Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 14, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36421 | ||
Entity Registrant Name | Aurinia Pharmaceuticals Inc. | ||
Entity Incorporation, State or Country Code | Z4 | ||
Entity Address, Address Line One | #140, 14315 - 118 Avenue | ||
Entity Tax Identification Number | 98-1231763 | ||
Entity Address, City or Town | Edmonton | ||
Entity Address, State or Province | AB | ||
Entity Address, Postal Zip Code | T5L 4S6 | ||
City Area Code | (250) | ||
Local Phone Number | 744-2487 | ||
Title of 12(b) Security | Common shares, no par value | ||
Trading Symbol | AUPH | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,380 | ||
Entity Common Stock, Shares Outstanding | 144,617,762 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement to be filed with the U.S. Securities and Exchange Commission pursuant to Regulation 14A within 120 days after registrant’s fiscal year end of December 31, 2023 are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001600620 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor [Abstract] | |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | Toronto, Canada |
Auditor Firm ID | 271 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash, cash equivalents and restricted cash | $ 48,875 | $ 94,172 |
Short-term investments | 301,614 | 295,218 |
Accounts receivable, net | 24,089 | 13,483 |
Inventories, net | 39,705 | 24,752 |
Prepaid expenses | 9,486 | 13,580 |
Other current assets | 1,031 | 1,334 |
Total current assets | 424,800 | 442,539 |
Non-current assets: | ||
Long-term investments | 201 | 0 |
Other non-current assets | 1,517 | 13,339 |
Property and equipment, net | 3,354 | 3,650 |
Acquired intellectual property and other intangible assets, net | 4,977 | 6,425 |
Finance right-of-use asset, net | 108,715 | 0 |
Operating right-of-use assets, net | 4,498 | 4,907 |
Total assets | 548,062 | 470,860 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 54,389 | 39,990 |
Deferred revenue | 4,813 | 3,148 |
Other current liabilities (of which $0.8 million in 2023 is due to a related party) | 2,388 | 2,033 |
Finance lease liability | 14,609 | 0 |
Operating lease liabilities | 989 | 936 |
Total current liabilities | 77,188 | 46,107 |
Non-current liabilities: | ||
Finance lease liability | 75,479 | 0 |
Operating lease liabilities | 6,530 | 7,152 |
Deferred compensation and other non-current liabilities (of which $7.6 million in 2023 is due to a related party) | 10,911 | 12,166 |
Total liabilities | 170,108 | 65,425 |
Commitments and Contingencies (Note 13) | ||
Total liabilities and shareholders' equity | 548,062 | 470,860 |
SHAREHOLDERS' EQUITY | ||
Common shares - no par value, unlimited shares authorized, 143,833 and 142,268 shares issued and outstanding at December 31, 2023 and 2022, respectively | 1,200,218 | 1,185,309 |
Additional paid-in capital | 120,788 | 85,489 |
Accumulated other comprehensive loss | (730) | (1,061) |
Accumulated deficit | (942,322) | (864,302) |
Total shareholders' equity | $ 377,954 | $ 405,435 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other current liabilities (of which $0.8 million in 2023 is due to a related party) | $ 2,388 | $ 2,033 |
Deferred compensation and other non-current liabilities (of which $7.6 million in 2023 is due to a related party) | $ 10,911 | $ 12,166 |
Common stock, par value (in usd per share) | $ 0 | $ 0 |
Common stock, issued (in shares) | 143,833,000 | 142,268,000 |
Common stock, outstanding (in shares) | 143,833,000 | 142,268,000 |
Related Party | ||
Other current liabilities (of which $0.8 million in 2023 is due to a related party) | $ 800 | |
Deferred compensation and other non-current liabilities (of which $7.6 million in 2023 is due to a related party) | $ 7,600 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | |||
Total revenue, net | $ 175,513 | $ 134,030 | $ 45,605 |
Operating expenses | |||
Cost of sales | 14,148 | 5,664 | 1,091 |
Selling, general and administrative | 195,036 | 196,371 | 173,536 |
Research and development | 49,641 | 44,988 | 51,139 |
Other expense (income), net | 8,379 | (1,523) | 574 |
Total cost of sales and operating expenses | 267,204 | 245,500 | 226,340 |
Loss from operations | (91,691) | (111,470) | (180,735) |
Interest expense | (2,775) | 0 | 0 |
Interest income | 16,997 | 5,118 | 529 |
Net loss before income taxes | (77,469) | (106,352) | (180,206) |
Income tax expense | 551 | 1,828 | 760 |
Net loss | (78,020) | (108,180) | (180,966) |
Other comprehensive loss: | |||
Unrealized gain (loss) on available-for-sale securities, net of tax of nil | 331 | (209) | (47) |
Comprehensive loss | $ (77,689) | $ (108,389) | $ (181,013) |
Basic loss per share (in usd per share) | $ (0.54) | $ (0.76) | $ (1.40) |
Diluted loss per share (in usd per share) | $ (0.54) | $ (0.76) | $ (1.40) |
Weighted-average common shares outstanding used in computation of basic loss per share (in shares) | 143,236 | 141,915 | 129,369 |
Weighted-average common shares outstanding used in computation diluted loss per share (in shares) | 143,236 | 141,915 | 129,369 |
Product revenue, net | |||
Revenue: | |||
Total revenue, net | $ 158,533 | $ 103,468 | $ 45,488 |
License, collaboration and royalty revenue | |||
Revenue: | |||
Total revenue, net | $ 16,980 | $ 30,562 | $ 117 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2020 | 126,725,000 | ||||
Balance at Dec. 31, 2020 | $ 407,750 | $ 944,328 | $ 39,383 | $ (805) | $ (575,156) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common shares upon public offerings, net of issuance costs (in shares) | 10,166,000 | ||||
Issuance of common shares upon public offerings, net of issuance costs | 196,740 | $ 196,740 | |||
Exercise of warrants (in shares) | 1,434,000 | ||||
Exercise of warrants | 365 | $ 2,102 | (1,737) | ||
Shares issued on exercise of stock options and vesting of performance awards and restricted stock units (in shares) | 3,238,000 | ||||
Shares issued on exercise of stock options and vesting of restricted stock units | 23,421 | $ 33,073 | (9,652) | ||
Issuance of common shares in conjunction with ESPP program (in shares) | 37,000 | ||||
Issuance of common shares in conjunction with ESPP program | 585 | $ 808 | (223) | ||
Share-based compensation | 31,243 | 31,243 | |||
Unrealized gain (loss) on available-for-sale securities, net of tax of nil | (47) | (47) | |||
Net loss | $ (180,966) | (180,966) | |||
Balance (in shares) at Dec. 31, 2021 | 141,600,000 | 141,600,000 | |||
Balance at Dec. 31, 2021 | $ 479,091 | $ 1,177,051 | 59,014 | (852) | (756,122) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards and restricted stock units (in shares) | 383,000 | ||||
Shares issued on exercise of stock options and vesting of restricted stock units | 521 | $ 5,064 | (4,543) | ||
Issuance of common shares in conjunction with ESPP program (in shares) | 285,000 | ||||
Issuance of common shares in conjunction with ESPP program | 1,912 | $ 3,194 | (1,282) | ||
Share-based compensation | 32,300 | 32,300 | |||
Unrealized gain (loss) on available-for-sale securities, net of tax of nil | (209) | (209) | |||
Net loss | $ (108,180) | (108,180) | |||
Balance (in shares) at Dec. 31, 2022 | 142,268,000 | 142,268,000 | |||
Balance at Dec. 31, 2022 | $ 405,435 | $ 1,185,309 | 85,489 | (1,061) | (864,302) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards and restricted stock units (in shares) | 563,000 | 1,146,000 | |||
Shares issued on exercise of stock options and vesting of restricted stock units | $ 3,047 | $ 11,256 | (8,209) | ||
Issuance of common shares in conjunction with ESPP program (in shares) | 419,000 | ||||
Issuance of common shares in conjunction with ESPP program | 1,850 | $ 3,653 | (1,803) | ||
Share-based compensation | 45,311 | 45,311 | |||
Unrealized gain (loss) on available-for-sale securities, net of tax of nil | 331 | 331 | |||
Net loss | $ (78,020) | (78,020) | |||
Balance (in shares) at Dec. 31, 2023 | 143,833,000 | 143,833,000 | |||
Balance at Dec. 31, 2023 | $ 377,954 | $ 1,200,218 | $ 120,788 | $ (730) | $ (942,322) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Cash flows from operating activities: | |||
Net loss | $ (78,020) | $ (108,180) | $ (180,966) |
Adjustments to reconcile consolidated net loss to net cash used in operating activities: | |||
Depreciation and amortization | 11,647 | 2,706 | 2,761 |
Net amortization of premiums and discounts on investments | (12,141) | (1,572) | 660 |
Upfront license and milestone expense | 0 | 0 | 10,000 |
Share-based compensation | 45,311 | 32,300 | 31,243 |
Write-down of inventory | 916 | 3,646 | 245 |
Foreign exchange on finance lease liability | 5,949 | 0 | 0 |
Other, net | (1,515) | (1,612) | (2) |
Net changes in operating assets and liabilities: | |||
Accounts receivable, net | (10,606) | 1,927 | (15,415) |
Inventories, net | (15,869) | (9,072) | (5,644) |
Prepaid expenses and other current assets | 4,399 | (2,404) | (5,335) |
Non-current operating assets | (16) | (363) | 353 |
Accounts payable, accrued and other liabilities | 13,394 | 699 | 4,076 |
Deferred revenue | 3,763 | 3,048 | 0 |
Operating lease liabilities | (673) | (652) | 332 |
Net cash used in operating activities | (33,461) | (79,529) | (157,692) |
Cash flows from investing activities: | |||
Proceeds from investments | 529,376 | 464,316 | 354,427 |
Purchase of investments | (523,500) | (523,993) | (438,958) |
Upfront lease payment | (11,864) | (663) | (11,838) |
Upfront license payment | 0 | 0 | (6,000) |
Purchase of long-lived assets and intangibles | (718) | (292) | (303) |
Additions to internal use-software implementation costs | 0 | 0 | (1,198) |
Net cash used in investing activities | (6,706) | (60,632) | (103,870) |
Cash flows from financing activities: | |||
Proceeds from issuance of common shares pursuant to Public Offering, net of issuance costs | 0 | 0 | 196,740 |
Proceeds from exercise of stock options, employee share purchase plan and warrants | 4,895 | 2,433 | 24,372 |
Financing cash flows from finance lease | (10,025) | 0 | 0 |
Net cash (used in) provided by financing activities | (5,130) | 2,433 | 221,112 |
Net decrease in cash and cash equivalents during the year | (45,297) | (137,728) | (40,450) |
Cash and cash equivalents, beginning of the year | 94,172 | 231,900 | 272,350 |
Cash, cash equivalents and restricted cash, end of the year | 48,875 | 94,172 | 231,900 |
Supplemental cash flow information: | |||
Cash paid for taxes | (496) | (1,979) | (257) |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets | |||
Cash, cash equivalents | 48,755 | 94,088 | 231,643 |
Restricted cash | 120 | 84 | 257 |
Total cash, cash equivalents and restricted cash | $ 48,875 | $ 94,172 | $ 231,900 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Financial Position [Abstract] | |||
Unrealized gain (loss) on available-for-sale securities, net of tax | $ 0 | $ 0 | $ 0 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Aurinia Pharmaceuticals Inc. (Aurinia or the Company) is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first U.S. Food and Drug Administration (FDA) approved oral therapy for the treatment of adult patients with active lupus nephritis (LN) and continues to conduct clinical and regulatory activities to support the LUPKYNIS development program. Aurinia contracted with Otsuka Pharmaceutical Co., Ltd. (Otsuka) as a collaboration partner for development and commercialization of LUPKYNIS in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine (collectively, the Otsuka Territories). On September 15, 2022, the European Commission (EC) granted marketing authorization of LUPKYNIS to Otsuka. The centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. Effective February 14, 2024, the Company's Board of Directors elected to conclude its strategic review process and that it was in the best interest of the Company and its shareholders to undergo a restructuring. In principal, the corporate restructuring will involve the Company reaffirming its commitment to LUPKYNIS growth, while maintaining a sharp focus on operating efficiencies and maximizing cash flows. As a result, the Company is ceasing future development efforts on AUR200 and its pre-clinical asset AUR300. As of April 1, 2023, Aurinia's head office and registered office is located at #140, 14315-118 Avenue, Edmonton, Alberta, Canada T5L 4S6. Aurinia also has a U.S. commercial office located at 77 Upper Rock Circle Suite 700, Rockville, Maryland, 20850 United States. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of presentation: The Company follows accounting standards established by the Financial Accounting Standards Board (FASB) to ensure consistent reporting of financial condition, results of operations, and cash flows. These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP). Principles of consolidation: These financial statements present the consolidated financial position of the Company and its wholly owned subsidiaries, Aurinia Pharma U.S., Inc. (Delaware incorporated) and Aurinia Pharma Limited (UK incorporated) as of December 31, 2023 and 2022, and the results of operations and cash flows for the three years ended December 31, 2023, 2022 and 2021. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates: The preparation of the accompanying financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from those estimates. Segment information: The Company operates in one operating segment engaged in the research, development and commercialization of therapeutic drugs in which revenues are derived from product, license, and contract revenues. Operating segments are defined as components of an enterprise where separate financial information is evaluated regularly by the chief operating decision maker (CODM), the chief executive officer, in deciding how to allocate resources and assessing performance. The Company's CODM allocates resources and assesses performance based upon discrete financial information at the consolidated level. Functional currency: The functional currency for the Company and all of its foreign subsidiaries is determined to be the U.S. dollar, therefore there is no currency translation adjustment upon consolidation as the remeasurement of gains or losses are recorded in the consolidated statement of operations. All monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at the exchange rate on the balance sheet date. Non-monetary assets and liabilities (along with their related expenses) are translated at the rate of exchange in effect on the date assets were acquired. Monetary income and expense items are translated at the average foreign exchange rate for the period. Foreign exchange gains and losses arising on translation or settlement of a foreign currency denominated monetary item are included in the consolidated statements of operations and comprehensive loss in other expense (income), net. Fair value measurements: The Company's financial instruments consist primarily of cash and cash equivalents, investments, accounts receivable, accounts payable and accrued liabilities. The Company has determined the carrying values of these financial instruments approximate their fair value because of the relatively short period to maturity of the instruments. Financial assets and liabilities are categorized based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels. Concentration of credit risk: Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash, cash equivalents and restricted cash, investments and accounts receivable, net. The Company attempts to minimize the risks related to cash and cash equivalents and restricted cash and investments by investing in a range of financial instruments. The Company established guidelines related to credit ratings and maturities intended to safeguard principal balances, earn a return on investments and to maintain liquidity. The Company's investment portfolio is maintained in accordance with its investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company does not enter into any investment transaction for trading or speculative purposes. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as high quality corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the Federal Deposit Insurance Corporation and Canada Deposit Insurance Corporation and concentrated within a limited number of financial institutions. The accounts are monitored by management to mitigate the risk. The Company is exposed to financial risk related to the fluctuation of foreign currency exchange rates which could have a material effect on its future operating results or cash flows. Foreign currency risk is the risk that variations in exchange rates between the U.S. dollar and foreign currencies, primarily with the Swiss Franc, Canadian Dollar and Great British Pound will affect the Company's operating and financial results. The Company holds the majority of its cash and cash equivalents in U.S. dollars and the majority of its expenses, including commercial and clinical trial costs are also denominated in U.S. dollars. The Company's monoplant finance lease is denominated in Swiss Francs. These foreign currency balances can result in fluctuations in foreign exchange gain or loss. Major customers : The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and a collaboration partnership with Otsuka for sales of semi-finished product and royalty, collaboration and manufacturing services revenue in Otsuka Territories. The percentages of total revenues, net from our main customers were as follows: 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% In late March 2022, the Company provided a nominal additional discount to both of its two main U.S. customers, applicable for the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. In December 2022, the Company extended the nominal discount to the end of 2024. Such discounts, or any future discounts, may result in reduced sales to these customers in subsequent periods and substantial fluctuations in our revenues from period to period. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically re-evaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. The Company has had no historical write-offs related to our customers or receivables. Accounts receivable, net: Accounts receivables are stated at their net realizable value. The Company's accounts receivable represents amounts primarily due to the Company from product sales and from its Otsuka collaboration agreement (Note 10). Sales and services that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. As of December 31, 2023 and December 31, 2022, accounts receivable, net were $24.1 million and $13.5 million, respectively. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. The Company's standard credit terms range from 30 to 45 days. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. The Company's estimates allowances using the current expected credit loss (CECL) model. Under the CECL model, the allowances reflect the net amount expected to be collected from the account receivables. The Company evaluates the collectability of these cash flows based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to the Company. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature of the Company's accounts receivable, it determined that an allowance for current expected credit losses was nil at December 31, 2023 and December 31, 2022. Accounts receivables for the Company's U.S commercial customers are recorded net of estimates of variable consideration for which reserves are established and which result from discounts that are offered within contracts between us and two specialty pharmacies and one specialty distributor in the U.S. These reserves are recorded as a reduction of accounts receivable. Cash and cash equivalents: The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of operating accounts, money market funds and bank money market accounts, which are recorded at fair value. Cash and cash equivalents totaled $48.9 million and $94.2 million as of December 31, 2023 and December 31, 2022, respectively. The Company has invested its cash reserves mainly in short term U.S. dollar denominated, fixed rate, highly liquid and highly rated financial instruments such as treasury notes, banker acceptances, bank bonds, and term deposits. Restricted cash : Restricted cash consists of the 2021 Employee Share Purchase Plan (ESPP) deposits of $120 thousand and $84 thousand as of December 31, 2023 and December 31, 2022, respectively. Refer to note 17 "Share-Based Compensation" for further details on the ESPP. Investments: The Company classifies its debt securities as available-for-sale in accordance with the FASB Accounting Standards Codification (ASC) Topic 320, Investments — Debt Securities . Investments classified as available-for-sale are carried at fair value with unrealized gains or losses reported in other comprehensive loss within shareholders’ equity. Realized gains and losses on available-for-sale securities are recorded in other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest income is accrued when earned and the amortization of premiums and accretion of discounts to maturity arising from acquisition is included in interest income on the consolidated statements of operations and comprehensive loss. Intangible assets: Intangible assets are amortized on a straight-line basis over their useful lives using methods that correlate to the pattern in which the economic benefits are expected to be realized. The Company evaluates the estimated remaining useful life of its intangible assets and whether events or changes in circumstances warrant a revision to the remaining period of amortization. The carrying amounts of these assets are reviewed at least annually for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. Refer to the long-lived assets section below for impairment considerations. Acquired intellectual property and patents External patent costs specifically associated with preparing, filing, obtaining and protecting patents are capitalized and amortized straight-line over the shorter of the estimated useful life and the patent life, commencing in the year of the grant of the patent. Patents do not contain the option to extend or renew. External legal costs incurred to defend a patent are capitalized when it is believed that the future economic benefit of the patent will be increased and a successful defense is probable. Separately acquired intellectual property is shown at historical cost. The initial recognition of purchased intellectual property or a reacquired right is recognized as an intangible asset measured on the basis of the remaining contractual term of the related contract. If the terms of the contract giving rise to a reacquired right are favorable relative to the terms of current market transactions for the same or similar items, the difference is recognized as a gain or loss in the consolidated statements of operations and comprehensive loss. Purchased intellectual property and reacquired rights are capitalized and amortized on a straight-line basis in the consolidated statements of operations and comprehensive loss over periods ranging from 10 to 12 years. Property and equipment: Property and equipment are recorded at cost and are depreciated using the straight-line method. Expenditures for additions are capitalized and leasehold improvements are amortized over the lesser of the expected lease term or the estimated useful life of the improvement. Expenditures for maintenance and repairs are charged to expense as incurred; however, maintenance and repairs that improve or extend the life of existing assets are capitalized. The carrying amount of assets disposed of and the related accumulated depreciation are eliminated from the accounts in the year of disposal. Gains or losses from property and equipment disposals are recognized in the year of disposal. Recoverability and impairment of long-lived assets: ASC Topic 360 requires long-lived assets, including definite-lived intangible assets, to be evaluated for impairment at least annually or when events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The judgments made related to the expected useful lives of long-lived assets, definitions of lease terms and the Company’s ability to realize undiscounted cash flows in excess of the carrying amounts of these assets are affected by factors such as the ongoing maintenance and improvements of the assets, changes in economic conditions, changes in usage or operating performance and other factors. If indicators are present, assets are grouped to the lowest level for which identifiable cash flows are largely independent of other asset groups and cash flows are estimated for each asset group over the remaining estimated life of each asset group. If the undiscounted cash flows estimated to be generated by the asset group are less than the asset’s carrying amount, impairment is recognized in the amount of excess of the carrying value over the fair value. The Company recorded no asset impairment charges during the years ended December 31, 2023, 2022 and 2021. Leases : The Company assesses all contracts at inception to determine whether a lease exists. The Company’s leases are all classified either as operating or finance leases per ASC 842. The Company leases office space under operating leases that typically provide for the payment of minimum annual rentals and may include scheduled rent increases. The Company also entered into a manufacturing agreement that contained an embedded lease of a dedicated manufacturing facility that was accounted for as a finance lease when the lease commencement began (see Note 15). The Company made an accounting policy election to use the practical expedient that allows lessees to treat the lease and non-lease components of leases as a single lease component. Leases with an initial term of 12 months or less are not recorded on the Company's consolidated balance sheets and to recognize those lease payments on a straight-line basis in its consolidated statements of operations and comprehensive loss. Fixed costs associated with these arrangements are disclosed in Note 15 of the financial statements. Operating and finance lease ROU assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company used the incremental borrowing rate for all of its leases, as the implicit interest rate was not readily determinable. In determining the Company’s incremental borrowing rate of each lease, the Company considered recent rates on secured borrowings, observable risk-free interest rates and credit spreads correlating to the Company's creditworthiness, the impact of collateralization and the term of each of the Company's lease agreements. The lease terms range from 12 to 128 months. Deferred Compensation Arrangements : The Company has recorded deferred compensation arrangements in liabilities for estimated future employee benefits relating to applicable historical employment arrangements. The deferred compensation arrangements are part of the resolution of the board of directors of the company dated March 8, 2012. Pursuant to ASC Topic 710, the Company recognizes future benefits provided by employee retention arrangements, as deferred compensation, which is recognized when the Company determines that it is probable to make future payments. The deferred compensation is based on an income approach for the estimated future net revenues of voclosporin using an internal risk-adjusted net present value of the future payments to be made to the individuals. The Company is required to use judgment to determine the most appropriate model to measure the deferred compensation liability and is required to use significant judgment and estimates in determining the inputs into the model. The royalty rates applied to the net revenue are dependent on the type of net revenue earned, which includes product sales and royalty revenue. There are multiple unobservable and inherently uncertain inputs. The determination of this deferred compensation is subject to significant judgments and estimates in determining the assumptions related to future net revenues and the determination of the discount rate for the net present value calculation. The net revenue estimate for the United States includes assumptions related to the number of patients being treated (including patients who initially start taking the product but subsequently discontinue), dosing adjustments, duration of treatment, timing of generics and competitors entering the market, market penetration and potential future use in new indications. Additional variables for ex-U.S. geographies include timing of approval in ex-U.S. territories, escalating royalty rates, net pricing, government payor coverage of the product, and market penetration. In determining the estimate for ex-U.S. revenues, the Company relies on forecasts provided by its collaboration partner. Management developed the model and inputs in conjunction with their internal scientific team and utilized third party scientific studies, information provided by third party consultants engaged by the Company, information from medical and pharmacy claims databases and research papers as sources to develop their inputs; application and usage of these inputs is also informed by product sales and distribution data, ongoing market research fielded by the Company and third parties, and our continually evolving understanding of the market as the U.S. launch progresses. Management believes the liability is based on reasonable assumptions; however, these assumptions may be incomplete or inaccurate and unanticipated events and circumstances may occur. There are numerous significant inputs into the model all of which individually or in combination may result in a material change to the obligation. Initially, these obligations are measured at the present value of expected future payments to be made in respect of services provided by employees up to the end of the reporting periods. Subsequent re-measurements as a result of performance obligations met by the Company or changes in assumptions are recognized in the consolidated statement of operations and comprehensive loss. Contingencies: In the normal course of business, the Company may be subject to loss contingencies, such as legal proceedings, amounts arising from contractual arrangements and claims arising out of the Company’s business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies , (ASC 450), the Company records accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company, in accordance with this guidance, does not recognize gain contingencies until realized or realizable. Common Shares: The Company’s shares have no par value and therefore, upon issuance of shares, all amounts related to the shares are credited to common shares on the balance sheet. The value of common shares includes cash amounts received or paid for the shares and the fair value of equity awards and warrants. Amounts for common shares are offset by share issue costs associated with equity offerings. Inventories: Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories mainly include third party manufacturing costs, transportation, storage, insurance and allocated internal labor. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. Revenue Recognition: Pursuant to Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), the Company recognizes revenue when a customer obtains control of promised goods or services. The Company records the amount of revenue that reflects the consideration that it expects to receive in exchange for those goods or services. Revenue is recognized through a five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations. Revenue is recognized for the applicable performance element when each distinct performance obligation is satisfied. Product Revenues In the United States (and territories), the Company sells LUPKYNIS primarily to a limited number of specialty pharmacies and specialty distributors. These customers subsequently resell LUPKYNIS to health care providers and patients. Revenues from product sales are recognized when the customer obtains control of the Company's product, which typically occurs upon delivery to the customer. Reserves for discounts and allowances: Product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). The Company estimates of reserves established for variable consideration are calculated based upon utilizing the expected value method. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as addition information becomes available. Significant judgment is required in estimating variable consideration. In making these estimates, the Company considers historical data, including patient mix and inventory sold to our customers that has not yet been dispensed. The Company uses a data aggregator and historical claims to estimate variable consideration for inventory sold to our customers, including specialty pharmacies and specialty distributors, that has not yet been dispensed. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. As of December 31, 2023, the Company did not have any material adjustments to variable consideration estimates based on actual results. More specifically, these adjustments include the following: Prompt Pay Discounts: The Company generally provides invoice discounts on product sales to its customers for prompt payment. The Company estimates that its customers will earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. Customer Fees: The Company pays certain customer fees, such as fees for certain data that customers provide to the Company. The Company records fees paid to its customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and the Company can reasonably estimate the fair value of the goods or services received. If both conditions are met, the Company records the consideration paid to the customer as SG&A expense. Government Rebates: The Company estimates its government rebates, primarily Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. Medicaid rebates relate to the Company's estimated obligations to states under established reimbursement arrangements. Rebate accruals are recorded in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability, which is included in other current liabilities. The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for the current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, invoices received for claims from the prior quarters that have not been paid and an estimate of potential claims that will be made for inventory that exists in the distribution channel at period end. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Co-payment Assistance: Co-payment assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance. The program is administered by the specialty pharmacies. The calculation of the accrual for co-payment assistance is based on the co-payments administered on the Company's behalf by the specialty pharmacies. Payor Rebates and Administration Fees: Payor rebates and administration fees represent our estimated obligations to third parties, primarily benefit managers. Accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability. These rebates and fees result from formulary position and price increase limit allowances (price protection) and administration fees. The calculation of the accrual for these items are based on the estimated payors buying patterns and the resulting applicable contractual rebate rate(s) to be earned over a contractual period. Supply of Drug Substance and Semi-finished Goods: The Company also has agreements with its partners that include options related to the promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded as product sales when the licensee obtains control of the goods, which is typically upon delivery. Certain agreements include terms where the Company can partially bill for drug substance used before the manufacturing cycle is complete, resulting in a deferred revenue which is to be recognized once delivery occurs. License, Collaboration and Royalty Revenue The Company enters into out-licensing agreements that are within the scope of ASC 606, under which it licenses certain rights to LUPKYNIS to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments, payments for manufacturing supply services the Company provides through its contract manufacturers, and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Licenses of Intellectual Property : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For lice |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement The Company's financial instruments consist primarily of cash and cash equivalents, investments, accounts receivable, accounts payable and accrued liabilities. The carrying value of accounts receivable, accounts payable and accrued liabilities approximate their fair values because of their short-term nature. Estimated fair values of available-for-sale debt securities are generally based on prices obtained from commercial pricing services. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: • Level 1 - Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. • Level 2 - Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. • Level 3 - Unobservable inputs that reflect the reporting entity’s own assumptions. The following table summarizes the financial assets (cash, cash equivalents, restricted cash and investments) measured at fair value on a recurring basis: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 48,875 $ — $ — $ 48,875 U.S. agency security — — — — Corporate bond — 33,781 — 33,781 Commercial paper — 39,304 — 39,304 Treasury bill — 122,806 — 122,806 Treasury bond — 105,924 — 105,924 Total financial assets $ 48,875 $ 301,815 $ — $ 350,690 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 94,172 $ — $ — $ 94,172 U.S. agency security — 4,948 — 4,948 Corporate bond — 104,080 — 104,080 Commercial paper — 125,187 — 125,187 Treasury bill — 12,282 — 12,282 Treasury bond — 42,220 — 42,220 Yankee bond — 6,501 — 6,501 Total financial assets $ 94,172 $ 295,218 $ — $ 389,390 The Company's Level 1 instruments include cash, cash equivalents and restricted cash that are valued using quoted market prices. Aurinia estimates the fair values of our investments in corporate debt securities, government and government related securities and certificates of deposits by taking into consideration valuations obtained from third-party pricing services. The fair value of the Company's investments classified within Level 2 is based upon observable inputs that may include benchmark yield curves, reported trades, issuer spreads, benchmark securities and reference data including market research publications. Additionally, at December 31, 2023 and December 31, 2022, the weighted average remaining contractual maturities of Aurinia's Level 2 investments were approximately 7 months for both periods. It is the Company's intent for these investments to have an overall rating of A-1, or higher, by Standard & Poor’s, or an equivalent rating by Moody’s or Fitch. No credit loss allowance was recorded as of December 31, 2023 and December 31, 2022, as we do not believe the unrealized loss is a result of a credit loss due to the nature of our investments. We also considered the current and expected future economic and market conditions and determined that the estimate of credit losses was not significantly impacted. Refer to Note 4, “Cash, Cash Equivalents and Restricted Cash and Investments,” for the carrying amount and related unrealized gains (losses) by type of investment. |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash and Investments | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents and Restricted Cash and Investments | Cash, Cash Equivalents, Restricted Cash and Investments As of December 31, 2023 and December 31, 2022, the Company had $350.7 million and $389.4 million, respectively, of cash, cash equivalents, restricted cash and investments, which are summarized below. As of December 31, 2023 and December 31, 2022, $301.8 million and $295.2 million the Company's investments, which are available-for-sale debt securities, are carried at fair market value. December 31, 2023 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash, cash equivalents and restricted cash $ 48,875 $ — $ — $ 48,875 Corporate bond 33,576 4 — 33,580 Commercial paper 39,305 — (1) 39,304 Treasury bill 122,757 49 — 122,806 Treasury bond 105,903 21 — 105,924 Total cash, cash equivalents, restricted cash and short-term investments $ 350,416 $ 74 $ (1) $ 350,489 Total long-term investment corporate bond 200 1 — 201 Total cash, cash equivalents, restricted cash and investments $ 350,616 $ 75 $ (1) $ 350,690 December 31, 2022 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash, cash equivalents and restricted cash $ 94,172 $ — $ — $ 94,172 U.S. agency security 4,951 — (3) 4,948 Corporate bond 104,174 — (94) 104,080 Commercial paper 125,255 — (68) 125,187 Treasury bill 12,290 — (8) 12,282 Treasury bond 42,301 — (81) 42,220 Yankee bond 6,503 — (2) 6,501 Total cash, cash equivalents, restricted cash and short-term investments $ 389,646 $ — $ (256) $ 389,390 As of December 31, 2023 and December 31, 2022, accrued interest receivable from the investments were $0.7 million and $1.1 million, respectively and recorded as other current assets on the consolidated balance sheets. As of December 31, 2023, December 31, 2022 and December 31, 2021 the Company had $331 thousand, $209 thousand and $47 thousand of net unrealized gains and losses on available-for-sale securities, respectively, which are included as a component of comprehensive loss on the consolidated statement of operations and comprehensive loss. Currently, the Company does not intend to sell the investments before recovery of their amortized cost basis, which may be maturity. Realized gains or losses were immaterial for the years ended December 31, 2023 and December 31, 2022. The Company's short-term investments as of December 31, 2023 mature at various dates through November 2024 and the long-term investment matures in August 2025. |
