Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 001-36421 | ||
Entity Registrant Name | Aurinia Pharmaceuticals Inc. | ||
Entity Incorporation, State or Country Code | Z4 | ||
Entity Tax Identification Number | 46-4129078 | ||
Entity Address, Address Line One | #1203-4464 Markham Street | ||
Entity Address, City or Town | Victoria | ||
Entity Address, State or Province | BC | ||
Entity Address, Postal Zip Code | V8Z 7X8 | ||
City Area Code | (250) | ||
Local Phone Number | 708-4272 | ||
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 | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,660 | ||
Entity Common Stock, Shares Outstanding | 141,653,780 | ||
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, 2021 are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001600620 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor [Abstract] | |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | Edmonton, Canada |
Auditor Firm ID | 271 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash, cash equivalents and restricted cash | $ 231,900 | $ 272,350 |
Total short term investments | 234,178 | 125,979 |
Accounts receivable, net | 15,414 | 0 |
Inventories, net | 19,326 | 13,927 |
Prepaid expenses and other current assets | 12,506 | 7,171 |
Total current assets | 513,324 | 419,427 |
Non-current assets: | ||
Long-term investments | 0 | 24,380 |
Other non-current assets | 11,838 | 247 |
Property and equipment, net | 4,418 | 4,786 |
Acquired intellectual property and other intangible assets, net | 8,404 | 9,332 |
Right-of-use assets | 5,383 | 5,489 |
Total assets | 543,367 | 463,661 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 34,947 | 24,797 |
Other current liabilities (of which $6,000 due to related party in 2020) | 4,640 | 6,412 |
Operating lease liabilities | 1,059 | 788 |
Total current liabilities | 40,646 | 31,997 |
Non-current liabilities: | ||
Deferred compensation and other non-current liabilities | 15,950 | 16,295 |
Operating lease liabilities | 7,680 | 7,619 |
Liabilities | 64,276 | 55,911 |
Commitments and Contingencies | ||
Stockholders' equity | ||
Common shares - no par value, unlimited shares authorized, 141,600 and 126,725 shares issued and outstanding at December 31, 2021 and 2020, respectively | 1,177,051 | 944,328 |
Additional paid-in capital | 59,014 | 39,383 |
Accumulated other comprehensive loss | (852) | (805) |
Accumulated deficit | (756,122) | (575,156) |
Total shareholders' equity | 479,091 | 407,750 |
Total liabilities and shareholders' equity | $ 543,367 | $ 463,661 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Due to related party, current | $ 6,000 | |
Common stock, par value ($ per share) | $ 0 | $ 0 |
Common stock, issued (shares) | 141,600,000 | 126,725,000 |
Common stock, outstanding (shares) | 141,600,000 | 126,725,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Net revenue: | |||
Total revenue, net | $ 45,605 | $ 50,118 | $ 318 |
Operating expenses: | |||
Cost of sales | 1,091 | 0 | 0 |
Selling, general and administrative | 171,438 | 95,983 | 22,338 |
Research and development | 51,139 | 50,327 | 52,866 |
Amortization of intangible assets | 2,098 | 1,289 | 1,138 |
Other expense, net | 574 | 6,809 | 14,919 |
Total cost of sales and operating expenses | 226,340 | 154,408 | 91,261 |
Loss from operations | (180,735) | (104,290) | (90,943) |
Interest income | 529 | 1,516 | 2,702 |
Net loss before income taxes | (180,206) | (102,774) | (88,241) |
Income tax expense (benefit) | 760 | (94) | 144 |
Net loss | (180,966) | (102,680) | (88,385) |
Other comprehensive loss: | |||
Unrealized (loss) gain on available-for-sale securities, net of tax of nil | (47) | 0 | 0 |
Comprehensive loss | $ (181,013) | $ (102,680) | $ (88,385) |
Basic loss per common share (in dollars per share) | $ (1.40) | $ (0.87) | $ (0.95) |
Diluted loss per common share (in dollars per share) | $ (1.40) | $ (0.87) | $ (0.95) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share (in dollars per share) | 129,369,000 | 118,473,000 | 93,024,000 |
Product revenue, net | |||
Net revenue: | |||
Total revenue, net | $ 45,488 | $ 0 | $ 0 |
License and contract revenue | |||
Net revenue: | |||
Total revenue, net | $ 117 | $ 50,118 | $ 318 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity Statement - USD ($) $ in Thousands | Total | Common Shares | Additional Paid-In Capital | Accumulated other comprehensive loss | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2018 | 85,500,000 | ||||
Balance at Dec. 31, 2018 | $ 135,717 | $ 488,744 | $ 31,869 | $ (805) | $ (384,091) |
Increase (Decrease) in Stockholders' Equity | |||||
Issue of common shares upon public offerings, net of issuance costs | 223,118 | $ 223,118 | |||
Issuance of common shares (in shares) | 19,735,000 | ||||
Exercise of warrants | 6,988 | $ 12,428 | (5,440) | ||
Exercise of warrants (in shares) | 2,983,000 | ||||
Exercise of stock options | $ 13,748 | $ 22,197 | (8,449) | ||
Exercise of stock options (in shares) | 3,578,000 | 3,580,000 | |||
Share-based compensation | $ 7,414 | 7,414 | |||
Net loss | $ (88,385) | (88,385) | |||
Balance (in shares) at Dec. 31, 2019 | 111,800,000 | 111,798,000 | |||
Balance at Dec. 31, 2019 | $ 298,600 | $ 746,487 | 25,394 | (805) | (472,476) |
Increase (Decrease) in Stockholders' Equity | |||||
Issue of common shares upon public offerings, net of issuance costs | 187,732 | $ 187,732 | |||
Issuance of common shares (in shares) | 13,333,000 | ||||
Exercise of warrants | 1 | $ 2 | (1) | ||
Exercise of warrants (in shares) | 1,000 | ||||
Exercise of stock options | $ 6,643 | $ 10,107 | (3,464) | ||
Exercise of stock options (in shares) | 1,593,000 | 1,593,000 | |||
Share-based compensation | $ 17,454 | 17,454 | |||
Net loss | $ (102,680) | (102,680) | |||
Balance (in shares) at Dec. 31, 2020 | 126,725,000 | 126,725,000 | |||
Balance at Dec. 31, 2020 | $ 407,750 | $ 944,328 | 39,383 | (805) | (575,156) |
Increase (Decrease) in Stockholders' Equity | |||||
Issue of common shares upon public offerings, net of issuance costs | 196,740 | $ 196,740 | |||
Issuance of common shares (in shares) | 10,166,000 | ||||
Exercise of warrants | 365 | $ 2,102 | (1,737) | ||
Exercise of warrants (in shares) | 1,434,000 | ||||
Exercise of stock options | $ 23,421 | $ 33,073 | (9,652) | ||
Exercise of stock options (in shares) | 3,238,000 | 3,238,000 | |||
Issuance of common shares in conjunction with ESPP program (in shares) | 37,000 | ||||
Issued pursuant to ESPP | $ 585 | $ 808 | (223) | ||
Share-based compensation | 31,243 | 31,243 | |||
Other comprehensive income | (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) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Cash flows from operating activities: | |||
Net loss | $ (180,966) | $ (102,680) | $ (88,385) |
Adjustments to reconcile consolidated net loss to net cash used in operating activities: | |||
Depreciation of property and equipment | 663 | 82 | 33 |
Amortization of intangible assets | 2,098 | 1,289 | 1,138 |
Upfront license and milestone expense | 10,000 | 0 | 0 |
Share-based compensation | 31,243 | 17,454 | 7,414 |
Other, net | 903 | 9,477 | 14,186 |
Net changes in operating assets and liabilities: | |||
Accounts receivable, net | (15,415) | (650) | (151) |
Inventories, net | (5,644) | (13,927) | 0 |
Prepaid expenses and other current assets | (5,335) | 2,559 | (1,826) |
Non-current assets | 247 | 0 | 0 |
Right of use assets | 106 | (5,489) | 0 |
Accounts payable and accrued liabilities | 4,076 | 13,620 | 4,006 |
Lease liabilities | 332 | 8,407 | 0 |
Net cash used in operating activities | (157,692) | (69,858) | (63,585) |
Cash flows from investing activities: | |||
Proceeds on investments | 354,427 | 52,108 | 7,884 |
Purchase of investments | (438,958) | (202,951) | 0 |
Upfront lease payment | (11,838) | 0 | 0 |
Upfront license payment | (6,000) | 0 | 0 |
Purchase of long-lived assets | (297) | (5,584) | (85) |
Additions to internal use-software implementation costs | (1,198) | (1,675) | 0 |
Capitalized patent costs | (6) | (84) | (16) |
Net cash used in investing activities | (103,870) | (158,186) | 7,783 |
Cash flows from financing activities: | |||
Proceeds from issuance of common shares pursuant to Public Offering, net of issuance costs | 196,740 | 187,732 | 223,118 |
Proceeds from exercise of share options and employee share purchase plan | 24,007 | 6,642 | 13,748 |
Proceeds from exercise of warrants | 365 | 1 | 6,988 |
Net cash provided by financing activities | 221,112 | 194,375 | 243,854 |
Net (decrease) increase in cash and cash equivalents during the year | (40,450) | (33,669) | 188,052 |
Cash and cash equivalents, beginning of the year | 272,350 | 306,019 | 117,967 |
Cash, cash equivalents and restricted cash, end of the year | 231,900 | 272,350 | 306,019 |
Supplemental cash flow information: | |||
Cash paid for legal settlement | 0 | 0 | (100) |
Cash received for interest | 749 | 1,884 | 2,619 |
Cash paid for taxes | (257) | (261) | (59) |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets | |||
Cash, cash equivalents | 231,643 | 272,350 | 306,019 |
Restricted cash | 257 | 0 | 0 |
Total cash, cash equivalents and restricted cash | $ 231,900 | $ 272,350 | $ 306,019 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
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 commercial-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The Company has commercially launched LUPKYNIS in the United States for the treatment of adult patients with active LN, and continues to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN. On August 17, 2021, the Company announced the addition of two novel assets AUR200 and AUR300. AUR200 is currently undergoing pre-clinical development with projected submission of an Investigational New Drug Application (IND) to the FDA in 2023. The Company anticipates that an IND for AUR300 will be submitted during the first half of 2023. Aurinia's head office is located at #1203-4464 Markham Street, Victoria, British Columbia, Canada and its registered office is located at #201, 17873-106 A Avenue, Edmonton, Alberta. Aurinia also has a U.S. Commercial office located at 77 Upper Rock Circle, Rockville, Maryland, United States. Aurinia is incorporated pursuant to the Business Corporations Act (Alberta). The Company’s common shares are currently listed and traded on the Nasdaq Global Market (Nasdaq) under the symbol AUPH and on the Toronto Stock Exchange (TSX) under the symbol AUP until July 30, 2021. As of July 30, 2021, the Company's common shares no longer trade on the TSX following the voluntary delisting by the Company and are solely traded on the Nasdaq. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
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. References to generally accepted accounting principles (GAAP) or U.S. GAAP in these footnotes are to the FASB Accounting Standards Codification (ASC or the Codification). At the end of the second quarter of 2020, the Company determined that it no longer qualified as a Foreign Private Issuer under the SEC rules. As a result, beginning January 1, 2021 the Company is required to report with the SEC on domestic forms and comply with domestic company rules in the United States. 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, 2021 and 2020, and the results of operations and cash flows for the three years ended December 31, 2021, 2020 and 2019. All significant 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 assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at the exchange rate on the balance sheet date. Revenues and expenses are remeasured at the average exchange rate during 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. Fair value measurements: The Company's financial instruments consist primarily of cash and cash equivalents, short-term and long-term 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 and cash equivalents and short term investments. The Company attempts to minimize the risks related to cash and cash equivalents 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 Canadian dollar, Swiss France, Great British Pound and Japanese Yen 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, which mitigates the risk of material foreign exchange fluctuations. Major customers : The Company currently has three main customers for the U.S. commercial sales of LUPKYNIS and one customer for sales of voclosporin in the European Union, Japan, as well as United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Revenues from two customers accounted for approximately 56% and 43% of the Company's total revenues for the year ending December 31, 2021. Two individual customers accounted for 99% of the Company’s net trade accounts receivable balances as of December 31, 2021. 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, including their payment plans and obtains positive confirmation of the validity of the receivables. COVID-19: U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the annual consolidated financial statements and accompanying notes. The annual consolidated financial statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. The full extent to which the novel coronavirus (COVID-19) pandemic will directly or indirectly impact the Company’s financial statements related to items such as investments (Note 4), inventories (Note 6), income taxes (Note 13), leases (Note 16), share-based compensation (Note 18) or results of operations will depend on future developments that are uncertain at this time. As events continue to evolve and additional information becomes available, the Company’s estimates may change materially in future periods. 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 $231.9 million as of December 31, 2021. The Company has invested its cash reserves 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 $0.3 million and nil as of December 31, 2021 and December 31, 2020, respectively. Investments: The Company classifies its debt securities as either held to maturity or available-for-sale in accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 320, Investments — Debt Securities . Investments classified as held to maturity are carried at amortized cost when management has the positive intent and ability to hold them to maturity. Investments classified as available-for-sale are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses on held to maturity and available-for-sale securities are recorded in other income (expense), net. Interest income (expense) is recorded separately on the consolidated statements of operations. The cost of securities sold is based on the specific-identification method. Accounts receivable, net: Accounts receivables are stated at their net realizable value less an allowance for doubtful accounts. As of December 31, 2021, accounts receivable, net are $15.4 million. We estimate the allowance for doubtful accounts using current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. We evaluate 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 us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature of our accounts receivable, we determined that an allowance for doubtful accounts was nil at December 31, 2021. Accounts receivables 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 United States. These reserves are recorded as a reduction of accounts receivable. Intangible assets: Intangible assets are amortized over their useful lives using methods that correlate to the pattern in which the economic benefits are expected to be realized. All intangible assets are amortized on a straight-line basis. 