false2022Q30001570562--12-31http://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberP1Y00015705622022-01-012022-09-3000015705622022-11-04xbrli:shares00015705622022-09-30iso4217:USD00015705622021-12-31iso4217:USDxbrli:shares0001570562us-gaap:ProductMember2022-07-012022-09-300001570562us-gaap:ProductMember2021-07-012021-09-300001570562us-gaap:ProductMember2022-01-012022-09-300001570562us-gaap:ProductMember2021-01-012021-09-300001570562us-gaap:ServiceMember2022-07-012022-09-300001570562us-gaap:ServiceMember2021-07-012021-09-300001570562us-gaap:ServiceMember2022-01-012022-09-300001570562us-gaap:ServiceMember2021-01-012021-09-3000015705622022-07-012022-09-3000015705622021-07-012021-09-3000015705622021-01-012021-09-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2020-12-310001570562us-gaap:CommonStockMember2020-12-310001570562us-gaap:AdditionalPaidInCapitalMember2020-12-310001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001570562us-gaap:RetainedEarningsMember2020-12-3100015705622020-12-310001570562us-gaap:CommonStockMember2021-01-012021-03-310001570562us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-3100015705622021-01-012021-03-310001570562us-gaap:RetainedEarningsMember2021-01-012021-03-310001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2021-03-310001570562us-gaap:CommonStockMember2021-03-310001570562us-gaap:AdditionalPaidInCapitalMember2021-03-310001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-03-310001570562us-gaap:RetainedEarningsMember2021-03-3100015705622021-03-310001570562eols:FollowOnOfferingMemberus-gaap:CommonStockMember2021-04-012021-06-300001570562eols:FollowOnOfferingMemberus-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-300001570562eols:FollowOnOfferingMember2021-04-012021-06-300001570562us-gaap:CommonStockMembereols:ATMSalesAgreementMember2021-04-012021-06-300001570562us-gaap:AdditionalPaidInCapitalMembereols:ATMSalesAgreementMember2021-04-012021-06-300001570562eols:ATMSalesAgreementMember2021-04-012021-06-300001570562us-gaap:CommonStockMember2021-04-012021-06-300001570562us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-3000015705622021-04-012021-06-300001570562us-gaap:RetainedEarningsMember2021-04-012021-06-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2021-06-300001570562us-gaap:CommonStockMember2021-06-300001570562us-gaap:AdditionalPaidInCapitalMember2021-06-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-300001570562us-gaap:RetainedEarningsMember2021-06-3000015705622021-06-300001570562us-gaap:CommonStockMembereols:ATMSalesAgreementMember2021-07-012021-09-300001570562us-gaap:AdditionalPaidInCapitalMembereols:ATMSalesAgreementMember2021-07-012021-09-300001570562eols:ATMSalesAgreementMember2021-07-012021-09-300001570562us-gaap:CommonStockMember2021-07-012021-09-300001570562us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001570562us-gaap:RetainedEarningsMember2021-07-012021-09-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2021-09-300001570562us-gaap:CommonStockMember2021-09-300001570562us-gaap:AdditionalPaidInCapitalMember2021-09-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-09-300001570562us-gaap:RetainedEarningsMember2021-09-3000015705622021-09-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2021-12-310001570562us-gaap:CommonStockMember2021-12-310001570562us-gaap:AdditionalPaidInCapitalMember2021-12-310001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001570562us-gaap:RetainedEarningsMember2021-12-310001570562us-gaap:CommonStockMember2022-01-012022-03-310001570562us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-3100015705622022-01-012022-03-310001570562us-gaap:RetainedEarningsMember2022-01-012022-03-310001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2022-03-310001570562us-gaap:CommonStockMember2022-03-310001570562us-gaap:AdditionalPaidInCapitalMember2022-03-310001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-310001570562us-gaap:RetainedEarningsMember2022-03-3100015705622022-03-310001570562us-gaap:CommonStockMember2022-04-012022-06-300001570562us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-3000015705622022-04-012022-06-300001570562us-gaap:RetainedEarningsMember2022-04-012022-06-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-04-012022-06-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2022-06-300001570562us-gaap:CommonStockMember2022-06-300001570562us-gaap:AdditionalPaidInCapitalMember2022-06-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-300001570562us-gaap:RetainedEarningsMember2022-06-3000015705622022-06-300001570562us-gaap:CommonStockMember2022-07-012022-09-300001570562us-gaap:AdditionalPaidInCapitalMember2022-07-012022-09-300001570562us-gaap:RetainedEarningsMember2022-07-012022-09-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-07-012022-09-300001570562us-gaap:PreferredStockMemberus-gaap:ConvertiblePreferredStockMember2022-09-300001570562us-gaap:CommonStockMember2022-09-300001570562us-gaap:AdditionalPaidInCapitalMember2022-09-300001570562us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-09-300001570562us-gaap:RetainedEarningsMember2022-09-300001570562eols:FollowOnOfferingMember2022-01-012022-09-300001570562eols:FollowOnOfferingMember2021-01-012021-09-300001570562eols:ATMSalesAgreementMember2022-01-012022-09-300001570562eols:ATMSalesAgreementMember2021-01-012021-09-300001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansMember2021-12-310001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMember2021-12-310001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansTwoMember2021-12-310001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMember2021-12-012021-12-31eols:reporting_unit0001570562us-gaap:DistributionRightsMember2022-01-012022-09-300001570562us-gaap:SoftwareDevelopmentMember2022-01-012022-09-3000015705622022-06-012022-06-300001570562eols:IntellectualPropertyDisputesJeuveauMember2021-02-280001570562eols:IntellectualPropertyDisputesJeuveauMember2021-02-012021-02-280001570562eols:IntellectualPropertyDisputesJeuveauMember2021-07-012021-09-300001570562eols:IntellectualPropertyDisputesJeuveauMember2022-01-012022-03-310001570562us-gaap:CommonStockMember2021-02-012021-02-2800015705622020-10-012020-12-310001570562eols:IntellectualPropertyDisputesJeuveauMember2020-12-3100015705622021-02-012021-02-2800015705622021-03-012021-03-310001570562us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001570562us-gaap:EmployeeStockOptionMember2022-07-012022-09-300001570562us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001570562us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2022-07-012022-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2021-07-012021-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2021-01-012021-09-300001570562us-gaap:NotesPayableOtherPayablesMember2022-09-300001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel1Member2022-09-300001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel2Member2022-09-300001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel3Member2022-09-300001570562us-gaap:NotesPayableOtherPayablesMember2021-12-310001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel1Member2021-12-310001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel2Member2021-12-310001570562us-gaap:NotesPayableOtherPayablesMemberus-gaap:FairValueInputsLevel3Member2021-12-310001570562us-gaap:MeasurementInputDiscountRateMembereols:ContingentRoyaltyObligationMember2021-09-30xbrli:pure0001570562us-gaap:MeasurementInputDiscountRateMembereols:ContingentRoyaltyObligationMember2022-09-300001570562eols:PharmakonTermLoansMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2022-09-300001570562eols:PharmakonTermLoansMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2021-12-310001570562us-gaap:DistributionRightsMember2022-09-300001570562us-gaap:ComputerSoftwareIntangibleAssetMember2022-01-012022-09-300001570562us-gaap:ComputerSoftwareIntangibleAssetMember2022-09-300001570562us-gaap:DistributionRightsMember2021-01-012021-12-310001570562us-gaap:DistributionRightsMember2021-12-310001570562us-gaap:ComputerSoftwareIntangibleAssetMember2021-01-012021-12-310001570562us-gaap:ComputerSoftwareIntangibleAssetMember2021-12-310001570562eols:SCHAEONLLCMembereols:EvolusIncMember2022-01-012022-09-300001570562eols:SCHAEONLLCMembereols:EvolusIncMember2019-01-012019-12-310001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansMember2021-12-14eols:tranche0001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMember2021-12-140001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansTwoMember2021-12-140001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansMember2021-12-142021-12-140001570562us-gaap:SecuredDebtMemberus-gaap:LondonInterbankOfferedRateLIBORMembereols:PharmakonTermLoansMember2021-12-142021-12-14eols:payment0001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMember2021-12-142021-12-140001570562us-gaap:SecuredDebtMember2021-12-140001570562us-gaap:SecuredDebtMembereols:TermOneMembereols:PharmakonTermLoansOneMember2021-12-140001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMembereols:TermTwoMember2021-12-140001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansOneMembereols:TermThreeMember2021-12-140001570562us-gaap:SecuredDebtMembereols:PharmakonTermLoansMember2022-09-300001570562us-gaap:SecuredDebtMember2019-03-15eols:advance0001570562eols:OxfordTermLoanFacilityTrancheOneMemberus-gaap:SecuredDebtMember2019-03-150001570562us-gaap:SecuredDebtMembereols:OxfordTermLoanFacilityTrancheTwoMember2019-03-150001570562us-gaap:SecuredDebtMemberus-gaap:LondonInterbankOfferedRateLIBORMember2019-03-152019-03-150001570562us-gaap:SecuredDebtMember2019-03-152019-03-150001570562eols:TermLoanFacilityMember2019-03-150001570562eols:OxfordTermLoanFacilityMember2021-01-042021-01-040001570562eols:OxfordTermLoanFacilityMember2021-01-012021-09-300001570562eols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMember2020-07-060001570562eols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMember2021-03-230001570562eols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMemberus-gaap:CommonStockMember2021-03-232021-03-23eols:position0001570562eols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMember2021-03-232021-03-2300015705622020-10-162020-10-28eols:complaint00015705622020-11-272020-12-02eols:plaintiff0001570562us-gaap:CommonStockMember2021-02-282021-02-280001570562eols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMemberus-gaap:CommonStockMember2021-03-252021-03-250001570562eols:ATMSalesAgreementMember2021-03-262021-03-260001570562eols:ATMSalesAgreementMember2021-03-260001570562us-gaap:CommonStockMembereols:ATMSalesAgreementMember2021-01-012021-09-300001570562us-gaap:AdditionalPaidInCapitalMembereols:ATMSalesAgreementMember2021-01-012021-09-3000015705622017-11-2100015705622017-11-212017-11-210001570562us-gaap:EmployeeStockOptionMember2022-02-012022-02-280001570562us-gaap:RestrictedStockUnitsRSUMember2022-02-012022-02-280001570562us-gaap:EmployeeStockOptionMember2022-09-012022-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2022-09-012022-09-300001570562us-gaap:EmployeeStockOptionMember2022-09-300001570562us-gaap:RestrictedStockUnitsRSUMember2022-09-300001570562srt:MinimumMember2022-01-012022-09-300001570562srt:MaximumMember2022-01-012022-09-300001570562eols:RestrictedStockUnitsRSUsMarketConditionsMember2022-01-012022-09-300001570562eols:RestrictedStockUnitsRSUsPerformanceConditionsMember2022-01-012022-09-300001570562us-gaap:EmployeeStockOptionMember2022-07-012022-09-300001570562us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001570562us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001570562us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001570562us-gaap:EmployeeStockOptionMember2021-12-310001570562us-gaap:EmployeeStockOptionMember2021-01-012021-12-310001570562us-gaap:RestrictedStockUnitsRSUMember2021-12-310001570562us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-09-300001570562us-gaap:SellingGeneralAndAdministrativeExpensesMember2022-07-012022-09-300001570562us-gaap:SellingGeneralAndAdministrativeExpensesMember2021-07-012021-09-300001570562us-gaap:SellingGeneralAndAdministrativeExpensesMember2022-01-012022-09-300001570562us-gaap:SellingGeneralAndAdministrativeExpensesMember2021-01-012021-09-300001570562us-gaap:ResearchAndDevelopmentExpenseMember2022-07-012022-09-300001570562us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012021-09-300001570562us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-09-300001570562us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-09-300001570562eols:IntellectualPropertyDisputesJeuveauMember2021-02-180001570562eols:IntellectualPropertyDisputesJeuveauMember2021-02-182021-02-180001570562us-gaap:CommonStockMember2021-02-182021-02-180001570562srt:ScenarioForecastMember2023-09-150001570562srt:ScenarioForecastMember2024-09-150001570562srt:ScenarioForecastMember2025-09-1500015705622021-02-182021-02-180001570562eols:DaewoongSettlementAgreementMember2021-03-232021-03-230001570562srt:MaximumMembereols:DaewoongConvertibleNoteMemberus-gaap:ConvertibleDebtMember2021-03-232021-03-23
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________________________________________________
FORM 10-Q
_________________________________________________________________
(Mark One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended September 30, 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)
_________________________________________________________________
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Delaware
|
|
|
|
46-1385614 |
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
|
|
(I.R.S. Employer
Identification Number)
|
|
|
|
|
|
|
|
|
|
520 Newport Center Drive Suite 1200
Newport Beach, California
|
|
|
|
92660 |
|
|
(Address of Principal Executive Offices) |
|
|
|
(Zip Code) |
|
|
|
|
(949) 284-4555
|
|
|
|
|
|
|
(Registrant’s Telephone Number, Including Area Code) |
|
|
|
Securities registered pursuant to Section 12(b) of the
Act:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Title of Class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
Common Stock, par value $0.00001 per share |
|
EOLS |
|
The Nasdaq Stock Market LLC
(Nasdaq Global Market)
|
|
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, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
|
|
|
|
|
|
|
|
|
|
|
|
Large accelerated filer |
☐
|
Accelerated filer |
☐
|
Non-accelerated filer |
☒
|
Smaller reporting company |
☒ |
|
|
Emerging growth company |
☒ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☒
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the
Act). Yes ☐ No ☒
As of November 4, 2022, 56,246,570 shares of
the
registrant’s common stock, par value $0.00001, were
outstanding.