Inventories, net
Inventories, net | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories, net | Inventories, net Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories for LUPKYNIS mainly include third party manufacturing costs, transportation, storage, insurance and allocated internal labor. Due to the nature of the Company's supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. The Company assesses recoverability of inventory at each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. As of December 31, 2023 and December 31, 2022, Aurinia had recorded reserves of finished goods inventories of approximately $0.8 million and $3.9 million, respectively, which were primarily related to potential inventory obsolescence. The components of inventories, net are as follows: (in thousands) December 31, 2023 December 31, 2022 Raw materials $ 1,746 $ 2,217 Work in process 37,376 21,059 Finished goods 583 1,476 Total inventories, net $ 39,705 $ 24,752 |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Prepaid Expenses | Prepaid Expenses Prepaid expenses are as follows: (in thousands) December 31, 2023 December 31, 2022 Prepaid assets $ 6,892 $ 5,451 Prepaid deposits 1,345 6,330 Prepaid insurance 1,249 1,799 Total prepaid expenses $ 9,486 $ 13,580 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment, net are as follows: (in thousands) Estimated Useful Life December 31, 2023 December 31, 2022 Construction in progress — $ — $ 255 Leasehold improvements Shorter of term of the lease or estimated useful life 3,243 2,978 Office equipment 5 631 645 Furniture 7 1,155 976 Computer equipment 3 235 251 5,264 5,105 Less accumulated depreciation (1,910) (1,455) Property and equipment, net $ 3,354 $ 3,650 Depreciation expense for the years ended December 31, 2023, 2022 and 2021 was $606 thousand, $629 thousand and $663 thousand, respectively, which is recorded in operating expenses on the consolidated statements of operations and comprehensive loss. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets The following table summarizes the carrying amount of intangible assets, net of accumulated amortization. December 31, 2023 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,847 $ (1,297) $ 550 Acquired intellectual property and reacquired rights 12 15,126 (10,737) 4,389 Internal-use software implementation costs 3 2,873 (2,835) 38 $ 19,846 $ (14,869) $ 4,977 December 31, 2022 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,569 $ (1,262) $ 307 Acquired intellectual property and reacquired rights 12 15,126 (9,838) 5,288 Internal-use software implementation costs 3 2,873 (2,043) 830 $ 19,568 $ (13,143) $ 6,425 Amortization expense recognized by the Company related to intangible assets was $1.7 million, $2.1 million and $2.1 million for the years ended December 31, 2023, 2022 and 2021, respectively. Amortization expense as it relates to the amortization of acquired intellectual property and other intangible assets is recorded in operating expenses on the consolidated statements of operations and comprehensive loss. The estimated aggregate amortization expense for intangible assets over the next five fiscal years ending December 31, 2024 through December 31, 2028 is approximately $4.6 million. |
Accounts payable and accrued li
Accounts payable and accrued liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accounts payable and accrued liabilities | Accounts payable and accrued liabilities Accounts payable and accrued liabilities are as follows: December 31, 2023 December 31, 2022 Employee accruals $ 22,486 $ 20,157 Commercial accruals 16,216 8,620 Accrued R&D projects 5,503 5,350 Trade payables 4,327 3,087 Other accrued liabilities 5,190 2,151 Income taxes payable 667 625 Total accounts payable and accrued liabilities $ 54,389 $ 39,990 |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements Otsuka Contract On December 17, 2020, the Company entered into a collaboration and license agreement with Otsuka for the development and commercialization of LUPKYNIS in the Otsuka Territories. As part of the agreement, the Company received an upfront cash payment of $50.0 million in 2020 for the license agreement and thereafter has received $40.0 million in regulatory and pricing approval milestones as detailed below. The Company has the potential to receive an additional $10.0 million milestone related to Japan regulatory approval. The Company provides semi-finished product of LUPKYNIS to Otsuka on a cost-plus basis, and will receive tiered royalties on future sales ranging from 10 to 20 percent (dependent on territory and achievement of sale thresholds) on net product sales by Otsuka, along with additional milestone payments based on the attainment of certain annual sales. In addition, certain collaboration services are to be provided to Otsuka on agreed upon rates. In furtherance of the collaboration and license agreement with Otsuka mentioned above, on August 1, 2022, the Company entered into a commercial supply agreement with Otsuka, formalizing the terms to supply semi-finished goods of LUPKYNIS to Otsuka in the Otsuka Territories, including capacity sharing of the monoplant to provide manufacturing services. On September 15, 2022, the European Commission (EC) granted marketing authorization of LUPKYNIS. The centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. The approval triggered a $30.0 million milestone payment to the Company, which was recognized as collaboration revenue for the year ended December 31, 2022. On November 29, 2022 Aurinia announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization of LUPKYNIS in Great Britain. On April 24, 2023, LUPKYNIS received regulatory approval in Switzerland. The Company continues to progress with regulatory approval with Otsuka in the other Otsuka Territories. During the third quarter of 2023, the Company received notification that the pricing and reimbursement milestone was secured. As a result, this triggered a $10.0 million milestone which was recognized as collaboration revenue in the quarter. On November 13, 2023, Otsuka filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin. For the years ended December 31, 2023, December 31, 2022 and December 31, 2021 the Company recognized $6.0 million, $0.5 million and nil respectively, of additional collaboration revenue from services provided under the agreement. Riptide License On August 17, 2021, a license for AUR300 (M2 macrophage modulation via CD206 binding) was secured through a global licensing and research agreement with Riptide Bioscience, Inc. (Riptide), a private company. As part of the agreement, in 2021 the Company paid Riptide an upfront license fee of $6.0 million, which was expensed as research and development on the consolidated statements of operations and comprehensive loss. During the first quarter of 2022, Aurinia paid an additional $4.0 million to Riptide for the achievement of a onetime milestone, which was expensed as research and development on the consolidated statements of operations and comprehensive loss. Effective February 14, 2024 the Company is ceasing future development of AUR300. |
Segment Information and Geograp
Segment Information and Geographic Data | 12 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
Segment Information and Geographic Data | Segment Information and Geographic Data As the operations comprise a single reporting segment, amounts disclosed in the consolidated financial statements represent those of the single reporting unit. Aurinia elected to disclose geographical revenue from customers based on geographical location of contracting entity (and where the related payment stream of the customer is located). The Company currently has two main customers for U.S. commercial sales of LUPKYNIS which accounted in total of approximately 51% and 40% and 45% and 35% of the Company's total revenues for the year ending December 31, 2023 and December 31, 2022, respectively. The company has a collaboration partnership with Otsuka for sales of semi-finished product and license, royalty and collaboration revenue in Otsuka Territories. The percentage of total revenues, net from our main customers were as follows: 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% Revenues by Geographic Location The following geographic information reflects revenue, net of adjustments, based on customer location: (in thousands) 2023 2022 2021 Revenue United States $ 157,958 $ 102,460 $ 45,488 Japan 17,555 31,481 — Other — 89 117 Total $ 175,513 $ 134,030 $ 45,605 Long-lived Assets by Location Long-lived assets by location consist of net property and equipment and right-of-use assets: (in thousands) December 31, 2023 December 31, 2022 Long-lived assets, net Switzerland $ 108,715 $ — United States 7,324 8,235 Canada 528 322 Total $ 116,567 $ 8,557 The increase in Switzerland as of December 31, 2023 was due to the monoplant finance lease. For further discussion, refer to Note 15, "Leases". |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income (losses) before income taxes for the years ended December 31, 2023, 2022 and 2021 was as follows: (in thousands) 2023 2022 2021 Canada $ (90,226) $ (112,359) $ (180,374) Foreign 12,757 6,007 168 $ (77,469) $ (106,352) $ (180,206) The components of income tax expense consisted of the following for the years ended December 31, 2023, 2022 and 2021: (in thousands) 2023 2022 2021 Current: Canada $ — $ — $ — Foreign 551 1,828 760 551 1,828 760 Deferred: Canada — — — Foreign — — — Total deferred — — — Income tax expense (benefit) $ 551 $ 1,828 $ 760 The Company's parent entity is located in Canada and therefore the Canadian statutory rate is utilized. The provision for income taxes varied from the income taxes provided based on the Canadian statutory rate of 24.6%, 26.7%, and 26.8% for the years ending December 31, 2023, 2022 and 2021, respectively. The decrease in the statutory rate is a result of the Company’s Canadian operations moving to primarily Alberta, which has a lower provincial rate. The Company's December 31, 2022 increase in tax expense is primarily driven by withholding tax payments paid, and such decrease for December 31, 2023 is due to such withholding tax payments not recurring during the year. 2023 2022 2021 Canada statutory income tax benefit 24.6 % 26.7 % 26.8 % Effect of tax rates on foreign jurisdictions 0.6 0.3 — Withholding taxes (0.2) (1.1) — Impact of future rates and tax rate changes (15.6) (0.1) (0.1) Foreign tax credit 0.2 1.1 — Non-deductible share-based compensation (13.8) (8.1) (4.5) State income taxes (0.9) (0.1) — Change in valuation allowance 3.1 (21.5) (21.8) Scientific Research and Experimental Development (SRED) and Research Credits 1.3 1.1 0.3 Other — — (1.1) Effective tax rate (0.7) % (1.7) % (0.4) % The net deferred tax assets (liabilities) consisted of the following for the years ended December 31, 2023 and 2022: (in thousands) 2023 2022 Deferred tax assets: Net operating loss carry-forwards $ 137,907 $ 141,020 Share issue costs 2,325 4,209 Lease liability 23,837 1,860 Intangible assets 1,479 1,400 Research credit carry-forwards 8,263 7,462 Capitalized research and development — 1,663 Deferred compensation 2,384 3,391 Accruals 3,646 2,887 Other 2,688 2,427 Gross deferred tax assets 182,529 166,319 Valuation allowance (161,898) (164,514) Total deferred tax assets 20,631 1,805 Deferred tax liabilities: Right-of-use asset (20,060) (1,128) Property and equipment and intangible assets (571) (677) Total deferred tax liabilities (20,631) (1,805) Net deferred tax assets (liabilities) $ — $ — The Company’s valuation allowance decreased by net $2.6 million in 2023 as compared to 2022 as a result of the decrease in the deferred blended tax rate applied to Canada deferred tax balances offset by additional pre-tax losses which are not more likely than not to be realized. The Company’s net deferred tax asset, including net operating loss carryforwards, are not more likely than not realizable as a result of the Company’s significant cumulative pre-tax losses. As of December 31, 2023, the Company has $557.1 million of Canada gross net operating loss (NOL) carryforwards and approximately $6.5 million of Canada Investment Tax Credits and British Columbia Scientific Research and Experimental Development (SRED) with an expiration period of 2029 through 2043. The Company also has approximately $4.1 million of U.S. federal gross NOL carryforwards that carryforward indefinitely, although limited to eighty percent of taxable income annually, and research and development tax credits of $0.1 million with an expiration of 2043. The Company’s ability to utilize the U.S. federal and state tax attribute carryforwards to offset any taxable income or tax liability in certain taxable periods may be limited under Section 382/383 of the Internal Revenue Code. Uncertain Income Tax Positions The Company was under audit by the Comptroller of Maryland for years 2019 through 2021 and during the year was notified that the audit is now complete with no significant changes. The Company is currently under examination by the Canadian Revenue Agency for the years 2019, 2020 and 2021. The Company is subject to examination in the U.S., UK and Canada. In the UK, tax periods remain open from 2021 through 2023. In the U.S. and Canada, tax periods remain open from 2020 through 2023 and 2009 through 2023, respectively, due to the tax attribute carryforwards. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies The Company may, from time to time, be subject to claims and legal proceedings brought against it in the normal course of business. Such matters are subject to many uncertainties. Management believes the ultimate resolution of such contingencies will not have a material adverse effect on the consolidated financial statements. On December 18, 2020, the Company commenced an action in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries, Inc., Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE (collectively, "Sun"). The action was a claim for patent infringement under the patent laws of the United States arising from Sun's commercial manufacture, use, offer to sell, or sales within the United States, and/or importation into the United States of Sun's CEQUA product. In January 2023, we announced a settlement of this action with Sun. On February 24, 2022, Sun Pharmaceuticals Inc. petitioned for an IPR by the USPTO in respect of the '036 patent. The IPR was instituted on July 26, 2022. On January 25, 2023, the USPTO announced that the inter partes review had been terminated, based on a Joint Motion for Termination filed by us and Sun Pharmaceuticals Inc. On April 15, 2022, a purported shareholder class action complaint, Ortmann v. Aurinia Pharmaceuticals, Inc. et al., case no. 1:22-cv-02185, was filed in the United States District Court for the Eastern District of New York (Eastern District of New York), naming us and certain of our officers as defendants. The lawsuit alleges that we made materially false and misleading statements regarding our financial guidance and commercial prospects in violation of certain federal securities laws. The plaintiff seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including reasonable attorneys’ fees. On June 2, 2022, the case was transferred from the Eastern District of New York to the United States District Court for the District of Maryland. On February 20, 2023, the Court appointed a lead plaintiff and approved lead plaintiff’s selection of lead counsel. On May 22, 2023, the lead plaintiff filed its amended complaint. On October 20, 2023, we filed a motion to dismiss the amended complaint (the "Motion to Dismiss"). On December 8, 2023, the lead plaintiff filed its opposition to the Motion to Dismiss. On January 12, 2024, we filed our reply in support of the Motion to Dismiss. We intend to vigorously defend ourselves against this action. Manufacturing Commitments The Company has various manufacturing agreements to support our commercial and clinical product supply requirements. We rely on Lonza, a third party manufacturer, to produce a portion of commercial and clinical quantities of our commercial and clinical drug substance requirements. We have firm orders with Lonza for future purchases of drug substance, with remaining total non-cancellable future commitments of approximately $11.0 million through 2024 of which $0.9 million was paid during 2023. If we terminate certain firm orders with Lonza without cause, we will be required to pay for drug substance scheduled for manufacture under our arrangement. |
Deferred Compensation and Other
