QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Alberta, | |||||
(State or other jurisdiction of incorporation or organization) | |||||
(Address of principal executive offices) | (I.R.S. Employer Identification Number) |
☒ | Accelerated filer | ☐ | ||||||||||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
Emerging growth company |
Title of each class | Trading Symbol | Name of exchange on which registered | ||||||
Page | ||||||||||||||
March 31, 2023 | December 31, 2022 | |||||||||||||
(unaudited) | ||||||||||||||
ASSETS | ||||||||||||||
Current assets | ||||||||||||||
Cash, cash equivalents and restricted cash | $ | $ | ||||||||||||
Short-term investments | ||||||||||||||
Accounts receivable, net | ||||||||||||||
Inventories, net | ||||||||||||||
Prepaid expenses | ||||||||||||||
Other current assets | ||||||||||||||
Total current assets | ||||||||||||||
Non-current assets | ||||||||||||||
Other non-current assets | ||||||||||||||
Property and equipment, net | ||||||||||||||
Acquired intellectual property and other intangible assets, net | ||||||||||||||
Right-of-use assets, net | ||||||||||||||
Total assets | $ | $ | ||||||||||||
LIABILITIES | ||||||||||||||
Current liabilities | ||||||||||||||
Accounts payable and accrued liabilities | ||||||||||||||
Deferred revenue | ||||||||||||||
Other current liabilities | ||||||||||||||
Operating lease liabilities | ||||||||||||||
Total current liabilities | ||||||||||||||
Non-current liabilities | ||||||||||||||
Deferred compensation and other non-current liabilities | ||||||||||||||
Operating lease liabilities | ||||||||||||||
Total liabilities | ||||||||||||||
Commitments and contingencies (Note 17) | ||||||||||||||
SHAREHOLDER’S EQUITY | ||||||||||||||
Common shares - | ||||||||||||||
Additional paid-in capital | ||||||||||||||
Accumulated other comprehensive loss | ( | ( | ||||||||||||
Accumulated deficit | ( | ( | ||||||||||||
Total shareholders' equity | ||||||||||||||
Total liabilities and shareholders’ equity | $ | $ |
Three months ended | ||||||||||||||
March 31, | ||||||||||||||
2023 | 2022 | |||||||||||||
(unaudited) | ||||||||||||||
Revenue | ||||||||||||||
Product revenue, net | $ | $ | ||||||||||||
License, royalty and collaboration revenue | ||||||||||||||
Total revenue, net | ||||||||||||||
Operating expenses | ||||||||||||||
Cost of sales | ||||||||||||||
Selling, general and administrative | ||||||||||||||
Research and development | ||||||||||||||
Other expense, net | ||||||||||||||
Total cost of sales and operating expenses | ||||||||||||||
Loss from operations | ( | ( | ||||||||||||
Interest income | ||||||||||||||
Net loss before income taxes | ( | ( | ||||||||||||
Income tax expense | ||||||||||||||
Net loss | ( | ( | ||||||||||||
Other comprehensive loss: | ||||||||||||||
Unrealized gain (loss) on available-for-sale securities, net of tax of | ( | |||||||||||||
Comprehensive loss | $ | ( | $ | ( | ||||||||||
Basic and diluted loss per share | $ | ( | $ | ( | ||||||||||
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
Common Shares | ||||||||||||||||||||||||||||||||||||||
Three Months Ended March 31, 2023 | Shares | Amount | Additional paid in capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||
Balance at December 31, 2022 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Shares issued on exercise of stock options and vesting of restricted stock units | ( | — | — | |||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||
Unrealized gain on available-for-sale securities, net | — | — | — | — | ||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||
Balance at March 31, 2023 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Common Shares | ||||||||||||||||||||||||||||||||||||||
Three Months Ended March 31, 2022 | Shares | Amount | Additional paid in capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Shares issued on exercise of stock options and vesting of performance awards | ( | — | — | |||||||||||||||||||||||||||||||||||
Shared-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||
Unrealized loss on available-for-sale securities, net | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2023 | 2022 | |||||||||||||
(in thousands) | (unaudited) | |||||||||||||
Cash flows used in operating activities: | ||||||||||||||
Net loss | $ | ( | $ | ( | ||||||||||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||||||||
Depreciation and amortization | ||||||||||||||
Amortization of right-of-use assets | ||||||||||||||
Net amortization of premiums and discounts on short-term investments | ( | |||||||||||||
Share-based compensation expense | ||||||||||||||
Other, net | ||||||||||||||
Net changes in operating assets and liabilities | ||||||||||||||
Accounts receivable, net | ( | ( | ||||||||||||
Inventories, net | ( | ( | ||||||||||||
Prepaid expenses and other current assets | ||||||||||||||
Non-current assets | ( | |||||||||||||
Accounts payable, accrued and other liabilities | ( | ( | ||||||||||||
Lease liabilities | ( | ( | ||||||||||||
Net cash used in operating activities | ( | ( | ||||||||||||
Cash flows used in investing activities: | ||||||||||||||
Purchase of investments | ( | ( | ||||||||||||
Proceeds from investments | ||||||||||||||
Purchase of long-lived assets | ( | ( | ||||||||||||
Capitalized patent costs | ( | |||||||||||||
Net cash provided by (used in) investing activities | ( | |||||||||||||
Cash flows from financing activities | ||||||||||||||
Proceeds from exercise of stock options | ||||||||||||||
Cash provided by financing activities | ||||||||||||||
Net decrease in cash, cash equivalents and restricted cash | ( | ( | ||||||||||||
Cash, cash equivalents and restricted cash, beginning of period | ||||||||||||||
Cash, cash equivalents and restricted cash, end of period | $ | $ | ||||||||||||
Supplemental cash flow information | ||||||||||||||
Cash received for interest | $ | $ | ||||||||||||
Cash paid for income taxes | $ | ( | $ | |||||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | ( | $ | ( | ||||||||||
Supplemental disclosure of noncash transactions | ||||||||||||||
Initial recognition of operating lease right-of-use asset | $ | $ | ||||||||||||
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets | ||||||||||||||
Cash, cash equivalents | $ | $ | ||||||||||||
