Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36421 | |
Entity Registrant Name | Aurinia Pharmaceuticals Inc. | |
Entity Incorporation, State or Country Code | Z4 | |
Entity Address, Address Line One | #1203-4464 Markham Street | |
Entity Tax Identification Number | 98-1231763 | |
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 | |
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 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 141,892,181 | |
Title of 12(b) Security | Common shares, no par value | |
Trading Symbol | AUPH | |
Security Exchange Name | NASDAQ | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001600620 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash, cash equivalents and restricted cash | $ 151,632 | $ 231,900 |
Short-term investments | 240,104 | 234,178 |
Accounts receivable, net | 18,173 | 15,414 |
Inventories, net | 25,863 | 19,326 |
Prepaid expenses and other current assets | 17,421 | 12,506 |
Total current assets | 453,193 | 513,324 |
Non-current assets | ||
Other non-current assets | 12,355 | 11,838 |
Property and equipment, net | 4,183 | 4,418 |
Acquired intellectual property and other intangible assets, net | 7,338 | 8,404 |
Right-of-use assets, net | 5,079 | 5,383 |
Total assets | 482,148 | 543,367 |
Current liabilities | ||
Accounts payable and accrued liabilities | 32,380 | 34,947 |
Other current liabilities | 1,293 | 4,640 |
Operating lease liabilities | 953 | 1,059 |
Total current liabilities | 34,626 | 40,646 |
Non-current liabilities | ||
Deferred compensation and other non-current liabilities | 16,323 | 15,950 |
Operating lease liabilities | 7,431 | 7,680 |
Total liabilities | 58,380 | 64,276 |
Commitments and contingencies | ||
SHAREHOLDER’S EQUITY | ||
Common shares - no par value, unlimited shares authorized, 141,892 and 141,600 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1,180,884 | 1,177,051 |
Additional paid-in capital | 74,004 | 59,014 |
Accumulated other comprehensive loss | (1,853) | (852) |
Accumulated deficit | (829,267) | (756,122) |
Total shareholders' equity | 423,768 | 479,091 |
Total liabilities and shareholders’ equity | $ 482,148 | $ 543,367 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets(Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value ($ per share) | $ 0 | $ 0 |
Common stock, issued (shares) | 141,892,000 | 141,600,000 |
Common stock, outstanding (shares) | 141,892,000 | 141,600,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue | ||||
Total revenue, net | $ 28,191 | $ 6,620 | $ 49,816 | $ 7,534 |
Operating expenses | ||||
Cost of sales | 1,599 | 308 | 1,855 | 356 |
Selling, general and administrative | 51,532 | 44,322 | 96,729 | 84,127 |
Research and development | 11,525 | 10,091 | 24,145 | 19,924 |
Other (income) expense, net | (476) | (967) | 958 | 804 |
Total cost of sales and operating expenses | 64,180 | 53,754 | 123,687 | 105,211 |
Loss from operations | (35,989) | (47,134) | (73,871) | (97,677) |
Interest income | 483 | 142 | 745 | 314 |
Net loss before income taxes | (35,506) | (46,992) | (73,126) | (97,363) |
Income tax expense | 9 | 18 | 19 | 26 |
Net loss | (35,515) | (47,010) | (73,145) | (97,389) |
Other comprehensive loss: | ||||
Unrealized (loss) gain on available-for-sale securities, net of tax of nil | (235) | 7 | (1,001) | 13 |
Comprehensive loss | $ (35,750) | $ (47,003) | $ (74,146) | $ (97,376) |
Basic loss per share ($ per share) | $ (0.25) | $ (0.37) | $ (0.52) | $ (0.76) |
Diluted loss per share ($ per share) | $ (0.25) | $ (0.37) | $ (0.52) | $ (0.76) |
Weighted-average common shares outstanding used in computation of basic loss per share (in shares) | 141,726 | 128,222 | 141,734 | 127,814 |
Weighted-average common shares outstanding used in computation of diluted loss per share (in shares) | 141,726 | 128,222 | 141,734 | 127,814 |
Product revenue, net | ||||
Revenue | ||||
Total revenue, net | $ 28,148 | $ 6,591 | $ 49,640 | $ 7,475 |
License and collaboration revenue | ||||
Revenue | ||||
Total revenue, net | $ 43 | $ 29 | $ 176 | $ 59 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Unrealized gain on available-for-sale securities, tax | $ 0 | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Common Shares | Additional paid in capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2020 | 126,725,000 | ||||
Balance at Dec. 31, 2020 | $ 407,750 | $ 944,328 | $ 39,383 | $ (805) | $ (575,156) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards (in shares) | 1,152,000 | ||||
Shares issued on exercise of stock options and vesting of performance awards | 6,278 | $ 9,518 | (3,240) | ||
Exercise of warrants (in shares) | 519,000 | ||||
Exercise of warrants | 31 | $ 726 | (695) | ||
Shared-based compensation | 15,574 | 15,574 | |||
Unrealized loss on available-for-sale securities | 13 | 13 | |||
Net loss | (97,389) | (97,389) | |||
Balance (in shares) at Jun. 30, 2021 | 128,396,000 | ||||
Balance at Jun. 30, 2021 | 332,257 | $ 954,572 | 51,022 | (792) | (672,545) |
Balance (in shares) at Mar. 31, 2021 | 128,121,000 | ||||
Balance at Mar. 31, 2021 | 370,228 | $ 952,673 | 43,889 | (799) | (625,535) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards (in shares) | 275,000 | ||||
Shares issued on exercise of stock options and vesting of performance awards | 1,279 | $ 1,899 | (620) | ||
Shared-based compensation | 7,753 | 7,753 | |||
Unrealized loss on available-for-sale securities | 7 | 7 | |||
Net loss | (47,010) | (47,010) | |||
Balance (in shares) at Jun. 30, 2021 | 128,396,000 | ||||
Balance at Jun. 30, 2021 | $ 332,257 | $ 954,572 | 51,022 | (792) | (672,545) |
Balance (in shares) at Dec. 31, 2021 | 141,600,000 | 141,600,000 | |||
Balance at Dec. 31, 2021 | $ 479,091 | $ 1,177,051 | 59,014 | (852) | (756,122) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards (in shares) | 77,000 | 165,000 | |||
Shares issued on exercise of stock options and vesting of performance awards | $ 522 | $ 1,928 | (1,406) | ||
Issuance of common shares in conjunction with ESPP program (in shares) | 127,000 | ||||
Issuance of common shares in conjunction with ESPP program | 1,223 | $ 1,905 | (682) | ||
Shared-based compensation | 17,078 | 17,078 | |||
Unrealized loss on available-for-sale securities | (1,001) | (1,001) | |||
Net loss | $ (73,145) | (73,145) | |||
Balance (in shares) at Jun. 30, 2022 | 141,892,000 | 141,892,000 | |||
Balance at Jun. 30, 2022 | $ 423,768 | $ 1,180,884 | 74,004 | (1,853) | (829,267) |
Balance (in shares) at Mar. 31, 2022 | 141,742,000 | ||||
Balance at Mar. 31, 2022 | 448,123 | $ 1,178,807 | 64,686 | (1,618) | (793,752) |
Increase (Decrease) in Stockholders' Equity | |||||
Shares issued on exercise of stock options and vesting of performance awards (in shares) | 23,000 | ||||
Shares issued on exercise of stock options and vesting of performance awards | 117 | $ 172 | (55) | ||
Issuance of common shares in conjunction with ESPP program (in shares) | 127,000 | ||||
Issuance of common shares in conjunction with ESPP program | 1,223 | $ 1,905 | (682) | ||
Shared-based compensation | 10,055 | 10,055 | |||
Unrealized loss on available-for-sale securities | (235) | (235) | 0 | ||
Net loss | $ (35,515) | (35,515) | |||
Balance (in shares) at Jun. 30, 2022 | 141,892,000 | 141,892,000 | |||
Balance at Jun. 30, 2022 | $ 423,768 | $ 1,180,884 | $ 74,004 | $ (1,853) | $ (829,267) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows used in operating activities: | ||
Net loss | $ (73,145) | $ (97,389) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 1,678 | 1,264 |
Share-based compensation expense | 17,078 | 15,574 |
Other, net | 2,511 | (2,904) |
Net changes in operating assets and liabilities | ||
Accounts receivable | (2,758) | (4,418) |
Inventories, net | (7,953) | (3,449) |
Prepaid expenses and other current assets | (4,914) | (1,987) |
Non-current assets | (517) | 229 |
Accounts payable, accrued and other liabilities | (6,242) | 1,031 |
Lease liabilities | (355) | 529 |
Net cash used in operating activities | (74,617) | (91,520) |
Cash flows used in investing activities: | ||
Purchase of investments | (232,955) | (216,987) |
Proceeds from investments | 225,677 | 164,651 |
Upfront lease payment | 0 | (11,838) |
Purchase of non-current assets | (118) | (364) |
Additions to internal use-software implementation costs | 0 | (1,039) |
Net cash used in investing activities | (7,396) | (65,577) |
Cash flows from financing activities | ||
Proceeds from exercise of stock options and employee share purchase plan | 1,745 | 6,278 |
Proceeds from exercise of warrants | 0 | 30 |
Cash provided by financing activities | 1,745 | 6,308 |
Net decrease in cash, cash equivalents and restricted cash | (80,268) | (150,789) |
Cash, cash equivalents and restricted cash, beginning of period | 231,900 | 272,350 |