Deferred Compensation and Other Non-current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Deferred Compensation and Other Non-current Liabilities | Deferred Compensation and Other Non-current LiabilitiesThe Company recorded other non-current liabilities of $10.9 million and $12.2 million as of December 31, 2023 and December 31, 2022, respectively. The balance as of December 31, 2023 and December 31, 2022 primarily included deferred compensation arrangements whereby certain executive officers as of March 8, 2012 were provided with future potential employee benefit obligations for remaining with the Company, for a certain period of time. These obligations were also contingent on the occurrence of uncertain future events. One of the former officers, Dr. Robert T. Foster, is considered a related party following his appointment to the Board of Directors on September 21, 2023. For further discussion, refer to Note 19, “Related Party”. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company has the following lease obligations: Victoria, British Columbia In December 2020, Aurinia entered into a lease for office space in Victoria, British Columbia. During September 2022, the fixed lease term ended on the Victoria lease and the Company exercised its right to enter into a short-term month to month lease, of which expenses were incurred in SG&A. On March 31, 2023, the Company terminated the Victoria lease. Rockville, Maryland During March 2020, the Company entered into a lease for its U.S. commercial office in Rockville, Maryland for a total of 30,531 square feet of office space. The lease has a remaining term of approximately 8 years and has an option to extend for two five-year periods after the 11 years has elapsed and has an option to terminate after seven years. During 2020, the Company received lease incentives for tenant leasehold improvements by the landlord in the amount of $2.3 million for the Maryland lease. The Company recorded the lease incentives as additions to the lease liability. The lease term commenced on March 12, 2020. When measuring the lease liability, the Company discounted lease payments using its incremental borrowing rate at March 12, 2020. The incremental borrowing rate applied to the lease liability on March 12, 2020 was 5.2% based on the financial position of the Company, geographical region and term of lease. As of December 31, 2023, the Company had a right-of-use asset of $4.5 million and lease liability of $7.4 million included in the consolidated balance sheets. As of December 31, 2022, the Company had a right of use asset of $4.9 million and lease liability of $8.0 million included in the consolidated balance sheets. Edmonton, Alberta During October 2022, the Company entered into a long term lease in Edmonton for a total of 4,375 square feet of office space. The lease is for a six year term and has an option to renew after five years at prevailing market rates. The lease commenced on November 1, 2022 and the Company recorded the lease as an operating lease. The lease is not material to the Company's financial position. For all operating leases, the Company incurs variable lease costs. These costs include operation and maintenance costs included in SG&A and are expensed as incurred. The variable lease costs are not material to the Company's financial position. The operating lease costs for the years ended December 31, 2023, December 31, 2022 and December 31, 2021 were approximately $0.8 million, $1.0 million and $1.0 million, respectively. Monoplant On December 15, 2020, the Company entered into a collaborative agreement with Lonza to build a dedicated manufacturing facility within Lonza’s existing small molecule facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") is equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacturing of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand. Following U.S. regulatory approval of LUPKYNIS in January 2021, the construction of the monoplant began. The Company has completed a capital expenditure payment program for the monoplant totaling approximately CHF 21.0 million. The first capital expenditure payment was made in February 2021 of $11.8 million (CHF 10.5 million) and was treated as an upfront lease payment and recorded under other non-current assets on consolidated balance sheets. The second payment of $11.9 million (CHF 10.5 million) became due when the facility fulfilled the required operational qualifications, which occurred during the second quarter of 2023. The Company now has the exclusive right to use the monoplant by paying a quarterly fixed facility fee. The Company has determined that the monoplant arrangement will be accounted for as a finance lease under ASC 842. Under ASC 842, the lease term begins at the commencement date and is based on the noncancellable period for which a lessee has the right to use an underlying asset. Aurinia determined that the lease commencement occurred at the point when the FDA manufacturing validation process began, which occurred during the three months ended June 30, 2023. The Company, at lease inception, recorded an ROU asset of approximately $117.6 million and a corresponding lease liability of $94.1 million, which is the present value of the minimum lease payments beginning July 2023 and ending in 2030. The incremental borrowing rate applied to value the lease liability at inception is 6.19%, which was based on the financial position of the Company, geographical region and term of lease. As of December 31, 2023 the ROU asset, net and corresponding lease liability balance were $108.7 million and $90.1 million, respectively. For the year ending December 31, 2023, ROU amortization related to the finance lease and interest expense was $8.9 million and $2.8 million, respectively. For the year ending December 31, 2023, approximately $5.9 million foreign exchange loss related to the revaluation of the monoplant finance lease liability was recorded in other expense (income) on the consolidated statements of operations and comprehensive loss. The monoplant finance lease commenced in June 2023 and is denominated in CHF. The following table represents the weighted-average remaining lease term and discount rates for the Company's leases for the years ended December 31, 2023 and December 31, 2022: As of December 31, 2023 As of December 31, 2022 Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Operating leases 7.6 5.28% 8.7 5.3% Finance lease 6.3 6.19% — — Supplemental cash flow information related to leases for the years ended December 31, 2023, December 31, 2022 and December 31, 2021 are as follows: (in thousands) 2023 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Financing cash flows from finance lease $ (10,025) $ — $ — Operating cash flows from finance leases $ (2,311) $ — $ — Operating cash flows from operating lease $ (1,080) $ (1,160) $ (646) Initial recognition of operating lease right-of-use asset $ — $ 57 $ 419 Supplemental disclosure of noncash transactions Finance right-of-use asset obtained in exchange for lease obligations (monoplant) $ 117,622 $ — $ — Finance lease liability arising from obtaining right-of-use assets (monoplant) $ 94,140 $ — $ — Future maturities of lease liabilities as of December 31, 2023 are as follows: (in thousands) Finance Lease Payments Operating Lease Payments 2024 $ 17,240 $ 1,114 2025 17,240 1,142 2026 17,240 1,170 2027 17,240 1,199 2028 17,240 1,228 Thereafter 21,551 3,302 Total lease payments 107,751 9,155 Less: imputed interest (17,663) (1,636) Total $ 90,088 $ 7,519 Beinheim The Company has entered into an equipment and facility finance lease for a backup manufacturing encapsulation site in Beinheim, France that has not yet commenced and is therefore, not included in the above table. As part of the agreement, the Company expects to make payments of approximately $1.0 million prior to lease commencement and the future value of minimum lease payments will total approximately $0.1 million. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders' Equity Common shares: The Company has authorized an unlimited number of common shares with no par value. As of December 31, 2023, 2022 and 2021, 143.8 million, 142.3 million and 141.6 million common shares, respectively, were issued and outstanding. Each common share entitles the holder to one vote on all matters submitted to a vote of the Company’s shareholders. Common shareholders are not entitled to receive dividends unless declared by the Company’s Board of Directors. Any future determination regarding the declaration and payment of dividends is expected to be declared and paid in the Company's functional currency, the U.S. dollar. As discussed below from time to time, we intend to use the net proceeds from the sale of securities to fund our operations, which includes, but is not limited to, commercial activities, inventory costs, R&D programs, FDA related post approval commitments and funding our working capital obligations. November 19, 2021 At-the-market (ATM) facility On November 19, 2021 the Company entered into an Open Market Sale Agreement with Cantor Fitzgerald & Co. pursuant to which the Company may from time to time sell, through ATM offerings, common shares that would have an aggregate offering price of up to $250.0 million. Pursuant to this agreement the Company issued 10.2 million common shares at a weighted average price of $19.90 resulting in gross proceeds of $202.4 million as of December 31, 2021. The Company incurred share issue costs of approximately $5.6 million which included up to a 3% underwriting commission of $5.3 million and professional fees of $0.3 million directly related to the ATM. On February 25, 2022, the Company gave notice to Cantor Fitzgerald & Co. to terminate the Open Market Sale Agreement. No further sales occurred under the Open Market Sale Agreement. Warrants: Warrant related to December 28, 2016 bought deal public offering: On December 28, 2016, the Company completed a $28.8 million Bought Deal public offering (2016 Public Offering). Under the terms of the 2016 Public Offering, each Unit consisted of one common share and one-half (0.50) of a common share purchase warrant (December 2016 Warrant). The Company issued 12.8 million Units at a subscription price per Unit of $2.25, exercisable for a period of five years from the date of issuance at an exercise price of $3.00. These December 2016 Warrants also met the scope exceptions provided in ASC 815, Derivatives and Hedging , as they were indexed to the Company’s own shares, and therefore were accounted for under ASC 505, Equity . At initial recognition on December 28, 2016, the Company recorded warrants in the amount of $7.2 million based on the estimated fair value of the December 2016 Warrants with allocated share issuance costs of $655 thousand recognized as a reduction of equity. During 2019, certain holders of these Warrants exercised at $3.00 per share for gross proceeds of $5.5 million. During 2020, a holder exercised 500 Warrants at $3.00 per share for gross proceeds of $2 thousand. During 2021, 1.7 million warrants had been exercised at $3.00 per share for gross proceeds of $0.3 million. Of these 1.7 million warrants, the Company issued 1.3 million common shares in lieu of 1.6 million warrants . All gross proceeds were recorded as an increase in cash and equity. The remaining 6,000 warrants expired as of December 31, 2021. There was no warrant activity during 2023 and 2022 . The warrant activity for 2021 is as follows: Number of warrants Balance at December 31, 2020 1,690 Warrants exercised (1,684) Warrants expired (6) Balance at December 31, 2021 — |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Shared-Based Compensation The Company's Amended and Restated Equity Incentive Plan (the Plan), which was adopted and approved by the Company's shareholders in June 2021, allows for an issuance of up to an aggregate of 23.8 million shares (inclusive of then outstanding awards) and provides for grants of stock options, performance awards (PAs) and restricted stock units (RSUs) that may be settled in cash and common shares. Also in June 2021, the Company's shareholders adopted and approved the Company's Employee Stock Purchase Plan (2021 ESPP), which allows for the issuance of up to 2.5 million shares of which 419 thousand and 286 thousand were purchased during 2023 and 2022, respectively. The 2021 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code (the Code) but also permits the Company to include the employees, including non-United States employees, in offerings not intended to qualify under Section 423. The purpose of the 2021 ESPP is to provide eligible employees with opportunities to purchase the Company’s common shares at a discounted price. During 2022, the Company modified the 2021 ESPP for the current and future offerings. The new ESPP terms shortened the plan from four (4) purchases over a 24 month offering period to two (2) purchases over a 12 month offering period. Additionally, the ESPP now contains a rollover mechanism; that is, if the stock price on the purchase date is less than the offering price (as that is determined under the 2021 ESPP), that offering is then canceled and any participants are rolled into the new 12 month offering period at the lower price. As a result of the modification, we recorded incremental expense during 2022 which was immaterial to the consolidated statements of operations and comprehensive loss. In addition to stock options, PAs and RSUs granted under the Plan, the Company has granted certain stock options and RSUs as inducements material to new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The inducements were granted outside of the Plan during 2023 and 2022. Stock Options The Plan requires the exercise price of each option not to be less than the closing market price of the Company’s common shares on the day immediately prior to the date of grant. The board of directors approves the vesting criteria and periods at its discretion. The options issued under the plan are accounted for as equity-settled share-based payments. The stock options and inducement stock options have a ten-year term and vest over three years with one-third of the shares vesting on the twelve month anniversary from the grant date, and the remaining options vesting in twenty-four The following table summarizes the number of stock options outstanding under the Plan for the years ended December 31, 2023. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2022 13,295 $ 12.09 7.74 $ 21 Granted 760 $ 9.53 Exercised/released (563) $ 5.50 Cancelled/forfeited (1,936) $ 16.08 Outstanding at December 31, 2023 11,556 $ 10.63 7.03 $ 7,967 Options exercisable, December 31, 2023 9,422 $ 11.73 Vested and expected to vest, December 31, 2023 11,379 $ 11.55 The weighted average grant date fair value of stock options granted during the years ended December 31, 2023, 2022 and 2021 was $5.86, $6.52 and $7.34, respectively. The total fair value of options vested during the years ended December 31, 2023, 2022 and 2021 was $40.9 million, $49.2 million and $24.9 million, respectively. Total intrinsic value of options exercised was $2.0 million, $0.9 million and $50.3 million for years ended December 31, 2023, 2022 and 2021, respectively. In determining the fair value of the options granted, the Company uses the Black-Scholes option pricing model and reviews the following assumptions each reporting period: Expected Term - Expected term (in years) is based upon the contractual term, taking into account expected employee exercise and expected post-vesting employment termination behavior. Based on the Company's historical expected lives data during 2023 and 2022, the expected life remained constant. The length of the expected life in 2023 is in line with historic data and what management expects in the future. Volatility - The Company considers historical volatility of its common shares in estimating its future stock price volatility. The expected life is used to determine market volatility of the underlying stock. The change in the volatility in 2023 and 2022 was due to the Company's stock being more volatile. Given the growth of the Company, the expected life used to determine previous market volatility and comparable peer group reflects an appropriate estimate of future volatility. Risk-free interest rate - The risk-free interest rate for the expected life of the options was based on the yield available on government benchmark bonds with an approximate equivalent remaining term at the time of the grant. Dividend yield - The Company has never paid dividends on its common shares and has no plans to pay dividends on our common shares in the near future. Therefore, the Company dividend yield is zero. The following weighted average assumptions were used to estimate the fair value of the options granted during the years ended December 31, 2023, 2022 and 2021: 2023 2022 2021 Expected term (in years) 5 years 5 years 4 years Volatility 71 % 70 % 66 % Risk-free interest rate 3.99 % 2.06 % 0.46 % Dividend yield 0.0 % 0.0 % 0.0 % Performance Awards and Restricted Stock Units The Company has granted PAs and RSUs and intends to grant RSUs and PAs under the Plan, as well as inducements for certain new hires as discussed above. The RSUs and PAs are fair valued based on the market price of our common shares on the date of the grant. The RSUs and PAs and inducement RSUs and PAs shall vest in three equal annual installments on the first, second and third anniversary of the grant date. The following table summarizes the PA and RSU activity for the year ended December 31, 2023: Number of Shares Weighted-Average Grant Date Fair Value Unvested balance, December 31, 2022 1,980 $ 10.84 Granted 6,827 $ 9.03 Vested (583) $ 11.57 Forfeited (417) $ 9.33 Unvested balance, December 31, 2023 7,807 $ 9.29 The weighted-average grant date fair value of RSUs and PAs granted during the years December 31, 2023, 2022 and 2021 was $9.03, $11.16 and $14.42, respectively. Total intrinsic value of RSUs and PAs vested and released was $5.4 million, $2.9 million and nil for years ended December 31, 2023, 2022 and 2021, respectively. Compensation Expense Share-based compensation expense for the years ended December 31, 2023, 2022 and 2021 totaled approximately $45.3 million, $32.3 million and $31.2 million, respectively, as shown in the table below. Share-based compensation capitalized under inventories is recognized in cost of sales when the related product is expensed. (in thousands) 2023 2022 2021 Research and development $ 7,533 $ 3,271 $ 4,442 Selling, general and administrative 36,512 28,438 26,432 Capitalized under inventories 1,266 591 369 Share-based compensation expense $ 45,311 $ 32,300 $ 31,243 Unrecognized Share-Based Compensation Expense and Weighted Average Remaining Amortization Period As of December 31, 2023, the unrecognized share-based cost, and the estimated weighted-average amortization period, using the straight-line attribution method, was as follows (in thousands, except amortization period): Unrecognized share-based compensation expense Weighted average remaining amortization period (in years) Stock Options $ 3,795 Restricted Stock Units and Performance Awards 25,956 ESPP 708 Total unrecognized share-based compensation expense $ 30,459 1.3 |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss Per Common Share Basic and diluted net loss per Common Share is computed by dividing net loss by the weighted average number of common shares outstanding. The numerator and denominator used in the calculation of basic and diluted net loss amounts per Common Share are as follows: 2023 2022 2021 Net loss for the year $ (78,020) $ (108,180) $ (180,966) Weighted average number of common shares outstanding 143,236 141,915 129,369 Net loss per common share (expressed in $ per share) $ (0.54) $ (0.76) $ (1.40) The Company did not include the securities in the following table in the computation of the net loss per common share because the effect would have been anti-dilutive during each period: 2023 2022 2021 Outstanding stock options 11,556 13,295 12,074 Unvested performance awards 921 — 64 Unvested restricted units 6,886 1,980 191 19,363 15,275 12,329 |
