Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
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 $0.001 per share | |
Trading Symbol | RVNC | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 82,273,582 | |
Entity Central Index Key | 0001479290 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 104,491 | $ 110,623 |
Short-term investments | 274,136 | 114,448 |
Accounts receivable, net | 11,732 | 3,348 |
Inventories | 17,178 | 10,154 |
Prepaid expenses and other current assets | 8,057 | 7,544 |
Total current assets | 415,594 | 246,117 |
Property and equipment, net | 22,677 | 24,661 |
Goodwill | 146,964 | 146,964 |
Intangible assets, net | 42,866 | 55,334 |
Operating lease right-of-use assets | 40,522 | 44,340 |
Finance lease right-of-use asset | 10,021 | 0 |
Restricted cash | 5,921 | 5,046 |
Other non-current assets | 27,026 | 8,701 |
TOTAL ASSETS | 711,591 | 531,163 |
CURRENT LIABILITIES | ||
Accounts payable | 744 | 10,603 |
Accruals and other current liabilities | 48,007 | 39,558 |
Deferred revenue, current | 12,481 | 9,362 |
Finance lease liability, current | 9,396 | 0 |
Operating lease liabilities, current | 4,104 | 4,746 |
Derivative liability | 0 | 3,020 |
Total current liabilities | 74,732 | 67,289 |
Debt, non-current | 378,889 | 280,635 |
Deferred revenue, non-current | 75,254 | 74,152 |
Operating lease liabilities, non-current | 35,518 | 39,131 |
Other non-current liabilities | 1,485 | 1,485 |
TOTAL LIABILITIES | 565,878 | 462,692 |
Commitments and Contingencies (Note 11) | ||
STOCKHOLDERS’ EQUITY | ||
Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, par value $0.001 per share — 190,000,000 shares authorized both as of September 30, 2022 and December 31, 2021; 82,286,868 and 71,584,057 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 82 | 72 |
Additional paid-in capital | 1,754,513 | 1,466,369 |
Accumulated other comprehensive loss | (460) | (18) |
Accumulated deficit | (1,608,422) | (1,397,952) |
TOTAL STOCKHOLDERS’ EQUITY | 145,713 | 68,471 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 711,591 | $ 531,163 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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) | 82,286,868 | 71,584,057 |
Common stock, shares outstanding (in shares) | 82,286,868 | 71,584,057 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 29,015 | $ 19,745 | $ 82,644 | $ 51,848 |
Operating expenses: | ||||
Selling, general and administrative | 65,775 | 52,782 | 158,697 | 152,385 |
Research and development | 26,103 | 30,095 | 81,745 | 86,787 |
Amortization | 3,885 | 3,705 | 11,597 | 10,219 |
Total operating expenses | 106,499 | 92,468 | 280,191 | 264,920 |
Loss from operations | (77,484) | (72,723) | (197,547) | (213,072) |
Interest income | 1,165 | 84 | 1,860 | 266 |
Interest expense | (6,917) | (1,571) | (12,722) | (4,700) |
Changes in fair value of derivative liability | (875) | (20) | (980) | (98) |
Other income (expense), net | 118 | (146) | (381) | (608) |
Loss before income taxes | (83,993) | (74,376) | (209,770) | (218,212) |
Income tax provision | (700) | 0 | (700) | 0 |
Net loss | (84,693) | (74,376) | (210,470) | (218,212) |
Unrealized loss | (74) | (1) | (442) | (3) |
Comprehensive loss | (84,767) | (74,377) | (210,912) | (218,215) |
Basic net loss | (84,693) | (74,376) | (210,470) | (218,212) |
Diluted net loss | $ (84,693) | $ (74,376) | $ (210,470) | $ (218,212) |
Basic net loss (in dollars per share) | $ (1.17) | $ (1.10) | $ (3) | $ (3.24) |
Diluted net loss (in dollars per share) | $ (1.17) | $ (1.10) | $ (3) | $ (3.24) |
Basic weighted-average number of shares used in computing net loss per share (in shares) | 72,208,285 | 67,782,033 | 70,215,148 | 67,297,954 |
Diluted weighted-average number of shares used in computing net loss per share (in shares) | 72,208,285 | 67,782,033 | 70,215,148 | 67,297,954 |
Product revenue | ||||
Revenue: | ||||
Total revenue | $ 26,081 | $ 18,296 | $ 72,401 | $ 46,982 |
Operating expenses: | ||||
Cost of product revenue /service revenue (exclusive of amortization) | 8,681 | 5,827 | 24,130 | 15,453 |
Collaboration revenue | ||||
Revenue: | ||||
Total revenue | 970 | 1,129 | 6,197 | 4,034 |
Service revenue | ||||
Revenue: | ||||
Total revenue | 1,964 | 320 | 4,046 | 832 |
Operating expenses: | ||||
Cost of product revenue /service revenue (exclusive of amortization) | $ 2,055 | $ 59 | $ 4,022 | $ 76 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Additional Paid-In Capital Cumulative Effect, Period of Adoption, Adjustment | Other Accumulated Comprehensive Loss | Accumulated Deficit | Accumulated Deficit Cumulative Effect, Period of Adoption, Adjustment |
Beginning Balance (in shares) at Dec. 31, 2020 | 0 | 69,178,666 | 0 | 0 | ||||
Beginning Balance at Dec. 31, 2020 | $ 0 | $ 69 | $ 1,500,514 | $ (108,509) | $ 0 | $ (1,126,293) | $ 9,651 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with offerings (in shares) | 761,526 | |||||||
Issuance of common stock in connection with at-the-market offerings | $ 1 | 21,553 | ||||||
Issuance of common stock relating to employee stock purchase plan (in shares) | 91,562 | |||||||
Issuance of common stock relating to employee stock purchase plan | 2,206 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 921,376 | |||||||
Issuance of common stock upon exercise of stock options | $ 1 | 12,823 | ||||||
Issuance of restricted stock awards and performance stock awards, net of cancellation (in shares) | 1,136,221 | |||||||
Issuance of restricted stock awards and performance stock awards, net of cancellation | $ 1 | (1) | ||||||
Shares withheld related to net settlement of restricted stock awards (in shares) | (250,574) | |||||||
Shares withheld related to net settlement of restricted stock awards | (6,944) | |||||||
Stock-based compensation | $ 33,305 | |||||||
Unrealized loss | $ (3) | $ (3) | ||||||
Net loss | $ (218,212) | $ (218,212) | ||||||
Ending Balance (in shares) at Sep. 30, 2021 | 71,838,777 | 71,838,777 | 0 | 0 | 0 | |||
Ending Balance at Sep. 30, 2021 | $ 120,162 | $ 72 | $ 1,454,947 | $ (3) | $ (1,334,854) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Accounting Standards Update [Extensible List] | Accounting Standards Update 2020-06 [Member] | |||||||
Beginning Balance (in shares) at Jun. 30, 2021 | 0 | 71,798,624 | 0 | 0 | ||||
Beginning Balance at Jun. 30, 2021 | $ 0 | $ 72 | 1,446,643 | $ (2) | $ (1,260,478) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with at-the-market offerings | (70) | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 41,900 | |||||||
Issuance of common stock upon exercise of stock options | 314 | |||||||
Issuance of restricted stock awards and performance stock awards, net of cancellation (in shares) | 99,965 | |||||||
Shares withheld related to net settlement of restricted stock awards (in shares) | (101,712) | |||||||
Shares withheld related to net settlement of restricted stock awards | (2,694) | |||||||
Stock-based compensation | $ 10,754 | |||||||
Unrealized loss | $ (1) | $ (1) | ||||||
Net loss | $ (74,376) | $ (74,376) | ||||||
Ending Balance (in shares) at Sep. 30, 2021 | 71,838,777 | 71,838,777 | 0 | 0 | 0 | |||
Ending Balance at Sep. 30, 2021 | $ 120,162 | $ 72 | $ 1,454,947 | $ (3) | $ (1,334,854) | |||
Beginning Balance (in shares) at Dec. 31, 2021 | 71,584,057 | 0 | 71,584,057 | 0 | 0 | |||
Beginning Balance at Dec. 31, 2021 | $ 68,471 | $ 0 | $ 72 | 1,466,369 | $ (18) | $ (1,397,952) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with follow on offering, net of issuance costs (in shares) | 9,200,000 | |||||||
Issuance of common stock in connection with offerings, net of issuance cost | $ 9 | |||||||
Issuance of common stock in connection with follow-on offering, net of underwriting discounts, commissions, and offering costs | 215,921 | |||||||
Issuance of common stock in connection with offerings (in shares) | 1,734,853 | |||||||
Issuance of common stock in connection with at-the-market offerings | $ 1 | 31,554 | ||||||
Issuance of common stock relating to employee stock purchase plan (in shares) | 171,824 | |||||||
Issuance of common stock relating to employee stock purchase plan | 2,018 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 122,377 | |||||||
Issuance of common stock upon exercise of stock options | 621 | |||||||
Issuance of restricted stock awards and performance stock awards, net of cancellation (in shares) | (257,611) | |||||||
Shares withheld related to net settlement of restricted stock awards (in shares) | (268,632) | |||||||
Shares withheld related to net settlement of restricted stock awards | (4,613) | |||||||
Stock-based compensation | 42,295 | |||||||
Other | $ 348 | |||||||
Unrealized loss | (442) | $ (442) | ||||||
Net loss | $ (210,470) | $ (210,470) | ||||||
Ending Balance (in shares) at Sep. 30, 2022 | 82,286,868 | 82,286,868 | 0 | 0 | 0 | |||
Ending Balance at Sep. 30, 2022 | $ 145,713 | $ 82 | $ 1,754,513 | $ (460) | $ (1,608,422) | |||
Beginning Balance (in shares) at Jun. 30, 2022 | 0 | 73,123,363 | 0 | 0 | 0 | |||
Beginning Balance at Jun. 30, 2022 | $ 0 | $ 73 | $ 1,521,411 | $ (386) | $ (1,523,729) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with follow on offering, net of issuance costs (in shares) | 9,200,000 | |||||||
Issuance of common stock in connection with offerings, net of issuance cost | $ 9 | |||||||
Issuance of common stock in connection with follow-on offering, net of underwriting discounts, commissions, and offering costs | 215,921 | |||||||
Issuance of common stock in connection with at-the-market offerings | (31) | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 91,743 | |||||||
Issuance of common stock upon exercise of stock options | 512 | |||||||
Issuance of restricted stock awards and performance stock awards, net of cancellation (in shares) | (44,752) | |||||||
Shares withheld related to net settlement of restricted stock awards (in shares) | (83,486) | |||||||
Shares withheld related to net settlement of restricted stock awards | (1,853) | |||||||
Stock-based compensation | $ 18,553 | |||||||
Unrealized loss | (74) | $ (74) | ||||||
Net loss | $ (84,693) | $ (84,693) | ||||||
Ending Balance (in shares) at Sep. 30, 2022 | 82,286,868 | 82,286,868 | 0 | 0 | 0 | |||
Ending Balance at Sep. 30, 2022 | $ 145,713 | $ 82 | $ 1,754,513 | $ (460) | $ (1,608,422) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (210,470) | $ (218,212) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 41,613 | 32,513 |
Depreciation and amortization | 16,266 | 14,434 |
Amortization of finance lease right-of-use asset | 4,502 | 0 |
Amortization of debt discount and debt issuance costs | 1,373 | 935 |
Amortization of discount on investments | (399) | (16) |
Other non-cash operating activities | 1,265 | 140 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (8,384) | 171 |
Inventories | (6,606) | (4,316) |
Prepaid expenses and other current assets | (947) | 5,141 |
Lease right-of-use assets | (10,705) | (15,901) |
Other non-current assets | (297) | (7,537) |
Accounts payable | (9,711) | (4,578) |
Accruals and other liabilities | 3,928 | 5,784 |
Deferred revenue | 4,222 | (447) |
Lease liabilities | 10,984 | 13,712 |
Other non-current liabilities | 0 | 1,250 |
Net cash used in operating activities | (163,366) | (176,927) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of investments | (321,199) | (178,588) |
Finance lease prepayments | (17,820) | (7,700) |
Purchases of property and equipment | (1,922) | (6,018) |
Proceeds from maturities of investments | 161,183 | 135,000 |
Net cash used in investing activities | (179,758) | (57,306) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common stock in connection with follow-on offering, net of discounts and commissions | 216,200 | 0 |
Proceeds from issuance of notes payable, net of debt discount | 98,150 | 0 |
Proceeds from issuance of common stock in connection with at-the-market offerings, net of commissions | 31,814 | 21,706 |
Proceeds from the exercise of stock options and employee stock purchase plan | 2,639 | 15,029 |
Principal payments on finance lease obligations | (5,000) | 0 |
Taxes paid related to net settlement of restricted stock awards | (4,613) | (6,944) |
Payment of debt issuance costs and offering costs | (1,671) | (327) |
Other financing activities | 348 | 0 |
Net cash provided by financing activities | 337,867 | 29,464 |
NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | (5,257) | (204,769) |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period | 115,669 | 337,003 |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period | 110,412 | 132,234 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||
Accrued debt issuance costs and offering costs | 749 | 0 |
Capitalized stock-based compensation | 682 | 792 |
