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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Evolus, Inc.    EOLS

EVOLUS, INC.

(EOLS)
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EVOLUS : Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

10/29/2020 | 03:26pm EST
The following discussion contains management's discussion and analysis of our
financial condition and results of operations and should be read together with
the unaudited condensed financial statements and related notes include in Part
I, Item 1 of this Quarterly Report on Form 10-Q and in conjunction with our
Annual Report on Form 10-K for the year ended December 31, 2019 and other
documents previously filed with the SEC. 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 Item 1A "Risk Factors" of this Quarterly Report on Form 10-Q.
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" of Part II of this Quarterly Report on
Form 10-Q.

Overview

We are a performance beauty company with a customer-centric approach focused on
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 28 EU member states, Iceland, Norway
and Liechtenstein. We currently plan to launch Jeuveau® in Europe in 2021.
We have a limited history of generating revenue from Jeuveau® and have never
been profitable. As of September 30, 2020, we had an accumulated deficit of
$265.4 million. We recorded net revenues of $17.7 million and $36.0 million for
the three and nine months ended September 30, 2020, respectively. We recorded
net losses of $11.5 million and $52.3 million for the three and nine months
ended September 30, 2020, respectively.
We expect to continue to incur significant expenses for the foreseeable future
as we continue marketing efforts for Jeuveau® and maintain our regulatory
approvals.
Potential Impact of Adverse Ruling by the U.S. International Trade Commission on
our Business
As described elsewhere in this Quarterly Report, on January 30, 2019, Allergan,
plc (now Allergan Limited) and Allergan, Inc., who we refer to collectively as
Allergan and Medytox, Inc., or Medytox filed a complaint against us and Daewoong
Pharmaceuticals Co., Ltd., or Daewoong in the U.S. International Trade
Commission, or ITC alleging that Jeuveau® is manufactured based on
misappropriated trade secrets of Medytox and therefore the importation of
Jeuveau® is an unfair act. The ITC matter is entitled In the Matter of Certain
Botulinum Toxin Products. The ITC instituted an investigation as ITC Inv. No.
337-TA-1145.
In July 2020, the Administrative Law Judge assigned to the ITC action to which
we are a party issued an initial determination in which the judge found a
violation of Section 337 of the Tariff Act of 1930 had occurred by reason of a
misappropriation of trade secrets and recommended the entry of an exclusion
order that would prevent us from importing Jeuveau® into the United States for a
period of ten years and a cease and desist order that would prevent us from
selling Jeuveau® in the United States for the same period of time. A final
determination by the ITC is expected to be issued in November 2020, with such
final determination subject to a 60-day presidential review period before
becoming final. In order to make any sales of Jeuveau® during the presidential
review period we would be required to pay a bond at a rate set by the ITC for
any sales
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during the period. Except in certain limited circumstances, the amount of the
bond may make any sales during the period prohibitively expensive. We strongly
disagree with the initial determination by the Administrative Law Judge and
intend to continue to vigorously defend ourselves in this matter. Specifically,
we petitioned for review with respect to subject matter jurisdiction, standing,
trade secret existence and misappropriation, and domestic industry, including
the existence of such domestic industry as well as any actual or threatened
injury thereto. In the event that the ITC's final determination affirms the
Administrative Law Judge's initial determination, we would be prevented from
importing Jeuveau® into the United States and from marketing and selling
Jeuveau® in the United States, which would prevent the Company from generating
revenue from its sole product, Jeuveau® and would materially and adversely
affect our ability to carry out our business and to continue as a going concern.
Even if we are successful in having the decision modified or reversed during the
presidential review or in appealing any such final determination, we may find it
difficult or be prevented from importing, marketing or selling Jeuveau® in the
United States during the pendency of those events. Further, any modification of
the Administrative Law Judge's initial determination in the ITC's final
determination or any final decision following any such presidential review or
other appeal may nonetheless still result in restrictions on our ability to
import and market and sell Jeuveau® in the United States, which could also
materially and adversely affect our ability to generate revenue from Jeuveau®,
to carry out our business, and to continue as a going concern. In any such
event, we may be required to seek protection under the bankruptcy laws,
including a possible liquidation of our assets, or may be forced to reduce,
significantly restructure or discontinue our operations entirely, any of which
would have a material adverse effect on our business, financial position,
results of operations, or cash flows, would cause our stock price to decline and
would also result in reputational harm. Even if we are successful, the ITC
action may result in reputational damage or other collateral consequences. In
addition, it is expected that an event of default under our credit agreement
with Oxford would occur after the imposition of an exclusion order and cease and
desist order and Oxford would be able to declare an event of default after the
exhaustion of all appeals that we may have or earlier. If Oxford were to declare
an event of default under the credit facility and exercise its remedies, it
would materially and negatively affect our business, results of operation,
financial condition and could result in our declaring bankruptcy.
Impact of COVID-19 Outbreak on Our Business
A novel strain of coronavirus (COVID-19) was first identified in Wuhan, China in
December 2019, and subsequently declared a pandemic by the World Health
Organization. The COVID-19 outbreak has caused economic and social disruption on
an unprecedented scale. This disruption has resulted in business closures across
the United States and significant job loss due to quarantines,
government-mandated actions, stay-at-home orders and other restrictions. While
it is not possible to know the full extent of these impacts as of the date this
filing, we are disclosing potentially material items of which we are aware.
Health and Safety
In response to the COVID-19 outbreak, we have taken and will continue to take
temporary precautionary measures intended to help minimize the risk of COVID-19
to our employees, including requiring our employees and sales professionals, to
work remotely if required by their local government and maintaining social
distancing during any in-person work-related meetings. We expect to continue to
implement these measures until we determine that the COVID-19 pandemic is
adequately contained for purposes of our business, and we may take further
actions as government authorities require or recommend or as we determine to be
in the best interests of our employees, customers, business partners and
third-party service providers.
Financial position and results of operations
The COVID-19 outbreak and restrictions intended to slow the spread of COVID-19
have resulted in temporary business closures for many of our customers and,
starting in mid-March 2020, have negatively affected our sales. Jeuveau® is
utilized in elective procedures, the costs of which are borne by the consumer
and not third-party payors. As a result of the COVID-19 outbreak and
restrictions intended to slow its spread, these elective procedures declined
dramatically in March 2020 due to the temporary business closures or deferment
of the elective procedures. While the impact of the COVID-19 outbreak on the
U.S. aesthetic neurotoxin market was significant during the first half of 2020,
we experienced a relatively significant increase in sales starting in June 2020
that continued into the third quarter of 2020 as many states started easing
restrictions on elective procedures and many of our customers re-opened their
businesses. However, due to the uncertainty of the recovery and the recent
increase in COVID-19 infections, we cannot reasonably estimate the immediate and
full impact of the COVID-19 outbreak on our ongoing business, results of
operations and overall financial performance. Furthermore, even after the
current COVID-19 outbreak has subsided, we may continue to experience negative
impacts to our business and financial results if customers continue to defer or
avoid altogether elective procedures to administer Jeuveau® due to the continued