Cash, cash equivalents and restricted cash, end of period | 151,632 | 121,561 |
Supplemental cash flow information | ||
Cash received for interest | 528 | 376 |
Cash paid for taxes | (779) | (236) |
Cash paid for amounts included in the measurement of lease liabilities | (572) | (128) |
Supplemental disclosure of noncash transactions | ||
Initial recognition of operating lease right-of-use asset | 0 | 419 |
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets | ||
Cash, cash equivalents | 151,408 | 121,561 |
Restricted cash | 224 | 0 |
Total cash, cash equivalents and restricted cash | $ 151,632 | $ 121,561 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Aurinia Pharmaceuticals Inc. (Aurinia or the Company) is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS™ (voclosporin), the first U.S. Food and Drug Administration (FDA) approved oral therapy for the treatment of adult patients with active lupus nephritis (LN) and continue to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program as well as our other assets. 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 also be submitted during 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 Suite 700, Rockville, Maryland, 20850 United States. Aurinia is incorporated pursuant to the Business Corporations Act (Alberta). The Company’s common shares are traded on the Nasdaq Global Market (Nasdaq) under the symbol AUPH. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments considered necessary for fair presentation in accordance with U.S. GAAP. The condensed consolidated balance sheet as of December 31, 2021 was derived from audited annual consolidated financial statements but does not include all annual disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. The results of operations for the six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other future periods. These unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Aurinia Pharma U.S., Inc. (Delaware incorporated) and Aurinia Pharma Limited (UK incorporated). All intercompany balances and transactions have been eliminated in consolidation and operate in one segment. These unaudited condensed consolidated financial statements are presented in U.S. dollars which is the Company's functional currency therefore there is no currency translation adjustment upon consolidation as the remeasurement of gains or losses are recorded in the condensed consolidated statements 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 condensed consolidated statements of operations. The Company is devoting the majority of our operational efforts and financial resources towards the commercialization and post approval commitments of our approved drug, LUPKYNIS. The Company is also expending efforts towards our newly acquired assets AUR200 and AUR300. Taking into consideration the Company's cash, cash equivalents, restricted cash and investments of $391.7 million as of June 30, 2022, the Company believes that it has sufficient resources to fund its operations for at least the next few years beyond the date that the unaudited condensed consolidated financial statements are issued. Significant Accounting Policies Other than as described below, the Company's significant accounting policies have not changed from those previously described in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Restricted cash : Restricted cash consists of the 2021 Employee Share Purchase Plan (2021 ESPP) deposits of $0.2 million and $0.3 million as of June 30, 2022 and December 31, 2021, respectively. Major Customers: The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and one customer for sales of voclosporin in the European Union, Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Revenues from the two main customers in the U.S. accounted for approximately 54% and 45% respectively of the Company's total revenues for the three and six months ended June 30, 2022. In late March 2022, we provided a nominal additional discount to both of our two main customers, applicable for the remainder of the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically re-evaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. Accounts receivable, net: Accounts receivable are stated at their net realizable value. As of June 30, 2022 and December 31, 2021, accounts receivable, net are $18.2 million and $15.4 million. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Our standard credit terms, range from 30 to 45 days. We do not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. We estimate the allowance for doubtful accounts using the 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. The allowance for doubtful accounts was $nil as of June 30, 2022 and as of December 31, 2021. Share-Based Compensation: The Company follows ASC Topic 718, Compensation - Stock Compensation (ASC 718), which requires the measurement and recognition of compensation expense, based on estimated fair values, for all share-based awards made to employees and directors. The Company records compensation expense based on the fair value on the grant date using the graded accelerated vesting method for all share-based payments related to stock options, performance awards (PAs), restricted stock units (RSUs) and purchases under the Company's 2021 ESPP. For stock options, forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. For RSUs and PAs, forfeitures are accounted for as they occur. Recently adopted accounting pronouncements 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 such as eliminating the exception to the general intraperiod tax allocation principle. 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 condensed consolidated financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which requires business entities to make annual disclosures about transactions with a government (including government assistance) by analogizing to a grant or contribution accounting model. The required disclosures include the nature of the transaction, the entity's related accounting policy, the financial statement line items affected and the amounts reflected in the current period financial statements, as well as any significant terms and conditions. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted the ASU effective January 1, 2022, with no material impact on the condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value MeasurementsThe Company's financial instruments consist primarily of cash and cash equivalents, short-term investments, accounts receivable, accounts payable and accrued liabilities. The carrying value of accounts receivable, accounts payable and accrued liabilities approximate their fair value because of their short-term nature. Estimated fair value of available-for-sale securities are generally based on prices obtained from commercial pricing services. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: • Level 1 - Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. • Level 2 - Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. • Level 3 - Unobservable inputs that reflect the reporting entity’s own assumptions. The following table summarizes the financial assets (cash, cash equivalents, restricted cash and short-term investments) measured at fair value on a recurring basis: June 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 151,632 $ — $ — $ 151,632 Certificates of deposit — 3,132 — 3,132 Corporate bond — 80,852 — 80,852 Commercial paper 93,041 — — 93,041 Treasury bill — 11,002 — 11,002 Treasury bond — 49,744 — 49,744 Yankee bond — 2,333 — 2,333 Total financial assets $ 244,673 $ 147,063 $ — $ 391,736 December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 231,900 $ — $ — $ 231,900 Certificates of deposit — 3,140 — 3,140 Corporate bond — 21,820 — 21,820 Commercial paper 206,724 — — 206,724 Treasury bill — 2,494 — 2,494 Total financial assets $ 438,624 $ 27,454 $ — $ 466,078 The Company's Level 1 instruments include cash, cash equivalents, restricted cash and commercial paper that are valued using quoted market prices. We estimate the fair values of our investments in corporate debt securities, government and government related securities and certificates of deposits by taking into consideration valuations obtained from third-party pricing services. The fair value of our short-term investments classified within Level 2 is based upon observable inputs that may include benchmark yield curves, reported trades, issuer spreads, benchmark securities and reference data including market research publications. At June 30, 2022, and December 31, 2021, the weighted average remaining contractual maturities of our Level 1 and 2 investments were 8 months for both periods. These investments are rated A-1, or higher, by Moody’s and Standard & Poor’s. There were no sales of available-for-sale securities. No