance sheets.
Long-Term Debt
Long-term debt represents the debt balance with Pharmakon
(see
Note 6. Term Loans),
net of discount and issuance costs. Debt issuance costs represent
legal, lender and consulting costs or fees associated with debt
financing. Debt discounts and issuance costs are amortized
into interest expense over the term of the debt.
Foreign Currency Translation
The financial statements of foreign subsidiaries are measured using
the local currency as the functional currency. Assets and
liabilities are translated into U.S. dollars at current exchange
rates as of balance sheet date, and income and expense items are
translated into U.S. dollars using the average rates of exchange
prevailing during the period. Gains and losses arising from
translation are recorded in other comprehensive loss as a separate
component of stockholders’ equity. Foreign currency gains or losses
on transactions denominated in a currency other than the Company’s
functional currency are recorded in other expenses, net in the
accompanying consolidated statements of operations and
comprehensive loss.
Revenue Recognition
The Company recognizes revenue when control of the promised goods
or services is transferred to its customers, in an amount that
reflects the consideration to which the Company expects to be
entitled in exchange for the goods or services. In order to achieve
that core principle, a five-step approach is applied: (1) identify
the contract with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price,
(4) allocate the transaction price to the performance obligations
in the contract, and (5) recognize revenue allocated to each
performance obligation when the Company satisfies the performance
obligation. A performance obligation is a promise in a contract to
transfer a distinct good or service to the customer and is the unit
of account for revenue recognition.
General
The Company generates product revenue from the sale of
Jeuveau®
in the United States and Great Britain and service revenue from the
sale of Jeuveau®
through a distribution partner in Canada.
For product revenue, the Company recognizes revenue when control of
the promised goods under a contract is transferred to a customer,
in an amount that reflects the consideration the Company expects to
receive in exchange for those goods as specified in the customer
contract. The transfer of control occurs upon receipt of the goods
by the customer since that is when the customer has obtained
control of the goods’ economic benefits. The Company does not
provide any service-type warranties and does not accept product
returns except under limited circumstances such as damages in
transit or ineffective product. The Company also excludes any
amounts related to taxes assessed by governmental authorities from
revenue measurement. Shipping and handling costs associated with
outbound product freight are accounted for as fulfillment costs and
are included in selling, general and administrative expenses in the
accompanying consolidated statements of operations and
comprehensive loss.
For service revenue, the Company evaluated the arrangement with the
distribution partner in Canada and determined that it acts as an
agent in the distribution of Jeuveau®
in Canada as it does not control the product before control is
transferred to a customer. The indicators of which party exercises
control include primary responsibility over performance
obligations, inventory risk before the good or service is
transferred and discretion in establishing the price. Accordingly,
the Company records the sale as service revenue on a net basis.
Revenue from services is recognized in the period the service is
performed for the amount of consideration expected to be received.
For the years ended December 31, 2022 and 2021, the Company
recognized $2,024 and $702, respectively, of revenues related to
service revenues.
Disaggregation of Revenue
The Company’s disaggregation of revenue is consistent with its
operating segment as disclosed above.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Gross-to-Net Revenue Adjustments
The Company provides customers with discounts, such as trade and
volume discounts and prompt pay discounts, that are directly
reflected in the invoice price. Revenues are recorded net of
sales-related adjustments, wherever applicable, primarily for the
volume based rebates, consumer loyalty programs and co-branded
marketing programs.
•Volume-based
Rebates
— Volume-based rebates are contractually offered to certain
customers. The rebates payable to each customer are determined
based on the contract and quarterly purchase volumes.
