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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 June 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 statement 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 July 31, 2023: 87,955,357
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.
“GPV” means gross-processing volume of the Fintech Platform or the total dollar amount of all transactions processed in the period through the Fintech Platform, net of refunds.
“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.
“JPM” means JPMorgan Chase & Co., and its assigns.
“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.
“PDUFA” means Prescription Drug User Fee Act.
“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.
“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 $50.0 million in Notes Payable that remains available to Revance until September 18, 2023, subject to the satisfaction of certain conditions set forth in the Note Purchase Agreement.
“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) | | | | | | | | | | | |
| June 30, | | December 31, |
| 2023 | | 2022 |
ASSETS |
CURRENT ASSETS | | | |
Cash and cash equivalents | $ | 141,235 | | | $ | 108,965 | |
Restricted cash, current | 275 | | | — | |
Short-term investments | 178,488 | | | 231,742 | |
Accounts receivable, net | 17,043 | | | 11,339 | |
Inventories | 34,448 | | | 18,325 | |
Prepaid expenses and other current assets | 7,458 | | | 4,356 | |
Total current assets | 378,947 | | | 374,727 | |
Property and equipment, net | 12,690 | | | 13,799 | |
Goodwill | 77,175 | | | 77,175 | |
Intangible assets, net | 28,461 | | | 35,344 | |
Operating lease right-of-use assets | 34,438 | | | 39,223 | |
Finance lease right-of-use asset | 26,460 | | | 6,393 | |
Restricted cash, non-current | 7,145 | | | 6,052 | |
Finance lease prepaid expense | 27,500 | | | 27,500 | |
Other non-current assets | 4,719 | | | 1,687 | |
TOTAL ASSETS | $ | 597,535 | | | $ | 581,900 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
CURRENT LIABILITIES | | | |
Accounts payable | $ | 8,345 | | | $ | 4,546 | |
Accruals and other current liabilities | 39,535 | | | 59,357 | |
Deferred revenue, current | 5,433 | | | 6,867 | |
Finance lease liability, current | 15,505 | | | 669 | |
Operating lease liabilities, current | 5,261 | | | 4,243 | |
Total current liabilities | 74,079 | | | 75,682 | |
Debt, non-current | 380,348 | | | 379,374 | |
Deferred revenue, non-current | 82,213 | | | 78,577 | |
Operating lease liabilities, non-current | 31,274 | | | 34,182 | |
Other non-current liabilities | 2,835 | | | 1,485 | |
TOTAL LIABILITIES | 570,749 | | | 569,300 | |
Commitments and Contingencies (Note 11) | | | |
STOCKHOLDERS’ EQUITY | | | |
Preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2023 and December 31, 2022 | — | | | — | |
Common stock, par value $0.001 per share — 190,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 87,949,987 and 82,385,810 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 88 | | | 82 | |
Additional paid-in capital | 1,908,244 | | | 1,767,266 | |
Accumulated other comprehensive loss | (61) | | | (374) | |
Accumulated deficit | (1,881,485) | | | (1,754,374) | |
TOTAL STOCKHOLDERS’ EQUITY | 26,786 | | | 12,600 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 597,535 | | | $ | 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 June 30, | | Six Months Ended June 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Revenue: | | | | | | | |
Product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 100,051 | | | $ | 46,320 | |
Service revenue | 3,721 | | | 1,226 | | | 7,278 | | | 2,082 | |
Collaboration revenue | 20 | | | 1,659 | | | 136 | | | 5,227 | |
Total revenue | 58,134 | | | 28,368 | | | 107,465 | | | 53,629 | |
Operating expenses: | | | | | | | |
Cost of product revenue (exclusive of depreciation and amortization) | 17,607 | | | 8,121 | | | 30,094 | | | 15,449 | |
Cost of service revenue (exclusive of amortization) | 3,700 | | | 1,402 | | | 7,384 | | | 1,967 | |
Selling, general and administrative | 77,384 | | | 47,847 | | | 143,395 | | | 92,922 | |
Research and development | 22,807 | | | 24,913 | | | 45,984 | | | 55,642 | |
Depreciation and amortization | 2,135 | | | 3,927 | | | 4,139 | | | 7,712 | |
Total operating expenses | 123,633 | | | 86,210 | | | 230,996 | | | 173,692 | |
Loss from operations | (65,499) | | | (57,842) | | | (123,531) | | | (120,063) | |
Interest income | 3,148 | | | 619 | | | 6,118 | | | 695 | |
Interest expense | (4,368) | | | (3,874) | | | (8,865) | | | (5,805) | |
Other expense, net | (599) | | | (338) | | | (833) | | | (604) | |
| | | | | | | |
| | | | | | | |
Net loss | (67,318) | | | (61,435) | | | (127,111) | | | (125,777) | |
Unrealized gain (loss) | 64 | | | (327) | | | 313 | | | (368) | |
Comprehensive loss | $ | (67,254) | | | $ | (61,762) | | | $ | (126,798) | | | $ | (126,145) | |
Basic and diluted net loss | $ | (67,318) | | | $ | (61,435) | | | $ | (127,111) | | | $ | (125,777) | |
Basic and diluted net loss per share | $ | (0.80) | | | $ | (0.88) | | | $ | (1.54) | | | $ | (1.82) | |
Basic and diluted weighted-average number of shares used in computing net loss per share | 83,685,919 | | | 70,061,457 | | | 82,417,064 | | | 69,202,062 | |
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 June 30, | | Six Months Ended June 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount |
Preferred Stock | — | | | $ | — | | | — | | | $ | — | | | — | | | $ | — | | | — | | | $ | — | |
Common Stock | | | | | | | | | | | | | | | |
Balance — Beginning of period | 84,017,208 | | | 84 | | | 71,763,765 | | | 72 | | | 82,385,810 | | | 82 | | | 71,584,057 | | | 72 | |
Issuance of common stock related to ATM | 3,223,767 | | | 3 | | | 1,264,783 | | | 1 | | | 3,223,767 | | | 3 | | | 1,734,853 | | | 1 | |
Issuance of common stock related to stock awards | 513,443 | | | 1 | | | — | | | — | | | 1,720,310 | | | 2 | | | — | | | — | |
Issuance of common stock related to 2014 ESPP | 157,313 | | | — | | | 171,824 | | | — | | | 157,313 | | | — | | | 171,824 | | | — | |
Issuance of common stock upon exercise of stock options | 109,185 | | | — | | | 11,234 | | | — | | | 671,224 | | | 1 | | | 30,634 | | | — | |
Cancellation of stock awards, net of issuance | (52,874) | | | — | | | (63,711) | | | — | | | (71,493) | | | — | | | (212,859) | | | — | |
Shares withheld related to net settlement of stock awards | (18,055) | | | — | | | (24,532) | | | — | | | (136,944) | | | — | | | (185,146) | | | — | |
Balance — End of period | 87,949,987 | | | 88 | | | 73,123,363 | | | 73 | | | 87,949,987 | | | 88 | | | 73,123,363 | | | 73 | |
Additional Paid-In Capital | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | 1,787,535 | | | — | | | 1,487,822 | | | — | | | 1,767,266 | | | — | | | 1,466,369 | |
Issuance of common stock related to ATM, net of commissions and issuance costs | — | | | 99,956 | | | — | | | 22,661 | | | — | | | 99,956 | | | — | | | 31,585 | |
Issuance of common stock related to 2014 ESPP | — | | | 2,455 | | | — | | | 2,018 | | | — | | | 2,455 | | | — | | | 2,018 | |
Issuance of common stock upon exercise of stock options | — | | | 2,034 | | | — | | | 30 | | | — | | | 11,515 | | | — | | | 109 | |
Shares withheld related to net settlement of stock awards | — | | | (564) | | | — | | | (383) | | | — | | | (4,294) | | | — | | | (2,760) | |
Issuance of common stock related to stock awards | — | | | (1) | | | — | | | — | | | — | | | (2) | | | — | | | — | |
Stock-based compensation | — | | | 16,829 | | | — | | | 9,379 | | | — | | | 31,318 | | | — | | | 23,742 | |
Other | — | | | — | | | — | | | (116) | | | — | | | 30 | | | — | | | 348 | |
Balance — End of period | — | | | $ | 1,908,244 | | | — | | | $ | 1,521,411 | | | — | | | $ | 1,908,244 | | | — | | | $ | 1,521,411 | |
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 June 30, | | Six Months Ended June 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount |
Other Accumulated Comprehensive Loss | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | (125) | | | — | | | (59) | | | — | | | (374) | | | — | | | (18) | |
Unrealized gain (loss) | — | | | 64 | | | — | | | (327) | | | — | | | 313 | | | — | | | (368) | |
Balance — End of period | — | | | (61) | | | — | | | (386) | | | — | | | (61) | | | — | | | (386) | |
Accumulated Deficit | | | | | | | | | | | | | | | |
Balance — Beginning of period | — | | | (1,814,167) | | | — | | | (1,462,294) | | | — | | | (1,754,374) | | | — | | | (1,397,952) | |
Net loss | — | | | (67,318) | | | — | | | (61,435) | | | — | | | (127,111) | | | — | | | (125,777) | |
Balance — End of period | — | | | (1,881,485) | | | — | | | (1,523,729) | | | — | | | (1,881,485) | | | — | | | (1,523,729) | |
Total Stockholders’ Equity (Deficit) | 87,949,987 | | | $ | 26,786 | | | 73,123,363 | | | $ | (2,631) | | | 87,949,987 | | | $ | 26,786 | | | 73,123,363 | | | $ | (2,631) | |
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)
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2023 | | 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES | | | |
Net loss | $ | (127,111) | | | $ | (125,777) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Stock-based compensation | 28,681 | | | 23,626 | |
Depreciation and amortization | 10,149 | | | 11,985 | |
Amortization of debt discount and debt issuance costs | 1,035 | | | 834 | |
Amortization of discount on investments | (3,197) | | | (14) | |
Other non-cash operating activities | 498 | | | 295 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | (5,704) | | | (2,242) | |
Inventories | (11,652) | | | (3,446) | |
Prepaid expenses and other current assets | (3,102) | | | 12 | |
Lease right-of-use assets | (18,949) | | | (16,018) | |
Other non-current assets | (3,093) | | | (454) | |
Accounts payable | 3,703 | | | 1,975 | |
Accruals and other liabilities | (19,536) | | | (12,138) | |
Deferred revenue | 2,202 | | | (3,243) | |
Lease liabilities | 21,844 | | | 17,908 | |
Other non-current liabilities | 1,350 | | | 1,202 | |
Net cash used in operating activities | (122,882) | | | (105,495) | |
CASH FLOWS FROM INVESTING ACTIVITIES | | | |
Proceeds from maturities of investments | 185,247 | | | 113,183 | |
Purchases of investments | (128,859) | | | (163,676) | |
Purchases of property and equipment | (604) | | | (920) | |
Finance lease prepayments | — | | | (9,900) | |
Net cash provided by (used in) investing activities | 55,784 | | | (61,313) | |
CASH FLOWS FROM FINANCING ACTIVITIES | | | |
Proceeds from issuance of common stock in connection with ATM, net of commissions | 100,183 | | | 31,814 | |
Proceeds from the exercise of stock options and employee stock purchase plan | 13,970 | | | 2,127 | |
Taxes paid related to net settlement of stock awards | (4,294) | | | (2,760) | |
Principal payments on finance lease obligations | (8,899) | | | (1,760) | |
Payment of debt issuance costs and offering costs | (224) | | | (1,441) | |
Proceeds from issuance of notes payable, net of debt discount | — | | | 98,150 | |
Other financing activities | — | | | 348 | |
Net cash provided by financing activities | 100,736 | | | 126,478 | |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | 33,638 | | | (40,330) | |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period | 115,017 | | | 115,669 | |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period | $ | 148,655 | | | $ | 75,339 | |
| | | |
| | | |
| | | |
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 aesthetics portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers from Teoxane and OPUL®, a relational commerce platform for aesthetic practices. Revance has also partnered with Viatris to develop an onabotulinumtoxinA biosimilar, which would compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders, including evaluating DAXXIFY® in two debilitating conditions, cervical dystonia and upper limb spasticity.
Liquidity and Financial Condition
Since our inception, most of our resources have been dedicated to the research, development, manufacturing development, regulatory approval and/or commercialization of our Products and Services. We began generating revenue from commercial sales in July 2020 when we acquired the HintMD Platform, followed by the launch of the RHA® Collection of dermal fillers in August 2020. Although we received DAXXIFY® GL Approval, we expect to continue to incur losses for the foreseeable future. For the three and six months ended June 30, 2023, we had a net loss of $67.3 million and $127.1 million. As of June 30, 2023, we had a working capital surplus of $304.9 million and an accumulated deficit of $1.9 billion. 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. As of June 30, 2023, we had capital resources of $319.7 million consisting of cash, cash equivalents, and short-term investments. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million, provided certain conditions are met. We also have a remaining capacity to sell up to $47.2 million of our common stock under the 2022 ATM Agreement as of June 30, 2023. We believe that our existing capital resources along with our ability to draw on the Second Tranche will be sufficient to fund the operating plan through at least the next 12 months following the issuance of the condensed consolidated financial statements.
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 consolidated balance sheet for the year ended December 31, 2022 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 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 4 for further detail as of June 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 12). The following table presents our revenue disaggregated by timing of transfer of goods or service:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, 2023 | | Six Months Ended June 30, 2023 |
| Transferred | | Transferred |
(in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total |
Product revenue | $ | 54,393 | | | $ | — | | | $ | 54,393 | | | $ | 100,051 | | | $ | — | | | $ | 100,051 | |
Service revenue | 2 | | | 3,719 | | | 3,721 | | | 59 | | | 7,219 | | | 7,278 | |
Collaboration revenue | — | | | 20 | | | 20 | | | — | | | 136 | | | 136 | |
Total revenue | $ | 54,395 | | | $ | 3,739 | | | $ | 58,134 | | | $ | 100,110 | | | $ | 7,355 | | | $ | 107,465 | |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, 2022 | | Six Months Ended June 30, 2022 |
| Transferred | | Transferred |
(in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total |
Product revenue | $ | 25,483 | | | $ | — | | | $ | 25,483 | | | $ | 46,320 | | | $ | — | | | $ | 46,320 | |
Service revenue | 148 | | | 1,078 | | | 1,226 | | | 239 | | | 1,843 | | | 2,082 | |
Collaboration revenue | — | | | 1,659 | | | 1,659 | | | — | | | 5,227 | | | 5,227 | |
Total revenue | $ | 25,631 | | | $ | 2,737 | | | $ | 28,368 | | | $ | 46,559 | | | $ | 7,070 | | | $ | 53,629 | |
Product Revenue
Our product revenue breakdown is summarized below: | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Product: | | | | | | | |
RHA® Collection of dermal fillers | $ | 31,767 | | | $ | 25,483 | | | $ | 62,047 | | | $ | 46,320 | |
DAXXIFY® | 22,626 | | | — | | | 38,004 | | | — | |
Total product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 100,051 | | | $ | 46,320 | |
Accounts receivables and contract liabilities from contracts with our product customers are as follows:
| | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivables: | | | |
Accounts receivable, net | $ | 16,878 | | | $ | 10,966 | |
Total accounts receivable, net | $ | 16,878 | | | $ | 10,966 | |
| | | |
Contract liabilities: | | | |
Deferred revenue, current | $ | 471 | | | $ | 705 | |
Total contract liabilities | $ | 471 | | | $ | 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, was recognized at a point in time and revenue related to the OPUL® payment processing service is recognized over time. The migration of the remaining HintMD customers to OPUL® was completed during the three months ended June 30, 2023. For the Fintech Platform, revenue related to the value-added services component is recognized over time.
Accounts receivable from contracts with our service customers are as follows:
| | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivable: | | | |
Accounts receivable, net | $ | 165 | | | $ | 59 | |
| | | |
| | | |
| | | |
| | | |
Total accounts receivable, net | $ | 165 | | | $ | 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 June 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 June 30, 2023, the transaction price allocated to the unfulfilled performance obligations was $54.5 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 six months ended June 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 six months ended June 30, 2023, we recognized no revenue related to development services under the Viatris Agreement. For the three and six months ended June 30, 2022, we recognized $1.7 million and $5.2 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 June 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 June 30, 2023, the transaction price allocated to unfulfilled performance obligation is $38.0 million.
For the three and six months ended June 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 six months ended June 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:
| | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accounts receivables: | | | |
Accounts receivable, net — Fosun | $ | — | | | $ | 315 | |
Total accounts receivable, net | $ | — | | | $ | 315 | |
| | | |
Contract liabilities: | | | |
Deferred revenue, current — Viatris | $ | 4,962 | | | $ | 6,162 | |
| | | |
Total contract liabilities, current | $ | 4,962 | | | $ | 6,162 | |
| | | |
Deferred revenue, non-current — Viatris | $ | 44,236 | | | $ | 40,600 | |
Deferred revenue, non-current — Fosun | 37,977 | | | 37,977 | |
Total contract liabilities, non-current | $ | 82,213 | | | $ | 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 six months ended June 30, 2023 are as follows:
| | | | | |
| (in thousands) |
Balance on December 31, 2022 | $ | 84,739 | |
Revenue recognized | (136) | |
Billings and adjustments, net | 2,572 | |
Balance on June 30, 2023 | $ | 87,175 | |
3. Cash Equivalents and Short-Term Investments
The following table summarizes our cash equivalents and short-term investments:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2023 | | December 31, 2022 |
(in thousands) | Adjusted Cost | | Gains | | Losses | | Fair Value | | Adjusted Cost | | Losses | | Fair Value |
U.S. treasury securities | $ | 136,829 | | | $ | — | | | $ | (52) | | | $ | 136,777 | | | $ | 109,984 | | | $ | (228) | | | $ | 109,756 | |
Money market funds | 98,349 | | | — | | | — | | | 98,349 | | | 85,206 | | | — | | | 85,206 | |
Commercial paper | 57,843 | | | — | | | (6) | | | 57,837 | | | 80,946 | | | — | | | 80,946 | |
U.S. government agency obligations | 14,760 | | | 5 | | | — | | | 14,765 | | | 4,480 | | | — | | | 4,480 | |
Corporate bonds | 7,531 | | | — | | | (8) | | | 7,523 | | | 41,186 | | | (146) | | | 41,040 | |
Total cash equivalents and short-term investments | $ | 315,312 | | | $ | 5 | | | $ | (66) | | | $ | 315,251 | | | $ | 321,802 | | | $ | (374) | | | $ | 321,428 | |
| | | | | | | | | | | | | |
Classified as: | | | | | | | | | | | | | |
Cash equivalents | | | | | | | $ | 136,763 | | | | | | | $ | 89,686 | |
Short-term investments | | | | | | | 178,488 | | | | | | | 231,742 | |
Total cash equivalents and short-term investments | | | | | | | $ | 315,251 | | | | | | | $ | 321,428 | |
As of June 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.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
4. 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:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | June 30, 2023 | | December 31, 2022 |
(in thousands, except for in years) | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount |
Distribution rights | | 4.8 | | $ | 32,334 | | | $ | (21,974) | | | $ | 10,360 | | | 1.4 | | $ | 32,334 | | | $ | (20,882) | | | $ | 11,452 | |
Acquired developed technology | | 3.8 | | 16,200 | | | (6,075) | | | 10,125 | | | 4.2 | | 35,800 | | | (24,325) | | | 11,475 | |
Internally developed technology | | 2.0 | | 8,918 | | | (3,798) | | | 5,120 | | | 2.4 | | 8,062 | | | (2,271) | | | 5,791 | |
Customer relationships | | 1.1 | | 10,300 | | | (7,510) | | | 2,790 | | | 1.6 | | 10,300 | | | (6,223) | | | 4,077 | |
Other software | | 0.6 | | 879 | | | (813) | | | 66 | | | 1.8 | | 3,166 | | | (1,592) | | | 1,574 | |
Development in progress | | N/A | | — | | | — | | | — | | | N/A | | 975 | | | — | | | 975 | |
Total intangible assets | | | | $ | 68,631 | | | $ | (40,170) | | | $ | 28,461 | | | | | $ | 90,637 | | | $ | (55,293) | | | $ | 35,344 | |
N/A - Not applicableAmortization expense of intangible assets for the three and six months ended June 30, 2023 was $2.8 million and $6.8 million, respectively. Amortization expense of intangible assets for the three and six months ended June 30, 2022 was $4.9 million and $9.9 million, respectively.