Restricted cash | ||||||||||||||
Total cash, cash equivalents and restricted cash | $ | $ |
March 31, 2023 | ||||||||||||||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||||
Financial assets: | ||||||||||||||||||||||||||
Cash, cash equivalents and restricted cash | $ | $ | $ | $ | ||||||||||||||||||||||
Corporate bond | ||||||||||||||||||||||||||
Commercial paper | ||||||||||||||||||||||||||
Treasury bill | ||||||||||||||||||||||||||
Treasury bond | ||||||||||||||||||||||||||
Yankee bond | ||||||||||||||||||||||||||
Total financial assets | $ | $ | $ | $ | ||||||||||||||||||||||
December 31, 2022 | ||||||||||||||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||||
Financial assets: | ||||||||||||||||||||||||||
Cash, cash equivalents and restricted cash | $ | $ | $ | $ | ||||||||||||||||||||||
U.S. agency security | ||||||||||||||||||||||||||
Corporate bond | ||||||||||||||||||||||||||
Commercial paper | ||||||||||||||||||||||||||
Treasury bill | ||||||||||||||||||||||||||
Treasury bond | ||||||||||||||||||||||||||
Yankee bond | ||||||||||||||||||||||||||
Total financial assets | $ | $ | $ | $ | ||||||||||||||||||||||
March 31, 2023 | ||||||||||||||||||||||||||
(in thousands) | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||||
Cash, cash equivalents and restricted cash | $ | $ | $ | $ | ||||||||||||||||||||||
Corporate bond | ( | |||||||||||||||||||||||||
Commercial paper | ( | |||||||||||||||||||||||||
Treasury bill | ||||||||||||||||||||||||||
Treasury bond | ( | |||||||||||||||||||||||||
Yankee bond | ( | |||||||||||||||||||||||||
Total cash, cash equivalents, restricted cash and short-term investments | $ | $ | $ | ( | $ | |||||||||||||||||||||
December 31, 2022 | ||||||||||||||||||||||||||
(in thousands) | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||||
Cash, cash equivalents and restricted cash | $ | $ | $ | $ | ||||||||||||||||||||||
Certificates of deposit | ( | |||||||||||||||||||||||||
Corporate bond | ( | |||||||||||||||||||||||||
Commercial paper | ( | |||||||||||||||||||||||||
Treasury bill | ( | |||||||||||||||||||||||||
Treasury bond | ( | |||||||||||||||||||||||||
Yankee bond | ( | |||||||||||||||||||||||||
Total cash, cash equivalents, restricted cash and short-term investments | $ | $ | $ | ( | $ |
(in thousands) | March 31, 2023 | December 31, 2022 | ||||||||||||
Raw materials | $ | $ | ||||||||||||
Work in process | ||||||||||||||
Finished goods | ||||||||||||||
Total inventories | $ | $ |
(in thousands) | March 31, 2023 | December 31, 2022 | ||||||||||||
Prepaid assets | $ | $ | ||||||||||||
Prepaid deposits | ||||||||||||||
Prepaid insurance | ||||||||||||||
Total prepaid expenses | $ | $ |
March 31, 2023 | ||||||||||||||||||||
(in thousands) | Gross Carrying Value | Accumulated Amortization | Net Carrying Amount | |||||||||||||||||
Patents | $ | $ | ( | $ | ||||||||||||||||
Acquired intellectual property and reacquired rights | ( | |||||||||||||||||||
Internal-use software implementation costs | ( | |||||||||||||||||||
$ | $ | ( | $ |
December 31, 2022 | ||||||||||||||||||||
(in thousands) | Gross Carrying Value | Accumulated Amortization | Net Carrying Amount | |||||||||||||||||
Patents | $ | $ | ( | $ | ||||||||||||||||
Acquired intellectual property and reacquired rights | ( | |||||||||||||||||||
Internal-use software implementation costs | ( | |||||||||||||||||||
$ | $ | ( | $ |
(in thousands) | March 31, 2023 | December 31, 2022 | ||||||||||||
Construction in progress | $ | $ | ||||||||||||
Leasehold improvements | ||||||||||||||
Office equipment | ||||||||||||||
Furniture | ||||||||||||||
Computer equipment | ||||||||||||||
Less accumulated depreciation | ( | ( | ||||||||||||
Property and equipment, net | $ | $ |
As of March 31, 2023 | ||||||||||||||
Weighted Average Remaining Lease Term (years) | Weighted Average Discount Rate | |||||||||||||
Operating leases |
(in thousands) | Operating Lease Payments | |||||||
Remainder of 2023 | $ | |||||||
2024 | ||||||||
2025 | ||||||||
2026 | ||||||||
2027 | ||||||||
Thereafter | ||||||||
Total future minimum lease payments | ||||||||
Less: lease imputed interest | ( | |||||||
Total future minimum lease payments | $ |
(in thousands) | March 31, 2023 | December 31, 2022 | ||||||||||||
Employee accruals | $ | $ | ||||||||||||
Commercial accruals | ||||||||||||||
Accrued R&D projects | ||||||||||||||
Trade payables | ||||||||||||||
Other accrued liabilities | ||||||||||||||
Income taxes payable | ||||||||||||||
Total accounts payable and accrued liabilities | $ | $ |
Three months ended March 31, | |||||||||||||||||
(in thousands, except per share data) | 2023 | 2022 | |||||||||||||||
Net loss | $ | ( | $ | ( | |||||||||||||
Weighted average common shares outstanding | |||||||||||||||||
Net loss per common share (expressed in $ per share) | $ | ( | $ | ( |
Three months ended March 31, | ||||||||||||||
(in thousands) | 2023 | 2022 | ||||||||||||
Stock options | ||||||||||||||
Unvested restricted stock units | ||||||||||||||
2023 | 2022 | |||||||||||||
Annualized volatility | % | % | ||||||||||||
Risk-free interest rate | % | % | ||||||||||||
Expected life of options in years | ||||||||||||||
Estimated forfeiture rate | % | % | ||||||||||||
Dividend rate | % | |||||||||||||
Fair value per common share option | $ | $ |
March 31, 2023 | ||||||||||||||
Number of shares (in thousands) | Weighted average exercise price $ | |||||||||||||
Outstanding - December 31, 2022 | $ | |||||||||||||
Granted | ||||||||||||||
Exercised | ( | |||||||||||||
Forfeited | ( | |||||||||||||
Outstanding - March 31, 2023 | $ | |||||||||||||
March 31, 2023 | ||||||||||||||
Number of shares (in thousands) | Weighted average fair value price $ | |||||||||||||
Outstanding - December 31, 2022 | $ | |||||||||||||
Granted | ||||||||||||||
Vested | ( | |||||||||||||
Forfeited | ( | |||||||||||||
Outstanding - March 31, 2023 | $ |
Three months ended March 31, | ||||||||||||||
(in thousands) | 2023 | 2022 | ||||||||||||
Research and development | $ | $ | ||||||||||||
Selling, general and administrative | ||||||||||||||
Capitalized under inventories | ||||||||||||||
Share-based compensation expense | $ | $ |
Three Months Ended March 31, | ||||||||||||||||||||
2023 | 2022 | Change | ||||||||||||||||||