•Consumer
Loyalty Program
— The Company’s consumer loyalty program allows participating
customers to earn rewards for qualifying treatments to their
patients (i.e. consumers) using Jeuveau®
and redeem the rewards for Jeuveau®
in the future at no additional cost. The loyalty program represents
a customer option that provides a material right and, accordingly,
is a performance obligation. At the time Jeuveau®
product is sold to customers, the invoice price is allocated
between the product sold and the estimated material right reward
(“Reward”) that the customer might redeem in the future. The
standalone selling price of the Reward is measured based on
historical sales data, estimated average selling price of
Jeuveau®
at the time of redemption, expected customer and consumer
participation rates in the loyalty program, and estimated number of
qualifying treatments to be performed by customers. The portion of
invoice price allocated to the Reward is initially recorded as
deferred revenue. Subsequently, when customers redeem the Reward
and the related product is delivered, the deferred revenue is
recognized in net revenues at that time.
•Co-Branded
Marketing Programs
— The Company offers eligible customers with a certain level of
Jeuveau®
purchases to receive advertising co-branded with the Company. The
co-branded advertising represents a performance obligation. At the
time Jeuveau®
product is sold to customers, the invoice price is allocated
between the product sold and the advertisement. The standalone
selling price of the advertisement is measured based on the
estimated market value of similar advertisement adjusted for the
customer’s portion of the advertisement. The portion of invoice
price allocated to the advertisement is initially recorded as
deferred revenue. Subsequently, when the advertisement airs, the
deferred revenue is recognized in net revenues at that
time.
Contract Balances
A contract with a customer states the terms of the sale, including
the description, quantity and price of each product purchased.
Amounts are recorded as accounts receivable when the Company’s
right to consideration becomes unconditional. The Company does not
have any significant financing components in customer contracts
given the expected time between transfer of the promised products
and the payment of the associated consideration is less than one
year. As of December 31, 2022 and 2021, all amounts
included in accounts receivable, net on the accompanying
consolidated balance sheets are related to contracts with
customers.
The Company did not have any contract assets nor unbilled
receivables as of December 31, 2022 or 2021. Sales
commissions are included in selling, general and administrative
expenses when incurred.
Contract liabilities reflect estimated amounts that the Company is
obligated to pay to customers or patients primarily under the
rebate and deferred revenue associated with Rewards under the
consumer loyalty program and co-branded marketing programs. The
Company’s contract liabilities are included in accounts payable and
accrued expenses in the accompanying consolidated balance
sheets.
As of December 31, 2022 and 2021, the accrued revenue contract
liabilities, primarily related to volume-based rebates, consumer
loyalty program, and co-branded marketing programs, were $9,011 and
$7,934, respectively, which were recorded in accrued expenses in
the accompanying consolidated balance sheets. For the years ended
December 31, 2022 and 2021, provisions for rebate, consumer loyalty
programs and co-branded marketing programs were $22,759 and
$16,139, respectively, which were offset by related payments,
redemptions and adjustments of $21,682 and $11,286,
respectively.
During the years ended December 31, 2022 and 2021, the Company
recognized $7,566 and $2,802, respectively, of revenue related to
amounts included in contract liabilities at the beginning of the
period and did not recognize any revenue related to changes in
transaction prices regarding its contracts with customers from
previous periods.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Collectability
Accounts receivable are recorded at the invoiced amount and do not
bear interest. At the time of contract inception or new customer
account set-up, the Company performs a collectability assessment of
the customer’s creditworthiness. The Company assesses the
probability that the Company will collect the entitled
consideration in exchange for the goods sold, by considering the
customer’s ability and intention to pay when consideration is due.
On a recurring basis, the Company estimates the amount of
receivables considered uncollectable to reflect an allowance for
doubtful accounts. The Company writes off accounts receivable
balances when it is determined that there is no possibility of
collection. As of December 31, 2022 and 2021, allowance for
doubtful accounts was $2,050 and $2,385, respectively. For the
years ended December 31, 2022 and 2021, provision for bad debts was
$1,598 and $589, respectively, and the write-off amount was $1,933
and $322, respectively.
Practical Expedients
The Company expenses sales commissions when incurred as the
amortization period is one year or less. These costs are recorded
within selling, general and administrative expenses in the
accompanying consolidated statements of operations and
comprehensive loss. The Company does not adjust the amount of
promised consideration for the effects of the time value of money
for contracts in which the anticipated period between when the
Company transfers the goods or services to the customer and when
the customer pays within one year.