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 periodically reviewed 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. Other intellectual property expenditures are recorded as R&D expenses on the consolidated statements of operations as incurred. Patents do not contain the option to extend or renew. Separately acquired intellectual property is shown at historical cost. The initial recognition of 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 20 years. Property, plant and equipment: Property, plant and equipment are recorded at cost and is 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 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, 2021, 2020 and 2019. 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. Certain leases have lease and non-lease components, which are accounted for as a single lease component. 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 will be accounted for as a financing lease once lease commencement begins (see Note 16). The Company adopted ASC Topic 842 on January 1, 2019, which requires lessees to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use asset (ROU asset), which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. ASC 842 also requires lessees to classify leases as either finance or operating leases based on whether or not the lease is effectively a financed purchase of the leased asset by the lessee. This classification is used to evaluate whether the lease expense should be recognized based on an effective interest method or on a straight-line basis over the term of the lease. The Company elected, for all asset classes, 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 sheet, and fixed costs associated with these arrangements are disclosed in Note 16 of the financial statements. The Company has elected to recognize lease incentives, such as tenant improvement allowances, at the lease commencement date as a reduction of the ROU asset and lease liability until paid to the Company by the lessor, to the extent that the lease provides a specified fixed or maximum level of reimbursement, and the Company is reasonably certain to incur reimbursable costs at least equaling such amounts. Operating 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. The table in Note 16 provides supplemental balance sheet information related to the operating lease ROU assets and lease liabilities. 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 use 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-US geographies include timing of approval in ex-US territories, escalating royalty rates, net pricing, government payor coverage of the product, and market penetration. In determining the estimate for ex-US revenues, the Company relies heavily 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 our US 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. 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. 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 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, depreciation 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 specialty pharmacies and specialty distributors. These customers subsequently resell the Company's products to health care providers and patients. Revenues from product sales are recognized when the customer obtains control of our 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's 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. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjust these estimates, which could have an effect on earnings in the period of adjustment. 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. License, Collaboration and Other Revenues The Company enters into out-licensing agreements that are within the scope of ASC 606, under which it licenses certain rights to its product candidates 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. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. 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 in license, collaboration and other revenues when the licensee obtains control of the goods, which is typically upon delivery. 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 |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The standard requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The adoption of the standard as of January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirement for Fair Value Measurement . Topic 820 requires to disclose transfers into and out of Level 3 of the fair value hierarchy and purchases and issues of Level 3 assets and liabilities. For investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when the restrictions from redemptions might lapse only if the investee has communicated the timing to the entity or announced the timing publicly. The new standard also amends that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The new standard is effective for fiscal years beginning after December 15, 2019. The standard should be applied retrospectively to the date of initial application of ASU 2014-09, Revenue from Contracts with Customers (Topic 606) . The Company elected to adopt the amendment as of January 1, 2020, which did not have a material impact on the consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40)-Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which aligns the accounting for implementation costs incurred in a hosting arrangement that is a service contract with the accounting for implementation costs incurred to develop or obtain internal-use software under ASC 350-40, in order to determine which costs to capitalize and recognize as an asset and which costs to expense. ASU 2018-15 is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2019, and can be applied either prospectively to implementation costs incurred after the date of adoption or retrospectively to all arrangements. The Company adopted ASU 2018-15 effective January 1, 2020 and applied the standard prospectively to implementation costs incurred in its cloud computing arrangements, resulting in capitalized costs of $1.7 million in 2020. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangement (Topic 808): Clarifying the Integration between Topic 808 and Topic 606. The new standard clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. Further, the new standard adds unit-of-account guidance to Topic 808 to align with the guidance in Topic 606 when an entity is assessing whether the collaborative arrangement or part of the arrangement is within the scope of Topic 606. The new standard requires that in transactions with a collaborative arrangement participant that is not directly related to sales to third parties, presenting under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The new standard is effective for fiscal years beginning after December 15, 2019. The standard should be applied retrospectively to the date of initial application of ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) . The Company elected to adopt the amendment as of January 1, 2020, which did not have a material impact on the consolidated financial statements. In December 2019, the FASB issued ASU 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. New Accounting Standards Not Yet Adopted 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 15 December 2021. For the period ended December 31, 2021, the new standard would not have a material impact on our financial statements. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments At December 31, 2021 the Company had $234.2 million and nil of short and long term investments, respectively, consisting mainly of commercial paper and corporate bonds. As of December 31, 2021, $19.2 million are held to maturity debt securities which are carried at amortized cost and are approximately equal to fair market value. As of December 31, 2021, $214.9 million are available-for-sale debt securities which are carried at fair market value and are approximately equal to amortized cost. As of December 31, 2020, $150.4 million were classified as held to maturity and nil were available-for-sale. (in thousands) December 31, 2021 December 31, 2020 Cashable Guaranteed Investment Certificate $ 3,140 $ 2,000 Corporate Bond 21,820 40,372 Commercial Paper 206,724 67,747 Treasury Bill 2,494 7,999 Treasury Bond — 5,045 Yankee Bond — 2,816 Total short term investments 234,178 125,979 Corporate Bonds - total long term investments — 24,380 Total investments $ 234,178 $ 150,359 Currently, the Company does not intend to sell investments that are classified as held-to-maturity and has the ability and intent to hold these investments until maturity in order to collect interest payments over the life of the investments. As of December 31, 2021 and December 31, 2020, accrued interest receivable from the investments were $0.1 million and $0.5 million, respectively recorded as part of prepaid and other current assets on the consolidated balance sheets. During the year ended December 31, 2021, the Company had $47 thousand of unrealized losses on available-for-sale securities, net of tax and nil for the years ended December 31, 2020 and 2019, which are included as a component of comprehensive loss on the consolidated statements of operations. The Company's investments as of December 31, 2021 mature at various dates through November 2022. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2021 | |
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 held to maturity and 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 Company's Level 1 instruments include deposits held with banks and short-term investments that are valued using quoted market prices. Level 2 instruments include the Company's short and long-term investments that are valued through third-party pricing services that use verifiable observable market data. The Company had no Level 3 instruments as of December 31, 2021 and December 31, 2020. The following tables summarizes the Company's financial assets measured at fair value on a recurring basis: December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents: Deposits held with banks $ 214,702 $ — $ — $ 214,702 Short-term highly liquid investments 17,198 — — 17,198 Investments 206,724 27,454 234,178 Total $ 438,624 $ 27,454 $ — $ 466,078 December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents: Deposits held with banks $ 130,807 $ — $ — $ 130,807 Short-term highly liquid investments 141,543 — — 141,543 Investments 69,746 80,613 — 150,359 Total $ 342,096 $ 80,613 $ — $ 422,709 Refer to Note 4, “Investments,” for the carrying amount and related unrealized gains (losses) by type of investment. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | InventoriesInventories 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. For our product LUPKYNIS, the Company commenced capitalization of inventory once FDA approval was deemed to be probable, which occurred during the third quarter of 2020. Capitalized costs of inventories for LUPKYNIS mainly include third party manufacturing costs, transportation, storage, insurance, depreciation 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. The components of inventory are as follows: (in thousands) December 31, 2021 December 31, 2020 Raw materials $ 2,217 $ — Work in process 12,566 13,927 Finished goods 4,543 — Total inventories, net $ 19,326 $ 13,927 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Receivables [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets are as follows: (in thousands) December 31, 2021 December 31, 2020 Prepaid assets $ 5,316 $ 3,701 Prepaid insurance 1,632 2,054 Prepaid deposits 4,762 398 Other current assets 796 1,018 Total prepaid expenses and other current assets $ 12,506 $ 7,171 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are as follows: (in thousands) Estimated Useful Life December 31, 2021 December 31, 2020 Construction in progress — $ 393 $ 4,467 Leasehold improvements Shorter of term of the lease or estimated useful life 2,978 34 Office equipment 5 645 83 Furniture 7 976 — Computer equipment 3 262 381 5,254 4,965 Less accumulated depreciation (836) (179) Property and equipment, net $ 4,418 $ 4,786 Construction in progress assets during 2021 relate primarily to the design of the proposed new corporate headquarters in Victoria, British Columbia. Construction in progress assets during 2020 were related to leasehold improvements and office equipment and furniture for the Company's Rockville, MD office, which were placed into service upon occupancy in January 2021. Depreciation expense for the years ended December 31, 2021, 2020 and 2019, was $663 thousand, $82 thousand and $33 thousand, respectively, which is included in SG&A expenses on the consolidated statements of operations. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets are amortized over their useful lives on a straight-line basis. The Company’s intangible assets, net of accumulated amortization are as follows: December 31, 2021 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,471 $ (1,176) $ 295 Acquired intellectual property and reacquired rights 12 15,126 (8,804) 6,322 Internal-use software implementation costs 3 2,873 (1,086) 1,787 $ 19,470 $ (11,066) $ 8,404 December 31, 2020 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,651 $ (1,203) $ 448 Acquired intellectual property and reacquired rights 12 15,126 (7,770) 7,356 Internal-use software implementation costs 3 1,675 (147) 1,528 $ 18,452 $ (9,120) $ 9,332 Amortization expense recognized by the Company related to intangible assets was $2.1 million, $1.3 million and $1.1 million for the years ended December 31, 2021, 2020 and 2019, respectively. Amortization expense as it relates to the amortization of acquired intellectual property and other intangible assets resides within amortization on the consolidated statements of |
Accounts payable and accrued li