Property and equipment purchases included in accounts payable and accruals | $ 342 | $ 1,206 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company and Summary of Significant Accounting Policies | The Company and Summary of Significant Accounting Policies The Company 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 SA (“Teoxane”) and OPUL ® , a relational commerce platform for aesthetic practices. Revance has also partnered with Viatris Inc. to develop a biosimilar to BOTOX ® , 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. Since inception, we have devoted substantial efforts to identifying and developing product candidates for the aesthetic and therapeutic pharmaceutical markets, recruiting personnel, raising capital, conducting preclinical and clinical development of, and manufacturing development for DAXXIFY™, DaxibotulinumtoxinA Topical, the onabotulinumtoxinA biosimilar, obtaining regulatory approval of DAXXIFY™ and the commercial launch of our products and services. As a result, we have incurred net losses and net cash outflows from operations. For the three and nine months ended September 30, 2022, we had a net loss of $84.7 million and $210.5 million, respectively. As of September 30, 2022, we had a working capital surplus of $340.9 million and an accumulated deficit of $1.6 billion. In recent years, we have funded our operations primarily through the sale of common stock, convertible senior notes, payments received from collaboration arrangements, sales of the RHA® Collection of dermal fillers and, in March 2022, we received the proceeds from notes issued in an aggregate principal amount of $100.0 million pursuant to the Note Purchase Agreement (defined in Note 8 ). As of September 30, 2022, we had capital resources of $378.6 million consisting of cash, cash equivalents, short-term investments. Since the FDA approval of DAXXIFY™ for the temporary improvement of moderate to severe glabellar lines in September 2022, we are eligible to draw on the Second Tranche (defined in Note 8 ) of $100.0 million in full under the Note Purchase Agreement provided certain conditions are met. We may also sell up to $150.0 million of our common stock under the 2022 ATM Agreement (defined in Note 9 ). Based on our updated evaluation of our ability to continue as a going concern, we have concluded that the factors which previously raised substantial doubt about our ability to continue as a going concern no longer exist as of the issuance date of this Report. We believe that our existing capital resources will be sufficient to fund the operating plan through at least the next 12 months following the issuance of this Report. Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements are unaudited, and reflect all adjustments which are, in the opinion of management, of a normal recurring nature and necessary for a fair statement of the results for the interim periods presented. Our condensed consolidated balance sheet for the year ended December 31, 2021 was derived from audited consolidated financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles (“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, 2021, or any other future period. Our condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (the “SEC”), on February 28, 2022. 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. 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. The full extent of the impact of the COVID-19 pandemic on our future operational and financial performance will depend on future developments that are highly uncertain, including variant strains of the virus and the degree of their vaccine resistance and as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects. The ongoing COVID-19 pandemic has and may continue to negatively affect global economic activity, the regulatory approval process for our product candidates, our supply chain, research and development activities, end user demand for our products and services and commercialization activities. For example, the timing of the FDA’s inspection of our manufacturing facility as a part of the regulatory approval process for DAXXIFY™ was delayed due to the FDA’s travel restrictions associated with the COVID-19 pandemic. We cannot be certain of the continued impact of the COVID-19 pandemic on the timing of the regulatory approval process for DAXXIFY™ in indications other than glabellar lines or on any supplemental biologics license applications (each, a “BLA”) or post-approval supplements we may file. 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. Inventory Inventories consist of raw materials, work in process, and finished goods held for sale to customers. Cost is determined using the first-in-first-out (FIFO) method. Inventory costs include raw materials, labor, quality control, and overhead associated with the cost of production. Inventory valuation reserves are established based on a number of factors including, but not limited to, inventory not conforming to product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, may require judgment. No inventory valuation reserves have been recorded for any periods presented. Products manufactured at a third-party contract manufacturer site prior to that site’s regulatory approval may be capitalized as inventory when the future economic benefit is deemed highly probable. A number of factors are considered in determining probability, including the historical experience of achieving regulatory approvals for the manufacturing process, the progress along the approval process, the shelf life of the product, and any other impediments identified. If the criteria for capitalizing inventory are not met, the pre-approval manufacturing costs of products are recognized as research and development expense in the period incurred. No inventories from any third-party contract manufacturer have been recognized for any periods presented. Leases We account for a contract as a lease when it has an identified asset that is physically distinct and we have the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. We determine if an arrangement is a lease or contains a lease at inception. For arrangements that meet the definition of a lease, we determine the initial classification and measurement of our right-of-use asset and lease liability at the lease commencement date and thereafter if modified. We do not recognize right-of-use assets or lease liabilities for those leases that qualify as a short-term lease. The lease term includes any renewal options that we are reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, we use our estimated secured incremental borrowing rate for that lease term. For our real estate operating leases, rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the condensed consolidated statements of operations and comprehensive loss. In addition to rent, the real estate operating leases may require us to pay additional amounts for variable lease costs which includes taxes, insurance, maintenance, and other expenses, and the variable lease costs are generally referred to as non-lease components. For real estate operating leases, we account for lease and non-lease components separately. For a finance lease for a manufacturing fill-and-finish line, interest expense from fixed payments on finance lease is recognized using the effective interest method. Finance lease right-of-use asset amortization is recorded within research and development expense on the condensed consolidated statements of operations and comprehensive loss, and finance lease liability interest expense is recorded in the interest expense on the condensed consolidated statements of operations and comprehensive loss. For our manufacturing fill-and-finish line asset group, we have elected to apply the practical expedient and account for the lease and non-lease components as a single lease component. Variable lease costs related to finance leases are expensed as research and development expense as incurred. 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. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue Our revenue is primarily generated from U.S. customers. Our product and collaboration revenue is generated from the Product Segment, and our service revenue is generated from the Service Segment ( Note 12 ). The following tables present our revenue disaggregated by the timing of transfer of goods or services: Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 (in thousands) Product Revenue Collaboration Revenue Service Revenue Total Product Revenue Collaboration Revenue Service Revenue Total Timing of revenue recognition: Transferred at a point in time $ 26,081 $ — $ 121 $ 26,202 $ 72,401 $ — $ 360 $ 72,761 Transferred over time — 970 1,843 2,813 — 6,197 3,686 9,883 Total $ 26,081 $ 970 $ 1,964 $ 29,015 $ 72,401 $ 6,197 $ 4,046 $ 82,644 Three Months Ended September 30, 2021 Nine Months Ended September, 2021 (in thousands) Product Revenue Collaboration Revenue Service Revenue Total Product Revenue Collaboration Revenue Service Revenue Total Timing of revenue recognition: Transferred at a point in time $ 18,296 $ — $ 166 $ 18,462 $ 46,982 $ — $ 379 $ 47,361 Transferred over time — 1,129 154 1,283 — 4,034 453 4,487 Total $ 18,296 $ 1,129 $ 320 $ 19,745 $ 46,982 $ 4,034 $ 832 $ 51,848 Product Revenue For the three and nine months ended September 30, 2022 and 2021, product revenue was generated from the sale of the RHA® Collection of dermal fillers. Receivables and contract liabilities from contracts with our product customers are as follows: September 30, December 31, (in thousands) 2022 2021 Receivables: Accounts receivable, net $ 5,341 $ 3,297 Total accounts receivable, net $ 5,341 $ 3,297 Contract liabilities: Deferred revenue, current $ 2,491 $ 1,331 Total contract liabilities $ 2,491 $ 1,331 Collaboration Revenue Viatris Collaboration and License Agreement Agreement Terms We entered into a collaboration and license agreement with Viatris (the “Viatris Collaboration”) in February 2018, pursuant to which we are collaborating with Viatris exclusively, on a world-wide basis (excluding Japan), to develop, manufacture, and commercialize an onabotulinumtoxinA biosimilar. Viatris has paid us an aggregate of $60 million in non-refundable upfront and milestone fees as of September 30, 2022, 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 re-evaluate the transaction price at each reporting period. We estimated the transaction price for the Viatris Collaboration using the most likely amount method. 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 Collaboration 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. 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 Collaboration. As of September 30, 2022, the transaction price allocated to the unfulfilled performance obligations was $92.6 million. We recognize revenue and estimate deferred revenue based on the cost of development services 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. For the three and nine months ended September 30, 2022, we recognized revenue related to development services of $1.0 million and $6.2 million, respectively. For the three and nine months ended September 30, 2021, we recognized revenue related to development services of $1.1 million and $4.0 million, respectively. Fosun License Agreement Agreement Terms In December 2018, we entered into a license agreement (the “Fosun License Agreement”) with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun”), whereby we granted Fosun the exclusive rights to develop and commercialize DAXXIFY™ in mainland China, Hong Kong and Macau (the “Fosun Territory”) and certain sublicense rights. As of September 30, 2022, Fosun has paid us non-refundable upfront and other payments totaling $31.0 million before foreign withholding taxes. In accordance with the Fosun License Agreement, we are eligible to receive a milestone payment $7.0 million before foreign withholding taxes upon the FDA approval of the BLA of DAXXIFY™, which was approved in September 2022. We recorded this milestone payment in “accounts receivable, net” on the condensed consolidated balance sheets as of September 30, 2022, and the payment was received in November 2022. We are also eligible to receive (i) additional remaining contingent payments of up to $222.5 million upon the achievement of certain milestones based on the first calendar year net sales, and (ii) tiered royalty payments in low double digits to high teen percentages on annual net sales. The royalty percentages are subject to reduction in the event that (i) we do not have any valid and unexpired patent claims that cover the product in the Fosun Territory, (ii) biosimilars of the product are sold in the Fosun Territory or (iii) Fosun needs to pay compensation to third parties to either avoid patent infringement or market the product in the Fosun Territory. Revenue Recognition We estimated the transaction price for the Fosun License Agreement using the most likely amount method. We evaluated all of the variable payments to be received during the duration of the contract, which