Related Party
Related Party | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party | Related Party ILJIN SNT Co., Ltd (ILJIN) is considered to be a related party due to their equity ownership of over 5% as per their public filings. During 2023, 2022 and 2021, Aurinia paid $0.5 million, nil and $6.0 million, respectively, upon achievement of specific milestones. The amount payable to ILJIN is nil as of December 31, 2023 and 2022. On September 21, 2023, the Company appointed Dr. Robert T. Foster to the Board of Directors. Dr. Foster is considered a related party since he is one of the former executive officers of the Company who, as of March 8, 2012 was provided with future potential employee benefit obligations for remaining with the Company for a certain period of time. These obligations are contingent on the occurrence of uncertain future events. Dr. Foster was not a related party of the Company between his resignation from the Company in 2014, and his appointment to the Board of Directors on September 21, 2023. As of December 31, 2023, the Company had $0.8 million and $7.6 million of current and noncurrent liabilities related to Dr. Foster, respectively. From the time that Dr. Foster became a related party, the Company made a payment of $0.1 million to him for the deferred compensation. |
Selected Quarterly Financial In
Selected Quarterly Financial Information (unaudited) | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Information (unaudited) | Selected Quarterly Financial Information (unaudited) The following condensed quarterly financial information is for the years December 31, 2023 and 2022: (in thousands, except per share data) March 31, 2023 June 30, September 30, 2023 December 31, 2023 Total revenue, net $ 34,409 $ 41,494 $ 54,515 $ 45,095 Cost of sales and operating expenses 63,993 57,664 70,778 74,769 Loss from operations (29,584) (16,170) (16,263) (29,674) Net loss (26,206) (11,492) (13,447) (26,875) Basic and diluted loss per common share $ (0.18) $ (0.08) $ (0.09) $ (0.19) March 31, 2022 June 30, September 30, 2022 December 31, 2022 Total revenue $ 21,625 $ 28,191 $ 55,779 $ 28,435 Operating expenses 59,507 64,180 65,278 56,535 Loss from operations (37,882) (35,989) (9,499) (28,100) Net loss (37,630) (35,515) (8,989) (26,046) Basic and diluted loss per common share $ (0.27) $ (0.25) $ (0.06) $ (0.18) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Effective February 14, 2024, the Board of Directors of Aurinia elected to conclude its strategic review process and to discontinue future development of AUR200 and AUR300 research and development programs and prioritize resource allocation. This will result in a one-time charge in the first quarter of 2024 of approximately $11 - $15 million. The charge will primarily be made up of severance costs, contract termination costs and other costs associated with terminating the programs. The Board also approved a share repurchase program of up to $150 million worth of the Company's common shares (each, a “common share”) (the maximum value of which is subject to receipt of regulatory approval in Canada). |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||||||||||
Net loss | $ (26,875) | $ (13,447) | $ (11,492) | $ (26,206) | $ (26,046) | $ (8,989) | $ (35,515) | $ (37,630) | $ (78,020) | $ (108,180) | $ (180,966) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation: The Company follows accounting standards established by the Financial Accounting Standards Board (FASB) to ensure consistent reporting of financial condition, results of operations, and cash flows. These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP). |
Principles of consolidation | Principles of consolidation: |
Use of estimates | Use of estimates: |
Segment information | Segment information: The Company operates in one operating segment engaged in the research, development and commercialization of therapeutic drugs in which revenues are derived from product, license, and contract revenues. Operating segments are defined as components of an enterprise where separate financial information is evaluated regularly by the chief operating decision maker (CODM), the chief executive officer, in deciding how to allocate resources and assessing performance. The Company's CODM allocates resources and assesses performance based upon discrete financial information at the consolidated level. |
Functional currency | Functional currency: The functional currency for the Company and all of its foreign subsidiaries is determined to be the U.S. dollar, therefore there is no currency translation adjustment upon consolidation as the remeasurement of gains or losses are recorded in the consolidated statement of operations. All monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at the exchange rate on the balance sheet date. Non-monetary assets and liabilities (along with their related expenses) are translated at the rate of exchange in effect on the date assets were acquired. Monetary income and expense items are translated at the average foreign exchange rate for the period. Foreign exchange gains and losses arising on translation or settlement of a foreign currency denominated monetary item are included in the consolidated statements of operations and comprehensive loss in other expense (income), net. |
Fair value measurements | Fair value measurements: The Company's financial instruments consist primarily of cash and cash equivalents, investments, accounts receivable, accounts payable and accrued liabilities. The Company has determined the carrying values of these financial instruments approximate their fair value because of the relatively short period to maturity of the instruments. |
Concentration of credit risk | Concentration of credit risk: Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash, cash equivalents and restricted cash, investments and accounts receivable, net. The Company attempts to minimize the risks related to cash and cash equivalents and restricted cash and investments by investing in a range of financial instruments. The Company established guidelines related to credit ratings and maturities intended to safeguard principal balances, earn a return on investments and to maintain liquidity. The Company's investment portfolio is maintained in accordance with its investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company does not enter into any investment transaction for trading or speculative purposes. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as high quality corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the Federal Deposit Insurance Corporation and Canada Deposit Insurance Corporation and concentrated within a limited number of financial institutions. The accounts are monitored by management to mitigate the risk. The Company is exposed to financial risk related to the fluctuation of foreign currency exchange rates which could have a material effect on its future operating results or cash flows. Foreign currency risk is the risk that variations in exchange rates between the U.S. dollar and foreign currencies, primarily with the Swiss Franc, Canadian Dollar and Great British Pound will affect the Company's operating and financial results. The Company holds the majority of its cash and cash equivalents in U.S. dollars and the majority of its expenses, including commercial and clinical trial costs are also denominated in U.S. dollars. The Company's monoplant finance lease is denominated in Swiss Francs. These foreign currency balances can result in fluctuations in foreign exchange gain or loss. Major customers : The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and a collaboration partnership with Otsuka for sales of semi-finished product and royalty, collaboration and manufacturing services revenue in Otsuka Territories. The percentages of total revenues, net from our main customers were as follows: 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% In late March 2022, the Company provided a nominal additional discount to both of its two main U.S. customers, applicable for the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. In December 2022, the Company extended the nominal discount to the end of 2024. Such discounts, or any future discounts, may result in reduced sales to these customers in subsequent periods and substantial fluctuations in our revenues from period to period. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically re-evaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. The Company has had no historical write-offs related to our customers or receivables. |
Accounts receivable, net | Accounts receivable, net: Accounts receivables are stated at their net realizable value. The Company's accounts receivable represents amounts primarily due to the Company from product sales and from its Otsuka collaboration agreement (Note 10). Sales and services that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. As of December 31, 2023 and December 31, 2022, accounts receivable, net were $24.1 million and $13.5 million, respectively. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. The Company's standard credit terms range from 30 to 45 days. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. The Company's estimates allowances using the current expected credit loss (CECL) model. Under the CECL model, the allowances reflect the net amount expected to be collected from the account receivables. The Company evaluates the collectability of these cash flows based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to the Company. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature of the Company's accounts receivable, it determined that an allowance for current expected credit losses was nil at December 31, 2023 and December 31, 2022. Accounts receivables for the Company's U.S commercial customers are recorded net of estimates of variable consideration for which reserves are established and which result from discounts that are offered within contracts between us and two specialty pharmacies and one specialty distributor in the U.S. These reserves are recorded as a reduction of accounts receivable. |
Cash and cash equivalents and Restricted cash | Cash and cash equivalents: The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of operating accounts, money market funds and bank money market accounts, which are recorded at fair value. Cash and cash equivalents totaled $48.9 million and $94.2 million as of December 31, 2023 and December 31, 2022, respectively. The Company has invested its cash reserves mainly in short term U.S. dollar denominated, fixed rate, highly liquid and highly rated financial instruments such as treasury notes, banker acceptances, bank bonds, and term deposits. Restricted cash : Restricted cash consists of the 2021 Employee Share Purchase Plan (ESPP) deposits of $120 thousand and $84 thousand as of December 31, 2023 and December 31, 2022, respectively. Refer to note 17 "Share-Based Compensation" for further details on the ESPP. |
Investments | Investments: The Company classifies its debt securities as available-for-sale in accordance with the FASB Accounting Standards Codification (ASC) Topic 320, Investments — Debt Securities . Investments classified as available-for-sale are carried at fair value with unrealized gains or losses reported in other comprehensive loss within shareholders’ equity. Realized gains and losses on available-for-sale securities are recorded in other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest income is accrued when earned and the amortization of premiums and accretion of discounts to maturity arising from acquisition is included in interest income on the consolidated statements of operations and comprehensive loss. |
Intangible assets | Intangible assets: Intangible assets are amortized on a straight-line basis over their useful lives using methods that correlate to the pattern in which the economic benefits are expected to be realized. The Company evaluates the estimated remaining useful life of its intangible assets and whether events or changes in circumstances warrant a revision to the remaining period of amortization. The carrying amounts of these assets are reviewed at least annually for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. Refer to the long-lived assets section below for impairment considerations. Acquired intellectual property and patents External patent costs specifically associated with preparing, filing, obtaining and protecting patents are capitalized and amortized straight-line over the shorter of the estimated useful life and the patent life, commencing in the year of the grant of the patent. Patents do not contain the option to extend or renew. External legal costs incurred to defend a patent are capitalized when it is believed that the future economic benefit of the patent will be increased and a successful defense is probable. Separately acquired intellectual property is shown at historical cost. The initial recognition of purchased intellectual property or a reacquired right is recognized as an intangible asset measured on the basis of the remaining contractual term of the related contract. If the terms of the contract giving rise to a reacquired right are favorable relative to the terms of current market transactions for the same or similar items, the difference is recognized as a gain or loss in the consolidated statements of operations and comprehensive loss. Purchased intellectual property and reacquired rights are capitalized and amortized on a straight-line basis in the consolidated statements of operations and comprehensive loss over periods ranging from 10 |
Property, plant and equipment | Property and equipment: |
Recoverability and impairment of long-lived assets | Recoverability and impairment of long-lived assets: |
Leases | Leases : The Company assesses all contracts at inception to determine whether a lease exists. The Company’s leases are all classified either as operating or finance leases per ASC 842. The Company leases office space under operating leases that typically provide for the payment of minimum annual rentals and may include scheduled rent increases. The Company also entered into a manufacturing agreement that contained an embedded lease of a dedicated manufacturing facility that was accounted for as a finance lease when the lease commencement began (see Note 15). The Company made an accounting policy election to use the practical expedient that allows lessees to treat the lease and non-lease components of leases as a single lease component. Leases with an initial term of 12 months or less are not recorded on the Company's consolidated balance sheets and to recognize those lease payments on a straight-line basis in its consolidated statements of operations and comprehensive loss. Fixed costs associated with these arrangements are disclosed in Note 15 of the financial statements. Operating and finance lease ROU assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company used the incremental borrowing rate for all of its leases, as the implicit |
Deferred Compensation Arrangements | Deferred Compensation Arrangements : The Company has recorded deferred compensation arrangements in liabilities for estimated future employee benefits relating to applicable historical employment arrangements. The deferred compensation arrangements are part of the resolution of the board of directors of the company dated March 8, 2012. Pursuant to ASC Topic 710, the Company recognizes future benefits provided by employee retention arrangements, as deferred compensation, which is recognized when the Company determines that it is probable to make future payments. The deferred compensation is based on an income approach for the estimated future net revenues of voclosporin using an internal risk-adjusted net present value of the future payments to be made to the individuals. The Company is required to use judgment to determine the most appropriate model to measure the deferred compensation liability and is required to use significant judgment and estimates in determining the inputs into the model. The royalty rates applied to the net revenue are dependent on the type of net revenue earned, which includes product sales and royalty revenue. There are multiple unobservable and inherently uncertain inputs. The determination of this deferred compensation is subject to significant judgments and estimates in determining the assumptions related to future net revenues and the determination of the discount rate for the net present value calculation. The net revenue estimate for the United States includes assumptions related to the number of patients being treated (including patients who initially start taking the product but subsequently discontinue), dosing adjustments, duration of treatment, timing of generics and competitors entering the market, market penetration and potential future use in new indications. Additional variables for ex-U.S. geographies include timing of approval in ex-U.S. territories, escalating royalty rates, net pricing, government payor coverage of the product, and market penetration. In determining the estimate for ex-U.S. revenues, the Company relies on forecasts provided by its collaboration partner. Management developed the model and inputs in conjunction with their internal scientific team and utilized third party scientific studies, information provided by third party consultants engaged by the Company, information from medical and pharmacy claims databases and research papers as sources to develop their inputs; application and usage of these inputs is also informed by product sales and distribution data, ongoing market research fielded by the Company and third parties, and our continually evolving understanding of the market as the U.S. launch progresses. Management believes the liability is based on reasonable assumptions; however, these assumptions may be incomplete or inaccurate and unanticipated events and circumstances may occur. There are numerous significant inputs into the model all of which individually or in combination may result in a material change to the obligation. Initially, these obligations are measured at the present value of expected future payments to be made in respect of services provided by employees up to the end of the reporting periods. Subsequent re-measurements as a result of performance obligations met by the Company or changes in assumptions are recognized in the consolidated statement of operations and comprehensive loss. |
Contingencies | Contingencies: In the normal course of business, the Company may be subject to loss contingencies, such as legal proceedings, amounts arising from contractual arrangements and claims arising out of the Company’s business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies , (ASC 450), the Company records accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company, in accordance with this guidance, does not recognize gain contingencies until realized or realizable. |
Common Shares | Common Shares: |
Inventories | Inventories: Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories mainly include third party manufacturing costs, transportation, storage, insurance and allocated internal labor. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. |
