Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Jan. 31, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K/A | ||
Amendment Flag | true | ||
Amendment Description | This Amendment No. 1 to the Annual Report on Form 10-K (this “Amendment”) amends FibroGen, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Form 10-K”), as filed with the Securities and Exchange Commission on February 28, 2022, and is being filed solely to amend the report titled “Report of Independent Registered Public Accounting Firm” contained in Part II, Item 8 “Consolidated Financial Statements and Supplementary Data” of the Form 10-K (the “Audit Report”) to correct typographical formatting errors which occurred upon conversion of the Form 10-K into the appropriate EDGAR-filing format. The Audit Report in the Form 10-K inadvertently contained strikethrough formatting of the words “Internal Control – Integrated Framework” in the first and second paragraph of the Audit Report and the subheading “Change in Accounting Principle” inadvertently set in bold text. Pursuant to Rule 12b-15 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we have included the entire text of Item 8 of the Form 10-K in this Amendment. However, there have been no changes made to the text of such item other than the changes stated in the immediately preceding paragraph. As required by Rule 12b-15 under the Exchange Act, new certifications by our principal executive officer and principal financial officer are being filed as Exhibits 31.1, 31.2 and 32.1 to this Amendment. Except as expressly set forth above, this Amendment does not, and does not purport to, amend, update, or restate the information in the remainder of the Form 10-K or reflect any events that have occurred after the filing of the Form 10-K. Accordingly, this Amendment should be read in conjunction with the Form 10-K. | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | FGEN | ||
Entity Registrant Name | FIBROGEN, INC. | ||
Entity Central Index Key | 0000921299 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36740 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 77-0357827 | ||
Entity Address, Address Line One | 409 Illinois Street | ||
Entity Address, City or Town | San Francisco | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94158 | ||
City Area Code | 415 | ||
Local Phone Number | 978-1200 | ||
Entity Common Stock, Shares Outstanding | 93,001,968 | ||
Entity Public Float | $ 1,446.8 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Firm ID | 238 | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Location | San Jose, California | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K for the year ended December 31, 2021 (the “Annual Report”) incorporate information by reference from the definitive proxy statement for the registrant’s 2022 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than after 120 days after the end of the fiscal year covered by this Annual Report |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 171,223 | $ 678,393 |
Short-term investments | 233,967 | 8,144 |
Accounts receivable, net ($10,930 and $4,127 from related parties) | 17,401 | 41,883 |
Inventories | 31,015 | 16,530 |
Prepaid expenses and other current assets ($0 and $889 from a related party) | 20,453 | 10,160 |
Total current assets | 474,059 | 755,110 |
Restricted time deposits | 2,072 | 2,072 |
Long-term investments | 167,796 | 244 |
Property and equipment, net | 28,277 | 33,647 |
Finance lease right-of-use assets | 761 | 29,606 |
Equity method investment in unconsolidated variable interest entity | 3,825 | 2,728 |
Operating lease right-of-use assets | 91,112 | 2,043 |
Other assets | 5,919 | 1,390 |
Total assets | 773,821 | 826,840 |
Current liabilities: | ||
Accounts payable ($0 and $1,118 to a related party) | 26,097 | 24,789 |
Accrued and other current liabilities ($4 and $24 to a related party) | 172,588 | 118,333 |
Deferred revenue ($3,201 and $2,907 to related parties) | 15,857 | 6,547 |
Finance lease liabilities, current | 11 | 12,330 |
Operating lease liabilities, current | 10,944 | 1,188 |
Total current liabilities | 225,497 | 163,187 |
Product development obligations | 17,613 | 18,697 |
Deferred revenue, net of current ($25,891 and $4,636 to a related party) | 186,801 | 138,474 |
Finance lease liabilities, non-current | 3 | 25,391 |
Operating lease liabilities, non-current | 88,776 | 853 |
Other long-term liabilities | 26,018 | 38,789 |
Total liabilities | 544,708 | 385,391 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at December 31, 2021 and 2020 | 0 | |
Common stock, $0.01 par value; 225,000 shares authorized at December 31, 2021 and 2020; 92,881 and 91,441 shares issued and outstanding at December 31, 2021 and 2020 | 929 | 914 |
Additional paid-in capital | 1,476,414 | 1,399,774 |
Accumulated other comprehensive loss | (4,163) | (4,499) |
Accumulated deficit | (1,264,034) | (974,011) |
Total stockholders’ equity | 209,146 | 422,178 |
Non-controlling interests | 19,967 | 19,271 |
Total equity | 229,113 | 441,449 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 773,821 | $ 826,840 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related parties | $ 10,930 | $ 4,127 |
Prepaid expenses and other current assets from related parties | 0 | 889 |
Accounts payable to related party | 0 | 1,118 |
Accrued and other current liabilities to related party | 4 | 24 |
Deferred revenue current to related party | 3,201 | 2,907 |
Deferred revenue non-current to related party | $ 25,891 | $ 4,636 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 125,000,000 | 125,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 92,881,000 | 91,441,000 |