credit loss allowance was recorded as of June 30, 2022, as we do not believe the unrealized loss is a result of a credit loss due to the nature of our investments. We also considered the current and expected future economic and market conditions and determined that the estimate of credit losses was not significantly impacted. |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments | Cash, Cash Equivalents, Restricted Cash and Short-Term Investments As of June 30, 2022 and December 31, 2021, the Company had $391.7 million and $466.1 million, respectively of cash, cash equivalents, restricted cash and short-term investments summarized below. As of June 30, 2022, $3.4 million are held to maturity debt securities which are carried at amortized cost which is approximately equal to their fair market value. As of June 30, 2022, $388.4 million are available-for-sale debt securities which are carried at fair market value. As of December 31, 2021, $446.9 million were classified as available-for-sale and $19.2 million were held-to-maturity. June 30, 2022 (in thousands) Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value Cash, cash equivalents and restricted cash $ 151,632 $ — $ — $ 151,632 Certificates of deposit 3,144 — (11) 3,133 Corporate bond 78,001 — (511) 77,490 Commercial paper 93,357 — (316) 93,041 Treasury bill 11,045 — (44) 11,001 Treasury bond 49,901 — (157) 49,744 Yankee bond 2,342 — (9) 2,333 Total $ 389,422 $ — $ (1,048) $ 388,374 Total held to maturity securities at amortized cost 3,362 Total cash, cash equivalents, restricted cash and short-term investments $ 391,736 December 31, 2021 (in thousands) Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value Cash, cash equivalents and restricted cash $ 231,900 $ — $ — $ 231,900 Certificates of deposit 3,144 — (4) 3,140 Corporate bond 2,592 — (1) 2,591 Commercial paper 206,764 — (40) 206,724 Treasury bill 2,497 — (2) 2,495 Total $ 446,897 $ — $ (47) $ 446,850 Total held to maturity securities at amortized cost 19,228 Total cash, cash equivalents, restricted cash and short-term investments $ 466,078 |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories, netInventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories for LUPKYNIS mainly include third party manufacturing costs, transportation, storage, insurance, and allocated internal labor. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. During the quarter ended June 30, 2022, we recorded a write down of finished goods inventories of approximately $1.4 million, which was related to safety stock inventory that the Company carried to mitigate supply chain disruptions. The components of inventory, net are as follows: (in thousands) June 30, 2022 December 31, 2021 Raw materials $ 2,217 $ 2,217 Work in process 19,418 12,566 Finished goods 4,228 4,543 Total inventories $ 25,863 $ 19,326 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets are as follows: (in thousands) June 30, 2022 December 31, 2021 Prepaid assets $ 8,320 $ 5,316 Prepaid deposits 4,109 4,762 Prepaid insurance 3,904 1,632 Other current assets 1,088 796 Total prepaid expenses and other current assets $ 17,421 $ 12,506 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets The following table summarizes the carrying amount of intangible assets, net of accumulated amortization. June 30, 2022 (in thousands) Gross Carrying Accumulated Net Carrying Patents $ 1,450 $ (1,225) $ 225 Acquired intellectual property and reacquired rights 15,126 (9,321) 5,805 Internal-use software implementation costs 2,873 (1,565) 1,308 $ 19,449 $ (12,111) $ 7,338 December 31, 2021 (in thousands) Gross Carrying Accumulated Net Carrying Patents $ 1,471 $ (1,176) $ 295 Acquired intellectual property and reacquired rights 15,126 (8,804) 6,322 Internal-use software implementation costs 2,873 (1,086) 1,787 $ 19,470 $ (11,066) $ 8,404 Amortization expense for the three months ended June 30, 2022 and 2021 was $0.5 million for both periods and for the six months ended June 30, 2022 and 2021 was $1.0 million and $1.1 million, respectively. |
Property, Plant and Equipment,
Property, Plant and Equipment, net | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, net | Property and Equipment, net Property and equipment, net are as follows: (in thousands) June 30, 2022 December 31, 2021 Construction in progress $ 488 $ 393 Leasehold improvements 2,978 2,978 Office equipment 645 645 Furniture 976 976 Computer equipment 257 262 5,344 5,254 Less accumulated depreciation (1,161) (836) Property and equipment, net $ 4,183 $ 4,418 |
Lease Obligations
Lease Obligations | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Lease Obligations | Lease Obligations 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 space of 13,206 square feet of office space for the facility lease. The lease terms commenced on January 1, 2021 for the facility and furniture leases. As of June 30, 2022, the Company had $43 thousand right-of-use assets (ROU assets) and $43 thousand lease liabilities related to the leases. The Company recognized operating lease costs that are included in SG&A expenses in the condensed consolidated statements 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 lease. During August 2020, the Company signed a lease for commercial office space in Victoria, British Columbia. The present value of the expected minimum lease payments for this lease are $2.2 million. As of June 30, 2022, the lease has not commenced and as a result, there has been no accounting recognition associated with the lease. On August 3, 2022, we provided notice of termination of the lease for commercial office space in Victoria on the basis that the landlord's work was not completed by the time required under 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 9 years and has an option to extend for two five-year periods after the initial term of 11 years has elapsed and has an option to terminate after seven years. As of June 30, 2022, the Company had a right-of-use asset of $5.0 million and lease liability of $8.3 million included in the condensed consolidated balance sheets. 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 condensed consolidated balance sheets. The Company recorded leasehold improvement incentives in the amount of $2.3 million as additions to the lease liability. The lease term commenced on March 12, 2020. When measuring the lease liability, the Company discounted lease payments using its incremental borrowing rate at March 12, 2020. The incremental borrowing rate applied to the lease liability on March 12, 2020 was 5.2% based on the financial position of the Company, geographical region and term of lease. Edmonton, Alberta The Company recognized the lease premises in Edmonton, Alberta as a short-term lease in which expenses are incurred in SG&A. The lease is not material to the Company's financial position. 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 included in SG&A and are expensed as incurred. The variable lease costs are not material to the Company's financial position. The operating lease costs for the three and six months ended June 30, 2022 and June 30, 2021 are $0.3 million and $0.5 million for both periods respectively. The following table represents the weighted-average remaining lease term and discount rate as of June 30, 2022: As of June 30, 2022 Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Operating leases 9.1 5.22% The following table provides a summary of operating lease liabilities payments for the next five years and thereafter: (in thousands) Operating Lease Payments Remainder of 2022 $ 566 2023 1,061 2024 1,085 2025 1,110 2026 1,135 Thereafter 5,638 Total future minimum lease payments 10,595 Less: lease imputed interest (2,211) Total future minimum lease payments $ 8,384 On December 15, 2020, the Company entered into a collaborative agreement with Lonza to build a dedicated manufacturing facility within Lonza’s existing small molecule facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") 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 LUPKYNIS in January 2021, the Company has commenced a capital expenditure payment program for the monoplant totaling approximately CHF 21.0 million. The first capital expenditure payment was made in February 2021 of $11.8 million (CHF 10.5 million) and was treated as an upfront lease payment and recorded under other non-current assets on the condensed consolidated balance sheets. The second payment is not due until the facility fulfills the required operational qualifications which is estimated to be during the first half of 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 $74.0 million, beginning April 2023 and expiring in 2030, and are not included in the above table. |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities are as follows: (in thousands) June 30, 2022 December 31, 2021 Employee accruals $ 12,449 $ 18,278 Commercial accruals 8,880 5,916 Accrued R&D projects 5,731 6,412 Other accrued liabilities 4,499 3,527 Income taxes payable 821 814 Total accounts payable and accrued liabilities $ 32,380 $ 34,947 |