Based on the amount of intangible assets as of June 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 six months | $ | 5,271 | |
2024 | 8,752 | |
2025 | 6,147 | |
2026 | 4,890 | |
2027 | 2,856 | |
2028 and thereafter | 545 | |
Total | $ | 28,461 | |
5. Inventories
Inventories consist of the following: | | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Raw materials | $ | 2,208 | | | $ | 505 | |
Work in process | 9,397 | | | 4,933 | |
Finished goods | 22,843 | | | 12,887 | |
Total inventories | $ | 34,448 | | | $ | 18,325 | |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
6. Accruals and other current liabilities
Accruals and other current liabilities consists of the following:
| | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
Accruals related to: | | | |
Compensation | $ | 17,771 | | | $ | 28,014 | |
Selling, general and administrative | 7,143 | | | 9,681 | |
Research and development | 5,374 | | | 9,012 | |
Interest expense | 1,887 | | | 1,912 | |
Clinical trials | 1,173 | | | 1,863 | |
Inventories | 872 | | | 2,312 | |
Other current liabilities | 5,315 | | | 6,563 | |
Total accruals and other current liabilities | $ | 39,535 | | | $ | 59,357 | |
7. 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, 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
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
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 June 30, | | Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Finance lease: | | | | | | | |
Amortization of finance lease right-of-use asset (1) | $ | 1,350 | | | $ | 1,158 | | | $ | 3,668 | | | $ | 1,158 | |
Interest on finance lease liability | 442 | | | 751 | | | 1,008 | | | 2,259 | |
Variable lease cost (2) | — | | | 323 | | | 374 | | | 1,713 | |
Total finance lease costs | 1,792 | | | 2,232 | | | 5,050 | | | 5,130 | |
Operating leases: | | | | | | | |
Operating lease cost | 4,312 | | | 2,223 | | | 6,519 | | | 4,446 | |
Variable lease cost (3) | 548 | | | 431 | | | 1,055 | | | 865 | |
Total operating lease costs | 4,860 | | | 2,654 | | | 7,574 | | | 5,311 | |
Total lease costs | $ | 6,652 | | | $ | 4,886 | | | $ | 12,624 | | | $ | 10,441 | |
(1)Starting in the three months ended June 30, 2023, amortization of the finance lease right-of-use asset is capitalized into inventories on the condensed consolidated balance sheets resulting from 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 June 30, 2023, maturities of our lease liabilities are as follows:
| | | | | | | | | | | | | | | | | |
(in thousands) | Finance Lease | | Operating Leases | | Total |
Year Ending December 31, | | | | | |
2023 remaining six months | $ | 12,855 | | | $ | 3,952 | | | $ | 16,807 | |
2024 | 3,102 | | | 8,723 | | | 11,825 | |
2025 | — | | | 8,981 | | | 8,981 | |
2026 | — | | | 9,242 | | | 9,242 | |
2027 | — | | | 2,535 | | | 2,535 | |
2028 and thereafter | — | | | 14,612 | | | 14,612 | |
Total lease payments | 15,957 | | | 48,045 | | | 64,002 | |
Less imputed interest | (452) | | | (11,510) | | | (11,962) | |
Present value of lease payments | $ | 15,505 | | | $ | 36,535 | | | $ | 52,040 | |
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 June 30, 2023, weighted-average remaining lease terms and discount rates are as follows:
| | | | | | | | | | | |
| Finance Leases | | Operating Leases |
Weighted-average remaining lease term (years) | 2.8 | | 7.2 |
Weighted-average discount rate | 10.7 | % | | 9.8 | % |
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
Supplemental cash flow information related to the leases was as follows:
| | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 |
Cash paid for amounts included in the measurement of lease liabilities | | | |
Operating cash flows from operating leases | $ | 4,188 | | | $ | 4,192 | |
Operating cash flows from finance lease | $ | 1,008 | | | $ | 627 | |
Financing cash flows from finance lease | $ | 8,899 | | | $ | 1,760 | |
Right-of-use assets obtained in exchange for lease liabilities | | | |
Finance lease | $ | 23,735 | | | $ | 18,556 | |
Leases 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 June 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 June 30, 2023, we have made prepayments of $27.5 million to PCI which is recorded within “Finance lease prepaid expense” in the condensed consolidated balance sheets. Based on our best estimate as of June 30, 2023, our remaining minimum commitment under the PCI Supply Agreement will be $12.7 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 aggregate.
Nashville Lease Expansion Premises
In November 2020, we entered into the Nashville Lease, a non-cancelable operating lease for an office space in Nashville, Tennessee. The lease commenced and was recognized on the condensed consolidated balance sheets in June 2021. In July 2021, we entered into the second amendment to the Nashville Lease, which provided for the expansion of the initial premises to include the Expansion Premises, an additional 30,591 square feet with an expected term to 2034. The lease accounting commencement date of the Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023 at the earliest. The monthly base rent payments for the lease escalate over the term. The total undiscounted basic rent payments currently determinable for the Expansion Premises are $16 million with an expected term to 2034.
REVANCE THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
In January 2023, we entered into the third amendment to the Nashville Lease, which provides for the expansion of the current premises to include the Second Expansion Premises, an additional 17,248 square feet with an expected term to 2032. The monthly base rent payments for the lease escalate over the term, and the total undiscounted basic rent payments determinable for the Second Expansion Premises are $7 million. The lease accounting commencement date of the Second Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023.
8. Debt
The following table provides information regarding our debt:
| | | | | | | | | | | |
| June 30, | | December 31, |
(in thousands) | 2023 | | 2022 |
2027 Notes | $ | 287,500 | | | $ | 287,500 | |
Less: Unamortized debt issuance costs | (4,937) | | | (5,587) | |
Carrying amount of the 2027 Notes | 282,563 | | | 281,913 | |
| | | |
Notes Payable | 100,000 | | | 100,000 | |
Less: Unamortized debt discount | (1,175) | | | (1,347) | |
Less: Unamortized debt issuance costs | (1,040) | | | (1,192) | |
Carrying amount of Notes Payable | 97,785 | | | 97,461 | |
Debt, non-current | $ | 380,348 | | | $ | 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 June 30, | | Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Contractual interest expense | $ | 3,407 | | | $ | 3,383 | | | $ | 6,790 | | | $ | 4,971 | |
Amortization of debt issuance costs | 431 | | | 417 | | | 863 | | | 749 | |
Amortization of debt discount | 87 | | | 74 | | | 172 | | | 85 | |
Total interest expense | $ | 3,925 | | | $ | 3,874 | | | $ | 7,825 | | | $ | 5,805 | |
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 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 five business day period after any ten 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 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.
Capped Call Transactions
Concurrently with the 2027 Notes, we entered into capped call transactions with the option counterparties and 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 Notes and/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.
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 $28.9 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 June 30, 2023 and December 31, 2022, we had not purchased any shares under the capped call transactions.
REVANCE THERAPEUTICS, INC.
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 $100 million. On August 8, 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, and the uncommitted Third Tranche was increased from $100 million to $150 million. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50 million, provided certain conditions are met. 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 to be issued pursuant to the Second Tranche will 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
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Notes to Condensed Consolidated Financial Statements — (Continued)
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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.
9. Stockholders’ 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 3.3 million shares. For the six months ended June 30, 2023, 2.4 million shares of stock awards and 0.2 million stock options were granted under the 2014 EIP. As of June 30, 2023, 4.0 million shares were available for issuance under the 2014 EIP.
2014 IN
For the six months ended June 30, 2023, no stock options or awards were granted under the 2014 IN. As of June 30, 2023, 0.8 million shares were available for issuance under the 2014 IN.
HintMD Plan
For the six months ended June 30, 2023, no stock options or awards were granted under the HintMD Plan. As of June 30, 2023, 0.1 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 0.3 million shares. As of June 30, 2023, 1.8 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.
Common stock equivalents that were excluded from the computation of diluted net loss per share are presented below:
| | | | | | | | | | | |
| June 30, |
| 2023 | | 2022 |
Convertible senior notes | 8,878,938 | | 8,878,938 |
Outstanding stock options | 4,391,679 | | 5,063,074 |
Unvested RSUs and PSUs | 3,281,382 | | 2,492,797 | |
Unvested RSAs and PSAs | 1,577,981 | | 2,656,703 |
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 $125.0 million. We were not obligated to sell any shares under the 2020 ATM Agreement. Subject to the terms and
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Notes to Condensed Consolidated Financial Statements — (Continued)
(Unaudited)
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 3.0% 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 1.7 million shares of common stock under the 2020 ATM Agreement 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. 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 $150.0 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 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Cowen with customary indemnification and contribution rights.
For the three months ended June 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 March 31, 2023.
Stock-Based Compensation Expense
The following table summarizes our stock-based compensation expense by line item in our condensed consolidated statements of operations and comprehensive loss:
| | | | | | | | | | | | | | | | | | | | | | | |
(in thousands) | Three Months Ended June 30, | | Six Months Ended June 30, |
2023 | | 2022 | | 2023 | | 2022 |
Selling, general and administrative | $ | 12,178 | | | $ | 6,528 | | | $ | 22,443 | | | $ | 14,692 | |
Research and development | 3,421 | | | 2,735 | | | 6,238 | | | 8,934 | |
Cost of product revenue (exclusive of depreciation and amortization) | 948 | | | — | | | 948 | | | — | |
Total stock-based compensation expense | $ | 16,547 | | | $ | 9,263 | | | $ | 29,629 | | | $ | 23,626 | |
Capitalized Stock-based Compensation Expense
For the three and six months ended June 30, 2023, stock-based compensation expense of $0.9 million and $1.9 million, respectively, was capitalized in inventories on the condensed consolidated balance sheets, which is subsequently expensed to cost of product revenue (exclusive of depreciation and amortization) on the condensed consolidated statements of operations and comprehensive loss as shown in the table above.
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Notes to Condensed Consolidated Financial Statements — (Continued)
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10. Fair Value Measurements
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.
| | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2023 |
(in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 |
Assets | | | | | | | |
U.S. treasury securities | $ | 136,777 | | | $ | 136,777 | | | $ | — | | | $ | — | |
Money market funds | 98,349 | | | 98,349 | | | — | | | — | |
U.S. government agency obligations | 14,765 | | | 14,765 | | | — | | | — | |
Commercial paper | 57,837 | | | — | | | 57,837 | | | — | |
Corporate bonds | 7,523 | | | — | | | 7,523 | | | — | |
Total assets measured at fair value | $ | 315,251 | | | $ | 249,891 | | | $ | 65,360 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2022 |
(in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 |
Assets | | | | | | | |
U.S. treasury securities | $ | 109,756 | | | $ | 109,756 | | | $ | — | | | $ | — | |
Money market funds | 85,206 | | | 85,206 | | | — | | | — | |
U.S. government agency obligations | 4,480 | | | 4,480 | | | — | | | — | |
Commercial paper | 80,946 | | | — | | | 80,946 | | | — | |
Corporate bonds | 41,040 | | | — | | | 41,040 | | | — | |
Total assets measured at fair value | $ | 321,428 | | | $ | 199,442 | | | $ | 121,986 | | | $ | — | |
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 8) 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 June 30, 2023, and December 31, 2022, the fair value of the 2027 Notes was $302.9 million and $288.2 million, respectively. As of June 30, 2023 and December 31, 2022, the fair value of the Notes Payable was approximately the same as its unamortized carrying value.
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Notes to Condensed Consolidated Financial Statements — (Continued)
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11. Commitments 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 2,500,000 shares of our common stock and certain other commitments by us. The Teoxane Agreement is effective for a term of ten years from product launch in September 2020 and may be extended for a two-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 $40 million and $52 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 $34 million and $36 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 June 30, 2023, we are obligated to pay BTRX up to a remaining $15.5 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 six months ended June 30, 2023 and 2022, no 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
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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 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 we await the court’s decision on claim construction.
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 is scheduled for August 10, 2023, but 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 June 30, 2023 and December 31, 2022, no such provision for liabilities related to the above litigation matters were recorded on the condensed consolidated balance sheets.
12. Segment 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 two 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.
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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.
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 two segments. For the three months ended June 30, 2023 and 2022, intersegment revenue was $0.7 million and $0.3 million, respectively. For the six months ended June 30, 2023 and 2022, intersegment revenue was $1.3 million and $0.6 million, respectively.
Reconciliation of Segment Revenue to Consolidated Revenue
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Revenue: | | | | | | | |
Product Segment | $ | 54,413 | | | $ | 27,142 | | | $ | 100,187 | | | $ | 51,547 | |
Service Segment | 3,721 | | | 1,226 | | | 7,278 | | | 2,082 | |
Total revenue | $ | 58,134 | | | $ | 28,368 | | | $ | 107,465 | | | $ | 53,629 | |
Reconciliation of Segment Loss from Operations to Consolidated Loss from Operations
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 | | 2023 | | 2022 |
Loss from operations: | | | | | | | |
Product Segment | $ | (19,335) | | | $ | (24,969) | | | $ | (32,065) | | | $ | (49,920) | |
Service Segment | (4,978) | | | (5,598) | | | (12,065) | | | (9,533) | |
Corporate and other expenses | (41,186) | | | (27,275) | | | (79,401) | | | (60,610) | |
Total loss from operations | $ | (65,499) | | | $ | (57,842) | | | $ | (123,531) | | | $ | (120,063) | |
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; our plans regarding the Second Tranche; the evaluation of the variable transaction price related to Viatris Agreement; the availability of the Second and Third Tranches; our ability to sell stock under the 2022 ATM Agreement; our future financing plans and strategies; 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®; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers, including with respect to DAXXIFY® for indications other than glabellar lines and the RHA® Pipeline Products; our opportunity in aesthetics and therapeutics; our expectations regarding the Fintech Platform, including its features, functionality, GPV and profitability; 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, neuromodulator and fintech services markets; the markets for our current and future products and services; our business strategy, plans and prospects, including our commercialization plans and ability to commercialize DAXXIFY® and continued commercialization of the RHA® Collection of dermal fillers; the potential benefits of DAXXIFY®, the RHA® Collection of dermal fillers, our drug product candidates and the Fintech Platform; the potential safety, efficacy and duration of our Products; our ability to maintain and seek out new strategic third-party collaborations to support our goals; the extent to which our products and services are considered innovative, differentiated, exclusive or premium; consumer preferences related to our Products and Services; the rate and degree of economic benefit of DAXXIFY® , the RHA® Collection of dermal fillers, OPUL® and out 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; the commencement of the Second Expansion Premises; our ability to expand our operations to support the commercialization of our Products and attract and retain qualified personnel to support our business; 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.
Summary of Risk Factors
•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 and consumers, and may not be commercially successful, which would adversely affect our operating results and financial condition.
•We will require substantial additional funding to continue to operate our business and achieve our goals and a failure to obtain the necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts. We have incurred significant losses since our inception and we anticipate that these losses will continue. 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.
•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 and more established relationships. Our failure to effectively compete may prevent us from achieving significant market penetration and expansion.
•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 indications other than glabellar lines 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.
•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.
•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.
•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, any future product candidates or the Fintech Platform 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.
•The HintMD Acquisition may result in additional impairment charges from the recording of goodwill and intangible assets that could adversely affect our financial results.
•If we do not effectively manage our expanded operations in connection with the HintMD Acquisition, or if we are not able to achieve market acceptance of the Fintech Platform, then we may not achieve the anticipated benefits or recoup the substantial expense incurred in connection with the acquisition.
•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.
Overview
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY®, the RHA® Collection of dermal fillers and OPUL®, the first-of-its-kind relational commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for Revance’s elite practice partners and their consumers. Revance has also partnered with Viatris to develop an onabotulinumtoxinA biosimilar, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating DAXXIFY® in two debilitating conditions, cervical dystonia and upper limb spasticity.
Recent Developments
For the three and six months ended June 30, 2023, we generated $58.1 million and $107.3 million, respectively, in revenue from the sale of our Products and our Services. As of June 30, 2023, we had over 6,000 aesthetic accounts across our Products and Services.
First Amendment to Note Purchase Agreement
On August 8, 2023, the Company, HintMD and Athyrium entered into the First Amendment. 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. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million, provided certain conditions are met. The notes to be issued pursuant to the Second Tranche will 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. 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 focuses 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, and initiated the market introduction of DAXXIFY®, which has been focused on our existing customers. For the three and six months ended June 30, 2023, we recognized $22.6 million and $38.0 million, respectively, in product revenue from the sale of DAXXIFY®.
The FDA approved our PAS submission for the ABPS manufacturing facility, which is serving as one of our DAXXIFY® commercial supply sources, in addition to our Northern California manufacturing facility. All inventory produced at the ABPS facility prior to DAXXIFY® GL Approval has been released for commercial use.