included payments from specified milestones, royalties, and estimated supplies to be delivered. We will re-evaluate the transaction price at each reporting period and upon a change in circumstances. As of September 30, 2022, the transaction price allocated to unfulfilled performance obligation was $38.0 million. For the three and nine months ended September 30, 2022 and 2021, no revenue was recognized from the Fosun License Agreement. Receivables and contract liabilities from contracts with our collaboration customers are as follows: September 30, December 31, (in thousands) 2022 2021 Receivables: Accounts receivable, net — Fosun $ 6,300 $ — Total accounts receivable, net $ 6,300 $ — Contract liabilities: Deferred revenue, current — Viatris $ 9,930 $ 7,927 Total contract liabilities, current $ 9,930 $ 7,927 Deferred revenue, non-current — Viatris $ 37,259 $ 43,157 Deferred revenue, non-current — Fosun 37,995 30,995 Total contract liabilities, non-current $ 75,254 $ 74,152 Changes in our contract liabilities from contracts with our collaboration revenue customers for the nine months ended September 30, 2022 are as follows: (in thousands) Balance on January 1, 2022 $ 82,079 Revenue recognized 6,197 Billings and adjustments, net (3,092) Balance on September 30, 2022 $ 85,184 Service Revenue We offer customer payment processing and certain value-added services to aesthetic practices through the HintMD Platform, the legacy fintech platform, and OPUL ® , the next-generation relational commerce platform (together with the HintMD Platform, the “Fintech Platform”). Generally, revenue related to the HintMD Platform payment processing service is recognized at a point in time and revenue related to the OPUL ® payment processing service is recognized over time. For the Fintech Platform, revenue related to the value-added services component is recognized over time. Receivables and contract liabilities from contracts with our service customers are as follows: September 30, December 31, (in thousands) 2022 2021 Accounts receivable, net $ 91 $ 51 Total accounts receivable, net $ 91 $ 51 Contract liabilities: Deferred revenue, current $ 60 $ 104 Total contract liabilities, current $ 60 $ 104 |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash Equivalents and Short-Term Investments | Cash Equivalents and Short-Term Investments The following table is a summary of our cash equivalents and short-term investments: September 30, 2022 December 31, 2021 in thousands Cost Gains Losses Fair Value Cost Losses Fair Value U.S. treasury securities $ 134,772 $ 1 $ (187) $ 134,586 $ — $ — $ — Commercial paper 92,616 — — 92,616 87,964 — 87,964 Corporate bonds 60,621 — (265) 60,356 26,502 (18) 26,484 Money market funds 43,883 — — 43,883 90,355 — 90,355 U.S. government agency obligations 29,806 — — 29,806 — — — Yankee debt securities 3,024 — (9) 3,015 — — — Total cash equivalents and available-for-sale securities $ 364,722 $ 1 $ (461) $ 364,262 $ 204,821 $ (18) $ 204,803 Classified as: Cash equivalents $ 90,126 $ 90,355 Short-term investments 274,136 114,448 Total cash equivalents and available-for-sale securities $ 364,262 $ 204,803 As of September 30, 2022 and December 31, 2021, we have no other-than-temporary impairments on our available-for-sale securities, and the contractual maturities of the available-for-sale securities are less than one-year. |
Intangible Assets, net
Intangible Assets, net | 9 Months Ended |
Sep. 30, 2022 | |
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: September 30, 2022 December 31, 2021 (in thousands, except for in years) Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Distribution rights 1.7 $ 32,334 $ (18,861) $ 13,473 2.4 $ 32,334 $ (12,799) $ 19,535 Developed technology 4.1 35,800 (11,128) 24,672 4.9 35,800 (6,653) 29,147 Customer relationships 1.8 10,300 (5,579) 4,721 2.6 10,300 (3,648) 6,652 Total intangible assets $ 78,434 $ (35,568) $ 42,866 $ 78,434 $ (23,100) $ 55,334 Aggregate amortization expense for the intangible assets presented in the condensed consolidated statements of operations and comprehensive loss are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Amortization (1) $ 3,513 $ 3,512 $ 10,538 $ 9,862 Selling, general and administrative 644 653 1,931 1,990 Total amortization expense $ 4,157 $ 4,165 $ 12,469 $ 11,852 (1) The amortization expense related to Distribution rights and Developed technology was recorded to amortization in the condensed consolidated statement of operations and comprehensive loss. Based on the amount of intangible assets as of September 30, 2022, the expected amortization expense for each of the next five fiscal years was as follows: Year Ending December 31, (in thousands) 2022 remaining three months $ 4,157 2023 16,625 2024 10,837 2025 5,967 2026 4,606 2027 674 Total $ 42,866 |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: September 30, December 31, (in thousands) 2022 2021 Raw materials $ 57 $ — Work in process 2,356 — Finished goods 14,765 10,154 Total inventories $ 17,178 $ 10,154 |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Balance Sheet Components | Balance Sheet Components Accruals and Other Current Liabilities Accruals and other current liabilities consist of the following: September 30, December 31, (in thousands) 2022 2021 Compensation $ 23,333 $ 22,761 Selling, general and administrative 9,539 5,688 Inventories 5,653 456 Research and development 5,295 5,152 Clinical trials 1,842 2,172 Other current liabilities 1,716 1,442 Interest expense 629 1,887 Total accruals and other current liabilities $ 48,007 $ 39,558 Property and Equipment, net Property and equipment, net consists of the following: September 30, December 31, (in thousands) 2022 2021 Manufacturing and other equipment $ 21,774 $ 20,277 Platform and computer software 13,736 11,671 Leasehold improvements 7,533 7,481 Computer equipment 3,506 3,558 Furniture and fixtures 1,677 1,893 Other construction in progress 1,503 3,110 Total property and equipment 49,729 47,990 Less: Accumulated depreciation and amortization (27,052) (23,329) Total property and equipment, net $ 22,677 $ 24,661 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
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 7 years to 14 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, and in December 2020, we amended the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement with Ajinomoto Althea, Inc. dba Aji Bio-Pharma Services, a contract development and manufacturing organization (“ABPS”) (as amended, the “ABPS Agreement”). The ABPS 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 (1) 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 (2) the right to direct the use of the fill-and-finish line through our purchase orders to ABPS. Under the ABPS 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. Each party has the right to terminate the ABPS 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. In May 2022, we amended a statement of work under the ABPS 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 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. The operating and finance lease costs are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Finance lease: Amortization of finance lease right-of-use asset $ 3,344 $ — $ 4,502 $ — Variable lease cost - finance lease (1) 1,134 — 1,375 — Interest on finance lease liability 348 — 2,607 — Total finance lease costs 4,826 — 8,484 — Operating leases: Operating lease cost 2,223 2,224 6,669 5,802 Variable lease cost - operating leases (2) 423 385 1,288 1,016 Total operating lease costs 2,646 2,609 7,957 6,818 Total lease cost $ 7,472 $ 2,609 $ 16,441 $ 6,818 (1) Variable lease cost includes validation, qualification, materials, and other non-commercial related services which are not included in the lease liabilities and are expensed as incurred. (2) Variable lease cost includes management fees, common area maintenance, property taxes, and insurance, which are not included in the lease liabilities and are expensed as incurred. As of September 30, 2022, maturities of our lease liabilities are as follows: (in thousands) Finance Lease Operating Leases Total Year Ending December 31, 2022 remaining three months $ 8,523 $ 1,218 $ 9,741 2023 990 8,468 9,458 2024 — 8,723 8,723 2025 — 8,981 8,981 2026 — 9,242 9,242 2027 and thereafter — 17,146 17,146 Total lease payments 9,513 53,778 63,291 Less imputed interest (117) (14,156) (14,273) Present value of lease payments $ 9,396 $ 39,622 $ 49,018 Our lease contracts do not provide a readily determinable implicit rates, as such, we used the estimated incremental borrowing based on the information available at the adoption or commencement dates. As of September 30, 2022, remaining lease terms and discount rates are as follows: Finance Leases Operating Leases Weighted-average remaining lease term (years) 2.3 7.8 Weighted-average discount rate 8.5 % 9.8 % Supplemental cash flow information related to the leases was as follows: Nine Months Ended September 30, (in thousands) 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 6,259 $ 7,956 Operating cash flows from finance leases $ 2,541 $ — Financing cash flows from finance leases $ 5,000 $ — Right-of-use assets obtained in exchange for lease liabilities Finance lease $ 14,523 $ — Operating leases $ — $ 18,855 Leases Not Yet Commenced LSNE Agreement In April 2021, we and Lyophilization Services of New England, Inc. (“LSNE”), a contract development and manufacturing services organization, entered into a commercial supply agreement (the “LSNE Agreement”) pursuant to which LSNE would serve as a non-exclusive manufacturer and supplier of our products (the “Products”). The initial term of the LSNE Agreement is dependent upon the date of regulatory submission for the manufacturing of the applicable Product and may be terminated by either party in accordance with the terms of the LSNE Agreement. The term of the LSNE Agreement may also be extended for one additional three-year term upon mutual agreement of the parties. The LSNE Agreement may contain a lease related to a dedicated fill-and-finish line and closely related assets for the manufacturing of the Products 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 (1) 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 (2) the right to direct the use of the fill-and-finish line. The embedded lease had not yet commenced as of September 30, 2022. 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 LSNE 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 LSNE Agreement. As of September 30, 2022, we have made prepayments of $25.5 million to LSNE which is recorded within “other non-current assets” in the condensed consolidated balance sheets. Based on our best estimate as of September 30, 2022, our remaining commitment under the LSNE Agreement will be $2.0 million for 2022, $7.7 million for 2023, $14.4 million for 2024, $18.3 million for 2025, $25.3 million for 2026, and $164.0 million for 2027 and thereafter in aggregate. Nashville Lease Expansion Premises In November 2020, we entered into a non-cancelable operating lease for an office space in Nashville, Tennessee (the “Nashville Lease”), which 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 an additional 30,591 square feet (the “Expansion Premises”). The lease 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. 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. |
