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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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(Mark One) |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2023
or
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___ to ___
Commission File No. 001-36297
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Revance Therapeutics, Inc. |
| (Exact name of registrant as specified in its charter) | |
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| Delaware | 77-0551645 | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
1222 Demonbreun Street, Suite 2000, Nashville, Tennessee, 37203
(Address, including zip code, of principal executive offices)
(615) 724-7755
(Registrant’s telephone number, including area code)
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Securities Registered Pursuant to Section 12(b) of the Act: |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | RVNC | Nasdaq Global Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ý 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.
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Large accelerated filer | ☒ | Accelerated filer | ☐ | Emerging growth company | ☐ |
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ý
Number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of October 31, 2023: 87,813,480
Table of Contents
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DEFINED TERMS
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.
“Cowen” means Cowen and Company, LLC.
“CROs” means contract research organizations.
“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.
“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.
“HintMD” means Hint, Inc., our wholly owned subsidiary.
“HintMD Acquisition” means Revance’s acquisition of HintMD, completed on June 23, 2020.
“HintMD Plan” means the Hint, Inc. 2017 Equity Incentive Plan.
“HintMD Platform” means the legacy HintMD fintech platform.
“Indenture” means the indenture, by and between Revance and U.S. Bank National Association, as trustee, dated February 14, 2020.
“injector” means a professional licensed to inject our Products, including physicians.
“Maturity Date” means September 18, 2026, the maturity date of the Notes Payable set forth in the Note Purchase Agreement.
“Nashville Lease” means the office lease by and between Revance and 1222 Demonbreun, LP, dated November 19, 2020, as amended on January 4, 2021, July 1, 2021 and January 13, 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.
“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.
“Teoxane” means Teoxane SA.
“Teoxane Agreement” means the exclusive distribution agreement by and between Revance and Teoxane, dated January 10, 2020, as amended on September 30, 2020, December 22, 2020 and December 22, 2022.
“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.
PART I. FINANCIAL INFORMATION
ITEM 1. Condensed Consolidated Financial Statements (Unaudited)
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited) | | | | | | | | | | | |
| September 30, | | December 31, |
| 2023 | | 2022 |
ASSETS |
CURRENT ASSETS | | | |
Cash and cash equivalents | $ | 179,319 | | | $ | 108,965 | |
Restricted cash, current | 275 | | | — | |
Short-term investments | 120,926 | | | 231,742 | |
Accounts receivable, net | 25,414 | | | 11,339 | |
Inventories | 46,214 | | | 18,325 | |
Prepaid expenses and other current assets | 16,371 | | | 4,356 | |
Total current assets | 388,519 | | | 374,727 | |
Property and equipment, net | 17,179 | | | 13,799 | |
Goodwill | — | | | 77,175 | |
Intangible assets, net | 10,507 | | | 35,344 | |
Operating lease right-of-use assets | 54,810 | | | 39,223 | |
Finance lease right-of-use asset | 23,209 | | | 6,393 | |
Restricted cash, non-current | 7,145 | | | 6,052 | |
Finance lease prepaid expense | 30,883 | | | 27,500 | |
Other non-current assets | 235 | | | 1,687 | |
TOTAL ASSETS | $ | 532,487 | | | $ | 581,900 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
CURRENT LIABILITIES | | | |
Accounts payable | $ | 4,775 | | | $ | 4,546 | |
Accruals and other current liabilities | 53,493 | | | 59,357 | |
Deferred revenue, current | 5,371 | | | 6,867 | |
Finance lease liability, current | 8,610 | | | 669 | |
Operating lease liabilities, current | 8,659 | | | 4,243 | |
Debt, current | 1,250 | | | — | |