Research and Development Expenses
Research and development costs are expensed as incurred. Research
and development expenses include personnel-related costs, costs
associated with pre-clinical and clinical development activities,
costs associated with and costs for prototype products that are
manufactured prior to market approval for that prototype product,
internal and external costs associated with the Company’s
regulatory compliance and quality assurance functions, including
the costs of outside consultants and contractors that assist in the
process of submitting and maintaining regulatory filings, and
overhead costs, including allocated facility related
expenses.
In-process Research and Development
Intangible assets acquired that are used for research and
development and have no future alternative use are expensed as
in-process research and development.
In June 2022, the Company entered into a License and Research
Collaboration Agreement (the “Collaboration Agreement”) with a 3D
printing company with biomaterial capabilities (the “Licensor”).
Under the terms of the Collaboration Agreement, the Company was
granted a license to the Licensor’s technology to develop and
commercialize any aesthetic product or non-therapeutic product that
is created through the use or practice of the Licensor’s patents.
The Company paid $2,000 upon the signing of the Collaboration
Agreement and has research funding, ongoing milestone and royalty
payment obligations depending on the development plans, the success
of such development and approval and commercialization of products.
The upfront payment of $2,000 was recorded as in-process research
and development expense.
Litigation Settlement
In February 2021, upon entering into certain agreements to settle
intellectual property disputes relating to
Jeuveau®,
the Company agreed to pay to Allergan and Medytox
$35,000
in multiple payments over two years, of which the Company paid
$15,000 in the third quarter of 2021, $15,000 in the first quarter
of 2022, and
$5,000
in the first quarter of 2023, and issued 6,762,652 shares of its
common stock to Medytox. In addition, for the period from December
16, 2020 through September 16, 2022 (the “Restricted Period”), the
Company agreed to pay to Allergan and Medytox a royalty on the sale
of Jeuveau®,
based on a certain dollar amount per vial sold in the United States
and a low-double digit royalty on net sales of
Jeuveau®
sold in other Evolus territories. Royalties for sales during the
Restricted Period ended in the third quarter of 2022. For the
period from September 17, 2022 to September 16, 2032, the Company
agreed to pay to Medytox a mid-single digit royalty percentage on
all net sales of Jeuveau®.
The royalty payments are made quarterly and recorded as product
cost of sales on the accompanying consolidated statements of
operations and comprehensive loss in the periods the royalties are
incurred.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Separately, in March 2021, Daewoong and the Company entered into
certain agreements, pursuant to which Daewoong agreed to pay the
Company an amount equal to $25,500, which was recorded as a
settlement payment from Daewoong and included as part of cost of
sales on the accompanying consolidated statements of operations and
comprehensive loss for the year ended December 31, 2021. For the
period from December 16, 2020 to September 16, 2022, Daewoong
reimbursed the Company certain amounts with respect to the
royalties payable to Medytox and Allergan. This reimbursement was
received quarterly and recorded as an offset to the related
royalties to Medytox and Allergan in the product cost of sales on
the accompanying consolidated statements of operations and
comprehensive loss.
See
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for the details of all litigation settlement
agreements.
Stock-Based Compensation
The Company recognizes stock-based compensation expense for
employees, consultants and members of the Board of Directors based
on the fair value at the date of grant.
The Company uses the Black-Scholes option pricing model to value
stock option grants. The Black-Scholes option pricing model
requires the input of subjective assumptions, including the
expected volatility of the Company’s common stock, expected
risk-free interest rate, and the option’s expected life. The fair
value of the Company’s restricted stock units (“RSUs”) is based on
the fair value on the grant date of the Company’s common stock. The
Company also evaluates the impact of modifications made to the
original terms of equity awards when they occur.
The fair value of equity awards that are expected to vest is
amortized on a straight-line basis over the requisite service
period. Stock-based compensation expense is recognized net of
actual forfeitures when they occur, as an increase to additional
paid-in capital in the consolidated balance sheets and in the
selling, general and administrative or research and development
expenses in the consolidated statements of operations and
comprehensive loss.