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 7 years to 14 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, and in December 2020, we amended the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement with Ajinomoto Althea, Inc. dba Aji Bio-Pharma Services, a contract development and manufacturing organization (“ABPS”) (as amended, the “ABPS Agreement”). The ABPS 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 (1) 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 (2) the right to direct the use of the fill-and-finish line through our purchase orders to ABPS. Under the ABPS 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. Each party has the right to terminate the ABPS 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. In May 2022, we amended a statement of work under the ABPS 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 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. The operating and finance lease costs are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Finance lease: Amortization of finance lease right-of-use asset $ 3,344 $ — $ 4,502 $ — Variable lease cost - finance lease (1) 1,134 — 1,375 — Interest on finance lease liability 348 — 2,607 — Total finance lease costs 4,826 — 8,484 — Operating leases: Operating lease cost 2,223 2,224 6,669 5,802 Variable lease cost - operating leases (2) 423 385 1,288 1,016 Total operating lease costs 2,646 2,609 7,957 6,818 Total lease cost $ 7,472 $ 2,609 $ 16,441 $ 6,818 (1) Variable lease cost includes validation, qualification, materials, and other non-commercial related services which are not included in the lease liabilities and are expensed as incurred. (2) Variable lease cost includes management fees, common area maintenance, property taxes, and insurance, which are not included in the lease liabilities and are expensed as incurred. As of September 30, 2022, maturities of our lease liabilities are as follows: (in thousands) Finance Lease Operating Leases Total Year Ending December 31, 2022 remaining three months $ 8,523 $ 1,218 $ 9,741 2023 990 8,468 9,458 2024 — 8,723 8,723 2025 — 8,981 8,981 2026 — 9,242 9,242 2027 and thereafter — 17,146 17,146 Total lease payments 9,513 53,778 63,291 Less imputed interest (117) (14,156) (14,273) Present value of lease payments $ 9,396 $ 39,622 $ 49,018 Our lease contracts do not provide a readily determinable implicit rates, as such, we used the estimated incremental borrowing based on the information available at the adoption or commencement dates. As of September 30, 2022, remaining lease terms and discount rates are as follows: Finance Leases Operating Leases Weighted-average remaining lease term (years) 2.3 7.8 Weighted-average discount rate 8.5 % 9.8 % Supplemental cash flow information related to the leases was as follows: Nine Months Ended September 30, (in thousands) 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 6,259 $ 7,956 Operating cash flows from finance leases $ 2,541 $ — Financing cash flows from finance leases $ 5,000 $ — Right-of-use assets obtained in exchange for lease liabilities Finance lease $ 14,523 $ — Operating leases $ — $ 18,855 Leases Not Yet Commenced LSNE Agreement In April 2021, we and Lyophilization Services of New England, Inc. (“LSNE”), a contract development and manufacturing services organization, entered into a commercial supply agreement (the “LSNE Agreement”) pursuant to which LSNE would serve as a non-exclusive manufacturer and supplier of our products (the “Products”). The initial term of the LSNE Agreement is dependent upon the date of regulatory submission for the manufacturing of the applicable Product and may be terminated by either party in accordance with the terms of the LSNE Agreement. The term of the LSNE Agreement may also be extended for one additional three-year term upon mutual agreement of the parties. The LSNE Agreement may contain a lease related to a dedicated fill-and-finish line and closely related assets for the manufacturing of the Products 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 (1) 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 (2) the right to direct the use of the fill-and-finish line. The embedded lease had not yet commenced as of September 30, 2022. 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 LSNE 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 LSNE Agreement. As of September 30, 2022, we have made prepayments of $25.5 million to LSNE which is recorded within “other non-current assets” in the condensed consolidated balance sheets. Based on our best estimate as of September 30, 2022, our remaining commitment under the LSNE Agreement will be $2.0 million for 2022, $7.7 million for 2023, $14.4 million for 2024, $18.3 million for 2025, $25.3 million for 2026, and $164.0 million for 2027 and thereafter in aggregate. Nashville Lease Expansion Premises In November 2020, we entered into a non-cancelable operating lease for an office space in Nashville, Tennessee (the “Nashville Lease”), which 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 an additional 30,591 square feet (the “Expansion Premises”). The lease 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. 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. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table provides information regarding our debt: September 30, December 31, (in thousands) 2022 2021 Convertible senior notes (the “2027 Notes”) $ 287,500 $ 287,500 Less: Unamortized debt issuance costs (5,909) (6,865) Carrying amount of the 2027 Notes 281,591 280,635 Notes payable 100,000 — Less: Unamortized debt discount (1,434) — Less: Unamortized debt issuance costs (1,268) — Carrying amount of notes payable 97,298 — Debt, non-current $ 378,889 $ 280,635 Interest expense relating to our debt in the condensed consolidated statements of operations and comprehensive loss are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Contractual interest expense $ 3,454 $ 1,258 $ 8,425 $ 3,773 Amortization of debt issuance costs 441 313 1,190 935 Amortization of debt discount 98 — 183 — Total interest expense $ 3,993 $ 1,571 $ 9,798 $ 4,708 Notes Payable In March 2022, we entered into a note purchase agreement with Athyrium Buffalo LP (“Athyrium”), as administrative agent and Purchaser, and Hint, Inc., as a guarantor (the “Note Purchase Agreement”), pursuant to which the Purchasers (as defined therein) agreed to purchase from us, and we agreed to issue to such Purchasers, notes payable by us (the “Notes”). On March 18, 2022, we issued to the Purchasers Notes in an aggregate principal amount for all such Notes of $100.0 million (the “First Tranche”). Subject to satisfaction of certain conditions set forth in the Note Purchase Agreement, including the FDA approval of DAXXIFY™, $100.0 million in additional Notes (the “Second Tranche”) remains available to us under the Note Purchase Agreement until September 18, 2023. In addition, there is an uncommitted tranche of additional Notes in an aggregate amount of up to $100.0 million (the “Third Tranche”) 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 Capital Management, LP. 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. Initially, the Notes bear interest at an annual fixed interest rate equal to 8.50%. If the Third Tranche of Notes becomes committed, the Notes will then bear interest at an annual rate equal to the sum of (a) 7.0% and (b) Adjusted Three-Month LIBOR 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 the Notes, commencing on the last business day of the calendar month following the funding date thereof, and continuing until the last business day of each March, June, September and December through September 18, 2026 (the “Maturity Date”). 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. Upon the occurrence of an Amortization Trigger (as defined in the Note Purchase Agreement), we are required to repay the principal of the Second Tranche and 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, 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 Effective Date and (ii) 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the Effective Date but on or prior to the second anniversary of the Effective Date. Upon prepayment or repayment of all or any portion of the principal amount of the Notes (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 (as defined in the Note Purchase Agreement) 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 $287.5 million aggregate principal amount of convertible senior notes that are due in 2027 (the “2027 Notes”) pursuant to an indenture, dated February 14, 2020, between us and U.S. Bank National Association, as trustee (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, beginning 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. A portion of the net proceeds from the 2027 Notes were used to purchase the capped call transactions described below and the remainder will be used to fund expenses associated with commercial launch activities for both the RHA® Collection of dermal fillers and DAXXIFY™, research and development, and other corporate activities. 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: (1) 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; (2) 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; (3) 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 (4) 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 one of the initial purchasers and another financial institution (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 cap ped 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 September 30, 2022 and December 31, 2021, we had not purchased any shares under the capped call transactions. |
Stockholders_ Equity and Stock-
Stockholders’ Equity and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity (Deficit) and Stock-Based Compensation | Stockholders’ Equity and Stock-Based Compensation 2014 Equity Incentive Plan (the “2014 EIP”) On January 1, 2022, the number of shares of common stock reserved for issuance under the 2014 EIP increased by 2,863,362 shares. For the nine months ended September 30, 2022, 505,028 stock options, 42,413 restricted stock awards, and 2,912,530 restricted stock units, including 1,518,389 performance stock units, were granted under the 2014 EIP. As of September 30, 2022, 2,850,464 shares were available for issuance under the 2014 EIP. 2014 Inducement Plan (the “2014 IN”) For the nine months ended September 30, 2022, no stock options or awards were granted under the 2014 IN. As of September 30, 2022, 739,103 shares were available for issuance under the 2014 IN. HintMD Plan For the nine months ended September 30, 2022, no stock options or awards were granted under the Hint, Inc. 2017 Equity Incentive Plan (the “HintMD Plan”). As of September 30, 2022, 74,920 shares were available for issuance under the HintMD Plan. 2014 Employee Stock Purchase Plan (the “2014 ESPP”) On January 1, 2022, the number of shares of common stock reserved for issuance under the 2014 ESPP increased by 300,000 shares. As of September 30, 2022, 1,833,972 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, which includes the vested restricted stock awards. 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, unvested restricted stock awards/units and performance stock awards/units, and shares of common stock expected to be purchased under 2014 ESPP 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: September 30, 2022 2021 Convertible senior notes 8,878,938 8,878,938 Outstanding stock options 4,957,025 4,898,630 Unvested restricted stock awards and performance stock awards 2,339,999 3,951,037 Unvested restricted stock units and performance stock units 2,690,816 — Shares of common stock expected to be purchased on December 31st under the 2014 ESPP 188,715 89,919 At-The-Market Offering In November 2020, we entered into a sales agreement with Cowen and Company, LLC (“Cowen”) as sales agent (the “2020 ATM Agreement”). 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. The 2020 ATM Agreement was terminated on May 10, 2022. 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. On May 10, 2022, we entered into a new sales agreement (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. As of both September 30, 2022 and the filing date of this Report, no shares of common stock had been sold under the 2022 ATM Agreement. Follow-On Public Offering In September 2022, we completed a follow-on public offering, pursuant to which we issued 9.2 million shares of common stock at a public offering price of $25.00 per share, which included the exercise of the underwriters’ over-allotment option to purchase 1.2 million additional shares of common stock, for net proceeds of $215.9 million, after underwriting discounts, commission and other offering expenses. Stock-based compensation expense was allocated as follows: (in thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Selling, general and administrative $ 13,245 $ 6,624 $ 27,937 $ 21,193 Research and development 4,742 3,914 13,676 11,320 Total stock-based compensation expense $ 17,987 $ 10,538 $ 41,613 $ 32,513 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