Revenue Recognition | Revenue Recognition: Pursuant to Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), the Company recognizes revenue when a customer obtains control of promised goods or services. The Company records the amount of revenue that reflects the consideration that it expects to receive in exchange for those goods or services. Revenue is recognized through a five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations. Revenue is recognized for the applicable performance element when each distinct performance obligation is satisfied. Product Revenues In the United States (and territories), the Company sells LUPKYNIS primarily to a limited number of specialty pharmacies and specialty distributors. These customers subsequently resell LUPKYNIS to health care providers and patients. Revenues from product sales are recognized when the customer obtains control of the Company's product, which typically occurs upon delivery to the customer. Reserves for discounts and allowances: Product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). The Company estimates of reserves established for variable consideration are calculated based upon utilizing the expected value method. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as addition information becomes available. Significant judgment is required in estimating variable consideration. In making these estimates, the Company considers historical data, including patient mix and inventory sold to our customers that has not yet been dispensed. The Company uses a data aggregator and historical claims to estimate variable consideration for inventory sold to our customers, including specialty pharmacies and specialty distributors, that has not yet been dispensed. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. As of December 31, 2023, the Company did not have any material adjustments to variable consideration estimates based on actual results. More specifically, these adjustments include the following: Prompt Pay Discounts: The Company generally provides invoice discounts on product sales to its customers for prompt payment. The Company estimates that its customers will earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. Customer Fees: The Company pays certain customer fees, such as fees for certain data that customers provide to the Company. The Company records fees paid to its customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and the Company can reasonably estimate the fair value of the goods or services received. If both conditions are met, the Company records the consideration paid to the customer as SG&A expense. Government Rebates: The Company estimates its government rebates, primarily Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. Medicaid rebates relate to the Company's estimated obligations to states under established reimbursement arrangements. Rebate accruals are recorded in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability, which is included in other current liabilities. The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for the current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, invoices received for claims from the prior quarters that have not been paid and an estimate of potential claims that will be made for inventory that exists in the distribution channel at period end. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Co-payment Assistance: Co-payment assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance. The program is administered by the specialty pharmacies. The calculation of the accrual for co-payment assistance is based on the co-payments administered on the Company's behalf by the specialty pharmacies. Payor Rebates and Administration Fees: Payor rebates and administration fees represent our estimated obligations to third parties, primarily benefit managers. Accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability. These rebates and fees result from formulary position and price increase limit allowances (price protection) and administration fees. The calculation of the accrual for these items are based on the estimated payors buying patterns and the resulting applicable contractual rebate rate(s) to be earned over a contractual period. Supply of Drug Substance and Semi-finished Goods: The Company also has agreements with its partners that include options related to the promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded as product sales when the licensee obtains control of the goods, which is typically upon delivery. Certain agreements include terms where the Company can partially bill for drug substance used before the manufacturing cycle is complete, resulting in a deferred revenue which is to be recognized once delivery occurs. License, Collaboration and Royalty Revenue The Company enters into out-licensing agreements that are within the scope of ASC 606, under which it licenses certain rights to LUPKYNIS to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments, payments for manufacturing supply services the Company provides through its contract manufacturers, and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Licenses of Intellectual Property : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development or commercial sales milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in the period of adjustment. Manufacturing Services Revenue: The Company’s agreements may include manufacturing services to be performed by the Company on behalf of the counterparty. If these services are determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to these services as revenue. The revenue is recognized either over time based on an appropriate measure of progress when the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date; or at a point in time as the related performance obligations are satisfied. Certain agreements may include terms where the Company can partially bill for manufacturing services before the serves are provided, resulting in a deferred revenue which is to be recognized once the performance obligation is satisfied. Royalty Revenue: For arrangements that include sales-based royalties, revenue is recognized when the underlying product sales have occurred. Revenue is recorded based on estimated quarterly net sales reports provided by our partner. Differences between actual results and estimated amounts are adjusted in the period in which they become known, which typically follows the quarterly period in which the estimate is made. Sales-based milestone payments are recognized in the period once the milestone objectives have been achieved. Other Services Revenue : The Company’s agreements may include R&D or other services to be performed by the Company on behalf of the counterparty. If these services are determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to these services as revenue either over time based on an appropriate measure of progress when the performance by the Company does not create an asset with an alternative use and the Company has an enforceable right to payment for the performance completed to date or at a point in time as the related performance obligations are satisfied. Costs to obtain a contract As the majority of our contracts are short-term in nature, sales commissions are generally expensed when incurred as the amortization period would have been less than one year. These costs are recorded within SG&A. Cost of sales : Cost of sales consists primarily of cost of inventories for LUPKYNIS and semi-finished product, which mainly includes third party manufacturing costs, transportation, storage, insurance and allocated internal labor. Cost of sales also includes costs related to collaboration revenues. |
Research and development costs | Research and development costs: R&D costs are accounted for in accordance with ASC Topic 730, Research and Development , (ASC 730) and are expensed as incurred. R&D costs consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for R&D activities, including nonclinical studies, clinical trials, manufacturing costs and professional services. The costs of services performed by others in connection with the R&D activities of the Company, including R&D conducted by others on behalf of the Company, shall be included in R&D costs and expensed as the contracted work is performed. We accrue the costs incurred under our agreements with these third parties based on actual work completed in accordance with agreements established with these third parties. We determine the accruals for R&D costs through monitoring invoices received and discussions with internal personnel and external service providers as to the progress or stage of completion of the clinical studies and the agreed-upon fee to be paid for such services. Where contingent milestone payments are due to third parties under R&D arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are probable to be achieved. R&D expenses for the years ended December 31, 2023, 2022 and 2021, were $49.6 million, $45.0 million and $51.1 million, respectively, and are included in total cost of sales and operating expenses on the accompanying consolidated statements of operations and comprehensive loss. |
Selling, general and administrative (SG&A) expenses | Selling, general and administrative (SG&A) expenses : The Company's SG&A expenses include commercial and allocated administrative cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, corporate facility charges and external costs required to support the marketing and sales of LUPKYNIS. These SG&A costs include corporate facility operating expenses and allocated depreciation; commercial, marketing, advertising, pharmacovigilance, publications, tradeshows, advisory boards, samples and operations in support of LUPKYNIS; patient assistance program costs; human resources; finance, legal, information technology and support personnel expenses; and other corporate costs such as telecommunications, insurance, audit and government affairs. We expense SG&A expenses as they are incurred. The Company uses a third-party logistics provider to perform a full order to cash service, which includes warehousing and shipping directly to two specialty pharmacies and receiving orders from a specialty distributor for shipping to hospitals, on our behalf. As such, since these costs are not integral to bringing the inventories to a salable condition, we elected not to treat shipping and handling costs as a fulfillment activity. Shipping and handling costs related to order fulfillment are recorded in SG&A expenses. |
Advertising costs | Advertising and marketing costs are expensed as incurred and included in SG&A. |
Share-based compensation | Shared-based compensation: The Company follows ASC Topic 718, Compensation - Stock Compensation (ASC 718), which requires the measurement and recognition of compensation expense, based on estimated fair values, for all share-based awards made to employees and directors. The Company records compensation expense based on the fair value on the grant date using the graded accelerated vesting method for all share-based payments related to stock options, performance awards (PAs), restricted stock units (RSUs) and purchases under the Company's 2021 ESPP. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. The Company has elected a policy for all share-based awards to estimate forfeitures based on historical forfeiture experience at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. |
Income taxes | Income taxes: The Company accounts for income taxes under the asset and liability method in accordance with ASC Topic 740, Income Taxes |
Recent accounting pronouncements | Recent accounting pronouncements In December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740) : Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting, and therefore, this ASU is not adopted in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) : Improvements to Reportable Segment Disclosures which requires public entities to disclose significant segment expenses regularly provided to the chief operating decision-maker. Public entities with a single reporting segment have to provide all disclosures required by ASC 280, including the significant segment expense disclosures. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting, and therefore is not adopted in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832) : Disclosures by Business Entities about Government Assistance, which requires business entities to make annual disclosures about transactions with a government (including government assistance) by analogizing to a grant or contribution accounting model. The required disclosures include the nature of the transaction, the entity's related accounting policy, the financial statement line items affected and the amounts reflected in the current period financial statements, as well as any significant terms and conditions. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted the ASU effective January 1, 2022, with no material impact on the consolidated financial statements in 2022 and 2023. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) : Simplifying the Accounting for Income Taxes, which clarifies and simplifies certain aspects of the accounting for income taxes. The standard is effective for years beginning after December 15, 2020, and interim periods within annual periods beginning after December 15, 2020. The Company adopted the ASU effective January 1, 2021 with no material impact on the consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Total Revenues, Net From Main Customers | The percentages of total revenues, net from our main customers were as follows: 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table summarizes the financial assets (cash, cash equivalents, restricted cash and investments) measured at fair value on a recurring basis: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 48,875 $ — $ — $ 48,875 U.S. agency security — — — — Corporate bond — 33,781 — 33,781 Commercial paper — 39,304 — 39,304 Treasury bill — 122,806 — 122,806 Treasury bond — 105,924 — 105,924 Total financial assets $ 48,875 $ 301,815 $ — $ 350,690 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 94,172 $ — $ — $ 94,172 U.S. agency security — 4,948 — 4,948 Corporate bond — 104,080 — 104,080 Commercial paper — 125,187 — 125,187 Treasury bill — 12,282 — 12,282 Treasury bond — 42,220 — 42,220 Yankee bond — 6,501 — 6,501 Total financial assets $ 94,172 $ 295,218 $ — $ 389,390 |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash and Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investments | December 31, 2023 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash, cash equivalents and restricted cash $ 48,875 $ — $ — $ 48,875 Corporate bond 33,576 4 — 33,580 Commercial paper 39,305 — (1) 39,304 Treasury bill 122,757 49 — 122,806 Treasury bond 105,903 21 — 105,924 Total cash, cash equivalents, restricted cash and short-term investments $ 350,416 $ 74 $ (1) $ 350,489 Total long-term investment corporate bond 200 1 — 201 Total cash, cash equivalents, restricted cash and investments $ 350,616 $ 75 $ (1) $ 350,690 December 31, 2022 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value Cash, cash equivalents and restricted cash $ 94,172 $ — $ — $ 94,172 U.S. agency security 4,951 — (3) 4,948 Corporate bond 104,174 — (94) 104,080 Commercial paper 125,255 — (68) 125,187 Treasury bill 12,290 — (8) 12,282 Treasury bond 42,301 — (81) 42,220 Yankee bond 6,503 — (2) 6,501 Total cash, cash equivalents, restricted cash and short-term investments $ 389,646 $ — $ (256) $ 389,390 |
Inventories, net (Tables)
Inventories, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The components of inventories, net are as follows: (in thousands) December 31, 2023 December 31, 2022 Raw materials $ 1,746 $ 2,217 Work in process 37,376 21,059 Finished goods 583 1,476 Total inventories, net $ 39,705 $ 24,752 |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses are as follows: (in thousands) December 31, 2023 December 31, 2022 Prepaid assets $ 6,892 $ 5,451 Prepaid deposits 1,345 6,330 Prepaid insurance 1,249 1,799 Total prepaid expenses $ 9,486 $ 13,580 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property and equipment, net are as follows: (in thousands) Estimated Useful Life December 31, 2023 December 31, 2022 Construction in progress — $ — $ 255 Leasehold improvements Shorter of term of the lease or estimated useful life 3,243 2,978 Office equipment 5 631 645 Furniture 7 1,155 976 Computer equipment 3 235 251 5,264 5,105 Less accumulated depreciation (1,910) (1,455) Property and equipment, net $ 3,354 $ 3,650 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table summarizes the carrying amount of intangible assets, net of accumulated amortization. December 31, 2023 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,847 $ (1,297) $ 550 Acquired intellectual property and reacquired rights 12 15,126 (10,737) 4,389 Internal-use software implementation costs 3 2,873 (2,835) 38 $ 19,846 $ (14,869) $ 4,977 December 31, 2022 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,569 $ (1,262) $ 307 Acquired intellectual property and reacquired rights 12 15,126 (9,838) 5,288 Internal-use software implementation costs 3 2,873 (2,043) 830 $ 19,568 $ (13,143) $ 6,425 |
Accounts payable and accrued _2
Accounts payable and accrued liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accounts payable and accrued liabilities are as follows: December 31, 2023 December 31, 2022 Employee accruals $ 22,486 $ 20,157 Commercial accruals 16,216 8,620 Accrued R&D projects 5,503 5,350 Trade payables 4,327 3,087 Other accrued liabilities 5,190 2,151 Income taxes payable 667 625 Total accounts payable and accrued liabilities $ 54,389 $ 39,990 |
Segment Information and Geogr_2
Segment Information and Geographic Data (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
Schedule of Total Revenues, Net From Main Customers | The percentages of total revenues, net from our main customers were as follows: 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% 2023 2022 2021 U.S. main commercial customers 91% 80% 100% Collaboration partnership 8% 20% —% |
Schedule of Revenue from External Customers and Long-Lived Assets, by Geographical Areas | The following geographic information reflects revenue, net of adjustments, based on customer location: (in thousands) 2023 2022 2021 Revenue United States $ 157,958 $ 102,460 $ 45,488 Japan 17,555 31,481 — Other — 89 117 Total $ 175,513 $ 134,030 $ 45,605 |
Schedule of Long-lived Assets by Geographic Areas | Long-lived assets by location consist of net property and equipment and right-of-use assets: (in thousands) December 31, 2023 December 31, 2022 Long-lived assets, net Switzerland $ 108,715 $ — United States 7,324 8,235 Canada 528 322 Total $ 116,567 $ 8,557 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income (Losses) before Income Tax, Domestic and Foreign | Income (losses) before income taxes for the years ended December 31, 2023, 2022 and 2021 was as follows: (in thousands) 2023 2022 2021 Canada $ (90,226) $ (112,359) $ (180,374) Foreign 12,757 6,007 168 $ (77,469) $ (106,352) $ (180,206) |
Schedule of Components of Income Tax Expense (Benefit) | The components of income tax expense consisted of the following for the years ended December 31, 2023, 2022 and 2021: (in thousands) 2023 2022 2021 Current: Canada $ — $ — $ — Foreign 551 1,828 760 551 1,828 760 Deferred: Canada — — — Foreign — — — Total deferred — — — Income tax expense (benefit) $ 551 $ 1,828 $ 760 |
Schedule of Effective Income Tax Rate Reconciliation | 2023 2022 2021 Canada statutory income tax benefit 24.6 % 26.7 % 26.8 % Effect of tax rates on foreign jurisdictions 0.6 0.3 — Withholding taxes (0.2) (1.1) — Impact of future rates and tax rate changes (15.6) (0.1) (0.1) Foreign tax credit 0.2 1.1 — Non-deductible share-based compensation (13.8) (8.1) (4.5) State income taxes (0.9) (0.1) — Change in valuation allowance 3.1 (21.5) (21.8) Scientific Research and Experimental Development (SRED) and Research Credits 1.3 1.1 0.3 Other — — (1.1) Effective tax rate (0.7) % (1.7) % (0.4) % |