Common stock, shares outstanding | 92,881,000 | 91,441,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 |
Operating costs and expenses: | |||
Cost of goods sold | $ 12,871 | $ 8,869 | $ 1,147 |
Cost, Product and Service [Extensible List] | Product Revenue, Net [Member] | Product Revenue, Net [Member] | Product Revenue, Net [Member] |
Research and development | $ 387,043 | $ 252,924 | $ 209,265 |
Selling, general and administrative | 123,925 | 106,406 | 135,479 |
Total operating costs and expenses | 523,839 | 368,199 | 345,891 |
Loss from operations | (288,530) | (191,880) | (89,314) |
Interest and other, net | |||
Interest expense | (1,075) | (2,402) | (2,876) |
Interest income and other income (expenses), net | (1,078) | 5,553 | 15,548 |
Total interest and other, net | (2,153) | 3,151 | 12,672 |
Loss before income taxes | (290,683) | (188,729) | (76,642) |
Provision for income taxes | 347 | 360 | 328 |
Investment income (loss) in unconsolidated variable interest entity | 1,007 | (202) | 0 |
Net loss | $ (290,023) | $ (189,291) | $ (76,970) |
Net loss per share - basic and diluted | $ (3.14) | $ (2.11) | $ (0.89) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 92,349 | 89,854 | 86,633 |
License Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 116,434 | $ 14,323 | $ 177,086 |
Development and Other Revenue [Member] | |||
Revenue: | |||
Total revenue | 70,275 | 80,592 | 114,115 |
Product Revenue, Net [Member] | |||
Revenue: | |||
Total revenue | 47,638 | 72,498 | 1,700 |
Drug Product Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 962 | $ 8,906 | $ (36,324) |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
License and milestone revenue from a related party | $ 108,434 | $ 14,323 | $ 129,405 |
Collaboration services and other revenue from a related party | 21,928 | 19,174 | 29,393 |
Product revenue from a related party | 35,568 | 0 | 0 |
Drug product revenue from a related party | $ 3,186 | $ 4,281 | $ (36,324) |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (290,023) | $ (189,291) | $ (76,970) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments | 1,235 | (3,207) | 331 |
Available-for-sale investments: | |||
Unrealized gain (loss) on investments, net of tax effect | (899) | (545) | 592 |
Other comprehensive income (loss), net of taxes | 336 | (3,752) | 923 |
Comprehensive loss | $ (289,687) | $ (193,043) | $ (76,047) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment [Member] | Common Stock [Member] | Common Stock [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Other Comprehensive Loss [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Noncontrolling Interests [Member] | Noncontrolling Interests [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] |
Balance at Dec. 31, 2018 | $ 528,470 | $ 854 | $ 1,226,453 | $ (2,281) | $ (715,827) | $ 19,271 | ||||||
Balance (ASU 2016-02 [Member]) at Dec. 31, 2018 | $ 8,688 | $ 0 | $ 0 | $ 0 | $ 8,688 | $ 0 | ||||||
Balance (ASU 2018-02 [Member]) at Dec. 31, 2018 | $ 0 | $ 0 | $ 0 | $ 611 | $ (611) | $ 0 | ||||||
Balance, Shares at Dec. 31, 2018 | 85,432,102 | |||||||||||
Net loss | (76,970) | $ 0 | 0 | 0 | (76,970) | 0 | ||||||
Change in unrealized gain or loss on investments | 592 | 0 | 0 | 592 | 0 | 0 | ||||||
Foreign currency translation adjustments | 331 | 0 | 0 | 331 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 7,962 | $ 23 | 7,939 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 2,220,957 | |||||||||||
Stock-based compensation | 66,267 | $ 0 | 66,267 | 0 | 0 | 0 | ||||||
Warrants exercised | 66 | $ 0 | 66 | 0 | 0 | 0 | ||||||
Warrants exercised, Shares | 4,430 | |||||||||||
Balance at Dec. 31, 2019 | 535,406 | $ 877 | 1,300,725 | (747) | (784,720) | 19,271 | ||||||
Balance, Shares at Dec. 31, 2019 | 87,657,489 | |||||||||||
Net loss | (189,291) | $ 0 | 0 | 0 | (189,291) | 0 | ||||||
Change in unrealized gain or loss on investments | (545) | 0 | 0 | (545) | 0 | 0 | ||||||
Foreign currency translation adjustments | (3,207) | 0 | 0 | (3,207) | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 26,366 | $ 37 | 26,329 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 3,783,144 | |||||||||||
Stock-based compensation | 72,720 | $ 0 | 72,720 | 0 | 0 | 0 | ||||||
Balance at Dec. 31, 2020 | 441,449 | $ 914 | 1,399,774 | (4,499) | (974,011) | 19,271 | ||||||
Balance, Shares at Dec. 31, 2020 | 91,440,633 | |||||||||||
Net loss | (290,023) | $ 0 | 0 | 0 | (290,023) | 0 | ||||||
Change in unrealized gain or loss on investments | (899) | 0 | 0 | (899) | 0 | 0 | ||||||
Foreign currency translation adjustments | 1,235 | 0 | 0 | 1,235 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 5,494 | $ 15 | 5,479 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,439,900 | |||||||||||
Stock-based compensation | 71,161 | $ 0 | 71,161 | 0 | 0 | 0 | ||||||
Conversion of subsidiary's convertible note payable(Note 10) | 696 | 0 | 0 | 0 | 0 | 696 | ||||||
Balance at Dec. 31, 2021 | $ 229,113 | $ 929 | $ 1,476,414 | $ (4,163) | $ (1,264,034) | $ 19,967 | ||||||
Balance, Shares at Dec. 31, 2021 | 92,880,533 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities | |||
Net loss | $ (290,023) | $ (189,291) | $ (76,970) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation | 10,170 | 11,678 | 11,147 |
Amortization of finance lease right-of-use assets | 4,639 | 10,369 | 10,307 |
Net accretion of premium and discount on investments | 2,482 | 103 | (3,667) |
Unrealized loss on equity investments | 30 | 0 | (88) |
Investment (gain) loss in unconsolidated variable interest entity | (1,007) | 202 | 0 |
Loss (gain) on disposal of property and equipment | 233 | 933 | (42) |
Stock-based compensation | 71,161 | 72,720 | 66,267 |