(in thousands) | ||||||||||||||||||||
Revenue | ||||||||||||||||||||
Product revenue, net | $ | 34,337 | $ | 21,492 | $ | 12,845 | ||||||||||||||
License, royalty and collaboration revenue | 72 | 133 | (61) | |||||||||||||||||
Total revenue, net | 34,409 | 21,625 | 12,784 | |||||||||||||||||
Operating expenses | ||||||||||||||||||||
Cost of sales | 421 | 256 | 165 | |||||||||||||||||
Selling, general and administrative | 50,124 | 45,197 | 4,927 | |||||||||||||||||
Research and development | 13,158 | 12,620 | 538 | |||||||||||||||||
Other expense, net | 290 | 1,434 | (1,144) | |||||||||||||||||
Total cost of sales and operating expenses | 63,993 | 59,507 | 4,486 | |||||||||||||||||
Loss from operations | (29,584) | (37,882) | 8,298 | |||||||||||||||||
Interest income | 3,814 | 262 | 3,552 | |||||||||||||||||
Net loss before income taxes | (25,770) | (37,620) | 11,850 | |||||||||||||||||
Income tax expense | 436 | 10 | 426 | |||||||||||||||||
Net loss | $ | (26,206) | $ | (37,630) | $ | 11,424 |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2023 | 2022 | ||||||||||||
Salaries, incentive pay and employee benefits | $ | 22,298 | $ | 22,523 | ||||||||||
Professional fees and services | 13,258 | 10,898 | ||||||||||||
Share-based compensation expense | 7,589 | 5,972 | ||||||||||||
Other corporate costs | 3,822 | 3,628 | ||||||||||||
Travel, trade shows and sponsorships | 3,157 | 2,176 | ||||||||||||
$ | 50,124 | $ | 45,197 |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2023 | 2022 | ||||||||||||
Contract research organizations (CRO) and developmental expenses | $ | 4,230 | $ | 6,727 | ||||||||||
Clinical supply and distribution | 3,273 | 1,562 | ||||||||||||
Salaries, incentive pay and employee benefits | 3,825 | 3,273 | ||||||||||||
Share-based compensation expense | 1,590 | 976 | ||||||||||||
Other costs | 240 | 82 | ||||||||||||
$ | 13,158 | $ | 12,620 |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2023 | 2022 | ||||||||||||
Net cash (used in) provided by: | ||||||||||||||
Operating activities | $ | (31,670) | $ | (46,746) | ||||||||||
Investing activities | 24,860 | (53,017) | ||||||||||||
Financing activities | 1,639 | 405 | ||||||||||||
Net decrease in cash and cash equivalents | $ | (5,171) | $ | (99,358) |
Exhibit Number | Description | |||||||
3.1 | ||||||||
3.2 | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1** | ||||||||
32.2** | ||||||||
101.INS* | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | |||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | |||||||
* | Filed herewith. | |||||||
** | Furnished herewith. Exhibits 32.1 and 32.2 are being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing. |
AURINIA PHARMACEUTICALS INC. | ||||||||
May 3, 2023 | By: | /s/ Peter Greenleaf | ||||||
Peter Greenleaf | ||||||||
Chief Executive Officer, Director (Principal Executive Officer) | ||||||||
May 3, 2023 | By: | /s/ Joseph Miller | ||||||
Joseph Miller | ||||||||
Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: | May 3, 2023 | By: | /s/ Peter Greenleaf | ||||||||
Peter Greenleaf | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
Date: | May 3, 2023 | By: | /s/ Joseph Miller | ||||||||
Joseph Miller | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Financial and Accounting Officer) |
Date: | May 3, 2023 | By: | /s/ Peter Greenleaf | ||||||||
Peter Greenleaf | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
Date: | May 3, 2023 | By: | /s/ Joseph Miller | ||||||||
Joseph Miller | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Financial and Accounting Officer) |
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value ($ per share) | $ 0 | $ 0 |
Common stock, issued (shares) | 143,029,000 | 142,268,000 |
Common stock, outstanding (shares) | 143,029,000 | 142,268,000 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Statement [Abstract] | ||
Unrealized gain on available-for-sale securities, tax | $ 0 | $ 0 |
Organization and Description of Business |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Aurinia Pharmaceuticals Inc. (Aurinia or the Company) is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with a high unmet medical need that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first U.S. Food and Drug Administration (FDA) approved oral therapy for the treatment of adult patients with active lupus nephritis (LN) and continues to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program as well as our other assets. We engaged with Otsuka Pharmaceutical Co., Ltd. (Otsuka) as a collaboration partner for development and commercialization of LUPKYNIS in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine (collectively, the Otsuka Territories). On August 17, 2021, the Company announced the addition of two novel assets AUR200 and AUR300. AUR200 and AUR300 are currently undergoing pre-clinical development with projected submission of Investigational New Drug Applications (INDs) to the FDA (or their equivalent) for AUR200 in 2023 and for AUR300 in 2024. On September 15, 2022, the European Commission (EC) granted marketing authorization of LUPKYNIS to Otsuka. The centralized marketing authorization is valid in all European (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. As of April 1, 2023, Aurinia's head office and registered office is located at #140, 14315-118 Avenue, Edmonton, Alberta, Canada. 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 Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