Schedule of Deferred Tax Assets and Liabilities | The net deferred tax assets (liabilities) consisted of the following for the years ended December 31, 2023 and 2022: (in thousands) 2023 2022 Deferred tax assets: Net operating loss carry-forwards $ 137,907 $ 141,020 Share issue costs 2,325 4,209 Lease liability 23,837 1,860 Intangible assets 1,479 1,400 Research credit carry-forwards 8,263 7,462 Capitalized research and development — 1,663 Deferred compensation 2,384 3,391 Accruals 3,646 2,887 Other 2,688 2,427 Gross deferred tax assets 182,529 166,319 Valuation allowance (161,898) (164,514) Total deferred tax assets 20,631 1,805 Deferred tax liabilities: Right-of-use asset (20,060) (1,128) Property and equipment and intangible assets (571) (677) Total deferred tax liabilities (20,631) (1,805) Net deferred tax assets (liabilities) $ — $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Lease, Cost | The following table represents the weighted-average remaining lease term and discount rates for the Company's leases for the years ended December 31, 2023 and December 31, 2022: As of December 31, 2023 As of December 31, 2022 Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Operating leases 7.6 5.28% 8.7 5.3% Finance lease 6.3 6.19% — — Supplemental cash flow information related to leases for the years ended December 31, 2023, December 31, 2022 and December 31, 2021 are as follows: (in thousands) 2023 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Financing cash flows from finance lease $ (10,025) $ — $ — Operating cash flows from finance leases $ (2,311) $ — $ — Operating cash flows from operating lease $ (1,080) $ (1,160) $ (646) Initial recognition of operating lease right-of-use asset $ — $ 57 $ 419 Supplemental disclosure of noncash transactions Finance right-of-use asset obtained in exchange for lease obligations (monoplant) $ 117,622 $ — $ — Finance lease liability arising from obtaining right-of-use assets (monoplant) $ 94,140 $ — $ — |
Lessee, Operating Lease, Liability, Maturity | Future maturities of lease liabilities as of December 31, 2023 are as follows: (in thousands) Finance Lease Payments Operating Lease Payments 2024 $ 17,240 $ 1,114 2025 17,240 1,142 2026 17,240 1,170 2027 17,240 1,199 2028 17,240 1,228 Thereafter 21,551 3,302 Total lease payments 107,751 9,155 Less: imputed interest (17,663) (1,636) Total $ 90,088 $ 7,519 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Outstanding Warrants and Warrants Outstanding | The warrant activity for 2021 is as follows: Number of warrants Balance at December 31, 2020 1,690 Warrants exercised (1,684) Warrants expired (6) Balance at December 31, 2021 — |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Option Activity | The following table summarizes the number of stock options outstanding under the Plan for the years ended December 31, 2023. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2022 13,295 $ 12.09 7.74 $ 21 Granted 760 $ 9.53 Exercised/released (563) $ 5.50 Cancelled/forfeited (1,936) $ 16.08 Outstanding at December 31, 2023 11,556 $ 10.63 7.03 $ 7,967 Options exercisable, December 31, 2023 9,422 $ 11.73 Vested and expected to vest, December 31, 2023 11,379 $ 11.55 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following weighted average assumptions were used to estimate the fair value of the options granted during the years ended December 31, 2023, 2022 and 2021: 2023 2022 2021 Expected term (in years) 5 years 5 years 4 years Volatility 71 % 70 % 66 % Risk-free interest rate 3.99 % 2.06 % 0.46 % Dividend yield 0.0 % 0.0 % 0.0 % |
Schedule of Un-vested Share Activity | The following table summarizes the PA and RSU activity for the year ended December 31, 2023: Number of Shares Weighted-Average Grant Date Fair Value Unvested balance, December 31, 2022 1,980 $ 10.84 Granted 6,827 $ 9.03 Vested (583) $ 11.57 Forfeited (417) $ 9.33 Unvested balance, December 31, 2023 7,807 $ 9.29 |
Allocation of Share-Based Payments | Share-based compensation expense for the years ended December 31, 2023, 2022 and 2021 totaled approximately $45.3 million, $32.3 million and $31.2 million, respectively, as shown in the table below. Share-based compensation capitalized under inventories is recognized in cost of sales when the related product is expensed. (in thousands) 2023 2022 2021 Research and development $ 7,533 $ 3,271 $ 4,442 Selling, general and administrative 36,512 28,438 26,432 Capitalized under inventories 1,266 591 369 Share-based compensation expense $ 45,311 $ 32,300 $ 31,243 |
Share-based Payment Arrangement, Nonvested Award, Cost | As of December 31, 2023, the unrecognized share-based cost, and the estimated weighted-average amortization period, using the straight-line attribution method, was as follows (in thousands, except amortization period): Unrecognized share-based compensation expense Weighted average remaining amortization period (in years) Stock Options $ 3,795 Restricted Stock Units and Performance Awards 25,956 ESPP 708 Total unrecognized share-based compensation expense $ 30,459 1.3 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The numerator and denominator used in the calculation of basic and diluted net loss amounts per Common Share are as follows: 2023 2022 2021 Net loss for the year $ (78,020) $ (108,180) $ (180,966) Weighted average number of common shares outstanding 143,236 141,915 129,369 Net loss per common share (expressed in $ per share) $ (0.54) $ (0.76) $ (1.40) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The Company did not include the securities in the following table in the computation of the net loss per common share because the effect would have been anti-dilutive during each period: 2023 2022 2021 Outstanding stock options 11,556 13,295 12,074 Unvested performance awards 921 — 64 Unvested restricted units 6,886 1,980 191 19,363 15,275 12,329 |
Selected Quarterly Financial _2
Selected Quarterly Financial Information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following condensed quarterly financial information is for the years December 31, 2023 and 2022: (in thousands, except per share data) March 31, 2023 June 30, September 30, 2023 December 31, 2023 Total revenue, net $ 34,409 $ 41,494 $ 54,515 $ 45,095 Cost of sales and operating expenses 63,993 57,664 70,778 74,769 Loss from operations (29,584) (16,170) (16,263) (29,674) Net loss (26,206) (11,492) (13,447) (26,875) Basic and diluted loss per common share $ (0.18) $ (0.08) $ (0.09) $ (0.19) March 31, 2022 June 30, September 30, 2022 December 31, 2022 Total revenue $ 21,625 $ 28,191 $ 55,779 $ 28,435 Operating expenses 59,507 64,180 65,278 56,535 Loss from operations (37,882) (35,989) (9,499) (28,100) Net loss (37,630) (35,515) (8,989) (26,046) Basic and diluted loss per common share $ (0.27) $ (0.25) $ (0.06) $ (0.18) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 12 Months Ended | |||
Dec. 31, 2023 USD ($) segment numberOfDistributor numberOfStore | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Number of operating segments | segment | 1 | |||
Concentration risk, number of customers | segment | 2 | |||
Accounts receivable, net | $ 24,089,000 | $ 13,483,000 | ||
Number of stores | numberOfStore | 2 | |||
Number of distributor | numberOfDistributor | 1 | |||
Allowance for doubtful accounts | $ 0 | 0 | ||
Cash, cash equivalents | 48,875,000 | 94,172,000 | $ 231,900,000 | $ 272,350,000 |
Restricted cash | 120,000 | 84,000 | ||
Asset impairment charges | 0 | 0 | 0 | |
Research and development | 49,641,000 | 44,988,000 | 51,139,000 | |
Advertising expense | 15,400,000 | 16,300,000 | 15,400,000 | |
Selling, general and administrative expense | $ 195,000,000 | $ 196,400,000 | $ 173,500,000 | |
Minimum | ||||
Property, Plant and Equipment [Line Items] | ||||
Receivables, standard credit terms | 30 days | |||
Lease term | 12 months | |||
Minimum | Acquired intellectual property and reacquired rights | ||||
Property, Plant and Equipment [Line Items] | ||||
Acquired intangible assets useful life | 10 years | |||
Maximum | ||||
Property, Plant and Equipment [Line Items] | ||||
Receivables, standard credit terms | 45 days | |||
Lease term | 128 months | |||
Maximum | Acquired intellectual property and reacquired rights | ||||
Property, Plant and Equipment [Line Items] | ||||
Acquired intangible assets useful life | 12 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Total Revenues, Net From Main Customers (Details) - Two Specialty Pharmacy - Revenue Benchmark - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
U.S. main commercial customers | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk percentage | 91% | 80% | 100% |
Collaboration partnership | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk percentage | 8% | 20% | 0% |
Fair Value Measurement - Assets
Fair Value Measurement - Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Financial assets: | ||
Total financial assets | $ 350,690 | $ 389,390 |
Level 1 | ||
Financial assets: | ||
Total financial assets | 48,875 | 94,172 |
Level 2 | ||
Financial assets: | ||
Total financial assets | $ 301,815 | $ 295,218 |
Derivative, average remaining maturity | 7 months | 7 months |
Level 3 | ||
Financial assets: | ||
Total financial assets | $ 0 | $ 0 |
Cash, cash equivalents and restricted cash | ||
Financial assets: | ||
Total financial assets | 48,875 | 94,172 |
Cash, cash equivalents and restricted cash | Level 1 | ||
Financial assets: | ||
Total financial assets | 48,875 | 94,172 |
Cash, cash equivalents and restricted cash | Level 2 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Cash, cash equivalents and restricted cash | Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
U.S. agency security | ||
Financial assets: | ||
Total financial assets | 0 | 4,948 |
U.S. agency security | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
U.S. agency security | Level 2 | ||
Financial assets: | ||
Total financial assets | 0 | 4,948 |
U.S. agency security | Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Corporate bond | ||
Financial assets: | ||
Total financial assets | 33,781 | 104,080 |
Corporate bond | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Corporate bond | Level 2 | ||
Financial assets: | ||
Total financial assets | 33,781 | 104,080 |
Corporate bond | Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Commercial paper | ||
Financial assets: | ||
Total financial assets | 39,304 | 125,187 |
Commercial paper | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Commercial paper | Level 2 | ||
Financial assets: | ||
Total financial assets | 39,304 | 125,187 |
Commercial paper | Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Treasury bill | ||
Financial assets: | ||
Total financial assets | 122,806 | 12,282 |
Treasury bill | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Treasury bill | Level 2 | ||
Financial assets: | ||
Total financial assets | 122,806 | 12,282 |
Treasury bill | Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Treasury bond | ||
Financial assets: | ||
Total financial assets | 105,924 | 42,220 |
Treasury bond | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Treasury bond | Level 2 | ||
Financial assets: | ||
Total financial assets | 105,924 | 42,220 |
Treasury bond | Level 3 | ||
Financial assets: | ||
Total financial assets | $ 0 | 0 |
Yankee bond | ||
Financial assets: | ||
Total financial assets | 6,501 | |
Yankee bond | Level 1 | ||
Financial assets: | ||
Total financial assets | 0 | |
Yankee bond | Level 2 | ||
Financial assets: | ||
Total financial assets | 6,501 | |
Yankee bond | Level 3 | ||
Financial assets: | ||
Total financial assets | $ 0 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash and Investments - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |||
Cash, cash equivalents, restricted cash and investments | $ 350,700 | $ 389,400 | |
Available-for-sale debt securities | 301,800 | 295,200 | |
Interest receivable | 700 | 1,100 | |
Unrealized gains (losses) on available-for-sale securities | $ 331 | $ (209) | $ (47) |
Cash, Cash Equivalents and Re_4
Cash, Cash Equivalents and Restricted Cash and Investments - Investment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 350,416 | $ 389,646 |
Unrealized Gains | 74 | 0 |
Unrealized Losses | (1) | (256) |
Estimated Fair Value | 350,489 | 389,390 |
Total cash, cash equivalents, restricted cash and investments, amortized cost | 350,616 | |
Total cash, cash equivalents, restricted cash and investments, unrealized gains | 75 | |
Total cash, cash equivalents, restricted cash and investments, unrealized losses | (1) | |
Total cash, cash equivalents, restricted cash and investments | 350,690 | |
Cash, cash equivalents and restricted cash | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 48,875 | 94,172 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 48,875 | 94,172 |
Corporate bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 33,576 | 104,174 |
Unrealized Gains | 4 | 0 |
Unrealized Losses | 0 | (94) |
Estimated Fair Value | 33,580 | 104,080 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 39,305 | 125,255 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (1) | (68) |
Estimated Fair Value | 39,304 | 125,187 |
Treasury bill | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 122,757 | 12,290 |
Unrealized Gains | 49 | 0 |
Unrealized Losses | 0 | (8) |
Estimated Fair Value | 122,806 | 12,282 |
Treasury bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 105,903 | 42,301 |
Unrealized Gains | 21 | 0 |
Unrealized Losses | 0 | (81) |
Estimated Fair Value | 105,924 | 42,220 |
U.S. agency security | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 4,951 | |
Unrealized Gains | 0 | |
Unrealized Losses | (3) | |
Estimated Fair Value | 4,948 | |
Yankee bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 6,503 | |
Unrealized Gains | 0 | |
Unrealized Losses | (2) | |
Estimated Fair Value | $ 6,501 | |
Total long-term investment corporate bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 200 | |
Unrealized Gains | 1 | |
Unrealized Losses | 0 | |
Estimated Fair Value | $ 201 |
Inventories, Net (Details)
Inventories, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods inventories | $ 800 | $ 3,900 |
Raw materials | 1,746 | 2,217 |
Work in process | 37,376 | 21,059 |
Finished goods | 583 | 1,476 |
Total inventories, net | $ 39,705 | $ 24,752 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Receivables [Abstract] | ||
Prepaid assets | $ 6,892 | $ 5,451 |
Prepaid deposits | 1,345 | 6,330 |
Prepaid insurance | 1,249 | 1,799 |
Prepaid expenses | $ 9,486 | $ 13,580 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 5,264 | $ 5,105 | |
Less accumulated depreciation | (1,910) | (1,455) | |
Property and equipment, net | 3,354 | 3,650 | |
Depreciation | 606 | 629 | $ 663 |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 0 | 255 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 3,243 | 2,978 | |
Office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 5 years | ||
Property, plant and equipment, gross | $ 631 | 645 | |
Furniture | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 7 years | ||
Property, plant and equipment, gross | $ 1,155 | 976 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 3 years | ||
Property, plant and equipment, gross | $ 235 | $ 251 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 19,846 | $ 19,568 |
Accumulated Amortization | (14,869) | (13,143) |
Net Carrying Amount | $ 4,977 | $ 6,425 |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted Average Life (in years) | 12 years | 12 years |
Gross Carrying Value | $ 1,847 | $ 1,569 |
Accumulated Amortization | (1,297) | (1,262) |
Net Carrying Amount | $ 550 | $ 307 |
Acquired intellectual property and reacquired rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted Average Life (in years) | 12 years | 12 years |
Gross Carrying Value | $ 15,126 | $ 15,126 |
Accumulated Amortization | (10,737) | (9,838) |
Net Carrying Amount | $ 4,389 | $ 5,288 |
Internal-use software implementation costs | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted Average Life (in years) | 3 years | 3 years |
Gross Carrying Value | $ 2,873 | $ 2,873 |
Accumulated Amortization | (2,835) | (2,043) |
Net Carrying Amount | $ 38 | $ 830 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Upfront license and milestone expense | $ 1.7 | $ 2.1 | $ 2.1 |
2024 | 4.6 | ||
2025 | 4.6 | ||
2026 | 4.6 | ||
2027 | 4.6 | ||
2028 | $ 4.6 |
Accounts payable and accrued _3
Accounts payable and accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Employee accruals | $ 22,486 | $ 20,157 |
Commercial accruals | 16,216 | 8,620 |
Accrued R&D projects | 5,503 | 5,350 |
Trade payables | 4,327 | 3,087 |
Other accrued liabilities | 5,190 | 2,151 |
Income taxes payable | 667 | 625 |
Accounts payable and accrued liabilities | $ 54,389 | $ 39,990 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||||||
Aug. 17, 2021 | Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 15, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Revenues | $ 45,095,000 | $ 54,515,000 | $ 41,494,000 | $ 34,409,000 | $ 28,435,000 | $ 55,779,000 | $ 28,191,000 | $ 21,625,000 | $ 175,513,000 | $ 134,030,000 | $ 45,605,000 | |||
Research and development | 49,641,000 | 44,988,000 | 51,139,000 | |||||||||||
Otuska | License Agreement Terms | ||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Upfront payments received | $ 50,000,000 | |||||||||||||
Compensation received in regulatory | 40,000,000 | |||||||||||||
Potential regulatory milestone revenue | $ 10,000,000 | |||||||||||||
Triggered milestone, payments | $ 30,000,000 | |||||||||||||
Revenues | $ 10,000,000 | |||||||||||||
Otuska | License Agreement Terms | Service Revenue | ||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Revenues | $ 6,000,000 | $ 500,000 | $ 0 | |||||||||||
Otuska | License Agreement Terms | Minimum | ||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Tiered royalty percentages on future sales | 1,000% | |||||||||||||
Otuska | License Agreement Terms | Maximum | ||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Tiered royalty percentages on future sales | 2,000% | |||||||||||||
Riptide Bioscience, Inc. | License Agreement Terms | ||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||
Upfront license fee | $ 6,000,000 | |||||||||||||
Research and development | $ 4,000,000 |
Segment Information and Geogr_3
Segment Information and Geographic Data - Narrative (Details) - segment | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Concentration risk, number of customers | 2 | |
Customer One | Revenue Benchmark | Customer Concentration Risk | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Concentration risk percentage | 51% | 45% |
Customer Two | Revenue Benchmark | Customer Concentration Risk | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Concentration risk percentage | 40% | 35% |
Segment Information and Geogr_4
Segment Information and Geographic Data - Schedule of Total Revenues, Net From Main Customers (Details) - Revenue Benchmark - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Two Specialty Pharmacy | U.S. main commercial customers | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Concentration risk percentage | 91% | 80% | 100% |
Two Specialty Pharmacy | Collaboration partnership | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Concentration risk percentage | 8% | 20% | 0% |