We are pursuing regulatory approval of DAXXIFY® for the treatment of cervical dystonia. On January 6, 2023, the FDA accepted for review the supplemental BLA for DAXXIFY® for the treatment of cervical dystonia that we submitted in October 2022. The PDUFA date is August 19, 2023. If the supplemental BLA is approved on or by the PDUFA date, we plan to initiate an early experience program in late 2023, followed by broad commercial launch in 2024.
Fosun Partnership
In April 2023, Fosun announced that the BLA for DaxibotulinumtoxinA for Injection for the improvement of glabellar lines was accepted for review by the NMPA. In July 2023, the NMPA accepted the BLA for DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia.
RHA® Collection of Dermal Fillers
For the three and six months ended June 30, 2023, we recognized $31.8 million and $62.0 million, respectively, in product revenue from the sale of the RHA® Collection of dermal fillers.
OPUL® Relational Commerce Platform
For the three months ended June 30, 2023, we recognized $3.7 million in service revenue and $3.7 million in cost of service revenue (exclusive of amortization) from the Fintech Platform. For the six months ended June 30, 2023, we recognized $7.3 million in service revenue and $7.4 million in cost of service revenue (exclusive of amortization) from the Fintech Platform. Since the Fintech Platform generates revenue as a percentage of credit card processing volumes, we use GPV as a key indicator of the ability of the Fintech Platform to generate revenue. GPV measures the total dollar amount of all transactions processed in the period through the Fintech Platform, net of refunds. The Company also uses the Fintech Platform PayFac capabilities to process credit card transactions for Products purchased from the Company; these transactions are not included in GPV. GPV for OPUL® was approximately $173 million for the three months ended June 30, 2023. GPV for the trailing-twelve months ended June 30, 2023 totaled approximately $697 million.
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.
Revenue
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 28,910 | | | 113 | % | | $ | 100,051 | | | $ | 46,320 | | | $ | 53,731 | | | 116 | % |
Service revenue | 3,721 | | | 1,226 | | | $ | 2,495 | | | 204 | % | | 7,278 | | | 2,082 | | | $ | 5,196 | | | 250 | % |
Collaboration revenue | 20 | | | 1,659 | | | $ | (1,639) | | | (99) | % | | 136 | | | 5,227 | | | $ | (5,091) | | | (97) | % |
Total revenue | $ | 58,134 | | | $ | 28,368 | | | $ | 29,766 | | | 105 | % | | $ | 107,465 | | | $ | 53,629 | | | $ | 53,836 | | | 100 | % |
Product Revenue
Our breakdown of revenue by Product is summarized below:
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| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Product: | | | | | | | | | | | | | | | |
RHA® Collection of dermal fillers | $ | 31,767 | | | $ | 25,483 | | | $ | 6,284 | | | 25 | % | | $ | 62,047 | | | $ | 46,320 | | | $ | 15,727 | | | 34 | % |
DAXXIFY® | 22,626 | | | — | | | $ | 22,626 | | | N/M | | 38,004 | | | — | | | $ | 38,004 | | | N/M |
Total product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 28,910 | | | 113 | % | | $ | 100,051 | | | $ | 46,320 | | | $ | 53,731 | | | 116 | % |
N/M - Percentage not meaningful
For the three and six months ended June 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 U.S. market penetration as well as the launch of RHA® Redensity in the third quarter of 2022.
We started to generate product revenue from DAXXIFY® in the fourth quarter of 2022 from the PrevU program, which is a pre-launch promotional program for select practice partners. We completed the PrevU program in March 2023, and initiated the market introduction of DAXXIFY®, which has been focused on our existing customers.
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 have been onboarding new customers exclusively to OPUL® and the migration of the remaining HintMD customers to OPUL® was completed during the three months ended June 30, 2023. The migration did not have a material impact on the gross margin generated by the Fintech Platform in the near term.
For the three and six months ended June 30, 2023, our service revenue increased compared to the same periods in 2022, primarily due to the presentation difference in the revenue accounting method described above as well as the increased OPUL® GPV.
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 six months ended June 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 six months ended June 30, 2023, we recognized no revenue related to development services under the Viatris Agreement. For the three and six months ended June 30, 2022, we recognized $1.7 million and $5.2 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 six months ended June 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 six months ended June 30, 2022, no revenue was recognized from the Fosun License Agreement.
Operating Expenses
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Operating expenses: | | | | | | | | | | | | | | | |
Cost of product revenue (exclusive of depreciation and amortization) | $ | 17,607 | | | $ | 8,121 | | | $ | 9,486 | | | 117 | % | | $ | 30,094 | | | $ | 15,449 | | | $ | 14,645 | | | 95 | % |
Cost of service revenue (exclusive of amortization) | 3,700 | | | 1,402 | | | $ | 2,298 | | | 164 | % | | 7,384 | | | 1,967 | | | $ | 5,417 | | | 275 | % |
Selling, general and administrative | 77,384 | | | 47,847 | | | $ | 29,537 | | | 62 | % | | 143,395 | | | 92,922 | | | $ | 50,473 | | | 54 | % |
Research and development | 22,807 | | | 24,913 | | | $ | (2,106) | | | (8) | % | | 45,984 | | | 55,642 | | | $ | (9,658) | | | (17) | % |
Depreciation and amortization | 2,135 | | | 3,927 | | | $ | (1,792) | | | (46) | % | | 4,139 | | | 7,712 | | | $ | (3,573) | | | (46) | % |
Total operating expenses | $ | 123,633 | | | $ | 86,210 | | | $ | 37,423 | | | 43 | % | | $ | 230,996 | | | $ | 173,692 | | | $ | 57,304 | | | 33 | % |
Cost of product revenue (exclusive of depreciation and amortization)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 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) | $ | 15,192 | | | $ | 7,851 | | | $ | 7,341 | | | 94 | % | | $ | 25,613 | | | $ | 14,370 | | | $ | 11,243 | | | 78 | % |
Distribution, royalty and other fulfillment charges | 1,467 | | | 270 | | | $ | 1,197 | | | 443 | % | | 3,533 | | | 1,079 | | | $ | 2,454 | | | 227 | % |
Stock-based compensation | 948 | | | — | | | $ | 948 | | | N/M | | 948 | | | — | | | $ | 948 | | | N/M |
Total cost of product revenue (exclusive of depreciation and amortization) | $ | 17,607 | | | $ | 8,121 | | | $ | 9,486 | | | 117 | % | | $ | 30,094 | | | $ | 15,449 | | | $ | 14,645 | | | 95 | % |
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 consumer took place in the fourth quarter of 2022. Cost of product revenue (exclusive of depreciation and amortization) related to DAXXIFY® generally incur 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 six months ended June 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 DAXXIFY® in the respective periods. When Zero-cost Inventory (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 six months ended June 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 higher sales volumes of the RHA® Collection of dermal fillers and DAXXIFY®.
Distribution, royalty and other fulfillment charges
For the three and six months ended June 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
We started to incur stock-based compensation expense in cost of product revenue (exclusive of depreciation and amortization) during the three months ended June 30, 2023, which 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 six months ended June 30, 2023 would have increased by approximately $4 million and $8 million, respectively. We expect to utilize Zero-cost Inventory related to DAXXIFY® in the near-term until depleted.
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 six months ended June 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 well as the increase of OPUL® GPV and costs associated with OPUL® as described in the Service Revenue section above.
Selling, General and Administrative Expenses
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Selling, general and administrative | $ | 64,166 | | | $ | 40,301 | | | $ | 23,865 | | | 59 | % | | $ | 117,770 | | | $ | 76,078 | | | $ | 41,692 | | | 55 | % |
Stock-based compensation | 12,178 | | | 6,528 | | | $ | 5,650 | | | 87 | % | | 22,443 | | | 14,692 | | | $ | 7,751 | | | 53 | % |
Depreciation and amortization | 1,040 | | | 1,018 | | | $ | 22 | | | 2 | % | | 3,182 | | | 2,152 | | | $ | 1,030 | | | 48 | % |
Total selling, general and administrative expenses | $ | 77,384 | | | $ | 47,847 | | | $ | 29,537 | | | 62 | % | | $ | 143,395 | | | $ | 92,922 | | | $ | 50,473 | | | 54 | % |
Selling, general and administrative expenses (before stock-based compensation and depreciation and amortization)
Selling, general and administrative expenses (before stock-based compensation 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®; and
•Personnel and professional service costs in our finance, information technology, investor relations, legal, human resources, and other administrative departments;
We expect selling, general and administrative expenses to increase in the near term in connection with the expansion of our commercial sales team and incremental administrative and infrastructure support. For the three and six months ended June 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, of which $15.7 million and $26.8 million, respectively, was attributed to the Product Segment in connection with the infrastructure investment to support the DAXXIFY® launch for the respective periods.
Stock-based compensation
For the three and six months ended June 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 the DAXXIFY® GL Approval PSUs in March 2023; and (iii) the stock-based compensation expense recognized for the vesting of certain market-based PSUs in May 2023.
Research and Development Expenses
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| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Research and development | $ | 19,031 | | | $ | 21,672 | | | $ | (2,641) | | | (12) | % | | $ | 36,918 | | | $ | 45,745 | | | $ | (8,827) | | | (19) | % |
Stock-based compensation | 3,421 | | | 2,735 | | | $ | 686 | | | 25 | % | | 6,238 | | | 8,934 | | | $ | (2,696) | | | (30) | % |
Depreciation and amortization | 355 | | | 506 | | | $ | (151) | | | (30) | % | | 2,828 | | | 963 | | | $ | 1,865 | | | 194 | % |
Total research and development expenses | $ | 22,807 | | | $ | 24,913 | | | $ | (2,106) | | | (8) | % | | $ | 45,984 | | | $ | 55,642 | | | $ | (9,658) | | | (17) | % |
Research and development expenses (before stock-based compensation 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.
Research and development expenses (before stock-based compensation 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.
Our research and development expenses (before stock-based compensation 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 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 product development activities related to OPUL®, sharing certain development costs with Teoxane related to the RHA® Pipeline Products, and other activities related to the pursuit of approval for our third party manufacturing partner site.
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 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.
For the three months ended June 30, 2023, research and development expenses (before stock-based compensation and depreciation and amortization) decreased compared to the same period in 2022, primarily due to the effects of capitalizing certain manufacturing related expenses for DAXXIFY® since the third quarter of 2022, offset by an increase in clinical, regulatory and other research and development activities.
For the six months ended June 30, 2023, research and development expenses (before stock-based compensation and depreciation and amortization) decreased compared to the same period in 2022, primarily due to the effects of capitalizing certain manufacturing related expenses for DAXXIFY® since the third quarter of 2022.
Stock-based compensation
For the three months ended June 30, 2023, stock-based compensation included in research and development expenses increased compared to the same periods in 2022, primarily due to stock-based compensation expense related to achievement of certain performance-based PSUs in May 2023, partially offset by the capitalized stock-based compensation in the second quarter of 2023.
For the six months ended June 30, 2023, stock-based compensation included in research and development expenses decreased compared to the same period 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; and (ii) the capitalized stock-based compensation for the first and second quarter of 2023. These decreases were partially offset by (i) the stock-based compensation recognition for the DAXXIFY® GL Approval PSUs, which vested in March 2023, and (ii) a stock modification accounting adjustment related to achievement of certain performance-based PSUs in May 2023.
Depreciation and Amortization
For the three and six months ended June 30, 2023, depreciation and amortization decreased compared to the same periods in 2022, primarily due to extension of useful life of Teoxane distribution rights, capitalization of depreciation into inventory and completion of amortization for developed technology related to HintMD in 2022, offset primarily by an increased amortization expense from a finance lease in the first quarter of 2023.
Net Non-Operating Income and Expense
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| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands, except percentages) | 2023 | | 2022 | | Change | | % Change | | 2023 | | 2022 | | Change | | % Change |
Interest income | $ | 3,148 | | | $ | 619 | | | $ | 2,529 | | | 409 | % | | $ | 6,118 | | | $ | 695 | | | $ | 5,423 | | | 780 | % |
Interest expense | (4,368) | | | (3,874) | | | $ | (494) | | | 13 | % | | (8,865) | | | (5,805) | | | $ | (3,060) | | | 53 | % |
Other expense, net | (599) | | | (338) | | | $ | (261) | | | 77 | % | | (833) | | | (604) | | | $ | (229) | | | 38 | % |
Total net non-operating expense | $ | (1,819) | | | $ | (3,593) | | | $ | 1,774 | | | (49) | % | | $ | (3,580) | | | $ | (5,714) | | | $ | 2,134 | | | (37) | % |
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 six months ended June 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 and the six months ended June 30, 2023, interest expense increased compared to the same periods in 2022 due to the contractual interest on the Notes Payable, which we began to incur in late March 2022, and our finance lease liability interest expense.
Other Expense, net
Other expense, net primarily consists of miscellaneous tax and other expense items.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
| | | | | | | | | | | | | | | | | |
(in thousands) | June 30, 2023 | | December 31, 2022 | | Increase /(Decrease) |
Cash, cash equivalents, and short-term investments | $ | 319,723 | | | $ | 340,707 | | | $ | (20,984) | |
Working capital | $ | 304,868 | | | $ | 299,045 | | | $ | 5,823 | |
Stockholders’ equity | $ | 26,786 | | | $ | 12,600 | | | $ | 14,186 | |
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 June 30, 2023 and December 31, 2022, we had cash, cash equivalents and short-term investments of $319.7 million and $340.7 million, respectively, which reflected a decrease between these periods of $21.0 million. The decrease
was primarily due to cash used in our operating activities of $121.2 million, taxes paid related to net settlement of stock awards of $4.3 million, principal payments on a finance lease of $8.9 million, and the purchase of property and equipment of $0.6 million. The decrease was primarily offset by proceeds from the ATM of $100.0 million, net of commissions and offerings costs, 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:
| | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2023 | | 2022 |
Net cash provided by (used in): | | | |
Operating activities | $ | (122,882) | | | $ | (105,495) | |
Investing activities | $ | 55,784 | | | $ | (61,313) | |
Financing activities | $ | 100,736 | | | $ | 126,478 | |
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 six months ended June 30, 2023, primarily consisted of approximately $197 million in expenditures related to overall operations and other working capital adjustments of $28 million, partially offset by approximately $102 million in net cash receipts from our Products and Services sales and other non-cash adjustments. The increase in net cash used in operating activities for the six months ended June 30, 2023, compared to 2022 is primarily driven by the increase in revenue generated from our Products, partially offset by expenditures in supporting company growth.
Cash used in operating activities for the six months ended June 30, 2022 primarily consisted of approximately $143 million in expenditures related to overall operations and other working capital adjustment of $8 million, offset by approximately $46 million in net cash receipts from our product and service sales and other non-cash adjustments.
Cash Flows from Investing Activities
For the six months ended June 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 and prepayments for a finance lease.
Cash Flows from Financing Activities
For the six months ended June 30, 2023, net cash provided by financing activities was driven by the proceeds from the ATM offering program, net of commissions, 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.
For the six months ended June 30, 2022, net cash provided by financing activities was driven by the issuance of the Notes Payable pursuant to the Note Purchase Agreement, net of debt discount, the ATM offering program, net of commissions 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.
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. On August 8, 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, and the uncommitted Third Tranche was increased from $100 million to $150 million. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50 million, provided certain conditions are met. 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 to be issued pursuant to the Second Tranche will 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 Notes and/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 common stock. For the three months ended June 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 had been sold under the 2022 ATM Agreement for the three months ended March 31, 2023.
Common Stock and Common Stock Equivalents
As of July 31, 2023, outstanding shares of common stock were 88.0 million, outstanding stock options were 4.3 million, unvested RSUs and PSUs were 3.3 million, unvested RSAs and PSAs were 1.6 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 losses in future periods as we continue to devote our resources to the research, development, manufacturing development, regulatory approval and/or commercialization of our products and services.
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 in addition to preparing for the Company’s potential entry into therapeutics with DAXXIFY® for the treatment of cervical dystonia and supporting our ongoing operations. In particular, we anticipate our expenses will increase in the near term as we expand our commercial sales team in the United States and invest resources in our sales and marketing strategy; the manufacturing and supply of DAXXIFY® for commercialization; and seek approval of and prepare to commercialize DAXXIFY® for the treatment of cervical dystonia. In addition, we expect to continue to make capital outlays in connection with our partnerships and Services business. 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. Further, to grow the Services business, we plan to continue to develop OPUL® and other services that meet the needs of our customers. 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, in March 2022, we received proceeds from the First Tranche. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million, provided certain conditions are met; and, we have an established ATM program. We believe that our existing capital resources along with our ability to draw on the Second Tranche, 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 will require substantial additional financing to continue to operate our business and achieve our goals, in our FY2022 10-K for additional information. Critical Accounting Policies and Estimates
For the six months ended June 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
There were no material changes outside of the ordinary course of business in our contractual obligations as of June 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 six months ended June 30, 2023, our exposure to market risk did not change materially from what was disclosed in Item 7A in our FY2022 10-K.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
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 June 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.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
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 we await the court’s decision on claim construction.
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 is scheduled for August 10, 2023, but 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
Investing in our common stock involves a high degree of risk. You should carefully read and consider the risks we describe in Part I, Item IA of our FY2022 10-K and Quarterly Report on Form 10-Q for the period ended March 31, 2023, 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,” 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.
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
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 June 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 | | Total Shares to be Sold | | Expiration Date |
| | | |
Dwight Moxie, Senior Vice President, General Counsel and Corporate Secretary | | Adopt | | 6/5/2023 | | 34,853 | | 12/5/2023 |
During the three months ended June 30, 2023, none of our Section 16 officers or directors terminated a Rule 10b5-1 trading plan or adopted or terminated a non-Rule 10b5-1 trading arrangement.
First Amendment to Note Purchase Agreement
On August 8, 2023, the Company, HintMD and Athyrium entered into the First Amendment (the “First Amendment”) to the existing Note Purchase Agreement dated March 18, 2022, previously filed with the Securities and Exchange Commission as Exhibit 10.4 to a Quarterly Report on From 10-Q for the period ended March 31, 2022. 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. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million, provided certain conditions are met. The notes to be issued pursuant to the Second Tranche will 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. 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. 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. The foregoing description of the First Amendment is only a summary and does not purport to be complete and is qualified in its entirety by reference to the full text of such amendment, which will be filed as an exhibit to the Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2023.