|
|
|
|
|
|
|
|
|
|
TABLE OF CONTENTS
|
|
|
|
Page |
|
|
|
|
Summary of Risk Factors |
3 |
|
|
|
|
PART I - FINANCIAL INFORMATION
|
|
Item 1.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 2.
|
|
|
Item 3.
|
|
|
Item 4.
|
|
|
|
|
|
|
PART II - OTHER INFORMATION
|
|
Item 1.
|
|
|
Item 1A.
|
|
|
Item 2.
|
|
|
Item 3.
|
|
|
Item 4.
|
|
|
Item 5.
|
|
|
Item 6.
|
|
|
|
|
|
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q 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 based on
our current expectations, assumptions, estimates and projections
about 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 facts may be deemed to be
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 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 Quarterly 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.
The forward-looking statements included herein are based on current
expectations of our management based on available information and
are believed to be reasonable. 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 Quarterly Report on Form 10-Q and the 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 Quarterly Report on Form 10-Q 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 the scope of our operations.
•If
we or our counterparties do not comply with the terms of our
settlement agreements with Medytox Inc., or Medytox, and Allergan
Limited, Allergan Inc. and Allergan Pharmaceuticals Ireland, or,
collectively Allergan, 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 Medytox/Allergan Settlement Agreements with Medytox
and Allergan impacts 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
outbreaks of contagious diseases.
•Unfavorable
global economic conditions, which may adversely impact consumer
discretionary spending or cause our customers to delay making
payments for our product, could affect our ability to raise
additional capital when needed on acceptable terms, if at all, and
may result in supply chain disruptions impacting the availability
of our products.
•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 Quarterly
Report on Form 10-Q, 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 Quarterly Report
on Form 10-Q. 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 and Great Britain, but is referred to throughout this
Quarterly Report on Form 10-Q as Jeuveau®.
This Quarterly Report on Form 10-Q 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 Quarterly Report on
Form 10-Q as BOTOX. Solely for convenience, trademarks and trade
names referred to in this Quarterly Report on Form 10-Q 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.
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial
Statements
Evolus, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except par value and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
65,572 |
|
|
$ |
146,256 |
|
|
|
|
|
Accounts receivable, net |
20,920 |
|
|
14,657 |
|
Inventories |
21,565 |
|
|
1,762 |
|
|
|
|
|
|
|
|
|
Prepaid expenses |
3,656 |
|
|
5,082 |
|
Other current assets |
4,233 |
|
|
11,042 |
|
Total current assets |
115,946 |
|
|
178,799 |
|
Property and equipment, net |
1,882 |
|
|
1,371 |
|
Operating lease right-of-use assets |
2,149 |
|
|
2,722 |
|
Intangible assets, net |
49,108 |
|
|
50,625 |
|
Goodwill |
21,208 |
|
|
21,208 |
|
Other assets |
2,426 |
|
|
2,758 |
|
Total assets |
$ |
192,719 |
|
|
$ |
257,483 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
8,564 |
|
|
$ |
6,091 |
|
Accrued expenses |
29,883 |
|
|
29,993 |
|
Accrued litigation settlement |
5,000 |
|
|
15,000 |
|
|
|
|
|
Operating lease liabilities |
1,307 |
|
|
1,265 |
|
Contingent royalty obligation payable to Evolus
Founders |
6,517 |
|
|
5,314 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
51,271 |
|
|
57,663 |
|
Accrued litigation settlement |
— |
|
|
5,000 |
|
Operating lease liabilities |
1,491 |
|
|
2,256 |
|
Contingent royalty obligation payable to Evolus
Founders |
39,000 |
|
|
39,426 |
|
Term loan, net of discount and issuance costs |
71,712 |
|
|
71,222 |
|
|
|
|
|
Deferred tax liability |
25 |
|
|
40 |
|
Total liabilities |
163,499 |
|
|
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 September 30, 2022 and December
31, 2021, respectively
|
— |
|
|
— |
|
Common stock, $0.00001 par value; 100,000,000 shares authorized;
56,183,414 and 55,576,988 shares issued and outstanding at
September 30, 2022 and December 31, 2021, respectively
|
1 |
|
|
1 |
|
Additional paid-in capital |
513,717 |
|
|
504,757 |
|
Accumulated other comprehensive loss |
(368) |
|
|
— |
|
Accumulated deficit |
(484,130) |
|
|
(422,882) |
|
Total stockholders’ equity |
29,220 |
|
|
81,876 |
|
Total liabilities and stockholders’ equity |
$ |
192,719 |
|
|
$ |
257,483 |
|
See
accompanying notes to consolidated financial
statements.
Evolus, Inc.
Condensed Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
33,215 |
|
|
$ |
26,677 |
|
|
$ |
103,604 |
|
|
$ |
64,314 |
|
Service revenue |
684 |
|
|
— |
|
|
1,366 |
|
|
702 |
|
Total net revenues |
33,899 |
|
|
26,677 |
|
|
104,970 |
|
|
65,016 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
13,490 |
|
|
11,490 |
|
|
42,517 |
|
|
27,700 |
|
Settlement payment from Daewoong |
— |
|
|
— |
|
|
— |
|
|
(25,500) |
|
Selling, general and administrative |
34,794 |
|
|
31,673 |
|
|
105,111 |
|
|
78,801 |
|
Research and development |
1,376 |
|
|
301 |
|
|
3,394 |
|
|
1,641 |
|
In-process research and development |
— |
|
|
— |
|
|
2,000 |
|
|
— |
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
1,216 |
|
|
1,400 |
|
|
3,946 |
|
|
4,049 |
|
Depreciation and amortization |
920 |
|
|
923 |
|
|
2,695 |
|
|
4,702 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
51,796 |
|
|
45,787 |
|
|
159,663 |
|
|
91,393 |
|
Loss from operations |
(17,897) |
|
|
(19,110) |
|
|
(54,693) |
|
|
(26,377) |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
38 |
|
|
— |
|
|
42 |
|
|
1 |
|
Interest expense |
(2,343) |
|
|
(311) |
|
|
(6,466) |
|
|
(1,256) |
|
Loss from extinguishment of debts, net |
— |
|
|
— |
|
|
— |
|
|
(968) |
|
Other expense, net |
(62) |
|
|
— |
|
|
(93) |
|
|
— |
|
Loss before income taxes: |
(20,264) |
|
|
(19,421) |
|
|
(61,210) |
|
|
(28,600) |
|
Income tax expense |
12 |
|
|
12 |
|
|
38 |
|
|
33 |
|
Net loss |
$ |
(20,276) |
|
|
$ |
(19,433) |
|
|
$ |
(61,248) |
|
|
$ |
(28,633) |
|
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
Unrealized loss, net of tax |
(203) |
|
|
— |
|
|
(368) |
|
|
— |
|
|
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(20,479) |
|
|
$ |
(19,433) |
|
|
$ |
(61,616) |
|
|
$ |
(28,633) |
|
Net loss per share, basic and diluted |
$ |
(0.36) |
|
|
$ |
(0.35) |
|
|
$ |
(1.09) |
|
|
$ |
(0.60) |
|
Weighted-average shares outstanding used to compute basic and
diluted net loss per share |
56,176,949 |
|
|
55,007,132 |
|
|
55,997,545 |
|
|
47,818,288 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Condensed Consolidated Statements of Stockholders’
Equity
(in thousands, except share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Preferred Stock |
|
Common Stock |
|
Additional
Paid In
Capital |
|
Accumulated
Other Comprehensive Gain (Loss) |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Shares |
|
Amount |
|
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 in connection with the incentive equity
plan |
— |
|
|
— |
|
|
88,222 |
|
|
— |
|
|
11 |
|
|
— |
|
|
— |
|
|
11 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,606 |
|
|
— |
|
|
— |
|
|
1,606 |
|
Net income |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
6,401 |
|
|
6,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2021 |
— |
|
|
$ |
— |
|
|
43,736,971 |
|
|
$ |
1 |
|
|
$ |
392,959 |
|
|
$ |
— |
|
|
$ |
(369,671) |
|
|
$ |
23,289 |
|
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 |
— |
|
|
— |
|
|
209,532 |
|
|
— |
|
|
2,707 |
|
|
— |
|
|
— |
|
|
2,707 |
|
Issuance of common stock in connection with the incentive equity
plan |
— |
|
|
— |
|
|
76,289 |
|
|
— |
|
|
644 |
|
|
— |
|
|
— |
|
|
644 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,887 |
|
|
— |
|
|
— |
|
|
2,887 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(15,601) |
|
|
(15,601) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2021 |
— |
|
|
$ |
— |
|
|
54,372,792 |
|
|
$ |
1 |
|
|
$ |
491,409 |
|
|
$ |
— |
|
|
$ |
(385,272) |
|
|
$ |
106,138 |
|
Issuance of common stock under “at-the-market” (ATM)
program |
|
|
— |
|
|
724,835 |
|
|
— |
|
|
8,203 |
|
|
— |
|
|
— |
|
|
8,203 |
|
Issuance of common stock in connection with the incentive equity
plan |
— |
|
|
— |
|
|
456,165 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,496 |
|
|
— |
|
|
— |
|
|
2,496 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(19,433) |
|
|
(19,433) |
|
Balance at September 30, 2021 |
— |
|
|
$ |
— |
|
|
55,553,792 |
|
|
$ |
1 |
|
|
$ |
502,108 |
|
|
$ |
— |
|
|
$ |
(404,705) |
|
|
$ |
97,404 |
|
Evolus, Inc.