Deferred Compensation and Other
Deferred Compensation and Other Non-current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
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 $16.3 million and $16.0 million as of June 30, 2022 and December 31, 2021, respectively. The balance as of June 30, 2022 and December 31, 2021 primarily included deferred compensation arrangements whereby certain executive officers as of March 8, 2012 were provided with future potential employee benefit obligations for remaining with the Company, for a certain period of time. These obligations were also contingent on the occurrence of uncertain future events. Other non-current liabilities also include milestone payments deemed probable to be paid in the future. |
License and Collaboration Agree
License and Collaboration Agreement | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
License and Collaboration Agreement | License and Collaboration Agreements 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 in the EU, Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine (collectively, the "Otsuka Territories"). As part of the agreement, Aurinia received an upfront cash payment of $50.0 million for the license agreement and has the potential to receive up to $50.0 million in regulatory related milestones. Aurinia will receive tiered royalties on future sales ranging from 10 to 20 percent (dependent on achievement of sale thresholds) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. In addition, certain manufacturing services and product sales are provided to Otsuka on a cost-plus basis. 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 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 considered 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 thresholds) will be recognized when the related sales occur. For three and six months ended June 30, 2022, the Company recorded $13 thousand and $117 thousand, respectively, of collaboration revenue related to manufacturing services provided under the Otsuka contract. In furtherance of the collaboration and license agreement with Otsuka mentioned above, on August 1, 2022, the Company entered into a commercial supply agreement with Otsuka, formalizing the terms of its obligations to supply LUPKYNIS to Otsuka in the Otsuka Territories, on a cost-plus basis. Riptide License 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, in 2021 the Company paid Riptide an upfront license fee of $6.0 million which was expensed as research and development on the condensed |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2022 | |
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. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share. The numerator and denominator used in the calculation of basic and diluted net loss per common share are as follows: Three months ended Six Months Ended (in thousands, except per share data) 2022 2021 2022 2021 Net loss $ (35,515) $ (47,010) $ (73,145) $ (97,389) Weighted average common shares outstanding 141,726 128,222 141,734 127,814 Net loss per common share (expressed in $ per share) $ (0.25) $ (0.37) (0.52) (0.76) 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: Six months ended (in thousands) 2022 2021 Stock options 14,355 14,339 Unvested performance awards — 439 Unvested restricted units 2,008 — Warrants — 1,014 16,363 15,792 |
Share-based Compensation
Share-based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation | Share-based Compensation The Company's Amended and Restated Equity Incentive Plan (the Plan), which was adopted and approved by the Company's shareholders in June 2021, allows for an issuance of up to an aggregate of 23.8 million shares (inclusive of then outstanding awards) and provides for grants of stock options, performance awards, restricted stock and restricted stock units (RSUs) that may be settled in cash and common shares. Also in June 2021, the Company's shareholders adopted and approved the Company's 2021 ESPP, which allows for the issuance of up to 2.5 million shares. The 2021 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code (the “Code”) but also permits the Company to include the employees, including non-United States employees, in offerings not intended to qualify under Section 423. The purpose of the 2021 ESPP is to provide eligible employees with opportunities to purchase the Company’s common shares at a discounted price. During the second quarter of 2022, the Company modified the 2021 ESPP for the current and future offerings. The new ESPP terms shortened the plan from four (4) purchases over a 24 month Offering Period to two (2) purchases over a 12 month offering period. Additionally, the ESPP now contains a rollover mechanism; that is, if the stock price on the purchase date is less than the offering price (as that is determined under the 2021 ESPP), that offering is then canceled and any participants are rolled into the new 12 month offering period at the lower price. As a result of the modification, $475 thousand of incremental expense was added to the estimated expense for the November 2022 and May 2023 purchase dates (to be amortized over the new 12 month offering period). Additionally, the originally scheduled purchase date in November 2023 is no longer planned given the new 12 month offering period; therefore, the modification also resulted in a “repurchase for no consideration” under ASC 718. The Company recognized an additional $651 thousand of unamortized expense for the cancelled November 2023 purchase, which was recorded during the second quarter of 2022. Inducements The Company’s Compensation Committee granted 11 new employees inducement stock options to purchase an aggregate of 93,200 common shares, at a per share exercise price of $11.38, the closing price of Aurinia's common stock on June 3, 2022, and an aggregate of 54,300 inducement RSUs. The inducement RSUs have a grant date and vesting commencement date of June 6, 2022. The stock options and RSUs were granted as inducements material to the new employees entering employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). 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 Company used the Black-Scholes option pricing model to estimate the fair value of the options granted. The Company considers historical volatility of its common shares in estimating its future stock price volatility. 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. The expected life is based upon the contractual term, taking into account expected employee exercise and expected post-vesting employment termination behavior. The following weighted average assumptions were used to estimate the fair value of the options granted during the six months ended June 30, 2022 and June 30, 2021: 2022 2021 Annualized volatility 70 % 66 % Risk-free interest rate 1.83 % 0.35 % Expected life of options in years 5.0 years 4.0 years Estimated forfeiture rate 11.7 % 8.8 % Dividend rate 0.0 % 0.0% Fair value per common share option $ 7.00 $ 6.59 The following table summarizes the option award activity during the six months ended June 30, 2022: June 30, 2022 Number of shares (in thousands) Weighted average exercise price $ Outstanding - Beginning of Period 12,074 $ 12.84 Granted 3,061 11.96 Exercised (77) 6.75 Forfeited (703) 15.73 Outstanding - End of Period 14,355 $ 12.54 Performance Awards and Restricted Stock Units On October 23, 2020, the Company issued 439,000 PAs to executive management of the Company whose vesting was contingent upon meeting specific performance metrics based on the results for the year ended December 31, 2021. Each PA which vested entitled 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 June 30, 2022, approximately 88,000 PAs vested based on performance metrics achieved and 351,000 were canceled as of December 31, 2021 as performance metrics were not met. On August 6, 2021, the Company granted approximately 619,000 PAs and 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. During the quarter, the Company has granted RSUs and intends to grant RSUs throughout the year under the Plan, as well as inducements for certain new hires. The RSUs are fair valued based on the market price of our common shares on the date of the grant. The following table summarizes the PAs and RSU activity for the six months ended June 30, 2022: June 30, 2022 Number of shares (in thousands) Weighted average exercise price $ Outstanding - Beginning of Period 347 $ 13.33 Granted 1,863 12.01 Vested (88) 13.56 Forfeited (114) 13.99 Outstanding - End of Period 2,008 $ 12.03 Compensation Expense The Company recognized share-based compensation expense for the three and six month periods ended June 30, 2022 and June 30, 2021 as follows: Three months ended Six Months Ended (in thousands) 2022 2021 2022 2021 Research and development $ 1,066 $ 1,089 $ 2,042 $ 2,163 Selling, general and administrative 8,883 6,548 14,855 13,189 Capitalized under inventories 106 116 181 222 Share-based compensation expense $ 10,055 $ 7,753 $ 17,078 $ 15,574 As of June 30, 2022, there was $39.2 million of unrecognized share-based compensation expense related to unvested awards granted which is expected to be recognized over a weighted-average period of approximately 1.4 years. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The effective tax rates for the three and six months ended June 30, 2022 and June 30, 2021 differed from the federal statutory rate applied to losses before income taxes primarily as a result of the mix of income, losses and valuation allowances. The Company recognized an income tax expense of $9 thousand and $19 thousand for the three and six months ended June 30, 2022. respectively. The Company recognized an income tax expense of $18 thousand and $26 thousand for the three and six months ended June 30, 2021, respectively. The expense recognized for these periods is a result of income in certain jurisdictions. The Company currently has tax expense in certain jurisdictions that are not offset by tax benefits. Uncertain Tax Positions The Company was under examination by the Canadian Revenue Agency for years 2017 and 2018. In March 2022, the Company was notified by the Canadian Revenue Agency that the examination is now complete and there were no findings and as a result, there is no additional tax expense or benefit recognized in regards to the audit. There are no outstanding tax audits ongoing at June 30, 2022. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related Party TransactionsILJIN SNT Co., Ltd (ILJIN) was considered to be a related party due to their equity ownership of over 5% as per their public filing. 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 ILJIN $6.0 million upon achievement of specific milestones. The amount payable to ILJIN is nil as of June 30, 2022 and December 31, 2021. |
Commitment and Contingencies
Commitment and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
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 position of the Company. The Company's material commitments and contingencies have not changed in any material manner from those previously described in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 and the quarterly report for the quarter ended June 30, 2022. Other Funding Commitments In the normal course of business, the Company enters into agreements with contract research organizations, contract manufacturing organizations and other third parties for services to be provided to the Company. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The actual amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of services to be provided to the Company. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event The Company’s Compensation Committee granted 10 new employees an aggregate of 123,100 inducement stock options and an aggregate of 73,700 inducement RSUs. The options have a per share exercise price of $8.18, the closing price of Aurinia's common stock on July 29, 2022. The inducement RSUs have a grant date and vesting commencement date of August 1, 2022. The stock options and RSUs were granted as inducements material to the new employees entering employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). On July 14, 2022, Aurinia announced the appointment of Volker Knappertz, MD, as Executive Vice President (EVP), Research and Development and Scott Habig has been named Chief Commercial Officer. Max Colao, former Chief Commercial Officer is leaving the Company immediately to tend to personal matters. In connection with the announced appointments, the Company's Compensation Committee granted an aggregate of 488,095 inducement stock options and an aggregate of 290,343 inducement RSUs. In July 2022, Aurinia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending voclosporin (brand name, LUPKYNIS) for marketing authorization to treat adults with active LN. Upon approval by the EMA, we would be eligible for up to an additional $30.0 million as an approval related milestone, in addition to low double-digit royalties on sales and revenues for the supply of product to Otsuka under a cost-plus arrangement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments considered necessary for fair presentation in accordance with U.S. GAAP. The condensed consolidated balance sheet as of December 31, 2021 was derived from audited annual consolidated financial statements but does not include all annual disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. The results of operations for the six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other future periods. |
Restricted cash | Restricted cash : Restricted cash consists of the 2021 Employee Share Purchase Plan (2021 ESPP) deposits of $0.2 million and $0.3 million as of June 30, 2022 and December 31, 2021, respectively. |
Major Customers | Major Customers: The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and one customer for sales of voclosporin in the European Union, Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Revenues from the two main customers in the U.S. accounted for approximately 54% and 45% respectively of the Company's total revenues for the three and six months ended June 30, 2022. In late March 2022, we provided a nominal additional discount to both of our two main customers, applicable for the remainder of the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically re-evaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. |
Accounts receivable, net | Accounts receivable, net: Accounts receivable are stated at their net realizable value. As of June 30, 2022 and December 31, 2021, accounts receivable, net are $18.2 million and $15.4 million. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Our standard credit terms, range from 30 to 45 days. We do not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. |
Share-based Compensation | Share-Based Compensation: The Company follows ASC Topic 718, Compensation - Stock Compensation (ASC 718), which requires the measurement and recognition of compensation expense, based on estimated fair values, for all share-based awards made to employees and directors. The Company records compensation expense based on the fair value on the grant date using the graded accelerated vesting method for all share-based payments related to stock options, performance awards (PAs), restricted stock units (RSUs) and purchases under the Company's 2021 ESPP. For stock options, forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. For RSUs and PAs, forfeitures are accounted for as they occur. |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements 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 such as eliminating the exception to the general intraperiod tax allocation principle. 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 condensed consolidated financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which requires business entities to make annual disclosures about transactions with a government (including government assistance) by analogizing to a grant or contribution accounting model. The required disclosures include the nature of the transaction, the entity's related accounting policy, the financial statement line items affected and the amounts reflected in the current period financial statements, as well as any significant terms and conditions. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted the ASU effective January 1, 2022, with no material impact on the condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table summarizes the financial assets (cash, cash equivalents, restricted cash and short-term investments) measured at fair value on a recurring basis: June 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 151,632 $ — $ — $ 151,632 Certificates of deposit — 3,132 — 3,132 Corporate bond — 80,852 — 80,852 Commercial paper 93,041 — — 93,041 Treasury bill — 11,002 — 11,002 Treasury bond — 49,744 — 49,744 Yankee bond — 2,333 — 2,333 Total financial assets $ 244,673 $ 147,063 $ — $ 391,736 December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Financial assets: Cash, cash equivalents and restricted cash $ 231,900 $ — $ — $ 231,900 Certificates of deposit — 3,140 — 3,140 Corporate bond — 21,820 — 21,820 Commercial paper 206,724 — — 206,724 Treasury bill — 2,494 — 2,494 Total financial assets $ 438,624 $ 27,454 $ — $ 466,078 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | June 30, 2022 (in thousands) Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value Cash, cash equivalents and restricted cash $ 151,632 $ — $ — $ 151,632 Certificates of deposit 3,144 — (11) 3,133 Corporate bond 78,001 — (511) 77,490 Commercial paper 93,357 — (316) 93,041 Treasury bill 11,045 — (44) 11,001 Treasury bond 49,901 — (157) 49,744 Yankee bond 2,342 — (9) 2,333 Total $ 389,422 $ — $ (1,048) $ 388,374 Total held to maturity securities at amortized cost 3,362 Total cash, cash equivalents, restricted cash and short-term investments $ 391,736 December 31, 2021 (in thousands) Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value Cash, cash equivalents and restricted cash $ 231,900 $ — $ — $ 231,900 Certificates of deposit 3,144 — (4) 3,140 Corporate bond 2,592 — (1) 2,591 Commercial paper 206,764 — (40) 206,724 Treasury bill 2,497 — (2) 2,495 Total $ 446,897 $ — $ (47) $ 446,850 Total held to maturity securities at amortized cost 19,228 Total cash, cash equivalents, restricted cash and short-term investments $ 466,078 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The components of inventory, net are as follows: (in thousands) June 30, 2022 December 31, 2021 Raw materials $ 2,217 $ 2,217 Work in process 19,418 12,566 Finished goods 4,228 4,543 Total inventories $ 25,863 $ 19,326 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | Prepaid expenses and other current assets are as follows: (in thousands) June 30, 2022 December 31, 2021 Prepaid assets $ 8,320 $ 5,316 Prepaid deposits 4,109 4,762 Prepaid insurance 3,904 1,632 Other current assets 1,088 796 Total prepaid expenses and other current assets $ 17,421 $ 12,506 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | The following table summarizes the carrying amount of intangible assets, net of accumulated amortization. June 30, 2022 (in thousands) Gross Carrying Accumulated Net Carrying Patents $ 1,450 $ (1,225) $ 225 Acquired intellectual property and reacquired rights 15,126 (9,321) 5,805 Internal-use software implementation costs 2,873 (1,565) 1,308 $ 19,449 $ (12,111) $ 7,338 December 31, 2021 (in thousands) Gross Carrying Accumulated Net Carrying Patents $ 1,471 $ (1,176) $ 295 Acquired intellectual property and reacquired rights 15,126 (8,804) 6,322 Internal-use software implementation costs 2,873 (1,086) 1,787 $ 19,470 $ (11,066) $ 8,404 |
Property, Plant and Equipment_2
Property, Plant and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property and equipment, net are as follows: (in thousands) June 30, 2022 December 31, 2021 Construction in progress $ 488 $ 393 Leasehold improvements 2,978 2,978 Office equipment 645 645 Furniture 976 976 Computer equipment 257 262 5,344 5,254 Less accumulated depreciation (1,161) (836) Property and equipment, net $ 4,183 $ 4,418 |
Lease Obligations (Tables)
Lease Obligations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Lease, Cost | The following table represents the weighted-average remaining lease term and discount rate as of June 30, 2022: As of June 30, 2022 Weighted Average Remaining Lease Term (years) Weighted Average Discount Rate Operating leases 9.1 5.22% |
Lessee, Operating Lease, Liability, Maturity | The following table provides a summary of operating lease liabilities payments for the next five years and thereafter: (in thousands) Operating Lease Payments Remainder of 2022 $ 566 2023 1,061 2024 1,085 2025 1,110 2026 1,135 Thereafter 5,638 Total future minimum lease payments 10,595 Less: lease imputed interest (2,211) Total future minimum lease payments $ 8,384 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accounts payable and accrued liabilities are as follows: (in thousands) June 30, 2022 December 31, 2021 Employee accruals $ 12,449 $ 18,278 Commercial accruals 8,880 5,916 Accrued R&D projects 5,731 6,412 Other accrued liabilities 4,499 3,527 Income taxes payable 821 814 Total accounts payable and accrued liabilities $ 32,380 $ 34,947 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 per common share are as follows: Three months ended Six Months Ended (in thousands, except per share data) 2022 2021 2022 2021 Net loss $ (35,515) $ (47,010) $ (73,145) $ (97,389) Weighted average common shares outstanding 141,726 128,222 141,734 127,814 Net loss per common share (expressed in $ per share) $ (0.25) $ (0.37) (0.52) (0.76) 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: |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Six months ended (in thousands) 2022 2021 Stock options 14,355 14,339 Unvested performance awards — 439 Unvested restricted units 2,008 — Warrants — 1,014 16,363 15,792 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Payment Award Valuation Assumptions | The following weighted average assumptions were used to estimate the fair value of the options granted during the six months ended June 30, 2022 and June 30, 2021: 2022 2021 Annualized volatility 70 % 66 % Risk-free interest rate 1.83 % 0.35 % Expected life of options in years 5.0 years 4.0 years Estimated forfeiture rate 11.7 % 8.8 % Dividend rate 0.0 % 0.0% Fair value per common share option $ 7.00 $ 6.59 |
Schedule of Option Activity | The following table summarizes the option award activity during the six months ended June 30, 2022: June 30, 2022 Number of shares (in thousands) Weighted average exercise price $ Outstanding - Beginning of Period 12,074 $ 12.84 Granted 3,061 11.96 Exercised (77) 6.75 Forfeited (703) 15.73 Outstanding - End of Period 14,355 $ 12.54 |
Schedule of Performance Shares Activity | The following table summarizes the PAs and RSU activity for the six months ended June 30, 2022: June 30, 2022 Number of shares (in thousands) Weighted average exercise price $ Outstanding - Beginning of Period 347 $ 13.33 Granted 1,863 12.01 Vested (88) 13.56 Forfeited (114) 13.99 Outstanding - End of Period 2,008 $ 12.03 |
Allocation of Share-Based Payments | The Company recognized share-based compensation expense for the three and six month periods ended June 30, 2022 and June 30, 2021 as follows: Three months ended Six Months Ended (in thousands) 2022 2021 2022 2021 Research and development $ 1,066 $ 1,089 $ 2,042 $ 2,163 Selling, general and administrative 8,883 6,548 14,855 13,189 Capitalized under inventories 106 116 181 222 Share-based compensation expense $ 10,055 $ 7,753 $ 17,078 $ 15,574 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Number of operating segments | segment | 1 | ||
Cash and cash equivalents and investments | $ 391,700 | $ 391,700 | |
Restricted Cash | 200 | 200 | $ 300 |
Accounts receivable, net | 18,173 | 18,173 | 15,414 |
Allowance for doubtful accounts | $ 0 | $ 0 | $ 0 |
Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Receivable standard credit terms (in days) | 30 days | ||
Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Receivable standard credit terms (in days) | 45 days | ||
Customer Concentration Risk | Revenue Benchmark | Specialty Pharmacy One | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk | 54% | ||
Customer Concentration Risk | Revenue Benchmark | Specialty Pharmacy Two | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk | 45% |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Total financial assets | $ 391,736 | $ 466,078 |
Cash, cash equivalents and restricted cash | ||
Financial assets: | ||
Total financial assets | 151,632 | 231,900 |
Certificates of deposit | ||
Financial assets: | ||
Total financial assets | 3,132 | 3,140 |
Corporate bond | ||
Financial assets: | ||
Total financial assets | 80,852 | 21,820 |
Commercial paper | ||
Financial assets: | ||
Total financial assets | 93,041 | 206,724 |
Treasury bill | ||
Financial assets: | ||
Total financial assets | 11,002 | 2,494 |
Treasury bond | ||
Financial assets: | ||
Total financial assets | 49,744 | |
Yankee bond | ||
Financial assets: | ||
Total financial assets | 2,333 | |
Level 1 | ||
Financial assets: | ||
Total financial assets | 244,673 | 438,624 |
Level 1 | Cash, cash equivalents and restricted cash | ||
Financial assets: | ||
Total financial assets | 151,632 | 231,900 |
Level 1 | Certificates of deposit | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 1 | Corporate bond | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 1 | Commercial paper | ||
Financial assets: | ||
Total financial assets | 93,041 | 206,724 |
Level 1 | Treasury bill | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 1 | Treasury bond | ||
Financial assets: | ||
Total financial assets | 0 | |
Level 1 | Yankee bond | ||
Financial assets: | ||
Total financial assets | 0 | |
Level 2 | ||
Financial assets: | ||
Total financial assets | 147,063 | 27,454 |
Level 2 | Cash, cash equivalents and restricted cash | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 2 | Certificates of deposit | ||