Accounts payable and accrued liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accounts payable and accrued liabilities | Accounts payable and accrued liabilities Accounts payable and accrued liabilities are as follows: December 31, 2021 December 31, 2020 Trade payables $ 3,879 $ 2,635 Other accrued liabilities 8,443 6,616 Accrued R&D projects 4,383 4,185 Employee accruals 18,242 11,361 Total accounts payable and accrued liabilities $ 34,947 $ 24,797 |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements Riptide License As discussed in Note 1, on August 17, 2021, 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, the Company paid Riptide an upfront license fee of $6.0 million and accrued for a milestone payment deemed probable which were expensed as R&D on the consolidated statement of operations. Additional milestone payments are due upon certain development, clinical and regulatory milestones, and royalties will be payable upon commercialization which will be accrued when deemed probable. It is anticipated that clinical development for AUR300 will commence during the first half of 2023. Thunderbolt In 2020, Aurinia made an aggregate upfront payment of $750 thousand to the shareholders of Thunderbolt and will be responsible for future regulatory milestones upon investigational new drug (IND) acceptance by the United States’ Food and Drug Administration (FDA) or any equivalent authority. Additionally, Thunderbolt shareholders will receive low single digit royalties on any future net sales. AUR200, a recombinant Fc fusion protein designed to specifically block B-cell Activating Factor, known as BAFF, and A Proliferation-Inducing Ligand, known as APRIL, is currently undergoing pre-clinical development with projected submission of an IND to the FDA in 2023. Otsuka Contract On December 17, 2020, the Company entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka) for the development and commercialization of oral LUPKYNIS for the treatment of adult patients with active LN in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. As part of the agreement, Aurinia received in 2020 an upfront cash payment of $50.0 million for the license agreement, and has the potential to receive up to $50.0 million in additional regulatory and reimbursement milestones. Aurinia will receive tiered royalties on future sales ranging from 10 to 20 percent (dependent on achievement of sale milestones) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. In addition, we are currently negotiating a supply agreement. The Company evaluated the Otsuka Agreement under ASC 606. Based on that evaluation, the license transferred was determined to be functional intellectual property (IP) that has significant standalone functionality. That is, the treatment of LN and other diseases provides significant benefit to Otsuka at the point of transfer, and it is not expected that the utility of the IP will substantively change as a result of any remaining clinical trials or ongoing activities of Aurinia. The Company determined the upfront fee of $50.0 million is fixed consideration for the transfer of the license and is recognized as revenue upon transfer of the license in December 2020. The remaining forms of consideration are variable because they are dependent on achieving milestones or are based on aggregate future net sales for the regions. None of the regulatory, reimbursement, or sales-based milestones have been included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considers numerous factors, including the magnitude of a potential reversal of revenue, uncertainty about if or when the milestone related performance obligations might be achieved and that receipt of the milestones are outside the control of the Company since they are dependent on efforts to be undertaken by Otsuka and regulatory approval by various foreign government agencies. Any consideration related to sales-based royalties (and sales-based milestones) will be recognized as license revenue when the related sales occur. As of December 31, 2021, there has been no additional consideration earned or received since the upfront payment of $50.0 million during the fourth quarter of 2020. |
Segment Information and Geograp
Segment Information and Geographic Data | 12 Months Ended |
Dec. 31, 2021 | |
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. Revenues and accounts receivable, net from two customers accounted for approximately 56% and 43% for the year ending December 31, 2021. There was one customer and two customers that accounted for all of the revenues during 2020 and 2019, respectively. Revenues by Geographic Location The following geographic information reflects revenue, net of adjustments, based on customer location: (in thousands) 2021 2020 2019 Revenue Japan $ — $ 50,000 $ — Other 117 118 118 United States 45,488 — 200 Total $ 45,605 $ 50,118 $ 318 Long-lived Assets by Location Long-lived assets by location consist of property plant and equipment: (in thousands) 2021 2020 Long-lived assets Canada 454 $ 298 United States 3,964 4,488 Total $ 4,418 $ 4,786 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of pre-tax (losses) income before income taxes for the years ended December 31, 2021, 2020 and 2019 are as follows: (in thousands) 2021 2020 2019 Canada $ (180,374) $ (61,024) $ (88,694) Foreign 168 (41,750) 453 $ (180,206) $ (102,774) $ (88,241) Income tax expense (benefit) for the years ended December 31, 2021, 2020 and 2019 are as follows: (in thousands) 2021 2020 2019 Current: Canada $ — $ — $ — Foreign 760 (94) 144 760 (94) 144 Deferred: Canada — — — Foreign — — — Total deferred — — — Income tax expense (benefit) $ 760 $ (94) $ 144 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 26.8%, 26.8%, and 25.4% for the years ending December 31, 2021, 2020 and 2019, respectively. 2021 2020 2019 Canada statutory income tax benefit 26.8 % 26.8 % 25.4 % Effect of tax rates on foreign jurisdictions — (2.4) — Impact of future rates and tax rate changes (0.1) 6.1 (0.9) Non-deductible share-based compensation (4.5) (4.5) (2.1) Change in valuation allowance (21.8) (26.0) (22.3) Other (0.8) 0.1 (0.3) Effective tax rate (0.4) % 0.1 % (0.2) % The tax effects of the temporary differences giving rise to the Company's net deferred tax assets as of December 31, 2021 and 2020 are summarized as follows: (in thousands) 2021 2020 Deferred tax assets: Loss carry-forwards $ 120,274 $ 80,087 Share issue costs 6,016 6,295 Intangible assets 1,086 2,718 SRED (Scientific Research and Experimental Development) 6,059 4,808 Deferred compensation 3,980 4,006 Other 6,126 5,243 Total deferred tax assets 143,541 103,157 Valuation allowance (141,348) (101,792) Net deferred tax assets 2,193 1,365 Deferred tax liabilities: Other (1,356) (1,173) Property and equipment and intangible assets (837) (192) Deferred tax liabilities (2,193) (1,365) Net deferred tax assets (liabilities) $ — $ — The Company’s valuation allowance increased by $39.6 million in 2021 as compared to 2020 as a result of the additional pre-tax book losses. As of December 31, 2021, the Company has $429.8 million of Canada gross net operating loss (NOL) carryforwards with an expiration period of 2029 through 2040. As of December 31, 2021, the Company has approximately $4.8 million of Canada Investment Tax Credits and British Columbia Scientific Research and Experimental Development (SRED) with an expiration period of 2029-2040. As of December 31, 2021 the Company has approximately $31.4 million of U.S. federal gross NOL carryforwards that carryforward indefinitely. Uncertain Tax Positions The Company is under examination by the Canadian Revenue Agency for years 2017 and 2018. The Company is subject to examination in the U.S., UK, Canada and tax periods remain open in the range of 2015 through 2020. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
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 is 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 TM product, a CNI immunosuppressant ophthalmic solution, prior to the expiration of our United States Patent Nos. 10,265,375 and 10,973871. In our action, we request relief in the form of an order confirming Sun has infringed our patent, an injunction preventing Sun from manufacturing, using or selling CEQUA TM , and monetary relief (including costs). Sun responded by denying infringement and/or asserting that the patents at issue are invalid. The parties have exchanged initial pleadings and patent disclosures, and are in the process of claim construction proceedings. Trial is scheduled to commence on or around March 2023. Manufacturing Commitments The Company has various manufacturing agreements to support our commercial and clinical product supply requirements. |
Deferred Compensation and Other
Deferred Compensation and Other Non-current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
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 $16.0 million and $16.3 million as of December 31, 2021 and December 31, 2020, respectively. The balance as of December 31, 2021 and December 31, 2020 primarily included deferred compensation arrangements that are the result of a resolution of the board of directors of the Company dated March 8, 2012 whereby certain executive officers at that time 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. The other non-current liabilities also include milestone payments deemed probable to be paid in the future. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases The Company has the following lease obligations: Victoria, British Columbia During the fourth quarter of 2020, the Company entered into facility and furniture leases for its head office located in Victoria, British Columbia for a total of 13,206 square feet of office space. The lease terms commenced on January 1, 2021 for the facility and furniture leases. As of December 31, 2021, the Company had $0.2 million right-of-use assets (ROU assets) and $0.2 million lease liabilities related to the leases. The Company recognized operating lease costs that are included in SG&A expense in the consolidated statement of operations. The incremental borrowing rate applied to the lease liabilities on January 1, 2021 was 4.08% based on financial position of the Company, geographical region and terms of leases. During August 2020, the Company signed a lease for commercial office space in Victoria, British Columbia. The lease term is expected to begin in 2022. The present value of the minimum lease payments for this lease are $2.3 million. As of December 31, 2021, the lease has not commenced and as a result there has been no accounting recognition associated with the 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 11 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. As of December 31, 2021, the Company had a right-of-use asset of $5.2 million and lease liability of $8.6 million included in the consolidated balance sheets. As of December 31, 2020, the Company had a right of use asset of $5.5 million and lease liability of $8.4 million included in the consolidated balance sheets. During 2020, the Company received reimbursements for tenant leasehold improvements by the landlord in the amount of $2.3 million for the Maryland lease. The Company recorded these leasehold improvement 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 terms of lease. Edmonton, Alberta During the fourth quarter of 2020, the Company entered into an agreement to lease office space in Edmonton, Alberta, commencing on October 1, 2020 and ending September 30, 2021. During the third quarter of 2021, the lease was extended until September 30, 2022. The Company recognizes short-term leases on a straight-line basis and did not record a related lease asset or liability for the Edmonton lease. The Company recognized short-term rent expense for this lease, which is included in SG&A expense in the consolidated statement of operations. Supplemental balance sheet information related to the operating lease ROU asset and lease liabilities as of December 31, 2021 and December 31, 2020 are as follows: (in thousands) Balance Sheet Classification 2021 2020 Assets Operating lease right of-use assets Non-current assets $ 5,383 $ 5,489 Liabilities Current operating lease liabilities Current operating lease liabilities 1,059 788 Non-current operating lease liabilities Non-current operating lease liabilities 7,680 7,619 Total lease liabilities $ 8,739 $ 8,407 Beginning January 1, 2021, the Company began to incur variable lease costs under the existing Victoria and Rockville leases. These costs include operation and maintenance costs and are recorded under rent expense in SG&A. A summary of the components of leasing costs and rent for the years ended December 31, 2021 and December 31, 2020 are as follows: (in thousands) Consolidated Statement of Operations 2021 2020 2019 Operating lease costs Operating lease costs Selling, general and administrative $ 1,045 $ 653 $ 229 Short-term lease costs Office Building Selling, general and administrative 27 288 68 Variable lease costs Office building Selling, general and administrative 167 3 — Total rent expense $ 1,239 $ 944 $ 297 The weighted-average remaining lease term and discount rate for the years ended December 31, 2021 and December 31, 2020 are as follows: December 31, 2021 December 31, 2020 Weighted average remaining lease term (in years) 9.49 10.67 Weighted average discount rate 5.2% 5.2% Supplemental cash flow information related to operating leases for the years ended December 31, 2021, December 31, 2020 and December 31, 2019 are as follows: (in thousands) 2021 2020 2019 Cash paid for amounts included in the measurement of lease liabilities $ 646 $ 267 $ 182 Initial recognition of operating lease right-of-use asset $ 419 $ 5,804 $ — Future maturities of operating lease liabilities as of December 31, 2021 are as follows: (in thousands) Operating Lease Payments 2022 $ 1,143 2023 1,061 2024 1,085 2025 1,109 2026 1,135 Thereafter 5,638 Total lease payments 11,171 Less: imputed interest (2,432) Total $ 8,739 On December 15, 2020, the Company entered into a collaborative agreement with Lonza to build a dedicated manufacturing capacity within Lonza’s existing small molecule facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand. Following U.S. regulatory approval of voclosporin in January 2021, the Company has commenced a capital expenditure payment program totaling approximately CHF 21.0 million. The first capital expenditure payment of $11.8 million was made in February 2021 and was treated as an upfront lease payment and recorded under other non-current assets on the consolidated balance sheets. The second payment is not due until the facility fulfills the required operational qualifications which is estimated to be during 2023. Upon completion of the monoplant, the Company will have the right to maintain sole dedicated use of the monoplant by paying a quarterly fixed facility fee. The Company expects to account for the arrangement as a finance lease under ASC 842. The present value of the minimum lease payments total approximately $79.0 million, beginning April 2023 and expiring in 2030, and are not included in the above table. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021, 2020 and 2019, 141.6 million, 126.7 million and 111.8 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. The common share activity for 2021, 2020 and 2019 is as follows: Common Shares Number of shares Amount Balance at December 31, 2018 85,500 $ 488,744 Issued pursuant to Public Offering 12,782 191,737 Issued pursuant to At-the-Market (ATM) Facilities 6,953 45,010 Share issue costs — (13,629) Issued pursuant to exercise of warrants 2,983 12,428 Issued pursuant to exercise of stock options 3,580 22,197 Balance at December 31, 2019 111,798 746,487 Issued pursuant to Public Offering 13,333 200,000 Share issue costs — (12,268) Issued pursuant to exercise of warrants 1 2 Issued pursuant to exercise of stock options 1,593 10,107 Balance at December 31, 2020 126,725 944,328 Issued pursuant to ATM Facilities 10,166 202,356 Share issue costs — (5,616) Issued pursuant to exercise of warrants 1,434 2,102 Issued pursuant to exercise of stock options 3,238 33,073 Issued pursuant to ESPP 37 808 Balance at December 31, 2021 141,600 $ 1,177,051 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, clinical development and commercial production of voclosporin (whether for LN or other indications), advancing our pipeline, regulatory, additional clinical trials, business development opportunities, capital expenditures and working capital. November 19, 2021 ATM facility On November 19, 2021 the Company entered into an Open Market Sale Agreement (the "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 Sale Agreement. No further sales will occur under the Sale Agreement dated November 19, 2021. July 27, 2020 public offering On July 27, 2020 the Company completed a public offering of 13.3 million common shares at a price of $15.00 per share. Gross proceeds from this offering were $200.0 million and the share issue costs totaled an estimated $12.3 million which included a 6% underwriting commission of $12.0 million and professional fees of $0.3 million. December 12, 2019 public offering On December 12, 2019 the Company completed a public offering of 12.8 million common shares at a price of $15.00 per share. Gross proceeds from this offering were $191.7 million and the share issue costs totaled $11.8 million which included a 6% underwriting commission of $11.5 million and professional fees of $0.3 million. September 13, 2019 ATM facility On September 13, 2019 the Company entered into an Open Market Sale Agreement (the "Sale Agreement") with Jefferies 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 $40.0 million. Pursuant to this agreement the Company issued 2.3 million common shares at a weighted average price of $6.40 resulting in gross proceeds of $15.0 million. The Company incurred share issue costs of $640 thousand including a 3% commission of $450 thousand paid to the agent and professional fees of $190 thousand directly related to the ATM. On December 9, 2019, the Company terminated the September 13, 2019 Sale Agreement with Jefferies LLC related to the 2019 ATM. Warrants: Warrant related to February 14, 2014 private placement offering: On February 14, 2014, the Company completed a $52.0 million private placement (2014 Private Offering). Under the terms of the 2014 Private Offering, a Unit consisted of one common share and one-quarter (0.25) of a common share purchase price warrant (2014 Warrant). The Company issued 18.9 million Units at a subscription price per Unit of $2.7485, exercisable for a period of five years from the date of issuance, at an exercise price of $3.2204. These February 2014 Warrants meet the scope exceptions provided in ASC 815, Derivatives and Hedging , as they are indexed to the Company’s own shares, and therefore are accounted for under ASC 505, Equity . In 2019, certain holders of these 2014 Warrants elected the cashless exercise option and the Company issued 0.7 million common shares in lieu of 1.3 million 2014 Warrants, which was recorded through an increase in equity (common shares) and decrease in additional paid-in capital. One holder of 464,000 2014 Warrants exercised these 2014 Warrants for cash and received 464,000 common shares. The Company received cash proceeds of $1.5 million and recorded an increase in cash and additional paid in capital. In 2018, no holders of the 2014 Warrants elected the cashless exercise option. As a result, the Warrants related to the February 14, 2014 private placement offering have been extinguished upon the exercise of the aforementioned warrants, at December 31, 2019. 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 2016 Public Offering, each Unit consists 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 meet the scope exceptions provided in ASC 815, Derivatives and Hedging , as they are indexed to the Company’s own shares, and therefore are accounted for under ASC 505, Equity . At initial recognition on December 28, 2016, the Company recorded a warrant 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 have 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. The warrant activity for 2021 and 2020 is as follows: Number of warrants Balance at December 31, 2019 1,691 Warrants exercised (1) 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, 2021 | |
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 outstanding awards). 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 37 thousand were purchased during 2021. 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. As of December 31, 2021 and 2020, 141.6 million and 126.7 million, common shares were issued and outstanding. 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 following table summarizes the number of options outstanding under the Plan and inducement grants outside of the Plan for the years ended December 31, 2021, 2020 and 2019. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Balance as of December 31, 2018 7,591 $ 4.44 Granted 2,520 $ 6.00 Grant inducement 1,600 $ 6.28 Exercised/released (3,578) $ 4.03 Cancelled/forfeited (311) $ 5.40 Outstanding at December 31, 2019 7,822 $ 5.47 6.64 $ 115,655 Granted 7,129 $ 15.61 Granted inducement 925 $ 14.36 Exercised/released (1,593) $ 4.39 Cancelled/forfeited (236) $ 11.82 Outstanding at December 31, 2020 14,047 $ 11.35 7.51 $ 35,891 Granted 2,277 $ 14.44 Exercised/released (3,238) $ 7.21 Cancelled/forfeited (1,012) $ 13.84 Outstanding at December 31, 2021 12,074 $ 12.84 7.86 $ 121,141 Vested and exercisable options at December 31, 2021 5,849 $ 11.87 The weighted average grant date fair value of stock options granted during the years ended December 31, 2021, 2020 and 2019 was $7.34, $5.58 and $2.56, respectively. The total fair value of options vested during the years ended December 31, 2021, 2020 and 2019 was $24.9 million, $14.9 million and $8.5 million, respectively. Total intrinsic value of options exercised was $50.3 million, $13.1 million and $63.3 million for years ended December 31, 2021, 2020 and 2019, respectively. On November 20, 2020, the Company’s Compensation Committee granted the newly appointed Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer, a non-qualified stock option to purchase an aggregate of 298,924 common shares on November 16, 2020. The option has a per share exercise price of $13.40, the closing trading price on November 13, 2020. One-third of the shares underlying the option vest in November 2021, and the balance of the shares vest in a series of 24 equal monthly installments thereafter. On October 2, 2020, the Company’s Compensation Committee granted 9 new employees non-qualified stock options to purchase an aggregate of 96,000 common shares, at a per share exercise price of $14.73, the closing trading price on September 30, 2020. One-third of the options vest in October 2021, and the balance of the options vests in a series of 24 equal monthly installments thereafter. On September 4, 2020 the Company granted 105 new employees non-qualified stock options to purchase an aggregate of 530,000 common shares, at a per share exercise price of $14.83, the closing trading price on August 31, 2020. One-third of the options vest in September 2021, and the balance of the options vests in a series of 24 equal monthly installments thereafter. On April 29, 2019, the Company granted 1.6 million inducement stock options to the new Chief Executive Officer pursuant to Section 613(c) of the TSX Company Manual at a price of $6.28. The first 25% of these options vest on the one year anniversary of the grant, and the remaining 75% vest in equal amounts over 36 months following the one year anniversary date and are exercisable for a term of ten years. On May 2, 2016, the Company granted 200,000 inducement stock options to a new employee pursuant to Section 613(c) of the TSX Company Manual at a price of $2.92. These options vest in equal amounts over 36 months and are exercisable for a term of five years. The employee had exercised 150,000 of these options as of December 31, 2019. There are zero options remaining at December 31, 2020. The inducement options noted above were granted as an inducement material to the new employees entering into employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement stock options also have a ten-year term and are subject to the terms and conditions of the stock option agreement pursuant to which the option was granted. The inducement options are recorded outside of the Plan. 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 and the growth during 2021, the expected life extends further into the contractual life increasing the expected life. The increase of the expected life in 2021 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 from 52% in 2020 to 66% in 2021 was due to the Company's stock being more volatile throughout 2021 than in the prior year. Given the growth of the Company, the expected life used to determine previous market volatility and comparable peer group of 66% 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, 2021, 2020 and 2019: 2021 2020 2019 Expected term (in years) 4 years 3 years 4 years Volatility 66 % 52 % 52 % Risk-free interest rate 0.46 % 0.55 % 1.61 % Dividend yield 0.0 % 0.0 % 0.0 % Performance Awards and Restricted Stock Units On October 23, 2020, the Company issued 439,000 performance awards (PAs) to executive management of the Company whose vesting is contingent upon meeting specific performance metrics based on the results for the year ended December 31, 2021. Each PA which vests entitles the participant to receive common shares on the basis of the performance metrics set. On March 18, 2021 performance metrics were set and formally communicated. Therefore, March 18, 2021 was the grant date and the fair value on the grant date was $13.56 . As of December 31, 2021, approximately 88,000 PAs vested based on performance metrics achieved and 351,000 were cancelled as performance metrics were not met. On August 6, 2021, the Company granted approximately 418,000 PAs and 201,000 restricted stock units (RSUs). The grant date for the PAs and RSUs was August 6, 2021 and the fair value on the grant date was $14.42 as this was the date performance measures were set and communicated to employees. The PAs vest on the employee's first anniversary of the grant date and the employee must achieve at least one of the performance metrics to obtain the portion of the award associated with the metric. The RSUs have no performance metrics and will vest on the one year anniversary of the grant. As of December 31, 2021, none of the August 6, 2021 PAs and RSUs have vested. The Company recorded approximately $2.7 million of share-based compensation expense related to PAs and RSUs during the year ended December 31, 2021. Compensation Expense Share-based compensation expense for the years ended December 31, 2021, 2020 and 2019 totaled approximately $31.2 million, $17.5 million and $7.4 million, respectively, as shown in the table below. (in thousands) 2021 2020 2019 Research and development $ 4,442 $ 3,730 $ 2,693 Selling, general and administrative 26,432 13,615 4,721 Capitalized under inventories 369 109 — Share-based compensation expense $ 31,243 $ 17,454 $ 7,414 Unrecognized Share-Based Compensation Expense and Weighted Average Remaining Amortization Period As of December 31, 2021, 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 $ 13,563 1.2 Restricted Stock Units 2,197 0.6 ESPP 3,296 1.1 Total unrecognized share-based compensation expense $ 19,056 1.1 |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2021 | |
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: 2021 2020 2019 Net loss for the year $ (180,966) $ (102,680) $ (88,385) Weighted average number of common shares outstanding 129,369 118,473 93,024 Net loss per Common Share (expressed in $ per share) $ (1.40) $ (0.87) $ (0.95) 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: 2021 2020 2019 Outstanding stock options 12,074 14,047 7,822 Unvested performance awards 64 — — Unvested restricted units 191 — — Warrants — 1,690 1,691 12,329 15,737 9,513 |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related-Party Transactions ILJIN SNT Co., Ltd (ILJIN) was considered to be a related party due to their equity ownership of over 5% as per their public filings. The outstanding related party amount payable to ILJIN was the result of a settlement completed on September 20, 2013 between ILJIN and the Company. During 2021, Aurinia paid $6.0 million upon achievement of specific milestones. The amount payable to ILJIN was nil and $6.0 million as of December 31, 2021 and December 31, 2020 which was recorded in other current liabilities. Stephen P. Robertson, a partner at Borden Ladner Gervais (BLG) acted as our corporate secretary through October 2020. We incurred legal fees in the normal course of business to BLG of $392 thousand for the year ended December 31, 2020 compared to $473 thousand for the same period in 2019. For the year ended December 31, 2020, we had no ongoing contractual or other commitments as a result of engaging Mr. Robertson to act as our corporate secretary and Mr. Robertson received no additional compensation for acting as the corporate secretary. On November 2, 2020 we announced the appointment of Stephen Robertson as our Executive Vice President, General Counsel, Corporate Secretary and Chief Compliance Officer. |
Selected Quarterly Financial In
