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(Exact name of registrant as specified in its charter)
iDelaware
i77-0551645
(State
or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
i1222 Demonbreun Street, Suite 2000, iNashville, iTennessee,
i37203
(Address, including zip code, of principal executive offices)
(i615) i724-7755
(Registrant’s
telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
iCommon Stock, par value $0.001 per share
iRVNC
iNasdaq
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. iYesý 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). iYesý 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.
iLarge
accelerated filer
☒
Accelerated filer
☐
Emerging growth company
i☐
Non-accelerated filer
☐
Smaller reporting company
i☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes i☐ No ý
Number
of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of October 31, 2023: i87,813,480
Unless expressly indicated or the context requires otherwise, the terms “Revance,”“Company,”“we,”“us,” and “our,” in this Quarterly Report on Form 10-Q (this “Report”) refer to Revance Therapeutics, Inc., a Delaware corporation, and, where appropriate, its wholly-owned subsidiaries. We also have used several other terms in this Report, the consolidated financial statements and accompanying notes included herein, most of which are explained or defined below.
“2014 EIP” means the Company’s 2014 Equity Incentive Plan.
“2014 ESPP” means the
Company’s 2014 Employee Stock Purchase Plan.
“2014 IN” means the Company’s 2014 Inducement Plan.
“2020 ATM Agreement” means the Sales Agreement by and between Revance and Cowen, dated November 2020, and terminated on May 10, 2022.
“2022 ATM Agreement”means the Sales Agreement by and between Revance and Cowen, dated May 10, 2022.
“2027 Notes” means Revance’s 1.75% Convertible Senior Notes due 2027.
“ABPS” means
Ajinomoto Althaea, Inc., doing business as Ajinomoto Bio-Pharma Services, a contract development and manufacturing organization.
“ABPS Services Agreement” means the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement by and between the Company and ABPS, dated March 14, 2017, as amended on December 18, 2020.
“Adjusted Three-Month LIBOR”has the meaning set forth in the Note Purchase Agreement.
“Adjusted Three-Month Term SOFR”has the meaning set
forth in the Note Purchase Agreement, as amended by the First Amendment.
“Allergan” means Allergan, Inc.
“Amortization Trigger” has the meaning set forth in the Note Purchase Agreement.
“ASC” means the Accounting Standards Codification as set forth by the Financial Accounting Standards Board.
“Athyrium” means Athyrium Buffalo LP.
“ATM” means at-the-market offering program.
“BLA” means a biologics license application.
“BTRX”means Botulinum Toxin Research
Associates, Inc.
“CODM” means the chief operating decision maker.
“Consolidated Teoxane Distribution Net Product Sales” has the meaning set forth in the Note Purchase Agreement.
“consumers” means the patients of our aesthetic practice customers.
“DAXXIFY®” means (DaxibotulinumtoxinA-lanm) for injection.
“DAXXIFY®
GL Approval” means the FDA approval in September 2022, of DAXXIFY® in the United States for the temporary improvement of moderate to severe glabellar lines in adults.
“DAXXIFY® GL Approval PSUs” means performance stock units that vested on the 6-month anniversary of the date of DAXXIFY® GL Approval.
i
“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.
“Expansion Premises”
means the additional 30,591 square feet added to the initial premises pursuant to the Nashville Lease.
“FDA” means the United States Food and Drug Administration.
“Fintech Platform” means OPUL® and the HintMD Platform.
“First Amendment” means the first amendment to the Note Purchase Agreement, by and among the Company, HintMD and Athyrium, dated August 8, 2023.
“First Tranche” means the Notes Payable issued to the Purchasers in an aggregate principal amount of $100.0 million on March
18, 2022.
“Fosun” means Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
“Fosun License Agreement” means the License Agreement by and between Revance and Fosun, dated December 4, 2018, as amended on February 15, 2020.
“Fosun Territory” means mainland China, Hong Kong and Macau.
“FY2022 10-K” means our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on February
28, 2023.
“neuromodulator”
means injectable botulinum toxins and neurotoxins.
“NMPA” means China’s National Medical Products Administration.
“Note Purchase Agreement” means the note purchase agreement by and between Revance; Athyrium, as administrative agent; the Purchasers, including Athyrium; and HintMD, as a guarantor, dated March 18, 2022.
“Notes Payable” means notes payable by Revance pursuant to the Note Purchase Agreement.
“NPA Effective Date” means the effective date of the Note Purchase Agreement, March 18, 2022.
“onabotulinumtoxinA biosimilar”
means a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®.
“option counterparties” means capped call transactions with a purchasers and another financial institution.
“OPUL®” means the OPUL® Relational Commerce Platform.
“PAS” means prior approval supplement.
ii
“PayFac” means payment facilitator.
“PCI”means PCI Pharma Services, formerly known as Lyophilization Services of New England, Inc., which was acquired by PCI in December 2021.
“PCI Supply Agreement”means the Commercial Supply Agreement by and between Revance and PCI, dated April 6, 2021.
“POS” means point of sale.
“PrevU” means the early experience program for DAXXIFY®.
“Products” means DAXXIFY® and the RHA® Collection of dermal fillers.
“Product Segment”
means the business that includes the research, development and commercialization of our Products and product candidates.
“PSA” means a performance stock award.
“PSU” means a performance stock unit.
“Purchasers” means Athyrium and its successors and assigns.
“Q1 2023 10-Q” means our Quarterly Report on Form 10-Q for the period ended March 31, 2023.
“RHA® Collection of dermal fillers” means RHA® 2, RHA® 3 and RHA®
4, which have been approved by the FDA for the correction of moderate to severe dynamic facial wrinkles and folds; and RHA® Redensity.
“RHA® Pipeline Products” means future hyaluronic acid filler advancements and products by Teoxane.
“RHA® Redensity” means a dermal filler, which has been approved by the FDA for the treatment of moderate to severe dynamic perioral rhytids (lip lines).
“RSAs” means restricted stock awards.
“RSUs” means restricted stock units.
“SEC”
means the U.S. Securities and Exchange Commission.
“Second Expansion Premises”means the additional 17,248 square feet added to the current premises pursuant to the Nashville Lease.
“Second Tranche” means the Notes Payable issued to the Purchasers in an aggregate principal amount of $50.0 million on August 28, 2023.
“Securities Act” means the U.S. Securities Act of 1933, as amended.
“Services” means the Fintech Platform business.
“Service Segment” means the business that includes the development and commercialization of the Fintech Platform.
“SOFR”
has the meaning set forth in the Note Purchase Agreement, as amended by the First Amendment.
“stock awards”means RSAs, PSAs, RSUs and PSUs.
“Third Tranche” means the uncommitted tranche of additional Notes Payable in an aggregate amount of up to $150.0 million, available until March 31, 2024, subject to the satisfaction of certain conditions set forth in the Note Purchase Agreement.
“U.S. GAAP” means U.S. generally accepted accounting principles.
“Viatris” means Viatris Inc., formerly known as Mylan Ireland Ltd.
“Viatris Agreement” means the Collaboration and License Agreement by Revance and Viatris, dated February 28, 2018, as amended on August 22, 2019.
“Viatris
Territory” means world-wide (excluding Japan).
“Zero-cost Inventory” means DAXXIFY® inventory produced prior to the DAXXIFY® GL Approval in early September 2022, for which the related manufacturing costs were incurred and expensed to research and development expense prior to the FDA approval.
Revance®, the Revance logos, DAXXIFY®, OPUL® and other trademarks or service marks of Revance appearing in this Report are the property of Revance. This Report contains additional trade names, trademarks and service marks of others, which are the property of their respective owners. We do not intend our use
or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies.
Preferred
stock, par value $ii0.001/ per share — ii5,000,000/
shares authorized, and iiiino///
shares issued and outstanding as of September 30, 2023 and December 31, 2022
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. iThe
Company and Summary of Significant Accounting Policies
Overview
Revance is a biotechnology company focused on developing and commercializing innovative aesthetic and therapeutic offerings. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China.
Liquidity and Financial Condition
We are not profitable and have incurred losses in each year since our inception. For the three and nine months ended September
30, 2023, we had a net loss of $i141.2 million and $i268.3 million, respectively. As of September 30, 2023, we had an accumulated deficit of $i2.0
billion. Although we began generating revenue from the sale of our Products and Services during the three months ended September 30, 2020, we expect to continue to incur GAAP operating losses for the foreseeable future.
As of September 30, 2023, we had a working capital surplus of $i306.4 million and capital resources of $i300.2
million, consisting of cash, cash equivalents, and short-term investments. In recent years, we have funded our operations primarily through the sale of common stock, convertible senior notes, sales of Products, proceeds from notes issued pursuant to the Note Purchase Agreement, and payments received from collaboration arrangements. We also have a remaining capacity to sell up to $i47.2 million of our common stock under the 2022 ATM Agreement as of September 30, 2023. We believe that our existing capital resources will be sufficient to fund
the operating plan through at least the next 12 months following the issuance of the unaudited condensed consolidated financial statements in this Report.
i
Basis of Presentation and Principles of Consolidation
The accompanying condensed consolidated financial statements are unaudited, and reflect all adjustments which are, in the opinion of management, of a normal recurring nature and necessary for a fair statement of the results for the interim periods presented.
Our condensed consolidated balance sheet for the year ended December
31, 2022 included herein was derived from audited consolidated financial statements, but does not include all disclosures including notes required by U.S. GAAP. The interim results presented herein are not necessarily indicative of the results of operations that may be expected for the full fiscal year ending December 31, 2023, or any other future period. Our unaudited condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements contained in our FY2022 10-K.
Our condensed consolidated financial statements include our accounts and those of our wholly-owned subsidiaries, and have been prepared in conformity with U.S. GAAP. All intercompany transactions have been eliminated.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
iReclassification
At the beginning of 2023, we changed our presentation of internal-use software where approximately $i8.3 million
has been reclassified from property and equipment, net into intangible assets, net. Refer to Note 5 for further detail as of September 30, 2023 and December 31, 2022.
i
Use of Estimates & Risks and Uncertainties
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities in the condensed consolidated financial statements and accompanying notes. These estimates form the basis for judgments we make about the carrying values of our assets and liabilities, which are not readily apparent from other sources. We base our estimates and judgments on historical information and on various other assumptions that we believe are reasonable under the circumstances. U.S. GAAP requires us to make estimates and judgments in several areas, including, but not limited to, the incremental borrowing rate used to measure operating lease and finance lease liabilities, the recoverability of goodwill and long-lived assets, useful lives associated with property and equipment and intangible assets, the period of benefit associated with deferred costs, revenue recognition (including the timing of satisfaction of performance obligations, estimating variable consideration, estimating stand-alone selling prices of promised goods and services, and allocation
of transaction price to performance obligations), deferred revenue classification, accruals for clinical trial costs, valuation and assumptions underlying stock-based compensation and other equity instruments, and income taxes.
As of the date of issuance of these condensed consolidated financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities. These estimates may change as new events occur and additional information is obtained, and are recognized in the condensed consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to our condensed consolidated financial statements.
Significant Accounting Policies
There
have been no material changes to our significant accounting policies from our FY2022 10-K.
i
Recent Accounting Pronouncements
The recent accounting pronouncements did not have any material impact on the financial statements unless otherwise disclosed, and we do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our present or future financial statements.
2.
iRevenue
Our revenue is primarily generated from U.S. customers. Our product and collaboration revenues are generated from the Product Segment, and our service revenue is generated from the Service Segment (Note 13). iThe
following table presents our revenue disaggregated by timing of transfer of goods or service:
We offer customer payment processing and certain value-added services to aesthetic practices through the Fintech Platform. Generally, revenue related to the HintMD Platform payment processing service, which was discontinued in the second quarter of 2023, was recognized at a point in time and revenue related to the OPUL® payment processing service is recognized over time. For the Fintech Platform, revenue related to the value-added services component is recognized over time. In September 2023, we commenced a plan to exit the Fintech Platform business as discussed in Note 3.
Accounts receivable from contracts
with our service customers are as follows:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Collaboration Revenue
Viatris Agreement
Agreement Terms
We entered into the Viatris Agreement in February 2018, pursuant to which we are collaborating with Viatris exclusively in the Viatris Territory, to develop, manufacture, and commercialize an onabotulinumtoxinA biosimilar.
Viatris has paid us an aggregate of $i60 million
in non-refundable upfront and milestone fees as of September 30, 2023, and the agreement provides for additional remaining contingent payments of up to $i70 million in the aggregate, upon the achievement of certain clinical and regulatory milestones and of specified, tiered sales milestones of up to $i225 million.
The payments do not represent a financing component for the transfer of goods or services. In addition, Viatris is required to pay us low to mid-double digit royalties on any sales of the biosimilar in the U.S., mid-double digit royalties on any sales in Europe, and high single digit royalties on any sales in other ex-U.S. Viatris territories. However, we have agreed to waive royalties for U.S. sales, up to a maximum of $i50 million in annual sales, during the first approximately ifour
years after commercialization to defray launch costs.
Revenue Recognition
We estimated the transaction price for the Viatris Agreement using the most likely amount method within the scope of ASC 606. In order to determine the transaction price, we evaluated all of the payments to be received during the duration of the contract, which included milestones and consideration payable by Viatris. Other than the upfront payment, all other milestones and consideration we may earn under the Viatris Agreement are subject to uncertainties related to development achievements, Viatris’ rights to terminate the agreement, and estimated effort for cost-sharing payments. Components of such estimated effort for cost-sharing payments include both internal and external costs. Consequently, the transaction
price does not include any milestones and considerations that, if included, could result in a probable significant reversal of revenue when related uncertainties become resolved. At the end of each reporting period, we re-evaluate the probability of achievement of each such milestone and any related constraint, and if necessary, adjust our estimates of the overall transaction price. Sales-based milestones and royalties are not included in the transaction price until the sales occur because the underlying value relates to the license, and the license is the predominant feature in the Viatris Agreement. As of September 30, 2023, the transaction price allocated to the unfulfilled performance obligations was $i44.2
million.