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. September 30, 2022 (in thousands) Fair Value Level 1 Level 2 Level 3 Assets U.S. treasury securities $ 134,586 $ 134,586 $ — $ — Money market funds 43,883 43,883 — — U.S. government agency obligations 29,806 29,806 — — Commercial paper 92,616 — 92,616 — Corporate bonds 60,356 — 60,356 — Yankee debt securities 3,015 — 3,015 — Total assets measured at fair value $ 364,262 $ 208,275 $ 155,987 $ — December 31, 2021 (in thousands) Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 90,355 $ 90,355 $ — $ — Commercial paper 87,964 — 87,964 — Corporate bonds 26,484 — 26,484 — Total assets measured at fair value $ 204,803 $ 90,355 $ 114,448 $ — Liabilities Derivative liability $ 3,020 $ — $ — $ 3,020 Total liabilities measured at fair value $ 3,020 $ — $ — $ 3,020 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 following table summarizes the change in the fair value of our Level 3 financial instrument: (in thousands) Derivative Liability Fair value as of December 31, 2021 $ 3,020 Change in fair value 980 Derecognition of derivative liability (4,000) Fair value as of September 30, 2022 $ — Our Level 3 financial instrument was a derivative liability related to a settlement agreement from 2012, pursuant to which we were obligated to pay $4.0 million upon achieving regulatory approval for DAXXIFY™ or DaxibotulinumtoxinA Topical. We determined that such payment was a derivative instrument that requires fair value accounting as a liability and periodic fair value remeasurement until derecognized. The fair value of the derivative liability was determined by estimating the timing and probability of the related regulatory approval and multiplying the payment amount by this probability percentage and a discount factor based primarily on the estimated timing of the payment and a credit risk adjustment. Generally, increases or decreases in these unobservable inputs would result in a directionally similar impact to the fair value measurement of this derivative instrument. The significant unobservable inputs used in the fair value measurement of the product approval payment derivative are the expected timing and probability of the payments at the valuation date and the credit risk adjustment. In September 2022, the derivative liability was derecognized as a result of the FDA approval of DAXXIFY™. The liability is included within accruals and other current liabilities in the condensed consolidated balance sheets as of September 30, 2022. 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 September 30, 2022, and December 31, 2021 the fair value of the 2027 Notes was $300.5 million and $257.1 million, respectively. As of September 30, 2022 the fair value of the Notes payable was approximately the same as its unamortized carrying value. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Teoxane Agreement In January 2020, we entered into an exclusive distribution agreement (the “Teoxane Agreement”) with Teoxane SA (“Teoxane”), as amended in September and November 2020, 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® 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 (the “RHA® Collection”) and RHA® Redensity, which had been approved for the treatment of moderate to severe dynamic perioral rhytids (lip lines) (collectively, the “RHA® Collection of dermal fillers”), and (ii) future hyaluronic acid filler advancements and products by Teoxane (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 and are required to meet certain minimum expenditure requirements in connection with commercialization efforts unless prevented by certain conditions such as manufacturing delays. Either party may terminate the Teoxane Agreement in the event of the insolvency of, or a material breach by, the other party, including certain specified breaches that include the right for Teoxane to terminate the Teoxane Agreement for our failure to meet the minimum purchase requirements or commercialization expenditure during specified periods, or for our breach of the exclusivity obligations under the Teoxane Agreement. Other Contingencies As of September 30, 2022, we are obligated to pay Botulinum Toxin Research Associates, Inc. (“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 nine months ended September 30, 2022 and 2021, no amounts associated with the indemnification agreements have been recorded. Litigation In October 2021, Allergan, Inc. and Allergan Pharmaceuticals Ireland (collectively, “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 our 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. We dispute Allergan’s claims and intend to defend the matter vigorously. 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 August 19, 2022, the court denied our motion to dismiss. On September 2, 2022, we filed an answer and counterclaim to Allergan’s amended complaint. A jury trial is scheduled to begin on December 2, 2024. 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 the Exchange Act by making false or 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 a lead plaintiff and lead counsel on September 7, 2022. The lead plaintiff filed an amended complaint on November 7, 2022. We dispute these claims and intend to defend the matter 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. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
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 Chief Operating Decision Maker (“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 include operating expense related to general and administrative expenses, depreciation and amortization, stock-based compensation, in-process research and development 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 September 30, 2022 and 2021, intersegment revenue was $0.4 million and $0.5 million, respectively. For the nine months ended September 30, 2022 and 2021, intersegment revenue was $0.9 million and $0.8 million, respectively. Reconciliation of Segment Revenue to Consolidated Revenue Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Revenue: Product Segment $ 27,051 $ 19,425 $ 78,598 $ 51,016 Service Segment 1,964 320 4,046 832 Total revenue $ 29,015 $ 19,745 $ 82,644 $ 51,848 Reconciliation of Segment Loss from Operations to Condensed Consolidated Loss from Operations Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Loss from operations: Product Segment $ (32,100) $ (36,298) $ (82,020) $ (108,982) Service Segment (4,423) (4,155) (13,956) (12,178) Corporate and other expenses (40,961) (32,270) (101,571) (91,912) Total loss from operations $ (77,484) $ (72,723) $ (197,547) $ (213,072) We do not evaluate performance or allocate resources based on segment asset data, and therefore such information is not presented. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 condensed consolidated balance sheet for the year ended December 31, 2021 was derived from audited consolidated financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles (“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, 2021, or any other future period. Our condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (the “SEC”), on February 28, 2022. 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. |
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. The full extent of the impact of the COVID-19 pandemic on our future operational and financial performance will depend on future developments that are highly uncertain, including variant strains of the virus and the degree of their vaccine resistance and as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects. The ongoing COVID-19 pandemic has and may continue to negatively affect global economic activity, the regulatory approval process for our product candidates, our supply chain, research and development activities, end user demand for our products and services and commercialization activities. For example, the timing of the FDA’s inspection of our manufacturing facility as a part of the regulatory approval process for DAXXIFY™ was delayed due to the FDA’s travel restrictions associated with the COVID-19 pandemic. We cannot be certain of the continued impact of the COVID-19 pandemic on the timing of the regulatory approval process for DAXXIFY™ in indications other than glabellar lines or on any supplemental biologics license applications (each, a “BLA”) or post-approval supplements we may file. 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. |
Inventory | Inventory Inventories consist of raw materials, work in process, and finished goods held for sale to customers. Cost is determined using the first-in-first-out (FIFO) method. Inventory costs include raw materials, labor, quality control, and overhead associated with the cost of production. Inventory valuation reserves are established based on a number of factors including, but not limited to, inventory not conforming to product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, may require judgment. No inventory valuation reserves have been recorded for any periods presented. Products manufactured at a third-party contract manufacturer site prior to that site’s regulatory approval may be capitalized as inventory when the future economic benefit is deemed highly probable. A number of factors are considered in determining probability, including the historical experience of achieving regulatory approvals for the manufacturing process, the progress along the approval process, the shelf life of the product, and any other impediments identified. If the criteria for capitalizing inventory are not met, the pre-approval manufacturing costs of products are recognized as research and development expense in the period incurred. No inventories from any third-party contract manufacturer have been recognized for any periods presented. |
Leases | Leases We account for a contract as a lease when it has an identified asset that is physically distinct and we have the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. We determine if an arrangement is a lease or contains a lease at inception. For arrangements that meet the definition of a lease, we determine the initial classification and measurement of our right-of-use asset and lease liability at the lease commencement date and thereafter if modified. We do not recognize right-of-use assets or lease liabilities for those leases that qualify as a short-term lease. The lease term includes any renewal options that we are reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, we use our estimated secured incremental borrowing rate for that lease term. For our real estate operating leases, rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the condensed consolidated statements of operations and comprehensive loss. In addition to rent, the real estate operating leases may require us to pay additional amounts for variable lease costs which includes taxes, insurance, maintenance, and other expenses, and the variable lease costs are generally referred to as non-lease components. For real estate operating leases, we account for lease and non-lease components separately. For a finance lease for a manufacturing fill-and-finish line, interest expense from fixed payments on finance lease is recognized using the effective interest method. Finance lease right-of-use asset amortization is recorded within research and development expense on the condensed consolidated statements of operations and comprehensive loss, and finance lease liability interest expense is recorded in the interest expense on the condensed consolidated statements of operations and comprehensive loss. For our manufacturing fill-and-finish line asset group, we have elected to apply the practical expedient and account for the lease and non-lease components as a single lease component. Variable lease costs related to finance leases are expensed as research and development expense as incurred. |
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. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | The following tables present our revenue disaggregated by the timing of transfer of goods or services: Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 (in thousands) Product Revenue Collaboration Revenue Service Revenue Total Product Revenue Collaboration Revenue Service Revenue Total Timing of revenue recognition: Transferred at a point in time $ 26,081 $ — $ 121 $ 26,202 $ 72,401 $ — $ 360 $ 72,761 Transferred over time — 970 1,843 2,813 — 6,197 3,686 9,883 Total $ 26,081 $ 970 $ 1,964 $ 29,015 $ 72,401 $ 6,197 $ 4,046 $ 82,644 Three Months Ended September 30, 2021 Nine Months Ended September, 2021 (in thousands) Product Revenue Collaboration Revenue Service Revenue Total Product Revenue Collaboration Revenue Service Revenue Total Timing of revenue recognition: Transferred at a point in time $ 18,296 $ — $ 166 $ 18,462 $ 46,982 $ — $ 379 $ 47,361 Transferred over time — 1,129 154 1,283 — 4,034 453 4,487 Total $ 18,296 $ 1,129 $ 320 $ 19,745 $ 46,982 $ 4,034 $ 832 $ 51,848 |
Contract with Customer, Contract Asset, Contract Liability, and Receivable | Receivables and contract liabilities from contracts with our product customers are as follows: September 30, December 31, (in thousands) 2022 2021 Receivables: Accounts receivable, net $ 5,341 $ 3,297 Total accounts receivable, net $ 5,341 $ 3,297 Contract liabilities: Deferred revenue, current $ 2,491 $ 1,331 Total contract liabilities $ 2,491 $ 1,331 September 30, December 31, (in thousands) 2022 2021 Receivables: Accounts receivable, net — Fosun $ 6,300 $ — Total accounts receivable, net $ 6,300 $ — Contract liabilities: Deferred revenue, current — Viatris $ 9,930 $ 7,927 Total contract liabilities, current $ 9,930 $ 7,927 Deferred revenue, non-current — Viatris $ 37,259 $ 43,157 Deferred revenue, non-current — Fosun 37,995 30,995 Total contract liabilities, non-current $ 75,254 $ 74,152 Changes in our contract liabilities from contracts with our collaboration revenue customers for the nine months ended September 30, 2022 are as follows: (in thousands) Balance on January 1, 2022 $ 82,079 Revenue recognized 6,197 Billings and adjustments, net (3,092) Balance on September 30, 2022 $ 85,184 Receivables and contract liabilities from contracts with our service customers are as follows: September 30, December 31, (in thousands) 2022 2021 Accounts receivable, net $ 91 $ 51 Total accounts receivable, net $ 91 $ 51 Contract liabilities: Deferred revenue, current $ 60 $ 104 Total contract liabilities, current $ 60 $ 104 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Securities | The following table is a summary of our cash equivalents and short-term investments: September 30, 2022 December 31, 2021 in thousands Cost Gains Losses Fair Value Cost Losses Fair Value U.S. treasury securities $ 134,772 $ 1 $ (187) $ 134,586 $ — $ — $ — Commercial paper 92,616 — — 92,616 87,964 — 87,964 Corporate bonds 60,621 — (265) 60,356 26,502 (18) 26,484 Money market funds 43,883 — — 43,883 90,355 — 90,355 U.S. government agency obligations 29,806 — — 29,806 — — — Yankee debt securities 3,024 — (9) 3,015 — — — Total cash equivalents and available-for-sale securities $ 364,722 $ 1 $ (461) $ 364,262 $ 204,821 $ (18) $ 204,803 Classified as: Cash equivalents $ 90,126 $ 90,355 Short-term investments 274,136 114,448 Total cash equivalents and available-for-sale securities $ 364,262 $ 204,803 |