Total current liabilities | 82,158 | | | 75,682 | |
Debt, non-current | 427,101 | | | 379,374 | |
Deferred revenue, non-current | 84,315 | | | 78,577 | |
Operating lease liabilities, non-current | 42,279 | | | 34,182 | |
Other non-current liabilities | 2,835 | | | 1,485 | |
TOTAL LIABILITIES | 638,688 | | | 569,300 | |
Commitments and Contingencies (Note 12) | | | |
STOCKHOLDERS’ EQUITY (DEFICIT) | | | |
Preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of September 30, 2023 and December 31, 2022 | — | | | — | |
Common stock, par value $0.001 per share — 190,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 87,813,315 and 82,385,810 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 88 | | | 82 | |
Additional paid-in capital | 1,916,385 | | | 1,767,266 | |
Accumulated other comprehensive loss | (13) | | | (374) | |
Accumulated deficit | (2,022,661) | | | (1,754,374) | |
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | (106,201) | | | 12,600 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | 532,487 | | | $ | 581,900 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Revenue: | | | | | | | |
Product revenue | $ | 54,109 | | | $ | 26,081 | | | $ | 154,160 | | | $ | 72,401 | |
Service revenue | 2,664 | | | 1,964 | | | 9,942 | | | 4,046 | |
Collaboration revenue | 3 | | | 970 | | | 139 | | | 6,197 | |
Total revenue | 56,776 | | | 29,015 | | | 164,241 | | | 82,644 | |
Operating expenses: | | | | | | | |
Cost of product revenue (exclusive of depreciation and amortization) | 16,821 | | | 8,681 | | | 46,915 | | | 24,130 | |
Cost of service revenue (exclusive of amortization) | 2,592 | | | 2,055 | | | 9,976 | | | 4,022 | |
Selling, general and administrative | 69,094 | | | 65,775 | | | 212,489 | | | 158,697 | |
Research and development | 13,060 | | | 26,103 | | | 59,044 | | | 81,745 | |
Goodwill impairment | 77,175 | | | — | | | 77,175 | | | — | |
Intangible asset impairment | 16,007 | | | — | | | 16,007 | | | — | |
Depreciation and amortization | 1,320 | | | 3,885 | | | 5,459 | | | 11,597 | |
Total operating expenses | 196,069 | | | 106,499 | | | 427,065 | | | 280,191 | |
Loss from operations | (139,293) | | | (77,484) | | | (262,824) | | | (197,547) | |
Interest income | 3,733 | | | 1,165 | | | 9,851 | | | 1,860 | |
Interest expense | (5,093) | | | (6,917) | | | (13,958) | | | (12,722) | |
Other expense, net | (223) | | | (757) | | | (1,056) | | | (1,361) | |
Loss before income taxes | (140,876) | | | (83,993) | | | (267,987) | | | (209,770) | |
Income tax provision | (300) | | | (700) | | | (300) | | | (700) | |
Net loss | (141,176) | | | (84,693) | | | (268,287) | | | (210,470) | |
Unrealized gain (loss) | 48 | | | (74) | | | 361 | | | (442) | |
Comprehensive loss | $ | (141,128) | | | $ | (84,767) | | | $ | (267,926) | | | $ | (210,912) | |
Basic and diluted net loss | $ | (141,176) | | | $ | (84,693) | | | $ | (268,287) | | | $ | (210,470) | |
Basic and diluted net loss per share | $ | (1.63) | | | $ | (1.17) | | | $ | (3.20) | | | $ | (3.00) | |
Basic and diluted weighted-average number of shares used in computing net loss per share | 86,613,425 | | | 72,208,285 | | | 83,816,577 | | | 70,215,148 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(In thousands, except share and per share amounts)
(Unaudited) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount |
Preferred Stock | — | | | $ | — | | | — | | | $ | — | | | — | | | $ | — | | | — | | | $ | — | |
Common Stock | | | | | | | | | | | | | | | |
Balance — Beginning of period | 87,949,987 | | | 88 | | | 73,123,363 | | | 73 | | | 82,385,810 | | | 82 | | | 71,584,057 | | | 72 | |
Issuance of common stock related to ATM | — | | | — | | | — | | | — | | | 3,223,767 | | | 3 | | | 1,734,853 | | | 1 | |
Issuance of common stock related to stock awards | 75,419 | | | — | | | — | | | — | | | 1,795,729 | | | 2 | | | — | | | — | |
Issuance of common stock upon exercise of stock options | 23,076 | | | — | | | 91,743 | | | — | | | 694,300 | | | 1 | | | 122,377 | | | — | |
Issuance of common stock related to 2014 ESPP | — | | | — | | | — | | | — | | | 157,313 | | | — | | | 171,824 | | | — | |
Shares withheld related to net settlement of stock awards | (200,387) | | | — | | | (83,486) | | | — | | | (337,331) | | | — | | | (268,632) | | | — | |
Cancellation of stock awards, net of issuance | (34,780) | | | — | | | (44,752) | | | — | | | (106,273) | | | — | | | (257,611) | | | — | |