We recognize revenue and estimate deferred revenue based on the cost of development service incurred over the total estimated cost of development services to be provided for the development period. For revenue recognition purposes, the development period is estimated to be completed in 2026. It is possible that this period will change and is assessed at each reporting date. ASC Topic 606, Revenue from Contracts with Customers (ASC 606) requires that an entity include a constraint on the amount of variable consideration included in the transaction price. Variable consideration is considered “constrained” if there is a potential for significant reversal of cumulative revenue recognized. As part of the constraint evaluation, we considered numerous factors, including a potential shift in certain responsibilities between
the two parties which would result in changes to the net cost sharing payments, for which outcomes are difficult to predict as of the date of this Report. As a result, no collaboration revenue is recognized from the biosimilar program for the nine months ended September 30, 2023. We will continue to evaluate the variable transaction price and related revenue recognition in each reporting period and as the above uncertainties are resolved or other changes in circumstances occur. For the three and nine months ended September 30, 2023, we recognized iino/
revenue related to development services under the Viatris Agreement. For the three and nine months ended September 30, 2022, we recognized $i1.0 million and $i6.2 million related to the development services under the Viatris Agreement, respectively.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Fosun License Agreement
Agreement Terms
In December 2018, we entered into the Fosun License Agreement with Fosun, whereby we granted Fosun the exclusive rights to develop and commercialize DaxibotulinumtoxinA for Injection in the Fosun Territory and certain sublicense rights.
As of September 30, 2023, Fosun has paid us non-refundable upfront and other payments totaling $i38.0 million
before foreign withholding taxes. We are also eligible to receive (i) additional remaining contingent payments of up to $i222.5 million upon the achievement of certain milestones and (ii) tiered royalty payments in low double digits to high teen percentages on annual net sales. The royalty percentages are subject to reduction in the event that (i) we do not have any valid and unexpired patent claims that cover the product in the Fosun Territory, (ii) biosimilars of the product are sold in the Fosun Territory or (iii) Fosun needs to pay compensation to third parties to either avoid patent infringement or
market the product in the Fosun Territory.
Revenue Recognition
We estimated the transaction price for the Fosun License Agreement using the most likely amount method. We evaluated all of the variable payments to be received during the duration of the contract, which included payments from specified milestones, royalties, and estimated supplies to be delivered. We will re-evaluate the transaction price at each reporting period and upon a change in circumstances. As of September 30, 2023, the transaction price allocated to unfulfilled performance obligation is $i41.0 million.
For
the three and nine months ended September 30, 2023, revenue of less than $i0.1 million and $i0.1 million was recognized from the Fosun License Agreement, respectively. For the three and nine months ended September 30, 2022, iino/
revenue was recognized from the Fosun License Agreement.
Accounts receivables and contract liabilities from contracts with our collaboration customers are as follows:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Changes in our contract liabilities from contracts with our collaboration revenue customers for the nine months ended September 30, 2023 are as follows:
In September 2023, we commenced a plan to exit the Fintech Platform business because the significant costs and resources required to support OPUL® no longer aligned with the Company’s capital allocation priorities. The exit and restructuring activities predominantly include a reduction in OPUL® personnel headcount, the termination of OPUL®
research and development activities and a reduction of outside services expenses related to OPUL®. We intend to continue processing payments for current OPUL® customers through January 31, 2024.
All of our restructuring charges in connection with the exit of the Fintech Platformbusiness are recorded under our Service Segment. As of September 30, 2023, we recorded restructuring charges of $i95.2
million as shown in the table below. We expect to incur estimated additional restructuring charges of up to $i3 million, and such restructuring charges will be incurred over time through March 31, 2024.
iA
summary of our restructuring charges included within our condensed consolidated statement of operations for the three and nine months ended September 30, 2023 were as follows:
(in thousands)
Goodwill impairment
$
i77,175
Intangible
asset impairment
i16,007
Selling, general and administrative
i732
Research
and development
i1,293
Total restructuring charges
$
i95,207
/
iA
summary of severance and personnel liabilities, included within accruals and other current liabilities on the condensed consolidated balance sheet, is as follows:
(1)We anticipate that the completion of the restructuring activities, including the implementation of the workforce reduction will be substantially complete by or around
March 31, 2024, and the related cash payments are expected though the second quarter of 2024.
As
of September 30, 2023 and December 31, 2022, all of our cash equivalents and short-term investments were available-for-sale securities and had contractual maturities of less than one-year. There were no other-than-temporary impairments on such securities.
5. iGoodwill and intangible Assets, net
Goodwill
Goodwill
is not amortized but is tested for impairment at least annually at the reporting unit level in the fourth quarter of each calendar year, or more frequently if events or changes in circumstances indicate that the reporting unit might be impaired. In assessing goodwill for impairment, we first assess qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount.
All of our goodwill was acquired in 2020 as part of the HintMD Acquisition and was assigned to the Service Segment. Based on our plan to exit the Fintech Platform business (Note 3), we concluded that it was more likely than not that goodwill is impaired. Due to our decision to exit the Fintech Platform business, our projected negative future cash flows from the Service
Segment resulted in an estimated fair value of zero and full impairment of the related goodwill. We therefor recognized an impairment charge of $ii77.2/
million in our Service Segment for the three and nine months ended September 30, 2023 and was presented as goodwill impairment on the condensed consolidated statement of operations and comprehensive loss. The aggregate amount of accumulated impairment as of September 30, 2023 and December 31, 2022 was $i147.0 million and $i69.8
million, respectively.
The following table sets forth the major categories of intangible assets and the weighted-average remaining useful lives for those assets that are not already fully amortized:
Weighted Average Remaining Useful Lives (in years)
Gross Carrying Amount
Accumulated Amortization
Net Carrying Amount
Acquired developed technology
i4.2
$
i35,800
$
(i24,325)
$
i11,475
Distribution
rights
i1.4
i32,334
(i20,882)
i11,452
Internally
developed technology
i2.4
i8,062
(i2,271)
i5,791
Customer
relationships
i1.6
i10,300
(i6,223)
i4,077
Other
software
i1.8
i3,166
(i1,592)
i1,574
Development
in progress
N/A
i975
—
i975
Total
intangible assets
$
i90,637
$
(i55,293)
$
i35,344
//
N/A
- Not applicable
Intangible Asset Impairment
As discussed in Note 3, in September 2023, we commenced a plan to exit the Fintech Platform business and as a result, we concluded that it was more likely than not that the estimated fair value of the asset group for OPUL® was impaired. We estimated that the fair value of the asset group was effectively zero and recorded a full impairment charge to those intangible assets of $ii16.0/
million for the three and nine months ended September 30, 2023, which was presented as intangible asset impairment on the condensed consolidated statement of operations and comprehensive loss.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Intangible Assets Amortization
Amortization expense of the intangible assets in the table above were recorded on the condensed
consolidated statements of operations and comprehensive loss based on the function of the associated asset. iThe detail breakdown of the amortization expenses on the condensed consolidated statements of operations and comprehensive loss were summarized as below:
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands)
2023
2022
2023
2022
Depreciation and amortization
$
i1,320
$
i3,513
$
i5,459
$
i10,538
Selling,
general and administrative
i429
i644
i2,998
i1,931
Total
intangible asset amortization
$
i1,749
$
i4,157
$
i8,457
$
i12,469
i
Based
on the amount of intangible assets as of September 30, 2023, the expected amortization expense for each of the next five fiscal years was as follows:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
7. iAccruals and other current liabilities
i
Accruals
and other current liabilities consists of the following:
September 30,
December 31,
(in thousands)
2023
2022
Accruals related to:
Compensation(1)
$
i26,027
$
i28,014
Inventories
i8,376
i2,312
Selling,
general and administrative
i7,711
i9,681
Research
and development
i5,047
i9,012
Clinical
trials
i872
i1,863
Interest expense
i625
i1,912
Other
current liabilities
i4,835
i6,563
Total
accruals and other current liabilities
$
i53,493
$
i59,357
(1)Restructuring
related severance and personnel liabilities included within accruals and other current liabilities on the condensed consolidated balance sheets were discussed in Note 3.
/
8. iiLeases/
Operating
Leases
Our operating leases primarily consist of non-cancellable facilities leases for research, manufacturing, and administrative functions. Our non-cancellable facilities operating leases have original lease periods expiring between 2027 and 2034, and include ione or more options to renew for iseven
years to ifourteen years. The monthly payments for our operating leases escalate over the remaining lease term. Our lease contracts do not contain termination options, residual value guarantees or restrictive covenants.
Finance Lease
Our finance lease represents a dedicated fill-and-finish line for the manufacturing of DAXXIFY®. In March 2017, we entered into the ABPS Services Agreement. The ABPS Services Agreement contains a lease, which
commenced in January 2022, related to a dedicated fill-and-finish line for the manufacturing of DAXXIFY® because it has an identified asset that is physically distinct for which we have the right of control as defined under ASC 842. The right of control is conveyed because the embedded lease provides us with both (i) the right to obtain substantially all of the economic benefit from the fill-and-finish line resulting from the exclusivity of the dedicated manufacturing capacity and (ii) the right to direct the use of the fill-and-finish line through our purchase orders to ABPS. Each party has the right to terminate the ABPS Services Agreement without cause, with an i18-month
written notice to the other party. The lease is classified as a finance lease in the condensed consolidated balance sheets.
Under the ABPS Services Agreement, until May 2022, we were subject to minimum purchase obligations of up to $iii30.0//
million for each of the years ending December 31, 2022, 2023 and 2024. In May 2022, we amended a statement of work under the ABPS Services Agreement pursuant to which the minimum purchase obligations of $iii30.0//
million per year were eliminated, and instead the minimum purchase obligations would be negotiated prior to the beginning of each year over the term of the agreement. As a result of the amended statement of work, the finance lease was modified. The primary change was that the modification reflects payments in 2023 and 2024 as variable lease payments, contingent on negotiation at the beginning of each period and excludes such payments in the present value calculation in arriving at the remaining finance lease liabilities with a corresponding adjustment to the related right-of-use asset, among other considerations and changes.
In January 2023, we entered into a second amendment to the above mentioned statement of work under the ABPS Services Agreement. The second amendment established a minimum purchase obligation for the year ending December 31,
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
2023 of $i23.9 million, which represents ABPS’ practical manufacturing capability based on experience. The minimum purchase obligation for the year ending December 31, 2023 was determined to be fixed lease payments and such payments will increase the
present value calculation in arriving at the remaining finance lease liabilities with a corresponding adjustment to the related finance lease right-of-use asset.
i
The operating and finance lease costs are summarized as follows:
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands)
2023
2022
2023
2022
Finance lease:
Amortization of finance lease right-of-use asset (1)
$
i3,297
$
i3,344
$
i6,965
$
i4,502
Interest
on finance lease liability
i270
i348
i1,278
i2,607
Variable
lease cost (2)
i62
i1,134
i436
i1,375
Total
finance lease costs
i3,629
i4,826
i8,679
i8,484
Operating
leases:
Operating lease cost
i3,138
i2,223
i9,657
i6,669
Variable
lease cost (3)
i534
i423
i1,589
i1,288
Total
operating lease costs
i3,672
i2,646
i11,246
i7,957
Total
lease costs
$
i7,301
$
i7,472
$
i19,925
$
i16,441
(1)Amortization
of the finance lease right-of-use asset started to be capitalized into inventories on the condensed consolidated balance sheets in the second quarter of 2023 as a result of the FDA approval of the PAS of the ABPS manufacturing facility.
(2)Variable finance lease cost includes validation, qualification, materials, and other related services which are not included in the lease liabilities and are expensed as incurred.
(3)Variable operating lease cost includes management fees, common area maintenance, property taxes, insurance and parking fees, which are not included in the lease liabilities and are expensed as incurred.
/ii
As
of September 30, 2023, maturities of our lease liabilities are as follows:
Our
lease contracts do not provide readily determinable implicit rates, as such, we used the estimated incremental borrowing rate based on the information available at the adoption, commencement, or remeasurement date. As of September 30, 2023, weighted-average remaining lease terms and discount rates are as follows:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
i
Supplemental cash flow information related to the leases was as follows:
Nine
Months Ended September 30,
(in thousands)
2023
2022
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$
i6,264
$
i6,259
Operating
cash flows from finance lease
$
i1,280
$
i2,541
Financing
cash flows from finance lease
$
i15,513
$
i5,000
Right-of-use
assets obtained in exchange for lease liabilities
Finance lease
$
i23,781
$
i14,523
Operating
leases(1)
$
i22,694
$
i—
(1)In
September 2023, the Expansion Premises and Second Expansion Premises commenced resulting in recognition of $i22.7 million right-of-use asset and $i16.2 million lease liability.
/
Lease
Not Yet Commenced
PCI Supply Agreement
In April 2021, we entered into the PCI Supply Agreement pursuant to which PCI would serve as a non-exclusive manufacturer and supplier of DAXXIFY®. The initial term of the PCI Supply Agreement is dependent upon the date of regulatory submission for the manufacturing of DAXXIFY® and may be terminated by either party in accordance with the terms of the PCI Supply Agreement. The term of the PCI Supply Agreement may also be extended for ione
additional ithree-year term upon mutual agreement of the parties.
The PCI Supply Agreement contains a lease related to a dedicated fill-and-finish line and closely related assets for the manufacturing of DAXXIFY® because it has identified assets that are physically distinct for which we will have the right of control as defined under ASC 842. The right of control is conveyed because the embedded lease will provide us with both (i) the right to obtain substantially all of the economic benefit from the fill-and-finish line resulting from the exclusivity implied from the dedicated
manufacturing capacity and (ii) the right to direct the use of the fill-and-finish line.