Advertising Costs
Advertising costs are expensed as incurred and primarily include
costs related to social media ads and co-branded marketing
programs. Advertising costs are included in selling, general and
administrative expenses. For the years ended December 31, 2022 and
2021, the Company incurred advertising costs of $11,642 and
$16,391, respectively.
Income Taxes
The Company accounts for income taxes under the asset and liability
method. Under this method, deferred tax assets and liabilities are
determined on the basis of differences between the consolidated
financial statements and tax basis of assets and liabilities using
enacted tax rates in effect for the year in which the differences
are expected to reverse.
A valuation allowance is recorded against deferred tax assets to
reduce the net carrying value when it is more likely than not that
some portion or all of a deferred tax asset will not be realized.
In making such a determination, the Company considers all available
positive and negative evidence, including future reversals of
existing taxable temporary differences, projected future taxable
income, and ongoing prudent and feasible tax planning strategies in
assessing the amount of the valuation allowance. When the Company
establishes or reduces the valuation allowance against its deferred
tax assets, its provision for income taxes will increase or
decrease, respectively, in the period such determination is
made.
Additionally, the Company recognizes the tax benefit from an
uncertain tax position only if it is more likely than not that the
tax position will be sustained on examination by the taxing
authorities based on the technical merits of the position. The tax
benefit recognized in the consolidated financial statements for a
particular tax position is based on the largest benefit that is
more likely than not to be realized upon settlement. Accordingly,
the Company establishes reserves for uncertain tax positions. The
Company has not recognized interest or penalties in its
consolidated statement of operations and comprehensive
loss.
The Company is required to file federal and state income tax
returns in the United States and various other state jurisdictions.
The preparation of these income tax returns requires the Company to
interpret the applicable tax laws and regulations in effect in such
jurisdictions, which could affect the amount of tax paid by the
Company. An amount is accrued for the estimate of additional tax
liability, including interest and penalties, for any uncertain tax
positions taken or expected to be taken in an
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
income tax return. The Company reviews and updates the accrual for
uncertain tax positions as more definitive information becomes
available.
The Company’s income tax returns are based on calculations and
assumptions that are subject to examination by the Internal Revenue
Service and other tax authorities. In addition, the calculation of
the Company’s tax liabilities involves dealing with uncertainties
in the application of complex tax regulations. The Company
recognizes liabilities for uncertain tax positions based on a
two-step process. The first step is to evaluate the tax position
for recognition by determining if the weight of available evidence
indicates that it is more likely than not that the position will be
sustained on audit, including resolution of related appeals or
litigation processes, if any. The second step is to measure the tax
benefit as the largest amount that is more
than 50% likely of being realized upon settlement. While
the Company believes it has appropriate support for the positions
taken on its tax returns, the Company regularly assesses the
potential outcomes of examinations by tax authorities in
determining the adequacy of its provision for income taxes. The
Company continually assesses the likelihood and amount of potential
revisions and adjusts the income tax provision, income taxes
payable and deferred taxes in the period in which the facts that
give rise to a revision become known.
The Company monitors changes to the tax laws in the states it
conducts business and files corporate income tax returns. The
Company does not expect that changes to state tax laws through
December 31, 2022 to materially impact its consolidated
financial statements.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by
the weighted-average number of shares of common stock outstanding
during the period including contingently issuable shares. Diluted
earnings per share is based on the treasury stock method and
includes the effect from potential issuance of ordinary shares,
such as shares issuable pursuant to the exercise of stock options
and the vesting of restricted stock units. The dilutive effect of
stock options and restricted stock units is computed under the
treasury stock method. The dilutive effect of the Daewoong
Convertible Note is computed under the if-converted method.
Potentially dilutive securities are excluded from the computations
of diluted net loss per share if their effect would be
antidilutive.