Issuance of common stock in connection with follow-on offering | — | | | — | | | 9,200,000 | | | 9 | | | — | | | — | | | 9,200,000 | | | 9 | |
Balance — End of period | 87,813,315 | | | 88 | | | 82,286,868 | | | 82 | | | 87,813,315 | | | 88 | | | 82,286,868 | | | 82 | |
Additional Paid-In Capital | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | 1,908,244 | | | — | | | 1,521,411 | | | — | | | 1,767,266 | | | — | | | 1,466,369 | |
Issuance of common stock related to ATM, net of commissions and issuance costs | — | | | — | | | — | | | (31) | | | — | | | 99,956 | | | — | | | 31,554 | |
Issuance of common stock upon exercise of stock options | — | | | 58 | | | — | | | 512 | | | — | | | 11,573 | | | — | | | 621 | |
Issuance of common stock related to 2014 ESPP | — | | | — | | | — | | | — | | | — | | | 2,455 | | | — | | | 2,018 | |
Shares withheld related to net settlement of stock awards | — | | | (3,774) | | | — | | | (1,853) | | | — | | | (8,068) | | | — | | | (4,613) | |
Issuance of common stock related to stock awards | — | | | — | | | — | | | — | | | — | | | (2) | | | — | | | — | |
Issuance of common stock in connection with follow-on offering, net of underwriting discounts, commissions, and offering costs | — | | | — | | | — | | | 215,921 | | | — | | | — | | | — | | | 215,921 | |
Stock-based compensation | — | | | 11,857 | | | — | | | 18,553 | | | — | | | 43,175 | | | — | | | 42,295 | |
Other | — | | | — | | | — | | | — | | | — | | | 30 | | | — | | | 348 | |
Balance — End of period | — | | | $ | 1,916,385 | | | — | | | $ | 1,754,513 | | | — | | | $ | 1,916,385 | | | — | | | $ | 1,754,513 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) — (Continued)
(In thousands, except share and per share amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount |
Other Accumulated Comprehensive Loss | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | (61) | | | — | | | (386) | | | — | | | (374) | | | — | | | (18) | |
Unrealized gain (loss) | — | | | 48 | | | — | | | (74) | | | — | | | 361 | | | — | | | (442) | |
Balance — End of period | — | | | (13) | | | — | | | (460) | | | — | | | (13) | | | — | | | (460) | |
Accumulated Deficit | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | (1,881,485) | | | — | | | (1,523,729) | | | — | | | (1,754,374) | | | — | | | (1,397,952) | |
Net loss | — | | | (141,176) | | | — | | | (84,693) | | | — | | | (268,287) | | | — | | | (210,470) | |
Balance — End of period | — | | | (2,022,661) | | | — | | | (1,608,422) | | | — | | | (2,022,661) | | | — | | | (1,608,422) | |
Total Stockholders’ Equity (Deficit) | 87,813,315 | | | $ | (106,201) | | | 82,286,868 | | | $ | 145,713 | | | 87,813,315 | | | $ | (106,201) | | | 82,286,868 | | | $ | 145,713 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES | | | |
Net loss | $ | (268,287) | | | $ | (210,470) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Goodwill and intangible asset impairment | 93,182 | | | — | |
Stock-based compensation | 38,968 | | | 41,613 | |
Depreciation and amortization | 9,956 | | | 16,266 | |
Amortization of finance lease right-of-use asset | 2,318 | | | 4,502 | |
Amortization of debt discount and debt issuance costs | 1,639 | | | 1,373 | |
Amortization of discount on investments | (5,134) | | | (399) | |
Other non-cash operating activities | 572 | | | 1,265 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | (14,075) | | | (8,384) | |
Inventories | (18,068) | | | (6,606) | |
Prepaid expenses and other current assets | (12,015) | | | (947) | |
Lease right-of-use assets | (39,368) | | | (10,705) | |
Other non-current assets | 1,000 | | | (297) | |
Accounts payable | (127) | | | (9,711) | |
Accruals and other liabilities | (6,289) | | | 3,928 | |
Deferred revenue | 4,242 | | | 4,222 | |
Lease liabilities | 36,292 | | | 10,984 | |
Other non-current liabilities | 1,350 | | | — | |
Net cash used in operating activities | (173,844) | | | (163,366) | |
CASH FLOWS FROM INVESTING ACTIVITIES | | | |
Proceeds from maturities of investments | 295,782 | | | 161,183 | |
Purchases of investments | (179,922) | | | (321,199) | |
Purchases of property and equipment | (5,107) | | | (1,922) | |
Finance lease prepayments | (3,383) | | | (17,820) | |
Net cash provided by (used in) investing activities | 107,370 | | | (179,758) | |