The embedded lease had not yet commenced as of September 30, 2023. The accounting commencement and recognition of the right-of-use lease assets and lease liabilities related to the embedded lease will take place when we have substantively obtained the right of control. The embedded lease is preliminarily classified as a finance lease.
Pursuant to the PCI Supply Agreement, we are responsible for certain costs associated with the design, equipment procurement and validation, and facilities-related costs, monthly payments and minimum purchase obligations throughout the initial term of the PCI Supply Agreement. As of September 30, 2023, we have made prepayments of $i30.9
million to PCI which is recorded within “Finance lease prepaid expense” in the condensed consolidated balance sheets. Based on our best estimate as of September 30, 2023, our remaining minimum commitment under the PCI Supply Agreement will be $i10.9 million for 2023, $i15.9
million for 2024, $i18.3 million for 2025, $i25.3 million for 2026, $i29.5
million for 2027, and $i134.5 million for 2028 and thereafter in the aggregate.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
9. iDebt
i
The following table provides information regarding our debt:
September
30,
December 31,
(in thousands)
2023
2022
2027 Notes, non-current
$
i287,500
$
i287,500
Less:
Unamortized debt issuance costs
(i4,609)
(i5,587)
Carrying
amount of the 2027 Notes
i282,891
i281,913
Notes
Payable, current
i1,250
i—
Notes Payable, non-current
i148,750
i100,000
Less:
Unamortized debt discount
(i2,976)
(i1,347)
Less:
Unamortized debt issuance costs
(i1,564)
(i1,192)
Carrying
amount of Notes Payable
i145,460
i97,461
Total debt
$
i428,351
$
i379,374
Interest
expense relating to our debt in the condensed consolidated statements of operations and comprehensive loss are summarized as follows:
Three Months Ended September 30,
Nine Months Ended September 30,
(in thousands)
2023
2022
2023
2022
Contractual
interest expense
$
i3,830
$
i3,454
$
i10,620
$
i8,425
Amortization
of debt issuance costs
i447
i441
i1,310
i1,190
Amortization
of debt discount
i157
i98
i329
i183
Total
interest expense
$
i4,434
$
i3,993
$
i12,259
$
i9,798
/
Convertible
Senior Notes
In February 2020, we issued the 2027 Notes, in the aggregate principal amount of $i287.5 million pursuant to the Indenture. The 2027 Notes are senior unsecured obligations and bear interest at a rate of i1.75%
per year, payable semiannually in arrears on February 15 and August 15 of each year, began on August 15, 2020. The 2027 Notes will mature on February 15, 2027, unless earlier converted, redeemed or repurchased. In connection with issuing the 2027 Notes, we received $i278.3 million in net proceeds, after deducting the initial purchasers’ discount, commissions, and other issuance costs.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
The 2027 Notes may be converted at any time by the holders prior to the close of business on the business day immediately preceding November 15, 2026 only under the following circumstances: (i) during any fiscal quarter commencing after the fiscal quarter ending on June 30, 2020 (and only during such fiscal quarter), if the last reported sale price of our common stock for at least i20
trading days (whether or not consecutive) during a period of i30 consecutive trading days ending on, and including, the last trading day of the immediately preceding fiscal quarter is greater than or equal to i130%
of the conversion price on each applicable trading day; (ii) during the ifive business day period after any iten consecutive trading
day period (the “measurement period”) in which the trading price (as defined in the Indenture) per $1,000 principal amount of the 2027 Notes for each trading day of the measurement period was less than i98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; (iii) if we call any or all of the 2027 Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding
the redemption date; or (iv) upon the occurrence of specified corporate events. On or after November 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2027 Notes at any time, regardless of the foregoing circumstances. Upon conversion, we will pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election.
The conversion rate will initially be 30.8804 shares of our common stock per $1,000 principal amount of the 2027 Notes (equivalent to an initial conversion price of approximately $i32.38
per share of our common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if we deliver a notice of redemption, we will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2027 Notes in connection with such a corporate event or notice of redemption, as the case may be.
Contractually, we may not redeem the 2027 Notes prior to February 20, 2024. We may redeem for cash all or any portion of the 2027 Notes, at our option, on or after February 20, 2024 if the last reported sale price of our common stock has been at least i130%
of the conversion price then in effect for at least i20 trading days (whether or not consecutive) during any i30 consecutive trading day period (including the last trading day of such period) ending on, and
including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to i100% of the principal amount of the 2027 Notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2027 Notes.
If we undergo a fundamental change (as defined in the Indenture), holders may require us to repurchase for cash all or any portion of their 2027 Notes
at a fundamental change repurchase price equal to i100% of the principal amount of the 2027 Notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.
Capped Call Transactions
Concurrently with the 2027 Notes, we entered into capped call transactions with the option counterparties and used $i28.9
million of the net proceeds from the 2027 Notes to pay the cost of the capped call transactions. The capped call transactions are expected generally to reduce the potential dilutive effect upon conversion of the 2027 Notesand/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes, as the case may be, with such reduction and/or offset subject to a price cap of $i48.88 of our common stock per share, which represents a premium of i100%
over the last reported sale price of our common stock on February 10, 2020. The capped calls have an initial strike price of $i32.38 per share, subject to certain adjustments, which corresponds to the conversion option strike price in the 2027 Notes. The capped call transactions cover, subject to anti-dilution adjustments, approximately i8.9 million
shares of our common stock.
The capped call transactions are separate transactions that we entered into with the option counterparties and are not part of the terms of the 2027 Notes. As the capped call transactions meet certain accounting criteria, the premium paid of $i28.9 million was recorded as a reduction in additional paid-in capital in the condensed consolidated balance sheets, and will not be remeasured to fair value as long as the accounting criteria continue to be met. As of September 30, 2023 and
December 31, 2022, we had not purchased any shares under the capped call transactions.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Note Purchase Agreement
In March 2022, we entered into the Note Purchase Agreement and issued the First Tranche in an aggregate principal amount for all such Notes of $i100 million.
In August 2023, we entered into the First Amendment to reduce the Second Tranche from $i100 million to $i50 million, and we subsequently issued $i50 million
to the purchasers. Additionally, the First Amendment increased the uncommitted Third Tranche from $i100 million to $i150 million. The uncommitted Third Tranche is available until March 31, 2024, subject to the satisfaction
of certain conditions set forth in the Note Purchase Agreement, including the achievement of greater than or equal to $i50 million in trailing twelve months revenue for DAXXIFY® preceding the date of the draw request for the Third Tranche, and approval by Athyrium.
Our obligations under the Note Purchase Agreement are secured by substantially all of our assets and the assets of our wholly owned domestic subsidiaries,
including their respective intellectual property.
The notes issued pursuant to the First Tranche and Second Tranche bear interest at an annual fixed interest rate equal to i8.50%. The First Amendment modified the variable interest rate adjustment for the Third Tranche from Adjusted Three-Month LIBOR to Adjusted Three-Month Term SOFR. If the Third Tranche of Notes Payable becomes committed, the Notes Payable will then bear interest at an annual rate equal to the sum of (a) i7.0%
and (b) Adjusted Three-Month Term SOFR for such interest period (subject to a floor of i1.50% and a cap of i2.50%). We are required to make quarterly interest payments on each Notes Payable commencing on the last business day of the calendar month following
the funding date thereof, and continuing until the Maturity Date. Pursuant to the First Amendment, the Company is required to repay Athyrium the outstanding principal amount of the Second Tranche notes in installments on the last business day of each March, June, September and December (commencing in September 2024), in each case, based on the following principal amortization payment schedule: i2.5% in September and December 2024; i5.0%
in March and June 2025; i7.5% in September and December 2025; and i10.0% in March and June 2026; followed by repayment of the Second Tranche in full on September 18, 2026. The Maturity
Date may be extended to March 18, 2028 if, as of September 18, 2026, less than $i90 million principal amount of our existing 2027 Notes remain outstanding and with the consent of the Purchasers. Initially, all principal for each tranche is due and payable on the Maturity Date. If any Third Tranche notes are issued, upon the occurrence of an Amortization Trigger (as defined in the Note Purchase Agreement), we are required to repay the principal of the Third Tranche in equal monthly installments beginning on the last day of the month in which the
Amortization Trigger occurred and continuing through the Maturity Date. At our option, we may prepay the outstanding principal balance of all or any portion of the principal amount of the Notes Payable, subject to a prepayment fee equal to (i) a make-whole amount if the prepayment occurs on or prior to the first anniversary of the NPA Effective Date and (ii) i2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the NPA Effective Date but on or prior to the second anniversary of the NPA Effective Date. Upon prepayment or repayment of all or any portion of the principal amount of the Notes Payable (whether on the
Maturity Date or otherwise), we are also required to pay an exit fee to the Purchasers.
The Note Purchase Agreement includes affirmative and negative covenants applicable to us, our current subsidiaries and any subsidiaries we create in the future. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. We must also (i) maintain at least $i30.0 million
of unrestricted cash and cash equivalents in accounts subject to a control agreement in favor of Athyrium at all times and (ii) upon the occurrence of certain specified events set forth in the Note Purchase Agreement, achieve at least $i70.0 million of Consolidated Teoxane Distribution Net Product Sales on a trailing twelve-months basis. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments,
creating liens, selling assets and undergoing a change in control, in each case subject to certain exceptions.
If we do not comply with the affirmative and negative covenants, such non-compliance may be an event of default under the Note Purchase Agreement. The Note Purchase Agreement also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus i2.0% and would provide Athyrium, as administrative agent, with the right to exercise remedies against us and
the collateral, including foreclosure against our property securing the obligations under the Note Purchase Agreement, including our cash. These events of default include, among other things, our failure to pay principal or interest due under the Note Purchase Agreement, a breach of
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
certain covenants under the Note Purchase Agreement, our insolvency, the occurrence of a circumstance which could have a material
adverse effect and the occurrence of any default under certain other indebtedness.
10. iStockholders’ Equity and Stock-Based Compensation
Equity Compensation Plans
2014 EIP
On January 1, 2023, the number of shares of common stock reserved for issuance under the 2014 EIP increased by i3.3 million
shares. For the nine months ended September 30, 2023, i2.5 million shares of stock awards and i0.2 million
stock options were granted under the 2014 EIP. As of September 30, 2023, i4.3 million shares were available for issuance under the 2014 EIP.
2014 IN
For the nine months ended September 30, 2023, ino
stock options or awards were granted under the 2014 IN. As of September 30, 2023, i1.1 million shares were available for issuance under the 2014 IN.
HintMD Plan
For the nine months ended September 30, 2023, ino
stock options or awards were granted under the HintMD Plan. As of September 30, 2023, i0.1 million shares were available for issuance under the HintMD Plan.
2014 ESPP
On January 1, 2023, the number of shares of common stock reserved for issuance under the 2014 ESPP increased by i0.3 million
shares. As of September 30, 2023, i1.8 million shares were available for issuance under the 2014 ESPP.
Net Loss per Share
Our basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share is calculated by giving effect to all potential dilutive common stock equivalents outstanding for the period. For purposes
of this calculation, shares of common stock underlying the 2027 Notes at the initial conversion price, outstanding stock options, and unvested stock awards, are considered common stock equivalents, which were excluded from the computation of diluted net loss per share because including them would have been antidilutive.
i
Common stock equivalents that were excluded from the computation of diluted net loss per share are presented below:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
ATM Offering Programs
In November 2020, we entered into the 2020 ATM Agreement with Cowen. Under the 2020 ATM Agreement, we could offer and sell, from time to time, through Cowen, shares of our common stock having an aggregate offering price of up to $i125.0 million.
We were not obligated to sell any shares under the 2020 ATM Agreement. Subject to the terms and conditions of the 2020 ATM Agreement, Cowen was required to use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of The Nasdaq Global Market, to sell shares from time to time based upon our instructions, including any price, time or size limits specified by us. We paid Cowen a commission of up to i3.0% of the aggregate gross proceeds from each sale of shares, reimbursed legal fees and disbursements
and provided Cowen with customary indemnification and contribution rights. From January 1, 2022 through May 10, 2022, we sold i1.7 million shares of common stock under the 2020 ATM Agreement at a weighted average price of $i18.71
per share resulting in net proceeds of $i31.6 million after sales agent commissions and offering costs. The 2020 ATM Agreement was terminated on May 10, 2022.
On May 10, 2022, we entered into the 2022 ATM Agreement with Cowen. Under the 2022 ATM Agreement, we may sell up to $i150.0 million
of our common stock. We are not obligated to sell any shares under the 2022 ATM Agreement. Subject to the terms and conditions of the 2022 ATM Agreement, Cowen will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of The Nasdaq Global Market, to sell shares from time to time based upon our instructions, including any price, time or size limits specified by us. We pay Cowen a commission of up to i3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements
and provide Cowen with customary indemnification and contribution rights.
In the three months ended June 30, 2023, we sold i3.2 million shares of common stock under the 2022 ATM Agreement at a weighted average price of $i31.90
per share, resulting in net proceeds of $i100.0 million after sales agent commissions and offering costs. iiNo/
shares of common stock were sold for the three months ended March 31, 2023 or September 30, 2023 under the 2022 ATM Agreement.
Stock-Based Compensation Expense
i
The following table summarizes our stock-based compensation expense by line item in our condensed consolidated statements of operations and comprehensive loss:
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
11. iFair Value Measurements
i
The
following table summarizes, for assets and liabilities measured at fair value, the respective fair value and the classification by level of input within the fair value hierarchy.
For
Level 1 investments, we use quoted prices in active markets for identical assets to determine the fair value. For Level 2 investments, we use quoted prices for similar assets sourced from certain third-party pricing services. The third-party pricing services generally utilize industry standard valuation models for which all significant inputs are observable, either directly or indirectly, to estimate the price or fair value of the securities. The primary input generally includes reported trades of or quotes on the same or similar securities. We do not make additional judgments or assumptions made to the pricing data sourced from the third-party pricing services.