Condensed Consolidated Statements of Stockholders’
Equity
(in thousands, except share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Preferred Stock |
|
Common Stock |
|
Additional
Paid In
Capital |
|
Accumulated
Other Comprehensive Gain (Loss) |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
|
|
|
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 |
— |
|
|
— |
|
|
464,376 |
|
|
— |
|
|
17 |
|
|
— |
|
|
— |
|
|
17 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,959 |
|
|
— |
|
|
— |
|
|
2,959 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(17,501) |
|
|
(17,501) |
|
Other comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(103) |
|
|
— |
|
|
(103) |
|
Balance at March 31, 2022 |
— |
|
|
$ |
— |
|
|
56,041,364 |
|
|
$ |
1 |
|
|
$ |
507,733 |
|
|
$ |
(103) |
|
|
$ |
(440,383) |
|
|
$ |
67,248 |
|
Issuance of common stock in connection with the incentive equity
plan |
— |
|
|
— |
|
|
22,049 |
|
|
— |
|
|
167 |
|
|
— |
|
|
— |
|
|
167 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,979 |
|
|
— |
|
|
— |
|
|
2,979 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(23,471) |
|
|
(23,471) |
|
Other comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(62) |
|
|
— |
|
|
(62) |
|
Balance at June 30, 2022 |
— |
|
|
$ |
— |
|
|
56,063,413 |
|
|
$ |
1 |
|
|
$ |
510,879 |
|
|
$ |
(165) |
|
|
$ |
(463,854) |
|
|
$ |
46,861 |
|
Issuance of common stock in connection with the incentive equity
plan |
— |
|
|
— |
|
|
120,001 |
|
|
— |
|
|
355 |
|
|
— |
|
|
— |
|
|
355 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,483 |
|
|
— |
|
|
— |
|
|
2,483 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(20,276) |
|
|
(20,276) |
|
Other comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(203) |
|
|
— |
|
|
(203) |
|
Balance at September 30, 2022 |
— |
|
|
$ |
— |
|
|
56,183,414 |
|
|
$ |
1 |
|
|
$ |
513,717 |
|
|
$ |
(368) |
|
|
$ |
(484,130) |
|
|
$ |
29,220 |
|
See
accompanying notes to consolidated financial
statements.
Evolus, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
Cash flows from operating activities |
|
|
|
Net loss |
$ |
(61,248) |
|
|
$ |
(28,633) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation and amortization |
2,695 |
|
|
4,702 |
|
Stock-based compensation |
8,421 |
|
|
6,927 |
|
Provision for bad debts |
1,363 |
|
|
501 |
|
|
|
|
|
Amortization of operating lease right-of-use assets |
573 |
|
|
512 |
|
Amortization of debt discount and issuance costs |
805 |
|
|
882 |
|
Paid-in-kind interest on convertible note |
— |
|
|
272 |
|
Deferred income taxes |
(15) |
|
|
— |
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
3,946 |
|
|
4,049 |
|
Loss from extinguishment of debts |
— |
|
|
968 |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
(7,626) |
|
|
(4,110) |
|
Inventories |
(15,283) |
|
|
(7,161) |
|
|
|
|
|
Prepaid expenses |
1,426 |
|
|
344 |
|
Other assets |
2,300 |
|
|
— |
|
Accounts payable |
2,338 |
|
|
(2,312) |
|
Accrued expenses |
(110) |
|
|
14,334 |
|
Accrued litigation settlement |
(15,000) |
|
|
(15,000) |
|
Operating lease liabilities |
(723) |
|
|
(619) |
|
Net cash (used in) provided by operating activities |
(76,138) |
|
|
(24,344) |
|
Cash flows from investing activities |
|
|
|
Purchases of property and equipment |
(752) |
|
|
— |
|
Additions to capitalized software |
(796) |
|
|
(580) |
|
|
|
|
|
Maturities of short-term investments |
— |
|
|
5,000 |
|
Net cash (used in) provided by investing activities |
(1,548) |
|
|
4,420 |
|
Cash flows from financing activities |
|
|
|
Repayment of long term debt |
— |
|
|
(76,323) |
|
Payment of contingent royalty obligation to Evolus
Founders |
(3,169) |
|
|
(2,295) |
|
|
|
|
|
|
|
|
|
Proceeds from follow-on offering, net of underwriters
fees |
— |
|
|
92,426 |
|
Payments for offering costs |
— |
|
|
(214) |
|
Proceeds from ATM sales of shares |
— |
|
|
10,910 |
|
Issuance of common stock in connection with incentive equity
plan |
539 |
|
|
654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
(2,630) |
|
|
25,158 |
|
Effect of exchange rates on cash |
(368) |
|
|
— |
|
Change in cash and cash equivalents |
(80,684) |
|
|
5,234 |
|
Cash and cash equivalents, beginning of period |
146,256 |
|
|
102,562 |
|
Cash and cash equivalents, end of period |
$ |
65,572 |
|
|
$ |
107,796 |
|
See accompanying notes to consolidated financial
statements.
Evolus, Inc.
Condensed Consolidated Statements of Cash Flows
(Continued)
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
Supplemental disclosure of cash flow information |
|
|
|
Cash paid for interest |
$ |
5,651 |
|
|
$ |
79 |
|
Cash paid for income taxes |
$ |
70 |
|
|
$ |
— |
|
Non-cash investing and financing information |
|
|
|
Conversion of convertible note to equity |
$ |
— |
|
|
$ |
39,808 |
|
Issuance of common stock in exchange for accrued 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 Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 and the European
Commission (“EC”) in September 2019. 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, and in Great Britain in September 2022.
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 unaudited condensed consolidated financial
statements have been prepared on a basis
that assumes that the Company will continue as a going
concern. 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 $20,276 and $61,248 for the three and nine months ended
September 30, 2022, respectively. The Company used cash of $76,138
from operations during the nine months ended September 30, 2022,
which includes a settlement payment of $15,000. As of September 30,
2022, the Company had $65,572 in cash and cash equivalents and an
accumulated deficit of $484,130.
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 second tranche of $50,000 may be drawn at the
Company’s election no later than December 31, 2022, subject to the
terms and conditions of the loan agreement. As of September 30,
2022, the Company has not drawn the second tranche. The Company
received net proceeds of $68,695 from Pharmakon, after issuance
costs and debt discounts in December 2021. 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 12 months from the date the
accompanying condensed 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 unaudited condensed consolidated financial
statements have been prepared on a consistent basis with the annual
financial statements and in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) and the
requirements of the Securities and Exchange Commission (“SEC”) for
interim reporting. Pursuant to these SEC rules and regulations, the
Company has condensed or omitted certain financial information and
disclosures normally included in annual financial statements
prepared in accordance with GAAP. In the opinion of management, the
interim
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
consolidated financial statements reflect all adjustments, which
include only normal recurring adjustments, considered necessary for
a fair statement of the interim periods. The interim results
presented herein are not necessarily indicative of the results of
operations to be expected for the full year ending
December 31, 2022 or for any other interim
period.
The accompanying unaudited condensed consolidated financial
statements and related disclosures should be read in conjunction
with the financial statements and notes included in the Company’s
Annual Report on Form 10-K for the year ended December 31,
2021, as filed with the SEC on March 3, 2022.
Principles of Consolidation
The Company’s unaudited condensed 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.
The full impact of current global events, including rising
inflation, volatility in the financial and credit markets, the
COVID-19 pandemic and the Ukrainian-Russian war, is unknown
and cannot be reasonably estimated. However, where possible,
management has considered the potential impact of rising inflation,
volatility in the financial and credit markets, the COVID-19
pandemic, and the Ukrainian-Russian war, and their respective
market impacts, on its estimates and assumptions, and there was not
a material impact to the Company’s condensed consolidated financial
statements as of and for the nine months ended September 30, 2022.
The Company’s future assessment of the impact of these events, as
well as other factors, could result in material impacts to the
Company’s financial statements in future reporting
periods.
Risks and Uncertainties
In 2013, Evolus and Daewoong Pharmaceutical Co. Ltd. (“Daewoong”)
entered into an agreement (the “Daewoong Agreement”), 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, Russia, 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, and in Great Britain in September 2022
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,
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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.
The COVID-19 pandemic continues to evolve, and the severity and
magnitude of future outbreaks, or other similar public health
crises, could result in a period of business disruption and in
reduced sales and operations. In addition, any disruption and
volatility in the global capital markets caused by these or other
events, such as 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.
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 gain (loss) in the Company’s condensed 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 condensed
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.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 Settlement Agreement with respect to such
royalties. In the nine months ended September 30, 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 reviews 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
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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.
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 condensed 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 condensed 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 condensed 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 September 30, 2022.
Contingent Royalty Obligation Payable to 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
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
are determined at each reporting period end and recorded in
operating expenses in the accompanying condensed consolidated
statements of operations and comprehensive loss and as a liability
in the condensed 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 gain (loss) as a
separate component of shareholders’ 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 condensed 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 condensed 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.
The Company recognized $684 and $1,366 of service revenues for the
three and nine months ended September 30, 2022, respectively, and
$0 and $702, respectively, of service revenues for the three and
nine months ended September 30, 2021.
Disaggregation of Revenue
The Company’s disaggregation of revenue is consistent with its
operating segment as disclosed above.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 —
In May 2020, the Company launched 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, 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 September 30, 2022 and December 31, 2021, all
amounts included in accounts receivable, net on the accompanying
condensed consolidated balance sheets are related to contracts with
customers.
The Company did not have any contract assets nor unbilled
receivables as of September 30, 2022 or December 31, 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 condensed consolidated balance
sheets.
As of September 30, 2022 and December 31, 2021, the accrued
revenue contract liabilities, primarily related to volume-based
rebates, consumer loyalty program and co-branded marketing
programs, were $10,188 and $7,934, respectively, which were
recorded in accrued expenses in the accompanying condensed
consolidated balance sheets.
During the nine months ended September 30, 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.
Collectability
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 September 30, 2022 and December 31, 2021,
allowance for doubtful accounts was $3,271 and $2,385,
respectively. For the three and nine months ended September 30,
2022, reversal of and provision for bad debts were $623 and $1,363,
respectively, and the write-off amount was $392 and $477,
respectively. For the three and nine months ended September 30,
2021, provision for bad debts were $188 and $501, respectively, and
the write-off amount was $23 and $214, 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 condensed 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 $15,000 was paid in the
third quarter of 2021 and $15,000 was paid in the first quarter of
2022, and issued 6,762,652 shares of its common stock to Medytox.
In addition, for the period from December 16, 2020 to 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 condensed consolidated statements
of operations and comprehensive loss in the periods the royalties
are incurred.
The settlement agreements resulted in an $83,421 charge for the
fourth quarter of 2020, which consisted of $35,000 in deferred cash
payments and $48,421 from the issuance of 6,762,652 shares of the
Company’s common stock in February
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
2021. In the first quarter of 2022, the Company made the second
cash payment of $15,000 to Medytox and Allergan with the $5,000
balance due in 2023. As of September 30, 2022 and December 31,
2021, a current liability of $5,000 and $15,000, respectively, and
non-current liability of $0 and $5,000, respectively, were recorded
in the accompanying condensed consolidated balance
sheets.
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 condensed
consolidated statements of operations and comprehensive loss for
the nine months ended September 30, 2021. For the period from
December 16, 2020 to September 16, 2022, Daewoong also agreed to
reimburse the Company certain amounts with respect to the royalties
payable to Medytox and Allergan. This reimbursement is received
quarterly and recorded as an offset to the related royalties to
Medytox and Allergan in the product cost of sales on the
accompanying condensed 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 condensed consolidated balance sheets and in
the selling, general and administrative or research and development
expenses in the condensed consolidated statements of operations and
comprehensive loss.
Income Taxes
The Company applies an estimated annual effective tax rate (“ETR”)
approach for calculating a tax provision or benefit for interim
periods, as required under GAAP. The Company recorded an
income tax expense of $12 and $12 for the three months ended
September 30, 2022 and 2021, respectively, and an income tax
expense of $38 and $33 for the nine months ended September 30, 2022
and 2021, respectively. The Company’s ETR differs from the
U.S. federal statutory tax rate of 21% for the three and nine
months ended September 30, 2022 and 2021, primarily as a result of
the impact of the change of the valuation allowance to offset its
deferred tax assets.
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.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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
September 30, 2022 to materially impact its condensed 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. Because the impact of
the options and non-vested RSUs are anti-dilutive during periods of
net loss, there was no difference between the weighted-average
number of shares used to calculate basic and diluted net loss per
common share for the periods presented. Excluded from the dilutive
net loss per share computation for the three and nine months ended
September 30, 2022 and 2021 were stock options of 4,932,632 and
3,873,352, respectively, and non-vested RSUs of 2,638,803 and
1,771,938, respectively, because their inclusion would have been
anti-dilutive. Although these securities were anti-dilutive for
these periods, they could be dilutive in future
periods.
Recently Adopted Accounting 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 financial statements. ASU No. 2021-10 is effective for
financial statements issued for annual periods beginning after
December 15, 2021, with early application permitted. The Company
has adopted this guidance on the effective date of January 1, 2022.