CASH FLOWS FROM FINANCING ACTIVITIES | | | |
Proceeds from issuance of common stock in connection with ATM, net of commissions | 100,183 | | | 31,814 | |
Proceeds from issuance of notes payable, net of debt discount | 48,415 | | | 98,150 | |
Proceeds from the exercise of stock options and employee stock purchase plan | 14,028 | | | 2,639 | |
Principal payments on finance lease obligations | (15,513) | | | (5,000) | |
Taxes paid related to net settlement of stock awards | (8,068) | | | (4,613) | |
Payment of debt issuance costs and offering costs | (849) | | | (1,671) | |
Proceeds from issuance of common stock in connection with follow-on offering, net of discounts and commissions | — | | | 216,200 | |
Other financing activities | — | | | 348 | |
Net cash provided by financing activities | 138,196 | | | 337,867 | |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | 71,722 | | | (5,257) | |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period | 115,017 | | | 115,669 | |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period | $ | 186,739 | | | $ | 110,412 | |
| | | |
| | | |
| | | |
| | | |
| | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. The 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 $141.2 million and $268.3 million, respectively. As of September 30, 2023, we had an accumulated deficit of $2.0 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 $306.4 million and capital resources of $300.2 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 $47.2 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.
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.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Reclassification
At the beginning of 2023, we changed our presentation of internal-use software where approximately $8.3 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. 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.
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. Revenue
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). The following table presents our revenue disaggregated by timing of transfer of goods or service:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 |
| Transferred | | Transferred |
(in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total |
Product revenue | $ | 54,109 | | | $ | — | | | $ | 54,109 | | | $ | 154,160 | | | $ | — | | | $ | 154,160 | |
Service revenue | — | | | 2,664 | | | 2,664 | | | 59 | | | 9,883 | | | 9,942 | |
Collaboration revenue | — | | | 3 | | | 3 | | | — | | | 139 | | | 139 | |
Total revenue | $ | 54,109 | | | $ | 2,667 | | | $ | 56,776 | | | $ | 154,219 | | | $ | 10,022 | | | $ | 164,241 | |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2022 |
| Transferred | | Transferred |
(in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total |
Product revenue | $ | 26,081 | | | $ | — | | | $ | 26,081 | | | $ | 72,401 | | | $ | — | | | $ | 72,401 | |
Service revenue | 121 | | | 1,843 | | | 1,964 | | | 360 | | | 3,686 | | | 4,046 | |
Collaboration revenue | — | | | 970 | | | 970 | | | — | | | 6,197 | | | 6,197 | |
Total revenue | $ | 26,202 | | | $ | 2,813 | | | $ | 29,015 | | | $ | 72,761 | | | $ | 9,883 | | | $ | 82,644 | |
Product Revenue
Our product revenue breakdown is summarized below:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Product: | | | | | | | |
RHA® Collection of dermal fillers | $ | 32,133 | | | $ | 26,081 | | | $ | 94,180 | | | $ | 72,401 | |
DAXXIFY® | 21,976 | | | — | | | 59,980 | | | — | |
Total product revenue | $ | 54,109 | | | $ | 26,081 | | | $ | 154,160 | | | $ | 72,401 | |
Accounts receivables and contract liabilities from contracts with our product customers are as follows:
| | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivables: | | | |
Accounts receivable, net | $ | 22,661 | | | $ | 10,966 | |
Total accounts receivable, net | $ | 22,661 | | | $ | 10,966 | |
| | | |
Contract liabilities: | | | |
Deferred revenue, current | $ | 398 | | | $ | 705 | |
Total contract liabilities | $ | 398 | | | $ | 705 | |
Service Revenue
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:
| | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivable: | | | |
Accounts receivable, net | $ | 53 | | | $ | 59 | |
| | | |
| | | |
| | | |
| | | |
Total accounts receivable, net | $ | 53 | | | $ | 59 | |
| | | |
| | | |
| | | |
| | | |
REVANCE THERAPEUTICS, INC.