The fair value of the 2027 Notes and the Notes Payable (Note 9) was determined on the basis of market prices observable for
similar instruments and is considered Level 2 in the fair value hierarchy. We present the fair value of the 2027 Notes and the Notes payable for disclosure purposes only. As of September 30, 2023, and December 31, 2022, the fair value of the 2027 Notes was $i232.1 million and $i288.2 million,
respectively. As of September 30, 2023 and December 31, 2022, the fair value of the Notes Payable was approximately the same as its unamortized carrying value.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
12. iCommitments
and Contingencies
Teoxane Agreement
In January 2020, we entered into the Teoxane Agreement, pursuant to which Teoxane granted us the exclusive right to import, market, promote, sell and distribute Teoxane’s line of Resilient Hyaluronic Acid® dermal fillers, which include: (i) RHA® Collection of dermal fillers, and (ii) the RHA® Pipeline Products in the U.S. and U.S. territories and possessions, in exchange for i2,500,000
shares of our common stock and certain other commitments by us. The Teoxane Agreement is effective for a term of iten years from product launch in September 2020 and may be extended for a itwo-year period upon the mutual agreement of the parties. We are required to meet certain minimum purchase obligations during each year of the term. Our
minimum purchase obligation for the years ending December 31, 2023 and December 31, 2024 will be $i40 million and $i52 million,
respectively. Minimum purchase obligations after December 31, 2024 may be determined at a later date. We are also required to meet certain minimum expenditure requirements in connection with commercialization efforts. Our minimum expenditures related to the commercialization and promotion of RHA® Collection of dermal fillers and RHA® Pipeline Products for the years ended December 31, 2023 and 2024 will be $i34 million
and $i36 million, respectively. Minimum expenditures related to the commercialization and promotion of RHA® Collection of dermal fillers and RHA® Pipeline Products after December 31, 2024 may be determined at a later date.
Either party may terminate the Teoxane Agreement in the event of the insolvency of, or a material breach by,
the other party, including certain specified breaches that include the right for Teoxane to terminate the Teoxane Agreement for our failure to meet the minimum purchase requirements or commercialization expenditure during specified periods, or for our breach of the exclusivity obligations under the Teoxane Agreement.
Other Contingencies
As of September 30, 2023, we are obligated to pay BTRX up to a remaining $i15.5 million upon the satisfaction of certain milestones relating to our
product revenue, intellectual property, and clinical and regulatory events.
Indemnification
We have standard indemnification agreements in the ordinary course of business. Under these indemnification agreements, we indemnify, hold harmless, and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect to our technology. The term of these indemnification agreements is generally perpetual after the execution of the agreements. The maximum potential amount of future payments we are obligated to pay under other indemnification agreements is not determinable because it involves claims for indemnification that may be made against us in the future but have not been made. We have not yet incurred material costs
to defend lawsuits or settle claims related to indemnification agreements.
We have indemnification agreements with our directors and officers that may require us to indemnify them against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual.
For the nine months ended September 30, 2023 and 2022, iino/ material
amounts associated with the indemnification agreements have been recorded.
Litigation
In October 2021, Allergan filed a complaint against us and ABPS, one of our manufacturing sources of DAXXIFY®, in the U.S. District Court for the District of Delaware, alleging infringement of the following patents assigned and/or licensed to Allergan: U.S. Patent Nos. 11,033,625; 7,354,740; 8,409,828; 11,124,786; and 7,332,567. Allergan claims that our formulation for DAXXIFY® and ABPS’s manufacturing process used to produce DAXXIFY® infringes its patents. Allergan also asserted a patent with claims related to a substrate for use in a botulinum toxin detection assay. On November 3, 2021, we filed a motion to
dismiss. On November 24, 2021, Allergan filed an amended complaint against us and ABPS, alleging
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
infringement of an additional patent assigned and/or licensed to Allergan: U.S. Patent No. 11,147,878. On December 17, 2021, we filed a second motion to dismiss, and on January
14, 2022, Allergan filed an opposition to that motion. We filed a reply to Allergan’s opposition on January 21, 2022, and on August 19, 2022, the court denied our second motion to dismiss. On September 2, 2022, we filed an answer and counterclaims to Allergan’s amended complaint. On December 30, 2022, Allergan filed a second amended complaint against us and ABPS, alleging infringement of ithree additional
patents assigned and/or licensed to Allergan: U.S. Patent Nos. 11,203,748; 11,326,155; and 11,285,216. On January 20, 2023, we filed an answer and counterclaims to Allergan's second amended complaint. On March 3, 2023, we filed invalidity contentions, which challenge Allergan’s asserted patents. A Markman hearing was held on June 28, 2023, and a decision was issued on August 29, 2023. On September 15, 2023, U.S. Patent No. 7,332,567 was dismissed from the case with prejudice.
On December 10, 2021, a putative securities class action complaint was filed against the
Company and certain of its officers on behalf of a class of stockholders who acquired the Company’s securities from November 25, 2019 to October 11, 2021, in the U.S. District Court for the Northern District of California.The complaint alleges that the Company and certain of its officers violated Sections 10(b) and 20(a) of Exchange Act by making false and misleading statements regarding the manufacturing of DAXXIFY® and the timing and likelihood of regulatory approval and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including reasonable attorneys’
fees. The court appointed the lead plaintiff and lead counsel on September 7, 2022. The lead plaintiff filed an amended complaint on November 7, 2022. On January 23, 2023, we filed a motion to dismiss. On March 8, 2023, the lead plaintiff filed an opposition to our motion to dismiss. On April 7, 2023, we filed a reply in support of our motion to dismiss. A hearing on our motion to dismiss took place on August 10, 2023, and we are awaiting a decision from the court. We cannot be certain of whether that motion to dismiss will be granted.
We dispute the claims in these lawsuits and intend to defend the matters vigorously. These lawsuits
are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of either lawsuit, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with each lawsuit.
We record a provision for a liability when we believe that it is both probable that a liability has incurred, and the amount can be reasonably estimated. As of both September 30, 2023 and December 31, 2022, iino/
such provision for liabilities related to the above litigation matters were recorded on the condensed consolidated balance sheets.
13. iSegment Information
Reportable Segments
We report segment information based on the management approach. The management approach designates the internal reporting used by the CODM for making decisions and assessing performance as the source of our reportable segments.
We
have itwo reportable segments: the Product Segment and the Service Segment. Each reportable segment represents a component, or an operating segment, for which separate financial information is available that is utilized on a regular basis by our CODM in determining resource allocations and performance evaluation. We also considered whether the identified operating segments should be further aggregated based on factors including economic characteristics, the nature of products and services, production processes, customer base, distribution methods, and regulatory environment; however, no such aggregation was made
due to dissimilarity of the operating segments.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Product Segment
Our Product Segment refers to the business that includes the research, development and commercialization of our approved products and product candidates, including DAXXIFY®, the onabotulinumtoxinA biosimilar and the RHA®
Collection of dermal fillers.
Service Segment
Our Service Segment refers to the business that includes the development and commercialization of the Fintech Platform. In September 2023, we commenced a restructuring plan to exit the Fintech Platform business. We expect all Fintech Platform payment operations to be discontinued by or around March 31, 2024.
Corporate and Other Expenses
Corporate and other expenses include operating expenses related to general and administrative expenses, depreciation and amortization, stock-based compensation, and intersegment elimination that are not used in evaluating the results of, or in allocating resources to, our segments. Intersegment revenue represents the revenue generated between the itwo
segments. For the three months ended September 30, 2023 and 2022, intersegment revenue was $i0.7 million and $i0.4 million,
respectively. For the nine months ended September 30, 2023 and 2022, intersegment revenue was $i2.0 million and $i0.9 million,
respectively.
i
Reconciliation of Segment Revenue to Consolidated Revenue
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands)
2023
2022
2023
2022
Revenue:
Product Segment
$
i54,112
$
i27,051
$
i154,299
$
i78,598
Service
Segment
i2,664
i1,964
i9,942
i4,046
Total
revenue
$
i56,776
$
i29,015
$
i164,241
$
i82,644
/i
Reconciliation
of Segment Loss from Operations to Consolidated Loss from Operations
Three Months Ended September 30,
Nine Months Ended September 30,
(in thousands)
2023
2022
2023
2022
Loss
from operations:
Product Segment
$
(i9,032)
$
(i32,100)
$
(i41,097)
$
(i82,020)
Service
Segment (1)
(i98,169)
(i4,423)
(i110,234)
(i13,956)
Corporate
and other expenses
(i32,092)
(i40,961)
(i111,493)
(i101,571)
Total
loss from operations
$
(i139,293)
$
(i77,484)
$
(i262,824)
$
(i197,547)
/
(1)For
the three and nine months ended September 30, 2023, loss from operations for the Service Segment included an impairment loss of $ii93.2/
million as discussed in Note 5.
We do not evaluate performance or allocate resources based on segment asset data, and therefore such information is not presented.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the accompanying notes appearing elsewhere in this Report and in conjunction with our other SEC filings, including our FY2022 10-K.
This Report, including the documents incorporated by reference herein, contains forward-looking statements within the meaning of the Securities Act, and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this Report and the documents incorporated by reference herein, including statements regarding our future financial condition, regulatory approvals, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words
“may,”“will,”“could,”“would,”“should,”“expect,”“intend,”“plan,”“anticipate,”“believe,”“estimate,”“predict,”“project,”“potential,”“continue,”“ongoing” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. In addition, any statements that refer to our financial outlook or projected performance, anticipated growth, milestone expectations, future expenses and cash flows, anticipated working capital requirements, capital expenditures and capital allocation plans; our ability to comply with our debt obligations; the evaluation of the variable transaction price related to Viatris Agreement; the availability of the Third Tranche; our ability to sell stock under the 2022 ATM Agreement; our future financing plans and strategies; DAXXIFY® pricing
strategy, including in comparison to competing products; our future responses to macroeconomic and geopolitical factors, including the effects of the COVID-19 pandemic; our ability to successfully commercialize and maintain regulatory approvals for DAXXIFY®; the commercial launch timing for DAXXIFY® for the treatment of cervical dystonia; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers; our opportunity in aesthetics and therapeutics; our expectations regarding the Fintech Platform, including future cash flows, future restructuring charges and the timing and process related to the exit of the Fintech Platform business; the process and timing of, and ability to complete, the current and anticipated future pre-clinical
and clinical development of our product candidates, including the outcome of such clinical studies and trials; the design of our clinical studies; development of an onabotulinumtoxinA biosimilar, which would compete in the existing short-acting neuromodulator marketplace; the process and our ability to effectively and reliably manufacture supplies of DAXXIFY®; our ability to manufacture or receive sufficient supply of our Products in order to meet commercial demand; our ability to successfully compete in the dermal filler and neuromodulator markets; the markets for our current and future products; our business strategy, plans and prospects, including our commercialization plans; the potential benefits of our products; the potential safety, efficacy and duration of our products; our ability to maximize our Product outcomes; our third-party collaborations, including expansion into China through the Fosun partnership and the
timing of approvals in China; the extent to which our products are considered innovative; consumer preferences related to our Products; the rate and degree of economic benefit of DAXXIFY® and the RHA® Collection of dermal fillers, and our other drug product candidates, if approved; our ability to set a new standard in healthcare; patent defensive measures; timing related to our ongoing litigation matters; our ability to defend ourselves in ongoing litigation; international expansion; our ability to expand our operations to support the commercialization of our Products and attract and retain qualified personnel to support our business; shares of Common Stock to be purchased under the 2014 ESPP; and our ability to comply with applicable laws and regulations are forward-looking statements. We have based these forward-looking statements
on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in Item 1A. “Risk Factors” and elsewhere in this Report and our FY2022 10-K and our Quarterly Report on Form 10-Q for the period ended March 31, 2023.
You should not rely upon forward-looking statements as predictions of future events. These forward-looking statements represent our estimates and assumptions only as of the date of this Report. Except as required by law, we undertake no obligation to update
publicly any forward-looking statements for any reason to conform these statements to actual results or to changes in our expectations. You should read this Report, together with the information incorporated herein by reference, 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 these cautionary statements.
•Our success as a company, including our ability to finance our business and generate revenue, and our future growth is substantially dependent on the commercial and clinical success of our Products. Our longer-term prospects will also depend on the successful development, regulatory approval and commercialization of our onabotulinumtoxinA biosimilar product candidate and any future
product candidates. If we are unable to successfully commercialize our Products, complete the development and regulatory approval process of our product candidates, and maintain regulatory approval of our Products, we may not be able to generate sufficient revenue to continue our business.
•DAXXIFY®, the RHA® Collection of dermal fillers, and any future product candidates, if approved, may not achieve market acceptance among injectors, consumers and patients and may not be commercially successful, which would adversely affect our operating results and financial condition.
•We have incurred significant losses since our inception and we anticipate that we will
continue to incur GAAP operating losses for the foreseeable future, and may not achieve profitability in the future. Our prior losses, combined with expected future losses, may adversely affect the market price of our common stock and our ability to raise capital as needed and continue operations.
•DAXXIFY®, the RHA® Collection of dermal fillers and any future product candidates will face significant competition, including from companies that enjoy significant competitive advantages, such as substantially greater financial, research and development, regulatory, manufacturing, marketing resources and expertise, greater brand recognition, more favorable pricing and third-party reimbursement and more established relationships. Our failure to effectively compete may prevent
us from achieving significant market penetration and expansion.
•If we are not able to effectively and reliably manufacture DAXXIFY® or any future product candidates at sufficient scale, including through any third-party manufacturers, as well as acquire supplies of the RHA® Collection of dermal fillers from Teoxane, our product development, regulatory approval, commercialization and sales efforts and our ability to generate revenue may be adversely affected.