There are no material impacts to the condensed consolidated
financial statements as a result of this adoption.
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 adoption of this guidance will have a material impact on its
consolidated financial statements.
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 No.
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 is in the process of determining the effects the
adoption will have on its consolidated financial statements and
reviewing credit loss models to assess the impact of the adoption
of the standard on the consolidated financial statements. Based on
initial assessments, the Company believes that while adoption will
modify the way it analyzes financial instruments, it does not
expect adoption of this guidance will have a material impact to its
consolidated financial statements.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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. 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2022 |
|
Fair Value |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Liabilities |
|
|
|
|
|
|
|
Contingent royalty obligation payable to Evolus
Founders |
$ |
45,517 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
45,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2021 |
|
Fair Value |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Liabilities |
|
|
|
|
|
|
|
Contingent royalty obligation payable to Evolus
Founders |
$ |
44,740 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
44,740 |
|
The Company did not transfer any assets or liabilities measured at
fair value on a recurring basis between levels during the nine
months ended September 30, 2022 and 2021.
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 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 three and nine months ended September 30, 2022 and 2021, the
Company utilized a discount rate of 13.0%, reflecting the Company’s
risk profile. Net revenue projections are also updated to reflect
changes in the timing of expected sales.
The following table shows a reconciliation of the beginning and
ending fair value measurements of the contingent royalty obligation
payable:
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Fair value, beginning of period |
$ |
45,415 |
|
|
$ |
42,683 |
|
|
$ |
44,740 |
|
|
$ |
41,546 |
|
Payments |
(1,114) |
|
|
(783) |
|
|
(3,169) |
|
|
(2,295) |
|
Change in fair value recorded in operating expenses |
1,216 |
|
|
1,400 |
|
|
3,946 |
|
|
4,049 |
|
Fair value, end of period |
$ |
45,517 |
|
|
$ |
43,300 |
|
|
$ |
45,517 |
|
|
$ |
43,300 |
|
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 the 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 September 30, 2022 and December 31, 2021, the
fair value of long-term debt was $70,360 and $75,448, respectively.
The fair value of operating lease liabilities as of September
30, 2022 and December 31, 2021 approximated their carrying
value.
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Life (Years) |
|
Original Cost |
|
Accumulated Amortization |
|
Net Book Value |
|
Definite-lived intangible assets |
|
|
|
|
|
|
|
|
Distribution right |
20 |
|
$ |
59,076 |
|
|
$ |
(10,806) |
|
|
$ |
48,270 |
|
|
Capitalized software |
2 |
|
8,252 |
|
|
(7,414) |
|
|
838 |
|
|
Intangible assets, net |
|
|
67,328 |
|
|
(18,220) |
|
|
49,108 |
|
|
Indefinite-lived intangible asset |
|
|
|
|
|
|
|
|
Goodwill |
* |
|
21,208 |
|
|
— |
|
|
21,208 |
|
|
Total as of September 30, 2022 |
|
|
$ |
88,536 |
|
|
$ |
(18,220) |
|
|
$ |
70,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Life (Years) |
|
Original Cost |
|
Accumulated Amortization |
|
Net Book Value |
Definite-lived intangible assets |
|
|
|
|
|
|
|
Distribution right |
20 |
|
$ |
59,076 |
|
|
$ |
(8,589) |
|
|
$ |
50,487 |
|
Capitalized software |
2 |
|
7,314 |
|
|
(7,176) |
|
|
138 |
|
Intangible assets, net |
|
|
66,390 |
|
|
(15,765) |
|
|
50,625 |
|
Indefinite-lived intangible asset |
|
|
|
|
|
|
|
Goodwill |
* |
|
21,208 |
|
|
— |
|
|
21,208 |
|
Total as of December 31, 2021 |
|
|
$ |
87,598 |
|
|
$ |
(15,765) |
|
|
$ |
71,833 |
|
* Intangible assets with indefinite lives have an indeterminable
average life.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
The following table outlines the estimated future amortization
expense related to intangible assets held as of September 30,
2022 that are subject to amortization:
|
|
|
|
|
|
|
Fiscal year |
|
|
Remaining in 2022 |
$ |
859 |
|
|
2023 |
3,434 |
|
|
2024 |
3,195 |
|
|
2025 |
2,955 |
|
|
2026 |
2,955 |
|
|
Thereafter |
35,710 |
|
|
|
$ |
49,108 |
|
|
Distribution right represents the license and associated
distribution right to develop Jeuveau®,
the initial term of which expires in September 2023 and is
automatically extended for unlimited additional three-year terms
provided that the Company meets certain performance requirements.
The Company paid Daewoong $3,000 in milestone payments in 2019,
pursuant to the Daewoong Agreement, which increased the cost basis
of the distribution. Under the Daewoong Settlement Agreement (as
defined in Note 11.),
there is no additional cash consideration due to Daewoong.
See
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for additional information.
The Company capitalized $531 and $0 for the three months ended
September 30, 2022 and 2021, respectively, and $938 and $633 for
the nine months ended September 30, 2022 and 2021, respectively,
related to costs of computer software developed for internal use.
The Company recorded total intangible assets amortization expense
of $838 and $843 for the three months ended September 30, 2022 and
2021, respectively, and $2,454 and $4,463 for the nine months ended
September 30, 2022 and 2021, respectively, within depreciation and
amortization on the accompanying condensed consolidated statements
of operations and comprehensive loss.
Note 5. Accrued Expenses
Accrued expenses consisted of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
Accrued royalties under the Medytox/Allergan Settlement
Agreements |
$ |
7,936 |
|
|
$ |
12,447 |
|
|
Accrued payroll and related benefits |
7,094 |
|
|
6,856 |
|
|
Accrued revenue contract liabilities |
10,188 |
|
|
7,934 |
|
|
Other accrued expenses |
4,665 |
|
|
2,756 |
|
|
|
$ |
29,883 |
|
|
$ |
29,993 |
|
|
Note 6. Term Loans
Pharmakon Term Loans
On December 14, 2021, the Company entered into a loan agreement
with Pharmakon. Pursuant to the terms of the agreement, Pharmakon
agreed to make term loans to the Company in two tranches
(“Pharmakon Term Loans”). The first tranche of $75,000 was funded
on December 29, 2021. The second tranche of $50,000 may be drawn at
the Company’s election no later than December 31, 2022, subject to
the terms and conditions of the Pharmakon Term Loans. As of
September 30, 2022, the
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 (“Maturity Date”).
The Pharmakon Term Loans accrue interest at a per annum rate equal
to the greater of 1.0% or 3-month U.S. Dollar LIBOR rate plus 8.5%
per annum. In the event U.S. Dollar LIBOR rate is discontinued, the
interest rate for the Pharmakon Term Loans will be based on an
alternate benchmark rate established in the manner provided under
the loan agreement for the Pharmakon Term Loans. The Company agreed
to make 12 equal quarterly payments of principal on the outstanding
Pharmakon Term Loans commencing on or immediately following the
39th-month anniversary of the funding date of the first tranche
continuing through the Maturity Date.
The Company may elect to prepay all amounts, not less than $20,000,
owed prior to the Maturity Date. Prepayments of the first tranche
prior to the second anniversary of the closing date of the first
tranche and prepayments of the second tranche prior to the second
anniversary of the date on which the second tranche is drawn by the
Company will be accompanied by a make whole amount equal to the sum
of all interest that would have accrued through such second
anniversary. Prepayments of the Pharmakon Term Loans will also be
accompanied by a prepayment premium equal to the principal amount
so prepaid multiplied by 3.0% if made prior to the third
anniversary of the closing date of the first tranche, 2.0% if made
on or after the third anniversary of the closing date of the first
tranche but prior to the fourth anniversary of the closing date of
the first tranche, and 1.0% if made on or after the fourth
anniversary of the closing date of the first tranche but prior to
the Maturity Date. If the Pharmakon Term Loans are accelerated
following the occurrence of an event of default, including a
material adverse change, the Company is required to immediately pay
Pharmakon an amount equal to the sum of all outstanding principal,
unpaid interest, and applicable make whole and prepayment
premiums.
The Pharmakon Term Loans are secured by substantially all of the
Company’s assets. The Pharmakon Term Loans contain customary
affirmative and restrictive covenants and representations and
warranties. The affirmative covenants include, among others,
certain information delivery requirements, obligations to maintain
certain insurance, and certain notice requirements. The restrictive
covenants include, among others, incurring certain additional
indebtedness, consummating certain change in control transactions,
or incurring any non- permitted lien or other encumbrance on the
Company’s assets, without Pharmakon’s prior written consent. The
Pharmakon Term Loans do not contain covenants requiring the Company
to maintain a minimum cash threshold or minimum revenues or
earnings. As of September 30, 2022, the Company was in compliance
with its debt covenants.
At the closing date of the first tranche, the Company incurred
$3,042 and $3,263 in debt discounts and issuance costs related to
the Pharmakon Term Loans, respectively. Debt discounts and issuance
costs related to the entire Pharmakon Term Loans have been
allocated pro rata between the funded and unfunded portions. Debt
discounts and issuance costs allocated to the first tranche of
$75,000 have been presented as a deduction to the debt balance and
are amortized into interest expense using the effective interest
method. As of September 30, 2022, the borrowings outstanding under
the Pharmakon Term Loans were classified as long-term debt in the
accompanying condensed consolidated balance sheets. Debt discounts
and issuance costs associated with the unfunded tranche are
deferred as assets until the tranche is drawn and are amortized
into interest expense using the straight-line method over the term
of the debt. The overall effective interest rate was approximately
12.22% as of September 30, 2022.
As of September 30, 2022, the principal amounts of long-term debt
maturities for each of the next five fiscal years are as
follows:
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
Fiscal year |
|
|
Remainder of 2022 |
$ |
— |
|
|
2023 |
— |
|
|
2024 |
— |
|
|
2025 |
25,000 |
|
|
2026 |
25,000 |
|
|
Thereafter |
25,000 |
|
|
Total principal payments |
75,000 |
|
|
Unamortized debt discounts and issuance costs |
(3,288) |
|
|
Long term debt, net of discounts and issuance costs |
$ |
71,712 |
|
|
Oxford Term Loan
On March 15, 2019, the Company entered into a Loan and Security
Agreement with Oxford (the “Loan Agreement”), providing for a
credit facility of up to $100,000. Pursuant to the terms of the
credit facility, the lender extended term loans (the “Oxford Term
Loan”), available in two advances, to the Company. The first
tranche of $75,000 was funded on the closing date. The second
tranche of $25,000 was not drawn. The credit facility bore an
annual interest rate equal to the greater of 9.5%, or the 30-day
U.S. Dollar LIBOR rate plus 7.0%. The Company agreed to pay
interest-only for the first 36 months until May 2022, followed by a
23-month amortization period.
Upon the earliest to occur of the maturity date, the acceleration
of the Oxford Term Loan, or the prepayment of the Oxford Term Loan,
the Company was required to pay to Oxford a final payment of 5.5%
of the full principal amount of the Oxford Term Loan funded (“Final
Payment”). The Company could elect to prepay all amounts owed prior
to the maturity date, provided that a prepayment fee was also paid,
which would be equal to 2.0% of the amount prepaid if the
prepayment occurred after March 15, 2020 and on or prior to March
15, 2021, or 1.0% of the amount prepaid if the prepayment occurred
thereafter (“Prepayment Fee”).
On January 4, 2021, the Company and Oxford entered into an
agreement (“Payoff Letter”), pursuant to which (i) the Company paid
Oxford $76,447 to discharge in full all outstanding obligations,
including accrued interest, by and between Oxford, in its capacity
as collateral agent and lender, and the Company, and (ii) effective
upon such repayment, the Loan Agreement, and all unfunded
commitments thereunder, guarantees and other security interests
granted to Oxford in connection with the Loan Agreement and all
other obligations of and restrictions on the Company under the Loan
Agreement, terminated. As a condition to entering into the Payoff
Letter, Oxford agreed to waive a total of $4,300 of fees comprised
of (i) $2,800 of the Final Payment and (ii) the Prepayment Fee of
$1,500. As a result, the Company recorded a loss of $1,939 in
extinguishment of debts, net on the accompanying condensed
consolidated statements of operations and comprehensive loss in the
nine months ended September 30, 2021.