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 March 31, 2023 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, 2022. The results of operations for the three months ended March 31, 2023 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 and all of its foreign subsidiaries' 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 monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at the exchange rate on the balance sheet date. Non-monetary assets and liabilities (along with their related expenses) are translated at the rate of exchange in effect on the date assets were acquired. Monetary income and expense items are translated at the average foreign currency period. Foreign exchange gains and losses arising on translation or settlement of a foreign currency denominated monetary item are included in the consolidated statements of operations and recorded in other (income) expense, net. 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 pipeline assets AUR200 and AUR300. Taking into consideration the Company's cash, cash equivalents, restricted cash and investments of $361.5 million as of March 31, 2023, 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 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, 2022. Restricted Cash: Restricted cash consists of the 2021 Employee Share Purchase Plan (2021 ESPP) deposits of $0.7 million and $0.1 million as of March 31, 2023 and December 31, 2022, respectively. Major Customers: The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and a collaboration partnership with Otsuka for sales of semi-finished product in the Otsuka Territories. Revenues from the two main customers in the U.S. accounted in total of approximately 99% for the three months ended March 31, 2023 and March 31, 2022. In late March 2022, the Company provided a nominal additional discount to both of its two main U.S. customers, applicable for the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. In December 2022, the Company extended the nominal discount to the end of 2023. Such discounts, or any future discounts, may result in reduced sales to these customers in subsequent periods and substantial fluctuations in our revenues from period to period. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically reevaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. The Company has had no historical write-offs related to our customers or receivables. Product Revenues In the United States (and territories), the Company sells LUPKYNIS primarily to specialty pharmacies and specialty distributors. These customers subsequently resell the Company's products to patients and healthcare providers. Revenues from product sales are recognized when the customer obtains control of the Company's product, which typically occurs upon delivery to the customer. Reserves for discounts and allowances: Product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). The Company's estimates of reserves established for variable consideration are calculated based upon utilizing the expected value method. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. Significant judgment is required in estimating variable consideration. In making these estimates, the Company considers historical data, including patient mix and inventory sold to our customers that has not yet been dispensed. The Company uses a data aggregator and historical claims to estimate variable consideration for inventory sold to our customers, including specialty pharmacies and specialty distributors, that has not yet been dispensed. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. As of March 31, 2023, we did not have any material adjustments to variable consideration estimates based on actual results. These specific adjustments are detailed further in our Annual Report on Form 10-K for the year ended December 31, 2022. Accounts Receivable, Net: Accounts receivable are stated at their net realizable value. The Company's accounts receivable represents amounts due to the Company from product sales and from its Otsuka collaboration agreement (Note 12). As of March 31, 2023 and December 31, 2022, accounts receivable, net are $19.0 million and $13.5 million, respectively. The Company's standard credit terms range from 30 to 45 days and does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. The Company estimates the allowance for doubtful accounts using the current expected credit loss, or CECL, model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. Aurinia evaluates the collectability of these cash flows based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to 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 March 31, 2023 and December 31, 2022. 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. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. The Company has elected a policy for all share-based awards to estimate forfeitures based on historical forfeiture experience at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. Recently Adopted Accounting Pronouncements 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.
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Fair Value Measurements |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements The 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 debt securities are generally based on prices obtained from commercial pricing services. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: •Level 1 - Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. •Level 2 - Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. •Level 3 - Unobservable inputs that reflect the reporting entity’s own assumptions. The following table summarizes the financial assets (cash, cash equivalents, restricted cash and short-term investments) measured at fair value on a recurring basis:
The Company's Level 1 instruments include cash, cash equivalents and restricted cash that are valued using quoted market prices. Aurinia estimates the fair values of our investments in corporate debt securities, government and government related securities and certificates of deposits by taking into consideration valuations obtained from third-party pricing services. The fair value of 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 March 31, 2023 and December 31, 2022, the weighted average remaining contractual maturities of our Level 2 investments were approximately 7 months. It is the Company's intent for these investments to have an overall rating of A-1, or higher, by Moody’s, Standard & Poor’s and Fitch. No credit loss allowance was recorded as of March 31, 2023 and December 31, 2022, as the Company does not believe the unrealized loss is a result of a credit loss due to the nature of our investments. We also considered the current and expected future economic and market conditions and determined that the estimate of credit losses was not significantly impacted. Refer to Note 4, “Cash, Cash Equivalents, Restricted Cash and Short-Term Investments,” for the carrying amount and related unrealized gains (losses) by type of investment.