Selected Quarterly Financial Information (unaudited) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020: (in thousands, except per share data) March 31, 2021 June 30, 2021 September 30, 2021 December 31, 2021 Total revenue, net $ 914 $ 6,620 $ 14,667 $ 23,404 Cost of sales and operating expenses 51,457 53,754 65,020 56,109 Loss from operations (50,543) (47,134) (50,353) (32,705) Net loss (50,379) (47,010) (50,255) (33,322) Basic and diluted loss per common share $ (0.40) $ (0.37) $ (0.39) $ (0.25) March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 Total revenue $ 30 $ 29 $ 29 $ 50,030 Operating expenses 27,090 26,892 42,344 58,082 Loss from operations (27,060) (26,863) (42,315) (8,052) Net loss (25,932) (26,544) (42,130) (8,074) Basic and diluted loss per common share $ (0.23) $ (0.24) $ (0.34) $ (0.06) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsOn February 25, 2022, the Company gave notice to Cantor Fitzgerald & Co. to terminate the Sale Agreement. No further sales will occur under the Sale Agreement dated November 19, 2021. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
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. References to generally accepted accounting principles (GAAP) or U.S. GAAP in these footnotes are to the FASB Accounting Standards Codification (ASC or the Codification). At the end of the second quarter of 2020, the Company determined that it no longer qualified as a Foreign Private Issuer under the SEC rules. As a result, beginning January 1, 2021 the Company is required to report with the SEC on domestic forms and comply with domestic company rules in the United States. |
Principles of consolidation | 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, 2021 and 2020, and the results of operations and cash flows for the three years ended December 31, 2021, 2020 and 2019. All significant intercompany accounts and transactions have been eliminated in consolidation |
Use of estimates | 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 | 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 |
Fair value measurements | Fair value measurements: The Company's financial instruments consist primarily of cash and cash equivalents, short-term and long-term 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 and cash equivalents and short term investments. The Company attempts to minimize the risks related to cash and cash equivalents 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 Canadian dollar, Swiss France, Great British Pound and Japanese Yen 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, which mitigates the risk of material foreign exchange fluctuations. Major customers : The Company currently has three main customers for the U.S. commercial sales of LUPKYNIS and one customer for sales of voclosporin in the European Union, Japan, as well as United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Revenues from two customers accounted for approximately 56% and 43% of the Company's total revenues for the year ending December 31, 2021. Two individual customers accounted for 99% of the Company’s net trade accounts receivable balances as of December 31, 2021. 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, including their payment plans and obtains positive confirmation of the validity of the receivables. |
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 $231.9 million as of December 31, 2021. The Company has invested its cash reserves 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 $0.3 million and nil as of December 31, 2021 and December 31, 2020, respectively. |
Investments | Investments: The Company classifies its debt securities as either held to maturity or available-for-sale in accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 320, Investments — Debt Securities . Investments classified as held to maturity are carried at amortized cost when management has the positive intent and ability to hold them to maturity. Investments classified as available-for-sale are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses on held to maturity and available-for-sale securities are recorded in other income (expense), net. Interest income (expense) is recorded separately on the consolidated statements of operations. The cost of securities sold is based on the specific-identification method. |
Accounts receivable, net | Accounts receivable, net: Accounts receivables are stated at their net realizable value less an allowance for doubtful accounts. As of December 31, 2021, accounts receivable, net are $15.4 million. We estimate the allowance for doubtful accounts using current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. We evaluate 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 us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature of our accounts receivable, we determined that an allowance for doubtful accounts was nil at December 31, 2021. Accounts receivables 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 United States. These reserves are recorded as a reduction of accounts receivable. |
Intangible assets | Intangible assets: Intangible assets are amortized over their useful lives using methods that correlate to the pattern in which the economic benefits are expected to be realized. All intangible assets are amortized on a straight-line basis. 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 periodically reviewed 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. Other intellectual property expenditures are recorded as R&D expenses on the consolidated statements of operations as incurred. Patents do not contain the option to extend or renew. |
Property, plant and equipment | Property, plant and equipment: Property, plant and equipment are recorded at cost and is 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 |
Recoverability and impairment of long-lived assets | Recoverability and impairment of long-lived assets: ASC Topic 360 requires long-lived assets, including definite-lived intangible assets, to be evaluated for impairment 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. |
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. Certain leases have lease and non-lease components, which are accounted for as a single lease component. 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 will be accounted for as a financing lease once lease commencement begins (see Note 16). The Company adopted ASC Topic 842 on January 1, 2019, which requires lessees to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use asset (ROU asset), which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. ASC 842 also requires lessees to classify leases as either finance or operating leases based on whether or not the lease is effectively a financed purchase of the leased asset by the lessee. This classification is used to evaluate whether the lease expense should be recognized based on an effective interest method or on a straight-line basis over the term of the lease. The Company elected, for all asset classes, 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 sheet, and fixed costs associated with these arrangements are disclosed in Note 16 of the financial statements. The Company has elected to recognize lease incentives, such as tenant improvement allowances, at the lease commencement date as a reduction of the ROU asset and lease liability until paid to the Company by the lessor, to the extent that the lease provides a specified fixed or maximum level of reimbursement, and the Company is reasonably certain to incur reimbursable costs at least equaling such amounts. Operating 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. The table in Note 16 provides supplemental balance sheet information related to the operating lease ROU assets and lease liabilities. |
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 use 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-US geographies include timing of approval in ex-US territories, escalating royalty rates, net pricing, government payor coverage of the product, and market penetration. In determining the estimate for ex-US revenues, the Company relies heavily 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 our US 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. |
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. |
Common Shares | 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 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: 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, depreciation 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 specialty pharmacies and specialty distributors. These customers subsequently resell the Company's products to health care providers and patients. Revenues from product sales are recognized when the customer obtains control of our 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's 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. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjust these estimates, which could have an effect on earnings in the period of adjustment. 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. License, Collaboration and Other Revenues The Company enters into out-licensing agreements that are within the scope of ASC 606, under which it licenses certain rights to its product candidates 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. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. 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 in license, collaboration and other revenues when the licensee obtains control of the goods, which is typically upon delivery. 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. Any consideration related to sales-based royalties (and sales-based milestones) will be recognized when the related sales occur. Research, Development and/or Manufacturing Services : The Company’s agreements may include R&D or 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 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. If these services are determined not to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the combined performance obligation 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. There costs are recorded within SG&A. For contracts that extend beyond one year, the incremental expense recognition matches the recognition of related revenue, Cost of sales : Cost of sales consist primarily of cost of inventories for LUPKYNIS, which mainly includes third party manufacturing costs, transportation, storage, insurance and allocated internal labor and depreciation. |
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. |
Selling, general and administrative expenses | Selling, general and administrative expenses : The Company's SG&A expenses include commercial and allocated administrative personnel, corporate facility 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, 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. |
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 for all share-based payments related to stock options, performance awards, restricted stock units and purchases under the Company's ESPP. The estimated fair value of service-based awards is determined using option pricing models that use unobservable inputs and is generally amortized on a straight-line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. 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 to estimate forfeitures based on historical forfeiture experience. |
Income taxes | Income taxes: The Company accounts for income taxes under the asset and liability method in accordance with ASC Topic 740, Income Taxes |
Recently adopted accounting pronouncements and New accounting standards not yet adopted | Recently adopted accounting pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The standard requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The adoption of the standard as of January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirement for Fair Value Measurement . Topic 820 requires to disclose transfers into and out of Level 3 of the fair value hierarchy and purchases and issues of Level 3 assets and liabilities. For investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when the restrictions from redemptions might lapse only if the investee has communicated the timing to the entity or announced the timing publicly. The new standard also amends that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The new standard is effective for fiscal years beginning after December 15, 2019. The standard should be applied retrospectively to the date of initial application of ASU 2014-09, Revenue from Contracts with Customers (Topic 606) . The Company elected to adopt the amendment as of January 1, 2020, which did not have a material impact on the consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40)-Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which aligns the accounting for implementation costs incurred in a hosting arrangement that is a service contract with the accounting for implementation costs incurred to develop or obtain internal-use software under ASC 350-40, in order to determine which costs to capitalize and recognize as an asset and which costs to expense. ASU 2018-15 is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2019, and can be applied either prospectively to implementation costs incurred after the date of adoption or retrospectively to all arrangements. The Company adopted ASU 2018-15 effective January 1, 2020 and applied the standard prospectively to implementation costs incurred in its cloud computing arrangements, resulting in capitalized costs of $1.7 million in 2020. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangement (Topic 808): Clarifying the Integration between Topic 808 and Topic 606. The new standard clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. Further, the new standard adds unit-of-account guidance to Topic 808 to align with the guidance in Topic 606 when an entity is assessing whether the collaborative arrangement or part of the arrangement is within the scope of Topic 606. The new standard requires that in transactions with a collaborative arrangement participant that is not directly related to sales to third parties, presenting under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The new standard is effective for fiscal years beginning after December 15, 2019. The standard should be applied retrospectively to the date of initial application of ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) . The Company elected to adopt the amendment as of January 1, 2020, which did not have a material impact on the consolidated financial statements. In December 2019, the FASB issued ASU 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. New Accounting Standards Not Yet Adopted 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 15 December 2021. For the period ended December 31, 2021, the new standard would not have a material impact on our financial statements. |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | (in thousands) December 31, 2021 December 31, 2020 Cashable Guaranteed Investment Certificate $ 3,140 $ 2,000 Corporate Bond 21,820 40,372 Commercial Paper 206,724 67,747 Treasury Bill 2,494 7,999 Treasury Bond — 5,045 Yankee Bond — 2,816 Total short term investments 234,178 125,979 Corporate Bonds - total long term investments — 24,380 Total investments $ 234,178 $ 150,359 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following tables summarizes the Company's financial assets measured at fair value on a recurring basis: December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents: Deposits held with banks $ 214,702 $ — $ — $ 214,702 Short-term highly liquid investments 17,198 — — 17,198 Investments 206,724 27,454 234,178 Total $ 438,624 $ 27,454 $ — $ 466,078 December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents: Deposits held with banks $ 130,807 $ — $ — $ 130,807 Short-term highly liquid investments 141,543 — — 141,543 Investments 69,746 80,613 — 150,359 Total $ 342,096 $ 80,613 $ — $ 422,709 Refer to Note 4, “Investments,” for the carrying amount and related unrealized gains (losses) by type of investment. |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The components of inventory are as follows: (in thousands) December 31, 2021 December 31, 2020 Raw materials $ 2,217 $ — Work in process 12,566 13,927 Finished goods 4,543 — Total inventories, net $ 19,326 $ 13,927 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Receivables [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are as follows: (in thousands) December 31, 2021 December 31, 2020 Prepaid assets $ 5,316 $ 3,701 Prepaid insurance 1,632 2,054 Prepaid deposits 4,762 398 Other current assets 796 1,018 Total prepaid expenses and other current assets $ 12,506 $ 7,171 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment are as follows: (in thousands) Estimated Useful Life December 31, 2021 December 31, 2020 Construction in progress — $ 393 $ 4,467 Leasehold improvements Shorter of term of the lease or estimated useful life 2,978 34 Office equipment 5 645 83 Furniture 7 976 — Computer equipment 3 262 381 5,254 4,965 Less accumulated depreciation (836) (179) Property and equipment, net $ 4,418 $ 4,786 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The Company’s intangible assets, net of accumulated amortization are as follows: December 31, 2021 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,471 $ (1,176) $ 295 Acquired intellectual property and reacquired rights 12 15,126 (8,804) 6,322 Internal-use software implementation costs 3 2,873 (1,086) 1,787 $ 19,470 $ (11,066) $ 8,404 December 31, 2020 (in thousands) Weighted Average Gross Carrying Accumulated Net Carrying Patents 12 $ 1,651 $ (1,203) $ 448 Acquired intellectual property and reacquired rights 12 15,126 (7,770) 7,356 Internal-use software implementation costs 3 1,675 (147) 1,528 $ 18,452 $ (9,120) $ 9,332 |
Accounts payable and accrued _2
Accounts payable and accrued liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accounts payable and accrued liabilities are as follows: December 31, 2021 December 31, 2020 Trade payables $ 3,879 $ 2,635 Other accrued liabilities 8,443 6,616 Accrued R&D projects 4,383 4,185 Employee accruals 18,242 11,361 Total accounts payable and accrued liabilities $ 34,947 $ 24,797 |
Segment Information and Geogr_2
Segment Information and Geographic Data (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
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) 2021 2020 2019 Revenue Japan $ — $ 50,000 $ — Other 117 118 118 United States 45,488 — 200 Total $ 45,605 $ 50,118 $ 318 |
Long-lived Assets by Geographic Areas | Long-lived assets by location consist of property plant and equipment: (in thousands) 2021 2020 Long-lived assets Canada 454 $ 298 United States 3,964 4,488 Total $ 4,418 $ 4,786 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign | The components of pre-tax (losses) income before income taxes for the years ended December 31, 2021, 2020 and 2019 are as follows: (in thousands) 2021 2020 2019 Canada $ (180,374) $ (61,024) $ (88,694) Foreign 168 (41,750) 453 $ (180,206) $ (102,774) $ (88,241) |
Schedule of Components of Income Tax Expense (Benefit) | Income tax expense (benefit) for the years ended December 31, 2021, 2020 and 2019 are as follows: (in thousands) 2021 2020 2019 Current: Canada $ — $ — $ — Foreign 760 (94) 144 760 (94) 144 Deferred: Canada — — — Foreign — — — Total deferred — — — Income tax expense (benefit) $ 760 $ (94) $ 144 |
Schedule of Effective Income Tax Rate Reconciliation | The provision for income taxes varied from the income taxes provided based on the Canadian statutory rate of 26.8%, 26.8%, and 25.4% for the years ending December 31, 2021, 2020 and 2019, respectively. 2021 2020 2019 Canada statutory income tax benefit 26.8 % 26.8 % 25.4 % Effect of tax rates on foreign jurisdictions — (2.4) — Impact of future rates and tax rate changes (0.1) 6.1 (0.9) Non-deductible share-based compensation (4.5) (4.5) (2.1) Change in valuation allowance (21.8) (26.0) (22.3) Other (0.8) 0.1 (0.3) Effective tax rate (0.4) % 0.1 % (0.2) % |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of the temporary differences giving rise to the Company's net deferred tax assets as of December 31, 2021 and 2020 are summarized as follows: (in thousands) 2021 2020 Deferred tax assets: Loss carry-forwards $ 120,274 $ 80,087 Share issue costs 6,016 6,295 Intangible assets 1,086 2,718 SRED (Scientific Research and Experimental Development) 6,059 4,808 Deferred compensation 3,980 4,006 Other 6,126 5,243 Total deferred tax assets 143,541 103,157 Valuation allowance (141,348) (101,792) Net deferred tax assets 2,193 1,365 Deferred tax liabilities: Other (1,356) (1,173) Property and equipment and intangible assets (837) (192) Deferred tax liabilities (2,193) (1,365) Net deferred tax assets (liabilities) $ — $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Supplemental Balance Sheet Information | Supplemental balance sheet information related to the operating lease ROU asset and lease liabilities as of December 31, 2021 and December 31, 2020 are as follows: (in thousands) Balance Sheet Classification 2021 2020 Assets Operating lease right of-use assets Non-current assets $ 5,383 $ 5,489 Liabilities Current operating lease liabilities Current operating lease liabilities 1,059 788 Non-current operating lease liabilities Non-current operating lease liabilities 7,680 7,619 Total lease liabilities $ 8,739 $ 8,407 |
Lease, Cost | (in thousands) Consolidated Statement of Operations 2021 2020 2019 Operating lease costs Operating lease costs Selling, general and administrative $ 1,045 $ 653 $ 229 Short-term lease costs Office Building Selling, general and administrative 27 288 68 Variable lease costs Office building Selling, general and administrative 167 3 — Total rent expense $ 1,239 $ 944 $ 297 The weighted-average remaining lease term and discount rate for the years ended December 31, 2021 and December 31, 2020 are as follows: December 31, 2021 December 31, 2020 Weighted average remaining lease term (in years) 9.49 10.67 Weighted average discount rate 5.2% 5.2% Supplemental cash flow information related to operating leases for the years ended December 31, 2021, December 31, 2020 and December 31, 2019 are as follows: (in thousands) 2021 2020 2019 Cash paid for amounts included in the measurement of lease liabilities $ 646 $ 267 $ 182 Initial recognition of operating lease right-of-use asset $ 419 $ 5,804 $ — |
Lessee, Operating Lease, Liability, Maturity | Future maturities of operating lease liabilities as of December 31, 2021 are as follows: (in thousands) Operating Lease Payments 2022 $ 1,143 2023 1,061 2024 1,085 2025 1,109 2026 1,135 Thereafter 5,638 Total lease payments 11,171 Less: imputed interest (2,432) Total $ 8,739 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Common Stock Outstanding Roll Forward | The common share activity for 2021, 2020 and 2019 is as follows: Common Shares Number of shares Amount Balance at December 31, 2018 85,500 $ 488,744 Issued pursuant to Public Offering 12,782 191,737 Issued pursuant to At-the-Market (ATM) Facilities 6,953 45,010 Share issue costs — (13,629) Issued pursuant to exercise of warrants 2,983 12,428 Issued pursuant to exercise of stock options 3,580 22,197 Balance at December 31, 2019 111,798 746,487 Issued pursuant to Public Offering 13,333 200,000 Share issue costs — (12,268) Issued pursuant to exercise of warrants 1 2 Issued pursuant to exercise of stock options 1,593 10,107 Balance at December 31, 2020 126,725 944,328 Issued pursuant to ATM Facilities 10,166 202,356 Share issue costs — (5,616) Issued pursuant to exercise of warrants 1,434 2,102 Issued pursuant to exercise of stock options 3,238 33,073 Issued pursuant to ESPP 37 808 Balance at December 31, 2021 141,600 $ 1,177,051 |
Summary of Outstanding Warrants and Warrants Outstanding | The warrant activity for 2021 and 2020 is as follows: Number of warrants Balance at December 31, 2019 1,691 Warrants exercised (1) 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, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Option Activity | The following table summarizes the number of options outstanding under the Plan and inducement grants outside of the Plan for the years ended December 31, 2021, 2020 and 2019. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Balance as of December 31, 2018 7,591 $ 4.44 Granted 2,520 $ 6.00 Grant inducement 1,600 $ 6.28 Exercised/released (3,578) $ 4.03 Cancelled/forfeited (311) $ 5.40 Outstanding at December 31, 2019 7,822 $ 5.47 6.64 $ 115,655 Granted 7,129 $ 15.61 Granted inducement 925 $ 14.36 Exercised/released (1,593) $ 4.39 Cancelled/forfeited (236) $ 11.82 Outstanding at December 31, 2020 14,047 $ 11.35 7.51 $ 35,891 Granted 2,277 $ 14.44 Exercised/released (3,238) $ 7.21 Cancelled/forfeited (1,012) $ 13.84 Outstanding at December 31, 2021 12,074 $ 12.84 7.86 $ 121,141 Vested and exercisable options at December 31, 2021 5,849 $ 11.87 |
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, 2021, 2020 and 2019: 2021 2020 2019 Expected term (in years) 4 years 3 years 4 years Volatility 66 % 52 % 52 % Risk-free interest rate 0.46 % 0.55 % 1.61 % Dividend yield 0.0 % 0.0 % 0.0 % |
Allocation of Share-Based Payments | Share-based compensation expense for the years ended December 31, 2021, 2020 and 2019 totaled approximately $31.2 million, $17.5 million and $7.4 million, respectively, as shown in the table below. (in thousands) 2021 2020 2019 Research and development $ 4,442 $ 3,730 $ 2,693 Selling, general and administrative 26,432 13,615 4,721 Capitalized under inventories 369 109 — Share-based compensation expense $ 31,243 $ 17,454 $ 7,414 |
Share-based Payment Arrangement, Nonvested Award, Cost | As of December 31, 2021, 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 $ 13,563 1.2 Restricted Stock Units 2,197 0.6 ESPP 3,296 1.1 Total unrecognized share-based compensation expense $ 19,056 1.1 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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: 2021 2020 2019 Net loss for the year $ (180,966) $ (102,680) $ (88,385) Weighted average number of common shares outstanding 129,369 118,473 93,024 Net loss per Common Share (expressed in $ per share) $ (1.40) $ (0.87) $ (0.95) |
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: 2021 2020 2019 Outstanding stock options 12,074 14,047 7,822 Unvested performance awards 64 — — Unvested restricted units 191 — — Warrants — 1,690 1,691 12,329 15,737 9,513 |
Selected Quarterly Financial _2
Selected Quarterly Financial Information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | The following condensed quarterly financial information is for the years December 31, 2021 and 2020: (in thousands, except per share data) March 31, 2021 June 30, 2021 September 30, 2021 December 31, 2021 Total revenue, net $ 914 $ 6,620 $ 14,667 $ 23,404 Cost of sales and operating expenses 51,457 53,754 65,020 56,109 Loss from operations (50,543) (47,134) (50,353) (32,705) Net loss (50,379) (47,010) (50,255) (33,322) Basic and diluted loss per common share $ (0.40) $ (0.37) $ (0.39) $ (0.25) March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 Total revenue $ 30 $ 29 $ 29 $ 50,030 Operating expenses 27,090 26,892 42,344 58,082 Loss from operations (27,060) (26,863) (42,315) (8,052) Net loss (25,932) (26,544) (42,130) (8,074) Basic and diluted loss per common share $ (0.23) $ (0.24) $ (0.34) $ (0.06) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Number of operating segments | segment | 1 | ||
Cash, cash equivalents | $ 231,643 | $ 272,350 | $ 306,019 |
Asset impairment charges | 0 | 0 | 0 |
Research and development | 51,139 | 50,327 | 52,866 |
Selling, general and administrative expense | 171,400 | 96,000 | $ 22,300 |
Inventories, net | 19,326 | 13,927 | |
Restricted cash | $ 300 | $ 0 | |
Specialty Pharmacy One | Revenue Benchmark | Customer Concentration Risk | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk percentage | 56.00% | ||
Specialty Pharmacy Two | Revenue Benchmark | Customer Concentration Risk | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk percentage | 43.00% | ||
Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Lease term | 12 months | ||
Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Lease term | 128 months | ||
Acquired intellectual property and reacquired rights | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Acquired intangible assets useful life | 10 years | ||
Acquired intellectual property and reacquired rights | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Acquired intangible assets useful life | 20 years |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Shareholders' equity | $ 479,091 | $ 407,750 | $ 298,600 | $ 135,717 |
Accounting Standards Update 2018-15 | Cumulative Effect, Period of Adoption, Adjustment | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Shareholders' equity | $ 1,700 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Dec. 31, 2021 | Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||
Debt securities, Held-to-maturity | $ 19,200 | $ 150,400 |
Debt securities, Available-for-sale | 214,900 | 0 |
Marketable Securities [Line Items] | ||
Total short term investments | 234,178 | 125,979 |
Corporate Bonds - total long term investments | 0 | 24,380 |
Total investments | 234,178 | 150,359 |
Interest receivable | 100 | 500 |
Unrealized gains on available-for-sale securities | (47) | 0 |
Cashable Guaranteed Investment Certificate | ||
Marketable Securities [Line Items] | ||
Total short term investments | 3,140 | 2,000 |
Corporate Bond | ||
Marketable Securities [Line Items] | ||
Total short term investments | 21,820 | 40,372 |
Commercial Paper | ||
Marketable Securities [Line Items] | ||
Total short term investments | 206,724 | 67,747 |
Treasury Bill | ||
Marketable Securities [Line Items] | ||
Total short term investments | 2,494 | 7,999 |
Treasury Bond | ||
Marketable Securities [Line Items] | ||
Total short term investments | 0 | 5,045 |