Note 7. Daewoong Convertible Note
On July 6, 2020, the Company entered into a Convertible Promissory
Note Purchase Agreement with Daewoong for the principal amount of
$40,000 (the “Daewoong Convertible Note”), which was funded on July
30, 2020. Additionally, on July 6, 2020, the Company, Daewoong and
Oxford entered into a Subordination Agreement pursuant to which the
Daewoong Convertible Note was subordinated to the Company’s
obligations under the Loan Agreement.
The Daewoong Convertible Note bore interest at a rate of 3.0%
payable semi-annually in arrears on June 30th and December 31st of
each year and was to mature on July 30, 2025, subject to earlier
conversion as provided below. Interest was 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 remained outstanding and the Subordination
Agreement was not terminated. Interest became payable in cash after
the Oxford Term Loan was repaid in full, and the Subordination
Agreement was terminated on January 4, 2021.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
On March 23, 2021, the outstanding principal balance including all
accrued and unpaid interest thereon, of $40,779 was converted, at
the conversion price of $13.00 per share, into 3,136,869 shares of
the Company’s common stock under the Conversion Agreement (as
defined in
Note 11.).
The conversion was accounted for as an extinguishment of debt
resulting in a gain of $971, which is recorded in loss from
extinguishment of debts, net on the accompanying condensed
consolidated statements of operations and comprehensive loss. The
Daewoong Convertible Note was not registered, and the shares of the
Company’s common stock issued upon 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. See
Note 11.
Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for the details of the Conversion Agreement.
Note 8. Operating Leases
The Company’s corporate headquarters in Newport Beach, California
is leased under a five-year non-cancelable operating lease, which
expires on January 31, 2025. Lease payments increase each year on
February 1 based on an annual rent escalation clause. The Company
may, under certain circumstances, terminate the lease on the
36-month 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. The Company has an option to extend the term of the
lease for an additional 60 months, which is not recognized as part
of its ROU assets and lease liabilities.
The Company’s lease agreement does not contain any residual value
guarantees or material restrictive covenants. The payments
associated with the renewal will only be included in the
measurement of the lease liability and ROU assets if the exercise
of the renewal option is determined to be reasonably certain. The
Company considers the timing of the renewal period and other
economic factors such as the financial implications of a decision
to extend or not to extend a lease in determining if
the renewal option is reasonably certain to be
exercised.
The components of operating lease expense are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Fixed operating lease expense |
$ |
273 |
|
|
$ |
268 |
|
|
$ |
811 |
|
|
$ |
797 |
|
Variable operating lease expense |
18 |
|
|
20 |
|
|
65 |
|
|
40 |
|
|
|
|
|
|
|
|
|
|
$ |
291 |
|
|
$ |
288 |
|
|
$ |
876 |
|
|
$ |
837 |
|
The weighted-average remaining lease term and discount rate are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, |
|
2022 |
|
2021 |
Weighted-average remaining lease term (years) |
2.3 |
|
3.3 |
Weighted-average discount rate |
9.4 |
% |
|
9.4 |
% |
Operating lease expenses were included in the selling, general
and administrative expenses in the accompanying condensed
consolidated statements of operations and comprehensive loss.
Operating lease right-of-use assets and related current and
noncurrent operating lease liabilities are presented in the
accompanying condensed consolidated balance sheets.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
The following table presents the future minimum payments under the
operating lease agreements with non-cancelable terms as of
September 30, 2022:
|
|
|
|
|
|
Fiscal year |
|
Remainder of 2022 |
$ |
318 |
|
2023 |
1,320 |
|
2024 |
1,377 |
|
2025 |
115 |
|
2026 |
— |
|
Total operating lease payments |
3,130 |
|
Less: imputed interest |
(332) |
|
Present value of operating lease liabilities |
$ |
2,798 |
|
Note 9. Commitments and
Contingencies
Purchase Commitments
As of September 30, 2022, the Company has entered into commitments
to purchase services and products for an aggregate amount of
approximately $1,074. Certain minimum purchase commitments related
to the purchase of Jeuveau®
are described below.
License and Supply Agreement
The Daewoong Agreement includes certain minimum annual purchases
that the Company is required to make in order to maintain the
exclusivity of the license. The Company may, however, meet these
minimum purchase obligations by achieving certain market share in
the licensed territories. These potential minimum purchase
obligations are contingent upon the occurrence of future events,
including receipt of governmental approvals and the Company’s
future market share in various jurisdictions.
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 the Company and certain of its
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 the Company’s
acquisition of the right to sell Jeuveau®,
the complaint against the Company 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 the
Company, three of its officers, and Alphaeon Corporation, the
Company’s former majority shareholder. On January 18, 2022, the
Company and the officer defendants served their 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 the Company 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 the Company’s officers
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
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 the Company and/or
its officers and directors as defendants. The Company believes 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 the
Company at present, management cannot reasonably estimate a range
of loss with respect to this matter.
Books and Records Demand
On March 5, 2021, the Company received a letter from a putative
stockholder demanding inspection of specified categories of the
Company’s books and records under Section 220 of the Delaware
General Corporations Law. The Company was subsequently informed
that the stockholder sold his shares of the Company’s common stock.
On October 13, 2021, the Company received a substantially similar
demand to inspect specified categories of the Company’s 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. The Company
responded to the demand in December 2021. The outcome of this
matter is uncertain at this point. Based on information available
to the Company at present, management cannot reasonably estimate a
range of loss with respect to this matter.
Other Legal Matters
The Company is, from time to time, involved in various litigation
matters or regulatory encounters arising in the ordinary course of
business that could result in unasserted or asserted claims or
litigation. These other matters may raise difficult and complex
legal issues and are subject to many uncertainties, including, but
not limited to, the facts and circumstances of each particular case
or claim, the jurisdiction in which each suit or regulatory
encounter is brought, and differences in applicable laws and
regulations. Except as set forth above, the Company does not
believe that these other matters would have a material adverse
effect on its accompanying financial position, results of
operations or cash flows. However, the resolution of one or more of
the other matters in any reporting period could have a material
adverse impact on the Company’s financial results for that
period.
In the normal course of business, the Company enters into contracts
and agreements that contain a variety of representations and
warranties and provide for general indemnifications. The Company’s
exposure under these agreements is unknown because they involve
claims that may be made against the Company in the future, but have
not yet been made. The Company accrues a liability for such matters
when it is probable that future expenditures will be made, and such
expenditures can be reasonably estimated. No amounts were accrued
as of September 30, 2022 and December 31, 2021.
Note 10. Stockholders’ Equity
Preferred Stock
The Company has 10,000,000 authorized shares of preferred stock
with a par value of $0.00001 per share. As of September 30, 2022,
no shares of its preferred stock were issued and
outstanding.
Common Stock
The Company has 100,000,000 authorized shares of common stock with
a par value of $0.00001 per share. As of September 30, 2022,
56,183,414 shares of its common stock were issued and
outstanding.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
On February 28, 2021, the Company issued 6,762,652 shares of its
common stock to Medytox pursuant to the Share Issuance Agreement.
See
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
for additional information.
On March 25, 2021, the Company issued 3,136,869 shares of its
common stock to Daewoong in connection with the conversion of
Daewoong Convertible Note. See
Note 7. Daewoong Convertible Note
for additional information.
“At-the-market” Offerings of Common Stock
On March 26, 2021, the Company entered into an “at-the-market”
sales agreement with SVB Leerink LLC (the “Sales Agent”) pursuant
to which shares of the Company’s common stock could be sold from
time to time for aggregate gross proceeds of up to $75,000 (the
“ATM Program”). The Sales Agent was entitled to compensation, at a
commission rate equal to 3.0% of the gross proceeds from sales of
the Company’s common shares under the ATM Program. Since August
2021, the Company has not sold any shares under the ATM Program and
the Company terminated the ATM Program in May 2022.
For the three months ended September 30, 2021, the Company sold a
total of 724,835 shares of its common stock pursuant to the ATM
Program at the prevailing market prices for total net proceeds of
$8,203 and paid total commissions of $254 to the Sales Agent. For
the nine months ended September 30, 2021, the Company sold a total
of 934,367 shares of its common stock pursuant to the ATM Program
at the prevailing market prices for a total net proceeds of $10,910
and paid total commissions of $337 to the Sales Agent.
2017 Omnibus Incentive Plan and Stock-based Compensation
Allocation
The Company’s 2017 Omnibus Incentive Plan (the “Plan”) provides for
the grant of incentive options to employees of the Company, and for
the grant of non-statutory options, restricted stock awards,
restricted stock unit awards, stock appreciation rights,
performance stock awards and other forms of stock compensation to
the Company’s officers, directors, consultants and employees of the
Company. The maximum number of shares of common stock that may be
issued under the Plan is 4,361,291 shares, plus an annual increase
on each anniversary of November 21, 2017 equal to 4.0% of the total
issued and outstanding shares of the Company’s common stock as of
such anniversary (or such lesser number of shares as may be
determined by the Company’s Board of Directors). As of September
30, 2022, the Company had an aggregate of 1,447,855 shares of its
common stock available for future issuance under the
Plan.
Inducement Grants
From time to time, the Company has granted equity awards to its
newly hired employees, including executives, in accordance with
Nasdaq Listing Rule 5635(c)(4) and outside of the Company’s Plan.
Such grants were made pursuant to a stand-alone nonstatutory stock
option agreement and a stand-alone RSU agreement, which were
approved by the Compensation Committee of the Board of Directors.
Any shares underlying the inducement grants are not, upon
forfeiture, cancellation or expiration, returned to a pool of
shares reserved for future issuance.
In February 2022, the Company granted options to purchase 171,103
shares of common stock and 39,012 RSUs as a material inducement for
the employment of the Senior Vice President of Corporate
Development. In September 2022, the Company granted options to
purchase 169,158 shares of common stock and 36,443 RSUs as a
material inducement for the employment of the Chief Financial
Officer. As of September 30, 2022, stock options to purchase
340,261 shares of common stock and 75,455 RSUs remained outstanding
outside of the Plan.
Stock-Based Award Activity and Balances
Options are granted at exercise prices based on the Company’s
common stock price on the date of grant. The options and RSU grants
generally vest over a
one- to four-year period. There have been no awards granted
with performance conditions or market conditions for the periods
presented. The options have a contractual term of ten years. The
fair value of options is estimated using the Black-Scholes option
pricing model, which has various inputs, including the grant date
common share price, exercise price, risk-free interest rate,
volatility, expected life and dividend yield. The change of any of
these inputs could significantly impact the determination of the
fair value of the Company’s options as well as significantly impact
its results of operations. The fair value of RSU grants is
determined at the grant date based on the common share price. The
Company records stock-based compensation expense net of actual
forfeitures when they occur.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
The weighted-average assumptions used in determining the fair value
of stock options granted were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Volatility |
83.8 |
% |
|
79.6 |
% |
|
78.6 |
% |
|
78.9 |
% |
Risk-free interest rate |
3.25 |
% |
|
1.12 |
% |
|
1.92 |
% |
|
1.16 |
% |
Expected life (years) |
6.25 |
|
6.25 |
|
6.19 |
|
6.25 |
Dividend yield rate |
— |
% |
|
— |
% |
|
— |
% |
|
— |
% |
A summary of stock option activity for the nine months ended
September 30, 2022, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Stock |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
Options |
|
Per Share |
|
Terms (Years) |
|
Value |
|
Outstanding, December 31, 2021 |
3,922,286 |
|
|
$ |
11.23 |
|
|
7.10 |
|
$ |
455 |
|
|
Granted
|
1,665,786 |
|
|
6.74 |
|
|
|
|
|
|
Exercised
|
(53,098) |
|
|
10.08 |
|
|
|
|
|
|
Canceled/forfeited
|
(602,342) |
|
|
14.17 |
|
|
|
|
|
|
Outstanding, September 30, 2022 |
4,932,632 |
|
|
$ |
9.37 |
|
|
7.23 |
|
$ |
4,245 |
|
|
Exercisable, September 30, 2022 |
2,860,912 |
|
|
$ |
10.35 |
|
|
6.01 |
|
$ |
1,338 |
|
|
The aggregate intrinsic value of outstanding and exercisable
options represents the excess of the fair market value of the
Company’s common stock over the exercise price of underlying
options as of September 30, 2022 and December 31,
2021.