ITEM 6. EXHIBITS
The following exhibits are included herein or incorporated herein by reference: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Incorporated by Reference | | |
Exhibit Number | | Exhibit Description | | Form | | File No. | | Exhibit | | Filling Date | | Filed Herewith |
3.1 | | | | 8-K | | 001-36297 | | 3.1 | | February 11, 2014 | | — |
3.2 | | | | 8-K | | 001-36297 | | 3.1 | | May 7, 2021 | | — |
3.3 | | | | 8-K | | 001-36297 | | 3.1 | | December 22, 2021 | | — |
4.1 | | | | S-1/A | | 333-193154 | | 4.4 | | February 3, 2014 | | — |
4.2 | | | | 8-K | | 001-36297 | | 4.1 | | February 14, 2020 | | — |
4.3 | | | | 8-K | | 001-36297 | | 4.2 | | February 14, 2020 | | — |
31.1 | | | | — | | — | | — | | — | | X |
31.2 | | | | — | | — | | — | | — | | X |
32.1† | | | | — | | — | | — | | — | | X |
32.2† | | | | — | | — | | — | | — | | X |
101.INS | | 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 | | — | | — | | — | | — | | X |
101.SCH | | Inline XBRL Taxonomy Extension Schema Document | | — | | — | | — | | — | | X |
101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | — | | — | | — | | — | | X |
101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document | | — | | — | | — | | — | | X |
101.LAB | | Inline XBRL Taxonomy Extension Labels Linkbase Document | | — | | — | | — | | — | | X |
101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | — | | — | | — | | — | | X |
104 | | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101) | | — | | — | | — | | — | | X |
† 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, and 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.
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.
| | | | | | | | | | | |
| | | |
| REVANCE THERAPEUTICS, INC. |
| | |
Date: August 8, 2023 | By: | | /s/ Mark J. Foley |
| | | Mark J. Foley |
| | | Chief Executive Officer |
| | | (Duly Authorized Principal Executive Officer) |
| | | |
| By: | | /s/ Tobin C. Schilke |
| | | Tobin C. Schilke |
| | | Chief Financial Officer |
| | | (Duly Authorized Principal Financial Officer and Principal Accounting Officer) |
Exhibit 31.1
CERTIFICATIONS
I, Mark J. Foley, certify that:
1. I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 8, 2023
| | | | | |
| /s/ Mark J. Foley |
| Mark J. Foley |
| Chief Executive Officer |
| (Duly Authorized Principal Executive Officer) |
Exhibit 31.2
CERTIFICATIONS
I, Tobin C. Schilke, certify that:
1. I have reviewed this Form 10-Q of Revance Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 8, 2023
| | | | | |
| /s/ Tobin C. Schilke |
| Tobin C. Schilke |
| Chief Financial Officer |
| (Duly Authorized Principal Financial Officer and Principal Accounting Officer) |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Mark J. Foley, Chief Executive Officer of Revance Therapeutics, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2023 (the “Periodic Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: August 8, 2023
IN WITNESS WHEREOF, the undersigned has set his hands hereto as of the 8th day of August, 2023.
| | | | | |
| /s/ Mark J. Foley |
| Mark J. Foley |
| Chief Executive Officer |
| (Duly Authorized Principal Executive Officer) |
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Revance Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
Exhibit 32.2
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Tobin C. Schilke, Chief Financial Officer of Revance Therapeutics, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:
1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2023 (the “Periodic Report”), to which this Certification is attached as Exhibit 32.2, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: August 8, 2023
IN WITNESS WHEREOF, the undersigned has set his hands hereto as of the 8th day of August, 2023.
| | | | | |
| /s/ Tobin C. Schilke |
| Tobin C. Schilke |
| Chief Financial Officer |
| (Duly Authorized Principal Financial Officer and Principal Accounting Officer) |
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Revance Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
v3.23.2
Cover - shares
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6 Months Ended |
|
Jun. 30, 2023 |
Jul. 31, 2023 |
Cover [Abstract] |
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10-Q
|
|
Document Quarterly Report |
true
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Transition Report |
false
|
|
Entity File Number |
001-36297
|
|
Entity Registrant Name |
Revance Therapeutics, Inc.
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
77-0551645
|
|
Entity Address, Address Line One |
1222 Demonbreun Street, Suite 2000
|
|
Entity Address, City or Town |
Nashville
|
|
Entity Address, State or Province |
TN
|
|
Entity Address, Postal Zip Code |
37203
|
|
City Area Code |
615
|
|
Local Phone Number |
724-7755
|
|
Title of 12(b) Security |
Common Stock, par value $0.001 per share
|
|
Trading Symbol |
RVNC
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
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Entity Interactive Data Current |
Yes
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Entity Filer Category |
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Entity Emerging Growth Company |
false
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false
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
CURRENT ASSETS |
|
|
Cash and cash equivalents |
$ 141,235
|
$ 108,965
|
Restricted cash, current |
275
|
0
|
Short-term investments |
178,488
|
231,742
|
Accounts receivable, net |
17,043
|
11,339
|
Inventories |
34,448
|
18,325
|
Prepaid expenses and other current assets |
7,458
|
4,356
|
Total current assets |
378,947
|
374,727
|
Property and equipment, net |
12,690
|
13,799
|
Goodwill |
77,175
|
77,175
|
Intangible assets, net |
28,461
|
35,344
|
Operating lease right-of-use assets |
34,438
|
39,223
|
Finance lease right-of-use asset |
26,460
|
6,393
|
Restricted cash, non-current |
7,145
|
6,052
|
Finance lease prepaid expense |
27,500
|
27,500
|
Other non-current assets |
4,719
|
1,687
|
TOTAL ASSETS |
597,535
|
581,900
|
CURRENT LIABILITIES |
|
|
Accounts payable |
8,345
|
4,546
|
Accruals and other current liabilities |
39,535
|
59,357
|
Deferred revenue, current |
5,433
|
6,867
|
Finance lease liability, current |
15,505
|
669
|
Operating lease liabilities, current |
5,261
|
4,243
|
Total current liabilities |
74,079
|
75,682
|
Debt, non-current |
380,348
|
379,374
|
Deferred revenue, non-current |
82,213
|
78,577
|
Operating lease liabilities, non-current |
31,274
|
34,182
|
Other non-current liabilities |
2,835
|
1,485
|
TOTAL LIABILITIES |
570,749
|
569,300
|
Commitments and Contingencies (Note 11) |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2023 and December 31, 2022 |
0
|
0
|
Common stock, par value $0.001 per share — 190,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 87,949,987 and 82,385,810 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
88
|
82
|
Additional paid-in capital |
1,908,244
|
1,767,266
|
Accumulated other comprehensive loss |
(61)
|
(374)
|
Accumulated deficit |
(1,881,485)
|
(1,754,374)
|
TOTAL STOCKHOLDERS’ EQUITY |
26,786
|
12,600
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 597,535
|
$ 581,900
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value (in dollars per share) |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized (in shares) |
5,000,000
|
5,000,000
|
Preferred stock, shares issued (in shares) |
0
|
0
|
Preferred stock, shares outstanding (in shares) |
0
|
0
|
Common stock, par value (in dollars per share) |
$ 0.001
|
$ 0.001
|
Common stock authorized (in shares) |
190,000,000
|
190,000,000
|
Common stock, shares issued (in shares) |
87,949,987
|
82,385,810
|
Common stock, shares outstanding (in shares) |
87,949,987
|
82,385,810
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenue: |
|
|
|
|
Total revenue |
$ 58,134
|
$ 28,368
|
$ 107,465
|
$ 53,629
|
Operating expenses: |
|
|
|
|
Selling, general and administrative |
77,384
|
47,847
|
143,395
|
92,922
|
Research and development |
22,807
|
24,913
|
45,984
|
55,642
|
Depreciation and amortization |
2,135
|
3,927
|
4,139
|
7,712
|
Total operating expenses |
123,633
|
86,210
|
230,996
|
173,692
|
Loss from operations |
(65,499)
|
(57,842)
|
(123,531)
|
(120,063)
|
Interest income |
3,148
|
619
|
6,118
|
695
|
Interest expense |
(4,368)
|
(3,874)
|
(8,865)
|
(5,805)
|
Other expense, net |
(599)
|
(338)
|
(833)
|
(604)
|
Net loss |
(67,318)
|
(61,435)
|
(127,111)
|
(125,777)
|
Unrealized gain (loss) |
64
|
(327)
|
313
|
(368)
|
Comprehensive loss |
(67,254)
|
(61,762)
|
(126,798)
|
(126,145)
|
Basic net loss |
(67,318)
|
(61,435)
|
(127,111)
|
(125,777)
|
Diluted net loss |
$ (67,318)
|
$ (61,435)
|
$ (127,111)
|
$ (125,777)
|
Basic net loss (in dollars per share) |
$ (0.80)
|
$ (0.88)
|
$ (1.54)
|
$ (1.82)
|
Diluted net loss (in dollars per share) |
$ (0.80)
|
$ (0.88)
|
$ (1.54)
|
$ (1.82)
|
Basic weighted-average number of shares used in computing net loss per share (in shares) |
83,685,919
|
70,061,457
|
82,417,064
|
69,202,062
|
Diluted weighted-average number of shares used in computing net loss per share (in shares) |
83,685,919
|
70,061,457
|
82,417,064
|
69,202,062
|
Product revenue |
|
|
|
|
Revenue: |
|
|
|
|
Total revenue |
$ 54,393
|
$ 25,483
|
$ 100,051
|
$ 46,320
|
Operating expenses: |
|
|
|
|
Cost of product revenue /service revenue (exclusive of amortization) |
17,607
|
8,121
|
30,094
|
15,449
|
Service revenue |
|
|
|
|
Revenue: |
|
|
|
|
Total revenue |
3,721
|
1,226
|
7,278
|
2,082
|
Operating expenses: |
|
|
|
|
Cost of product revenue /service revenue (exclusive of amortization) |
3,700
|
1,402
|
7,384
|
1,967
|
Collaboration revenue |
|
|
|
|
Revenue: |
|
|
|
|
Total revenue |
$ 20
|
$ 1,659
|
$ 136
|
$ 5,227
|
X |
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v3.23.2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) - USD ($) $ in Thousands |
Total |
Preferred Stock |
Common Stock |
Common Stock
At the Market Offering
|
Additional Paid-In Capital |
Other Accumulated Comprehensive Loss |
Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2021 |
|
0
|
71,584,057
|
|
0
|
0
|
0
|
Beginning Balance at Dec. 31, 2021 |
|
$ 0
|
$ 72
|
|
$ 1,466,369
|
$ (18)
|
$ (1,397,952)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs (in shares) |
|
|
|
1,734,853
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs |
|
|
|
$ 1
|
31,585
|
|
|
Issuance of common stock relating to employee stock purchase plan (in shares) |
|
|
171,824
|
|
|
|
|
Issuance of common stock related to 2014 ESPP |
|
|
|
|
2,018
|
|
|
Issuance of common stock upon exercise of stock options (in shares) |
|
|
30,634
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
|
|
109
|
|
|
Cancellation of stock awards, net of issuance (in shares) |
|
|
(212,859)
|
|
|
|
|
Shares withheld related to net settlement of restricted stock awards (in shares) |
|
|
(185,146)
|
|
|
|
|
Shares withheld related to net settlement of stock awards |
|
|
|
|
(2,760)
|
|
|
Stock-based compensation |
|
|
|
|
23,742
|
|
|
Other |
|
|
|
|
$ 348
|
|
|
Unrealized gain (loss) |
$ (368)
|
|
|
|
|
$ (368)
|
|
Net loss |
$ (125,777)
|
|
|
|
|
|
$ (125,777)
|
Ending Balance (in shares) at Jun. 30, 2022 |
73,123,363
|
|
73,123,363
|
|
0
|
0
|
0
|
Ending Balance at Jun. 30, 2022 |
$ (2,631)
|
|
$ 73
|
|
$ 1,521,411
|
$ (386)
|
$ (1,523,729)
|
Beginning Balance (in shares) at Mar. 31, 2022 |
|
0
|
71,763,765
|
|
0
|
0
|
0
|
Beginning Balance at Mar. 31, 2022 |
|
$ 0
|
$ 72
|
|
$ 1,487,822
|
$ (59)
|
$ (1,462,294)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs (in shares) |
|
|
|
1,264,783
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs |
|
|
|
$ 1
|
22,661
|
|
|
Issuance of common stock relating to employee stock purchase plan (in shares) |
|
|
171,824
|
|
|
|
|
Issuance of common stock related to 2014 ESPP |
|
|
|
|
2,018
|
|
|
Issuance of common stock upon exercise of stock options (in shares) |
|
|
11,234
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
|
|
30
|
|
|
Cancellation of stock awards, net of issuance (in shares) |
|
|
(63,711)
|
|
|
|
|
Shares withheld related to net settlement of restricted stock awards (in shares) |
|
|
(24,532)
|
|
|
|
|
Shares withheld related to net settlement of stock awards |
|
|
|
|
(383)
|
|
|
Stock-based compensation |
|
|
|
|
9,379
|
|
|
Other |
|
|
|
|
$ (116)
|
|
|
Unrealized gain (loss) |
(327)
|
|
|
|
|
$ (327)
|
|
Net loss |
$ (61,435)
|
|
|
|
|
|
$ (61,435)
|
Ending Balance (in shares) at Jun. 30, 2022 |
73,123,363
|
|
73,123,363
|
|
0
|
0
|
0
|
Ending Balance at Jun. 30, 2022 |
$ (2,631)
|
|
$ 73
|
|
$ 1,521,411
|
$ (386)
|
$ (1,523,729)
|
Beginning Balance (in shares) at Dec. 31, 2022 |
82,385,810
|
0
|
82,385,810
|
|
0
|
0
|
0
|
Beginning Balance at Dec. 31, 2022 |
$ 12,600
|
$ 0
|
$ 82
|
|
$ 1,767,266
|
$ (374)
|
$ (1,754,374)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs (in shares) |
|
|
|
3,223,767
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs |
|
|
|
$ 3
|
99,956
|
|
|
Issuance of common stock related to stock awards (in shares) |
|
|
1,720,310
|
|
|
|
|
Issuance of common stock related to stock awards |
|
|
$ 2
|
|
(2)
|
|
|
Issuance of common stock relating to employee stock purchase plan (in shares) |
|
|
157,313
|
|
|
|
|
Issuance of common stock related to 2014 ESPP |
|
|
|
|
2,455
|
|
|
Issuance of common stock upon exercise of stock options (in shares) |
|
|
671,224
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
$ 1
|
|
11,515
|
|
|
Cancellation of stock awards, net of issuance (in shares) |
|
|
(71,493)
|
|
|
|
|
Shares withheld related to net settlement of restricted stock awards (in shares) |
|
|
(136,944)
|
|
|
|
|
Shares withheld related to net settlement of stock awards |
|
|
|
|
(4,294)
|
|
|
Stock-based compensation |
|
|
|
|
31,318
|
|
|
Other |
|
|
|
|
$ 30
|
|
|
Unrealized gain (loss) |
313
|
|
|
|
|
$ 313
|
|
Net loss |
$ (127,111)
|
|
|
|
|
|
$ (127,111)
|
Ending Balance (in shares) at Jun. 30, 2023 |
87,949,987
|
|
87,949,987
|
|
0
|
0
|
0
|
Ending Balance at Jun. 30, 2023 |
$ 26,786
|
|
$ 88
|
|
$ 1,908,244
|
$ (61)
|
$ (1,881,485)
|
Beginning Balance (in shares) at Mar. 31, 2023 |
|
0
|
84,017,208
|
|
0
|
0
|
0
|
Beginning Balance at Mar. 31, 2023 |
|
$ 0
|
$ 84
|
|
$ 1,787,535
|
$ (125)
|
$ (1,814,167)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs (in shares) |
|
|
|
3,223,767
|
|
|
|
Issuance of common stock related to ATM, net of commissions and issuance costs |
|
|
|
$ 3
|
99,956
|
|
|
Issuance of common stock related to stock awards (in shares) |
|
|
513,443
|
|
|
|
|
Issuance of common stock related to stock awards |
|
|
$ 1
|
|
(1)
|
|
|
Issuance of common stock relating to employee stock purchase plan (in shares) |
|
|
157,313
|
|
|
|
|
Issuance of common stock related to 2014 ESPP |
|
|
|
|
2,455
|
|
|
Issuance of common stock upon exercise of stock options (in shares) |
|
|
109,185
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
|
|
2,034
|
|
|
Cancellation of stock awards, net of issuance (in shares) |
|
|
(52,874)
|
|
|
|
|
Shares withheld related to net settlement of restricted stock awards (in shares) |
|
|
(18,055)
|
|
|
|
|
Shares withheld related to net settlement of stock awards |
|
|
|
|
(564)
|
|
|
Stock-based compensation |
|
|
|
|
16,829
|
|
|
Other |
|
|
|
|
$ 0
|
|
|
Unrealized gain (loss) |
64
|
|
|
|
|
$ 64
|
|
Net loss |
$ (67,318)
|
|
|
|
|
|
$ (67,318)
|
Ending Balance (in shares) at Jun. 30, 2023 |
87,949,987
|
|
87,949,987
|
|
0
|
0
|
0
|
Ending Balance at Jun. 30, 2023 |
$ 26,786
|
|
$ 88
|
|
$ 1,908,244
|
$ (61)
|
$ (1,881,485)
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net loss |
$ (127,111)
|
$ (125,777)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Stock-based compensation |
28,681
|
23,626
|
Depreciation and amortization |
10,149
|
11,985
|
Amortization of debt discount and debt issuance costs |
1,035
|
834
|
Amortization of discount on investments |
(3,197)
|
(14)
|
Other non-cash operating activities |
498
|
295
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(5,704)
|
(2,242)
|
Inventories |
(11,652)
|
(3,446)
|
Prepaid expenses and other current assets |
(3,102)
|
12
|
Lease right-of-use assets |
(18,949)
|
(16,018)
|
Other non-current assets |
(3,093)
|
(454)
|
Accounts payable |
3,703
|
1,975
|
Accruals and other liabilities |
(19,536)
|
(12,138)
|
Deferred revenue |
2,202
|
(3,243)
|
Lease liabilities |
21,844
|
17,908
|
Other non-current liabilities |
1,350
|
1,202
|
Net cash used in operating activities |
(122,882)
|
(105,495)
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
Proceeds from maturities of investments |
185,247
|
113,183
|
Purchases of investments |
(128,859)
|
(163,676)
|
Purchases of property and equipment |
(604)
|
(920)
|
Finance lease prepayments |
0
|
(9,900)
|
Net cash provided by (used in) investing activities |
55,784
|
(61,313)
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
Proceeds from issuance of common stock in connection with ATM, net of commissions |
100,183
|
31,814
|
Proceeds from the exercise of stock options and employee stock purchase plan |
13,970
|
2,127
|
Taxes paid related to net settlement of stock awards |
(4,294)
|
(2,760)
|
Principal payments on finance lease obligations |
(8,899)
|
(1,760)
|
Payment of debt issuance costs and offering costs |
(224)
|
(1,441)
|
Proceeds from issuance of notes payable, net of debt discount |
0
|
98,150
|
Other financing activities |
0
|
348
|
Net cash provided by financing activities |
100,736
|
126,478
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH |
33,638
|
(40,330)
|
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period |
115,017
|
115,669
|
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period |
$ 148,655
|
$ 75,339
|
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v3.23.2
The Company and Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The Company and Summary of Significant Accounting Policies |
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 aesthetics portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers from Teoxane and OPUL®, a relational commerce platform for aesthetic practices. Revance has also partnered with Viatris to develop an onabotulinumtoxinA biosimilar, which would compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders, including evaluating DAXXIFY® in two debilitating conditions, cervical dystonia and upper limb spasticity. Liquidity and Financial Condition Since our inception, most of our resources have been dedicated to the research, development, manufacturing development, regulatory approval and/or commercialization of our Products and Services. We began generating revenue from commercial sales in July 2020 when we acquired the HintMD Platform, followed by the launch of the RHA® Collection of dermal fillers in August 2020. Although we received DAXXIFY® GL Approval, we expect to continue to incur losses for the foreseeable future. For the three and six months ended June 30, 2023, we had a net loss of $67.3 million and $127.1 million. As of June 30, 2023, we had a working capital surplus of $304.9 million and an accumulated deficit of $1.9 billion. 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. As of June 30, 2023, we had capital resources of $319.7 million consisting of cash, cash equivalents, and short-term investments. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50.0 million, provided certain conditions are met. We also have a remaining capacity to sell up to $47.2 million of our common stock under the 2022 ATM Agreement as of June 30, 2023. We believe that our existing capital resources along with our ability to draw on the Second Tranche will be sufficient to fund the operating plan through at least the next 12 months following the issuance of the condensed consolidated financial statements. 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 consolidated balance sheet for the year ended December 31, 2022 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 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. 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 4 for further detail as of June 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.