perceived risk of infection or concern of a resurgence of the COVID-19 outbreak
as well as COVID-19's global economic impact,
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including decreases in consumer discretionary spending and any economic slowdown
or recession that has occurred or may occur in the future.
In light of the negative impacts of the COVID-19 outbreak, we took the following
measures to reduce our operating expenses to conserve our cash resources in
April 2020:
•delaying non-essential projects and suspending discretionary spending;
•reducing our headcount by over 100 employees;
•temporarily reducing executive salaries and Board of Directors fees;
•reducing the size of our Board by two members; and
•delaying the European launch of Jeuveau®, which is now expected in 2021.
As a result of our headcount reductions, we are increasingly utilizing our
proprietary digital platform to support sales in the current COVID-19
environment.
Asset and liability valuation
As of September 30, 2020, we did not have any impairment with respect to our
goodwill or long-lived assets, including intangible assets. Because the full
extent of the impact of the COVID-19 outbreak and restrictions intended to slow
the spread of COVID-19 are unknown at this time, they could, under certain
circumstances, cause impairment and result in a non-cash impairment charge being
recorded in future periods.
Any continued adverse impact of the COVID-19 outbreak and restrictions intended
to slow its spread could also cause us to make further adjustments in the future
to the fair value of our contingent royalty obligation payable to Evolus
Founders, which is based on Level 3 inputs using a discounted cash flows method,
and these adjustments could be significant. Such Level 3 inputs that might be
further impacted by uncertainties due to the COVID-19 outbreak include projected
and timing of net revenues during the payment period, which terminates in the
quarter following the 10-year anniversary of the first commercial sale of
Jeuveau® in the United States, the discount rate and the timing of payments.
Other estimates used in the preparation of financial statements
Additionally, any continued adverse impact of the COVID-19 outbreak and
restrictions intended to slow its spread might also impact other estimates and
assumptions utilized to prepare our financial statement in conformity with GAAP.
Such significant estimates relate to net revenues, allowance for doubtful
accounts, fair value measurements, inventory valuations, income tax valuations,
and stock-based compensation, among others.
Liquidity
The COVID-19 outbreak has negatively impacted and disrupted the global economy
and financial markets which could interfere with our ability to access financing
when and on terms that we desire. As of September 30, 2020, we had $110.1
million in cash, cash equivalents and short-term investments and $133.0 million
in long-term debt. In July 2020, we received $40 million from Daewoong in
exchange for the Convertible Promissory Note, or Daewoong Convertible Note (as
described in more detail in "-Liquidity and Capital Resources" below). We do not
have any near-term maturities on our long-term debts. The principal payment of
the Oxford Term Loan may start in May 2022. Interest on the Daewoong Convertible
Note is initially paid in kind and will begin to be paid in cash if and when the
Oxford Term Loan is repaid in full. Our promissory note payable to the Evolus
Founders matures in November 2021. The Daewoong Convertible Promissory Note is
due in July 2025 unless earlier converted into our shares. Although there is
uncertainty related to the anticipated impact of the recent COVID-19 outbreak on
our future results, we believe our business model, our current cash reserves and
the steps we have taken to reduce our operating expenses position us to manage
our business for at least the next twelve months as the outbreak continues. The
adequacy of our current liquidity and capital resources would be materially
adversely affected in the event of a negative outcome in the ITC action. See
"-Formation of Committee of the Board of Directors" and "-Liquidity and Capital
Resources" for additional information regarding our liquidity and capital
resources, our current and future capital requirements and the assumptions and
risks underlying those projections.
We continue to monitor the rapidly evolving situation and guidance from
international and domestic authorities, including federal, state and local
public health authorities and may take additional actions based on their
recommendations. In these
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circumstances, there may be developments outside our control requiring us to
adjust our operating plan. As such, given the dynamic nature of this situation,
we cannot reasonably estimate the full impact of COVID-19 on our financial
condition, results of operations or cash flows in the future. In addition, see
Part II. Item 1A, "Risk Factors," included herein for updates to our risk
factors regarding risks associated with the COVID-19 outbreak.
Formation of Independent Committee of the Board of Directors
As described above, in the event that the ITC's final determination affirms the
Administrative Law Judge's initial determination, we would be prevented from
importing Jeuveau® into the United States and from marketing and selling
Jeuveau® in the United States, which would prevent the Company from generating
revenue from the Company's sole product, Jeuveau® and would materially and
adversely affect our ability to carry out our business and to continue as a
going concern. Even if we are successful in having the decision modified or
reversed during the presidential review or in appealing any such final
determination, we may find it difficult or be prevented from importing,
marketing or selling Jeuveau® in the United States during the pendency of those
events. Further, any modification of the Administrative Law Judge's initial
determination in the ITC's final determination or any final decision following
any such presidential review or other appeal may nonetheless still result in
restrictions on our ability to import and market and sell Jeuveau® in the United
States, which could also materially and adversely affect our ability to generate
revenue from Jeuveau®, to carry out our business, and to continue as a going
concern.
As a result of the challenging conditions described above, we have formed a
committee of independent members of our Board of Directors (the "Committee") to
evaluate all available alternatives in the event of a negative outcome in the
ITC action. The Committee has engaged outside legal counsel and financial
advisors to assist with this process. The Committee, with its outside advisors'
assistance, is evaluating such alternatives to maximize our business, liquidity
and financial position in the event of negative outcome in the ITC action.
Daewoong License and Supply Agreement
In 2013, we and Daewoong Pharmaceuticals Co. Ltd., or Daewoong, entered into the
Daewoong Agreement pursuant to which we have an exclusive distribution license
to Jeuveau® from Daewoong, for aesthetic indications in the United States, EU,
Great Britain, Canada, Australia, Russia, C.I.S. 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. 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.
While we anticipate that we will be able to meet the minimum purchase
obligations, the COVID-19 outbreak may make meeting those obligations more
difficult. In connection with our entry into the Daewoong Agreement, we made an
upfront payment to Daewoong of $2.5 million. Upon FDA approval in February 2019
and EMA approval in September 2019, we paid $2.0 million and $1.0 million
milestone payments, respectively. Under the Daewoong Agreement, the maximum
aggregate amount of milestone payments that could be owed to Daewoong upon the
satisfaction of all milestones is $13.5 million. As of September 30, 2020,
Daewoong is eligible to receive remaining contingent milestone payments of up to
$10.5 million. 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®. We had the option to expand the permitted use
of the product beyond aesthetic indications and into therapeutic indications.
This option was assigned to AEON Biopharma, Inc. which was previously known as
Alphaeon Corporation, or Alphaeon, who exercised the option by remitting payment
directly to Daewoong in November 2018.
Royalties and Notes Payable to Evolus Founders
We are obligated to make the following future payments to the founders of Evolus
(i) quarterly royalty payments of a low single digit percentage of net sales of
Jeuveau® and (ii) a $20.0 million promissory note that matures in November 2021.
The obligations set forth in (i) above will terminate in the quarter following
the 10-year anniversary of the first commercial sale of Jeuveau® in the United
States. The fair value of the obligations set forth in items (i) and (ii) are
valued quarterly and are referred to in our financial statements as the
"contingent royalty obligation."