Customer One | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Concentration risk percentage | 51% | 45% | |
Customer Two | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Concentration risk percentage | 40% | 35% |
Segment Information and Geogr_5
Segment Information and Geographic Data - Revenue by Geographic Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | $ 45,095 | $ 54,515 | $ 41,494 | $ 34,409 | $ 28,435 | $ 55,779 | $ 28,191 | $ 21,625 | $ 175,513 | $ 134,030 | $ 45,605 |
United States | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | 157,958 | 102,460 | 45,488 | ||||||||
Japan | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | 17,555 | 31,481 | 0 | ||||||||
Other | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | $ 0 | $ 89 | $ 117 |
Segment Information and Geogr_6
Segment Information and Geographic Data - Long-lived Assets by Location (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets, net | $ 116,567 | $ 8,557 |
Switzerland | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets, net | 108,715 | 0 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets, net | 7,324 | 8,235 |
Canada | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets, net | $ 528 | $ 322 |
Income Taxes - Components of In
Income Taxes - Components of Income (Losses) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Canada | $ (90,226) | $ (112,359) | $ (180,374) |
Foreign | 12,757 | 6,007 | 168 |
Net loss before income taxes | $ (77,469) | $ (106,352) | $ (180,206) |
Income Taxes - Provision For In
Income Taxes - Provision For Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | |||
Canada | $ 0 | $ 0 | $ 0 |
Foreign | 551 | 1,828 | 760 |
Total Current | 551 | 1,828 | 760 |
Deferred: | |||
Canada | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | 0 |
Income tax expense (benefit) | $ 551 | $ 1,828 | $ 760 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Canada statutory income tax benefit | 24.60% | 26.70% | 26.80% |
Effect of tax rates on foreign jurisdictions | 0.60% | 0.30% | 0% |
Withholding taxes | (0.20%) | (1.10%) | 0% |
Impact of future rates and tax rate changes | (15.60%) | (0.10%) | (0.10%) |
Foreign tax credit | 0.20% | 1.10% | 0% |
Non-deductible share-based compensation | (13.80%) | (8.10%) | (4.50%) |
State income taxes | (0.90%) | (0.10%) | 0% |
Change in valuation allowance | 3.10% | (21.50%) | (21.80%) |
Scientific Research and Experimental Development (SRED) and Research Credits | 1.30% | 1.10% | 0.30% |
Other | 0% | 0% | (1.10%) |
Effective tax rate | (0.70%) | (1.70%) | (0.40%) |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carry-forwards | $ 137,907 | $ 141,020 |
Share issue costs | 2,325 | 4,209 |
Lease liability | 23,837 | 1,860 |
Intangible assets | 1,479 | 1,400 |
Research credit carry-forwards | 8,263 | 7,462 |
Capitalized research and development | 0 | 1,663 |
Deferred compensation | 2,384 | 3,391 |
Accruals | 3,646 | 2,887 |
Other | 2,688 | 2,427 |
Gross deferred tax assets | 182,529 | 166,319 |
Valuation allowance | (161,898) | (164,514) |
Total deferred tax assets | 20,631 | 1,805 |
Deferred tax liabilities: | ||
Right-of-use asset | (20,060) | (1,128) |
Property and equipment and intangible assets | (571) | (677) |
Total deferred tax liabilities | (20,631) | (1,805) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||
Canada statutory income tax benefit | 24.60% | 26.70% | 26.80% |
Increase in valuation allowance | $ 2.6 | ||
Operating loss carryforwards | 557.1 | ||
Domestic Tax Authority | Research Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | 6.5 | ||
Foreign Tax Authority | United States | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 4.1 | ||
Foreign Tax Authority | Research Tax Credit Carryforward | United States | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | $ 0.1 |
Commitment and Contingencies (D
Commitment and Contingencies (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Long-term Purchase Commitment [Line Items] | |||
Purchase of long-lived assets | $ 718 | $ 292 | $ 303 |
Lonza | |||
Long-term Purchase Commitment [Line Items] | |||
Non-cancellable future commitments | 11,000 | ||
Purchase of long-lived assets | $ 900 |
Deferred Compensation and Oth_2
Deferred Compensation and Other Non-current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Other non-current liabilities | $ 10,911 | $ 12,166 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands, SFr in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Feb. 28, 2021 USD ($) | Feb. 28, 2021 CHF (SFr) | Jan. 31, 2021 CHF (SFr) | Mar. 31, 2020 ft² extension_option | Sep. 30, 2023 USD ($) | Sep. 30, 2023 CHF (SFr) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jul. 31, 2023 USD ($) | Oct. 31, 2022 ft² | Mar. 12, 2020 | |
Lessee, Lease, Description [Line Items] | |||||||||||||
Operating lease, weighted average discount rate | 5.28% | 5.30% | |||||||||||
Operating right-of-use assets, net | $ 4,498 | $ 4,907 | |||||||||||
Operating lease, liability | 7,519 | ||||||||||||
Operating lease, cost | 800 | 1,000 | $ 1,000 | ||||||||||
Finance lease payments | 10,025 | 0 | $ 0 | ||||||||||
Finance right-of-use asset, net | 108,715 | 0 | |||||||||||
Finance lease, liability | $ 90,088 | ||||||||||||
Finance lease, weighted average discount rate | 6.19% | ||||||||||||
Rockville, Maryland | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Area of property (in sqft) | ft² | 30,531 | ||||||||||||
Remaining lease term | 8 years | ||||||||||||
Number of extension options | extension_option | 2 | ||||||||||||
Lease extension term | 5 years | ||||||||||||
Lease term | 11 years | ||||||||||||
Lease termination option term | 7 years | ||||||||||||
Proceeds from tenant improvements | $ 2,300 | ||||||||||||
Operating lease, weighted average discount rate | 5.20% | ||||||||||||
Operating right-of-use assets, net | $ 4,500 | 4,900 | |||||||||||
Operating lease, liability | 7,400 | $ 8,000 | |||||||||||
Edmonton, Alberta | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Area of property (in sqft) | ft² | 4,375 | ||||||||||||
Remaining lease term | 6 years | ||||||||||||
Lease extension term | 5 years | ||||||||||||
Visp, Switzerland | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Payments for capital improvements | SFr | SFr 21 | ||||||||||||
Finance lease payments | $ 11,800 | SFr 10.5 | $ 11,900 | SFr 10.5 | |||||||||
Finance right-of-use asset, net | 108,700 | $ 117,600 | |||||||||||
Finance lease, liability | 90,100 | $ 94,100 | |||||||||||
Finance lease, weighted average discount rate | 6.19% | ||||||||||||
Right-of-use asset, amortization | 8,900 | ||||||||||||
Finance lease, interest expense | 2,800 | ||||||||||||
Foreign exchange loss | 5,900 | ||||||||||||
Beinheim, France | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Expected payments prior to commencement of lease | 1,000 | ||||||||||||
Future value of minimum lease payments of leases not yet commenced | $ 100 |
Leases - Cash Flow and Suppleme
Leases - Cash Flow and Supplemental Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | |||
Operating lease, weighted average remaining lease term (years) | 7 years 7 months 6 days | 8 years 8 months 12 days | |
Operating lease, weighted average discount rate | 5.28% | 5.30% | |
Finance lease, operating lease, weighted average remaining lease term (years) | 6 years 3 months 18 days | ||
Finance lease, weighted average discount rate | 6.19% | ||
Cash paid for amounts included in the measurement of lease liabilities | |||
Financing cash flows from finance lease | $ (10,025) | $ 0 | $ 0 |
Operating cash flows from finance leases | (2,311) | 0 | 0 |
Operating cash flows from operating lease | (1,080) | (1,160) | (646) |
Operating right-of-use assets, net | 0 | 57 | 419 |
Supplemental disclosure of noncash transactions | |||
Finance right-of-use asset obtained in exchange for lease obligations (monoplant) | 117,622 | 0 | 0 |
Finance lease liability arising from obtaining right-of-use assets (monoplant) | $ 94,140 | $ 0 | $ 0 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
2024 | $ 17,240 |
2025 | 17,240 |
2026 | 17,240 |
2027 | 17,240 |
2028 | 17,240 |
Thereafter | 21,551 |
Total lease payments | 107,751 |
Less: imputed interest | (17,663) |
Total | 90,088 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
2024 | 1,114 |
2025 | 1,142 |
2026 | 1,170 |
2027 | 1,199 |
2028 | 1,228 |
Thereafter | 3,302 |
Total lease payments | 9,155 |
Less: imputed interest | (1,636) |
Total | $ 7,519 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||||||
Nov. 19, 2021 USD ($) $ / shares shares | Dec. 28, 2016 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) $ / shares shares | Dec. 31, 2019 USD ($) $ / shares | Dec. 31, 2023 numberOfVote shares | Dec. 31, 2022 shares | |
Class of Stock [Line Items] | ||||||||
Common stock, outstanding (in shares) | 141,600,000 | 141,600,000 | 143,833,000 | 142,268,000 | ||||
Common stock, issued (in shares) | 141,600,000 | 141,600,000 | 143,833,000 | 142,268,000 | ||||
Number of vote | numberOfVote | 1 | |||||||
Warrants exercised during period (in shares) | 1,700,000 | 500 | ||||||
Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants exercised during period (in shares) | 1,684,000 | |||||||
Number of warrants outstanding (in shares) | 0 | 0 | 1,690,000 | |||||
Warrants expired (in shares) | 6,000 | |||||||
Common Shares | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, outstanding (in shares) | 141,600,000 | 141,600,000 | 126,725,000 | 143,833,000 | 142,268,000 | |||
November 2021 Open Market Sale Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate offering price | $ | $ 250,000,000 | |||||||
Number of shares issued (in share) | 10,200,000 | |||||||
Weighted average price per share (in usd per share) | $ / shares | $ 19.90 | |||||||
Proceeds from offering | $ | $ 202,400,000 | |||||||
Share issuance costs | $ | $ 5,600,000 | |||||||
Underwriting commissions percentage | 3% | |||||||
Underwriting commissions | $ | $ 5,300,000 | |||||||
Professional fees | $ | $ 300,000 | |||||||
2016 Bought Deal Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued (in share) | 12,800,000 | |||||||
Subscription price per unit (in usd per share) | $ / shares | $ 2.25 | |||||||
Exercise price of warrants (in usd per share) | $ / shares | $ 3 | $ 3 | $ 3 | $ 3 | $ 3 | |||
Finance lease payments | $ | $ 300,000 | $ 2,000 | $ 5,500,000 | |||||
Warrants expired (in shares) | 6,000 | |||||||
2016 Bought Deal Public Offering | Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from offering | $ | $ 28,800,000 | |||||||
Share issuance costs | $ | $ 655,000 | |||||||
Warrant exercise period | 5 years | |||||||
Fair value of warrants | $ | $ 7,200,000 | |||||||
Number of warrants outstanding (in shares) | 1,600,000 | 1,600,000 | ||||||
2016 Bought Deal Public Offering | Warrants | 2014 Warrant | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares called by each warrant (in shares) | 0.50 | |||||||
2016 Bought Deal Public Offering | Common Shares | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||
Number of shares converted (in shares) | 1,300,000 |
Shareholders' Equity - Warrant
Shareholders' Equity - Warrant Activity (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Warrant or Right [Roll Forward] | ||
Warrants exercised (in shares) | (1,700,000) | (500) |
Warrants | ||
Class of Warrant or Right [Roll Forward] | ||
Beginning balance (in shares) | 1,690,000 | |
Warrants exercised (in shares) | (1,684,000) | |
Warrants expired (in shares) | (6,000) | |
Ending balance (in shares) | 0 | 1,690,000 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) purchase_period $ / shares shares | Dec. 31, 2021 USD ($) purchase_period $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average price (in usd per share) | $ / shares | $ 5.86 | $ 6.52 | $ 7.34 | |
Fair value of options vested in period | $ 40,900,000 | $ 49,200,000 | $ 24,900,000 | |
Intrinsic value of options exercised | 2,000,000 | 900,000 | 50,300,000 | |
Share-based compensation expense | $ 45,311,000 | $ 32,300,000 | $ 31,243,000 | |
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares authorized (in shares) | shares | 2,500,000 | |||
Number of shares purchased (in shares) | shares | 419,000 | 286,000 | ||
Number of purchase periods | purchase_period | 2 | 4 | ||
Purchase period | 12 months | 24 months | ||
Offering period | 12 months | |||
Inducement Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise period | 10 years | |||
Award vesting period | 3 years | |||
Inducement Stock Option | Tranche One | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Award vesting period | 12 months | |||
Inducement Stock Option | Tranche Two | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Award vesting period | 24 months | |||
Restricted Stock Units and Performance Awards | Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average price (in usd per share) | $ / shares | $ 9.03 | $ 11.16 | $ 14.42 | |
Fair value of options vested in period | $ 5,400,000 | $ 2,900,000 | $ 0 | |
Amended and Restated Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of additional shares authorized (in shares) | shares | 23,800,000 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares (in thousands) | ||
Beginning balance (in shares) | 13,295 | |
Granted (in shares) | 760 | |
Exercised/released (in shares) | (563) | |
Cancelled/forfeited (in shares) | (1,936) | |
Ending balance (in shares) | 11,556 | 13,295 |
Options exercisable (in shares) | 9,422 | |
Vested and expected to vest (in shares) | 11,379 | |
Weighted-Average Exercise Price | ||
Beginning balance (in usd per share) | $ 10.63 | $ 12.09 |
Granted (in usd per share) | 9.53 | |
Exercised/released (in usd per share) | 5.50 | |
Cancelled/forfeited (in usd per share) | 16.08 | |
Ending balance (in usd per share) | 10.63 | $ 12.09 |
Options exercisable (in usd per share) | 11.73 | |
Vested and expected to vest (in usd per share) | $ 11.55 | |
Weighted-Average Remaining Contractual Life (in years) | 7 years 10 days | 7 years 8 months 26 days |
Aggregate Intrinsic Value | $ 7,967 | $ 21 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |||
Expected term (in years) | 5 years | 5 years | 4 years |
Volatility | 71% | 70% | 66% |
Risk-free interest rate | 3.99% | 2.06% | 0.46% |
Dividend yield | $ 0 | $ 0 | $ 0 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Un-vested Share Activity (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Number of Shares (in thousands) | |
Unvested balance (in shares) | shares | 1,980 |
Granted (in shares) | shares | 6,827 |
Vested (in shares) | shares | (583) |
Forfeited (in shares) | shares | (417) |
Unvested balance (in shares) | shares | 7,807 |
Weighted-Average Grant Date Fair Value | |
Unvested balance (in usd per share) | $ / shares | $ 10.84 |
Granted (in usd per share) | $ / shares | 9.03 |
Vested (in usd per share) | $ / shares | 11.57 |
Forfeited (in usd per share) | $ / shares | 9.33 |
Unvested balance (in usd per share) | $ / shares | $ 9.29 |
Share-Based Compensation - Allo
Share-Based Compensation - Allocated Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 45,311 | $ 32,300 | $ 31,243 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 7,533 | 3,271 | 4,442 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 36,512 | 28,438 | 26,432 |
Capitalized under inventories | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 1,266 | $ 591 | $ 369 |
Share-Based Compensation - Unre
Share-Based Compensation - Unrecognized Share-Based Compensation Expense (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 30,459 |
Weighted average remaining amortization period (in years) | 1 year 3 months 18 days |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 3,795 |
Weighted average remaining amortization period (in years) | |
Restricted Stock Units and Performance Awards | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 25,956 |
Weighted average remaining amortization period (in years) | |
ESPP | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 708 |
Weighted average remaining amortization period (in years) |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (26,875) | $ (13,447) | $ (11,492) | $ (26,206) | $ (26,046) | $ (8,989) | $ (35,515) | $ (37,630) | $ (78,020) | $ (108,180) | $ (180,966) |
Weighted average number of common shares outstanding, basic (in shares) | 143,236 | 141,915 | 129,369 | ||||||||
Weighted average number of common shares outstanding, diluted (in shares) | 143,236 | 141,915 | 129,369 | ||||||||
Net loss per common Share, basic (in usd per share) | $ (0.19) | $ (0.09) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.06) | $ (0.25) | $ (0.27) | $ (0.54) | $ (0.76) | $ (1.40) |
Net loss per common Share, diluted (in usd per share) | $ (0.19) | $ (0.09) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.06) | $ (0.25) | $ (0.27) | $ (0.54) | $ (0.76) | $ (1.40) |
Net Loss Per Common Share - Ant
Net Loss Per Common Share - Anti-Dilutive Securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 19,363,000 | 15,275,000 | 12,329,000 |
Outstanding stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 11,556,000 | 13,295,000 | 12,074,000 |
Unvested performance awards | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 921,000 | 0 | 64,000 |
Unvested restricted units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,886,000 | 1,980,000 | 191,000 |
Related Party (Details)
Related Party (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Other current liabilities | $ 2,388,000 | $ 2,033,000 | |
Other non-current liabilities | 10,911,000 | 12,166,000 | |
Related Party | |||
Related Party Transaction [Line Items] | |||
Other current liabilities | 800,000 | ||
Other non-current liabilities | 7,600,000 | ||
Dr. Robert T. Foster | |||
Related Party Transaction [Line Items] | |||
Payments of deferred compensation | 100,000 | ||
Milestone Payment | Affiliated Shareholder | ILJIN | |||
Related Party Transaction [Line Items] | |||
Payments to related party | 500,000 | $ 0 | $ 6,000,000 |
Employee Benefit Obligations | Dr. Robert T. Foster | |||
Related Party Transaction [Line Items] | |||
Other current liabilities | 800,000 | ||
Other non-current liabilities | $ 7,600,000 | ||
ILJIN | Milestone Achieved | Related Party | |||
Related Party Transaction [Line Items] | |||
Ownership percentage | 5% |
Selected Quarterly Financial _3
Selected Quarterly Financial Information (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenue, net | $ 45,095 | $ 54,515 | $ 41,494 | $ 34,409 | $ 28,435 | $ 55,779 | $ 28,191 | $ 21,625 | $ 175,513 | $ 134,030 | $ 45,605 |
Cost of sales and operating expenses | 74,769 | 70,778 | 57,664 | 63,993 | 56,535 | 65,278 | 64,180 | 59,507 | |||
Loss from operations | (29,674) | (16,263) | (16,170) | (29,584) | (28,100) | (9,499) | (35,989) | (37,882) | (91,691) | (111,470) | (180,735) |
Net loss | $ (26,875) | $ (13,447) | $ (11,492) | $ (26,206) | $ (26,046) | $ (8,989) | $ (35,515) | $ (37,630) | $ (78,020) | $ (108,180) | $ (180,966) |
Basic loss per share (in usd per share) | $ (0.19) | $ (0.09) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.06) | $ (0.25) | $ (0.27) | $ (0.54) | $ (0.76) | $ (1.40) |
Diluted loss per share (in usd per share) | $ (0.19) | $ (0.09) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.06) | $ (0.25) | $ (0.27) | $ (0.54) | $ (0.76) | $ (1.40) |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Feb. 14, 2024 | |
Subsequent Event [Line Items] | ||
Share repurchase program | $ 150 | |
Minimum | Forecast | ||
Subsequent Event [Line Items] | ||
Research and development process | $ 11 | |
Maximum | Forecast | ||
Subsequent Event [Line Items] | ||
Research and development process | $ 15 |