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 $60 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 $70 million in the aggregate, upon the achievement of certain clinical and regulatory milestones and of specified, tiered sales milestones of up to $225 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 $50 million in annual sales, during the first approximately four 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 $44.2 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 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.
REVANCE THERAPEUTICS, INC.
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 $38.0 million before foreign withholding taxes. We are also eligible to receive (i) additional remaining contingent payments of up to $222.5 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 $41.0 million.
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.
Accounts receivables and contract liabilities from contracts with our collaboration customers are as follows:
| | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivables: | | | |
Accounts receivable, net — Fosun | $ | 2,700 | | | $ | 315 | |
Total accounts receivable, net | $ | 2,700 | | | $ | 315 | |
| | | |
Contract liabilities: | | | |
Deferred revenue, current — Viatris | $ | 4,973 | | | $ | 6,162 | |
| | | |
Total contract liabilities, current | $ | 4,973 | | | $ | 6,162 | |
| | | |
Deferred revenue, non-current — Viatris | $ | 43,340 | | | $ | 40,600 | |
Deferred revenue, non-current — Fosun | 40,975 | | | 37,977 | |
Total contract liabilities, non-current | $ | 84,315 | | | $ | 78,577 | |
REVANCE THERAPEUTICS, INC.
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 thousands) |
Balance on December 31, 2022 | $ | 84,739 | |
Revenue recognized | (139) | |
Billings and adjustments, net | 4,688 | |
Balance on September 30, 2023 | $ | 89,288 | |
3. Restructuring
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 Platform business are recorded under our Service Segment. As of September 30, 2023, we recorded restructuring charges of $95.2 million as shown in the table below. 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.
A 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 | $ | 77,175 | |
Intangible asset impairment | 16,007 | |
Selling, general and administrative | 732 | |
Research and development | 1,293 | |
Total restructuring charges | $ | 95,207 | |
A summary of severance and personnel liabilities, included within accruals and other current liabilities on the condensed consolidated balance sheet, is as follows: | | | | | |
| (in thousands) |
Balance on December 31, 2022 | $ | — | |
Severance and other personnel costs | 1,432 | |
Cash payment during the period | — | |
Balance on September 30, 2023 (1) | $ | 1,432 | |
(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.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
4. Cash Equivalents and Short-Term Investments
The following table summarizes our cash equivalents and short-term investments:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
(in thousands) | Adjusted Cost | | Gain | | Loss | | Fair Value | | Adjusted Cost | | Losses | | Fair Value |
U.S. treasury securities | $ | 197,446 | | | $ | 4 | | | $ | — | | | $ | 197,450 | | | $ | 109,984 | | | $ | (228) | | | $ | 109,756 | |
Commercial paper | 55,162 | | | — | | | (17) | | | 55,145 | | | 80,946 | | | — | | | 80,946 | |
Money market funds | 29,416 | | | — | | | — | | | 29,416 | | | 85,206 | | | — | | | 85,206 | |
Corporate bonds | — | | | — | | | — | | | — | | | 41,186 | | | (146) | | | 41,040 | |
U.S. government agency obligations | — | | | — | | | — | | | — | | | 4,480 | | | — | | | 4,480 | |
Total cash equivalents and short-term investments | $ | 282,024 | | | $ | 4 | | | $ | (17) | | | $ | 282,011 | | | $ | 321,802 | | | $ | (374) | | | $ | 321,428 | |
| | | | | | | | | | | | | |
Classified as: | | | | | | | | | | | | | |
Cash equivalents | | | | | | | $ | 161,085 | | | | | | | $ | 89,686 | |
Short-term investments | | | | | | | 120,926 | | | | | | | 231,742 | |
Total cash equivalents and short-term investments | | | | | | | $ | 282,011 | | | | | | | $ | 321,428 | |