Yankee Bond | ||
Marketable Securities [Line Items] | ||
Total short term investments | 0 | 2,816 |
Corporate Bonds | ||
Marketable Securities [Line Items] | ||
Corporate Bonds - total long term investments | $ 0 | $ 24,380 |
Fair Value Measurement - Assets
Fair Value Measurement - Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Investments | $ 234,178 | $ 150,359 |
Total | 466,078 | 422,709 |
Deposits held with banks | ||
Assets: | ||
Cash and cash equivalents: | 214,702 | 130,807 |
Short-term highly liquid investments | ||
Assets: | ||
Cash and cash equivalents: | 17,198 | 141,543 |
Level 1 | ||
Assets: | ||
Investments | 206,724 | 69,746 |
Total | 438,624 | 342,096 |
Level 1 | Deposits held with banks | ||
Assets: | ||
Cash and cash equivalents: | 214,702 | 130,807 |
Level 1 | Short-term highly liquid investments | ||
Assets: | ||
Cash and cash equivalents: | 17,198 | 141,543 |
Level 2 | ||
Assets: | ||
Investments | 27,454 | 80,613 |
Total | 27,454 | 80,613 |
Level 2 | Deposits held with banks | ||
Assets: | ||
Cash and cash equivalents: | 0 | 0 |
Level 2 | Short-term highly liquid investments | ||
Assets: | ||
Cash and cash equivalents: | 0 | 0 |
Level 3 | ||
Assets: | ||
Investments | 0 | |
Total | 0 | 0 |
Level 3 | Deposits held with banks | ||
Assets: | ||
Cash and cash equivalents: | 0 | 0 |
Level 3 | Short-term highly liquid investments | ||
Assets: | ||
Cash and cash equivalents: | $ 0 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,217 | $ 0 |
Work in process | 12,566 | 13,927 |
Finished goods | 4,543 | 0 |
Total inventories, net | 19,326 | $ 13,927 |
Inventory deposits | $ 3,900 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Receivables [Abstract] | ||
Prepaid assets | $ 5,316 | $ 3,701 |
Prepaid insurance | 1,632 | 2,054 |
Prepaid deposits | 4,762 | 398 |
Other current assets | 796 | 1,018 |
Total prepaid expenses and other current assets | $ 12,506 | $ 7,171 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 5,254 | $ 4,965 | |
Less accumulated depreciation | (836) | (179) | |
Property and equipment, net | 4,418 | 4,786 | |
Depreciation of property and equipment | 663 | 82 | $ 33 |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 393 | 4,467 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 2,978 | 34 | |
Office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 5 years | ||
Property, plant and equipment, gross | $ 645 | 83 | |
Furniture | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 7 years | ||
Property, plant and equipment, gross | $ 976 | 0 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (in years) | 3 years | ||
Property, plant and equipment, gross | $ 262 | $ 381 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 19,470 | $ 18,452 |
Accumulated Amortization | (11,066) | (9,120) |
Net Carrying Amount | $ 8,404 | $ 9,332 |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted Average Life (in years) | 12 years | 12 years |
Gross Carrying Value | $ 1,471 | $ 1,651 |
Accumulated Amortization | (1,176) | (1,203) |
Net Carrying Amount | $ 295 | $ 448 |
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 | (8,804) | (7,770) |
Net Carrying Amount | $ 6,322 | $ 7,356 |
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 | $ 1,675 |
Accumulated Amortization | (1,086) | (147) |
Net Carrying Amount | $ 1,787 | $ 1,528 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization of intangible assets | $ 2,098 | $ 1,289 | $ 1,138 |
2022 | 6,700 | ||
2023 | 6,700 | ||
2024 | 6,700 | ||
2025 | 6,700 | ||
2026 | $ 6,700 |
Accounts payable and accrued _3
Accounts payable and accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Trade payables | $ 3,879 | $ 2,635 |
Other accrued liabilities | 8,443 | 6,616 |
Accrued R&D projects | 4,383 | 4,185 |
Employee accruals | 18,242 | 11,361 |
Accounts payable and accrued liabilities | $ 34,947 | $ 24,797 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Thousands | Aug. 17, 2021 | Dec. 17, 2020 | Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Revenues | $ 23,404 | $ 14,667 | $ 6,620 | $ 914 | $ 50,030 | $ 29 | $ 29 | $ 30 | $ 45,605 | $ 50,118 | $ 318 | ||
Thunderbolt | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Upfront payment | $ 750 | ||||||||||||
License Agreement Terms | Otuska | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Upfront payments received | $ 50,000 | $ 0 | |||||||||||
Potential regulatory milestone revenue | 50,000 | ||||||||||||
Revenues | $ 50,000 | ||||||||||||
License Agreement Terms | Otuska | Minimum | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Tiered royalty percentages on future sales | 10.00% | ||||||||||||
License Agreement Terms | Otuska | Maximum | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Tiered royalty percentages on future sales | 20.00% | ||||||||||||
License Agreement Terms | Riptide Bioscience, Inc. | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||||
Payments to acquire productive assets | $ 6,000 |
Segment Information and Geogr_3
Segment Information and Geographic Data - Narrative (Details) - Customer Concentration Risk | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue Benchmark | Customer One | ||
Product Information [Line Items] | ||
Concentration risk percentage | 56.00% | |
Revenue Benchmark | Customer Two | ||
Product Information [Line Items] | ||
Concentration risk percentage | 43.00% | |
Accounts Receivable | Customer One | ||
Product Information [Line Items] | ||
Concentration risk percentage | 56.00% | |
Accounts Receivable | Customer Two | ||
Product Information [Line Items] | ||
Concentration risk percentage | 43.00% |
Segment Information and Geogr_4
Segment Information and Geographic Data - Revenue by Geographic Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | $ 23,404 | $ 14,667 | $ 6,620 | $ 914 | $ 50,030 | $ 29 | $ 29 | $ 30 | $ 45,605 | $ 50,118 | $ 318 |
Japan | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | 0 | 50,000 | 0 | ||||||||
Other | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | 117 | 118 | 118 | ||||||||
United States | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Revenues | $ 45,488 | $ 0 | $ 200 |
Segment Information and Geogr_5
Segment Information and Geographic Data - Long-lived Assets by Location (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived Assets | $ 4,418 | $ 4,786 |
Canada | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived Assets | 454 | 298 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived Assets | $ 3,964 | $ 4,488 |
Income Taxes - Components of In
Income Taxes - Components of Income Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Canada | $ (180,374) | $ (61,024) | $ (88,694) |
Foreign | 168 | (41,750) | 453 |
Net loss before income taxes | $ (180,206) | $ (102,774) | $ (88,241) |
Income Taxes - Provision For In
Income Taxes - Provision For Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Canada | $ 0 | $ 0 | $ 0 |
Foreign | 760 | (94) | 144 |
Total Current | 760 | (94) | 144 |
Deferred: | |||
Canada | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | 0 |
Income tax expense (benefit) | $ 760 | $ (94) | $ 144 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Canada statutory income tax benefit | 26.80% | 26.80% | 25.40% |
Effect of tax rates on foreign jurisdictions | 0.00% | (2.40%) | 0.00% |
Impact of future rates and tax rate changes | (0.10%) | 6.10% | (0.90%) |
Non-deductible share-based compensation | (4.50%) | (4.50%) | (2.10%) |
Change in valuation allowance | (21.80%) | (26.00%) | (22.30%) |
Other | (0.80%) | 0.10% | (0.30%) |
Effective tax rate | (0.40%) | 0.10% | (0.20%) |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Loss carry-forwards | $ 120,274 | $ 80,087 |
Share issue costs | 6,016 | 6,295 |
Intangible assets | 1,086 | 2,718 |
SRED (Scientific Research and Experimental Development) | 6,059 | 4,808 |
Deferred compensation | 3,980 | 4,006 |
Other | 6,126 | 5,243 |
Total deferred tax assets | 143,541 | 103,157 |
Valuation allowance | (141,348) | (101,792) |
Net deferred tax assets | 2,193 | 1,365 |
Deferred tax liabilities: | ||
Other | (1,356) | (1,173) |
Property and equipment and intangible assets | (837) | (192) |
Deferred tax liabilities | (2,193) | (1,365) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Increase in valuation allowance | $ (39.6) |
Operating loss carryforwards | 429.8 |
Canada Investment Tax Credits and British Columbia Scientific Research and Experimental Development | Domestic Tax Authority | |
Operating Loss Carryforwards [Line Items] | |
Tax credit carryforward | 4.8 |
United States | Foreign Tax Authority | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | $ 31.4 |
Commitment and Contingencies -
Commitment and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Long-term Purchase Commitment [Line Items] | ||||
Purchase of long-lived assets | $ 297 | $ 5,584 | $ 85 | |
Lonza | ||||
Long-term Purchase Commitment [Line Items] | ||||
Non-cancellable future commitments | $ 26,400 | |||
Purchase of long-lived assets | $ 3,500 |
Deferred Compensation and Oth_2
Deferred Compensation and Other Non-current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Other non-current liabilities | $ 15,950 | $ 16,295 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands, SFr in Millions | 1 Months Ended | 12 Months Ended | ||||
Feb. 28, 2021USD ($) | Jan. 31, 2021CHF (SFr) | Mar. 31, 2020ft²extension_option | Dec. 31, 2020USD ($)ft² | Dec. 31, 2021USD ($) | Mar. 12, 2020 | |
Lessee, Lease, Description [Line Items] | ||||||
Right-of-use assets | $ 5,489 | $ 5,383 | ||||
Total | $ 8,407 | $ 8,739 | ||||
Incremental borrowing rate | 5.20% | 5.20% | ||||
Minimum lease payments | $ 11,171 | |||||
Payments for capital improvements | SFr | SFr 21 | |||||
Capital expenditure payments | $ 11,800 | |||||
Minimum finance lease liability payments due | 79,000 | |||||
Victoria, British Columbia | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Area of property (in sqft) | ft² | 13,206 | |||||
Right-of-use assets | 200 | |||||
Total | $ 200 | |||||
Incremental borrowing rate | 4.08% | |||||
Minimum lease payments | $ 2,300 | |||||
Rockville, Maryland | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Area of property (in sqft) | ft² | 30,531 | |||||
Right-of-use assets | $ 5,500 | 5,200 | ||||
Total | 8,400 | $ 8,600 | ||||
Incremental borrowing rate | 5.20% | |||||
Remaining lease term | 11 years | |||||
Number of extension options | extension_option | 2 | |||||
Lease extension term | 5 years | |||||
Lease termination option term | 7 years | |||||
Proceeds from tenant improvements | $ 2,300 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Right-of-use assets | $ 5,383 | $ 5,489 |
Liabilities | ||
Current operating lease liabilities | 1,059 | 788 |
Non-current operating lease liabilities | ||
Non-current operating lease liabilities | 7,680 | 7,619 |
Total lease liabilities | $ 8,739 | $ 8,407 |
Leases - Summary of Components
Leases - Summary of Components of Leasing Costs and Rent (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease costs | $ 1,045 | $ 653 | $ 229 |
Short-term lease costs | 27 | 288 | 68 |
Variable lease costs | 167 | 3 | 0 |
Total rent expense | $ 1,239 | $ 944 | $ 297 |
Leases - Cash Flow and Suppleme
Leases - Cash Flow and Supplemental Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Weighted average remaining lease term (in years) | 9 years 5 months 26 days | 10 years 8 months 1 day | |
Weighted average discount rate | 5.20% | 5.20% | |
Cash paid for amounts included in the measurement of lease liabilities | $ 646 | $ 267 | $ 182 |
Initial recognition of operating lease right-of-use asset | $ 419 | $ 5,804 | $ 0 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 1,143 | |
2023 | 1,061 | |
2024 | 1,085 | |
2025 | 1,109 | |
2026 | 1,135 | |
Thereafter | 5,638 | |
Total lease payments | 11,171 | |
Less: imputed interest | (2,432) | |
Total | $ 8,739 | $ 8,407 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) - USD ($) | Nov. 19, 2021 | Jul. 27, 2020 | Dec. 12, 2019 | Sep. 13, 2019 | Mar. 29, 2018 | Dec. 28, 2016 | Feb. 14, 2014 | Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Class of Stock [Line Items] | ||||||||||||
Common stock, outstanding (shares) | 141,600,000 | 141,600,000 | 126,725,000 | 111,800,000 | ||||||||
Common stock, issued (shares) | 141,600,000 | 141,600,000 | 126,725,000 | 111,800,000 | ||||||||
Proceeds from offering | $ 15,000,000 | |||||||||||
Proceeds from exercise of warrants | $ 365,000 | $ 1,000 | $ 6,988,000 | |||||||||
Warrants exercised during period (in shares) | 1,700,000 | 500 | ||||||||||
Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of warrants outstanding | 0 | 0 | 1,690,000 | 1,691,000 | ||||||||
Warrants exercised during period (in shares) | 1,684,000 | 1,000 | ||||||||||
Warrants expired, in shares | 6,000 | |||||||||||
Common Shares | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, outstanding (shares) | 141,600,000 | 141,600,000 | 126,725,000 | 111,798,000 | 85,500,000 | |||||||
Share issuance costs | $ 5,616,000 | $ 12,268,000 | $ 13,629,000 | |||||||||
November 2021 Open Market Sale Agreement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate offering price | $ 250,000,000 | |||||||||||
Number of shares issued | 10,200,000 | |||||||||||
Weighted average price per share (in usd per share) | $ 19.90 | |||||||||||
Proceeds from offering | $ 202,400,000 | |||||||||||
Share issuance costs | $ 5,600,000 | |||||||||||
Underwriting commissions percentage | 3.00% | |||||||||||
Underwriting commissions | $ 5,300,000 | |||||||||||
Professional fees | $ 300,000 | |||||||||||
July 2020 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares issued | 13,300,000 | |||||||||||
Proceeds from offering | $ 200,000,000 | |||||||||||
Share issuance costs | $ 12,300,000 | |||||||||||
Underwriting commissions percentage | 6.00% | |||||||||||
Underwriting commissions | $ 12,000,000 | |||||||||||
Professional fees | $ 300,000 | |||||||||||
Share price (in usd per share) | $ 15 | |||||||||||
December 2019 Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares issued | 12,800,000 | |||||||||||
Proceeds from offering | $ 191,700,000 | |||||||||||
Share issuance costs | $ 11,800,000 | |||||||||||
Underwriting commissions percentage | 6.00% | |||||||||||
Underwriting commissions | $ 11,500,000 | |||||||||||
Professional fees | $ 300,000 | |||||||||||
Share price (in usd per share) | $ 15 | |||||||||||
2019 Open Market Sale Agreement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate offering price | $ 40,000,000 | |||||||||||
Number of shares issued | 2,300,000 | |||||||||||
Weighted average price per share (in usd per share) | $ 6.40 | |||||||||||
Share issuance costs | $ 640,000 | |||||||||||
Underwriting commissions percentage | 3.00% | |||||||||||
Underwriting commissions | $ 450,000 | |||||||||||