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Cash, Cash Equivalents, Restricted Cash and Short-Term Investments |
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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 March 31, 2023 and December 31, 2022, the Company had $361.5 million and $389.4 million, respectively of cash, cash equivalents, restricted cash and short-term investments summarized below. As of March 31, 2023 and December 31, 2022, $272.5 million and $295.2 million were available-for-sale debt securities which are carried at fair market value.
As of March 31, 2023 and December 31, 2022, accrued interest receivable from the investments were $0.6 million and $1.1 million, respectively. During the three months ended March 31, 2023, the Company had $0.1 million unrealized gains on available-for-sale securities, net of tax, respectively, which are included as a component of comprehensive loss on the consolidated statements of operations. Currently, the Company does not intend to sell investments that are in an unrealized loss position, and it is unlikely we will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity. The Company has determined that the gross unrealized losses on our investments at March 31, 2023, were temporary in nature. Realized gains or losses were immaterial during the three months ended March 31, 2023 and 2022. The Company's short-term investments as of March 31, 2023 mature at various dates through December 2023.
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Inventories, net |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories, net | Inventories, net Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories for LUPKYNIS mainly include third party manufacturing costs, transportation, storage, insurance, and allocated internal labor. The Company assesses recoverability of inventory each reporting period to determine any write-down to net realizable value resulting from excess or obsolete inventories. As of March 31, 2023, Aurinia recorded reserves of finished goods inventories of approximately $3.9 million which were primarily related to process validation batches used for FDA approval. The components of inventory, net are as follows:
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Prepaid Expenses |
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Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Prepaid Expenses | Prepaid Expenses Prepaid expenses are as follows:
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Intangible Assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets | Intangible Assets The following table summarizes the carrying amount of intangible assets, net of accumulated amortization.
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Property and Equipment, net |
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Property and Equipment, net | Property and Equipment, net Property and equipment, net are as follows:
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Lease Obligations |
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Lease Obligations | Lease Obligations The Company has the following lease obligations: Victoria, British Columbia In December 2020, Aurinia entered into a lease for office space in Victoria, British Columbia. During September 2022, the fixed lease term ended on the Victoria lease and the Company exercised its right to enter into a short-term month to month lease, of which expenses are incurred in SG&A. On March 31, 2023, the Company terminated the Victoria lease. Rockville, Maryland During March 2020, the Company entered into a lease for its U.S. commercial office in Rockville, Maryland for a total of 30,531 square feet of office space. The lease has a remaining term of approximately eight 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 March 31, 2023, the Company had a right-of-use asset of $4.8 million and lease liability of $7.9 million included in the condensed consolidated balance sheets. As of December 31, 2022, the Company had a right of use asset of $4.9 million and lease liability of $8.0 million included in the 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 During October 2022, the Company entered into a long term lease in Edmonton for a total of 4,375 square feet of office space. The lease is a six year lease and has an option to renew of five years at prevailing market rates. The lease commenced on November 1, 2022 and the Company recorded the lease as an operating lease. The lease is not material to the Company's financial position. For all leases, the Company incurs variable lease costs. These costs include operation and maintenance costs included in SG&A and are expensed as incurred. The variable lease costs are not material to the Company's financial position. The operating lease costs for all leases for the three months ended March 31, 2023 and March 31, 2022 are $0.2 million and $0.3 million respectively. The following table represents the weighted-average remaining lease term and discount rate as of March 31, 2023:
The following table provides a summary of lease liabilities payments for the next five years and thereafter:
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 became due when the facility fulfilled the required operational qualifications in April 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 will account for the arrangement as a finance lease under ASC 842. At lease inception, which is considered to be the operational qualification date that occurred in April 2023. The Company expects to record a right of use (ROU) asset of approximately $111.0 million and a corresponding lease liability of $88.0 million, which is the present value of the minimum lease payments beginning April 2023 and expiring in 2030, and not included in the above table. The incremental borrowing rate applied to the lease liability in April 2023 is 7.25% based on the financial position of the Company, geographical region and term of lease. The Company has entered into an equipment and facility finance lease for a backup manufacturing encapsulation site in Beinheim, France that has not yet commenced and is therefore, not included in the above table. As part of the agreement, the Company expects to make payments of approximately $1.0 million prior to lease commencement and the present value of minimum lease payments will total approximately $0.1 million.