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v3.23.2
Revenue
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
RevenueOur 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 12). The following table presents our revenue disaggregated by timing of transfer of goods or service:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, 2023 | | Six Months Ended June 30, 2023 | | Transferred | | Transferred | (in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total | Product revenue | $ | 54,393 | | | $ | — | | | $ | 54,393 | | | $ | 100,051 | | | $ | — | | | $ | 100,051 | | Service revenue | 2 | | | 3,719 | | | 3,721 | | | 59 | | | 7,219 | | | 7,278 | | Collaboration revenue | — | | | 20 | | | 20 | | | — | | | 136 | | | 136 | | Total revenue | $ | 54,395 | | | $ | 3,739 | | | $ | 58,134 | | | $ | 100,110 | | | $ | 7,355 | | | $ | 107,465 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, 2022 | | Six Months Ended June 30, 2022 | | Transferred | | Transferred | (in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total | Product revenue | $ | 25,483 | | | $ | — | | | $ | 25,483 | | | $ | 46,320 | | | $ | — | | | $ | 46,320 | | Service revenue | 148 | | | 1,078 | | | 1,226 | | | 239 | | | 1,843 | | | 2,082 | | Collaboration revenue | — | | | 1,659 | | | 1,659 | | | — | | | 5,227 | | | 5,227 | | Total revenue | $ | 25,631 | | | $ | 2,737 | | | $ | 28,368 | | | $ | 46,559 | | | $ | 7,070 | | | $ | 53,629 | |
Product Revenue Our product revenue breakdown is summarized below: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Product: | | | | | | | | RHA® Collection of dermal fillers | $ | 31,767 | | | $ | 25,483 | | | $ | 62,047 | | | $ | 46,320 | | DAXXIFY® | 22,626 | | | — | | | 38,004 | | | — | | Total product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 100,051 | | | $ | 46,320 | |
Accounts receivables and contract liabilities from contracts with our product customers are as follows: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivables: | | | | Accounts receivable, net | $ | 16,878 | | | $ | 10,966 | | Total accounts receivable, net | $ | 16,878 | | | $ | 10,966 | | | | | | Contract liabilities: | | | | Deferred revenue, current | $ | 471 | | | $ | 705 | | Total contract liabilities | $ | 471 | | | $ | 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, was recognized at a point in time and revenue related to the OPUL® payment processing service is recognized over time. The migration of the remaining HintMD customers to OPUL® was completed during the three months ended June 30, 2023. For the Fintech Platform, revenue related to the value-added services component is recognized over time.
Accounts receivable from contracts with our service customers are as follows: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivable: | | | | Accounts receivable, net | $ | 165 | | | $ | 59 | | | | | | | | | | | | | | | | | | Total accounts receivable, net | $ | 165 | | | $ | 59 | | | | | | | | | | | | | | | | | |
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 June 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 June 30, 2023, the transaction price allocated to the unfulfilled performance obligations was $54.5 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 six months ended June 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 six months ended June 30, 2023, we recognized no revenue related to development services under the Viatris Agreement. For the three and six months ended June 30, 2022, we recognized $1.7 million and $5.2 million related to the development services under the Viatris Agreement, respectively. 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 June 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 June 30, 2023, the transaction price allocated to unfulfilled performance obligation is $38.0 million. For the three and six months ended June 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 six months ended June 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: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivables: | | | | Accounts receivable, net — Fosun | $ | — | | | $ | 315 | | Total accounts receivable, net | $ | — | | | $ | 315 | | | | | | Contract liabilities: | | | | Deferred revenue, current — Viatris | $ | 4,962 | | | $ | 6,162 | | | | | | Total contract liabilities, current | $ | 4,962 | | | $ | 6,162 | | | | | | Deferred revenue, non-current — Viatris | $ | 44,236 | | | $ | 40,600 | | Deferred revenue, non-current — Fosun | 37,977 | | | 37,977 | | Total contract liabilities, non-current | $ | 82,213 | | | $ | 78,577 | |
Changes in our contract liabilities from contracts with our collaboration revenue customers for the six months ended June 30, 2023 are as follows: | | | | | | | (in thousands) | Balance on December 31, 2022 | $ | 84,739 | | Revenue recognized | (136) | | Billings and adjustments, net | 2,572 | | Balance on June 30, 2023 | $ | 87,175 | |
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v3.23.2
Cash Equivalents and Short-Term Investments
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Cash Equivalents and Short-Term Investments |
Cash Equivalents and Short-Term Investments The following table summarizes our cash equivalents and short-term investments: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | (in thousands) | Adjusted Cost | | Gains | | Losses | | Fair Value | | Adjusted Cost | | Losses | | Fair Value | U.S. treasury securities | $ | 136,829 | | | $ | — | | | $ | (52) | | | $ | 136,777 | | | $ | 109,984 | | | $ | (228) | | | $ | 109,756 | | Money market funds | 98,349 | | | — | | | — | | | 98,349 | | | 85,206 | | | — | | | 85,206 | | Commercial paper | 57,843 | | | — | | | (6) | | | 57,837 | | | 80,946 | | | — | | | 80,946 | | U.S. government agency obligations | 14,760 | | | 5 | | | — | | | 14,765 | | | 4,480 | | | — | | | 4,480 | | Corporate bonds | 7,531 | | | — | | | (8) | | | 7,523 | | | 41,186 | | | (146) | | | 41,040 | | Total cash equivalents and short-term investments | $ | 315,312 | | | $ | 5 | | | $ | (66) | | | $ | 315,251 | | | $ | 321,802 | | | $ | (374) | | | $ | 321,428 | | | | | | | | | | | | | | | | Classified as: | | | | | | | | | | | | | | Cash equivalents | | | | | | | $ | 136,763 | | | | | | | $ | 89,686 | | Short-term investments | | | | | | | 178,488 | | | | | | | 231,742 | | Total cash equivalents and short-term investments | | | | | | | $ | 315,251 | | | | | | | $ | 321,428 | |
As of June 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.
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- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.23.2
Intangible Assets, net
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets, net |
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: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | (in thousands, except for in years) | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | Distribution rights | | 4.8 | | $ | 32,334 | | | $ | (21,974) | | | $ | 10,360 | | | 1.4 | | $ | 32,334 | | | $ | (20,882) | | | $ | 11,452 | | Acquired developed technology | | 3.8 | | 16,200 | | | (6,075) | | | 10,125 | | | 4.2 | | 35,800 | | | (24,325) | | | 11,475 | | Internally developed technology | | 2.0 | | 8,918 | | | (3,798) | | | 5,120 | | | 2.4 | | 8,062 | | | (2,271) | | | 5,791 | | Customer relationships | | 1.1 | | 10,300 | | | (7,510) | | | 2,790 | | | 1.6 | | 10,300 | | | (6,223) | | | 4,077 | | Other software | | 0.6 | | 879 | | | (813) | | | 66 | | | 1.8 | | 3,166 | | | (1,592) | | | 1,574 | | Development in progress | | N/A | | — | | | — | | | — | | | N/A | | 975 | | | — | | | 975 | | Total intangible assets | | | | $ | 68,631 | | | $ | (40,170) | | | $ | 28,461 | | | | | $ | 90,637 | | | $ | (55,293) | | | $ | 35,344 | | N/A - Not applicableAmortization expense of intangible assets for the three and six months ended June 30, 2023 was $2.8 million and $6.8 million, respectively. Amortization expense of intangible assets for the three and six months ended June 30, 2022 was $4.9 million and $9.9 million, respectively. Based on the amount of intangible assets as of June 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 six months | $ | 5,271 | | 2024 | 8,752 | | 2025 | 6,147 | | 2026 | 4,890 | | 2027 | 2,856 | | 2028 and thereafter | 545 | | Total | $ | 28,461 | |
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v3.23.2
Inventories
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Inventories |
InventoriesInventories consist of the following: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Raw materials | $ | 2,208 | | | $ | 505 | | Work in process | 9,397 | | | 4,933 | | Finished goods | 22,843 | | | 12,887 | | Total inventories | $ | 34,448 | | | $ | 18,325 | |
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- DefinitionThe entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory.
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v3.23.2
Accruals and other current liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accruals and other current liabilities |
Accruals and other current liabilities Accruals and other current liabilities consists of the following: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accruals related to: | | | | Compensation | $ | 17,771 | | | $ | 28,014 | | Selling, general and administrative | 7,143 | | | 9,681 | | Research and development | 5,374 | | | 9,012 | | Interest expense | 1,887 | | | 1,912 | | Clinical trials | 1,173 | | | 1,863 | | Inventories | 872 | | | 2,312 | | Other current liabilities | 5,315 | | | 6,563 | | Total accruals and other current liabilities | $ | 39,535 | | | $ | 59,357 | |
|
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Leases |
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, 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 June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Finance lease: | | | | | | | | Amortization of finance lease right-of-use asset (1) | $ | 1,350 | | | $ | 1,158 | | | $ | 3,668 | | | $ | 1,158 | | Interest on finance lease liability | 442 | | | 751 | | | 1,008 | | | 2,259 | | Variable lease cost (2) | — | | | 323 | | | 374 | | | 1,713 | | Total finance lease costs | 1,792 | | | 2,232 | | | 5,050 | | | 5,130 | | Operating leases: | | | | | | | | Operating lease cost | 4,312 | | | 2,223 | | | 6,519 | | | 4,446 | | Variable lease cost (3) | 548 | | | 431 | | | 1,055 | | | 865 | | Total operating lease costs | 4,860 | | | 2,654 | | | 7,574 | | | 5,311 | | Total lease costs | $ | 6,652 | | | $ | 4,886 | | | $ | 12,624 | | | $ | 10,441 | |
(1)Starting in the three months ended June 30, 2023, amortization of the finance lease right-of-use asset is capitalized into inventories on the condensed consolidated balance sheets resulting from 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 June 30, 2023, maturities of our lease liabilities are as follows: | | | | | | | | | | | | | | | | | | (in thousands) | Finance Lease | | Operating Leases | | Total | Year Ending December 31, | | | | | | 2023 remaining six months | $ | 12,855 | | | $ | 3,952 | | | $ | 16,807 | | 2024 | 3,102 | | | 8,723 | | | 11,825 | | 2025 | — | | | 8,981 | | | 8,981 | | 2026 | — | | | 9,242 | | | 9,242 | | 2027 | — | | | 2,535 | | | 2,535 | | 2028 and thereafter | — | | | 14,612 | | | 14,612 | | Total lease payments | 15,957 | | | 48,045 | | | 64,002 | | Less imputed interest | (452) | | | (11,510) | | | (11,962) | | Present value of lease payments | $ | 15,505 | | | $ | 36,535 | | | $ | 52,040 | |
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 June 30, 2023, weighted-average remaining lease terms and discount rates are as follows: | | | | | | | | | | | | | Finance Leases | | Operating Leases | Weighted-average remaining lease term (years) | 2.8 | | 7.2 | Weighted-average discount rate | 10.7 | % | | 9.8 | % |
Supplemental cash flow information related to the leases was as follows: | | | | | | | | | | | | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | Cash paid for amounts included in the measurement of lease liabilities | | | | Operating cash flows from operating leases | $ | 4,188 | | | $ | 4,192 | | Operating cash flows from finance lease | $ | 1,008 | | | $ | 627 | | Financing cash flows from finance lease | $ | 8,899 | | | $ | 1,760 | | Right-of-use assets obtained in exchange for lease liabilities | | | | Finance lease | $ | 23,735 | | | $ | 18,556 | |
Leases 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 June 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 June 30, 2023, we have made prepayments of $27.5 million to PCI which is recorded within “Finance lease prepaid expense” in the condensed consolidated balance sheets. Based on our best estimate as of June 30, 2023, our remaining minimum commitment under the PCI Supply Agreement will be $12.7 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 aggregate.
Nashville Lease Expansion Premises In November 2020, we entered into the Nashville Lease, a non-cancelable operating lease for an office space in Nashville, Tennessee. The lease commenced and was recognized on the condensed consolidated balance sheets in June 2021. In July 2021, we entered into the second amendment to the Nashville Lease, which provided for the expansion of the initial premises to include the Expansion Premises, an additional 30,591 square feet with an expected term to 2034. The lease accounting commencement date of the Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023 at the earliest. The monthly base rent payments for the lease escalate over the term. The total undiscounted basic rent payments currently determinable for the Expansion Premises are $16 million with an expected term to 2034. In January 2023, we entered into the third amendment to the Nashville Lease, which provides for the expansion of the current premises to include the Second Expansion Premises, an additional 17,248 square feet with an expected term to 2032. The monthly base rent payments for the lease escalate over the term, and the total undiscounted basic rent payments determinable for the Second Expansion Premises are $7 million. The lease accounting commencement date of the Second Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023.
|
Leases |
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, 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 June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Finance lease: | | | | | | | | Amortization of finance lease right-of-use asset (1) | $ | 1,350 | | | $ | 1,158 | | | $ | 3,668 | | | $ | 1,158 | | Interest on finance lease liability | 442 | | | 751 | | | 1,008 | | | 2,259 | | Variable lease cost (2) | — | | | 323 | | | 374 | | | 1,713 | | Total finance lease costs | 1,792 | | | 2,232 | | | 5,050 | | | 5,130 | | Operating leases: | | | | | | | | Operating lease cost | 4,312 | | | 2,223 | | | 6,519 | | | 4,446 | | Variable lease cost (3) | 548 | | | 431 | | | 1,055 | | | 865 | | Total operating lease costs | 4,860 | | | 2,654 | | | 7,574 | | | 5,311 | | Total lease costs | $ | 6,652 | | | $ | 4,886 | | | $ | 12,624 | | | $ | 10,441 | |
(1)Starting in the three months ended June 30, 2023, amortization of the finance lease right-of-use asset is capitalized into inventories on the condensed consolidated balance sheets resulting from 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 June 30, 2023, maturities of our lease liabilities are as follows: | | | | | | | | | | | | | | | | | | (in thousands) | Finance Lease | | Operating Leases | | Total | Year Ending December 31, | | | | | | 2023 remaining six months | $ | 12,855 | | | $ | 3,952 | | | $ | 16,807 | | 2024 | 3,102 | | | 8,723 | | | 11,825 | | 2025 | — | | | 8,981 | | | 8,981 | | 2026 | — | | | 9,242 | | | 9,242 | | 2027 | — | | | 2,535 | | | 2,535 | | 2028 and thereafter | — | | | 14,612 | | | 14,612 | | Total lease payments | 15,957 | | | 48,045 | | | 64,002 | | Less imputed interest | (452) | | | (11,510) | | | (11,962) | | Present value of lease payments | $ | 15,505 | | | $ | 36,535 | | | $ | 52,040 | |
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 June 30, 2023, weighted-average remaining lease terms and discount rates are as follows: | | | | | | | | | | | | | Finance Leases | | Operating Leases | Weighted-average remaining lease term (years) | 2.8 | | 7.2 | Weighted-average discount rate | 10.7 | % | | 9.8 | % |
Supplemental cash flow information related to the leases was as follows: | | | | | | | | | | | | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | Cash paid for amounts included in the measurement of lease liabilities | | | | Operating cash flows from operating leases | $ | 4,188 | | | $ | 4,192 | | Operating cash flows from finance lease | $ | 1,008 | | | $ | 627 | | Financing cash flows from finance lease | $ | 8,899 | | | $ | 1,760 | | Right-of-use assets obtained in exchange for lease liabilities | | | | Finance lease | $ | 23,735 | | | $ | 18,556 | |
Leases 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 June 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 June 30, 2023, we have made prepayments of $27.5 million to PCI which is recorded within “Finance lease prepaid expense” in the condensed consolidated balance sheets. Based on our best estimate as of June 30, 2023, our remaining minimum commitment under the PCI Supply Agreement will be $12.7 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 aggregate.