Financial assets: | ||
Total financial assets | 3,132 | 3,140 |
Level 2 | Corporate bond | ||
Financial assets: | ||
Total financial assets | 80,852 | 21,820 |
Level 2 | Commercial paper | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 2 | Treasury bill | ||
Financial assets: | ||
Total financial assets | 11,002 | 2,494 |
Level 2 | Treasury bond | ||
Financial assets: | ||
Total financial assets | 49,744 | |
Level 2 | Yankee bond | ||
Financial assets: | ||
Total financial assets | 2,333 | |
Level 3 | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 3 | Cash, cash equivalents and restricted cash | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 3 | Certificates of deposit | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 3 | Corporate bond | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 3 | Commercial paper | ||
Financial assets: | ||
Total financial assets | 0 | 0 |
Level 3 | Treasury bill | ||
Financial assets: | ||
Total financial assets | 0 | $ 0 |
Level 3 | Treasury bond | ||
Financial assets: | ||
Total financial assets | 0 | |
Level 3 | Yankee bond | ||
Financial assets: | ||
Total financial assets | $ 0 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |||
Short-term investments | $ 240,104 | $ 240,104 | $ 234,178 |
Total cash, cash equivalents, restricted cash and short-term investments | 391,736 | 391,736 | 466,078 |
Total held to maturity securities at amortized cost | 3,362 | 3,362 | 19,228 |
Available-for-sale debt securities | 388,400 | 388,400 | 446,900 |
Interest receivable | 900 | 900 | $ 100 |
Unrealized gains on available-for-sale securities | $ 235 | $ 1,000 |
Cash, Cash Equivalents, Restr_4
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments - Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 389,422 | $ 446,897 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | (1,048) | (47) |
Estimated Fair Value | 388,374 | 446,850 |
Total held to maturity securities at amortized cost | 3,362 | 19,228 |
Total cash, cash equivalents, restricted cash and short-term investments | 391,736 | 466,078 |
Cash, cash equivalents and restricted cash | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 151,632 | 231,900 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | 0 | 0 |
Estimated Fair Value | 151,632 | 231,900 |
Certificates of deposit | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,144 | 3,144 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | (11) | (4) |
Estimated Fair Value | 3,133 | 3,140 |
Corporate bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 78,001 | 2,592 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | (511) | (1) |
Estimated Fair Value | 77,490 | 2,591 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 93,357 | 206,764 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | (316) | (40) |
Estimated Fair Value | 93,041 | 206,724 |
Treasury bill | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 11,045 | 2,497 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | (44) | (2) |
Estimated Fair Value | 11,001 | $ 2,495 |
Treasury bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 49,901 | |
Unrealized Gains | 0 | |
Unrealized (Losses) | (157) | |
Estimated Fair Value | 49,744 | |
Yankee bond | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,342 | |
Unrealized Gains | 0 | |
Unrealized (Losses) | (9) | |
Estimated Fair Value | $ 2,333 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Finished goods inventories | $ 1,400 | |
Raw materials | 2,217 | $ 2,217 |
Work in process | 19,418 | 12,566 |
Finished goods | 4,228 | 4,543 |
Total inventories | $ 25,863 | $ 19,326 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid assets | $ 8,320 | $ 5,316 |
Prepaid deposits | 4,109 | 4,762 |
Prepaid insurance | 3,904 | 1,632 |
Other current assets | 1,088 | 796 |
Prepaid expenses and other current assets | $ 17,421 | $ 12,506 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 19,449 | $ 19,470 |
Accumulated Amortization | (12,111) | (11,066) |
Net Carrying Amount | 7,338 | 8,404 |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 1,450 | 1,471 |
Accumulated Amortization | (1,225) | (1,176) |
Net Carrying Amount | 225 | 295 |
Acquired intellectual property and reacquired rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 15,126 | 15,126 |
Accumulated Amortization | (9,321) | (8,804) |
Net Carrying Amount | 5,805 | 6,322 |
Internal-use software implementation costs | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 2,873 | 2,873 |
Accumulated Amortization | (1,565) | (1,086) |
Net Carrying Amount | $ 1,308 | $ 1,787 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization of intangible assets | $ 0.5 | $ 0.5 | $ 1 | $ 1.1 |
Property, Plant and Equipment_3
Property, Plant and Equipment, net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,344 | $ 5,254 |
Less accumulated depreciation | (1,161) | (836) |
Property and equipment, net | 4,183 | 4,418 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 488 | 393 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,978 | 2,978 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 645 | 645 |
Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 976 | 976 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 257 | $ 262 |
Lease Obligations - Narrative (
Lease Obligations - Narrative (Details) $ in Thousands, SFr in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Feb. 28, 2021 USD ($) | Feb. 28, 2021 CHF (SFr) | Jan. 31, 2021 CHF (SFr) | Mar. 31, 2020 ft² extension_option | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Jan. 01, 2021 | Dec. 31, 2020 ft² | Aug. 31, 2020 USD ($) | Mar. 12, 2020 | |
Lessee, Lease, Description [Line Items] | |||||||||||||
Right-of-use assets, net | $ 5,079 | $ 5,079 | $ 5,383 | ||||||||||
Total lease liabilities | $ 8,384 | $ 8,384 | |||||||||||
Incremental borrowing rate | 5.22% | 5.22% | |||||||||||
Minimum lease payments | $ 10,595 | $ 10,595 | |||||||||||
Operating lease costs | 300 | $ 300 | 500 | $ 500 | |||||||||
Payments for capital improvements | SFr | SFr 21 | ||||||||||||
Capital expenditure payments | $ 11,800 | SFr 10.5 | |||||||||||
Minimum finance lease liability payments due | 74,000 | 74,000 | |||||||||||
Expected payments prior to commencement of lease | 885 | 885 | |||||||||||
Future value of minimum lease payments of leases not yet commenced | 119 | 119 | |||||||||||
Victoria, British Columbia | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Area of property (in sqft) | ft² | 13,206 | ||||||||||||
Right-of-use assets, net | 43 | 43 | |||||||||||
Total lease liabilities | 43 | 43 | |||||||||||
Incremental borrowing rate | 4.08% | ||||||||||||
Minimum lease payments | $ 2,200 | ||||||||||||
Rockville, Maryland | |||||||||||||
Lessee, Lease, Description [Line Items] | |||||||||||||
Area of property (in sqft) | ft² | 30,531 | ||||||||||||
Right-of-use assets, net | 5,000 | 5,000 | 5,200 | ||||||||||
Total lease liabilities | $ 8,300 | $ 8,300 | 8,600 | ||||||||||
Incremental borrowing rate | 5.20% | ||||||||||||
Remaining lease term | 9 years | ||||||||||||
Number of extension options | extension_option | 2 | ||||||||||||
Lease extension term | 5 years | ||||||||||||
Lease term | 11 years | ||||||||||||
Lease termination option term | 7 years | ||||||||||||
Proceeds from tenant improvements | $ 2,300 |
Lease Obligations - Summary of
Lease Obligations - Summary of Components of Leasing Costs and Rent (Details) | Jun. 30, 2022 |
Leases [Abstract] | |
Weighted average remaining lease term - operating leases (in years) | 9 years 1 month 6 days |
Weighted average discount rate - operating leases | 5.22% |
Lease Obligations - Schedule of
Lease Obligations - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Leases [Abstract] | |
Remainder of 2022 | $ 566 |
2023 | 1,061 |
2024 | 1,085 |
2025 | 1,110 |
2026 | 1,135 |
Thereafter | 5,638 |
Total future minimum lease payments | 10,595 |
Less: lease imputed interest | (2,211) |
Total future minimum lease payments | $ 8,384 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Employee accruals | $ 12,449 | $ 18,278 |
Commercial accruals | 8,880 | 5,916 |
Accrued R&D projects | 5,731 | 6,412 |
Other accrued liabilities | 4,499 | 3,527 |
Income taxes payable | 821 | 814 |
Accounts payable and accrued liabilities | $ 32,380 | $ 34,947 |
Deferred Compensation and Oth_2
Deferred Compensation and Other Non-current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Other non-current liabilities | $ 16,323 | $ 15,950 |
License and Collaboration Agr_2
License and Collaboration Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Aug. 17, 2021 | Dec. 17, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Revenues | $ 28,191 | $ 6,620 | $ 49,816 | $ 7,534 | ||