•We use third-party collaborators, including Teoxane, Viatris, Fosun, ABPS and PCI to help us develop, validate, manufacture and/or commercialize our products. Our ability to commercialize our products could be impaired
or delayed if these collaborations are unsuccessful.
•Reports of adverse events or safety concerns involving DAXXIFY®, the RHA® Collection of dermal fillers or other Teoxane approved product candidates, could delay or prevent the Company or Teoxane from maintaining regulatory approval or obtaining additional regulatory approval for DAXXIFY® for additional indications or the RHA® Pipeline Products. The denial, delay or withdrawal of any such approval would negatively impact commercialization and could have a material adverse effect on our ability to generate revenue, business prospects,
and results of operations.
•Unfavorable publicity relating to one or more of our product offerings may affect the public perception of our entire portfolio of Products.
•Macroeconomic and geopolitical factors, including the COVID-19 pandemic, have and may continue to adversely affect our business, as well as those of third-parties on which we rely for significant manufacturing, clinical or other business operations. They may also impact disposable income levels, which could reduce consumer spending and lower demand for our products.
•Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies
and trials may not be predictive of future trial results or actual consumer outcomes.
•If our efforts to protect our intellectual property related to DAXXIFY®, the RHA® Collection of dermal fillers or any future product candidates are not adequate, we may not be able to compete effectively. Additionally, we are currently and in the future may become involved in lawsuits or administrative proceedings to defend against claims that we infringe the intellectual property of others and to
protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming and would have a material adverse effect on our ability to generate revenue if we are unsuccessful.
•We have in the past, and may in the future, undertake restructuring plans, including the exit of the Fintech Platform business, to adjust our investment priorities and manage our operating expenses, which plans may not result in the savings or operational efficiencies anticipated and could result in total costs and expenses that are greater than expected.
•Servicing our debt, including the Notes Payable and 2027 Notes, requires a significant amount of cash to pay our substantial debt. If we are unable to generate such
cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive.
•We are currently, and in the future, may be subject to litigation. If product liability, stockholder derivative actions, additional securities class actions, intellectual property lawsuits or other lawsuits are brought against us and we cannot successfully defend ourselves, we may incur substantial liabilities or be required to limit commercialization of our Products. Even a successful defense would require significant financial and management resources.
•As our business and operations continue to grow, we may need to expand our development, manufacturing, regulatory,
sales, marketing and distribution capabilities. If and when we expand such capabilities, we may encounter difficulties in managing our growth, which could disrupt our operations.
•If we are not successful in discovering, developing, acquiring and commercializing additional product candidates other than our Products, our ability to expand our business and achieve our strategic objectives may be impaired.
•Significant disruptions of information technology systems or security incidents impacting us or third parties upon which we rely could materially adversely affect our business, our reputation, our customer relationships, results of operations and financial condition.
•Changes
in and failures to comply with applicable laws, regulations and standards may adversely affect our business, operations and financial performance.
•If we fail to attract and retain qualified personnel at all levels and functions, we may be unable to successfully execute our objectives.
Revance is a biotechnology company focused on developing
and commercializing innovative aesthetic and therapeutic offerings. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China.
Recent Developments
For the three and nine months ended September 30, 2023, we generated $56.8 million and $164.1 million, respectively, in revenue from the sale of our Products
and our Services. As of September 30, 2023, we had over 6,500 accounts across our aesthetic portfolio of Products, with over 2,500 accounts ordering DAXXIFY®.
DAXXIFY®
Following DAXXIFY® GL Approval, we trained a group of faculty members on DAXXIFY® as part of PrevU, our early experience program for the product, which we initiated in December 2022. PrevU focused on providing practices with product education, tools for practice integration, and the opportunity to gain real-world clinical insights for DAXXIFY®
with the goal of optimizing aesthetic outcomes. We completed the PrevU program in March 2023, which was followed by the targeted commercial launch of DAXXIFY®. Based on real-world learnings and customer feedback, in September 2023, we introduced new pricing for DAXXIFY®, which prices the product to be more competitive with other neuromodulators.
For the three and nine months ended September 30, 2023, we recognized $22.0 million and $60.0 million, respectively, in product revenue from the sale of DAXXIFY®.
In April 2023, the FDA approved our PAS submission for the ABPS manufacturing facility, which is serving as a key DAXXIFY®
commercial drug product supply source. All inventory produced at the ABPS facility prior to DAXXIFY® GL Approval has been released for commercial use.
In August 2023, the FDA approved DAXXIFY® for the treatment of cervical dystonia, and in September 2023, we initiated PrevU, our early experience program for the product. We expect the commercial launch to begin in mid-year 2024.
RHA® Collection of Dermal Fillers
For the three and nine months ended September 30, 2023, we recognized $32.1 million and $94.2 million, respectively, in product revenue from the sale of the RHA®
Collection of dermal fillers.
Fosun Partnership
In April and July 2023, the NMPA accepted Fosun's BLA for DaxibotulinumtoxinA for Injection for the improvement of glabellar lines and treatment of cervical dystonia, respectively. The anticipated approvals for both indications are expected in 2024.
First Amendment to Note Purchase Agreement
On August 8, 2023, we entered into the First Amendment with Athyrium. Pursuant to the First Amendment, the Second Tranche commitment was reduced from $100.0 million to $50.0 million,
and the uncommitted Third Tranche was increased from $100.0 million to $150.0 million. In August 2023, we issued to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million. The notes issued pursuant to the Second Tranche bear interest at an annual fixed interest rate equal to 8.50%.
The First Amendment eliminated the applicability of the Amortization Trigger to the amortization of the Second Tranche and provided for a principal amortization payment schedule for the Second Tranche. See “—Liquidity and Capital
Resources—First Amendment to Note Purchase Agreement” for additional information. Except as explicitly amended, all of the terms and conditions of the Note Purchase Agreement remain in full force and effect.
Exit of the Fintech Platform Business
In September 2023, we commenced a plan to exit the Fintech Platform business because the significant costs and resources required to support OPUL® no longer aligned with the Company’s capital allocation priorities.
The exit and restructuring activities predominantly include a reduction in OPUL® personnel headcount, the termination of OPUL® research and development activities and a reduction of outside services expenses related to OPUL®. We intend to continue processing payments for current OPUL® customers through January 31, 2024.
In connection with these activities, for the three and nine months ended September 30, 2023, we recorded a restructuring charge, primarily consisting of non-cash impairment charges from goodwill and intangible assets of $93.2 million and severance and related costs of $2.0 million. We expect to incur estimated additional restructuring
charges of up to $3 million, and such restructuring charges will be incurred over time through March 31, 2024. See Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 3 — Restructuring” in this Report for additional information regarding restructuring charges.
Results of Operations
We operate in two reportable segments: our Product Segment and our Service Segment. Our Product Segment refers to the business that includes the research, development and commercialization of our approved products and product candidates,
including DAXXIFY®, the onabotulinumtoxinA biosimilar and the RHA® Collection of dermal fillers. Our Service Segment refers to the business that includes the development and commercialization of the Fintech Platform. In September 2023, we commenced a restructuring plan to exit the Fintech Platform business. We expect all Fintech Platform payment operations to be discontinued by or around March 31, 2024.
Revenue
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except percentages)
2023
2022
Change
% Change
2023
2022
Change
% Change
Product
revenue
$
54,109
$
26,081
$
28,028
107
%
$
154,160
$
72,401
$
81,759
113
%
Service
revenue
2,664
1,964
$
700
36
%
9,942
4,046
$
5,896
146
%
Collaboration
revenue
3
970
$
(967)
(100)
%
139
6,197
$
(6,058)
(98)
%
Total
revenue
$
56,776
$
29,015
$
27,761
96
%
$
164,241
$
82,644
$
81,597
99
%
Product
Revenue
Our breakdown of revenue by Product is summarized below:
For the three and nine months ended September 30, 2023, our Product revenue from the sale of the RHA® Collection of dermal fillers increased compared to the same periods in 2022 primarily due to increased sales volume of the RHA® Collection of dermal fillers.
We started to generate product revenue from DAXXIFY® in the fourth quarter of 2022 from the pre-launch promotional PrevU program for select
practice partners. We completed the PrevU program in March 2023, which was followed by the targeted commercial launch of DAXXIFY®.Based on real-world learnings and customer feedback, in September 2023, we introduced new pricing for DAXXIFY®, which prices the product to be more competitive with other neuromodulators.
Service Revenue
Our service revenue is generated from the Fintech Platform, which earns revenues through payment processing fees and certain value-added services. In our HintMD Platform service offerings, we generally recognize service revenue net of costs as an accounting agent. In our OPUL® service offerings, we generally recognize service revenue on a gross basis as the accounting
principal because, as the PayFac, we maintain control of the service offerings to our customers. Since the fourth quarter of 2021, we onboarded new customers exclusively to OPUL® and completed the migration of the remaining HintMD customers to OPUL® during the second quarter of 2023. The migration did not have a material impact on the gross margin generated by the Fintech Platform. In September 2023, we commenced a plan to exit the Fintech Platform business. We intend to continue processing payments for current OPUL® customers through January 31, 2024.
For the three and nine months ended September 30, 2023, our service revenue increased compared to the same periods in 2022, primarily due
tothe presentation difference in the revenue accounting method described above. We will continue to recognize service revenue from the Fintech Platform until the completion of the wind down of the payment operations of the Fintech Platform business, which we expect to be by or around January 31, 2024.
Collaboration Revenue
We are actively developing an onabotulinumtoxinA biosimilar in collaboration with Viatris. As described in Part I, Item 1. “Condensed Consolidated Financial Statements (Unaudited)—Notes to Condensed Consolidated Financial Statements (Unaudited) —Note 2—Revenue,” we generally recognize
collaboration revenue for the onabotulinumtoxinA biosimilar program based on the determined transactions price of the contract multiplied by the quotient of the cost of development services incurred over the total estimated cost of development services for the expected duration of our performance obligations in the biosimilar development program per the Viatris Agreement. ASC Topic 606, Revenue from Contracts with Customers (ASC 606) requires that an entity include a constraint on the amount of variable consideration included in the transaction price. Variable consideration is considered “constrained” if there is a potential for significant reversal of cumulative revenue recognized. As part of the constraint evaluation, we considered numerous factors, including a potential shift
in certain responsibilities between the two parties which would result in changes to the net cost sharing payments, for which outcomes are difficult to predict as of the date of this Report. As a result, no collaboration revenue is recognized from the biosimilar program for the nine months ended September 30, 2023. We will continue to evaluate the variable transaction price and related revenue recognition in each reporting period and as the above uncertainties are resolved or other changes in circumstances occur. For the three and nine months ended September 30, 2023, we recognized no revenue related to development services under the Viatris Agreement. For the three and nine months ended September 30, 2022, we recognized $1.0 million and $6.2 million related to the development services under the Viatris Agreement, respectively.
We
are also working with Fosun to develop and commercialize DaxibotulinumtoxinA for Injection in the Fosun Territory under the Fosun License Agreement. As described in Part I, Item 1. “Condensed Consolidated Financial Statements (Unaudited)—Notes to Condensed Consolidated Financial Statements (Unaudited) —Note 2—Revenue,” we evaluated all of the variable payments to be received during the duration of the contract, which included payments from specified milestones, royalties, and estimated supplies to be delivered. For the three and nine months ended September 30, 2023, revenue of less than $0.1 million and $0.1 million was recognized from the Fosun License Agreement, respectively. For
the three and nine months ended September 30, 2022, no revenue was recognized from the Fosun License Agreement.
Cost of product revenue (exclusive of depreciation and amortization)
$
16,821
$
8,681
$
8,140
94
%
$
46,915
$
24,130
$
22,785
94
%
Cost
of service revenue (exclusive of amortization)
2,592
2,055
$
537
26
%
9,976
4,022
$
5,954
148
%
Selling,
general and administrative
69,094
65,775
$
3,319
5
%
212,489
158,697
$
53,792
34
%
Research
and development
13,060
26,103
$
(13,043)
(50)
%
59,044
81,745
$
(22,701)
(28)
%
Goodwill
impairment
77,175
—
$
77,175
N/M
77,175
—
$
77,175
N/M
Intangible asset impairment
16,007
—
$
16,007
N/M
16,007
—
$
16,007
N/M
Depreciation
and amortization
1,320
3,885
$
(2,565)
(66)
%
5,459
11,597
$
(6,138)
(53)
%
Total
operating expenses
$
196,069
$
106,499
$
89,570
84
%
$
427,065
$
280,191
$
146,874
52
%
N/M - Percentage
not meaningful
Cost of product revenue (exclusive of depreciation and amortization)
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except percentages)
2023
2022
Change
% Change
2023
2022
Change
% Change
Cost
of product revenue (exclusive of depreciation and amortization)
Purchasing and manufacturing costs (exclusive of stock-based compensation)
$
15,055
$
8,037
$
7,018
87
%
$
40,668
$
22,407
$
18,261
81
%
Distribution,
royalty and other fulfillment charges
1,408
644
$
764
119
%
4,941
1,723
$
3,218
187
%
Stock-based
compensation
358
—
$
358
N/M
1,306
—
$
1,306
N/M
Total cost of product revenue (exclusive
of depreciation and amortization)
$
16,821
$
8,681
$
8,140
94
%
$
46,915
$
24,130
$
22,785
94
%
N/M - Percentage
not meaningful
Cost of product revenue (exclusive of depreciation and amortization) primarily consists of the purchasing cost of the RHA® Collection of dermal fillers and manufacturing costs of DAXXIFY® inventory (exclusive of stock-based compensation), distribution expenses, royalty, other fulfillment costs related to the RHA® Collection of dermal fillers and DAXXIFY®, and stock-based compensation expenses related to manufacturing efforts.