Nashville Lease Expansion Premises In November 2020, we entered into the Nashville Lease, a non-cancelable operating lease for an office space in Nashville, Tennessee. The lease commenced and was recognized on the condensed consolidated balance sheets in June 2021. In July 2021, we entered into the second amendment to the Nashville Lease, which provided for the expansion of the initial premises to include the Expansion Premises, an additional 30,591 square feet with an expected term to 2034. The lease accounting commencement date of the Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023 at the earliest. The monthly base rent payments for the lease escalate over the term. The total undiscounted basic rent payments currently determinable for the Expansion Premises are $16 million with an expected term to 2034. In January 2023, we entered into the third amendment to the Nashville Lease, which provides for the expansion of the current premises to include the Second Expansion Premises, an additional 17,248 square feet with an expected term to 2032. The monthly base rent payments for the lease escalate over the term, and the total undiscounted basic rent payments determinable for the Second Expansion Premises are $7 million. The lease accounting commencement date of the Second Expansion Premises has not occurred and is expected to take place when the office space is made available to us after the completion of certain improvement work, which is currently expected in late 2023.
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v3.23.2
Debt
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
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Debt |
Debt The following table provides information regarding our debt: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | 2027 Notes | $ | 287,500 | | | $ | 287,500 | | Less: Unamortized debt issuance costs | (4,937) | | | (5,587) | | Carrying amount of the 2027 Notes | 282,563 | | | 281,913 | | | | | | Notes Payable | 100,000 | | | 100,000 | | Less: Unamortized debt discount | (1,175) | | | (1,347) | | Less: Unamortized debt issuance costs | (1,040) | | | (1,192) | | Carrying amount of Notes Payable | 97,785 | | | 97,461 | | Debt, non-current | $ | 380,348 | | | $ | 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 June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Contractual interest expense | $ | 3,407 | | | $ | 3,383 | | | $ | 6,790 | | | $ | 4,971 | | Amortization of debt issuance costs | 431 | | | 417 | | | 863 | | | 749 | | Amortization of debt discount | 87 | | | 74 | | | 172 | | | 85 | | Total interest expense | $ | 3,925 | | | $ | 3,874 | | | $ | 7,825 | | | $ | 5,805 | |
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 five business day period after any ten 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 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. Capped Call Transactions Concurrently with the 2027 Notes, we entered into capped call transactions with the option counterparties and 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 Notes and/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. 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 $28.9 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 June 30, 2023 and December 31, 2022, we had not purchased any shares under the capped call transactions. 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. On August 8, 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, and the uncommitted Third Tranche was increased from $100 million to $150 million. On or before August 31, 2023, the Company expects to issue to the purchasers under the Note Purchase Agreement notes in an aggregate principal amount of $50 million, provided certain conditions are met. 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 to be issued pursuant to the Second Tranche will 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.
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v3.23.2
Stockholders’ Equity and Stock-Based Compensation
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6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity (Deficit) and Stock-Based Compensation |
Stockholders’ 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 3.3 million shares. For the six months ended June 30, 2023, 2.4 million shares of stock awards and 0.2 million stock options were granted under the 2014 EIP. As of June 30, 2023, 4.0 million shares were available for issuance under the 2014 EIP. 2014 IN For the six months ended June 30, 2023, no stock options or awards were granted under the 2014 IN. As of June 30, 2023, 0.8 million shares were available for issuance under the 2014 IN. HintMD Plan For the six months ended June 30, 2023, no stock options or awards were granted under the HintMD Plan. As of June 30, 2023, 0.1 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 0.3 million shares. As of June 30, 2023, 1.8 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. Common stock equivalents that were excluded from the computation of diluted net loss per share are presented below: | | | | | | | | | | | | | June 30, | | 2023 | | 2022 | Convertible senior notes | 8,878,938 | | 8,878,938 | Outstanding stock options | 4,391,679 | | 5,063,074 | Unvested RSUs and PSUs | 3,281,382 | | 2,492,797 | | Unvested RSAs and PSAs | 1,577,981 | | 2,656,703 |
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 $125.0 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 3.0% 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 1.7 million shares of common stock under the 2020 ATM Agreement 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. 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 $150.0 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 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Cowen with customary indemnification and contribution rights. For the three months ended June 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 March 31, 2023. Stock-Based Compensation Expense The following table summarizes our stock-based compensation expense by line item in our condensed consolidated statements of operations and comprehensive loss: | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | Three Months Ended June 30, | | Six Months Ended June 30, | 2023 | | 2022 | | 2023 | | 2022 | Selling, general and administrative | $ | 12,178 | | | $ | 6,528 | | | $ | 22,443 | | | $ | 14,692 | | Research and development | 3,421 | | | 2,735 | | | 6,238 | | | 8,934 | | Cost of product revenue (exclusive of depreciation and amortization) | 948 | | | — | | | 948 | | | — | | Total stock-based compensation expense | $ | 16,547 | | | $ | 9,263 | | | $ | 29,629 | | | $ | 23,626 | |
Capitalized Stock-based Compensation Expense For the three and six months ended June 30, 2023, stock-based compensation expense of $0.9 million and $1.9 million, respectively, was capitalized in inventories on the condensed consolidated balance sheets, which is subsequently expensed to cost of product revenue (exclusive of depreciation and amortization) on the condensed consolidated statements of operations and comprehensive loss as shown in the table above.
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v3.23.2
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
Fair Value Measurements 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. | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | (in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 | Assets | | | | | | | | U.S. treasury securities | $ | 136,777 | | | $ | 136,777 | | | $ | — | | | $ | — | | Money market funds | 98,349 | | | 98,349 | | | — | | | — | | U.S. government agency obligations | 14,765 | | | 14,765 | | | — | | | — | | Commercial paper | 57,837 | | | — | | | 57,837 | | | — | | Corporate bonds | 7,523 | | | — | | | 7,523 | | | — | | Total assets measured at fair value | $ | 315,251 | | | $ | 249,891 | | | $ | 65,360 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | (in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 | Assets | | | | | | | | U.S. treasury securities | $ | 109,756 | | | $ | 109,756 | | | $ | — | | | $ | — | | Money market funds | 85,206 | | | 85,206 | | | — | | | — | | U.S. government agency obligations | 4,480 | | | 4,480 | | | — | | | — | | Commercial paper | 80,946 | | | — | | | 80,946 | | | — | | Corporate bonds | 41,040 | | | — | | | 41,040 | | | — | | Total assets measured at fair value | $ | 321,428 | | | $ | 199,442 | | | $ | 121,986 | | | $ | — | |
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 8) 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 June 30, 2023, and December 31, 2022, the fair value of the 2027 Notes was $302.9 million and $288.2 million, respectively. As of June 30, 2023 and December 31, 2022, the fair value of the Notes Payable was approximately the same as its unamortized carrying value.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Commitments 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 2,500,000 shares of our common stock and certain other commitments by us. The Teoxane Agreement is effective for a term of ten years from product launch in September 2020 and may be extended for a two-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 $40 million and $52 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 $34 million and $36 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 June 30, 2023, we are obligated to pay BTRX up to a remaining $15.5 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 six months ended June 30, 2023 and 2022, no 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 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 we await the court’s decision on claim construction. 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 is scheduled for August 10, 2023, but 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 June 30, 2023 and December 31, 2022, no such provision for liabilities related to the above litigation matters were recorded on the condensed consolidated balance sheets.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Segment Information
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6 Months Ended |
Jun. 30, 2023 |
Segment Reporting [Abstract] |
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Segment Information |
Segment 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 two 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. 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. 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 two segments. For the three months ended June 30, 2023 and 2022, intersegment revenue was $0.7 million and $0.3 million, respectively. For the six months ended June 30, 2023 and 2022, intersegment revenue was $1.3 million and $0.6 million, respectively. Reconciliation of Segment Revenue to Consolidated Revenue | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Revenue: | | | | | | | | Product Segment | $ | 54,413 | | | $ | 27,142 | | | $ | 100,187 | | | $ | 51,547 | | Service Segment | 3,721 | | | 1,226 | | | 7,278 | | | 2,082 | | Total revenue | $ | 58,134 | | | $ | 28,368 | | | $ | 107,465 | | | $ | 53,629 | |
Reconciliation of Segment Loss from Operations to Consolidated Loss from Operations | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Loss from operations: | | | | | | | | Product Segment | $ | (19,335) | | | $ | (24,969) | | | $ | (32,065) | | | $ | (49,920) | | Service Segment | (4,978) | | | (5,598) | | | (12,065) | | | (9,533) | | Corporate and other expenses | (41,186) | | | (27,275) | | | (79,401) | | | (60,610) | | Total loss from operations | $ | (65,499) | | | $ | (57,842) | | | $ | (123,531) | | | $ | (120,063) | |
We do not evaluate performance or allocate resources based on segment asset data, and therefore such information is not presented.
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.23.2
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Pay vs Performance Disclosure |
|
|
|
|
Net loss |
$ (67,318)
|
$ (61,435)
|
$ (127,111)
|
$ (125,777)
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v3.23.2
Insider Trading Arrangements
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023
shares
|
Jun. 30, 2023
shares
|
Trading Arrangements, by Individual |
|
|
Non-Rule 10b5-1 Arrangement Adopted |
false
|
|
Rule 10b5-1 Arrangement Terminated |
false
|
|
Non-Rule 10b5-1 Arrangement Terminated |
false
|
|
Dwight Moxie [Member] |
|
|
Trading Arrangements, by Individual |
|
|
Material Terms of Trading Arrangement |
|
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 June 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 | | Total Shares to be Sold | | Expiration Date | | | | | Dwight Moxie, Senior Vice President, General Counsel and Corporate Secretary | | Adopt | | 6/5/2023 | | 34,853 | | 12/5/2023 |
|
Name |
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|
|
Title |
Senior Vice President, General Counsel and Corporate Secretary
|
|
Rule 10b5-1 Arrangement Adopted |
true
|
|
Adoption Date |
6/5/2023
|
|
Arrangement Duration |
183 days
|
|
Aggregate Available |
34,853
|
34,853
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v3.23.2
The Company and Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Basis of Presentation and Principles of Consolidation |
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 consolidated balance sheet for the year ended December 31, 2022 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 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.
|
Reclassification |
ReclassificationAt 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.
|
Use of Estimates & Risks and Uncertainties |
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.
|
Recent Accounting Pronouncements |
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.
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v3.23.2
Revenue (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Disaggregation of Revenue |
The following table presents our revenue disaggregated by timing of transfer of goods or service: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, 2023 | | Six Months Ended June 30, 2023 | | Transferred | | Transferred | (in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total | Product revenue | $ | 54,393 | | | $ | — | | | $ | 54,393 | | | $ | 100,051 | | | $ | — | | | $ | 100,051 | | Service revenue | 2 | | | 3,719 | | | 3,721 | | | 59 | | | 7,219 | | | 7,278 | | Collaboration revenue | — | | | 20 | | | 20 | | | — | | | 136 | | | 136 | | Total revenue | $ | 54,395 | | | $ | 3,739 | | | $ | 58,134 | | | $ | 100,110 | | | $ | 7,355 | | | $ | 107,465 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, 2022 | | Six Months Ended June 30, 2022 | | Transferred | | Transferred | (in thousands) | at a point in time | | over time | | Total | | at a point in time | | over time | | Total | Product revenue | $ | 25,483 | | | $ | — | | | $ | 25,483 | | | $ | 46,320 | | | $ | — | | | $ | 46,320 | | Service revenue | 148 | | | 1,078 | | | 1,226 | | | 239 | | | 1,843 | | | 2,082 | | Collaboration revenue | — | | | 1,659 | | | 1,659 | | | — | | | 5,227 | | | 5,227 | | Total revenue | $ | 25,631 | | | $ | 2,737 | | | $ | 28,368 | | | $ | 46,559 | | | $ | 7,070 | | | $ | 53,629 | |
Product Revenue Our product revenue breakdown is summarized below: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Product: | | | | | | | | RHA® Collection of dermal fillers | $ | 31,767 | | | $ | 25,483 | | | $ | 62,047 | | | $ | 46,320 | | DAXXIFY® | 22,626 | | | — | | | 38,004 | | | — | | Total product revenue | $ | 54,393 | | | $ | 25,483 | | | $ | 100,051 | | | $ | 46,320 | |
|
Schedule of Contract with Customer, Contract Asset, Contract Liability, and Receivable |
Accounts receivables and contract liabilities from contracts with our product customers are as follows: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivables: | | | | Accounts receivable, net | $ | 16,878 | | | $ | 10,966 | | Total accounts receivable, net | $ | 16,878 | | | $ | 10,966 | | | | | | Contract liabilities: | | | | Deferred revenue, current | $ | 471 | | | $ | 705 | | Total contract liabilities | $ | 471 | | | $ | 705 | |
Accounts receivable from contracts with our service customers are as follows: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivable: | | | | Accounts receivable, net | $ | 165 | | | $ | 59 | | | | | | | | | | | | | | | | | | Total accounts receivable, net | $ | 165 | | | $ | 59 | | | | | | | | | | | | | | | | | |
Accounts receivables and contract liabilities from contracts with our collaboration customers are as follows: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accounts receivables: | | | | Accounts receivable, net — Fosun | $ | — | | | $ | 315 | | Total accounts receivable, net | $ | — | | | $ | 315 | | | | | | Contract liabilities: | | | | Deferred revenue, current — Viatris | $ | 4,962 | | | $ | 6,162 | | | | | | Total contract liabilities, current | $ | 4,962 | | | $ | 6,162 | | | | | | Deferred revenue, non-current — Viatris | $ | 44,236 | | | $ | 40,600 | | Deferred revenue, non-current — Fosun | 37,977 | | | 37,977 | | Total contract liabilities, non-current | $ | 82,213 | | | $ | 78,577 | |
Changes in our contract liabilities from contracts with our collaboration revenue customers for the six months ended June 30, 2023 are as follows: | | | | | | | (in thousands) | Balance on December 31, 2022 | $ | 84,739 | | Revenue recognized | (136) | | Billings and adjustments, net | 2,572 | | Balance on June 30, 2023 | $ | 87,175 | |
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v3.23.2
Cash Equivalents and Short-Term Investments (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Schedule of Available-for-sale Securities |
The following table summarizes our cash equivalents and short-term investments: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | (in thousands) | Adjusted Cost | | Gains | | Losses | | Fair Value | | Adjusted Cost | | Losses | | Fair Value | U.S. treasury securities | $ | 136,829 | | | $ | — | | | $ | (52) | | | $ | 136,777 | | | $ | 109,984 | | | $ | (228) | | | $ | 109,756 | | Money market funds | 98,349 | | | — | | | — | | | 98,349 | | | 85,206 | | | — | | | 85,206 | | Commercial paper | 57,843 | | | — | | | (6) | | | 57,837 | | | 80,946 | | | — | | | 80,946 | | U.S. government agency obligations | 14,760 | | | 5 | | | — | | | 14,765 | | | 4,480 | | | — | | | 4,480 | | Corporate bonds | 7,531 | | | — | | | (8) | | | 7,523 | | | 41,186 | | | (146) | | | 41,040 | | Total cash equivalents and short-term investments | $ | 315,312 | | | $ | 5 | | | $ | (66) | | | $ | 315,251 | | | $ | 321,802 | | | $ | (374) | | | $ | 321,428 | | | | | | | | | | | | | | | | Classified as: | | | | | | | | | | | | | | Cash equivalents | | | | | | | $ | 136,763 | | | | | | | $ | 89,686 | | Short-term investments | | | | | | | 178,488 | | | | | | | 231,742 | | Total cash equivalents and short-term investments | | | | | | | $ | 315,251 | | | | | | | $ | 321,428 | |
|
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v3.23.2
Intangible Assets, net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Acquired Finite-lived Intangible Assets by Major Class |
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: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | (in thousands, except for in years) | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | Distribution rights | | 4.8 | | $ | 32,334 | | | $ | (21,974) | | | $ | 10,360 | | | 1.4 | | $ | 32,334 | | | $ | (20,882) | | | $ | 11,452 | | Acquired developed technology | | 3.8 | | 16,200 | | | (6,075) | | | 10,125 | | | 4.2 | | 35,800 | | | (24,325) | | | 11,475 | | Internally developed technology | | 2.0 | | 8,918 | | | (3,798) | | | 5,120 | | | 2.4 | | 8,062 | | | (2,271) | | | 5,791 | | Customer relationships | | 1.1 | | 10,300 | | | (7,510) | | | 2,790 | | | 1.6 | | 10,300 | | | (6,223) | | | 4,077 | | Other software | | 0.6 | | 879 | | | (813) | | | 66 | | | 1.8 | | 3,166 | | | (1,592) | | | 1,574 | | Development in progress | | N/A | | — | | | — | | | — | | | N/A | | 975 | | | — | | | 975 | | Total intangible assets | | | | $ | 68,631 | | | $ | (40,170) | | | $ | 28,461 | | | | | $ | 90,637 | | | $ | (55,293) | | | $ | 35,344 | | N/A - Not applicable Amortization expense of intangible assets for the three and six months ended June 30, 2023 was $2.8 million and $6.8 million, respectively. Amortization expense of intangible assets for the three and six months ended June 30, 2022 was $4.9 million and $9.9 million, respectively.
|
Schedule of Acquired Indefinite-lived Intangible Assets by Major Class |
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: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | (in thousands, except for in years) | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | | Weighted Average Remaining Useful Lives (in years) | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | Distribution rights | | 4.8 | | $ | 32,334 | | | $ | (21,974) | | | $ | 10,360 | | | 1.4 | | $ | 32,334 | | | $ | (20,882) | | | $ | 11,452 | | Acquired developed technology | | 3.8 | | 16,200 | | | (6,075) | | | 10,125 | | | 4.2 | | 35,800 | | | (24,325) | | | 11,475 | | Internally developed technology | | 2.0 | | 8,918 | | | (3,798) | | | 5,120 | | | 2.4 | | 8,062 | | | (2,271) | | | 5,791 | | Customer relationships | | 1.1 | | 10,300 | | | (7,510) | | | 2,790 | | | 1.6 | | 10,300 | | | (6,223) | | | 4,077 | | Other software | | 0.6 | | 879 | | | (813) | | | 66 | | | 1.8 | | 3,166 | | | (1,592) | | | 1,574 | | Development in progress | | N/A | | — | | | — | | | — | | | N/A | | 975 | | | — | | | 975 | | Total intangible assets | | | | $ | 68,631 | | | $ | (40,170) | | | $ | 28,461 | | | | | $ | 90,637 | | | $ | (55,293) | | | $ | 35,344 | | N/A - Not applicable Amortization expense of intangible assets for the three and six months ended June 30, 2023 was $2.8 million and $6.8 million, respectively. Amortization expense of intangible assets for the three and six months ended June 30, 2022 was $4.9 million and $9.9 million, respectively.