Expense for acquired in-process research and development asset | 60,000 | 0 | 0 |
Realized loss on sales of available-for-sale securities | 0 | 258 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net ($(6,803), $718 and $42,365 from related parties) | 25,180 | (11,973) | 35,229 |
Inventories | (14,158) | (9,175) | (6,887) |
Prepaid expenses and other current assets ($889, $124,321 and $(125,210) from a related party) | (9,854) | 123,492 | (128,598) |
Operating lease right-of-use assets | 4,209 | (24) | (1,201) |
Other assets | (4,412) | 5,843 | (4,058) |
Accounts payable ($(1,118), $1,118 and $0 from a related party) | 805 | 17,731 | (3,051) |
Accrued and other liabilities ($(20), $(36,859) and $36,439 from a related party) | 16,380 | 30,914 | 17,707 |
Operating lease liabilities, current | 503 | 134 | 580 |
Deferred revenue ($21,549, $7,169 and $(3,137) from related parties) | 57,637 | 45,077 | (49,941) |
Accrued interest for finance lease liabilities | (75) | (177) | 194 |
Operating lease liabilities, non-current | (4,043) | (143) | 692 |
Other long-term liabilities | (12,089) | (27,069) | 53,675 |
Net cash provided by (used in) operating activities | (82,232) | 81,602 | (78,705) |
Investing activities | |||
Purchases of property and equipment | (5,186) | (3,994) | (5,762) |
Payment made for acquired in-process research and development asset | (25,000) | 0 | 0 |
Payment made for investment in unconsolidated variable interest entity | 0 | (3,896) | 0 |
Proceeds from equity transfer of unconsolidated variable interest entity | 0 | 1,063 | 0 |
Proceeds from sale of property and equipment | 0 | 0 | 7 |
Purchases of available-for-sale securities | (484,144) | (8,192) | (411,299) |
Proceeds from sales of available-for-sale securities | 4,214 | 10,606 | 0 |
Proceeds from maturities of investments | 83,144 | 456,900 | 537,072 |
Net cash provided by (used in) investing activities | (426,972) | 452,487 | 120,018 |
Financing activities | |||
Repayments of finance lease liabilities | (5,489) | (12,620) | (11,925) |
Repayments of lease obligations | (403) | (403) | (403) |
Cash paid for payroll taxes on restricted stock unit releases | (7,372) | (11,463) | (12,750) |
Proceeds from issuance of common stock | 12,701 | 37,829 | 20,778 |
Net cash provided by (used in) financing activities | (563) | 13,343 | (4,300) |
Effect of exchange rate change on cash and cash equivalents | 2,597 | 4,695 | (5) |
Net increase (decrease) in cash and cash equivalents | (507,170) | 552,127 | 37,008 |
Total cash and cash equivalents at beginning of period | 678,393 | 126,266 | 89,258 |
Total cash and cash equivalents at end of period | 171,223 | 678,393 | 126,266 |
Supplemental cash flow information: | |||
Interest payments | 94 | 135 | 174 |
Balance in accounts payable and accrued liabilities related to purchases of property and equipment | 1,009 | 884 | 460 |
Balance in accrued liabilities related to acquired in-process research and development asset | 35,000 | 0 | 0 |
Balance in other receivables related to stock option exercise | 165 | 0 | 0 |
Conversion of subsidiary's convertible note payable to non-controlling interests | $ 696 | $ 0 | $ 0 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement Of Cash Flows [Abstract] | |||
Accounts receivable from related parties | $ (6,803) | $ 718 | $ 42,365 |
Prepaid expenses and other current assets from related party | 889 | 124,321 | (125,210) |
Accounts payable from related party | (1,118) | 1,118 | 0 |
Accrued and other liabilities from related party | (20) | (36,859) | 36,439 |
Deferred revenue from related parties | $ 21,549 | $ 7,169 | $ (3,137) |
The Company
The Company | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company FibroGen, Inc. (“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”). FibroGen is a leading biopharmaceutical company developing and commercializing a pipeline of first-in-class therapeutics. FibroGen applies its pioneering expertise in hypoxia-inducible factor biology, 2-oxoglutarate enzymology, and connective tissue growth factor biology to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat is FibroGen’s most advanced product, an oral small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase activity. Roxadustat is currently approved for use in patients with anemia associated with chronic kidney disease (“CKD”) in China (2019), Japan (2020) and Europe (2021), under the tradename EVRENZO ® ® Roxadustat is in Phase 3 clinical development for anemia associated with myelodysplastic syndromes and Phase 2 clinical development for chemotherapy-induced anemia. Pamrevlumab is FibroGen’s first-in-class antibody developed to inhibit the activity of connective tissue growth factor, a common factor in fibrotic and fibro-proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In the second quarter of 2021, the Food and Drug Administration (“FDA”) granted both Rare Pediatric Disease designation and Fast Track designation for pamrevlumab for the treatment of patients with Duchenne Muscular Dystrophy. In addition, the FDA has granted Orphan Drug Designation to pamrevlumab for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, and Duchenne Muscular Dystrophy. Pamrevlumab has also received Fast Track designation from the FDA for the treatment of both idiopathic pulmonary fibrosis and locally advanced unresectable pancreatic cancer. FibroGen has a pipeline of late-stage clinical programs as well as pre-clinical drug candidates at various stages of development that include both small molecules and biologics. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. (“FibroGen Cayman”). All inter-company transactions and balances have been eliminated in consolidation. For any variable interest entity (“VIE”) for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting. The Company operates in one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications and recalculations had no impact on previously reported financial position, results of operations, or cash flows. Foreign Currency Translation The reporting currency of the Company and its subsidiaries is the U.S. dollar. The functional currency of FibroGen Europe is the Euro. The assets and liabilities of FibroGen Europe are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Prior to April 1, 2020, the functional currency of the Company’s subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), was the U.S. dollar. On April 1, 2020, FibroGen Beijing adopted CNY as its functional currency based on reassessment of the primary economic operational environment of FibroGen Beijing that is mainly associated with its growing manufacturing and product sales activities conducted in CNY. As such, monetary assets and liabilities of FibroGen Beijing in currencies other than CNY are remeasured using exchange rates in effect at the end of the period. The assets and liabilities of FibroGen Beijing are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. This change in FibroGen Beijing’s functional currency was accounted for prospectively from April 1, 2020, and the prior consolidated financial statements were not restated. The related currency translation adjustment was $ 1.3 million at April 1, 2020 upon adoption. The functional currency of FibroGen, Inc. and all other subsidiaries is the U.S. dollar. Accordingly, monetary assets and liabilities in the non-functional currency of these subsidiaries are remeasured using exchange rates in effect at the end of the period. Revenues and costs in local currency are remeasured using average exchange rates for the period, except for costs related to those balance sheet items that are remeasured using historical exchange rates. The resulting remeasurement gains and losses are included within interest income and other, net in the consolidated statements of operations as incurred and have not been material for all periods presented. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China performance obligation (as defined and discussed under Revenue Recognition Concentration of Credit Risk The Company is subject to risks associated with concentration of credit for cash and cash equivalents. Outside of short-term operating needs, the majority of cash on hand is invested in U.S. treasuries and money market funds. Any remaining cash is deposited with major financial institutions in the U.S., Finland, China and the Cayman Islands. At times, such deposits may be in excess of insured limits. The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2021 2020 Astellas Pharma Inc. (“Astellas”)—Related party 63 % 10 % AstraZeneca AB (“AstraZeneca”) 34 % 26 % As of December 31, 2021, the accounts receivable related to roxadustat sales in China from Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”) and direct sales to distributors were not material. As of December 31, 2020, the aggregate accounts receivable related to roxadustat sales in China from distributors represented 64% of the consolidated accounts receivable, with no material balance from any individual distributor. Other Risks and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Cash, Cash Equivalents and Restricted Time Deposits The Company considers all highly liquid investments with maturities of three months or less and that are used in the Company’s cash management activities at the date of purchase to be cash equivalents. Cash and cash equivalents also include money market accounts and various deposit accounts. Restricted time deposits include an irrevocable standby letter of credit as security deposit for a long-term property lease with the Company’s landlord. Restricted time deposits as of December 31, 2021 and 2020 totaled $2.1 million and $2.1 million, respectively. As of December 31, 2021 and 2020, a total of $91.2 million and $66.0 million, respectively, of the Company’s cash and cash equivalents was held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. Investments As of December 31, 2021, the Company’s investments consist primarily of diversified bonds, commercial paper, and asset-backed securities. Those investments with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered short-term investments. Those investments with maturities greater than 12 months (365 days) from the balance sheet date are considered long-term investments. When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses for available-for-sale debt investments that are deemed temporary in nature are recorded in accumulated other comprehensive income (loss) as a separate component of stockholder’ equity. Marketable equity securities are equity securities with readily determinable fair value, and are measured and recorded at fair value. Realized and unrealized gains or losses resulting from changes in value and sale of the Company’s marketable equity investments are recorded in other income (expenses) in the consolidated statement of operations. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums and discounts are amortized (accreted) over the life of the related security as an adjustment to its yield. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value (See Note 5, Fair Value Measurements Trade accounts receivable The allowance for doubtful accounts is based on the Company’s assessment of the collectability of customer accounts. The Company makes estimates of expected credit losses for the allowance for doubtful accounts by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, current economic and regulatory conditions that may affect a customer’s ability to pay, and estimates of expected future losses. The Company’s bad debt expense for the years ended December 31, 2021, 2020 and 2019 and the allowance for doubtful accounts as of December 31, 2021 and 2020 were immaterial. Credit losses – Available-for-sale debt securities The Company periodically assesses its available-for-sale investments for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through interest and other, net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through interest and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income. Changes in the allowance for credit losses are recorded as provision for, or reversal of, credit loss expense. Losses are charged against the allowance when the Company believes that an available-for-sale security is confirmed uncollectable or when either of the criteria regarding intent or requirement to sell is met. Inventories Inventories are stated at the lower of cost or net realizable value, on a first-in, first-out, or FIFO, basis. The cost of the Company’s inventories in China is determined using full absorption and standard costing method. The Company reviews the standard cost of raw materials, work-in-process and finished goods annually and more often as appropriate to ensure that its inventories approximate current actual cost. The cost of the Company’s inventories in the U.S. uses actual costs to determine its cost basis. The cost of inventories includes direct material cost, direct labor and manufacturing overhead. When the technical feasibility of the Company’s future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment, the Company capitalizes pre-launch inventory costs prior to regulatory approval. A number of factors are considered, including the status in the validation process in significant jurisdictions, regulatory application and approval process, and terms and condition for future sale of such inventory or future alternative use. The pre-launch inventory cost includes purchase cost of raw materials, cost paid to contract manufacturers for inventory manufacturing, freight and custom charges, and certain direct internal labor and overhead expenses. The Company periodically reviews its inventories to identify obsolete, slow-moving, excess or otherwise unsaleable items. If obsolete, excess or unsaleable items are observed and there are no alternate uses for the inventory, an inventory valuation adjustment is recorded through a charge to cost of goods sold on the Company’s consolidated statements of operations. The establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, requires judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others. Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, machinery and furniture and fixtures are depreciated over three to five years. Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter. Equity method investment - Variable Interest Entity Under the Accounting Standards Codification (“ASC”) 810, Consolidation On an ongoing basis, the Company re-evaluates the VIE assessment based on potential changes in facts and circumstances, including but not limited to, the shareholder loans to the entity and the execution of any future significant agreements between the entity and its shareholders and/or other third parties. Leases The Company determines if an arrangement is or contains a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company reassesses the incremental borrowing rate periodically for application to any new leases or lease modifications, which approximates the rate at which the Company would borrow, on a secured basis, in the country where the lease was executed. For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate, and adjusts the related ROU asset under the lease modification guidance under the ASC 842. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in operating lease ROU assets, operating lease liabilities, current and non-current on the Company’s consolidated balance sheets. Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. The Company’s impairment of long-lived assets for the years ended December 31, 2021, 2020 and 2019 were immaterial. Revenue Recognition Revenues under collaboration agreements The Company’s collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct. Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services. The Company’s process for identifying performance obligations and an enumeration of each obligation for each agreement is outlined in Note 3, Collaboration Agreements, License Agreement and Revenues The Company has identified the following material promises under its collaboration agreements: (1) license of FibroGen technology, (2) the performance of co-development services, including manufacturing of clinical supplies and other services during the development period, and (3) manufacture of commercial supply. The evaluation as to whether these promises are distinct, and therefore represent separate performance obligations, is described in more detail in Note 3, Collaboration Agreements, License Agreement and Revenues For revenue recognition purposes, the Company determines that the terms of its collaboration agreements begin on the effective date and end upon the completion of all performance obligations contained in the agreements. In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the existence of what it considers to be substantive termination penalties on the part of the counterparty create sufficient incentive for the counterparty to avoid exercising its right to terminate the agreement unless in exceptionally rare situations. The transaction price for each collaboration agreement is determined based on the amount of consideration the Company expects to be entitled for satisfying all performance obligations within the agreement. The Company’s collaboration agreements include payments to the Company of one or more of the following: non-refundable upfront license fees; co-development billings; development, regulatory, and commercial milestone payments; payments from sales of active pharmaceutical ingredient (“API”); payments from sales of bulk drug product and royalties on net sales of licensed products. Upfront license fees are non-contingent and non-refundable in nature and are included in the transaction price at the point when the license fees become due to the Company. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration. Determining the reimbursable amount of research and development efforts requires detailed analysis of the terms of the collaboration agreements and the nature of the research and development efforts incurred. Determining the amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, royalty revenue resulting from its collaboration arrangements was immaterial. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 3, Collaboration Agreements, License Agreement and Revenues For each performance obligation identified within an arrangement, the Company determines the period over which the promised services are transferred and the performance obligation is satisfied. Service revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. License revenue Under a license agreement, if the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company uses judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Product revenue, net Product revenue, net consists of revenues from sales of roxadustat commercial product to Falikang, and directly to pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. Falikang is jointly owned by AstraZeneca and FibroGen Beijing. The Company is not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and the Company lacks the power criterion to direct the activities of Falikang (see Note 4, Equity method investment - Variable Interest Entity Sales to Falikang Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang. Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang. Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors. The promises identified under the AstraZeneca China Agreement (as defined in Note 3, Collaboration Agreements, License Agreement and Revenues Collaboration Agreements, License Agreement and Revenues, The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation . Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period. Specifically, the transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which the Company determined it is likely those sales would occur. The price per unit is subject to reassessment on a quarterly basis, which may result in cumulative catch up adjustments due to changes in estimates. The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration: ● Non-refundable upfront license fees; development, regulatory, and commercial milestone payments based on the China Agreement allocated to the China performance obligation; ● Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under the China Agreement; ● Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020; and ● Net transaction price from product sales to Falikang from January 1, 2021 onwards. The net transaction price includes the following elements: o Gross transaction price: The gross transaction price is based on a percentage of Falikang’s net sales to its distributors, which takes into account Falikang’s operating expenses and its payments to AstraZeneca for roxadustat sales and marketing efforts, capped at a percentage of Falikang’s net roxadustat sales. o Profit share: The gross transaction price is then adjusted for an estimated amount to achieve the 50/50 profit share from current period roxadustat net sales in China. The adjustments to date have been a reduction to the transaction price and the related accounts receivable from Falikang. The non-refundable upfront license fees constitute a fixed consideration. The remainder of the above are variable consideration components, which may be constrained, and included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. The calculation of the above variable consideration includes significant assumptions such as total sales quantity, performance period, gross transaction price and profit share, which require a significant judgment. Any net transaction price in excess of the revenue recognized is deferred, and will be recognized over future periods as the performance obligations are satisfied. Direct Sales to Distributors The Company sells roxadustat in China directly to a number of pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. These pharmaceutical distributors are the Company’s customers. Hospitals order roxadustat through a distributor and the Company ships the product directly to the distributors. The delivery of roxadustat to a distributor represents a single performance obligation. Distributors are responsible for delivering product to end users, primarily hospitals. Distributors bear inventory risk once they receive and accept the product. Product revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration that the Company expects to be entitled to in exchange for the product. The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. As such, product revenue is not adjusted for the effects of a significant financing component. Product revenue is recorded at the net sales prices that includes the following estimates of variable