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Accounts Payable and Accrued Liabilities |
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Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities are as follows:
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Deferred Compensation and Other Non-current Liabilities |
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Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Deferred Compensation and Other Non-current Liabilities | Deferred Compensation and Other Non-current LiabilitiesThe Company recorded other non-current liabilities of $12.3 million and $12.2 million as of March 31, 2023 and December 31, 2022, respectively. The balance as of March 31, 2023 and December 31, 2022 primarily included deferred compensation arrangements whereby certain executive officers as of March 8, 2012 were provided with future potential employee benefit obligations for remaining with the Company, for a certain period of time. These obligations were also contingent on the occurrence of uncertain future events. |
License and Collaboration Agreement |
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Mar. 31, 2023 | |
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 for the development and commercialization of oral LUPKYNIS in the Otsuka Territories. As part of the agreement, the Company received an upfront cash payment of $50.0 million in 2020 for the license agreement and has the potential to receive up to $50.0 million in regulatory and pricing approval related milestones. The Company will provide semi-finished product of LUPKYNIS to Otsuka on a cost-plus basis, and will receive tiered royalties on future sales ranging from 10 to 20 percent (dependent on territory and achievement of sale thresholds) on net product sales by Otsuka, along with additional milestone payments based on the attainment of certain annual sales. In addition, certain collaboration services are to be provided to Otsuka on agreed upon rates. In furtherance of the collaboration and license agreement with Otsuka mentioned above, on August 1, 2022, the Company entered into a commercial supply agreement with Otsuka, formalizing the terms to supply semi-finished goods of LUPKYNIS to Otsuka in the Otsuka Territories, including sharing production capacity of the monoplant. On September 15, 2022, the European Commission (EC) granted marketing authorization of LUPKYNIS. The centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. The approval triggered a $30.0 million milestone to the Company, which was recognized as collaboration revenue for the year ended December 31, 2022. On November 29, 2022 Aurinia announced that the MHRA has granted marketing authorization of LUPKYNIS in Great Britain. On April 24, 2023, LUPKYNIS received regulatory approval in Switzerland. We continue to progress with regulatory approval with Otsuka in the other Otsuka Territories. For the three months ended March 31, 2023 and March 31, 2022, the Company recognized $0.1 million, for both periods, of additional collaboration revenue from services provided under the agreement. 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 consolidated statements of operations. During the first quarter of 2022, Aurinia paid $4.0 million for the achievement of a one- time milestone. Additional payments are due upon certain development, clinical and regulatory milestones, and royalties will be payable upon commercialization.
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Net Loss per Common Share |
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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:
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:
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Share-based Compensation |
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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 and provides for grants of stock options, performance awards (PAs), and restricted stock units (RSUs) that may be settled in cash and common shares. Also in June 2021, the Company's shareholders adopted and approved the Company's 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 2022, the Company modified the 2021 ESPP for the current and future offerings. The new ESPP terms shortened the plan from four purchases over a 24 month Offering Period to two 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. In addition to stock options, PAs and RSUs granted under the Plan, the Company has granted certain stock options and RSUs as inducements material to new employees entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The inducements were granted outside of the Plan. 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 business 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 assumptions used for the annual volatility and expected life of the options are reviewed and updated annually. 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 three months ended March 31, 2023 and March 31, 2022:
The increase of the risk-free interest rate during the three months ended March 31, 2023 was due to the increase of higher yields on government benchmark bonds. The following table summarizes the option award activity for the three months ended March 31, 2023:
Restricted Stock Units and Performance Awards The Company has granted RSUs and PAs under the Plan, as well as inducements for certain new hires as discussed above. The RSUs and PAs are fair valued based on the previous business days' market price of our common shares on the date of the grant. The following table summarizes the RSU and PA activity for the three months ended March 31, 2023:
Compensation Expense The Company recognized share-based compensation expense for the three month periods ended March 31, 2023 and March 31, 2022 as follows:
As of March 31, 2023, there was $50.9 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 1.6 years.
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Income Taxes |
3 Months Ended |
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Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The effective tax rates for the three months ended March 31, 2023 and March 31, 2022 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 approximately $436 thousand and $10 thousand for the three months ended March 31, 2023 and March 31, 2022, respectively. The expense recognized for these periods is a result of income in certain jurisdictions that are not offset by tax benefits as the Company has losses which are fully offset by a valuation allowance in its significant jurisdictions. 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 was complete and there were no findings and as a result, there was no additional tax expense or benefit recognized in regards to the audit. There are no outstanding tax audits ongoing at March 31, 2023. The Company is subject to examination in the U.S., U.K. and Canada. In the U.S. and U.K. tax periods remain open in 2015 through 2022 and 2020 through 2022, respectively. Canada's tax periods remain open from 2009 due to the tax attribute carryforwards.
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Related-Party Transactions |
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Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related Party TransactionsDuring the quarter ended March 31, 2023 and year ended December 31, 2022, the Company had no related party transactions. |
Commitment and Contingencies |
3 Months Ended |
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Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies The Company may, from time to time, be subject to claims and legal proceedings brought against it in the normal course of business. Such matters are subject to many uncertainties. Management believes the ultimate resolution of such contingencies will not have a material adverse effect on the consolidated financial 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, 2022 and the quarterly report for the quarter ended March 31, 2023. 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.
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Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
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Mar. 31, 2023 | |
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 March 31, 2023 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, 2022. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year or any other future periods.
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Restricted Cash | Restricted Cash: Restricted cash consists of the 2021 Employee Share Purchase Plan (2021 ESPP) deposits of $0.7 million and $0.1 million as of March 31, 2023 and December 31, 2022, respectively. |
Major Customers | Major Customers: The Company currently has two main customers for U.S. commercial sales of LUPKYNIS and a collaboration partnership with Otsuka for sales of semi-finished product in the Otsuka Territories. Revenues from the two main customers in the U.S. accounted in total of approximately 99% for the three months ended March 31, 2023 and March 31, 2022. In late March 2022, the Company provided a nominal additional discount to both of its two main U.S. customers, applicable for the 2022 calendar year, in connection with holding additional amounts of LUPKYNIS on hand due to supply chain concerns. In December 2022, the Company extended the nominal discount to the end of 2023. Such discounts, or any future discounts, may result in reduced sales to these customers in subsequent periods and substantial fluctuations in our revenues from period to period. The Company monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. The Company regularly communicates with its customers regarding the status of receivable balances. Global economic conditions and customer specific factors may require the Company to periodically reevaluate the collectability of its receivables and based on this evaluation the Company could potentially incur credit losses. The Company has had no historical write-offs related to our customers or receivables.