Research and development | 11,525 | $ 10,091 | 24,145 | $ 19,924 | ||
License Agreement Terms | Otuska | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Upfront payments received | $ 50,000 | |||||
Potential regulatory milestone revenue | $ 50,000 | |||||
Revenues | $ 13 | $ 117 | ||||
License Agreement Terms | Otuska | Minimum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Tiered royalty percentages on future sales | 10% | |||||
License Agreement Terms | Otuska | Maximum | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Tiered royalty percentages on future sales | 20% | |||||
License Agreement Terms | Riptide Bioscience, Inc. | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Upfront license fee | $ 6,000 | |||||
Research and development | $ 4,000 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (35,515) | $ (47,010) | $ (73,145) | $ (97,389) |
Weighted-average common shares outstanding used in computation of basic loss per share (in shares) | 141,726 | 128,222 | 141,734 | 127,814 |
Weighted-average common shares outstanding used in computation of diluted loss per share (in shares) | 141,726 | 128,222 | 141,734 | 127,814 |
Basic loss per share ($ per share) | $ (0.25) | $ (0.37) | $ (0.52) | $ (0.76) |
Diluted loss per share ($ per share) | $ (0.25) | $ (0.37) | $ (0.52) | $ (0.76) |
Net Loss per Common Share - Ant
Net Loss per Common Share - Anti-Dilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 16,363,000 | 15,792,000 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 14,355,000 | 14,339,000 |
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) | 0 | 439,000 |
Unvested restricted units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,008,000 | 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 | 1,014,000 |
Share-based Compensation - Narr
Share-based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Jun. 03, 2022 segment $ / shares shares | Aug. 06, 2021 $ / shares shares | Mar. 18, 2021 $ / shares | Oct. 23, 2020 shares | Jun. 30, 2021 shares | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) shares | Jun. 30, 2022 USD ($) purchase_period $ / shares shares | Jun. 30, 2021 USD ($) shares | Dec. 31, 2021 purchase_period shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation expense | $ | $ 10,055 | $ 7,753 | $ 17,078 | $ 15,574 | ||||||
Granted (in shares) | 3,061,000 | |||||||||
Granted (in usd per share) | $ / shares | $ 11.96 | |||||||||
Unrecognized share-based compensation expense | $ | $ 39,200 | $ 39,200 | ||||||||
Unrecognized share-based compensation expense weighted average recognition period | 1 year 4 months 24 days | |||||||||
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 | |||||||||
Employee Stock | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized | 2,500,000 | 2,500,000 | 2,500,000 | |||||||
Number of purchase periods | purchase_period | 2 | 4 | ||||||||
Purchase period | 12 months | 24 months | ||||||||
Offering period | 12 months | |||||||||
Share-based compensation expense | $ | $ 475 | |||||||||
Unamortized expense | $ | $ 651 | |||||||||
Inducement Stock Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of new employees | segment | 11 | |||||||||
Granted (in shares) | 93,200 | |||||||||
Granted (in usd per share) | $ / shares | $ 11.38 | |||||||||
Inducement Restricted Stock Units (RSUs) | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Granted (in shares) | 54,300 | |||||||||
Unvested performance awards | Officer | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Granted (in shares) | 439,000 | |||||||||
Granted, Weighted average exercise price (in usd per share) | $ / shares | $ 13.56 | |||||||||
Performance shares vested (in shares) | 88,000 | |||||||||
Shares forfeited/canceled (in shares) | 351,000 | |||||||||
Performance Share sand Restricted Stock Units (RSUs) | Officer | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Granted (in shares) | 619,000 | 1,863,000 | ||||||||
Granted, Weighted average exercise price (in usd per share) | $ / shares | $ 14.42 | $ 12.01 | ||||||||
Performance shares vested (in shares) | 88,000 | |||||||||
Shares forfeited/canceled (in shares) | 114,000 | |||||||||
Unvested restricted units | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Award vesting period | 1 year |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share-Based Payment Arrangement [Abstract] | ||
Annualized volatility | 70% | 66% |
Risk-free interest rate | 1.83% | 0.35% |
Expected life of options in years | 5 years | 4 years |
Estimated forfeiture rate | 11.70% | 8.80% |
Dividend rate | $ 0 | $ 0 |
Fair value per common share option (in usd per share) | $ 7 | $ 6.59 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) shares in Thousands | 6 Months Ended | |
Jun. 30, 2022 $ / shares shares | Dec. 31, 2021 $ / shares | |
Number of Shares (in thousands) | ||
Beginning balance (in shares) | shares | 12,074 | |
Granted (in shares) | shares | 3,061 | |
Exercised (in shares) | shares | (77) | |
Forfeited (in shares) | shares | (703) | |
Ending balance (in shares) | shares | 14,355 | |
Weighted-Average Exercise Price | ||
Beginning balance (in usd per share) | $ / shares | $ 12.54 | $ 12.84 |
Granted (in usd per share) | $ / shares | 11.96 | |
Exercised (in usd per share) | $ / shares | 6.75 | |
Forfeited (in usd per share) | $ / shares | 15.73 | |
Ending balance (in usd per share) | $ / shares | $ 12.54 |
Share-Based Compensation - Perf
Share-Based Compensation - Performance Awards and Restricted Stock Units Activity (Details) - Performance Share sand Restricted Stock Units (RSUs) - Officer - $ / shares shares in Thousands | 6 Months Ended | |
Aug. 06, 2021 | Jun. 30, 2022 | |
Number of shares (in thousands) | ||
Outstanding - Beginning of Period (in shares) | 347 | |
Granted (in shares) | 619 | 1,863 |
Performance shares vested (in shares) | (88) | |
Performance shares forfeited (in shares) | (114) | |
Outstanding - End of Period (in shares) | 2,008 | |
Weighted average exercise price $ | ||
Outstanding, Weighted average exercise price - Beginning of Period (in usd per share) | $ 13.33 | |
Performance shares awards, Weighted average grant date fair value (in usd per share) | $ 14.42 | 12.01 |
Performance shares vested, Weighted average grant date fair value (in usd per share) | 13.56 | |
Performance share forfeited, Weighted average exercise price (in usd per share) | 13.99 | |
Outstanding, Weighted average exercise price - End of Period (in usd per share) | $ 12.03 |
Share-Based Compensation - Allo
Share-Based Compensation - Allocated Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 10,055 | $ 7,753 | $ 17,078 | $ 15,574 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 1,066 | 1,089 | 2,042 | 2,163 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 8,883 | 6,548 | 14,855 | 13,189 |
Capitalized under inventories | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 106 | $ 116 | $ 181 | $ 222 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Income tax (benefit) expense | $ 9 | $ 18 | $ 19 | $ 26 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - ILJIN - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Jun. 30, 2022 | |
Other Current Liabilities | ||
Related Party Transaction [Line Items] | ||
Due to related parties | $ 0 | $ 0 |
Milestone Payment | Affiliated Shareholder | ||
Related Party Transaction [Line Items] | ||
Payments to related party | $ 6 |
Subsequent Event (Details)
Subsequent Event (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Jul. 29, 2022 employee $ / shares shares | Jul. 14, 2022 shares | Jun. 03, 2022 segment $ / shares shares | Jul. 31, 2022 USD ($) | Jun. 30, 2022 $ / shares shares | |
Subsequent Event [Line Items] | |||||
Granted (in shares) | 3,061,000 | ||||
Granted (in usd per share) | $ / shares | $ 11.96 | ||||
Inducement Stock Option | |||||
Subsequent Event [Line Items] | |||||
Number of new employees | segment | 11 | ||||
Granted (in shares) | 93,200 | ||||
Granted (in usd per share) | $ / shares | $ 11.38 | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Additional approval related milestones | $ | $ 30 | ||||
Subsequent Event | Restricted Stock Units (RSUs) | |||||
Subsequent Event [Line Items] | |||||
Granted (in shares) | 290,343 | ||||
Subsequent Event | Inducement Stock Option | |||||
Subsequent Event [Line Items] | |||||
Granted (in shares) | 488,095 | ||||
Subsequent Event | New Employees | |||||
Subsequent Event [Line Items] | |||||
Number of new employees | employee | 10 | ||||
Subsequent Event | New Employees | Restricted Stock Units (RSUs) | |||||
Subsequent Event [Line Items] | |||||
Granted (in shares) | 73,700 | ||||
Subsequent Event | New Employees | Inducement Stock Option | |||||
Subsequent Event [Line Items] | |||||
Granted (in shares) | 123,100 | ||||
Granted (in usd per share) | $ / shares | $ 8.18 |