consideration: ● Price adjustment: When China’s National Healthcare Security Administration releases price guidance for roxadustat under the National Reimbursement Drug List, any channel inventories that have not been sold through by distributors, or to patients by hospitals and retailers, would be eligible for a price adjustment under the price protection. The price adjustment is calculated based on estimated channel inventory levels; ● Contractual sales rebate: The contractual sales rebate is calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The contractual sales rebate is recorded as a reduction to revenue at the point of sale to the distributor; ● Non-key account hospital listing award: A one-time fixed-amount award is offered to a distributor who successfully lists the product with an eligible hospital, and who meets certain requirements. For the year ended December 31, 2020, the non-key account hospital listing award was capitalized when the distributor meets eligibility requirements, and amortized as reduction to product revenue over future sales orders made by the distributor until exhausted. For the year ended December 31, 2021, the non-key account hospital listing award was immaterial and recorded as a reduction to revenue when distributor meets eligibility requirements; ● Other discounts and rebates, including key account hospital sales rebate and transfer fee discount, are generally based on a percentage of eligible gross sales made by the distributor and recorded as a reduction to revenue at the point of sale to the distributor; and ● Sales returns |
Collaboration Agreements,Licens
Collaboration Agreements,License Agreement and Revenues | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements,License Agreement and Revenues | 3 . Collaboration Agreements, License Agreement and Revenues Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by the Japanese Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. During the fourth quarter of 2020, the Japanese Ministry of Health, Labour and Welfare approved EVRENZO® (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis. This approval triggered a $15.0 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $15.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the fourth quarter of 2020, substantially all of which was recognized as revenue during the year ended December 31, 2020 from performance obligations satisfied or partially satisfied. In September 2019, the Japanese Ministry of Health, Labour and Welfare approved EVRENZO® (generic name: roxadustat; tradename EVRENZO® in Japan) for the treatment of anemia associated with CKD in dialysis patients. This approval triggered a $12.5 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $12.5 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the third quarter of 2019, substantially all of which was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. The aggregate amount of the considerations received under the Japan Agreement, through December 31, 2021 totals $105.1 million, excluding drug product revenue that is discussed separately below. In 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Japan Amendment”). Under this amendment, FibroGen would continue to manufacture and supply roxadustat API Drug Product Revenue Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. During the third quarter of 2021, the European Commission approved EVRENZO ® During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiovascular event (“MACE”) and MACE+ data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for a Marketing Authorization Application (“MAA”) submission to the European Medicines Agency in the second quarter of 2020, following the Company’s NDA submission to the FDA that was accepted for review in February 2020. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during the year ended December 31, 2019 and immaterial amounts for the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments are billable to Astellas upon the submission of an MAA, therefore this $130.0 million was an unbilled contract asset as of December 31, 2019, and billed to Astellas upon the submission of an MAA in the second quarter of 2020 with the total $130.0 million received during the same quarter. The aggregate amount of the considerations received under the Europe Agreement through December 31, 2021 totals $660.0 million, excluding drug product revenue that is discussed separately below. Under the Europe Agreement, Astellas has an option to purchase roxadustat bulk drug product in support of commercial supplies. The Company fulfilled an inventory transfer obligation under the terms of the Europe Agreement in the fourth quarter of 2020. During the first quarter of 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company transferred bulk drug product to Astellas as pre-commercial supply for process validation purposes during the first quarter and commercial product during the fourth quarter of 2021. The Company recognized the related fully burdened manufacturing costs of $1.0 million as drug product revenue during the year ended December 21, 2021, and recorded the consideration of $25.9 million from these inventory transfers as deferred revenue as of December 31, 2021. See details under Drug Product Revenue Accounting for the Astellas Agreements For each of the Astellas agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundles of services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual services. There are no right-of-return provisions for the delivered items in the Astellas agreements. As of December 31, 2021, the transaction price for the Japan Agreement, excluding manufacturing services that is discussed separately below, included $40.1 million of non-contingent upfront payments, $65.