We obtained DAXXIFY® GL Approval in September 2022, and the first delivery of DAXXIFY® to a customer took place in the fourth quarter of 2022. Cost of product revenue
(exclusive of depreciation and amortization) related to
DAXXIFY® is generally incurred when delivered. Substantially all of DAXXIFY® manufacturing expenses incurred prior to DAXXIFY® GL Approval were classified as research and development expenses, resulting in Zero-cost Inventory.
Our cost of product revenue (exclusive of depreciation and amortization) for the three and nine months ended September 30, 2023 increased
compared to the same periods in 2022, which was due to the higher sales volumes of the RHA® Collection of dermal fillers and sales of DAXXIFY® during the three and nine months ended September 30, 2023. When Zero-cost Inventory, which is further discussed below, is depleted, we expect our cost of product revenue (exclusive of depreciation and amortization) associated with DAXXIFY® to increase. We also anticipate that our cost of product revenue (exclusive of depreciation and amortization) associated with the RHA® Collection of dermal fillers may increase if higher sales volumes result.
Purchasing and manufacturing costs (exclusive of stock-based compensation)
For
the three and nine months ended September 30, 2023, purchasing and manufacturing costs (exclusive of stock-based compensation) related to the RHA® Collection of dermal fillers and DAXXIFY® increased compared to the same periods in 2022 due to idle facility expense and higher sales volumes of our Products.
Distribution, royalty and other fulfillment charges
For the three and nine months ended September 30, 2023, distribution, royalty and other fulfillment charges related to the RHA® Collection of dermal fillers and DAXXIFY® increased compared to the same periods in 2022 due to higher sales volumes
of the RHA® Collection of dermal fillers and DAXXIFY®.
Stock-based compensation
Stock-based compensation expense in cost of product revenue (exclusive of depreciation and amortization) is related to the equity grants of employees in departments involved in the manufacturing of DAXXIFY®. DAXXIFY® manufacturing related stock-based compensation expense incurred prior to DAXXIFY® GL Approval was classified as research and development expenses.
Impact of Zero-cost Inventory for DAXXIFY®
If cost of product revenue included
previously expensed inventories, the cost of product revenue (exclusive of depreciation and amortization) for the three and nine months ended September 30, 2023 would have increased by approximately $3 million and $11 million, respectively, excluding the impact from lease accounting. We expect to utilize Zero-cost Inventory in the near-term until depleted. Once depleted, we expect our cost of product revenue (exclusive of depreciation and amortization) associated with DAXXIFY® to increase.
Cost of Service Revenue (exclusive of amortization)
Costs of service revenue (exclusive of amortization) primarily consists of payment processing costs and the cost of POS devices.
For the three and nine months ended September 30, 2023, cost of service revenue (exclusive of amortization) increased compared to the same periods in 2022 due to the change to the gross accounting presentation of revenue as described in the Service Revenue section above.
In September 2023, we commenced a plan to exit the Fintech Platform business. We intend to continue processing payments for current OPUL® customers through January 31, 2024, at which point we expect our cost of service revenue associated with the Fintech Platform to be eliminated.
Total
selling, general and administrative expenses
$
69,094
$
65,775
$
3,319
5
%
$
212,489
$
158,697
$
53,792
34
%
N/M - Percentage
not meaningful
Selling, general and administrative expenses (before stock-based compensation, restructuring charges and depreciation and amortization)
Selling, general and administrative expenses (before stock-based compensation, restructuring charges and depreciation and amortization) consist primarily of the following:
•Costs of sales and marketing activities and sales force compensation related to DAXXIFY®, the RHA® Collection of dermal fillers and the OPUL®.
•Personnel and professional service costs in our finance, information technology, investor relations, legal, human resources, and other administrative departments; and
For
the three and nine months ended September 30, 2023, selling, general and administrative expenses increased compared to the same periods in 2022, primarily due to an increase in sales and marketing expenses in connection with the DAXXIFY® launch for the respective periods, partially offset by an employee retention credit claim recognized during the three months ended September 30, 2023. We expect selling, general and administrative expenses to increase over the next year in connection with the expansion of our commercial sales team related to therapeutics and incremental administrative and infrastructure support, partially offset by the decrease in OPUL® selling, general and administrative expenses.
Stock-based
compensation
For the three months ended September 30, 2023, stock-based compensation included in selling, general and administrative expenses decreased compared to the same period in 2022, primarily due to the completion of recognizing stock-based compensation expense for the DAXXIFY® GL Approval PSUs in March 2023, which was initiated in September 2022. The decrease was offset by increased headcount in selling, general and administrative functions.
For the nine months ended September 30, 2023, stock-based compensation included in selling, general and administrative expenses increased compared to the same periods in 2022, primarily due to (i) increased headcount in selling, general and administrative functions; (ii) the stock-based compensation
expense recognized for the vesting of certain market-based PSUs in May 2023; offset by the completion of recognizing stock-based compensation expense for the DAXXIFY® GL Approval PSUs in March 2023, which was initiated in September 2022.
For the three and nine months ended September 30, 2023, restructuring charges in selling, general and administrative expenses was $0.7 million associated with the severance and other related costs in the OPUL® selling,
general and administrative function. See Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 3 — Restructuring” in this Report for additional information regarding restructuring charges.
Research and Development Expenses
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except percentages)
2023
2022
Change
% Change
2023
2022
Change
% Change
Research
and development
$
9,907
$
20,845
$
(10,938)
(52)
%
$
46,825
$
66,590
$
(19,765)
(30)
%
Stock-based
compensation
1,688
4,742
$
(3,054)
(64)
%
7,926
13,676
$
(5,750)
(42)
%
Restructuring
charges
1,293
—
$
1,293
N/M
1,293
—
$
1,293
N/M
Depreciation and amortization
172
516
$
(344)
(67)
%
3,000
1,479
$
1,521
103
%
Total
research and development expenses
$
13,060
$
26,103
$
(13,043)
(50)
%
$
59,044
$
81,745
$
(22,701)
(28)
%
N/M - Percentage
not meaningful
Research and development expenses (before stock-based compensation, restructuring charges and depreciation and amortization)
In the Product Segment, we generally do not allocate costs by product candidates unless contractually required by our business partners. In the Service Segment, our research and development expenses relate to the development and introduction of new functionalities and features of OPUL® that are not subject to capitalization. In September 2023, we commenced a restructuring plan to exit the Fintech Platform business. We expect all Fintech Platform payment operations to be discontinued by or around March 31, 2024.
Research and development expenses (before stock-based compensation, restructuring charges and
depreciation and amortization) consist primarily of:
•salaries and related expenses for personnel in research and development functions;
•expenses related to the initiation and completion of clinical trials and studies for DAXXIFY®, the RHA® Pipeline Products and an onabotulinumtoxinA biosimilar, including expenses related to the production of clinical supplies;
•expenses related to the manufacturing of supplies for clinical activities, regulatory approvals, and pre-commercial inventory;
•certain expenses related to the establishment and maintenance of our manufacturing facilities;
•expenses
related to medical affairs, medical information, publications and pharmacovigilance oversight;
•expenses related to license fees, milestone payments, and development efforts under in-licensing agreements;
•expenses related to compliance with drug development regulatory requirements in the U.S. and other foreign jurisdictions;
•fees paid to clinical consultants, CROs and other vendors, including all related fees for investigator grants,
patient
screening fees, laboratory work and statistical compilation and analysis;
•expenses related to the development of new features and functionalities of OPUL® and services that are not eligible for capitalization; and
•other consulting fees paid to third parties;
For the three and nine months ended September 30, 2023, research and development expenses (before stock-based compensation, restructuring charges and depreciation and amortization) decreased compared to the same periods in 2022, primarily due to the effects of capitalizing certain manufacturing related expenses for DAXXIFY® since the third quarter of 2022 and employee retention credit claim recognized
in the three months ended September 30, 2023.
Our research and development expenses (before stock-based compensation, restructuring charges and depreciation and amortization) are subject to numerous uncertainties, primarily related to the timing and cost needed to complete our respective projects. In our Product Segment, the development timelines, probability of success and development expenses can differ materially from expectations, and the completion of clinical trials may take several years or more depending on the type, complexity, novelty and intended use of a product candidate. Accordingly, the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development. We expect our research and development cost (before stock-based compensation, restructuring charges and depreciation and amortization) to be
relatively consistent in the near term, primarily due to deferring the Phase 3 clinical program for upper limb spasticity and other therapeutics pipeline activities. However, we will continue sharing certain development costs with Teoxane related to the RHA® Pipeline Products, and other activities related to the pursuit of approval for the PCI manufacturing facility.
When we conduct additional clinical trials, such as for our biosimilar program or additional DAXXIFY® therapeutic indications, we expect our research and development expenses (before stock-based compensation, restructuring charges and depreciation and amortization) to increase. Depending on the stage of completion and level of effort related to each development phase undertaken, we may reflect variations in our research and development expenses. We expense both internal
and external research and development expenses as they are incurred.
Stock-based compensation
For the three and nine months ended September 30, 2023, stock-based compensation included in research and development expenses decreased compared to the same periods in 2022, primarily due to (i) a stock modification accounting adjustment related to the separation of an executive officer from the Company in the first quarter of 2022; (ii) the capitalized stock-based compensation for 2023; and (iii) the completion of recognizing stock-based compensation expense for the DAXXIFY® GL Approval PSUs in March 2023, which was initiated in September 2022. These decreases were partially offset by a stock modification
accounting adjustment related to achievement of certain performance-based PSUs in May 2023.
Restructuring Charges
For the three and nine months ended September 30, 2023, restructuring charges in research and development expenses was $1.3 million related to severance and other related costs in the OPUL® research and development function. See Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 3 — Restructuring” in this Report for additional information regarding restructuring charges.
Goodwill
Impairment and Intangible Asset Impairment
For both the three and nine months ended September 30, 2023, we recorded goodwill impairment of $77.2 million and intangible asset impairment of $16.0 million. Both goodwill and asset group for OPUL® was impaired based on our plan to exit the Fintech Platform business. See Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 5 — Goodwill and intangible Assets, net ” in this Report for impairment discussion.
Depreciation and amortization presented separately on the condensed consolidated statements of operations and comprehensive loss represents the depreciation and amortization for the assets within the functional area of costs of revenue.
For the three and nine months ended September 30, 2023, depreciation and amortization decreased compared to the same periods in 2022, primarily due to the impairment of intangible assets related to the Fintech Platform, the extension of the useful life of Teoxane distribution rights, and completion of amortization for developed technology related to HintMD in 2022.
Net
Non-Operating Income and Expense
Three
Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except percentages)
2023
2022
Change
% Change
2023
2022
Change
% Change
Interest
income
$
3,733
$
1,165
$
2,568
220
%
$
9,851
$
1,860
$
7,991
430
%
Interest
expense
(5,093)
(6,917)
$
1,824
(26)
%
(13,958)
(12,722)
$
(1,236)
10
%
Other
expense, net
(223)
(757)
$
534
(71)
%
(1,056)
(1,361)
$
305
(22)
%
Total
net non-operating expense
$
(1,583)
$
(6,509)
$
4,926
(76)
%
$
(5,163)
$
(12,223)
$
7,060
(58)
%
Interest
Income
Interest income primarily consists of interest income earned on our deposit, money market fund, and investment balances. We expect interest income to vary each reporting period depending on our average deposit, money market fund, and investment balances during the period and market interest rates. For the three and nine months ended September 30, 2023, interest income increased compared to the same periods in 2022, primarily due to higher interest rates and higher investment balances.
Interest Expense
Interest expense includes cash and non-cash components. The cash component of the interest expense primarily consists of the contractual interest charges for our 2027 Notes and Notes Payable, as well as our finance lease liability interest expense. The non-cash component of the interest
expense primarily consists of the amortization of debt issuance costs for our 2027 Notes and the amortization of debt insurance cost and debt discount for the Notes Payable.
For three months ended September 30, 2023, interest expense decreased compared to the same period in 2022 due to the interest expense for our finance lease liability, offset by an increase in contractual interest due to the issuance of the Second Tranche of the Notes Payable in August 2023. For the nine months ended September 30, 2023, interest expense increased compared to the same period in 2022 due to the contractual interest on the Notes Payable, which began to incur in late March 2022, and the issuance of the Second Tranche of the Notes Payable in August 2023, offset by the interest expense for our finance lease liability.
Other
Expense, net
Other expense, net primarily consists of miscellaneous tax and other expense items.
Cash, cash equivalents, and short-term investments
$
300,245
$
340,707
$
(40,462)
Working capital
$
306,361
$
299,045
$
7,316
Stockholders’
equity (deficit)
$
(106,201)
$
12,600
$
(118,801)
Sources and Uses of Cash
We hold our cash, cash equivalents, and short-term investments in a variety of non-interest bearing bank accounts and interest-bearing instruments subject to investment guidelines for high credit quality. Our investment portfolio is structured to provide for investment maturities and access to cash to fund our anticipated working capital needs.
As of September
30, 2023 and December 31, 2022, we had cash, cash equivalents and short-term investments of $300.2 million and $340.7 million, respectively, which reflected a decrease between these periods of $40.5 million. The decrease was primarily due to cash used in our operating activities of $170.2 million, principal payments on a finance lease of $15.5 million, taxes paid related to net settlement of stock awards of $8.1 million, the purchase of property and equipment of $5.1 million, and finance lease prepayments of $3.4 million. The decrease was primarily offset by proceeds from the ATM of $100.0 million, net of commissions and offerings costs, issuance of the Notes Payable, net of debt discount and issuance costs of $47.8 million, and the proceeds from stock option exercises and ESPP purchases of $14.0 million.