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. Goodwill 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 $77.2 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 $147.0 million and $69.8 million, respectively.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
The changes in the carrying amount of goodwill by reporting unit during the nine months ended September 30, 2023 was as follows:
| | | | | | | | | | | | | | | | | |
(in thousands) | Product | | Service | | Total |
Balance at December 31, 2022 | $ | — | | | $ | 77,175 | | | $ | 77,175 | |
Impairment | — | | | (77,175) | | | (77,175) | |
Balance at September 30, 2023 | $ | — | | | $ | — | | | $ | — | |
Intangible Assets, net
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:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 |
(in thousands, except for in years) | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Accumulated Impairment | | Net Carrying Amount |
Distribution rights | 4.5 | | $ | 32,334 | | | $ | (22,518) | | | $ | — | | | $ | 9,816 | |
Internally developed technology | 1.7 | | 8,918 | | | (4,293) | | | (3,972) | | | 653 | |
Other software | 0.3 | | 879 | | | (841) | | | — | | | 38 | |
Acquired developed technology | 0.0 | | 16,200 | | | (6,525) | | | (9,675) | | | — | |
Customer relationships | 0.0 | | 10,300 | | | (7,940) | | | (2,360) | | | — | |
Total intangible assets | | | $ | 68,631 | | | $ | (42,117) | | | $ | (16,007) | | | $ | 10,507 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | December 31, 2022 |
(in thousands, except for in years) | | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount |
Acquired developed technology | | | 4.2 | | $ | 35,800 | | | $ | (24,325) | | | $ | 11,475 | |
Distribution rights | | | 1.4 | | 32,334 | | | (20,882) | | | 11,452 | |
Internally developed technology | | | 2.4 | | 8,062 | | | (2,271) | | | 5,791 | |
Customer relationships | | | 1.6 | | 10,300 | | | (6,223) | | | 4,077 | |
Other software | | | 1.8 | | 3,166 | | | (1,592) | | | 1,574 | |
Development in progress | | | N/A | | 975 | | | — | | | 975 | |
Total intangible assets | | | | | $ | 90,637 | | | $ | (55,293) | | | $ | 35,344 | |
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 $16.0 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.
REVANCE THERAPEUTICS, INC.
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. The 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 | $ | 1,320 | | | $ | 3,513 | | | $ | 5,459 | | | $ | 10,538 | |
Selling, general and administrative | 429 | | | 644 | | | 2,998 | | | 1,931 | |
Total intangible asset amortization | $ | 1,749 | | | $ | 4,157 | | | $ | 8,457 | | | $ | 12,469 | |
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:
| | | | | |
Year Ending December 31, | (in thousands) |
2023 remaining three months | $ | 700 | |
2024 | 2,567 | |
2025 | 2,333 | |
2026 | 2,181 | |
2027 | 2,181 | |
2028 and thereafter | 545 | |
Total | $ | 10,507 | |
6. Inventories
Inventories consist of the following: | | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Raw materials | $ | 2,894 | | | $ | 505 | |
Work in process | 13,490 | | | 4,933 | |
Finished goods | 29,830 | | | 12,887 | |
Total inventories | $ | 46,214 | | | $ | 18,325 | |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
7. Accruals and other current liabilities
Accruals and other current liabilities consists of the following:
| | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accruals related to: | | | |
Compensation(1) | $ | 26,027 | | | $ | 28,014 | |
Inventories | 8,376 | | | 2,312 | |
Selling, general and administrative | 7,711 | | | 9,681 | |
Research and development | 5,047 | | | 9,012 | |
Clinical trials | 872 | | | 1,863 | |
Interest expense | 625 | | | 1,912 | |
Other current liabilities | 4,835 | | | 6,563 | |
Total accruals and other current liabilities | $ | 53,493 | | | $ | 59,357 | |
(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. Leases
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 one or more options to renew for seven years to fourteen 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 18-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 $30.0 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 $30.0 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,
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
2023 of $23.9 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.