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Results of Operations
Comparison of the Three Months Ended September 30, 2020 and 2019
The following table summarizes our results of operations for the periods
indicated:
                                                                 Three Months Ended
                                                                   September 30,
(in millions)                                                  2020              2019             Change
Revenue:                                                   $    17.7$   13.2$    4.5
Cost of sales (excludes amortization of intangible assets)       4.9               3.7               1.2
Gross profit                                                    12.8               9.5               3.3
As a percentage of net revenues                                 72.5  %           71.8  %
Operating expenses:
Selling, general and administrative                             21.9              30.9              (9.0)
Research and development                                         0.4               0.7              (0.3)
Revaluation of contingent royalty obligation payable to
Evolus Founders                                                 (2.5)              1.8              (4.3)
Depreciation and amortization                                    1.7               1.2               0.5

Total operating expenses                                        21.6              34.6             (13.0)
Loss from operations                                            (8.8)            (25.1)             16.3

Non-operating expense, net                                      (2.7)             (2.0)             (0.7)

Loss before income taxes:                                      (11.5)            (27.1)             15.6
Income tax expense (benefit)                                       -              (0.1)              0.1
Net loss                                                   $   (11.5)$  (27.0)$   15.5


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 and rewards related to the consumer
loyalty program. 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 obligation and to which we expect to be
entitled in exchange for those products or services. Net revenues of Jeuveau®
sales increased by $4.5 million, or 34%, to $17.7 million for the three months
ended September 30, 2020 from $13.2 million for the three months ended September
30, 2019, primarily due to higher sales volume in the United States and service
revenue associated with international sales. For the three months ended
September 30, 2020, we continued to experience a significant increase in sales
volume as many of our customers re-opened their businesses. We anticipate that
our net revenues will continue to fluctuate during the COVID-19 outbreak and for
a period of time thereafter due to the expected reduced or deferred spending on
Jeuveau® procedures by consumers. In addition, in the event that the ITC's final
determination affirms the Administrative Law Judge's initial determination in
the ITC action, we will be prevented from importing Jeuveau® into the United
States and from marketing and selling Jeuveau® in the United States, which will
prevent us from generating revenue from our sole product. See "Potential Impact
of Adverse Ruling by the U.S. International Trade Commission on our Business"
above.
Cost of Sales
Our cost of sales, which primarily consisted of the cost of inventory purchased
from Daewoong, increased by $1.2 million, or 31%, to $4.9 million for the three
months ended September 30, 2020 from $3.7 million for the three months ended
September 30, 2019 due to higher sales volume. We anticipate that our cost of
sales will fluctuate as our revenues fluctuate. Our gross profit as a percentage
of net revenues was 72.5% and 71.8% for the three months ended September 30,
2020 and 2019, respectively. The increase in gross profit percentage was due to
changes in marketing programs for the three months ended September 30, 2020. Our
gross profit may fluctuate in the future as we implement various marketing
programs that may affect the average selling price of Jeuveau®.
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Selling, General and Administrative
Selling, general and administrative expenses decreased by $9.0 million, or,
29.0% to $21.9 million for the three months ended September 30, 2020 from $30.9
million for the three months ended September 30, 2019, primarily resulting from
delaying non-essential projects and suspending discretionary spending as a
measure we have taken to reduce our operating expenses to minimize the impact of
COVID-19 on our business. Personnel-related expenses, including stock-based
compensation, decreased by $1.6 million as a result of the termination of over
100 employees in April 2020. During the three months ended September 30, 2019,
we also incurred expenses under the Jeuveau® Experience Treatment, or J.E.T.,
program that ended in August 2019. Selling, general and administrative expenses
may fluctuate in the future primarily due to potential changes in marketing
strategies.
Research and Development
Research and development expenses decreased by $0.3 million, or 49.5%, to $0.4
million for the three months ended September 30, 2020 from $0.7 million for the
three months ended September 30, 2019. The decrease primarily resulted from
delaying non-essential projects and suspending discretionary spending as a
measure we have taken to reduce our operating expenses to minimize the impact of
COVID-19 on our business. We expect our overall research and development expense
to increase if and when we seek to develop further product candidates and pursue
regulatory approvals in other jurisdictions.
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 three months ended September 30, 2020 and 2019, the revaluation gain
of $2.5 million and charge of $1.8 million, respectively, were primarily driven
by changes in management assumptions relating to lower revenue forecasts due to
the impact of the COVID-19 outbreak, increased discount rate due to our
increased cost of capital following the decline of our stock price,
uncertainties surrounding the ITC action and timing of cash flows.
Depreciation and Amortization
Depreciation and amortization increased by $0.5 million, or 45.1%, to $1.7
million for the three months ended September 30, 2020 from $1.2 million for the
three months ended September 30, 2019. The increase was primarily attributable
to amortization of the internal-use software costs over two years.
Non-Operating Expense, Net
Non-operating expense, net, increased by $0.7 million, or 36.6%, to $2.7 million
for the three months ended September 30, 2020 from $2.0 million for the three
months ended September 30, 2019, primarily due to lower interest income on our
short-term investments.
Income Taxes (Benefit) Expense
Income tax benefit was trivial for the three months ended September 30, 2020
compared to an income tax benefit of $0.1 million for the three months ended
September 30, 2019.
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Results of Operations
Comparison of the Nine Months Ended September 30, 2020 and 2019
The following table summarizes our results of operations for the periods
indicated:
                                                                 Nine Months Ended
                                                                   September 30,
(in millions)                                                  2020              2019             Change
Revenue:                                                   $    36.0$   15.5$   20.5
Cost of sales (excludes amortization of intangible assets)      11.0               4.4               6.6
Gross profit                                                    25.0              11.1              13.9
As a percentage of net revenues                                 69.4  %           71.7  %
Operating expenses:
Selling, general and administrative                             70.8              83.3             (12.5)
Research and development                                         1.0               3.6              (2.6)
Revaluation of contingent royalty obligation payable to
Evolus Founders                                                 (9.9)              8.0             (17.9)
Depreciation and amortization                                    5.2               2.7               2.5
Restructuring costs                                              3.0                 -               3.0
Total operating expenses                                        70.0              97.5             (27.5)
Loss from operations                                           (45.0)            (86.4)             41.4
Non-operating expense, net                                      (7.1)             (4.0)             (3.1)
Loss before income taxes:                                      (52.1)            (90.4)             38.3
Income tax expense (benefit)                                     0.2             (14.9)             15.1
Net loss                                                   $   (52.3)$  (75.5)$   23.2