A summary of RSU activity for the nine months ended September 30,
2022, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Grant Date |
|
Restricted |
|
Fair Value |
|
Stock Units |
|
Per Share |
Outstanding, December 31, 2021 |
1,926,467 |
|
|
$ |
8.06 |
|
Granted |
1,667,320 |
|
|
6.88 |
|
Vested |
(553,328) |
|
|
8.22 |
|
Forfeited |
(401,656) |
|
|
6.88 |
|
Outstanding, September 30, 2022 |
2,638,803 |
|
|
$ |
7.46 |
|
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
The following table summarizes stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Selling, general and administrative |
$ |
2,398 |
|
|
$ |
2,399 |
|
|
$ |
8,236 |
|
|
$ |
6,784 |
|
Research and development |
85 |
|
|
77 |
|
|
185 |
|
|
143 |
|
|
$ |
2,483 |
|
|
$ |
2,476 |
|
|
$ |
8,421 |
|
|
$ |
6,927 |
|
Note 11. Medytox/Allergan Settlement Agreements and Daewoong
Arrangement
Medytox/Allergan Settlement Agreements
U.S. Settlement Agreement
Effective February 18, 2021, the Company, Allergan and Medytox
entered into a Settlement and License Agreement (the “U.S.
Settlement Agreement”), pursuant to which, among other things: (i)
Allergan and Medytox agreed to file a petition requesting the
remedial orders related to the ITC Action be rescinded with respect
to the Company; (ii) Medytox agreed to dismiss substantially
similar litigation in California against the Company; (iii) the
Company, on the one hand, and Medytox and Allergan, on the other
hand, agreed to mutually release certain claims they may have
against one another and their respective affiliates; (iv) Allergan
and Medytox granted to the Company and its agents a license to
manufacture and commercialize certain products identified in the
U.S. Settlement Agreement, including Jeuveau®
(the “Licensed Products”), in the United States during the 21 month
period that, pursuant to the ITC Action, the Company was restricted
from, among other things, selling, marketing, or promoting such
imported Jeuveau®
in the United States (the “Restricted Period”); (v) the Company
agreed to pay to Allergan and Medytox $35,000 in multiple payments
over two years, of which the Company paid the first cash payment of
$15,000 in the third quarter of 2021 and the second cash payment of
$15,000 in the first quarter of 2022; and (vi) during the
Restricted Period, the Company agreed to pay to Allergan and
Medytox certain confidential royalties on the sale of Licensed
Products, calculated on dollar amount per vial sold of Licensed
Products by or on behalf of the Company in the United States.
Royalties for sales during the Restricted Period ended on September
16, 2022.
ROW Settlement Agreement
Effective February 18, 2021, the Company and Medytox entered into a
Settlement and License Agreement (the “ROW Settlement Agreement”
and, together with the U.S. Settlement Agreement, the
“Medytox/Allergan Settlement Agreements”), pursuant to which, among
other things: (i) the Company and Medytox agreed to mutually
release certain claims they may have against one another and their
respective affiliates; (ii) Medytox granted to the Company and its
agents a license to manufacture and commercialize the Licensed
Products, in Canada, the European Union, Switzerland, member
countries and cooperating countries of the European Economic Area,
Russia, certain members of the Commonwealth of Independent States,
South Africa, Australia and Japan (the “ROW Territories”) during
the Restricted Period; (iii) Medytox granted to the Company and its
agents a fully paid up license to manufacture and commercialize the
Licensed Products in the ROW Territories and the United States from
the end of the Restricted Period (the “Medytox License Period”);
(iv) the Company and Medytox agreed to enter into the Share
Issuance Agreement (as defined below) pursuant to which the Company
issued 6,762,652 shares (the “Settlement Shares”) of the Company’s
common stock, par value $0.00001 per share, to Medytox; (v) the
Company and Medytox agreed to enter into the Registration Rights
Agreement (as defined below), pursuant to which the Company granted
certain registration rights to Medytox with respect to the
Settlement Shares; (vi) during the Restricted Period that ended
September 16, 2022, the Company agreed to pay Medytox a
confidential low-double digit royalty on net sales of the Licensed
Products sold by or on behalf of the Company in the ROW
Territories; and (vii) during the Medytox License Period from
September 17, 2022 to September 16, 2032, the Company agreed to pay
Medytox a confidential mid-single digit royalty percentage on net
sales of the Licensed Products sold by or on behalf of the Company
in the United States and the ROW Territories.
Share Issuance Agreement
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
In connection with the execution of the ROW Settlement Agreement,
the Company and Medytox entered into a Share Issuance Agreement
effective February 18, 2021 (the “Share Issuance Agreement”).
Pursuant to the Share Issuance Agreement and subject to the terms
and conditions set forth therein, among other things, the Company
issued to Medytox the Settlement Shares to enter into the ROW
Settlement Agreement and in consideration for Medytox’s
representations, warranties, and other agreements set forth in the
Share Issuance Agreement. The Settlement Shares are subject to
contractual restrictions on transfer that, subject to certain
limited exceptions such as transfers to affiliates, prevented
Medytox from transferring any shares of common stock prior to
February 16, 2022 and, thereafter, 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.
Registration Rights Agreement
In connection with the execution of the ROW Settlement Agreement,
the Company and Medytox also entered into a Registration Rights
Agreement effective February 18, 2021 (the “Registration Rights
Agreement”). Pursuant to the Registration Rights Agreement, among
other things, the Company agreed, after March 31, 2022, (i) to
comply with certain requests by Medytox to register for sale, under
the Securities Act, the Settlement Shares, and (ii) to include the
Settlement Shares in certain registrations by the Company of its
securities for sale under the Securities Act, to the extent
requested by Medytox, in each case subject to certain customary
conditions, exceptions and limitations as set forth in the
Registration Rights Agreement.
In addition, Medytox’s registration rights under the Registration
Rights Agreement will terminate at such time that Medytox is able
to sell all of the Settlement Shares over a three-month period, or
less, pursuant to an exemption to registration under the Securities
Act.
As of September 30, 2022, the Company accrued $7,936 for royalties
under the Medytox/Allergan Settlement Agreements and $5,000 of
accrued litigation settlement expense. As of December 31,
2021, the Company accrued $12,447 for royalties under the
Medytox/Allergan Settlement Agreements and $20,000 of accrued
litigation settlement expense.
Daewoong Arrangement
Daewoong Settlement Agreement
On March 23, 2021, the Company and Daewoong entered into a
Confidential Settlement and Release Agreement (the “Daewoong
Settlement Agreement”), pursuant to which, among other things: (i)
Daewoong agreed to (a) pay to the Company an amount equal to
$25,500, which the Company received in April 2021, (b) pay certain
legal fees incurred by the Company’s litigation counsel in
connection with its defense of the ITC Action (including any appeal
of the resulting remedial orders), (c) cancel all remaining
milestone payments totaling $10,500 in aggregate, and (d) reimburse
the Company certain amounts (calculated on a dollar amount per
vials sold basis in the United States) for sales of certain
products with respect to which the Company is required to pay
Medytox and Allergan royalties pursuant to the U.S. Settlement
Agreement; and (ii) the Company agreed to (a) release, on behalf of
itself and certain of its affiliates and representatives, certain
claims they may have against Daewoong related to the allegations
made in or the subject matter of the Medytox/Allergan Actions, or
any orders, remedies and losses resulting from the Medytox/Allergan
Actions, and (b) coordinate with Daewoong on certain matters
related to the Medytox/Allergan Actions.
Conversion Agreement
In connection with the execution of the Daewoong Settlement
Agreement, the Company and Daewoong also entered into a Convertible
Promissory Note Conversion Agreement (the “Conversion Agreement”),
pursuant to which, among other things, (i) the principal balance
under the Daewoong Convertible Note, together with all accrued and
unpaid interest thereon, in the amount of $40,779 was converted, at
the conversion price of $13.00 per share, into 3,136,869 shares of
Common Stock; and (ii) the Daewoong Convertible Note was deemed
cancelled and satisfied in full in connection with such
conversion.
After the conversion, shares owned by Daewoong, together with its
affiliates and attribution parties, did not exceed 9.99% of the
Company’s then outstanding common shares immediately following such
issuance, as required under the terms of the Daewoong Convertible
Note.
Evolus, Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
Daewoong Agreement Amendment
In connection with the execution of the Daewoong Settlement
Agreement, on March 23, 2021, the Company and Daewoong also entered
into the Third Amendment to the Supply Agreement (the “Daewoong
Agreement Amendment”). Pursuant to the Daewoong Agreement
Amendment, the parties amended the Daewoong Agreement to (i) expand
the territory within which the Company may distribute
Jeuveau®
to certain countries in Europe, (ii) reduce the period of time with
respect to which the Company is required to deliver binding
forecasts to Daewoong, (iii) introduce certain limitations on
Daewoong’s ability to convert the Company’s exclusive license for
certain territories to a non-exclusive license in the event the
Company fails to meet certain minimum purchase requirements for
such territory, (iv) adjust the minimum purchase requirements and
reduce the transfer price per vial of Jeuveau®
applicable to various territories, (v) require that any
Jeuveau®
supplied by Daewoong match certain shelf-life thresholds, and (vi)
prohibit the Company from sharing certain confidential information
of Daewoong with Medytox or its affiliates or
representatives.
As of September 30, 2022 and December 31, 2021, the Company
had $3,257 and $5,657, respectively, in reimbursement receivable
from Daewoong, respectively, in other current assets in the
accompanying condensed consolidated balance sheets. Total inventory
payments to Daewoong were $14,238 and $40,509 for the three and
nine months ended September 30, 2022, respectively. Total inventory
payments to Daewoong were $10,916 and $24,576 for the three and
nine months ended September 30, 2021.
Item 2. 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 results of operations and
should be read together with the unaudited condensed consolidated
financial statements and the notes thereto included 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,
2021 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 Part II 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 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 and we are finalizing plans for
entering additional countries in Europe as part of a phase rollout.
We received acceptance of our submission to the Australian
Therapeutics Good Administration, or TGA, for regulatory approval
of our neurotoxin product in Australia in the first quarter of
2022. We expect to receive full TGA regulatory approval and launch
the product in Australia in 2023.
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. We anticipate completing the
study in the first 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 ROW Settlement Agreement. We refer to the U.S. Settlement
Agreement and the ROW Settlement Agreement collectively as the
Medytox/Allergan Settlement Agreements.
Under the Medytox/Allergan Settlement Agreements, we agreed to (i)
make cash payments of $35.0 million in multiple payments over two
years to Allergan and Medytox,
of which we paid the first payment of
$15.0 million
in the third quarter of 2021 and the second payment of $15.0
million in the first quarter of 2022,
with the final payment of $5.0 million due in 2023, (ii) pay to
Allergan and Medytox 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 to
September 16, 2022, (iii) from December 16, 2020 to September 16,
2022, pay Medytox 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) from September 17, 2022 to September 16, 2032, 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. We also issued 6,762,652 shares of our common
stock to Medytox.
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 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. 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/Allergan Settlement Agreements, after giving
effect to the offset of a certain portion thereof that will be
reimbursed to us under the Daewoong Settlement Agreement, our cost
of sales and gross profit margin has been materially negatively
impacted through September 2022 and will be negatively impacted to
a lesser 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. The second
tranche of $50.0 million may be drawn at our election no later than
December 31, 2022, subject to the terms and conditions of the
Pharmakon Term Loans. As of September 30, 2022, 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 to Evolus Founders
We are obligated to make quarterly royalty payments of a low single
digit percentage of net sales of Jeuveau®
to the founders of Evolus, which we refer to as the Evolus
Founders. 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.