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Product Revenues | Product Revenues In the United States (and territories), the Company sells LUPKYNIS primarily to specialty pharmacies and specialty distributors. These customers subsequently resell the Company's products to patients and healthcare providers. Revenues from product sales are recognized when the customer obtains control of the Company's product, which typically occurs upon delivery to the customer. Reserves for discounts and allowances: Product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). The Company's estimates of reserves established for variable consideration are calculated based upon utilizing the expected value method. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. Significant judgment is required in estimating variable consideration. In making these estimates, the Company considers historical data, including patient mix and inventory sold to our customers that has not yet been dispensed. The Company uses a data aggregator and historical claims to estimate variable consideration for inventory sold to our customers, including specialty pharmacies and specialty distributors, that has not yet been dispensed. Actual amounts may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. As of March 31, 2023, we did not have any material adjustments to variable consideration estimates based on actual results. These specific adjustments are detailed further in our Annual Report on Form 10-K for the year ended December 31, 2022.
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Accounts Receivable, Net | Accounts Receivable, Net: Accounts receivable are stated at their net realizable value. The Company's accounts receivable represents amounts due to the Company from product sales and from its Otsuka collaboration agreement (Note 12). As of March 31, 2023 and December 31, 2022, accounts receivable, net are $19.0 million and $13.5 million, respectively. The Company's standard credit terms range from 30 to 45 days and does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between the transfer of the promised good to the customer and receipt of payment will be one year or less. The Company estimates the allowance for doubtful accounts using the current expected credit loss, or CECL, model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. Aurinia evaluates the collectability of these cash flows based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to 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 March 31, 2023 and December 31, 2022 |
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. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. The Company has elected a policy for all share-based awards to estimate forfeitures based on historical forfeiture experience at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. |
Recently Adopted Accounting pronouncements | Recently Adopted Accounting Pronouncements 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.
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Fair Value Measurements (Tables) |
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table summarizes the financial assets (cash, cash equivalents, restricted cash and short-term investments) measured at fair value on a recurring basis:
|
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments |
|
Inventories, net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventories, net | The components of inventory, net are as follows:
|
Prepaid Expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses are as follows:
|
Intangible Assets (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Intangible Assets | The following table summarizes the carrying amount of intangible assets, net of accumulated amortization.
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Property and Equipment, net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, net | Property and equipment, net are as follows:
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Lease Obligations (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lease, Cost | The following table represents the weighted-average remaining lease term and discount rate as of March 31, 2023:
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Lessee, Operating Lease, Liability, Maturity | The following table provides a summary of lease liabilities payments for the next five years and thereafter:
|
Accounts Payable and Accrued Liabilities (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Liabilities | Accounts payable and accrued liabilities are as follows:
|
Net Loss per Common Share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Loss 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:
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Schedule of Antidilutive Securities Excluded from Computation of Loss Per Share | The Company did not include the securities in the following table in the computation of the net loss per common share because the effect would have been anti-dilutive during each period:
|
Share-based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 three months ended March 31, 2023 and March 31, 2022:
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Schedule of Option Activity | The following table summarizes the option award activity for the three months ended March 31, 2023:
|
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Schedule of Performance Shares Activity | The following table summarizes the RSU and PA activity for the three months ended March 31, 2023:
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Allocation of Share-Based Payments | The Company recognized share-based compensation expense for the three month periods ended March 31, 2023 and March 31, 2022 as follows:
|
Organization and Description of Business (Details) |
Aug. 17, 2021
assets
|
---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of Additional Novel Assets | 2 |
Summary of Significant Accounting Policies (Details) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023
USD ($)
segment
|
Mar. 31, 2022 |
Dec. 31, 2022
USD ($)
|
|
Property, Plant and Equipment [Line Items] | |||
Number of operating segments | segment | 1 | ||
Cash and cash equivalents and investments | $ 361,500,000 | ||
Restricted cash | 700,000 | $ 100,000 | |
Accounts receivable, net | 19,046,000 | 13,483,000 | |
Allowance for doubtful accounts | $ 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 | ||
Two Specialty Pharmacy | Revenue Benchmark | Customer Concentration Risk | |||
Property, Plant and Equipment [Line Items] | |||
Concentration risk (as percent) | 99.00% | 99.00% |
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
|
Investments, Debt and Equity Securities [Abstract] | ||
Total cash, cash equivalents, restricted cash and short-term investments | $ 361.5 | $ 389.4 |
Available-for-sale debt securities | 272.5 | 295.2 |
Interest receivable | 0.6 | $ 1.1 |
Unrealized gains on available-for-sale securities | $ 0.1 |
Inventories, net (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Finished goods inventories | $ 3,900 | |