Net Revenues
We commercially launched and began shipping Jeuveau® to customers in the United
States in May 2019. Net revenues of Jeuveau® sales increased by $20.5 million,
or 132.3%, to $36.0 million for the nine months ended September 30, 2020 from
$15.5 million for the nine months ended September 30, 2019, primarily due to
higher sales volume in the United States as partially offset by lower average
selling price and service revenue associated with international sales. We
anticipate that our net revenues will continue to fluctuate during the COVID-19
outbreak and for a period of time thereafter due to the expected reduced or
deferred spending on Jeuveau® procedures by our customers. In addition, in the
event that the ITC's final determination affirms the Administrative Law Judge's
initial determination in the ITC action, we will be prevented from importing
Jeuveau® into the United States and from marketing and selling Jeuveau® in the
United States, which will prevent us from generating revenue from our sole
product. See "Potential Impact of Adverse Ruling by the U.S. International Trade
Commission on our Business" above.
Cost of Sales
Our cost of sales, which primarily consisted of the cost of inventory purchased
from Daewoong, increased by $6.6 million, or 151.7%, to $11.0 million for the
nine months ended September 30, 2020 from $4.4 million for the nine months ended
September 30, 2019 due to higher sales volume. We anticipate that our cost of
sales will fluctuate as our revenues fluctuate. Our gross profit as a percentage
of net revenues was 69.4% and 71.7% for the nine months ended September 30, 2020
and 2019, respectively. The decrease in gross profit percentage during the nine
months ended September 30, 2020 was primarily due to promotions offered to
customers in the first quarter of 2020. Our gross profit may fluctuate in the
future as we implement various marketing programs that may affect the average
selling price of Jeuveau®.
Selling, General and Administrative
Selling, general and administrative expenses decreased by $12.5 million, or
15.0%, to $70.8 million for the nine months ended September 30, 2020 from $83.3
million for the nine months ended September 30, 2019, primarily resulting from
delaying non-essential projects and suspending discretionary spending to
minimize the impact of COVID-19 on our business.
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During the nine months ended September 30, 2019, we also incurred expenses under
the Jeuveau® Experience Treatment, or J.E.T., program that ended in August 2019.
Personnel-related expenses, including stock-based compensation, increased by
$3.9 million as a result of hiring a U.S. sales force in the second quarter of
2019, which was partially offset by terminating over 100 employees in 2020.
Selling, general and administrative expenses may fluctuate in the future
primarily due to potential changes in marketing strategies.
Research and Development
Research and development expenses decreased by $2.6 million, or 71.8%, to $1.0
million for the nine months ended September 30, 2020 from $3.6 million for the
nine months ended September 30, 2019. The decrease was primarily attributable to
the completion of the U.S. clinical trial activities related to Jeuveau® and
delaying non-essential projects and suspending discretionary spending to
minimize the impact of COVID-19 on our business. We expect our overall research
and development expense to increase if and when we seek to develop further
product candidates and pursue regulatory approvals in other jurisdictions.
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 nine months ended September 30, 2020 and 2019, the revaluation gain
of $9.9 million and charge of $8.0 million, respectively, were primarily driven
by changes in management assumptions relating to lower revenue forecasts due to
the impact of the COVID-19 outbreak, increased discount rate due to our
increased cost of capital following the decline of our stock price,
uncertainties surrounding the ITC action and timing of cash flows.
Depreciation and Amortization
Depreciation and amortization increased by $2.5 million, or 93.4%, to $5.2
million for the nine months ended September 30, 2020 from $2.7 million for the
nine months ended September 30, 2019. This was primarily attributable to
amortization of the distribution right asset related to Jeuveau® over 20 years
starting in February 2019 as well as amortization of the internal-use software
costs over two years.
Restructuring Costs
Restructuring costs primarily included $3.0 million of termination benefits of
over 100 employees we separated to minimize the impact of COVID-19 on our
business during the nine months ended September 30, 2020.
Non-Operating Expense, Net
Non-operating expense, net, increased by $3.1 million, or 75.3%, to $7.1 million
for the nine months ended September 30, 2020 from $4.0 million for the nine
months ended September 30, 2019, primarily due to higher interest expense on the
long-term debt from Oxford Finance, LLC borrowed in March 2019 and lower
interest income on our short-term investments.
Income Taxes (Benefit) Expense
Income tax expense was $0.2 million for the nine months ended September 30, 2020
compared to an income tax benefit of $14.9 million for the nine months ended
September 30, 2019. Upon the reclassification of the indefinite-lived IPR&D
intangible asset to a definite-lived distribution right intangible asset in the
first quarter of 2019 upon FDA approval of Jeuveau®, the related deferred tax
liability became a source of future taxable income in the assessment of the
realization of deferred tax assets, and as a result, $14.9 million of the
previously existing valuation allowance was released in the nine months ended
September 30, 2019.