We derived the following summary of our condensed consolidated cash
flows for the periods indicated from Part I, Item 1, “Financial Information—Condensed Consolidated Financial Statements (Unaudited)” in this Report:
Nine Months Ended September 30,
(in thousands)
2023
2022
Net cash provided by (used in):
Operating
activities
$
(173,844)
$
(163,366)
Investing activities
$
107,370
$
(179,758)
Financing activities
$
138,196
$
337,867
Cash
Flows from Operating Activities
Our cash used in operating activities is primarily driven by personnel costs, manufacturing and facility costs, sales and marketing activities, clinical development activities, offset by revenue generated from our Products and Services. Our cash flows from operating activities will continue to be affected principally by the revenue generated from our Products and Services, our working capital requirements and the extent to which we increase spending on personnel, commercial activities, and research and development activities as our business grows.
Cash used in operating activities for the nine months ended September 30, 2023 consisted of approximately $326 million in expenditures related to overall operations, offset by approximately $152 million in cash receipts from our revenue. The increase in net
cash used in operating activities for the nine months ended September 30, 2023, compared to 2022 is primarily driven by expenditures related to supporting company growth, and partially offset by an increase in cash receipt from Product sales.
Cash used in operating activities for the nine months ended September 30, 2022 consisted of approximately $241 million in expenditures related to overall operations, offset by approximately $78 million in cash receipt from our revenue.
For the nine months ended September 30, 2023 and 2022, net cash provided by or used in investing activities was primarily due to fluctuations in the timing of purchases and maturities of investments, purchase of property and equipment and prepayments for a finance lease.
Cash Flows from Financing Activities
For the nine months ended September 30, 2023 and 2022, net cash provided by financing activities was driven by the proceeds from the ATM offering program, net of commissions, the issuance of the Notes Payable pursuant to the Note Purchase Agreement, net of debt discount and the exercise of stock options and purchases of our common
stock through the ESPP. The inflows were offset by the net settlement of stock awards for employee taxes, and principal payments on finance lease obligations.
Note Purchase Agreement
In March 2022, we entered into the Note Purchase Agreement and issued the First Tranche in an aggregate principal amount for all such Notes of $100 million. In August 2023, the Company, HintMD and Athyrium entered into the First Amendment. Pursuant to the First Amendment, the Second Tranche commitment was reduced from $100 million to $50 million. Additionally, the First Amendment increased the uncommitted Third Tranche from $100 million to $150 million. In August 2023, we issued to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50 million. The uncommitted Third Tranche is
available until March 31, 2024, subject to the satisfaction of certain conditions set forth in the Note Purchase Agreement, including the achievement of greater than or equal to $50 million in trailing twelve months revenue for DAXXIFY® preceding the date of the draw request for the Third Tranche, and approval by Athyrium.
Our obligations under the Note Purchase Agreement are secured by substantially all of our assets and the assets of our wholly owned domestic subsidiaries, including their respective intellectual property.
The notes issued pursuant to the First Tranche and Second Tranche bear interest at an annual fixed interest rate equal to 8.50%. The First Amendment modified the variable interest
rate adjustment for the Third Tranche from Adjusted Three-Month LIBOR to Adjusted Three-Month Term SOFR. If the Third Tranche of Notes Payable becomes committed, the Notes Payable will then bear interest at an annual rate equal to the sum of (a) 7.0% and (b) Adjusted Three-Month Term SOFR for such interest period (subject to a floor of 1.50% and a cap of 2.50%). We are required to make quarterly interest payments on each Notes Payable commencing on the last business day of the calendar month following the funding date thereof, and continuing until the Maturity Date. Pursuant to the First Amendment, the Company is required to repay Athyrium the outstanding principal amount of the Second Tranche notes in installments on the last business day of each March, June, September and December (commencing in September 2024), in each case, based on the following principal amortization payment
schedule: 2.5% in September and December 2024; 5.0% in March and June 2025; 7.5% in September and December 2025; and 10.0% in March and June 2026; followed by repayment of the Second Tranche in full on September 18, 2026. The Maturity Date may be extended to March 18, 2028 if, as of September 18, 2026, less than $90 million principal amount of our existing 2027 Notes remain outstanding and with the consent of the Purchasers. Initially, all principal for each tranche is due and payable on the Maturity Date. If any Third Tranche notes are issued, upon the occurrence of an Amortization Trigger (as defined in the Note Purchase Agreement), we are required to repay the principal of the Third Tranche in equal monthly installments beginning on the last day of the month in which the Amortization Trigger occurred and continuing through
the Maturity Date. At our option, we may prepay the outstanding principal balance of all or any portion of the principal amount of the Notes Payable, subject to a prepayment fee equal to (i) a make-whole amount if the prepayment occurs on or prior to the first anniversary of the NPA Effective Date and (ii) 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the NPA Effective Date but on or prior to the second anniversary of the NPA Effective Date. Upon prepayment or repayment of all or any portion of the principal amount of the Notes Payable (whether on the Maturity Date or otherwise), we are also required to pay an exit fee to the Purchasers.
The Note Purchase Agreement includes affirmative and negative covenants applicable to us, our current subsidiaries and any subsidiaries
we create in the future. The affirmative covenants include, among others, covenants requiring us to
maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. We must also (i) maintain at least $30.0 million of unrestricted cash and cash equivalents in accounts subject to a control agreement in favor of Athyrium at all times and (ii) upon the occurrence of certain specified events set forth in the Note Purchase Agreement, achieve at least $70.0 million of Consolidated Teoxane Distribution Net Product Sales on a trailing twelve-months
basis. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and undergoing a change in control, in each case subject to certain exceptions.
If we do not comply with the affirmative and negative covenants, such non-compliance may be an event of default under the Note Purchase Agreement. The Note Purchase Agreement also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 2.0% and would provide Athyrium, as administrative agent, with the right to exercise remedies against us and the collateral, including foreclosure against our property securing the obligations under the Note Purchase Agreement, including our cash. These events
of default include, among other things, our failure to pay principal or interest due under the Note Purchase Agreement, a breach of certain covenants under the Note Purchase Agreement, our insolvency, the occurrence of a circumstance which could have a material adverse effect and the occurrence of any default under certain other indebtedness.
Convertible Senior Notes
In February 2020, we issued the 2027 Notes, in the aggregate principal amount of $287.5 million, pursuant to the Indenture. The 2027 Notes are senior unsecured obligations and bear interest at a rate of 1.75% per year, payable semiannually in arrears on February 15 and August 15 of each year, began on August 15, 2020. The 2027 Notes will mature on February
15, 2027, unless earlier converted, redeemed or repurchased. In connection with issuing the 2027 Notes, we received $278.3 million in net proceeds, after deducting the initial purchasers’ discount, commissions, and other issuance costs.
The 2027 Notes may be converted at any time by the holders prior to the close of business on the business day immediately preceding November 15, 2026 only under the following circumstances: (i) during any fiscal quarter commencing after the fiscal quarter ending on June 30, 2020 (and only during such fiscal quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding fiscal quarter is greater than or equal to 130%
of the conversion price on each applicable trading day; (ii) during the measurement period in which the trading price (as defined in the Indenture) per $1,000 principal amount of the 2027 Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; (iii) if we call any or all of the 2027 Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after November 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2027 Notes at any time, regardless of the foregoing
circumstances. Upon conversion, we will pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election.
The conversion rate will initially be 30.8804 shares of our common stock per $1,000 principal amount of the 2027 Notes (equivalent to an initial conversion price of approximately $32.38 per share of our common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if we deliver a notice of redemption, we will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2027 Notes in connection with such a corporate event or notice of redemption, as the case may be.
Contractually, we may not redeem the 2027
Notes prior to February 20, 2024. We may redeem for cash all or any portion of the 2027 Notes, at our option, on or after February 20, 2024 if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the
principal
amount of the 2027 Notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2027 Notes.
If we undergo a fundamental change (as defined in the Indenture), holders may require us to repurchase for cash all or any portion of their 2027 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2027 Notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.
We used $28.9 million of the net proceeds from the 2027 Notes to pay the cost of the capped call transactions. The capped call transactions are expected generally to reduce the potential dilutive effect upon conversion of the 2027 Notesand/or
offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes, as the case may be, with such reduction and/or offset subject to a price cap of $48.88 of our common stock per share, which represents a premium of 100% over the last reported sale price of our common stock on February 10, 2020. The capped calls have an initial strike price of $32.38 per share, subject to certain adjustments, which corresponds to the conversion option strike price in the 2027 Notes. The capped call transactions cover, subject to anti-dilution adjustments, approximately 8.9 million shares of our common stock.
ATM Offering Programs
In November 2020, we entered into the 2020 ATM Agreement. From January
1, 2022 through May 10, 2022, we sold 1.7 million shares of common stock at a weighted average price of $18.71 per share resulting in net proceeds of $31.6 million after sales agent commissions and offering costs. We terminated the 2020 ATM Agreement on May 10, 2022.
On May 10, 2022, we entered into the 2022 ATM Agreement with Cowen. Under the 2022 ATM Agreement, we may sell up to $150.0 million of our common stock. For the nine months ended September 30, 2023, we sold 3.2 million shares of common stock under the 2022 ATM Agreement at a weighted average price of $31.90 per share, resulting in net proceeds of $100.0 million after sales agent commissions and offering costs. No shares of common stock were sold under the 2022 ATM
Agreement for the three months ended September 30, 2023.
Common Stock and Common Stock Equivalents
As of October 31, 2023, outstanding shares of common stock were 87.8 million, outstanding stock options were 3.9 million, unvested RSUs and PSUs were 3.2 million, unvested RSAs and PSAs were 0.9 million, shares expected to be purchased on December 31, 2023 under the 2014 ESPP were 0.1 million and shares of common stock underlying the 2027 Notes was 8.9 million, based upon the initial conversion price.
Operating
and Capital Expenditure Requirements
We expect to continue to incur GAAP operating losses for the foreseeable future as we continue to devote resources to the research, development, manufacturing development, regulatory approval and/or commercialization of our products.
Disciplined capital allocation continues to be a priority; however, we expect that we will continue to expend substantial resources for the foreseeable future to support the growth of the aesthetics portfolio of Products and DAXXIFY® for the treatment of cervical dystonia and to support our ongoing operations. In particular, we anticipate that we will continue to invest substantial resources in our commercialization efforts across aesthetics and therapeutics and the manufacturing and supply of DAXXIFY® for commercialization.
In addition, in connection with the Teoxane Agreement, we must continue to make specified annual minimum purchases of the RHA® Collection of dermal fillers and meet annual minimum investments in connection with the commercialization of the RHA® Collection of dermal fillers. In addition, we have dedicated manufacturing capacity, buyback obligations, cost sharing arrangements and related minimum purchase obligations under our manufacturing and supply agreements in connection with the manufacture and supply of DAXXIFY® and any product candidate. We also anticipate expending resources to continue to support the onabotulinumtoxinA biosimilar and Fosun partnerships. In the long term, in addition to the aforementioned expenditures, we anticipate our expenditures will include clinical programs for DAXXIFY®
in other potential indications and international regulatory investments.
To date, we have funded our operations primarily through the sale of common stock, convertible senior notes, payments received from collaboration arrangements, sales of our Products and, proceeds from notes issued pursuant to the Note Purchase Agreement. We believe that our existing capital resources will be sufficient to fund the operating plan through at least the next 12 months following the issuance of this Report.
However, we may need to raise substantial additional financing in the future to fund our operations. In addition,
our estimates regarding the amounts necessary to accomplish our business objectives may be inaccurate, other unanticipated costs may arise and our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional capital sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe that we have sufficient funds for our current or future operating plans.
Please read Part II, Item 1A. “Risk Factors —We have incurred significant losses since our inception, and we anticipate that we will continue to incur GAAP operating losses for the foreseeable future,
and may not achieve or maintain profitability in the future”, in this Report for additional information.
Critical Accounting Policies and Estimates
For the nine months ended September 30, 2023, there have been no material changes in our critical accounting policies compared to those disclosed in Item 7 in our FY2022 10-K.
Contractual Obligations
In August 2023, we entered into the First Amendment with Athyrium and subsequently issued $50 million Notes Payable. As of September
30, 2023, our total obligation for the principal and interest of the Second Tranche is $61.0 million through the maturity date of September 2026, of which $5.6 million consisted of short-term obligations and the remainder consisted of long term obligations. See Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 9—Debt” in this Report for details of Notes Payable.
Except for the issuance of the Second Tranche above, there were no material changes outside of the ordinary course of business in our contractual obligations as of September 30, 2023, from those as of December 31, 2022 as reported in our FY2022 10-K.
Recent
Accounting Pronouncements
Refer to “Recent Accounting Pronouncements” in Part I, Item 1, “Financial Information—Notes to Condensed Consolidated Financial Statements (Unaudited)—Note 1—The Company and Summary of Significant Accounting Policies” in this Report.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse
changes in financial market prices and rates. Our market risk exposure is primarily a result of fluctuations in interest rates. We do not hold or issue financial instruments for trading purposes. For the nine months ended September 30, 2023, our exposure to market risk did not change materially from what was disclosed in Item 7A in our FY2022 10-K.
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Report. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the
Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of the end of the period covered by this Report, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial
Reporting
For the three months ended September 30, 2023, there were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We are currently involved in litigation relating to claims arising out of our operations and may be involved in such litigation in the future. Such matters are subject to uncertainty and there can be no assurance that such legal proceedings will not have a material adverse effect on our business, results of operations, financial position or cash flows.