For the years ended December 31, 2022 and 2021, excluded from
the dilutive net loss per share computation were stock options of
4,769,521 and 3,922,286, respectively, and non-vested RSUs of
2,663,320 and 1,926,467, respectively. Although these securities
were anti-dilutive for these periods, they could be dilutive in
future periods.
Recent Accounting Pronouncements
Recently Adopted Pronouncements
In November 2021, the Financial Accounting Standards Board (“FASB”)
issued Accounting Standards Update (“ASU”) No. 2021-10,
Government Assistance (Topic 832): Disclosures by Business Entities
about Government Assistance.
This update will increase transparency of government assistance
received by most business entities by requiring the disclosure of:
(1) the types of transactions; (2) the accounting for the
transactions; and, (3) the effect of the transactions on a business
entity’s consolidated financial statements. ASU No. 2021-10 is
effective for consolidated financial statements issued for annual
periods beginning after December 15, 2021, with early application
permitted. The Company adopted this guidance effective January 1,
2022. There is no material impact to the consolidated financial
statements as a result of this adoption. If, at any point in time,
such amounts are deemed to be material, the Company will present
the required disclosures as applicable.
Recent Accounting Pronouncements Issued But
Not Adopted
In January 2017, the FASB issued ASU No.
2017-04, Intangibles—Goodwill
and Other (Topic 350): Simplifying the Test for Goodwill
Impairment.
The update simplifies the accounting for goodwill impairment by
removing step two of the goodwill impairment test, which requires a
hypothetical purchase price allocation. A goodwill impairment will
be the amount by which a reporting unit’s carrying amount,
including goodwill, exceeds its fair value. The impairment charge
will be limited to the amount of goodwill allocated to that
reporting unit. As amended by ASU No. 2019-10, the updated guidance
is effective for the Company as a smaller reporting company
beginning January 1, 2023. The standard requires prospective
application. Early adoption is permitted. The Company does not
expect the adoption of this guidance to result in a material impact
on its consolidated financial statements.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
In June 2016, the FASB issued ASU No.
2016-13, Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit
Losses on Financial Instruments,
which modifies the measurement and recognition of credit losses for
most financial assets and certain other instruments. The new
standard requires the use of forward-looking expected credit loss
models based on historical experience, current conditions, and
reasonable and supportable forecasts that affect the collectability
of the reported amount, which may result in earlier recognition of
credit losses under the new standard. The new guidance also
modifies the impairment models for available-for-sale debt
securities and for purchased financial assets with credit
deterioration since their origination. Subsequent to the issuance
of ASU No. 2016-13, the FASB issued ASU
2018-19, Codification
Improvements to Topic 326, Financial Instruments - Credit
Losses.
This ASU does not change the core principle of the guidance in ASU
No. 2016-13, instead these amendments are intended to clarify and
improve operability of certain topics included within the credit
losses standard. The FASB also subsequently issued ASU No.
2019-04 which did not change the core principle of the guidance in
ASU No. 2016-13 but clarified that expected recoveries of amounts
previously written off and expected to be written off should be
included in the valuation account and should not exceed amounts
previously written off and expected to be written off. As amended
by ASU No. 2019-10, the updated guidance is effective for the
Company as a smaller reporting company beginning January 1, 2023.
The Company adopted this guidance effective January 1, 2023. The
adoption of the standard did not result in a material impact to its
consolidated financial statements.
In March 2020, the FASB issued ASU No. 2020-04,
Reference Rate Reform (Topic 848): Facilitation of the Effects of
Reference Rate Reform on Financial Reporting
and in January 2021, the FASB issued ASU No. 2021-01,
Reference Rate Reform (Topic 848): Scope (“ASU 2021-01”).
Both ASU No. 2020-04 and ASU No. 2021-01 provides optional
expedients and exceptions for applying GAAP to contracts, hedging
relationships and other transactions that reference the London
Interbank Offered Rate (“LIBOR”) or another reference rate expected
to be discontinued because of reference rate reform. ASU No.