Liquidity and Capital Resources
As of September 30, 2020, we had cash and cash equivalents of $85.1 million,
short-term investments of $25.0 million, working capital of $119.7 million,
long-term debt of $133.0 million and stockholders' equity of $35.1 million.
We have a limited history of generating revenues and only began shipping
Jeuveau® in May 2019. We have incurred operating losses to date and have an
accumulated deficit of $265.4 million as of September 30, 2020 as a result of
ongoing efforts to develop and commercialize Jeuveau®, including providing
selling, general and administrative support for these operations. We had net
losses of $52.3 million and $75.5 million for the nine months ended September
30, 2020 and 2019,
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respectively, and we used net cash in operating activities of $55.6 million and
$77.5 million for the nine months ended September 30, 2020 and 2019,
respectively. Management expects operating losses and negative operating cash
flows to continue for at least the next 12 months.
In the event that the ITC's final determination in the ITC action described
above affirms the Administrative Law Judge's initial determination, we would be
prevented from importing Jeuveau® into the United States and from marketing and
selling Jeuveau® in the United States, which would prevent us from generating
revenue from our sole product, Jeuveau® and would materially and adversely
affect our ability to carry out our business and to continue as a going concern.
Even if we are successful in having the decision modified or reversed during the
presidential review or in appealing any such final determination, we may find it
difficult or be prevented from importing, marketing or selling Jeuveau® in the
United States during the pendency of those events. Further, any modification of
the Administrative Law Judge's initial determination in the ITC's final
determination or any final decision following any such presidential review or
other appeal may nonetheless still result in restrictions on our ability to
import and market and sell Jeuveau® in the United States, which could also
materially and adversely affect our ability to generate revenue from Jeuveau®,
to carry out our business, and to continue as a going concern. In any such
event, we may be required to seek protection under the bankruptcy laws,
including a possible liquidation of our assets, or may be forced to reduce,
significantly restructure or discontinue our operations entirely, any of which
would have a material adverse effect on our business, financial position,
results of operations, or cash flows, would cause our stock price to decline and
would also result in reputational harm. See "Potential Impact of Adverse Ruling
by the U.S. International Trade Commission on our Business" and "Formation of
Independent Committee of the Board of Directors" in the section entitled
"Overview" of Item 2. Management's Discussion and Analyses for further
discussion. The COVID-19 outbreak and restrictions intended to slow its spread
have adversely affected, and are expected to continue to adversely affect, our
business, financial condition, results of operations and cash flows. See "Impact
of COVID-19 Outbreak on Our Business" in the section entitled "Overview" of Item
2. Management's Discussion and Analyses for further discussion.
The Oxford Loan and Security Agreement
On March 15, 2019, or the closing date, we entered into a loan and security
agreement, or the credit facility, with Oxford Finance, LLC, as collateral
agent, or Oxford, and the lenders party thereto from time to time, pursuant to
which the lender will make term loans available to us of up to $100.0 million,
or the credit facility. The credit facility provides that the term loans are
funded in two advances. The first tranche of $75.0 million was funded on the
closing date, and the second tranche of $25.0 million could have been drawn, at
our request, no later than September 30, 2020, upon achieving specified minimum
net sales milestones and no event of default is occurring. As of September 30,
2020, we did not meet the net sales milestone to draw the second tranche, and
the $25.0 million tranche is no longer available to us. The credit facility
bears an annual interest rate equal to the greater of 9.5%, or the 30-day U.S.
Dollar LIBOR rate plus 7.0%. We have agreed to pay interest only pursuant to the
credit facility for the first 36 months until May 2022, which will be followed
by a 23-month amortization period.
Upon the earliest to occur of the maturity date, the acceleration of the term
loans, or the prepayment of the term loans, we will be required to pay to Oxford
a final payment of 5.5% of the full principal amount of the term loans funded,
or the final payment. We may elect to prepay all amounts owed prior to the
maturity date, provided that a prepayment fee is also paid, which shall be equal
to 2.0% of the amount prepaid if the prepayment occurs after March 15, 2020 and
on or prior to March 15, 2021, or 1.0% of the amount prepaid if the prepayment
occurs thereafter, or the Prepayment Fee. If the term loans are accelerated
following the occurrence of an event of default, we will be required to
immediately pay to Oxford an amount equal to the sum of all outstanding
principal of the term loans plus accrued and unpaid interest thereon through the
prepayment date, the final payment, the Prepayment Fee, and all other
obligations that are due and payable, including payment of Oxford's expenses and
interest at the default rate with respect to any past due amounts.
The credit facility is secured by substantially all of our assets. The credit
facility includes affirmative and negative covenants applicable to us, our
current subsidiary and any subsidiaries we may create in the future. The
affirmative covenants include, among others, covenants requiring us to maintain
our legal corporate existence and governmental approvals, deliver certain
financial reports, maintain insurance coverage and satisfy certain requirements
regarding deposit accounts. The negative covenants include, among others,
restrictions on us transferring collateral, incurring additional indebtedness,
engaging in mergers or acquisitions, paying dividends or making other
distributions, making investments, creating liens, selling assets and suffering
a change in control, in each case subject to certain exceptions.
The credit facility also includes events of default, the occurrence and
continuation of which could cause interest to be charged at a default interest