Intangible Assets, net (Tables)
Intangible Assets, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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: September 30, 2022 December 31, 2021 (in thousands, except for in years) Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Distribution rights 1.7 $ 32,334 $ (18,861) $ 13,473 2.4 $ 32,334 $ (12,799) $ 19,535 Developed technology 4.1 35,800 (11,128) 24,672 4.9 35,800 (6,653) 29,147 Customer relationships 1.8 10,300 (5,579) 4,721 2.6 10,300 (3,648) 6,652 Total intangible assets $ 78,434 $ (35,568) $ 42,866 $ 78,434 $ (23,100) $ 55,334 |
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: September 30, 2022 December 31, 2021 (in thousands, except for in years) Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Weighted-Average Remaining Useful Lives Gross Carrying Amount Accumulated Amortization Net Carrying Amount Distribution rights 1.7 $ 32,334 $ (18,861) $ 13,473 2.4 $ 32,334 $ (12,799) $ 19,535 Developed technology 4.1 35,800 (11,128) 24,672 4.9 35,800 (6,653) 29,147 Customer relationships 1.8 10,300 (5,579) 4,721 2.6 10,300 (3,648) 6,652 Total intangible assets $ 78,434 $ (35,568) $ 42,866 $ 78,434 $ (23,100) $ 55,334 |
Finite-lived Intangible Assets Amortization Expense | Aggregate amortization expense for the intangible assets presented in the condensed consolidated statements of operations and comprehensive loss are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Amortization (1) $ 3,513 $ 3,512 $ 10,538 $ 9,862 Selling, general and administrative 644 653 1,931 1,990 Total amortization expense $ 4,157 $ 4,165 $ 12,469 $ 11,852 (1) The amortization expense related to Distribution rights and Developed technology was recorded to amortization in the condensed consolidated statement of operations and comprehensive loss. |
Schedule of Finite-lived Intangible Assets, Future Amortization Expense | Based on the amount of intangible assets as of September 30, 2022, the expected amortization expense for each of the next five fiscal years was as follows: Year Ending December 31, (in thousands) 2022 remaining three months $ 4,157 2023 16,625 2024 10,837 2025 5,967 2026 4,606 2027 674 Total $ 42,866 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories consist of the following: September 30, December 31, (in thousands) 2022 2021 Raw materials $ 57 $ — Work in process 2,356 — Finished goods 14,765 10,154 Total inventories $ 17,178 $ 10,154 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accruals and other current liabilities consist of the following: September 30, December 31, (in thousands) 2022 2021 Compensation $ 23,333 $ 22,761 Selling, general and administrative 9,539 5,688 Inventories 5,653 456 Research and development 5,295 5,152 Clinical trials 1,842 2,172 Other current liabilities 1,716 1,442 Interest expense 629 1,887 Total accruals and other current liabilities $ 48,007 $ 39,558 |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following: September 30, December 31, (in thousands) 2022 2021 Manufacturing and other equipment $ 21,774 $ 20,277 Platform and computer software 13,736 11,671 Leasehold improvements 7,533 7,481 Computer equipment 3,506 3,558 Furniture and fixtures 1,677 1,893 Other construction in progress 1,503 3,110 Total property and equipment 49,729 47,990 Less: Accumulated depreciation and amortization (27,052) (23,329) Total property and equipment, net $ 22,677 $ 24,661 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Lease Costs | The operating and finance lease costs are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Finance lease: Amortization of finance lease right-of-use asset $ 3,344 $ — $ 4,502 $ — Variable lease cost - finance lease (1) 1,134 — 1,375 — Interest on finance lease liability 348 — 2,607 — Total finance lease costs 4,826 — 8,484 — Operating leases: Operating lease cost 2,223 2,224 6,669 5,802 Variable lease cost - operating leases (2) 423 385 1,288 1,016 Total operating lease costs 2,646 2,609 7,957 6,818 Total lease cost $ 7,472 $ 2,609 $ 16,441 $ 6,818 (1) Variable lease cost includes validation, qualification, materials, and other non-commercial related services which are not included in the lease liabilities and are expensed as incurred. (2) Variable lease cost includes management fees, common area maintenance, property taxes, and insurance, which are not included in the lease liabilities and are expensed as incurred. |
Finance Lease, Liability Maturities | As of September 30, 2022, maturities of our lease liabilities are as follows: (in thousands) Finance Lease Operating Leases Total Year Ending December 31, 2022 remaining three months $ 8,523 $ 1,218 $ 9,741 2023 990 8,468 9,458 2024 — 8,723 8,723 2025 — 8,981 8,981 2026 — 9,242 9,242 2027 and thereafter — 17,146 17,146 Total lease payments 9,513 53,778 63,291 Less imputed interest (117) (14,156) (14,273) Present value of lease payments $ 9,396 $ 39,622 $ 49,018 Our lease contracts do not provide a readily determinable implicit rates, as such, we used the estimated incremental borrowing based on the information available at the adoption or commencement dates. As of September 30, 2022, remaining lease terms and discount rates are as follows: Finance Leases Operating Leases Weighted-average remaining lease term (years) 2.3 7.8 Weighted-average discount rate 8.5 % 9.8 % |
Operating Lease, Liability Maturities | As of September 30, 2022, maturities of our lease liabilities are as follows: (in thousands) Finance Lease Operating Leases Total Year Ending December 31, 2022 remaining three months $ 8,523 $ 1,218 $ 9,741 2023 990 8,468 9,458 2024 — 8,723 8,723 2025 — 8,981 8,981 2026 — 9,242 9,242 2027 and thereafter — 17,146 17,146 Total lease payments 9,513 53,778 63,291 Less imputed interest (117) (14,156) (14,273) Present value of lease payments $ 9,396 $ 39,622 $ 49,018 Our lease contracts do not provide a readily determinable implicit rates, as such, we used the estimated incremental borrowing based on the information available at the adoption or commencement dates. As of September 30, 2022, remaining lease terms and discount rates are as follows: Finance Leases Operating Leases Weighted-average remaining lease term (years) 2.3 7.8 Weighted-average discount rate 8.5 % 9.8 % |
Supplemental Cash Flow Information | Supplemental cash flow information related to the leases was as follows: Nine Months Ended September 30, (in thousands) 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 6,259 $ 7,956 Operating cash flows from finance leases $ 2,541 $ — Financing cash flows from finance leases $ 5,000 $ — Right-of-use assets obtained in exchange for lease liabilities Finance lease $ 14,523 $ — Operating leases $ — $ 18,855 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The following table provides information regarding our debt: September 30, December 31, (in thousands) 2022 2021 Convertible senior notes (the “2027 Notes”) $ 287,500 $ 287,500 Less: Unamortized debt issuance costs (5,909) (6,865) Carrying amount of the 2027 Notes 281,591 280,635 Notes payable 100,000 — Less: Unamortized debt discount (1,434) — Less: Unamortized debt issuance costs (1,268) — Carrying amount of notes payable 97,298 — Debt, non-current $ 378,889 $ 280,635 Interest expense relating to our debt in the condensed consolidated statements of operations and comprehensive loss are summarized as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Contractual interest expense $ 3,454 $ 1,258 $ 8,425 $ 3,773 Amortization of debt issuance costs 441 313 1,190 935 Amortization of debt discount 98 — 183 — Total interest expense $ 3,993 $ 1,571 $ 9,798 $ 4,708 |
Stockholders_ Equity and Stoc_2
Stockholders’ Equity and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Summary 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: September 30, 2022 2021 Convertible senior notes 8,878,938 8,878,938 Outstanding stock options 4,957,025 4,898,630 Unvested restricted stock awards and performance stock awards 2,339,999 3,951,037 Unvested restricted stock units and performance stock units 2,690,816 — Shares of common stock expected to be purchased on December 31st under the 2014 ESPP 188,715 89,919 |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense was allocated as follows: (in thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Selling, general and administrative $ 13,245 $ 6,624 $ 27,937 $ 21,193 Research and development 4,742 3,914 13,676 11,320 Total stock-based compensation expense $ 17,987 $ 10,538 $ 41,613 $ 32,513 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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. September 30, 2022 (in thousands) Fair Value Level 1 Level 2 Level 3 Assets U.S. treasury securities $ 134,586 $ 134,586 $ — $ — Money market funds 43,883 43,883 — — U.S. government agency obligations 29,806 29,806 — — Commercial paper 92,616 — 92,616 — Corporate bonds 60,356 — 60,356 — Yankee debt securities 3,015 — 3,015 — Total assets measured at fair value $ 364,262 $ 208,275 $ 155,987 $ — December 31, 2021 (in thousands) Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 90,355 $ 90,355 $ — $ — Commercial paper 87,964 — 87,964 — Corporate bonds 26,484 — 26,484 — Total assets measured at fair value $ 204,803 $ 90,355 $ 114,448 $ — Liabilities Derivative liability $ 3,020 $ — $ — $ 3,020 Total liabilities measured at fair value $ 3,020 $ — $ — $ 3,020 |
Summary of Changes in Fair Value of Financial Instruments | The following table summarizes the change in the fair value of our Level 3 financial instrument: (in thousands) Derivative Liability Fair value as of December 31, 2021 $ 3,020 Change in fair value 980 Derecognition of derivative liability (4,000) Fair value as of September 30, 2022 $ — |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
Reconciliation of Segment Revenue to Consolidated Revenue | Reconciliation of Segment Revenue to Consolidated Revenue Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Revenue: Product Segment $ 27,051 $ 19,425 $ 78,598 $ 51,016 Service Segment 1,964 320 4,046 832 Total revenue $ 29,015 $ 19,745 $ 82,644 $ 51,848 |
Reconciliation of Segment Loss From Operations to Consolidated Loss From Operations | Reconciliation of Segment Loss from Operations to Condensed Consolidated Loss from Operations Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Loss from operations: Product Segment $ (32,100) $ (36,298) $ (82,020) $ (108,982) Service Segment (4,423) (4,155) (13,956) (12,178) Corporate and other expenses (40,961) (32,270) (101,571) (91,912) Total loss from operations $ (77,484) $ (72,723) $ (197,547) $ (213,072) |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||||
Net loss | $ 84,693,000 | $ 74,376,000 | $ 210,470,000 | $ 218,212,000 | ||
Working capital surplus | 340,900,000 | 340,900,000 | ||||
Accumulated deficit | 1,608,422,000 | 1,608,422,000 | $ 1,397,952,000 | |||
Proceeds from notes issued | $ 100,000,000 | |||||
Cash, cash equivalents and investments | 378,600,000 | 378,600,000 | ||||
Note Purchase Agreement | Second Tranche | Notes Payable | ||||||
Debt Instrument [Line Items] | ||||||
Principal amount | $ 100,000,000 | $ 100,000,000 | $ 100,000,000 |
Revenue - Revenues Disaggregate
Revenue - Revenues Disaggregated by Timing of Transfer of Goods or Services (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | $ 29,015 | $ 19,745 | $ 82,644 | $ 51,848 |
Transferred at a point in time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 26,202 | 18,462 | 72,761 | 47,361 |
Transferred over time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 2,813 | 1,283 | 9,883 | 4,487 |
Product revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 26,081 | 18,296 | 72,401 | 46,982 |
Product revenue | Transferred at a point in time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 26,081 | 18,296 | 72,401 | 46,982 |