Professional fees | $ 190,000 | |||||||||||
2014 Private Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares issued | 18,900,000 | |||||||||||
Subscription price per unit (in usd per share) | $ 2.7485 | |||||||||||
Exercise price of warrants (in usd per share) | $ 3.2204 | |||||||||||
2014 Private Offering | One Holder of Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from exercise of warrants | $ 1,500,000 | |||||||||||
2014 Private Offering | Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from offering | $ 52,000,000 | |||||||||||
Warrant exercise period | 5 years | |||||||||||
2014 Private Offering | Warrants | One Holder of Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of warrants outstanding | 464,000 | |||||||||||
2014 Private Offering | Warrants | 2014 Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares called by each warrant | 0.25 | |||||||||||
2014 Private Offering | Warrants | 2014 Warrant Cashless Exercise | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of warrants outstanding | 1,300,000 | |||||||||||
2014 Private Offering | Common Shares | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares called by each warrant | 1 | |||||||||||
Number of shares converted | 700,000 | |||||||||||
2014 Private Offering | Common Shares | One Holder of Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares converted | 464,000 | |||||||||||
2016 Bought Deal Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares issued | 12,800,000 | |||||||||||
Subscription price per unit (in usd per share) | $ 2.25 | |||||||||||
Exercise price of warrants (in usd per share) | $ 3 | $ 3 | $ 3 | $ 3 | $ 3 | |||||||
Proceeds from exercise of warrants | $ 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 | |||||||||||
Number of warrants outstanding | 1,600,000 | 1,600,000 | ||||||||||
Fair value of warrants | $ 7,200,000 | |||||||||||
2016 Bought Deal Public Offering | Warrants | 2014 Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares called by each warrant | 0.50 | |||||||||||
2016 Bought Deal Public Offering | Common Shares | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares called by each warrant | 1 | |||||||||||
Number of shares converted | 1,300,000 |
Shareholders' Equity - Common S
Shareholders' Equity - Common Stock Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Increase (Decrease) in Stockholders' Equity | |||
Balance (in shares) | 126,725,000 | 111,800,000 | |
Balance | $ 407,750 | $ 298,600 | $ 135,717 |
Issue of common shares upon public offerings, net of issuance costs | 196,740 | 187,732 | 223,118 |
Issued pursuant to exercise of warrants | $ 365 | $ 1 | $ 6,988 |
Issued pursuant to exercise of stock options (in shares) | 3,238,000 | 1,593,000 | 3,578,000 |
Issued pursuant to exercise of stock options | $ 23,421 | $ 6,643 | $ 13,748 |
Issued pursuant to ESPP | 585 | ||
Balance | $ 479,091 | $ 407,750 | $ 298,600 |
Balance (in shares) | 141,600,000 | 126,725,000 | 111,800,000 |
Common Shares | |||
Increase (Decrease) in Stockholders' Equity | |||
Balance (in shares) | 126,725,000 | 111,798,000 | 85,500,000 |
Balance | $ 944,328 | $ 746,487 | $ 488,744 |
Issuance of common shares (in shares) | 10,166,000 | 13,333,000 | 19,735,000 |
Issue of common shares upon public offerings, net of issuance costs | $ 196,740 | $ 187,732 | $ 223,118 |
Share issue costs | $ (5,616) | $ (12,268) | $ (13,629) |
Issued pursuant to exercise of warrants (in shares) | 1,434,000 | 1,000 | 2,983,000 |
Issued pursuant to exercise of warrants | $ 2,102 | $ 2 | $ 12,428 |
Issued pursuant to exercise of stock options (in shares) | 3,238,000 | 1,593,000 | 3,580,000 |
Issued pursuant to exercise of stock options | $ 33,073 | $ 10,107 | $ 22,197 |
Issued pursuant to ESPP (in shares) | 37,000 | ||
Issued pursuant to ESPP | $ 808 | ||
Balance | $ 1,177,051 | $ 944,328 | $ 746,487 |
Balance (in shares) | 141,600,000 | 126,725,000 | 111,798,000 |
Common Shares | Public Offering | |||
Increase (Decrease) in Stockholders' Equity | |||
Issuance of common shares (in shares) | 13,333,000 | 12,782,000 | |
Issue of common shares upon public offerings, net of issuance costs | $ 200,000 | $ 191,737 | |
Common Shares | At-the-Market Facilities | |||
Increase (Decrease) in Stockholders' Equity | |||
Issuance of common shares (in shares) | 10,166,000 | 6,953,000 | |
Issue of common shares upon public offerings, net of issuance costs | $ 202,356 | $ 45,010 |
Shareholders' Equity - Warrant
Shareholders' Equity - Warrant Activity (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
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 | 1,691,000 | |
Warrants exercised, in shares | (1,684,000) | (1,000) | |
Warrants expired, in shares | 6,000 | ||
Ending balance, in shares | 0 | 1,690,000 | 1,691,000 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | Aug. 06, 2021$ / sharesshares | Mar. 18, 2021$ / shares | Nov. 20, 2020$ / sharesshares | Oct. 02, 2020employee$ / sharesshares | Sep. 04, 2020employee$ / sharesshares | Apr. 29, 2019$ / sharesshares | May 02, 2016$ / sharesshares | Jun. 30, 2021shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock, issued (shares) | 141,600,000 | 126,725,000 | 111,800,000 | ||||||||
Common stock, outstanding (shares) | 141,600,000 | 126,725,000 | 111,800,000 | ||||||||
Intrinsic value of options exercised | $ | $ 50,300 | $ 13,100 | $ 63,300 | ||||||||
Granted inducement (in shares) | 925,000 | 1,600,000 | |||||||||
Granted inducements (in usd per share) | $ / shares | $ 14.36 | $ 6.28 | |||||||||
Number of new employees | employee | 9 | 105 | |||||||||
Granted (in shares) | 2,277,000 | 7,129,000 | 2,520,000 | ||||||||
Weighted average price (in usd per share) | $ / shares | $ 7.34 | $ 5.58 | $ 2.56 | ||||||||
Fair value of options vested in period | $ | $ 24,900 | $ 14,900 | $ 8,500 | ||||||||
Weighted average remaining amortization period (in years) | 1 year 1 month 6 days | ||||||||||
Volatility | 66.00% | 52.00% | 52.00% | ||||||||
Share-based compensation expense | $ | $ 31,243 | $ 17,454 | $ 7,414 | ||||||||
Unrecognized share-based compensation expense | $ | $ 19,056 | ||||||||||
Amended and Restated Equity Incentive Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of additional shares authorized | 23,800,000 | ||||||||||
Executive Vice President, General Counsel, Corporate Secretary and Chief Compliance Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Granted inducement (in shares) | 298,924 | ||||||||||
Granted inducements (in usd per share) | $ / shares | $ 13.40 | ||||||||||
Executive Vice President, General Counsel, Corporate Secretary and Chief Compliance Officer | Tranche One | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting rights | 33.00% | ||||||||||
Executive Vice President, General Counsel, Corporate Secretary and Chief Compliance Officer | Tranche Two | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting period | 24 months | ||||||||||
New Employees | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Granted inducement (in shares) | 96,000 | 530,000 | 200,000 | ||||||||
Granted inducements (in usd per share) | $ / shares | $ 14.73 | $ 14.83 | $ 2,920 | ||||||||
Award vesting period | 36 months | ||||||||||
Exercise period | 5 years | ||||||||||
Options exercised in period | 150,000 | ||||||||||
Number of options outstanding | 0 | ||||||||||
New Employees | Tranche One | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting rights | 33.00% | 33.00% | |||||||||
New Employees | Tranche Two | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting period | 24 months | 24 months | |||||||||
Chief Executive Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Granted inducement (in shares) | 1,600,000 | ||||||||||
Granted inducements (in usd per share) | $ / shares | $ 6.28 | ||||||||||
Exercise period | 10 years | ||||||||||
Chief Executive Officer | Tranche One | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting period | 1 year | ||||||||||
Award vesting rights | 25.00% | ||||||||||
Chief Executive Officer | Tranche Two | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Award vesting period | 36 months | ||||||||||
Award vesting rights | 75.00% | ||||||||||
Stock Options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Weighted average remaining amortization period (in years) | 1 year 2 months 12 days | ||||||||||
Unrecognized share-based compensation expense | $ | $ 13,563 | ||||||||||
Inducement Stock Option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Exercise period | 10 years | ||||||||||
ESPP | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares authorized | 2,500,000 | ||||||||||
Weighted average remaining amortization period (in years) | 1 year 1 month 6 days | ||||||||||
Unrecognized share-based compensation expense | $ | $ 3,296 | ||||||||||
Performance Share sand Restricted Stock Units (RSUs) | Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Fair value on grant date (in usd per share) | $ / shares | $ 14.42 | ||||||||||
Unvested performance awards | Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Awards granted in period | 418,000 | 439,000 | |||||||||
Fair value on grant date (in usd per share) | $ / shares | $ 13.56 | ||||||||||
Options exercised in period (in shares) | 88,000 | ||||||||||
Options cancelled (in shares) | 351,000 | ||||||||||
Share-based compensation expense | $ | $ 2,700 | ||||||||||
Restricted Stock Units | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Weighted average remaining amortization period (in years) | 7 months 6 days | ||||||||||
Unrecognized share-based compensation expense | $ | $ 2,197 | ||||||||||
Restricted Stock Units | Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Awards granted in period | 201,000 |
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, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares (in thousands) | ||||
Beginning balance (in shares) | 14,047 | 7,822 | 7,591 | |
Granted (in shares) | 2,277 | 7,129 | 2,520 | |
Granted inducement (in shares) | 925 | 1,600 | ||
Exercised/released (in shares) | (3,238) | (1,593) | (3,578) | |
Cancelled/forfeited (in shares) | (1,012) | (236) | (311) | |
Ending balance (in shares) | 12,074 | 14,047 | 7,822 | |
Exercisable - Options at end of period (in shares) | 5,849 | |||
Weighted-Average Exercise Price | ||||
Beginning balance (in usd per share) | $ 12.84 | $ 11.35 | $ 5.47 | $ 4.44 |
Granted (in usd per share) | 14,440 | 15.61 | 6 | |
Granted inducements (in usd per share) | 14.36 | 6.28 | ||
Exercised/released (in usd per share) | 7,210 | 4.39 | 4.03 | |
Cancelled/forfeited (in usd per share) | 13,840 | 11.82 | 5.40 | |
Ending balance (in usd per share) | 12.84 | $ 11.35 | $ 5.47 | |
Exercisable - Options at end of period (in usd per share) | $ 11.87 | |||
Weighted-Average Remaining Contractual Life (in years) | 7 years 10 months 9 days | 7 years 6 months 3 days | 6 years 7 months 20 days | |
Aggregate Intrinsic Value | $ 121,141 | $ 35,891 | $ 115,655 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |||
Expected term (in years) | 4 years | 3 years | 4 years |
Volatility | 66.00% | 52.00% | 52.00% |
Risk-free interest rate | 0.46% | 0.55% | 1.61% |
Dividend yield | $ 0 | $ 0 | $ 0 |
Share-Based Compensation - Allo
Share-Based Compensation - Allocated Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 31,243 | $ 17,454 | $ 7,414 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 4,442 | 3,730 | 2,693 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 26,432 | 13,615 | 4,721 |
Capitalized under inventories | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 369 | $ 109 | $ 0 |
Share-Based Compensation - Unre
Share-Based Compensation - Unrecognized Share-Based Compensation Expense (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 19,056 |
Weighted average remaining amortization period (in years) | 1 year 1 month 6 days |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 13,563 |
Weighted average remaining amortization period (in years) | 1 year 2 months 12 days |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 2,197 |
Weighted average remaining amortization period (in years) | 7 months 6 days |
ESPP | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized share-based compensation expense | $ 3,296 |
Weighted average remaining amortization period (in years) | 1 year 1 month 6 days |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (33,322) | $ (50,255) | $ (47,010) | $ (50,379) | $ (8,074) | $ (42,130) | $ (26,544) | $ (25,932) | $ (180,966) | $ (102,680) | $ (88,385) |
Weighted average number of common shares outstanding (in shares) | 129,369,000 | 118,473,000 | 93,024,000 | ||||||||
Diluted loss per common share (in dollars per share) | $ (0.25) | $ (0.39) | $ (0.37) | $ (0.40) | $ (0.06) | $ (0.34) | $ (0.24) | $ (0.23) | $ (1.40) | $ (0.87) | $ (0.95) |
Basic loss per common share (in dollars per share) | $ (0.25) | $ (0.39) | $ (0.37) | $ (0.40) | $ (0.06) | $ (0.34) | $ (0.24) | $ (0.23) | $ (1.40) | $ (0.87) | $ (0.95) |
Net Loss Per Common Share - Ant
Net Loss Per Common Share - Anti-Dilutive Securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 12,329,000 | 15,737,000 | 9,513,000 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 12,074,000 | 14,047,000 | 7,822,000 |
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) | 64,000 | 0 | 0 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 191,000 | 0 | 0 |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 1,690,000 | 1,691,000 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
ILJIN | Other Current Liabilities | |||
Related Party Transaction [Line Items] | |||
Due to related parties | $ 0 | $ 6,000 | |
Milestone Payment | Affiliated Shareholder | ILJIN | |||
Related Party Transaction [Line Items] | |||
Payments to related party | $ 6,000 | ||
Legal Fees | Management | |||
Related Party Transaction [Line Items] | |||
Expenses from related party | $ 392 | $ 473 |
Selected Quarterly Financial _3
Selected Quarterly Financial Information (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 23,404 | $ 14,667 | $ 6,620 | $ 914 | $ 50,030 | $ 29 | $ 29 | $ 30 | $ 45,605 | $ 50,118 | $ 318 |
Operating Expenses | 56,109 | 65,020 | 53,754 | 51,457 | 58,082 | 42,344 | 26,892 | 27,090 | |||
Loss from operations | (32,705) | (50,353) | (47,134) | (50,543) | (8,052) | (42,315) | (26,863) | (27,060) | (180,735) | (104,290) | (90,943) |
Net loss | $ (33,322) | $ (50,255) | $ (47,010) | $ (50,379) | $ (8,074) | $ (42,130) | $ (26,544) | $ (25,932) | $ (180,966) | $ (102,680) | $ (88,385) |
Basic loss per common share (in dollars per share) | $ (0.25) | $ (0.39) | $ (0.37) | $ (0.40) | $ (0.06) | $ (0.34) | $ (0.24) | $ (0.23) | $ (1.40) | $ (0.87) | $ (0.95) |
Diluted loss per common share (in dollars per share) | $ (0.25) | $ (0.39) | $ (0.37) | $ (0.40) | $ (0.06) | $ (0.34) | $ (0.24) | $ (0.23) | $ (1.40) | $ (0.87) | $ (0.95) |