rate equal to the applicable rate plus 5.0% and Oxford, as collateral agent,
with the right to exercise
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remedies against us and the collateral securing the credit facility, including
foreclosure against the property securing the credit facility, including by
obtaining control over our bank and investment accounts and taking our cash.
These events of default include, among other things, any failure by us to pay
principal or interest due under the credit facility, a breach of certain
covenants under the credit facility, our insolvency, a material adverse change,
the occurrence of any default under certain other indebtedness and one or more
judgments against us, the institution of certain temporary or permanent relief
in connection with our pending litigation, or the breach, termination or other
adverse events under the Daewoong Agreement.
In July 2020, the Administrative Law Judge assigned to the ITC action to which
we are a party issued an initial determination in which the judge found a
violation of Section 337 of the Tariff Act of 1930 had occurred by reason of a
misappropriation of trade secrets and recommended the entry of a an exclusion
order that would prevent us from importing Jeuveau® into the United States for a
period of ten years and a cease and desist order that would prevent us from
selling Jeuveau® in the United States for the same period of time. A final
determination by the ITC is expected to be issued in November 2020, with such
final determination subject to a 60-day presidential review period before
becoming final. We strongly disagree with the initial determination by the
Administrative Law Judge and intend to continue to vigorously defend ourself in
this matter. Specifically, the Company petitioned for review with respect to
subject matter jurisdiction, standing, trade secret existence and
misappropriation, and domestic industry, including the existence of such
domestic industry as well as any actual or threatened injury thereto. In the
event that the ITC's final determination affirms the Administrative Law Judge's
initial determination, we would be prevented from importing Jeuveau® into the
United States and from marketing and selling Jeuveau® in the United States for a
period of ten years. Even if we are successful in having the decision modified
or reversed during the presidential review or in appealing any such final
determination, we may find it difficult or be prevented from importing,
marketing or selling Jeuveau® in the United States during the pendency of those
events. Further, any modification of the Administrative Law Judge's initial
determination in the ITC's final determination or any final decision following
any such presidential review or other appeal may nonetheless still result in
restrictions on our ability to import and market and sell Jeuveau® in the United
States. In any of these scenarios, it is expected that an event of default of
the Oxford credit facility would occur after the imposition of an exclusion
order and cease and desist order and Oxford would be able to declare an event of
default after the exhaustion of all appeals that the Company may have or
earlier. If Oxford were to declare an event of default under the credit facility
and exercise its remedies, it would materially and negatively affect our
business, results of operation, financial condition and could result in our
declaring bankruptcy.
The credit facility also provides us with the ability, under certain conditions,
to obtain up to a $25.0 million revolving line of credit secured by our
inventory, accounts receivable and cash proceeds of both. Oxford has the right
of first refusal, but not the obligation, to provide such a revolving line of
credit. In light of the COVID-19 outbreak and the related global economic
disruptions it has caused, there is no guarantee that we would continue to meet
the conditions necessary to obtain the line of credit or that, given lending
constraints during the outbreak, such a line would be available from Oxford or
other lenders to us on terms favorable to us or at all.
The Daewoong Convertible Note
On July 6, 2020, we entered into a Convertible Promissory Note Purchase
Agreement with Daewoong for the purchase and sale of a Convertible Promissory
Note for the principal amount of $40 million, which we refer to as the Daewoong
Convertible Note, which was funded on July 30, 2020. Additionally, on July 6,
2020, we, Daewoong, and Oxford Finance, LLC entered into a Subordination
Agreement pursuant to which the Convertible Note will be subordinated to our
obligations under that certain Loan and Security Agreement, dated as of March
15, 2019, by and between Oxford and us.
The Daewoong Convertible Note bears interest at a rate of 3.0% payable
semi-annually in arrears on June 30th and December 31st of each year and matures
on July 30, 2025, subject to earlier conversion as provided below. Interest is
initially paid in kind by adding the accrued amount thereof to the outstanding
principal amount on a semi-annual basis on June 30th and December 31st of each
calendar year for so long as any principal amount under the Oxford Term Loan
remains outstanding and the Subordination Agreement has not been terminated.
Interest will begin to be paid in cash if and when the Oxford Term Loan is
repaid in full and the Subordination Agreement has been terminated.
During the term, the Daewoong Convertible Note will be convertible at the option
of Daewoong beginning on the date that is 12 months from the date of issuance,
subject to certain suspensions of that conversion right in the event of a final
determination of the ITC action resulting in an exclusion order with respect to
Jeuveau® as further set forth in the Daewoong Convertible Note. The initial
conversion price of the Daewoong Convertible Note is $13.00 per share. The
conversion price of the Daewoong Convertible Note is subject to adjustment for
stock splits, dividends or distributions, recapitalizations, spinoffs or similar
transactions. The Daewoong Convertible Note and the shares of our common stock
issuable upon
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conversion of the Daewoong Convertible Note have not been registered under the
Securities Act and may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements.
Starting 27 months from the date of issuance, we may prepay the Daewoong
Convertible Note without penalty, provided that we provide Daewoong with at
least ten business days' written notice during which Daewoong may convert all or