Product revenue | Transferred over time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
Collaboration revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 970 | 1,129 | 6,197 | 4,034 |
Collaboration revenue | Transferred at a point in time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
Collaboration revenue | Transferred over time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 970 | 1,129 | 6,197 | 4,034 |
Service revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 1,964 | 320 | 4,046 | 832 |
Service revenue | Transferred at a point in time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | 121 | 166 | 360 | 379 |
Service revenue | Transferred over time | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenue | $ 1,843 | $ 154 | $ 3,686 | $ 453 |
Revenue - Receivables and Contr
Revenue - Receivables and Contract Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Contract liabilities: | ||
Total contract liabilities, current | $ 12,481 | $ 9,362 |
Non-refundable upfront payment | 85,184 | 82,079 |
Product revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total accounts receivable, net | 5,341 | 3,297 |
Contract liabilities: | ||
Total contract liabilities, current | 2,491 | 1,331 |
Non-refundable upfront payment | $ 2,491 | $ 1,331 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Non-refundable upfront payment | $ 85,184,000 | $ 85,184,000 | $ 82,079,000 | ||
Remaining performance obligation | 38,000,000 | 38,000,000 | |||
Contract with customer, liability, revenue recognized | 6,197,000 | ||||
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 | 31,000,000 | 31,000,000 | |||
Contract with customer, liability, revenue recognized | 7,000,000 | ||||
Development Services | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenues | 1,000,000 | $ 1,100,000 | 6,200,000 | $ 4,000,000 | |
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 | 92,600,000 | 92,600,000 | |||
Fosun | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contract with customer, liability, revenue recognized | $ 0 | $ 0 | $ 0 | $ 0 |
Revenue - Contract Liabilities
Revenue - Contract Liabilities from Contracts (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Contract liabilities: | ||
Total contract liabilities, current | $ 12,481 | $ 9,362 |
Total contract liabilities, non-current | 75,254 | 74,152 |
Viatris | ||
Contract liabilities: | ||
Total contract liabilities, current | 9,930 | 7,927 |
Total contract liabilities, non-current | 37,259 | 43,157 |
Fosun | ||
Receivables: | ||
Total accounts receivable, net | 6,300 | 0 |
Contract liabilities: | ||
Total contract liabilities, non-current | $ 37,995 | $ 30,995 |
Revenue - Changes in Our Contra
Revenue - Changes in Our Contract Liabilities from Contracts (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Contract With Customer Asset and Liability Roll Forward [Abstract] | |
Beginning balance | $ 82,079 |
Revenue recognized | 6,197 |
Billings and adjustments, net | (3,092) |
Ending balance | $ 85,184 |
Revenue - Contract Assets from
Revenue - Contract Assets from Contracts (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Contract liabilities: | ||
Total contract liabilities, current | $ 12,481 | $ 9,362 |
Non-refundable upfront payment | 85,184 | 82,079 |
Service revenue | ||
Receivables: | ||
Total accounts receivable, net | 91 | 51 |
Contract liabilities: | ||
Total contract liabilities, current | 60 | 104 |
Non-refundable upfront payment | $ 60 | $ 104 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 364,722 | $ 204,821 |
Gains | 1 | |
Losses | (461) | (18) |
Fair Value | 364,262 | 204,803 |
Cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 90,126 | 90,355 |
Short-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | 274,136 | 114,448 |
U.S. treasury securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 134,772 | 0 |
Gains | 1 | |
Losses | (187) | 0 |
Fair Value | 134,586 | 0 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 92,616 | 87,964 |
Gains | 0 | |
Losses | 0 | 0 |
Fair Value | 92,616 | 87,964 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 60,621 | 26,502 |
Gains | 0 | |
Losses | (265) | (18) |
Fair Value | 60,356 | 26,484 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 43,883 | 90,355 |
Gains | 0 | |
Losses | 0 | 0 |
Fair Value | 43,883 | 90,355 |
U.S. government agency obligations | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 29,806 | 0 |
Gains | 0 | |
Losses | 0 | 0 |
Fair Value | 29,806 | 0 |
Yankee debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 3,024 | 0 |
Gains | 0 | |
Losses | (9) | 0 |
Fair Value | $ 3,015 | $ 0 |
Intangible Assets, net - Intang
Intangible Assets, net - Intangible Assets and the Remaining Useful Lives (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 78,434 | $ 78,434 |
Accumulated Amortization | (35,568) | (23,100) |
Total | 42,866 | |
Net Carrying Amount | $ 42,866 | $ 55,334 |
Distribution rights | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Remaining Useful Lives (in years) | 1 year 8 months 12 days | 2 years 4 months 24 days |
Finite-lived intangible assets, gross | $ 32,334 | $ 32,334 |
Accumulated Amortization | (18,861) | (12,799) |
Total | $ 13,473 | $ 19,535 |
Developed technology | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Remaining Useful Lives (in years) | 4 years 1 month 6 days | 4 years 10 months 24 days |
Finite-lived intangible assets, gross | $ 35,800 | $ 35,800 |
Accumulated Amortization | (11,128) | (6,653) |
Total | $ 24,672 | $ 29,147 |
Customer relationships | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Remaining Useful Lives (in years) | 1 year 9 months 18 days | 2 years 7 months 6 days |
Finite-lived intangible assets, gross | $ 10,300 | $ 10,300 |
Accumulated Amortization | (5,579) | (3,648) |
Total | $ 4,721 | $ 6,652 |
Intangible Assets, net - Additi
Intangible Assets, net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 4,157 | $ 4,165 | $ 12,469 | $ 11,852 |
Amortization | ||||
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | 3,513 | 3,512 | 10,538 | 9,862 |
Selling, general and administrative | ||||
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 644 | $ 653 | $ 1,931 | $ 1,990 |
Intangible Assets, net - Expect
Intangible Assets, net - Expected Amortization Expense for the Unamortized Acquired Intangible Assets (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2022 remaining three months | $ 4,157 |
2023 | 16,625 |
2024 | 10,837 |
2025 | 5,967 |
2026 | 4,606 |
2027 | 674 |
Total | $ 42,866 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 57 | $ 0 |
Work in process | 2,356 | 0 |
Finished goods | 14,765 | 10,154 |
Total inventories | $ 17,178 | $ 10,154 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Compensation | $ 23,333 | $ 22,761 |
Selling, general and administrative | 9,539 | 5,688 |
Inventories | 5,653 | 456 |
Research and development | 5,295 | 5,152 |
Clinical trials | 1,842 | 2,172 |
Other current liabilities | 1,716 | 1,442 |
Interest expense | 629 | 1,887 |
Total accruals and other current liabilities | $ 48,007 | $ 39,558 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 49,729 | $ 47,990 |
Less: Accumulated depreciation and amortization | (27,052) | (23,329) |
Total property and equipment, net | 22,677 | 24,661 |
Manufacturing and other equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 21,774 | 20,277 |
Platform and computer software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 13,736 | 11,671 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,533 | 7,481 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,506 | 3,558 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,677 | 1,893 |
Other construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,503 | $ 3,110 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Apr. 30, 2021 option_to_extend_lease_term | Sep. 30, 2022 USD ($) option_to_extend_lease_term | May 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jul. 31, 2021 USD ($) ft² | Dec. 31, 2020 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Number of options to renew (or more) | option_to_extend_lease_term | 1 | |||||
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 | $ 30,000 | |||||
Purchase obligation eliminated, year two | 30,000 | |||||
Purchase obligation eliminated, year three | $ 30,000 | |||||
Term of written notice | 18 months | |||||
Collaborative agreement, number of extension periods | option_to_extend_lease_term | 1 | |||||
Other non-current assets | $ 27,026 | $ 8,701 | ||||
Other commitment, to be paid, year one | 2,000 | |||||
Other commitment, to be paid, year two | 7,700 | |||||
Other commitment, to be paid, year three | 14,400 | |||||
Other commitment, to be paid, year four | 18,300 | |||||
Other commitment, to be paid, year five | 25,300 | |||||
Other commitment, to be paid, after year five | 164,000 | |||||
Nashville Lease Expansion Premises | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Area of land | ft² | 30,591 | |||||
Lessee, operating lease, lease not yet commenced, amount | $ 16,000 | |||||
LSNE | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Collaborative agreement, contractual period | 3 years | |||||
Other non-current assets | $ 25,500 | |||||
Minimum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Extended term of lease | 7 years | |||||
Maximum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Extended term of lease | 14 years |
Leases - Lease Costs (Details)
Leases - Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Finance lease: | ||||
Amortization of finance lease right-of-use asset | $ 3,344 | $ 0 | $ 4,502 | $ 0 |
Variable lease cost - finance lease | 1,134 | 0 | 1,375 | 0 |
Interest on finance lease liability | 348 | 0 | 2,607 | 0 |
Total finance lease costs | 4,826 | 0 | 8,484 | 0 |
Operating leases: | ||||
Operating lease cost | 2,223 | 2,224 | 6,669 | 5,802 |
Variable lease cost - operating leases | 423 | 385 | 1,288 | 1,016 |
Total operating lease costs | 2,646 | 2,609 | 7,957 | 6,818 |
Total lease cost | $ 7,472 | $ 2,609 | $ 16,441 | $ 6,818 |
Leases - Maturities of Lease Li
Leases - Maturities of Lease Liabilities (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Finance Lease | |
2022 remaining three months | $ 8,523 |
2023 | 990 |
2024 | 0 |
2025 | 0 |
2026 | 0 |
2027 and thereafter | 0 |
Total lease payments | 9,513 |
Less imputed interest | (117) |
Present value of lease payments | 9,396 |
Operating Leases | |
2022 remaining three months | 1,218 |
2023 | 8,468 |
2024 | 8,723 |
2025 | 8,981 |
2026 | 9,242 |
2027 and thereafter | 17,146 |
Total lease payments | 53,778 |
Less imputed interest | (14,156) |
Present value of lease payments | 39,622 |
Total | |
2022 remaining three months | 9,741 |
2023 | 9,458 |
2024 | 8,723 |
2025 | 8,981 |
2026 | 9,242 |
2027 and thereafter | 17,146 |
Total lease payments | 63,291 |
Less imputed interest | (14,273) |
Present value of lease payments | $ 49,018 |
Leases - Remaining Lease terms
Leases - Remaining Lease terms and Discount Rates (Details) | Sep. 30, 2022 |
Finance Leases | |
Weighted-average remaining lease term (year) | 2 years 3 months 18 days |
Weighted-average discount rate (percent) | 8.50% |
Operating Leases | |
Weighted-average remaining lease term (year) | 7 years 9 months 18 days |
Weighted average discount rate (percent) | 9.80% |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flow, Lessee [Abstract] | ||
Operating cash flows from operating leases | $ 6,259 | $ 7,956 |
Operating cash flows from finance leases | 2,541 | 0 |
Financing cash flows from finance leases | 5,000 | 0 |
Right-of-use assets obtained in exchange for lease liabilities | ||
Finance lease | 14,523 | 0 |
Operating leases | $ 0 | $ 18,855 |
Debt - Carrying Amount of Liabi
Debt - Carrying Amount of Liability Component (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Carrying amount of notes payable | $ 378,889 | $ 280,635 |
Debt, non-current | 378,889 | 280,635 |
Convertible Debt | ||
Debt Instrument [Line Items] | ||
Notes payable | 100,000 | 0 |
Less: Unamortized debt issuance costs | (1,268) | 0 |
Less: Unamortized debt discount | (1,434) | 0 |
Carrying amount of notes payable | 97,298 | 0 |
Debt, non-current | 97,298 | 0 |
2027 Notes | Convertible Debt | ||
Debt Instrument [Line Items] | ||
Notes payable | 287,500 | 287,500 |
Less: Unamortized debt issuance costs | (5,909) | (6,865) |
Carrying amount of notes payable | 281,591 | 280,635 |
Debt, non-current | $ 281,591 | $ 280,635 |
Debt - Interest Expense (Detail
Debt - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Disclosure [Abstract] | ||||
Contractual interest expense | $ 3,454 | $ 1,258 | $ 8,425 | $ 3,773 |
Amortization of debt issuance costs | 441 | 313 | 1,190 | 935 |
Amortization of debt discount | 98 | 0 | 183 | 0 |
Total interest expense | $ 3,993 | $ 1,571 | $ 9,798 | $ 4,708 |
Debt - Notes Payable (Details)