|
Schedule of Finite-lived Intangible Assets, Future Amortization Expense |
Based on the amount of intangible assets as of June 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 six months | $ | 5,271 | | 2024 | 8,752 | | 2025 | 6,147 | | 2026 | 4,890 | | 2027 | 2,856 | | 2028 and thereafter | 545 | | Total | $ | 28,461 | |
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v3.23.2
Inventories (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Inventories consist of the following: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Raw materials | $ | 2,208 | | | $ | 505 | | Work in process | 9,397 | | | 4,933 | | Finished goods | 22,843 | | | 12,887 | | Total inventories | $ | 34,448 | | | $ | 18,325 | |
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v3.23.2
Accruals and other current liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Liabilities |
Accruals and other current liabilities consists of the following: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | Accruals related to: | | | | Compensation | $ | 17,771 | | | $ | 28,014 | | Selling, general and administrative | 7,143 | | | 9,681 | | Research and development | 5,374 | | | 9,012 | | Interest expense | 1,887 | | | 1,912 | | Clinical trials | 1,173 | | | 1,863 | | Inventories | 872 | | | 2,312 | | Other current liabilities | 5,315 | | | 6,563 | | Total accruals and other current liabilities | $ | 39,535 | | | $ | 59,357 | |
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Lease Costs |
The operating and finance lease costs are summarized as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Finance lease: | | | | | | | | Amortization of finance lease right-of-use asset (1) | $ | 1,350 | | | $ | 1,158 | | | $ | 3,668 | | | $ | 1,158 | | Interest on finance lease liability | 442 | | | 751 | | | 1,008 | | | 2,259 | | Variable lease cost (2) | — | | | 323 | | | 374 | | | 1,713 | | Total finance lease costs | 1,792 | | | 2,232 | | | 5,050 | | | 5,130 | | Operating leases: | | | | | | | | Operating lease cost | 4,312 | | | 2,223 | | | 6,519 | | | 4,446 | | Variable lease cost (3) | 548 | | | 431 | | | 1,055 | | | 865 | | Total operating lease costs | 4,860 | | | 2,654 | | | 7,574 | | | 5,311 | | Total lease costs | $ | 6,652 | | | $ | 4,886 | | | $ | 12,624 | | | $ | 10,441 | |
(1)Starting in the three months ended June 30, 2023, amortization of the finance lease right-of-use asset is capitalized into inventories on the condensed consolidated balance sheets resulting from 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.
|
Schedule of Finance Lease, Liability Maturities |
As of June 30, 2023, maturities of our lease liabilities are as follows: | | | | | | | | | | | | | | | | | | (in thousands) | Finance Lease | | Operating Leases | | Total | Year Ending December 31, | | | | | | 2023 remaining six months | $ | 12,855 | | | $ | 3,952 | | | $ | 16,807 | | 2024 | 3,102 | | | 8,723 | | | 11,825 | | 2025 | — | | | 8,981 | | | 8,981 | | 2026 | — | | | 9,242 | | | 9,242 | | 2027 | — | | | 2,535 | | | 2,535 | | 2028 and thereafter | — | | | 14,612 | | | 14,612 | | Total lease payments | 15,957 | | | 48,045 | | | 64,002 | | Less imputed interest | (452) | | | (11,510) | | | (11,962) | | Present value of lease payments | $ | 15,505 | | | $ | 36,535 | | | $ | 52,040 | |
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 June 30, 2023, weighted-average remaining lease terms and discount rates are as follows: | | | | | | | | | | | | | Finance Leases | | Operating Leases | Weighted-average remaining lease term (years) | 2.8 | | 7.2 | Weighted-average discount rate | 10.7 | % | | 9.8 | % |
|
Schedule of Operating Lease, Liability Maturities |
As of June 30, 2023, maturities of our lease liabilities are as follows: | | | | | | | | | | | | | | | | | | (in thousands) | Finance Lease | | Operating Leases | | Total | Year Ending December 31, | | | | | | 2023 remaining six months | $ | 12,855 | | | $ | 3,952 | | | $ | 16,807 | | 2024 | 3,102 | | | 8,723 | | | 11,825 | | 2025 | — | | | 8,981 | | | 8,981 | | 2026 | — | | | 9,242 | | | 9,242 | | 2027 | — | | | 2,535 | | | 2,535 | | 2028 and thereafter | — | | | 14,612 | | | 14,612 | | Total lease payments | 15,957 | | | 48,045 | | | 64,002 | | Less imputed interest | (452) | | | (11,510) | | | (11,962) | | Present value of lease payments | $ | 15,505 | | | $ | 36,535 | | | $ | 52,040 | |
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 June 30, 2023, weighted-average remaining lease terms and discount rates are as follows: | | | | | | | | | | | | | Finance Leases | | Operating Leases | Weighted-average remaining lease term (years) | 2.8 | | 7.2 | Weighted-average discount rate | 10.7 | % | | 9.8 | % |
|
Schedule of Supplemental Cash Flow Information |
Supplemental cash flow information related to the leases was as follows: | | | | | | | | | | | | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | Cash paid for amounts included in the measurement of lease liabilities | | | | Operating cash flows from operating leases | $ | 4,188 | | | $ | 4,192 | | Operating cash flows from finance lease | $ | 1,008 | | | $ | 627 | | Financing cash flows from finance lease | $ | 8,899 | | | $ | 1,760 | | Right-of-use assets obtained in exchange for lease liabilities | | | | Finance lease | $ | 23,735 | | | $ | 18,556 | |
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v3.23.2
Debt (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Convertible Debt |
The following table provides information regarding our debt: | | | | | | | | | | | | | June 30, | | December 31, | (in thousands) | 2023 | | 2022 | 2027 Notes | $ | 287,500 | | | $ | 287,500 | | Less: Unamortized debt issuance costs | (4,937) | | | (5,587) | | Carrying amount of the 2027 Notes | 282,563 | | | 281,913 | | | | | | Notes Payable | 100,000 | | | 100,000 | | Less: Unamortized debt discount | (1,175) | | | (1,347) | | Less: Unamortized debt issuance costs | (1,040) | | | (1,192) | | Carrying amount of Notes Payable | 97,785 | | | 97,461 | | Debt, non-current | $ | 380,348 | | | $ | 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 June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Contractual interest expense | $ | 3,407 | | | $ | 3,383 | | | $ | 6,790 | | | $ | 4,971 | | Amortization of debt issuance costs | 431 | | | 417 | | | 863 | | | 749 | | Amortization of debt discount | 87 | | | 74 | | | 172 | | | 85 | | Total interest expense | $ | 3,925 | | | $ | 3,874 | | | $ | 7,825 | | | $ | 5,805 | |
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v3.23.2
Stockholders’ Equity and Stock-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Common Stock Equivalents Excluded From Computation of Diluted Net Income (Loss) Per Share |
Common stock equivalents that were excluded from the computation of diluted net loss per share are presented below: | | | | | | | | | | | | | June 30, | | 2023 | | 2022 | Convertible senior notes | 8,878,938 | | 8,878,938 | Outstanding stock options | 4,391,679 | | 5,063,074 | Unvested RSUs and PSUs | 3,281,382 | | 2,492,797 | | Unvested RSAs and PSAs | 1,577,981 | | 2,656,703 |
|
Schedule of Stock-based Compensation Expense |
The following table summarizes our stock-based compensation expense by line item in our condensed consolidated statements of operations and comprehensive loss: | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | Three Months Ended June 30, | | Six Months Ended June 30, | 2023 | | 2022 | | 2023 | | 2022 | Selling, general and administrative | $ | 12,178 | | | $ | 6,528 | | | $ | 22,443 | | | $ | 14,692 | | Research and development | 3,421 | | | 2,735 | | | 6,238 | | | 8,934 | | Cost of product revenue (exclusive of depreciation and amortization) | 948 | | | — | | | 948 | | | — | | Total stock-based compensation expense | $ | 16,547 | | | $ | 9,263 | | | $ | 29,629 | | | $ | 23,626 | |
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v3.23.2
Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value of Financial Instruments |
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. | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2023 | (in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 | Assets | | | | | | | | U.S. treasury securities | $ | 136,777 | | | $ | 136,777 | | | $ | — | | | $ | — | | Money market funds | 98,349 | | | 98,349 | | | — | | | — | | U.S. government agency obligations | 14,765 | | | 14,765 | | | — | | | — | | Commercial paper | 57,837 | | | — | | | 57,837 | | | — | | Corporate bonds | 7,523 | | | — | | | 7,523 | | | — | | Total assets measured at fair value | $ | 315,251 | | | $ | 249,891 | | | $ | 65,360 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | (in thousands) | Fair Value | | Level 1 | | Level 2 | | Level 3 | Assets | | | | | | | | U.S. treasury securities | $ | 109,756 | | | $ | 109,756 | | | $ | — | | | $ | — | | Money market funds | 85,206 | | | 85,206 | | | — | | | — | | U.S. government agency obligations | 4,480 | | | 4,480 | | | — | | | — | | Commercial paper | 80,946 | | | — | | | 80,946 | | | — | | Corporate bonds | 41,040 | | | — | | | 41,040 | | | — | | Total assets measured at fair value | $ | 321,428 | | | $ | 199,442 | | | $ | 121,986 | | | $ | — | |
|
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- DefinitionTabular disclosure of assets and liabilities, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3).
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v3.23.2
Segment Information (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Segment Reporting [Abstract] |
|
Schedule of Reconciliation of Segment Revenue to Consolidated Revenue |
Reconciliation of Segment Revenue to Consolidated Revenue | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Revenue: | | | | | | | | Product Segment | $ | 54,413 | | | $ | 27,142 | | | $ | 100,187 | | | $ | 51,547 | | Service Segment | 3,721 | | | 1,226 | | | 7,278 | | | 2,082 | | Total revenue | $ | 58,134 | | | $ | 28,368 | | | $ | 107,465 | | | $ | 53,629 | |
|
Schedule of Reconciliation of Segment Loss From Operations to Consolidated Loss From Operations |
Reconciliation of Segment Loss from Operations to Consolidated Loss from Operations | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | (in thousands) | 2023 | | 2022 | | 2023 | | 2022 | Loss from operations: | | | | | | | | Product Segment | $ | (19,335) | | | $ | (24,969) | | | $ | (32,065) | | | $ | (49,920) | | Service Segment | (4,978) | | | (5,598) | | | (12,065) | | | (9,533) | | Corporate and other expenses | (41,186) | | | (27,275) | | | (79,401) | | | (60,610) | | Total loss from operations | $ | (65,499) | | | $ | (57,842) | | | $ | (123,531) | | | $ | (120,063) | |
|
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v3.23.2
The Company and Summary of Significant Accounting Policies (Details)
|
|
3 Months Ended |
6 Months Ended |
|
|
May 10, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
condition
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
condition
|
Jun. 30, 2022
USD ($)
|
Aug. 31, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Number of debilitating conditions | condition |
|
2
|
|
2
|
|
|
|
Net loss |
|
$ (67,318,000)
|
$ (61,435,000)
|
$ (127,111,000)
|
$ (125,777,000)
|
|
|
Working capital surplus |
|
304,900,000
|
|
304,900,000
|
|
|
|
Accumulated deficit |
|
(1,881,485,000)
|
|
(1,881,485,000)
|
|
|
$ (1,754,374,000)
|
Cash, cash equivalents and investments |
|
319,700,000
|
|
319,700,000
|
|
|
|
Internally developed technology |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Net into intangible assets |
|
$ 8,300,000
|
|
8,300,000
|
|
|
|
ATM Offering, 2022 Plan |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Stock issuance sales agreement, authorized offering price, maximum |
$ 150,000,000
|
|
|
$ 47,200,000
|
|
|
|
Note Purchase Agreement | Notes Payable | Forecast |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
$ 50,000,000
|
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v3.23.2
Revenue - Schedule of Revenues Disaggregated by Timing of Transfer of Goods or Services (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
$ 58,134
|
$ 28,368
|
$ 107,465
|
$ 53,629
|
Transferred at a point in time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
54,395
|
25,631
|
100,110
|
46,559
|
Transferred at over Time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
3,739
|
2,737
|
7,355
|
7,070
|
Product revenue |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
54,393
|
25,483
|
100,051
|
46,320
|
Product revenue | Transferred at a point in time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
54,393
|
25,483
|
100,051
|
46,320
|
Product revenue | Transferred at over Time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
0
|
0
|
0
|
0
|
RHA® Collection of dermal fillers |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
31,767
|
25,483
|
62,047
|
46,320
|
DAXXIFY® |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
22,626
|
0
|
38,004
|
0
|
Service revenue |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
3,721
|
1,226
|
7,278
|
2,082
|
Service revenue | Transferred at a point in time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
2
|
148
|
59
|
239
|
Service revenue | Transferred at over Time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
3,719
|
1,078
|
7,219
|
1,843
|
Collaboration revenue |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
20
|
1,659
|
136
|
5,227
|
Collaboration revenue | Transferred at a point in time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
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0
|
0
|
0
|
0
|
Collaboration revenue | Transferred at over Time |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Total revenue |
$ 20
|
$ 1,659
|
$ 136
|
$ 5,227
|
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v3.23.2
Revenue - Schedule of Receivables and Contract Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Contract liabilities: |
|
|
Deferred revenue, current |
$ 5,433
|
$ 6,867
|
Product revenue |
|
|
Accounts receivables: |
|
|
Total accounts receivable, net |
16,878
|
10,966
|
Contract liabilities: |
|
|
Deferred revenue, current |
471
|
705
|
Service revenue |
|
|
Accounts receivables: |
|
|
Total accounts receivable, net |
$ 165
|
$ 59
|
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v3.23.2
Revenue - Narrative (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Non-refundable upfront payment |
$ 87,175,000
|
|
$ 87,175,000
|
|
$ 84,739,000
|
Remaining performance obligation |
38,000,000
|
|
38,000,000
|
|
|
Contract with customer, liability, revenue recognized |
|
|
136,000
|
|
|
Viatris |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Revenue recognition annual sales |
|
|
$ 50,000,000
|
|
|
Revenue recognition annual sales of maturity period |
|
|
4 years
|
|
|
Fosun |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Contingent payments |
222,500,000
|
|
$ 222,500,000
|
|
|
Remaining performance obligation |
38,000,000
|
|
38,000,000
|
|
|
Fosun | Development Services |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Revenues |
100,000
|
|
100,000
|
|
|
Viatris |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Non-refundable upfront payment |
60,000,000
|
|
60,000,000
|
|
|
Contingent payments |
70,000,000
|
|
70,000,000
|
|
|
Revenue maximum for receipt of tiered milestone payments |
|
|
225,000,000
|
|
|
Remaining performance obligation |
54,500,000
|
|
54,500,000
|
|
|
Viatris | Development Services |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Revenues |
$ 0
|
$ 1,700,000
|
$ 0
|
$ 5,200,000
|
|
Fosun |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Contract with customer, liability, revenue recognized |
|
$ 0
|
|
$ 0
|
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v3.23.2
Revenue - Schedule of Contract Liabilities from Contracts (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Contract liabilities: |
|
|
Total contract liabilities, current |
$ 5,433
|
$ 6,867
|
Total contract liabilities, non-current |
82,213
|
78,577
|
Fosun |
|
|
Accounts receivables: |
|
|
Total accounts receivable, net |
0
|
315
|
Contract liabilities: |
|
|
Total contract liabilities, non-current |
37,977
|
37,977
|
Viatris |
|
|
Contract liabilities: |
|
|
Total contract liabilities, current |
4,962
|
6,162
|
Total contract liabilities, non-current |
$ 44,236
|
$ 40,600
|
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Cash Equivalents and Short-Term Investments - Schedule of Available-for-sale Securities (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
$ 315,312
|
$ 321,802
|
Gains |
5
|
|
Losses |
(66)
|
(374)
|
Fair Value |
315,251
|
321,428
|
Cash equivalents |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Fair Value |
136,763
|
89,686
|
Short-term investments |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Fair Value |
178,488
|
231,742
|
U.S. treasury securities |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
136,829
|
109,984
|
Gains |
0
|
|
Losses |
(52)
|
(228)
|
Fair Value |
136,777
|
109,756
|
Money market funds |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
98,349
|
85,206
|
Gains |
0
|
|
Losses |
0
|
0
|
Fair Value |
98,349
|
85,206
|
Commercial paper |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
57,843
|
80,946
|
Gains |
0
|
|
Losses |
(6)
|
0
|
Fair Value |
57,837
|
80,946
|
U.S. government agency obligations |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
14,760
|
4,480
|
Gains |
5
|
|
Losses |
0
|
0
|
Fair Value |
14,765
|
4,480
|
Corporate bonds |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Adjusted Cost |
7,531
|
41,186
|
Gains |
0
|
|
Losses |
(8)
|
(146)
|
Fair Value |
$ 7,523
|
$ 41,040
|
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v3.23.2
Intangible Assets, net - Schedule of Acquired Finite-lived and Indefinite-lived Intangible Assets by Major Class (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Gross Carrying Amount |
$ 68,631
|
|
$ 68,631
|
|
$ 90,637
|
Accumulated Amortization |
(40,170)
|
|
(40,170)
|
|
(55,293)
|
Total |
28,461
|
|
28,461
|
|
|
Net Carrying Amount |
28,461
|
|
28,461
|
|
35,344
|
Amortization of intangible assets |
2,800
|
$ 4,900
|
6,800
|
$ 9,900
|
|
Development in progress |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Indefinite-lived intangible assets |
$ 0
|
|
$ 0
|
|
$ 975
|
Distribution rights |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Weighted Average Remaining Useful Lives (in years) |
4 years 9 months 18 days
|
|
4 years 9 months 18 days
|
|
1 year 4 months 24 days
|
Finite-lived intangible assets, gross |
$ 32,334
|
|
$ 32,334
|
|
$ 32,334
|
Accumulated Amortization |
(21,974)
|
|
(21,974)
|
|
(20,882)
|
Total |
$ 10,360
|
|
$ 10,360
|
|
$ 11,452
|
Acquired developed technology |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Weighted Average Remaining Useful Lives (in years) |
3 years 9 months 18 days
|
|
3 years 9 months 18 days
|
|
4 years 2 months 12 days
|
Finite-lived intangible assets, gross |
$ 16,200
|
|
$ 16,200
|
|
$ 35,800
|
Accumulated Amortization |
(6,075)
|
|
(6,075)
|
|
(24,325)
|
Total |
$ 10,125
|
|
$ 10,125
|
|
$ 11,475
|
Internally developed technology |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Weighted Average Remaining Useful Lives (in years) |
2 years
|
|
2 years
|
|
2 years 4 months 24 days
|
Finite-lived intangible assets, gross |
$ 8,918
|
|
$ 8,918
|
|
$ 8,062
|
Accumulated Amortization |
(3,798)
|
|
(3,798)
|
|
(2,271)
|
Total |
$ 5,120
|
|
$ 5,120
|
|
$ 5,791
|
Customer relationships |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Weighted Average Remaining Useful Lives (in years) |
1 year 1 month 6 days
|
|
1 year 1 month 6 days
|
|
1 year 7 months 6 days
|
Finite-lived intangible assets, gross |
$ 10,300
|
|
$ 10,300
|
|
$ 10,300
|
Accumulated Amortization |
(7,510)