Raw materials | 1,115 | $ 2,217 |
Work in process | 29,522 | 21,059 |
Finished goods | 1,108 | 1,476 |
Total inventories | $ 31,745 | $ 24,752 |
Prepaid Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid assets | $ 6,043 | $ 5,451 |
Prepaid deposits | 3,308 | 6,330 |
Prepaid insurance | 745 | 1,799 |
Total prepaid expenses | $ 10,096 | $ 13,580 |
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 19,723 | $ 19,568 |
Accumulated Amortization | (13,622) | (13,143) |
Net Carrying Amount | 6,101 | 6,425 |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 1,724 | 1,569 |
Accumulated Amortization | (1,268) | (1,262) |
Net Carrying Amount | 456 | 307 |
Acquired intellectual property and reacquired rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 15,126 | 15,126 |
Accumulated Amortization | (10,071) | (9,838) |
Net Carrying Amount | 5,055 | 5,288 |
Internal-use software implementation costs | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 2,873 | 2,873 |
Accumulated Amortization | (2,283) | (2,043) |
Net Carrying Amount | $ 590 | $ 830 |
Intangible Assets - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of intangible assets | $ 0.5 | $ 0.5 |
Property and Equipment, net (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,290 | $ 5,105 |
Less accumulated depreciation | (1,448) | (1,455) |
Property and equipment, net | 3,842 | 3,650 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 602 | 255 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,856 | 2,978 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 621 | 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 | $ 235 | $ 251 |
Lease Obligations - Summary of Components of Leasing Costs and Rent (Details) |
Mar. 31, 2023 |
---|---|
Leases [Abstract] | |
Weighted average remaining lease term - operating leases (in years) | 8 years 4 months 24 days |
Weighted average discount rate - operating leases | 5.25% |
Lease Obligations - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands |
Mar. 31, 2023
USD ($)
|
---|---|
Leases [Abstract] | |
Remainder of 2023 | $ 718 |
2024 | 1,113 |
2025 | 1,141 |
2026 | 1,169 |
2027 | 1,198 |
Thereafter | 4,532 |
Total future minimum lease payments | 9,871 |
Less: lease imputed interest | (1,940) |
Total future minimum lease payments | $ 7,931 |
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Payables and Accruals [Abstract] | ||
Employee accruals | $ 11,721 | $ 20,214 |
Commercial accruals | 10,689 | 8,620 |
Accrued R&D projects | 5,621 | 5,350 |
Trade payables | 3,680 | 3,087 |
Other accrued liabilities | 3,194 | 2,094 |
Income taxes payable | 1,060 | 625 |
Total accounts payable and accrued liabilities | $ 35,965 | $ 39,990 |
Deferred Compensation and Other Non-current Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Payables and Accruals [Abstract] | ||
Other non-current liabilities | $ 12,321 | $ 12,166 |
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 | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Net loss | $ (26,206) | $ (37,630) |
Weighted average common shares outstanding basic (in shares) | 142,641 | 141,675 |
Weighted average common shares outstanding diluted (in shares) | 142,641 | 141,675 |
Basic Net loss per common share (expressed in $ per share) | $ (0.18) | $ (0.27) |
Diluted Net loss per common share (expressed in $ per share) | $ (0.18) | $ (0.27) |
Net Loss per Common Share - Anti-Dilutive Securities (Details) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 20,582,000 | 16,601,000 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 12,678,000 | 14,649,000 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 7,904,000 | 1,952,000 |
Share-based Compensation - Narrative (Details) $ in Millions |
1 Months Ended | 3 Months Ended | 12 Months Ended | |
---|---|---|---|---|
Jun. 30, 2021
shares
|
Mar. 31, 2023
USD ($)
|
Dec. 31, 2022
purchase_period
|
Dec. 31, 2021
purchase_period
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized share-based compensation expense | $ | $ 50.9 | |||
Unrecognized share-based compensation expense weighted average recognition period | 1 year 7 months 6 days | |||
Employee Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares authorized | 2,500,000 | |||
Number of purchase periods | purchase_period | 2 | 4 | ||
Purchase period | 12 months | 24 months | ||
Offering period | 12 months | |||
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 |
Share-Based Compensation - Weighted Average Assumptions (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Share-Based Payment Arrangement [Abstract] | ||
Annualized volatility(as percent) | 71.00% | 70.00% |
Risk-free interest rate (as percent) | 4.08% | 1.73% |
Expected life of options in years | 5 years | 5 years |
Estimated forfeiture rate (as percent) | 12.70% | 11.60% |
Dividend rate | $ 0.000 | $ 0.000 |
Fair value per common share option (in usd per share) | $ 5.44 | $ 7.02 |
Share-Based Compensation - Stock Option Activity (Details) - $ / shares shares in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
|
Number of shares (in thousands) | ||
Beginning balance (in shares) | 13,295 | |
Granted (in shares) | 232 | |
Exercised (in shares) | (319) | |
Forfeited (in shares) | (530) | |
Ending balance (in shares) | 12,678 | |
Weighted average exercise price $ | ||
Beginning balance (in usd per share) | $ 12.11 | $ 12.09 |
Granted (in usd per share) | 8.84 | |
Exercised (in usd per share) | 5.09 | |
Forfeited (in usd per share) | 14.43 | |
Ending balance (in usd per share) | $ 12.11 |
Share-Based Compensation - Performance Awards and Restricted Stock Units Activity (Details) - Officer - Performance Share sand Restricted Stock Units (RSUs) shares in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2023
$ / shares
shares
| |
Number of shares (in thousands) | |
Outstanding - Beginning of Period (in shares) | shares | 1,980 |
Granted (in shares) | shares | 6,468 |
Vested (in shares) | shares | (442) |
Forfeited (in shares) | shares | (102) |
Outstanding - End of Period (in shares) | shares | 7,904 |
Weighted average exercise price $ | |
Outstanding, Weighted average exercise price - Beginning of Period (in usd per share) | $ / shares | $ 10.84 |
Weighted average grant date fair value (in usd per share) | $ / shares | 8.99 |
Weighted average grant date fair value (in usd per share) | $ / shares | 12.01 |
Weighted average exercise price (in usd per share) | $ / shares | 9.73 |
Outstanding, Weighted average exercise price - End of Period (in usd per share) | $ / shares | $ 9.27 |
Share-Based Compensation - Allocated Share-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 9,467 | $ 7,023 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 1,590 | 976 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 7,589 | 5,972 |
Capitalized under inventories | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 288 | $ 75 |
Income Taxes (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Tax Disclosure [Abstract] | ||
Income tax (benefit) expense | $ 436 | $ 10 |
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