Market Trends and Uncertainties
The global economy, including the financial and credit markets, has
recently experienced extreme volatility and disruptions, including
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 remainder of fiscal 2022
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 condensed
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
(in millions) |
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
Total net revenues |
$ |
33.9 |
|
|
$ |
26.7 |
|
|
$ |
105.0 |
|
|
$ |
65.0 |
|
|
|
|
|
Cost of sales: |
|
|
|
|
|
|
|
|
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
13.5 |
|
|
11.5 |
|
|
42.5 |
|
|
27.7 |
|
|
|
|
|
Settlement payment from Daewoong |
— |
|
|
— |
|
|
— |
|
|
(25.5) |
|
|
|
|
|
Amortization of distribution right intangible asset |
0.7 |
|
|
0.7 |
|
|
2.2 |
|
|
2.2 |
|
|
|
|
|
Total cost of sales |
14.2 |
|
|
12.2 |
|
|
44.7 |
|
|
4.4 |
|
|
|
|
|
Gross profit |
19.7 |
|
|
14.5 |
|
|
60.2 |
|
|
60.6 |
|
|
|
|
|
Gross profit margin |
58.0 |
% |
|
54.2 |
% |
|
57.4 |
% |
|
93.2 |
% |
|
|
|
|
Add: Settlement payment from Daewoong |
— |
|
|
— |
|
|
— |
|
|
(25.5) |
|
|
|
|
|
Add: Amortization of distribution right intangible
asset |
0.7 |
|
|
0.7 |
|
|
2.2 |
|
|
2.2 |
|
|
|
|
|
Adjusted gross profit |
$ |
20.4 |
|
|
$ |
15.2 |
|
|
$ |
62.5 |
|
|
$ |
37.3 |
|
|
|
|
|
Adjusted gross profit margin |
60.2 |
% |
|
56.9 |
% |
|
59.5 |
% |
|
57.4 |
% |
|
|
|
|
Results of Operations
Comparison of the Three Months Ended September 30, 2022 and
2021
The following table summarizes our consolidated results of
operations for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
|
(in millions) |
2022 |
|
2021 |
|
|
Product revenue, net |
$ |
33.2 |
|
|
$ |
26.7 |
|
|
|
Service revenue |
0.7 |
|
|
— |
|
|
|
Total net revenues |
33.9 |
|
|
26.7 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
13.5 |
|
|
11.5 |
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
34.8 |
|
|
31.7 |
|
|
|
Research and development |
1.4 |
|
|
0.3 |
|
|
|
|
|
|
|
|
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
1.2 |
|
|
1.4 |
|
|
|
Depreciation and amortization |
0.9 |
|
|
0.9 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
51.8 |
|
|
45.8 |
|
|
|
Loss from operations |
(17.9) |
|
|
(19.1) |
|
|
|
Other income (expense): |
|
|
|
|
|
Non operating expense, net |
(2.3) |
|
|
(0.3) |
|
|
|
|
|
|
|
|
|
Other expense, net |
(0.1) |
|
|
— |
|
|
|
Loss before income taxes: |
(20.3) |
|
|
(19.4) |
|
|
|
Income tax expense |
0.0 |
|
|
0.0 |
|
|
|
Net loss |
$ |
(20.3) |
|
|
$ |
(19.4) |
|
|
|
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 $7.2 million, or 27.0%, to $33.9 million for the
three months ended September 30, 2022 from $26.7 million for the
three months ended September 30, 2021, primarily due to higher
sales volumes. Net revenues during the three months ended September
30, 2022 included $0.7 million of service revenue. 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
includes 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 Settlement Agreement 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 $2.0 million, or 17.4%, to $13.5 million for the three
months ended September 30, 2022 from $11.5 million for the three
months ended September 30, 2021, primarily due to higher sales
volume. We anticipate that our product cost of sales will fluctuate
in line with changes in revenues.
Gross Profit Margin
Our gross profit margin was 58.0% and 54.2% for the three months
ended September 30, 2022 and 2021, respectively. Our adjusted gross
profit margin, calculated as total net revenues less product cost
of sales, excluding amortization of intangible assets, as a
percentage of net revenues was 60.2% and 56.9% for the three months
ended September 30, 2022
and 2021, respectively. Our gross profit margin and adjusted gross
profit margin were impacted negatively from royalty obligations
from December 2020 through September 2022, offset by payments we
receive under the Daewoong Settlement Agreement. Beginning on
September 17, 2022, our gross profit margin and adjusted gross
profit margin began to increase as royalty obligations to Allergan
concluded on September 16, 2022, and our royalty obligations to
Medytox were reduced to a mid-single digit percentage of net
revenue for ten years thereafter. We 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 $3.1
million, or 9.8%, to $34.8 million for the three months ended
September 30, 2022 from $31.7 million for the three months ended
September 30, 2021, primarily resulting from increasing personnel
costs and increasing commercial activities, offset by a decrease in
marketing related expenses. 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 $1.1 million, or
366.7%, to $1.4 million for the three months ended September 30,
2022 from $0.3 million for the three months ended September 30,
2021, primarily from 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.
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,
2022 and 2021, the revaluation charges of $1.2 million and $1.4
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 for the three months ended September
30, 2022 and 2021 was $0.9 million.
Non-Operating Expense, Net
Non-operating expense, net, increased by $2.0 million, or 641.2%,
to $2.3 million for the three months ended September 30, 2022 from
$0.3 million for the three months ended September 30, 2021,
primarily due to higher interest expense for the Pharmakon Term
Loans. The interest on Pharmakon Term Loans is based on a variable
interest rate, which will continue to result in higher interest
expense in the rising interest rate environment.
Income Taxes Expense
There was minimal income tax expense for the three months ended
September 30, 2022 and 2021.
Comparison of the Nine Months Ended September 30, 2022 and
2021
The following table summarizes our consolidated results of
operations for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
|
(in millions) |
2022 |
|
2021 |
|
|
Product revenue, net |
$ |
103.6 |
|
|
$ |
64.3 |
|
|
|
Service revenue |
1.4 |
|
|
0.7 |
|
|
|
Total net revenues |
105.0 |
|
|
65.0 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Product cost of sales (excludes amortization of intangible
assets) |
42.5 |
|
|
27.7 |
|
|
|
Settlement payment from Daewoong |
— |
|
|
(25.5) |
|
|
|
Selling, general and administrative |
105.1 |
|
|
78.8 |
|
|
|
Research and development |
3.4 |
|
|
1.6 |
|
|
|
In-process research and development |
2.0 |
|
|
— |
|
|
|
Revaluation of contingent royalty obligation payable to Evolus
Founders |
3.9 |
|
|
4.0 |
|
|
|
Depreciation and amortization |
2.7 |
|
|
4.7 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
159.7 |
|
|
91.4 |
|
|
|
Loss from operations |
(54.7) |
|
|
(26.4) |
|
|
|
Other income (expense): |
|
|
|
|
|
Non operating expense, net |
(6.4) |
|
|
(1.3) |
|
|
|
Loss from extinguishment of debts, net |
— |
|
|
(1.0) |
|
|
|
Other expense, net |
(0.1) |
|
|
— |
|
|
|
Loss before income taxes: |
(61.2) |
|
|
(28.6) |
|
|
|
Income tax expense |
0.0 |
|
|
0.0 |
|
|
|
Net loss |
$ |
(61.2) |
|
|
$ |
(28.6) |
|
|
|
Net Revenues
Net revenues of Jeuveau®
sales increased by $40.0 million, or 61.5%, to $105.0 million for
the nine months ended September 30, 2022 from $65.0 million for the
nine months ended September 30, 2021, primarily due to higher sales
volumes and a slightly higher average selling price of
Jeuveau®
in the United States. Net revenues during the first quarter of 2021
were negatively impacted prior to entering into the
Medytox/Allergan Settlement Agreements in February 2021 due to an
increase in pricing during the presidential review period related
to the ITC Action. 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,
increased by $14.8 million, or 53.4%, to $42.5 million for the nine
months ended September 30, 2022 from $27.7 million for the nine
months ended September 30, 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 57.4% and 93.2% for the nine months
ended September 30, 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 payment from Daewoong, as a percentage of net
revenues was 59.5% and 57.4% for the nine months ended September
30, 2022 and 2021, respectively. Our gross profit margin and
adjusted gross profit margin were impacted negatively from royalty
obligations through September 2022, offset by payments we receive
under the Daewoong Settlement Agreement. Beginning on September 17,
2022, our gross profit margin and adjusted gross profit margin
began to increase as our royalty obligations to Allergan concluded
on September 16, 2022, and our royalty obligations to Medytox were
reduced to a mid-single digit percentage of net revenue for ten
years thereafter. We 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 $26.3
million, or 33.4%, to $105.1 million for the nine months ended
September 30, 2022 from $78.8 million for the nine months ended
September 30, 2021, primarily resulting from increasing personnel
costs and increasing our 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 $1.8 million, or
112.5%, to $3.4 million for the nine months ended September 30,
2022 from $1.6 million for the nine months ended September 30,
2021, primarily from increasing our clinical operations and
research and development expense 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 nine months ended September 30,
2022 and 2021, the revaluation charges of $3.9 million and $4.0
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 $2.0 million, or 42.6%,
to $2.7 million for the nine months ended September 30, 2022 from
$4.7 million for the nine months ended September 30, 2021 due to
the decrease in amortization of internal-use software as most of
these assets are now fully amortized in 2021.
Non-Operating Expense, Net
Non-operating expense, net, increased by $5.2 million, or 400.0%,
to $6.5 million for the nine months ended September 30, 2022 from
$1.3 million for the nine months ended September 30, 2021,
primarily due to higher interest expense for the Pharmakon Term
Loans.
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
There was minimal income tax expense for the nine months ended
September 30, 2022 and 2021.
Liquidity and Capital Resources
As of September 30, 2022 we had cash and cash equivalents of $65.6
million, positive working capital of $64.7 million and
stockholders’ equity of $29.2 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 have an accumulated deficit of $484.1 million
as of September 30, 2022 as a result of ongoing efforts to develop
and commercialize Jeuveau®,
including providing selling, general and administrative support for
these operations. We had net loss of $61.2 million and $28.6
million for the nine months ended September 30, 2022 and 2021,
respectively. We had net loss from operations of $54.7 million and
$26.4 million for the nine months ended September 30, 2022 and
2021, respectively. We used net cash of $76.1 million and $24.3
million in operating activities for the nine months ended September
30, 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. and Europe 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. The second tranche
of $50.0 million may be drawn at our election no later than
December 31, 2022. We received net proceeds of approximately $68.7
million from Pharmakon, after issuance costs and debt discounts. As
of September 30, 2022, 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 six-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 to Evolus Founders
We are obligated to make quarterly royalty payments of a low-single
digit percentage of net sales of Jeuveau®
to Evolus Founders. The 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 condensed consolidated
financial statements as the contingent royalty
obligation.
As of September 30, 2022, we recorded an aggregate balance of
$45.5 million on our balance sheet for the future royalty
payment obligation to Evolus Founders.
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 the first
payment of
$15.0 million
in the third quarter of 2021,
$15.0 million in the first quarter of 2022,
and have
$5.0 million
due in the next twelve months. We also issued 6,762,652 shares of
common stock to Medytox. In addition, during the period from
December 16, 2020 to 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 will be made quarterly.
As described in “—Overview—Impact of Settlement Agreements,”
on March 23, 2021, upon entering the
Daewoong Settlement Agreement, Daewoong paid us $25.5 million in
April 2021, cancelled all remaining milestone payments
up
to $10.5 million in aggregate under the Daewoong Agreement 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, as well as the
public debt and equity markets, will be sufficient to satisfy both
our short-term and long-term cash requirements for working capital
to support our daily operations and meet commitments under our
contractual obligations with third parties. This includes our
obligation to make a $5.0 million payment in the first quarter of
2023 pursuant to the Medytox/Allergan Settlement Agreements (see
“—Litigation Settlement” above).