In October 2021, Allergan filed a complaint against us and ABPS, one of our manufacturing sources of DAXXIFY®, in the U.S. District Court for the District of Delaware, alleging infringement of the following patents assigned and/or licensed to Allergan: U.S. Patent Nos. 11,033,625; 7,354,740; 8,409,828; 11,124,786; and 7,332,567. Allergan claims that our formulation for DAXXIFY® and ABPS’s manufacturing process used to produce
DAXXIFY® infringes its patents. Allergan also asserted a patent with claims related to a substrate for use in a botulinum toxin detection assay. On November 3, 2021, we filed a motion to dismiss. On November 24, 2021, Allergan filed an amended complaint against us and ABPS, alleging infringement of an additional patent assigned and/or licensed to Allergan: U.S. Patent No. 11,147,878. On December 17, 2021, we filed a second motion to dismiss, and on January 14, 2022, Allergan filed an opposition to that motion. We filed a reply to Allergan’s opposition on January 21, 2022, and on August 19, 2022, the court denied our second motion
to dismiss. On September 2, 2022, we filed an answer and counterclaims to Allergan’s amended complaint. On December 30, 2022, Allergan filed a second amended complaint against us and ABPS, alleging infringement of three additional patents assigned and/or licensed to Allergan: U.S. Patent Nos. 11,203,748; 11,326,155; and 11,285,216. On January 20, 2023, we filed an answer and counterclaims to Allergan's second amended complaint. On March 3, 2023, we filed invalidity contentions, which challenge Allergan’s asserted patents. A Markman hearing was held on June 28, 2023, and a decision was issued on August 29, 2023. On September 15,
2023, U.S. Patent No. 7,332,567 was dismissed from the case with prejudice.
On December 10, 2021, a putative securities class action complaint was filed against the Company and certain of its officers on behalf of a class of stockholders who acquired the Company’s securities from November 25, 2019 to October 11, 2021, in the U.S. District Court for the Northern District of California.The complaint alleges that the Company and certain of its officers violated Sections 10(b)
and 20(a) of Exchange Act by making false and misleading statements regarding the manufacturing of DAXXIFY® and the timing and likelihood of regulatory approval and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including reasonable attorneys’ fees. The court appointed the lead plaintiff and lead counsel on September 7, 2022. The lead plaintiff filed an amended complaint on November 7, 2022. On January 23, 2023, we filed a motion to dismiss. On March 8, 2023, the lead plaintiff filed an opposition to our motion to dismiss. On April 7, 2023, we filed a reply in support of our motion to dismiss. A hearing on our motion to
dismiss took place on August 10, 2023, and we are awaiting a decision from the court. We cannot be certain of whether that motion to dismiss will be granted.
We dispute the claims in these lawsuits and intend to defend these matters vigorously. These lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcomes of the lawsuits are necessarily uncertain. We could be forced to expend significant resources in the defense of either lawsuit, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with each lawsuit.
ITEM 1A. RISK
FACTORS
You should carefully consider the risks described below, as well as all other information included in this Report, including our consolidated financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and Part I, Item IA of our FY2022 10-K and Part II, Item 1A in our Q1 2023 10-Q, before you decide to purchase shares of our common stock. If any of the following risks actually occurs, our business, prospects, financial condition and operating results could be materially harmed. As a result, the trading price of our common stock could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and stock price.
Below we are providing, in supplemental
form, material changes to our risk factors from those previously disclosed in Part I, Item 1A in our FY2022 10-K and Part II, Item 1A in our Q1 2023 10-Q. Our risk factors disclosed in Part I, Item 1A of the FY2022 10-K and Part II, Item 1A in our Q1 2023 10-Q provide additional discussion about these supplemental risks,
and we encourage you to read and carefully consider the risk factors disclosed in those reports for a more complete understanding of the risks and uncertainties material to our business.
We are substantially dependent on the clinical and commercial success of our Products.
Our
near-term prospects and our future growth, including our ability to finance our business and generate revenue, is substantially dependent on the clinical and commercial success of DAXXIFY® and our ability to continue to generate revenue from the sales of the RHA® Collection of dermal fillers.
In September 2022, we announced the DAXXIFY® GL Approval. Although we have generated $71.0 million in revenue from the commercial sale of DAXXIFY® as of September 30, 2023, we only began generating sales in late 2022 and have not yet demonstrated that DAXXIFY® can continue to be commercially successful in the aesthetics market. In addition, in September 2023,
we introduced new pricing for DAXXIFY®, which positions the product to be priced more in-line with its competitors. We cannot guarantee that our aesthetics strategy will lead to additional product adoption or be commercially successful. In August 2023, we announced the approval of DAXXIFY® for the treatment of cervical dystonia, which is our first therapeutics indication. We have limited experience in commercializing products in the therapeutics space and have not yet demonstrated that DAXXIFY® for the treatment of cervical dystonia will be commercially successful. In addition, we have not received regulatory approval for or completed the clinical development process for DAXXIFY® for indications other than glabellar lines and cervical dystonia.
Although
the commercialization of the RHA® Collection of dermal fillers has been successful, we cannot predict the extent to which it will continue to be successful. The successful commercialization of DAXXIFY® and continued commercial success of the RHA® Collection of dermal fillers will depend on a number of factors, including the risks identified in this “Item 1A. Risk Factors.” These factors include, among other things:
•the rate and degree of commercial acceptance, potential market size, opportunity and growth potential of our Products;
•our ability to effectively and reliably manufacture or obtain adequate and timely supplies of DAXXIFY® to meet
commercial demand and obtain adequate and timely supply of the RHA® Collection of dermal fillers;
•the timing, success, and cost of commercialization activities and other activities needed to operate our business;
•our ability to demonstrate in the medical community the safety, efficacy and duration of our Products and their potential advantages over and side effects compared to competing Products;
•our ability to establish and maintain relationships with injectors who will be treating the consumers and patients who may receive our products;
•our ability to obtain adequate pricing and reimbursement for DAXXIFY® in
therapeutics;
•our ability to continue to expand our own sales, marketing and other capabilities and infrastructure, or seek collaborative partners, to commercialize our Products as needed, including with respect to therapeutics;
•reports of adverse events or safety concerns involving our Products and the impact of any such reports on their commercialization;
•enforcing our intellectual property rights in and to our Products;
•avoiding third-party patent interference or intellectual property infringement claims;
•our ability to comply with the terms of the Teoxane Agreement, including our obligations with respect to purchase quantities and marketing efforts, which noncompliance could result in the termination of the Teoxane Agreement;
•our ability to collaborate with Teoxane to research, develop and obtain necessary approvals from the FDA and similar regulatory authorities for the RHA® Pipeline Products;
•our ability to comply with the legal and regulatory requirements for our Products, including regarding the sales, marketing, manufacturing, price reporting, registration and permitting of our Products, as applicable;
•our ability to adapt
to any changes to the labels for our Products that could place restrictions on how we market and sell the Products; and
•maintaining or establishing arrangements with third party logistics providers to distribute our Products to customers.
One or more of these factors, or other factors identified in this “Item 1A. Risk Factors”, Part I, Item 1A of the FY2022 10-K and Part II, Item 1A in our Q1 2023 10-Q, many of which are beyond our control, could impact the commercialization of and our ability to generate revenue from the sales of our Products, and any future products we may develop or acquire, which would materially impact the success of our business.
We have incurred significant losses since our inception and we anticipate that we will continue to incur GAAP operating losses for the foreseeable future,
and may not achieve or maintain profitability in the future.
We are not profitable and have incurred losses each year since we commenced operations in 2002. We cannot guarantee that we will be able to increase our revenue to offset our operating expenses. Our revenue may not increase or could decline for a number of other reasons, including reduced demand for our Products, increased competition, a decrease in the growth or reduction in size of the overall market for our Products, or if we cannot maintain our strategic partnerships, including with Teoxane, ABPS, PCI, Viatris and Fosun.
In addition, our operating expenses may increase in the future as we optimize and grow our business, including as a result of our commercialization efforts across aesthetics and therapeutics and continuing to invest in research, development, regulatory approvals and the manufacturing and supply of DAXXIFY®
for commercialization. Further, our estimates regarding the amounts necessary to accomplish our business objectives may be inaccurate; other unanticipated costs may arise; and, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional capital sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe that we have sufficient funds for our current or future operating plans.
Additional capital may not be available when needed, on terms that are acceptable to us or at all. If adequate funds are not available to us on a timely basis, or at all, we may be required to take capital preservation measures, including to reduce operating expense and delay, reduce the scope of, discontinue
or alter our research and development activities; our sales and marketing capabilities or other activities that may be necessary to continue to commercialize our Products and other aspects of our business plan. If we are unable to secure additional capital when needed or sufficiently reduce our operating expenses, our ability to capitalize on business opportunities will be limited, we may be unable to compete effectively, and our business may be harmed.
If we raise additional capital through marketing and distribution arrangements, royalty financings or other collaborations, strategic alliances or licensing arrangements with third parties, we may need 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, the ownership interest
of our existing stockholders will be diluted and the terms of any new equity securities may have a preference over our common stock. If we raise additional capital through debt financing, we may be subject to specified financial covenants or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or
pursuing certain transactions, any of which could restrict our ability to commercialize our product candidates or operate as a business; and our assets may be subject to liens. In addition, our ability to raise capital may be limited by restrictions under the Note Purchase
Agreement, including our ability to sell or license intellectual property, and other reasons like the global economy, inflation or other macro economic factors.
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 our ability to raise capital and continue operations.
We have, and may in the future, undertake restructuring plans to adjust our investment priorities and manage our operating expenses, which plans may not result in the savings or operational efficiencies anticipated and could result in total costs and expenses that are greater than expected.
In September 2023, we announced a plan to exit the Fintech Platform business. This plan was adopted because
the significant costs and resources required to support the Fintech Platform no longer aligned with the Company’s capital allocation priorities. We announced that this plan would free up capital for reinvestment in other areas of our business. We may not realize, in full or in part, the anticipated benefits and savings from the exit of the Fintech Platform business due to unforeseen difficulties, delays or unexpected costs.
Our restructuring plans, including the exit of the Fintech Platform business, may adversely affect our ability to recruit and retain skilled and motivated personnel, may result in a loss of continuity, loss of accumulated knowledge, or inefficiency during transitional periods, may require a significant amount of employees’ time and focus, and may be distracting to employees, which may divert attention from operating and
growing our business. The exit of the Fintech Platform business may also negatively impact relationships with our customers.
If we fail to achieve some or all of the expected benefits of any restructuring plans, including the exit of the Fintech Platform, if such activities negatively impact relationships with our customers or other stakeholders, or we are unable to manage the related transition effectively, which may be impacted by factors outside of our control, our business, operating results, and financial condition could be adversely affected.
Unfavorable publicity relating to one or more of our product offerings, whether related to aesthetic or therapeutic indications, may affect the public perception of our entire portfolio of Products.
DAXXIFY® has been approved for both aesthetic and
therapeutic indications. Concerns about product safety, efficacy or duration for any DAXXIFY® indication or the RHA® Collection of dermal fillers, whether raised by an injector, consumer, patient, litigant, regulator or consumer advocate, can result in safety alerts, product recalls, governmental investigations, regulatory action, private claims and lawsuits, payment of fines and settlements, declining sales and reputational damage for the entire portfolio of our Products, potentially impacting any approved DAXXIFY® indications and the RHA® Collection of dermal fillers. If any such events occur, the negative publicity could negatively impact our brand and results of operations.
We are subject to uncertainty relating to pricing and reimbursement.
Failure to obtain or maintain adequate coverage, pricing and reimbursement for DAXXIFY® for therapeutics uses, or our other future approved products, if any, could have a material adverse impact on our ability to commercialize such products.
Even if coverage and reimbursement from governmental and private healthcare payors for therapeutic uses of DAXXIFY® or any future approved product for therapeutic indications is provided, the approved reimbursement amount or acceptance of the drug in the market may be insufficient to establish or maintain pricing sufficient to realize a return on our investment. The market acceptance of any approved product, including DAXXIFY®, may vary among injectors, patients, administrators, or others in the healthcare community. In addition,
regional hospitals and healthcare organizations are increasingly using bidding procedures to determine which suppliers as well as which pharmaceutical and therapeutic products will be included in their drug formularies or lists of medications approved for use in their facility. The administration of regional hospitals and healthcare organizations may refuse to include a particular drug in their formularies or restrict patient
access to a branded drug when a less costly generic equivalent or other alternative is available. These measures could reduce
the ultimate demand for our products or put pressure on our product pricing.
Injectors play a significant role in determining the course of a patient’s treatment and the type of pharmaceutical and therapeutic products that are included on drug formularies and lists of medications approved for use within their healthcare organizations. An important part of our sales process includes the education of injectors on the safe and effective use of any approved product, including DAXXIFY®, as applicable. Acceptance of any approved product, including DAXXIFY®, depends on educating injectors regarding the distinctive characteristics, perceived benefits, safety, ease of use, and cost-effectiveness of the product as compared to our competitors’ products.
If a injector experiences difficulties during an initial procedure or otherwise, that injector may be less likely to continue to use our product or to recommend it to other injectors and healthcare administrators. Our efforts to educate injectors, patients, administrators, and others in the healthcare community on the proper use of any approved product, including DAXXIFY®, have required, and will continue to require, significant resources and these efforts may never be successful. If we are not successful in educating injectors, we may be unable to increase sales, sustain growth, or achieve profitability.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Arrangements
i
The adoption or termination of contracts,
instructions or written plans for the purchase or sale of our securities by our Section 16 officers and directors for the three months ended September 30, 2023, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act, were as follows:
Name
and Title
Action
Date of Action
Total Shares to be Sold
Expiration Date
iMark Foley, iChief Executive Officer
iTerminate(1)
i8/28/23
i442,576
5/31/2024
iOlivia
Ware, iDirector
iAdopt
i8/31/23
i9,593
8/30/2024
(1)Mr.
Foley entered into this 10b5-1 Plan on March 10, 2023
/
During the three months ended September 30, 2023, none of our Section 16 officers or directors iadopted or iterminated
a non-Rule 10b5-1 trading arrangement.
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101)
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Portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that (i) the omitted information is not material and (ii) the omitted information is of the type that the registrant treats as private or confidential.
† The certifications attached as Exhibit 32.1 and 32.2 that accompany this Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, shall not be deemed filed with the Securities and Exchange Commission for purposes of Section 18 of the Exchange Act. Such certifications shall not be deemed incorporated by reference
into any filing of Revance Therapeutics, Inc. under the Securities Act, or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
51
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