Debt - Notes Payable (Details) - USD ($) | 1 Months Ended | ||
Mar. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||
Aggregate principal amount | $ 378,889,000 | $ 280,635,000 | |
Note Purchase Agreement | Notes Payable | |||
Debt Instrument [Line Items] | |||
Stated percentage | 7% | ||
Prepaid fee, percentage | 2% | ||
Minimum cash balance maintained | $ 30,000,000 | ||
Minimum net sales requirement | $ 70,000,000 | ||
Debt instrument, debt default, additional interest rate to fixed | 2% | ||
Note Purchase Agreement | Notes Payable | London Interbank Offered Rate (LIBOR) Swap Rate | |||
Debt Instrument [Line Items] | |||
Variable rate | 1.50% | ||
Note Purchase Agreement | Notes Payable | London Interbank Offered Rate (LIBOR) | |||
Debt Instrument [Line Items] | |||
Variable rate | 2.50% | ||
Note Purchase Agreement | Notes Payable | Maximum | |||
Debt Instrument [Line Items] | |||
Debt instrument, trailing twelve months revenue | $ 50,000,000 | ||
Note Purchase Agreement | Notes Payable | First Tranche | |||
Debt Instrument [Line Items] | |||
Principal amount | 100,000,000 | ||
Note Purchase Agreement | Notes Payable | Second Tranche | |||
Debt Instrument [Line Items] | |||
Principal amount | 100,000,000 | $ 100,000,000 | |
Note Purchase Agreement | Notes Payable | Third Tranche | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 100,000,000 | ||
Stated percentage | 8.50% | ||
2027 Notes | Notes Payable | |||
Debt Instrument [Line Items] | |||
Aggregate principal amount | $ 90,000,000 |
Debt - Convertible Senior Notes
Debt - Convertible Senior Notes (Details) - 2027 Notes - Convertible Debt | 1 Months Ended | |
Feb. 14, 2020 | Feb. 29, 2020 USD ($) trading_day $ / shares | |
Debt Instrument [Line Items] | ||
Principal amount | $ | $ 287,500,000 | |
Stated percentage | 1.75% | |
Net proceeds | $ | $ 278,300,000 | |
Threshold trading days | 20 | |
Threshold consecutive trading days | 30 | |
Threshold percentage of stock price trigger | 130% | |
Conversion ratio | 0.0308804 | |
Conversion price (in dollars per share) | $ / shares | $ 32.38 | |
Redemption price, percentage | 100% | |
Debt Conversion Terms One | ||
Debt Instrument [Line Items] | ||
Threshold trading days | 20 | |
Threshold consecutive trading days | 30 | |
Threshold percentage of stock price trigger | 130% | |
Debt Conversion Terms Two | ||
Debt Instrument [Line Items] | ||
Threshold trading days | 5 | |
Threshold consecutive trading days | 10 | |
Threshold percentage of stock trading price | 98% |
Debt - Capped Call Transactions
Debt - Capped Call Transactions (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | Feb. 14, 2020 | Feb. 29, 2020 |
Debt Instrument [Line Items] | ||
Payment of capped call transactions | $ 28.9 | |
Price cap (in dollars per share) | $ 48.88 | |
Premium percentage over sale price | 100% | |
Number of shares subject to anti-dilution adjustments (in shares) | 8.9 | |
2027 Notes | Convertible Debt | ||
Debt Instrument [Line Items] | ||
Conversion price (in dollars per share) | $ 32.38 |
Stockholders_ Equity and Stoc_3
Stockholders’ Equity and Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 4 Months Ended | 9 Months Ended | |||||
May 10, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Nov. 30, 2020 | May 10, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Jan. 01, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Proceeds from issuance of common stock in connection with at-the-market offerings, net of commissions | $ 31,814,000 | $ 21,706,000 | ||||||
At The Market 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% | |||||||
Stock issued during period, shares, new issues (in shares) | 1,700,000 | |||||||
Proceeds from issuance of common stock in connection with at-the-market offerings, net of commissions | $ 31,600,000 | |||||||
At The Market Offering, 2020 Plan | Weighted Average | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 18.71 | |||||||
At The Market 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 | |||||||
Sale of stock, issuance costs, commission, percentage, maximum | 3% | |||||||
Stock issued during period, shares, new issues (in shares) | 0 | |||||||
Follow on Offering | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 9,200,000 | |||||||
Share price (in dollars per share) | $ 25 | $ 25 | ||||||
Over-Allotment Option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock issued during period, shares, new issues (in shares) | 1,200,000 | |||||||
Proceeds from issuance of common stock in connection with at-the-market offerings, net of commissions | $ 215,900,000 | |||||||
2014 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, capital shares reserved for future issuance (in shares) | 2,850,464 | 2,850,464 | 2,863,362 | |||||
2014 Inducement Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, capital shares reserved for future issuance (in shares) | 739,103 | 739,103 | ||||||
2017 Equity Incentive Plan, HintMD Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, capital shares reserved for future issuance (in shares) | 74,920 | 74,920 | ||||||
Shares underlying stock options granted (in shares) | 0 | |||||||
2014 Employee Stock Purchase Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, capital shares reserved for future issuance (in shares) | 300,000 | |||||||
Share-based Payment Arrangement | 2014 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares underlying stock options granted (in shares) | 505,028 | |||||||
Restricted Stock | 2014 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares underlying stock options granted (in shares) | 2,912,530 | |||||||
Shares granted under restricted stock awards (in shares) | 42,413 | |||||||
Performance-based Common Stock | 2014 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares granted under restricted stock awards (in shares) | 1,518,389 | |||||||
Employee Stock Option | 2014 Inducement Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares underlying stock options granted (in shares) | 0 | |||||||
Employee Stock | 2014 Employee Stock Purchase Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, capital shares reserved for future issuance (in shares) | 1,833,972 | 1,833,972 |
Stockholders_ Equity and Stoc_4
Stockholders’ Equity and Stock-Based Compensation - Common Stock Equivalents Excluded from the Calculation of Earnings per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
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) | 4,957,025 | 4,898,630 |
Outstanding stock options | 2014 Employee Stock Purchase Plan | ||
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) | 188,715 | 89,919 |
Unvested restricted stock awards and performance stock awards | ||
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) | 2,339,999 | 3,951,037 |
Unvested restricted stock units and performance stock units | ||
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) | 2,690,816 | 0 |
Stockholders_ Equity and Stoc_5
Stockholders’ Equity and Stock-Based Compensation - Stock Option Plan Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 17,987 | $ 10,538 | $ 41,613 | $ 32,513 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 13,245 | 6,624 | 27,937 | 21,193 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 4,742 | $ 3,914 | $ 13,676 | $ 11,320 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Financial Instruments (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | $ 364,262 | $ 204,803 |
Total liabilities measured at fair value | 3,020 | |
U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 134,586 | |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 43,883 | 90,355 |
U.S. government agency obligations | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 29,806 | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 92,616 | 87,964 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 60,356 | 26,484 |
Yankee debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 3,015 | |
Derivative liability | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total liabilities measured at fair value | 3,020 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 208,275 | 90,355 |
Total liabilities measured at fair value | 0 | |
Level 1 | U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 134,586 | |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 43,883 | 90,355 |
Level 1 | U.S. government agency obligations | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 29,806 | |
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 1 | Yankee debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 0 | |
Level 1 | Derivative liability | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total liabilities measured at fair value | 0 | |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 155,987 | 114,448 |
Total liabilities measured at fair value | 0 | |
Level 2 | U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 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 | |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 92,616 | 87,964 |
Level 2 | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 60,356 | 26,484 |
Level 2 | Yankee debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 3,015 | |
Level 2 | Derivative liability | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total liabilities measured at fair value | 0 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 0 | 0 |
Total liabilities measured at fair value | 3,020 | |
Level 3 | U.S. treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | 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 | |
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 |
Level 3 | Yankee debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total assets measured at fair value | $ 0 | |
Level 3 | Derivative liability | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total liabilities measured at fair value | $ 3,020 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Changes in Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Change in fair value | $ 980 | |
Convertible debt, fair value disclosures | 300,500 | $ 257,100 |
Derivative Liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value as of December 31, 2021 | 3,020 | |
Derecognition of derivative liability | (4,000) | |
Fair value as of September 30, 2022 | 0 | |
Fair value, product approval payment | $ 4,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 1 Months Ended | 9 Months Ended | |||
Oct. 31, 2021 co-defendant | Jan. 31, 2020 shares | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Loss Contingencies [Line Items] | |||||
Indemnification liability recorded during the period | $ 0 | $ 0 | |||
Number of co-defendants in patent infringement litigation | co-defendant | 1 | ||||
Estimated litigation liability | $ 0 | $ 0 | |||
Teoxane Agreement | |||||
Loss Contingencies [Line Items] | |||||
Issuance of common stock in connection with the teoxane agreement (in shares) | shares | 2,500,000 | ||||
Collaborative agreement, contractual period | 10 years | ||||
Collaborative agreement, extended contractual period | 2 years | ||||
Botulinum Toxin Research Associates, Inc. | |||||
Loss Contingencies [Line Items] | |||||
Accrued milestone obligations | $ 15,500,000 |
Segment Information - Reconcili
Segment Information - Reconciliation of Segment Revenue to Consolidated Revenue (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | |
Segment Reporting [Abstract] | ||||
Number of reportable segments | segment | 2 | 2 | ||
Segment Reporting Information [Line Items] | ||||
Total revenue | $ 29,015 | $ 19,745 | $ 82,644 | $ 51,848 |
Product Segment | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | 27,051 | 19,425 | 78,598 | 51,016 |
Service Segment | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | 1,964 | 320 | 4,046 | 832 |
Service Segment | Intersegment Eliminations | ||||
Segment Reporting Information [Line Items] | ||||
Total revenue | $ 400 | $ 500 | $ 900 | $ 800 |
Segment Information - Reconci_2
Segment Information - Reconciliation of Segment Loss from Operations to Consolidated Loss from Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Segment Reporting Information [Line Items] | ||||
Total loss from operations | $ (77,484) | $ (72,723) | $ (197,547) | $ (213,072) |
Corporate and other expenses | ||||
Segment Reporting Information [Line Items] | ||||
Total loss from operations | (40,961) | (32,270) | (101,571) | (91,912) |
Product Segment | Operating Segments | ||||
Segment Reporting Information [Line Items] | ||||
Total loss from operations | (32,100) | (36,298) | (82,020) | (108,982) |
Service Segment | Operating Segments | ||||
Segment Reporting Information [Line Items] | ||||
Total loss from operations | $ (4,423) | $ (4,155) | $ (13,956) | $ (12,178) |
Uncategorized Items - rvnc-2022
Label | Element | Value |
Accounting Standards Update [Extensible Enumeration] | us-gaap_AccountingStandardsUpdateExtensibleList | Accounting Standards Update 2020-06 [Member] |