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
resulting from the COVID-19 pandemic, 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;
•the
number and characteristics of any future product candidates we
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/Allergan Settlement
Agreements;
•the
amounts of the royalty payable to 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, 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
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
(in millions) |
2022 |
|
2021 |
Net cash (used in) provided by: |
|
|
|
Operating activities
|
$ |
(76.1) |
|
|
$ |
(24.3) |
|
Investing activities
|
(1.5) |
|
|
4.4 |
|
Financing activities
|
(2.6) |
|
|
25.2 |
|
Effect of exchange rates on cash |
(0.4) |
|
|
— |
|
Change in cash and cash equivalents |
(80.7) |
|
|
5.2 |
|
Cash and cash equivalents, beginning of period |
146.3 |
|
|
102.6 |
|
Cash and cash equivalents, end of period |
$ |
65.6 |
|
|
$ |
107.8 |
|
Operating Activities
For the nine months ended September 30, 2022, operating activities
used $76.1 million of cash, which primarily resulted from our net
loss of $61.2 million. Net operating assets and liabilities changed
by $32.7 million primarily driven by timing of collections from
customers, payments to vendors and the second cash payment of
litigation settlement of $15.0 million to Medytox and Allergan in
the first quarter of 2022. Operating activities also includes
adjustments for certain non-cash charges including $8.4 million of
stock-based compensation expense, $3.9 million in revaluation of
our contingent royalty obligation, $1.4 million of provision of
allowance for doubtful accounts and $2.7 million of depreciation
and amortization.
For the nine months ended September 30, 2021, operating activities
used $24.3 million of cash, which primarily resulted from our net
loss of $28.6 million. Net operating assets and liabilities changed
by $14.5 million primarily driven by timing of receipts from
customers and payments to vendors and the first cash payment of
litigation settlement of $15.0 million to Medytox and Allergan.
Operating activities also includes adjustments for certain non-cash
charges including $6.9 million of stock-based compensation expense,
$4.0 million in revaluation of our contingent royalty obligation,
$0.5 million of provision of allowance for doubtful accounts and
$4.7 million of depreciation and amortization.
Investing Activities
Cash used in investing activities was $1.5 million for the nine
months ended September 30, 2022 compared to cash provided by
investing activities of $4.4 million for the nine months ended
September 30, 2021. The increase in cash used in investing
activities was attributable to no maturities of short-term
investments during the nine months ended September 30,
2022.
Financing Activities
Cash used in financing activities was $2.6 million for
the nine months ended September 30, 2022, compared to $25.2
million of cash provided by financing activities for the nine
months ended September 30, 2021. For the nine months ended
September 30, 2022, cash used in financing activities primarily
resulted from the payment of contingent royalty obligation to
Evolus Founders of $3.2 million. For the nine months ended
September 30, 2021, cash provided by financing activities primarily
resulted from proceeds from our follow-on offering, net of
underwriter fees and offering costs, of $92.2 million and sales of
$10.9 million of our common shares under the ATM Program, offset by
the repayment of long-term debt with Oxford of $76.3 million in
January 2021.
Material Cash Requirements
We have future obligations under various contracts relating to debt
and interest payments to our Pharmakon Term Loans, royalty payments
to Evolus Founders, a $5.0 million settlement payment related to
the Medytox/Allergan Settlement Agreements, royalty payments to
Allergan and Medytox, operating leases and purchase obligations.
During the nine months ended September 30, 2022, there were no
material changes to these obligations as reported in our Annual
Report on Form 10-K for the year ended December 31,
2021.
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.
There have been no 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, 2021.
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.
Item 3. Quantitative and Qualitative
Disclosure About Market Risk.
Not applicable.
Item 4. Controls and
Procedures.
Evaluation of Disclosure Controls and Procedures
As of September 30, 2022, our management, with the participation of
our Chief Executive Officer and our Chief Financial Officer, who
serve as our principal executive officer and principal financial
officer, respectively, performed an evaluation of the effectiveness
of the design and operation of our disclosure controls and
procedures as defined in Rules 13a-15(e) and 15d-15(e) of the
Exchange Act. Our disclosure controls and procedures are designed
to ensure (a) that information required to be disclosed in the
reports we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods
specified in the SEC’s rules and forms, and (b) that information
required to be disclosed by us in reports filed or submitted under
the Exchange Act is accumulated and communicated to our management,
including our Chief Executive Officer and our Chief Financial
Officer, as appropriate, to allow timely decisions regarding
required disclosures. Based on this evaluation, our Chief Executive
Officer and our Chief Financial Officer concluded that, as of
September 30, 2022, our disclosure controls and procedures were
effective at a reasonable assurance level.
Any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the
desired control objective and management necessarily applies its
judgment in evaluating the cost-benefit relationship of possible
controls and procedures.
Changes in Internal Control over Financial Reporting
During the three months ended September 30, 2022, there were no
changes in our internal control over financial reporting identified
in connection with the evaluation required by Rule 13a-15(d) and
15d-15(d) of the Exchange Act that occurred with respect to the
quarter ended September 30, 2022 that have materially affected, or
are reasonably likely to materially affect, our internal control
over financial reporting.
Part II—Other Information
Item 1. Legal Proceedings
See “Legal Proceedings” in
Note 9. Commitments and Contingencies
for information regarding legal proceedings.
Item 1A. Risk Factors
The risks and uncertainties discussed below update, supersede and
replace the risks and uncertainties previously disclosed in Part I,
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2021, which was filed with the SEC on
March 3, 2022, and previously disclosed in Part II, Item 1A of
our Quarterly Report on Form 10-Q for the quarter ended June 30,
2022, which was filed with the SEC on August 2, 2022. Other
than the addition of a risk factor related to fluctuations in
currency exchange rates, we do not believe any of the changes
constitute material changes from the risk factors previously
disclosed in such prior Annual Report on Form 10-K.
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 Quarterly
Report on Form 10-Q, including Part I, Item 2“Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” and the consolidated financial statements and the
related notes included in Part I, Item 1. 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 and into
Great Britain in September 2022, 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 our competitors, and the sales and
marketing tactics of our competitors, including bundling of
multiple products, in response to our launch of
Jeuveau®.
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 will continue to
incur losses for the foreseeable 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, and into Great Britain in September 2022
and have a limited history of generating revenue. We were not
profitable during the nine months ended September 30, 2022, and we
do not expect to be profitable in 2022. 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 recorded a net loss of $61.2 million for the nine months ended
September
30, 2022, and we recorded a net loss of $46.8 million and net loss
of $163.0 million for the years ended December 31, 2021 and 2020,
respectively. We had an accumulated deficit as of September 30,
2022 of $484.1 million. We expect to continue to incur losses for
the foreseeable future, and we anticipate these losses will
continue as we commercialize Jeuveau®.
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 of Jeuveau®
in the United States, EU and Canada and in connection with the
launch of Jeuveau®
in the United States and Canada. 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.
In the near term, we expect to make a $5.0 million payment in 2023
associated with our settlement agreements with Medytox and
Allergan. Additionally, 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®,
payments related to the collaboration agreement depending on the
development plans, the success of such development and 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. We expect to
incur additional costs as we continue to operate as a public
company, hire additional personnel and expand our operations.
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, royalty financing 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 agreements with Medytox, Inc., or Medytox, and Allergan
Limited, Allergan, Inc. and Allergan Pharmaceuticals Ireland, or,
collectively, Allergan, 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 Allergan and Medytox, which we refer to as
the U.S. Settlement Agreement and into another Settlement and
License Agreement with Medytox only which we refer to as the ROW
Settlement Agreement. Collectively, we refer to the U.S. Settlement
Agreement and the ROW Settlement Agreement as the Medytox/Allergan
Settlement Agreements.
Under the Medytox/Allergan Settlement Agreements we obtained (i) a
license to commercialize, manufacture and to have manufactured for
us certain products identified in the Medytox/Allergan 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. In exchange, we agreed to (i)
make payments of $35.0 million in multiple payments over two years
to Allergan and Medytox, of which we have paid $30.0 million, (ii)
from December 16, 2020 to September 16, 2022, pay to Allergan and
Medytox certain royalties on the sale of Jeuveau®,
based on a specified dollar amount per vial sold of Licensed
Product by or on behalf of us in the United States, (iii) from
December 16, 2020 to September 16, 2022, pay to Medytox 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, (iv) from September 17, 2022 to September 16,
2032, we will 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, (v) issue to Medytox 6,762,652 shares of our
common stock, which we issued on February 18 2021, and (vi) enter
into a Registration Rights Agreement pursuant to which we granted
certain registration rights to Medytox with respect to such shares
of common stock beginning as of March 31, 2022. In addition, under
the Medytox/Allergan Settlement Agreements we made certain
representations and warranties and agreed to positive and negative
covenants.
In the event we fail to comply with the terms of the
Medytox/Allergan Settlement Agreements, subject to applicable cure
periods, Allergan and Medytox would have the ability to terminate
the Medytox/Allergan Settlement Agreements 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 or Allergan fail to comply with the terms
of the Medytox/Allergan Settlement Agreements and comply with the
covenants and agreements under the Medytox/Allergan Settlement
Agreements, 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. We
would also be required to engage in costly and time-consuming
litigation in order to enforce our rights under the
Medytox/Allergan Settlement Agreements.
The terms of the Medytox/Allergan Settlement Agreements 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/Allergan Settlement Agreements, 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/Allergan Settlement Agreements. 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.
Our business, financial condition and operations have been, and may
in the future be, adversely affected by the COVID-19 outbreak or
other outbreaks of contagious diseases.
COVID-19 has had, and may continue to have, material adverse
effects on our business, financial condition, results of operations
and cash flows. Other outbreaks of contagious diseases in the
future could have a similar material adverse effect on our
business.
The COVID-19 outbreak, and restrictions intended to slow the spread
of COVID-19, including quarantines, government-mandated actions,
stay-at-home orders and other restrictions, has adversely affected
our business in a number of ways. For
example, the spread of COVID-19 in the United States has resulted
in travel restrictions impacting our sales professionals and
closures of our customers’ businesses, which adversely affected our
sales and operations, particularly in 2020 and periods of 2021. If
similar or other restrictions are imposed in the future in response
COVID-19 outbreaks or outbreaks of other contagious disease, our
sales and operations may be adversely affected. Additionally,
surges of COVID-19 outbreaks or other outbreaks of contagious
disease, including closures of our customers’ businesses, may
impact our ability to enroll patients in our ongoing and future
clinical programs.
Other negative impacts of the COVID-19 outbreak or other outbreaks
of contagious diseases could include the availability of our key
personnel, temporary closures of our office or the facilities of
our business partners, customers, third party service providers or
other vendors, and the interruption of our supply chain,
distribution channels, liquidity and capital or financial markets,
including increased inflation and rising interest rates. Any of
these events may result in a period of business disruption and in
reduced sales and operations. In addition, any disruption and
volatility in the global capital markets may increase our cost of
capital and adversely affect our ability to access financing when
and on terms that we desire. Any of these events could have a
material adverse effect on our business, financial condition,
results of operations and cash flows.
Moreover, 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 to slow its spread, these
elective procedures declined dramatically in 2020 due to closures
of our customers’ businesses and as many customers are deferring
their procedures. Even after the current COVID-19 pandemic
subsides, we may continue to experience negative impacts to our
business and financial results if consumers 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, including new and more
contagious and/or vaccine resistant variants, as well as COVID-19’s
global economic impact, including decreases in consumer
discretionary spending and any economic slowdown or recession that
may occur in the future.
Unfavorable global economic conditions could adversely affect our
business, financial condition or results of
operations.
Our results of operations could be adversely affected by general
conditions in the global economy and in the global financial
markets. In addition, inflation has increased over the past year,
potentially impacting consumer discretionary spending for aesthetic
medical procedures. Markets experiencing uncertainty could have
substantial high rates of inflation. Inflation and rapid
fluctuations in inflation rates typically have negative effects on
such countries’ economies and markets. Significant increases in
unemployment stemming from the pandemic have also occurred which
may impact consumer discretionary spending. Furthermore, for the
discretionary nature of aesthetic medical procedures may be
particularly vulnerable to unfavorable economic conditions. 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 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. 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 and through a distribution partner in Canada and
in Great Britain. 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. 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 the 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/Allergan Settlement Agreements, 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 patie