|
|
(7,510)
|
|
(6,223)
|
Total |
$ 2,790
|
|
$ 2,790
|
|
$ 4,077
|
Other software |
|
|
|
|
|
Acquired Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Weighted Average Remaining Useful Lives (in years) |
7 months 6 days
|
|
7 months 6 days
|
|
1 year 9 months 18 days
|
Finite-lived intangible assets, gross |
$ 879
|
|
$ 879
|
|
$ 3,166
|
Accumulated Amortization |
(813)
|
|
(813)
|
|
(1,592)
|
Total |
$ 66
|
|
$ 66
|
|
$ 1,574
|
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v3.23.2
Accruals and other current liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Compensation |
$ 17,771
|
$ 28,014
|
Selling, general and administrative |
7,143
|
9,681
|
Research and development |
5,374
|
9,012
|
Interest expense |
1,887
|
1,912
|
Clinical trials |
1,173
|
1,863
|
Inventories |
872
|
2,312
|
Other current liabilities |
5,315
|
6,563
|
Total accruals and other current liabilities |
$ 39,535
|
$ 59,357
|
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v3.23.2
Leases - Narrative (Details) $ in Thousands |
1 Months Ended |
6 Months Ended |
|
|
|
|
|
Apr. 30, 2021
option_to_extend_lease_term
|
Jun. 30, 2023
USD ($)
option_to_extend_lease_term
|
Jan. 31, 2023
USD ($)
ft²
|
Dec. 31, 2022
USD ($)
|
May 31, 2022
USD ($)
|
Dec. 31, 2021
USD ($)
|
Jul. 31, 2021
USD ($)
ft²
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Number of options to renew (or more) | option_to_extend_lease_term |
|
1
|
|
|
|
|
|
Term of written notice |
|
18 months
|
|
|
|
|
|
Purchase obligation, to be paid, year one |
|
|
|
|
|
$ 30,000
|
|
Purchase obligation, to be paid, year two |
|
|
|
|
|
30,000
|
|
Purchase obligation, to be paid, year three |
|
|
|
|
|
$ 30,000
|
|
Purchase obligation eliminated, year one |
|
|
$ 23,900
|
|
$ 30,000
|
|
|
Purchase obligation eliminated, year two |
|
|
|
|
30,000
|
|
|
Purchase obligation eliminated, year three |
|
|
|
|
$ 30,000
|
|
|
Collaborative agreement, number of extension periods | option_to_extend_lease_term |
1
|
|
|
|
|
|
|
Other non-current assets |
|
$ 4,719
|
|
$ 1,687
|
|
|
|
Other commitment, to be paid, year one |
|
12,700
|
|
|
|
|
|
Other commitment, to be paid, year two |
|
15,900
|
|
|
|
|
|
Other commitment, to be paid, year three |
|
18,300
|
|
|
|
|
|
Other commitment, to be paid, year four |
|
25,300
|
|
|
|
|
|
Other commitment, to be paid, year five |
|
29,500
|
|
|
|
|
|
Other commitment, to be paid, after year five |
|
134,500
|
|
|
|
|
|
Nashville Lease Expansion Premises |
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Area of land | ft² |
|
|
17,248
|
|
|
|
30,591
|
Lessee, operating lease, lease not yet commenced, amount |
|
|
$ 7,000
|
|
|
|
$ 16,000
|
PCI Supply Agreement |
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Collaborative agreement, contractual period |
3 years
|
|
|
|
|
|
|
Other non-current assets |
|
$ 27,500
|
|
|
|
|
|
Minimum |
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Extended term of lease |
|
7 years
|
|
|
|
|
|
Maximum |
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Extended term of lease |
|
14 years
|
|
|
|
|
|
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v3.23.2
Leases - Schedule of Lease Costs (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Finance lease: |
|
|
|
|
Finance Lease, Right-of-Use Asset, Amortization |
$ 1,350
|
$ 1,158
|
$ 3,668
|
$ 1,158
|
Interest on finance lease liability |
442
|
751
|
1,008
|
2,259
|
Variable lease cost |
0
|
323
|
374
|
1,713
|
Total finance lease costs |
1,792
|
2,232
|
5,050
|
5,130
|
Operating leases: |
|
|
|
|
Operating lease cost |
4,312
|
2,223
|
6,519
|
4,446
|
Variable lease cost |
548
|
431
|
1,055
|
865
|
Total operating lease costs |
4,860
|
2,654
|
7,574
|
5,311
|
Total lease costs |
$ 6,652
|
$ 4,886
|
$ 12,624
|
$ 10,441
|
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v3.23.2
Leases - Schedule of Finance Lease and Operating Lease Liability Maturities (Details) $ in Thousands |
Jun. 30, 2023
USD ($)
|
Finance Lease |
|
2023 remaining six months |
$ 12,855
|
2024 |
3,102
|
2025 |
0
|
2026 |
0
|
2027 |
0
|
2028 and thereafter |
0
|
Total lease payments |
15,957
|
Less imputed interest |
(452)
|
Present value of lease payments |
15,505
|
Operating Leases |
|
2023 remaining six months |
3,952
|
2024 |
8,723
|
2025 |
8,981
|
2026 |
9,242
|
2027 |
2,535
|
2028 and thereafter |
14,612
|
Total lease payments |
48,045
|
Less imputed interest |
(11,510)
|
Present value of lease payments |
36,535
|
Total |
|
2023 remaining six months |
16,807
|
2024 |
11,825
|
2025 |
8,981
|
2026 |
9,242
|
2027 |
2,535
|
2028 and thereafter |
14,612
|
Total lease payments |
64,002
|
Less imputed interest |
(11,962)
|
Present value of lease payments |
$ 52,040
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v3.23.2
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v3.23.2
Leases - Schedule of Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash Flow, Lessee [Abstract] |
|
|
Operating cash flows from operating leases |
$ 4,188
|
$ 4,192
|
Operating cash flows from finance lease |
1,008
|
627
|
Financing cash flows from finance lease |
8,899
|
1,760
|
Right-of-use assets obtained in exchange for lease liabilities |
|
|
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$ 23,735
|
$ 18,556
|
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v3.23.2
Debt - Schedule of Convertible Debt (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Debt Instrument [Line Items] |
|
|
Carrying amount of Notes Payable |
$ 380,348
|
$ 379,374
|
Debt, non-current |
380,348
|
379,374
|
Convertible Debt |
|
|
Debt Instrument [Line Items] |
|
|
Notes Payable |
100,000
|
100,000
|
Less: Unamortized debt issuance costs |
(1,040)
|
(1,192)
|
Less: Unamortized debt discount |
(1,175)
|
(1,347)
|
Carrying amount of Notes Payable |
97,785
|
97,461
|
Debt, non-current |
97,785
|
97,461
|
2027 Notes | Convertible Debt |
|
|
Debt Instrument [Line Items] |
|
|
Notes Payable |
287,500
|
287,500
|
Less: Unamortized debt issuance costs |
(4,937)
|
(5,587)
|
Carrying amount of Notes Payable |
282,563
|
281,913
|
Debt, non-current |
$ 282,563
|
$ 281,913
|
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v3.23.2
Debt - Schedule of Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Debt Disclosure [Abstract] |
|
|
|
|
Contractual interest expense |
$ 3,407
|
$ 3,383
|
$ 6,790
|
$ 4,971
|
Amortization of debt issuance costs |
431
|
417
|
863
|
749
|
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87
|
74
|
172
|
85
|
Total interest expense |
$ 3,925
|
$ 3,874
|
$ 7,825
|
$ 5,805
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v3.23.2
Debt - Note Purchase Agreement (Details)
|
|
1 Months Ended |
|
|
|
|
|
Mar. 18, 2022
USD ($)
|
Mar. 31, 2022
USD ($)
|
Aug. 31, 2023
USD ($)
|
Aug. 08, 2023
USD ($)
|
Aug. 07, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Aggregate principal amount |
|
|
|
|
|
$ 380,348,000
|
$ 379,374,000
|
Note Purchase Agreement | Notes Payable |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Stated percentage |
|
7.00%
|
|
|
|
|
|
Prepaid fee, percentage |
2.00%
|
|
|
|
|
|
|
Minimum cash balance maintained |
$ 30,000,000
|
|
|
|
|
|
|
Minimum net sales requirement |
$ 70,000,000
|
|
|
|
|
|
|
Debt instrument, debt default, additional interest rate to fixed |
2.00%
|
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | Forecast |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
$ 50,000,000
|
|
|
|
|
Note Purchase Agreement | Notes Payable | Minimum | London Interbank Offered Rate (LIBOR) Swap Rate |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Variable rate |
|
1.50%
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | Maximum |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Debt instrument, trailing twelve months revenue |
|
$ 50,000,000
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | Maximum | London Interbank Offered Rate (LIBOR) Swap Rate |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Variable rate |
|
2.50%
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
$ 100,000,000
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche | Debt Instrument Principal Amortization Period One |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Debt Instrument, Principal Amortization, Payment Percentage |
0.025
|
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche | Debt Instrument Principal Amortization Period Two |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Debt Instrument, Principal Amortization, Payment Percentage |
0.050
|
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche | Debt Instrument Principal Amortization Period Three |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Debt Instrument, Principal Amortization, Payment Percentage |
0.075
|
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche | Debt Instrument Principal Amortization Period Four |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Debt Instrument, Principal Amortization, Payment Percentage |
0.100
|
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | First Tranche | Subsequent Event |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
$ 100,000,000
|
|
|
Note Purchase Agreement | Notes Payable | Second Tranche | Subsequent Event |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
|
$ 50,000,000
|
|
|
|
Note Purchase Agreement | Notes Payable | Third Tranche |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Stated percentage |
|
8.50%
|
|
|
|
|
|
Note Purchase Agreement | Notes Payable | Third Tranche | Subsequent Event |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Principal amount |
|
|
|
$ 150,000,000
|
|
|
|
2027 Notes | Notes Payable |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Aggregate principal amount |
$ 90,000,000
|
|
|
|
|
|
|
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v3.23.2
Stockholders’ Equity and Stock-Based Compensation - Narrative (Details) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
4 Months Ended |
6 Months Ended |
|
May 10, 2022 |
Nov. 30, 2020 |
Jun. 30, 2023 |
May 10, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jan. 01, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
$ 100,183,000
|
$ 31,814,000
|
|
Capitalized share based payment expense |
|
|
$ 900,000
|
|
1,900,000
|
|
|
ATM Offering, 2020 Plan |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Stock issuance sales agreement, authorized offering price, maximum |
|
$ 125,000,000
|
|
|
|
|
|
Sale of stock, issuance costs, commission, percentage, maximum |
|
3.00%
|
|
|
|
|
|
Stock issued during period, shares, new issues (in shares) |
|
|
|
1,700,000
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
$ 31,600,000
|
|
|
|
ATM Offering, 2020 Plan | Weighted Average |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share price (in dollars per share) |
|
|
|
$ 18.71
|
|
|
|
ATM Offering, 2022 Plan |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Stock issuance sales agreement, authorized offering price, maximum |
$ 150,000,000
|
|
|
|
$ 47,200,000
|
|
|
Sale of stock, issuance costs, commission, percentage, maximum |
3.00%
|
|
|
|
|
|
|
Stock issued during period, shares, new issues (in shares) |
|
|
3,200,000
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
$ 100,000,000
|
|
|
|
|
ATM Offering, 2022 Plan | Weighted Average |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Price per share (in dollars per share) |
|
|
$ 31.90
|
|
$ 31.90
|
|
|
2014 EIP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance (in shares) |
|
|
4,000,000
|
|
4,000,000
|
|
3,300,000
|
2014 IP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance (in shares) |
|
|
800,000
|
|
800,000
|
|
|
HintMD Plan |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance (in shares) |
|
|
100,000
|
|
100,000
|
|
|
Shares underlying stock options granted (in shares) |
|
|
|
|
0
|
|
|
2014 ESPP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance (in shares) |
|
|
|
|
|
|
300,000
|
Stock Award | 2014 EIP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Shares underlying stock options granted (in shares) |
|
|
|
|
2,400,000
|
|
|
Share-based Payment Arrangement | 2014 EIP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Shares underlying stock options granted (in shares) |
|
|
|
|
200,000
|
|
|
Employee Stock Option | 2014 IP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Shares underlying stock options granted (in shares) |
|
|
|
|
0
|
|
|
Employee Stock | 2014 ESPP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance (in shares) |
|
|
1,800,000
|
|
1,800,000
|
|
|
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v3.23.2
Stockholders’ Equity and Stock-Based Compensation -Schedule of Common Stock Equivalents Excluded From Computation of Diluted Net Income (Loss) Per Share (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Convertible senior notes |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Common stock equivalents excluded from computation of diluted net income (loss) per share (in shares) |
8,878,938
|
8,878,938
|
Outstanding stock options |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Common stock equivalents excluded from computation of diluted net income (loss) per share (in shares) |
4,391,679
|
5,063,074
|
Unvested RSUs and PSUs |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Common stock equivalents excluded from computation of diluted net income (loss) per share (in shares) |
3,281,382
|
2,492,797
|
Unvested RSAs and PSAs |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Common stock equivalents excluded from computation of diluted net income (loss) per share (in shares) |
1,577,981
|
2,656,703
|
X |
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v3.23.2
Stockholders’ Equity and Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 16,547
|
$ 9,263
|
$ 29,629
|
$ 23,626
|
Selling, general and administrative |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
12,178
|
6,528
|
22,443
|
14,692
|
Research and development |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
3,421
|
2,735
|
6,238
|
8,934
|
Cost of product revenue (exclusive of depreciation and amortization) |
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 948
|
$ 0
|
$ 948
|
$ 0
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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v3.23.2
Fair Value Measurements - Schedule of Fair Value of Financial Instruments (Details) - Recurring - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
$ 315,251
|
$ 321,428
|
U.S. treasury securities |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
136,777
|
109,756
|
Money market funds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
98,349
|
85,206
|
U.S. government agency obligations |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
14,765
|
4,480
|
Commercial paper |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
57,837
|
80,946
|
Corporate bonds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
7,523
|
41,040
|
Level 1 |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
249,891
|
199,442
|
Level 1 | U.S. treasury securities |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
136,777
|
109,756
|
Level 1 | Money market funds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
98,349
|
85,206
|
Level 1 | U.S. government agency obligations |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
14,765
|
4,480
|
Level 1 | Commercial paper |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 1 | Corporate bonds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 2 |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
65,360
|
121,986
|
Level 2 | U.S. treasury securities |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 2 | Money market funds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 2 | U.S. government agency obligations |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 2 | Commercial paper |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
57,837
|
80,946
|
Level 2 | Corporate bonds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
7,523
|
41,040
|
Level 3 |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 3 | U.S. treasury securities |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 3 | Money market funds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 3 | U.S. government agency obligations |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 3 | Commercial paper |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
0
|
0
|
Level 3 | Corporate bonds |
|
|
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] |
|
|
Total assets measured at fair value |
$ 0
|
$ 0
|
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v3.23.2
Commitments and Contingencies (Details) - USD ($)
|
1 Months Ended |
6 Months Ended |
|
|
Sep. 30, 2020 |
Jan. 31, 2020 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Purchase obligation, to be paid, year one |
|
|
|
|
|
$ 30,000,000.0
|
Purchase obligation, to be paid, year two |
|
|
|
|
|
$ 30,000,000.0
|
Indemnification liability recorded during the period |
|
|
$ 0
|
$ 0
|
|
|
Estimated litigation liability |
|
|
0
|
|
$ 0
|
|
Teoxane Agreement |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Issuance of common stock in connection with the teoxane agreement (in shares) |
|
2,500,000
|
|
|
|
|
Collaborative agreement, contractual period |
10 years
|
|
|
|
|
|
Collaborative agreement, extended contractual period |
2 years
|
|
|
|
|
|
Purchase obligation, to be paid, year one |
|
|
40,000,000
|
|
|
|
Purchase obligation, to be paid, year two |
|
|
52,000,000
|
|
|
|
Minimum expenditures related to commercialization 2023 |
|
|
34,000,000
|
|
|
|
Minimum expenditures related to commercialization 2024 |
|
|
36,000,000
|
|
|
|
Botulinum Toxin Research Associates, Inc. |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Accrued milestone obligations |
|
|
$ 15,500,000
|
|
|
|
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v3.23.2
Segment Information - Schedule of Reconciliation of Segment Revenue to Consolidated Revenue (Details) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
segment
|
Jun. 30, 2022
USD ($)
|
Segment Reporting Information [Line Items] |
|
|
|
|
Number of reportable segments | segment |
|
|
2
|
|
Total revenue |
$ 58,134
|
$ 28,368
|
$ 107,465
|
$ 53,629
|
Product Segment |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total revenue |
54,413
|
27,142
|
100,187
|
51,547
|
Service Segment |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total revenue |
3,721
|
1,226
|
$ 7,278
|
2,082
|
Intersegment Eliminations |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Number of reportable segments | segment |
|
|
2
|
|
Intersegment Eliminations | Service Segment |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total revenue |
$ 700
|
$ 300
|
$ 1,300
|
$ 600
|
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v3.23.2
Segment Information - Schedule of Reconciliation of Segment Loss from Operations to Consolidated Loss from Operations (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Segment Reporting Information [Line Items] |
|
|
|
|
Total loss from operations |
$ (65,499)
|
$ (57,842)
|
$ (123,531)
|
$ (120,063)
|
Corporate and other expenses |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total loss from operations |
(41,186)
|
(27,275)
|
(79,401)
|
(60,610)
|
Product Segment | Operating Segments |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total loss from operations |
(19,335)
|
(24,969)
|
(32,065)
|
(49,920)
|
Service Segment | Operating Segments |
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
Total loss from operations |
$ (4,978)
|
$ (5,598)
|
$ (12,065)
|
$ (9,533)
|
X |
- DefinitionThe net result for the period of deducting operating expenses from operating revenues.
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