2020-04 and ASU No. 2021-01 are effective upon issuance for
contract modifications and hedging relationships, and the Company
is allowed to elect to apply the amendments prospectively through
December 31, 2022. In December 2022, the FASB issued ASU No.
2022-06,
Reference Rate Reform (Topic 848): Deferral of the Sunset Date of
Topic 848,
which extends the temporary accounting rules under Topic 848 to
December 31, 2024. The Company does not expect adoption of this
guidance will have a material impact on its consolidated financial
statements.
Other recent accounting pronouncements issued by the FASB
(including its Emerging Issues Task Force), the American Institute
of Certified Public Accountants, and the SEC did not, or are not
believed by management to, have a material impact on the Company’s
present or future financial position, results of operations or cash
flows.
Note 3. Fair Value Measurements and
Short-Term Investments
Assets and Liabilities Measured at Fair Value on a Recurring
Basis
The Company measures and reports certain financial instruments as
assets and liabilities at fair value on a recurring basis. The fair
value of these instruments was as follows:
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As of December 31, 2022 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Liabilities |
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Contingent royalty obligation payable to Evolus
Founders |
$ |
46,310 |
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$ |
— |
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$ |
— |
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$ |
46,310 |
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As of December 31, 2021 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
Liabilities |
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Contingent royalty obligation payable to Evolus
Founders |
$ |
44,740 |
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$ |
— |
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$ |
— |
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$ |
44,740 |
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The Company did not transfer any assets or liabilities measured at
fair value on a recurring basis between levels during the year
ended December 31, 2022.
The Company determines the fair value of the contingent royalty
obligation payable to Evolus Founders based on Level 3 inputs using
a discounted cash flows method. The significant unobservable input
assumptions that can significantly change
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
the fair value include (i) projected amount and timing of net
revenues during the payment period, which terminates at the end of
the second quarter of 2029, (ii) the discount rate, and (iii) the
timing of payments. During the years ended December 31, 2022 and
2021, the Company utilized discount rates between 13.0% and 15.0%,
reflecting changes in the Company’s risk profile. Net revenue
projections are also updated to reflect changes in the timing of
expected sales. Significant increases (decreases) in the discount
rate would result in a significantly lower (higher) fair value
measurement, which could materially impact the fair value reported
on the consolidated balance sheet.
The following table shows a reconciliation of the beginning and
ending fair value measurements of the contingent royalty obligation
payable:
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Year Ended December 31, |
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2022 |
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2021 |
Fair value, beginning of period |
$ |
44,740 |
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$ |
41,546 |
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Payments |
(4,185) |
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(3,097) |
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Change in fair value recorded in operating expenses |
5,755 |
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6,290 |
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Fair value, end of period |
$ |
46,310 |
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$ |
44,740 |
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Other Financial Assets and Liabilities
The Company’s financial instruments consist primarily of cash and
cash equivalents, accounts receivable, accounts payable, accrued
expenses, lease liabilities, and long-term debt. The carrying
amount of cash and cash equivalents, accounts receivable, accounts
payable and accrued expenses approximates their fair value because
of the short-term maturity of such instruments.
The Company estimates the fair value of long-term debt and
operating lease liabilities using the discounted cash flow analysis
based on the interest rates for similar rated debt securities
(Level 2). As of December 31, 2022 and 2021, the fair value of the
long-term debt was $75,232 and $75,448, respectively. The fair
value of operating lease liabilities as of December 31,
2022 and 2021 approximated their carrying value.
Evolus, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Note 4. Goodwill and Intangible
Assets
The table below shows the weighted-average life, original cost,
accumulated amortization and net book value by major intangible
asset classification:
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Original Cost |
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Accumulated Amortization |
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Net Book Value |
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Definite-lived intangible assets |
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Distribution right |
20 |
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$ |
59,076 |
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$ |
(11,545) |
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$ |
47,531 |
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Capitalized software |
2 |
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8,636 |
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(7,570) |
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1,066 |
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Intangible assets, net |
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67,712 |
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(19,115) |
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48,597 |
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Indefinite-lived intangible asset |
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Goodwill |
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