any portion of the Daewoong Convertible Note at the conversion price.
Further, in the event we are awarded any recovery pursuant to a final,
non-appealable award or judgment issued by a court of competent jurisdiction
over the parties, or pursuant to any settlement acceptable in the sole and
absolute discretion of each of us and Daewoong, for any indemnification or other
claim for damages by us under the Daewoong Agreement, the amount of the
Daewoong's or its affiliate's indemnification obligation with respect to such
award, judgment or settlement shall be reduced on a dollar-for-dollar basis and
will be offset by the amount of the then-outstanding principal amount of the
Daewoong Convertible Note and any accrued but unpaid interest thereon.
Operating Leases
Our corporate headquarters is located in Newport Beach, California, in a
facility that we subleased until January 2020 under a non-cancelable operating
lease for a fixed amount each month. On May 15, 2019, we entered into a
non-cancelable operating lease for the same office facility with the original
lessor. This non-cancelable operating lease commenced on February 1, 2020 and
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. We
have an option to extend the term of the lease for an additional 60 months.
Current and Future Capital Requirements
We believe that our current capital resources, which consist of cash, cash
equivalents and short-term investments, will be sufficient to fund operations
through at least the next twelve months based on our expected cash burn rate
from the date of the issuance of this Quarterly Report on Form 10-Q.
We have based our projections of operating capital requirements on assumptions
that may prove to be incorrect and we may use all our available capital
resources, which consist of cash, cash equivalents and short-term investments,
sooner than we expect. 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.
Our future funding requirements will depend on many factors, including, but not
limited to:
•our ability to generate revenue and continue as a going concern if the ITC
affirms the initial determination issued by the Administrative Law Judge in a
final determination and imposes an exclusion order preventing us from importing
Jeuveau® into the United States and a cease and desist order that would prevent
us from marketing and selling Jeuveau® in the United States;
•the potential declaration of an event of default by Oxford in the event that
ITC issues a final determination affirming the initial determination of the
Administrative Law Judge and imposes an exclusion order preventing us from
importing Jeuveau® into the United States and a cease and desist order that
would prevent us from selling Jeuveau® in the United States, which would allow
Oxford to exercise its remedies such as demanding immediate repayment of our
debt plus all related final and prepayment fees or obtain control of our bank
and investment accounts and take the amount owed;
•the severity and duration of the COVID-19 outbreak;
•the results of any other current and any future legal proceedings, including
any potential remedies such as monetary damages or injunctive relief barring the
importation, sales or marketing of Jeuveau®;
•our ability to maintain compliance with the covenants in the Oxford credit
facility and avoid an event of default so that our long-term debt with Oxford
remains outstanding;
•the number and characteristics of any future product candidates we develop or
acquire;
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•the timing of any cash milestone payments to Daewoong if we successfully
achieve certain predetermined milestones;
•our ability to forecast demand for our products, scale our supply to meet that
demand and manage working capital effectively
•the cost of manufacturing our product or any future product candidates and any
products we successfully commercialize, including costs associated with building
our supply chain;
•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,
and the market acceptance of our products;
•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 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 patent claims, including ongoing litigation costs related to
Jeuveau® and the outcome of this and any other future patent litigation we may
be involved in; and
•the timing, receipt and amount of sales of any future approved or cleared
products, if any.
Until such time, if ever, as we can generate substantial product revenue to
cover our costs of operations, we expect to finance our cash needs by entering
into licensing or collaboration agreements with partners, other debt or equity
financings, or other sources of financing. Sufficient funds may not be available
to us at all or on attractive terms when needed from these sources. To the
extent that we raise additional capital through the future sale of equity, the
ownership interests of our stockholders will be diluted, and the terms of these
securities may include liquidation or other preferences that adversely affect
the rights of our existing common stockholders. If we raise additional funds
through the issuance of debt securities, these securities could contain
covenants that would restrict our operations. We may require additional capital
beyond our currently anticipated amounts. If we are unable to obtain additional
funding from these or other sources when needed, or to the extent needed. we may
need to significantly reduce our controllable and variable expenditures and
current rate of spending through reductions in staff and delaying, scaling back,
or suspending certain research and development, sales and marketing programs and
other operational goals. These events may occur even if we are ultimately
successful in the ITC action.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
                                                              Nine Months Ended
                                                                September 30,
        (in millions)                                         2020          2019
        Net cash (used in) provided by:
        Operating activities                              $    (55.6)$ (77.5)
        Investing activities                                    (7.5)       (37.4)
        Financing activities                                    38.3         60.8
        Change in cash and cash equivalents                    (24.8)       (54.1)
        Cash and cash equivalents, beginning of period         109.9         93.2
        Cash and cash equivalents, end of period          $     85.1$  39.1