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) | $ | 3,297 | | | $ | 3,344 | | | $ | 6,965 | | | $ | 4,502 | |
Interest on finance lease liability | 270 | | | 348 | | | 1,278 | | | 2,607 | |
Variable lease cost (2) | 62 | | | 1,134 | | | 436 | | | 1,375 | |
Total finance lease costs | 3,629 | | | 4,826 | | | 8,679 | | | 8,484 | |
Operating leases: | | | | | | | |
Operating lease cost | 3,138 | | | 2,223 | | | 9,657 | | | 6,669 | |
Variable lease cost (3) | 534 | | | 423 | | | 1,589 | | | 1,288 | |
Total operating lease costs | 3,672 | | | 2,646 | | | 11,246 | | | 7,957 | |
Total lease costs | $ | 7,301 | | | $ | 7,472 | | | $ | 19,925 | | | $ | 16,441 | |
(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.
As of September 30, 2023, maturities of our lease liabilities are as follows:
| | | | | | | | | | | | | | | | | |
(in thousands) | Finance Lease | | Operating Leases | | Total |
Year Ending December 31, | | | | | |
2023 remaining three months | $ | 5,647 | | | $ | 5,065 | | | $ | 10,712 | |
2024 | 3,102 | | | 10,491 | | | 13,593 | |
2025 | — | | | 10,854 | | | 10,854 | |
2026 | — | | | 11,185 | | | 11,185 | |
2027 | — | | | 4,536 | | | 4,536 | |
2028 and thereafter | — | | | 28,586 | | | 28,586 | |
Total lease payments | 8,749 | | | 70,717 | | | 79,466 | |
Less imputed interest | (139) | | | (19,779) | | | (19,918) | |
Present value of lease payments | $ | 8,610 | | | $ | 50,938 | | | $ | 59,548 | |
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:
| | | | | | | | | | | |
| Finance Leases | | Operating Leases |
Weighted-average remaining lease term (years) | 2.5 | | 8.4 |
Weighted-average discount rate | 10.7 | % | | 10.0 | % |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
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 | $ | 6,264 | | | $ | 6,259 | |
Operating cash flows from finance lease | $ | 1,280 | | | $ | 2,541 | |
Financing cash flows from finance lease | $ | 15,513 | | | $ | 5,000 | |
Right-of-use assets obtained in exchange for lease liabilities | | | |
Finance lease | $ | 23,781 | | | $ | 14,523 | |
Operating leases(1) | $ | 22,694 | | | $ | — | |
(1)In September 2023, the Expansion Premises and Second Expansion Premises commenced resulting in recognition of $22.7 million right-of-use asset and $16.2 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 one additional three-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 $30.9 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 $10.9 million for 2023, $15.9 million for 2024, $18.3 million for 2025, $25.3 million for 2026, $29.5 million for 2027, and $134.5 million for 2028 and thereafter in the aggregate.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
9. Debt
The following table provides information regarding our debt:
| | | | | | | | | | | |
| September 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
2027 Notes, non-current | $ | 287,500 | | | $ | 287,500 | |
Less: Unamortized debt issuance costs | (4,609) | | | (5,587) | |
Carrying amount of the 2027 Notes | 282,891 | | | 281,913 | |
| | | |
Notes Payable, current | 1,250 | | | — | |
Notes Payable, non-current | 148,750 | | | 100,000 | |
Less: Unamortized debt discount | (2,976) | | | (1,347) | |
Less: Unamortized debt issuance costs | (1,564) | | | (1,192) | |
Carrying amount of Notes Payable | 145,460 | | | 97,461 | |
Total debt | $ | 428,351 | | | $ | 379,374 | |
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 | $ | 3,830 | | | $ | 3,454 | | | $ | 10,620 | | | $ | 8,425 | |
Amortization of debt issuance costs | 447 | | | 441 | | | 1,310 | | | 1,190 | |
Amortization of debt discount | 157 | | | 98 | | | 329 | | | 183 | |
Total interest expense | $ | 4,434 | | | $ | 3,993 | | | $ | 12,259 | | | $ | 9,798 | |
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.
REVANCE THERAPEUTICS, INC.
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 busine