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Operating Activities
Cash used in operating activities was $55.6 million for the nine months ended
September 30, 2020 compared to $77.5 million for the nine months ended September
30, 2019. The decrease in net cash used in operating activities reflects the
decrease in net loss as well as timing of receipts from customers and payments
to vendors in the ordinary course of business.
For the nine months ended September 30, 2020, operating activities used $55.6
million of cash, which primarily resulted from our net loss of $52.3 million as
adjusted for certain non-cash charges including $8.0 million of stock-based
compensation expense, a gain of $9.9 million in revaluation of our contingent
royalty obligation, $2.4 million of provision of allowance for doubtful accounts
and $5.2 million of depreciation and amortization. Net operating assets and
liabilities changed by $11.4 million primarily driven by timing of collections
from customers and payments to vendors.
For the nine months ended September 30 2019, operating activities used $77.5
million of cash, which primarily resulted from our net loss of $75.5 million as
adjusted for certain non-cash charges including $7.0 million of stock-based
compensation expense, a charge of $8.0 million in revaluation of our contingent
royalty obligation, a gain of $14.9 million of deferred income tax provision and
$2.7 million of depreciation and amortization. Net operating assets and
liabilities changed by $6.0 million primarily driven by timing of collections
from customers and payments to vendors.
We expect our cash flows from operating activities to fluctuate as we experience
extended customer collection cycles and execute operating expenses reduction
efforts.
Investing Activities
Cash used in investing activities was $7.5 million for the nine months ended
September 30, 2020 compared to $37.4 million for the nine months ended September
30, 2019. The decrease in cash used in investing activities was attributable to
a decrease in purchases of short-term investments net of maturities as well as
lower additions to capitalized software for the nine months ended September 30,
2020.
Financing Activities
Cash used in financing activities was $38.3 million for the nine months ended
September 30, 2020, compared to $60.8 million of cash provided by financing
activities for the nine months ended September 30, 2019. Cash used in financing
activities in the 2020 period primarily resulted from the proceeds of $40.0
million received from the Convertible Note in July 2020 as partially offset by
payments of contingent royalty obligations to the Evolus Founders and debt
obligations. Cash provided by financing activities for the 2019 period primarily
resulted from the proceeds of $71.7 million received from our Oxford credit
facility net of discounts and issuance costs, partially offset by a $9.3 million
payment of contingent royalty obligations to the Evolus Founders and a $2.0
million payment to Daewoong upon FDA approval of Jeuveau® in February 2019.
Indebtedness
See "-Liquidity and Capital Resources" for a description of our credit facility
with Oxford and convertible note with Daewoong.

Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in the rules and
regulations of the SEC. We do not have any relationships with unconsolidated
entities or financial partnerships, such as entities often referred to as
structured finance or special purpose entities, which would have been
established for the purpose of facilitating off-balance sheet arrangements or
for any other contractually narrow or limited purpose.

Critical Accounting Policies
Management's discussion and analysis of our financial condition and results of
operations are based on our financial statements, which have been prepared in
accordance with GAAP. The preparation of these 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 financial statements as well as the expenses
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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 judgments and estimates in
light of changes in circumstances, facts and experience.
In May 2020, we announced the launch of a consumer loyalty program, which 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, 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 reversed and included in net revenue.
There have been no other material changes to our critical accounting policies
and estimates as discussed in our Annual Report on Form 10-K filed for the year
ended December 31, 2019.
Recently Issued and Adopted Accounting Pronouncements
We describe the recently issued and adopted accounting pronouncements that apply
to us in Note 2, Summary of Significant Accounting Policies-Recent Accounting
Pronouncements.

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