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $11.9 million of variable consideration related to co-development billings. The transaction price for the Europe Agreement, excluding manufacturing services that is discussed separately below, included $320.0 million of non-contingent upfront payments, $340.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $219.9 million of variable consideration related to co-development billings. For revenue recognition purposes, the Company determined that the term of each collaboration agreement with Astellas begins on the effective date and ends upon the completion of all performance obligations contained in the agreement. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and loss of product rights, along with non-refundable upfront payments already remitted by Astellas, create significant disincentive for Astellas to exercise its right to terminate the agreements. For the Astellas agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings allocated entirely to co-development services performance obligations. For the technology license under the Japan Agreement and the Europe Agreement, SSP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. SSP also considered certain future royalty payments associated with commercial performance of the Company’s compounds, transfer prices and expected gross margins. The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For both of the Astellas agreements, the license was delivered at the beginning of the agreement term. In both cases, the Company concluded at the time of the agreement that its collaboration partner, Astellas, would have the knowledge and capabilities to fully exploit the licenses without the Company’s further involvement. However, the Japan Agreement has contractual limitations that might affect Astellas’ ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is capable of being distinct. In the Japan Agreement, Astellas does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the agreement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of Astellas to benefit from the license together with other resources readily available to Astellas. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work in either agreement would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Manufacturing rights. In the case of the Japan Agreement, the Company retained manufacturing rights largely because of the way the parties chose for FibroGen to be compensated under the agreement. At the time the agreement was signed, the Company believed that it was more advantageous upon commercialization to have a transfer price revenue model in place as opposed to a traditional sales-based model. The manufacturing process does not require specialized knowledge or expertise uniquely held by FibroGen, and notwithstanding contractual restrictions, Astellas could employ manufacturing services from readily available third parties in order to benefit from the license. Therefore, along with the foregoing paragraph, the Company determined that the license in Japan is a distinct performance obligation despite the retention of manufacturing rights by the Company. In summary, the Company concludes that item (1) represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to Astellas. (2) Co-development services (Europe Agreement). This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is considered distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. Co-development services related to CKD continued over its development period through August 2021. In addition, the Company accounts for the indications related to chemotherapy-induced anemia and myelodysplastic syndromes separately through the end of 2021 and the third quarter of 2024, respectively. There was no provision for co-development services in the Japan Agreement. (3) License to the Company’s technology developed during the term of the agreement and development (referred to as “when and if available”) and information sharing services. These promises are generally satisfied throughout the term of the agreements. (4) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (5) Committee service . This promise is satisfied throughout the course of the agreements as meetings are attended. Items (2)-(5) are bundled into a single performance obligation that is distinct given the fact that all are highly interrelated during the development period (pre-commercial phase of development) such that satisfying them independently is not practicable. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. (6) Manufacturing commercial supplies of products. This promised service is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based payments related predominately to the license of intellectual property under both Astellas agreements. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. Under the Japan Amendment, the drug product revenue represents variable consideration and is estimated based on the quantity of product shipped, actual listed price for roxadustat issued by the Japanese Ministry of Health, Labour and Welfare and possible future changes to the listed price, adjusted for the timing of and estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk drug product tablets, and estimated yield from the manufacture of bulk product tablets, among others. Under the Europe Agreement, the drug product revenue amount represents variable consideration and is estimated based on the quantity of product transferred and an estimated price. The estimated price is based on the contractual transfer price percentage applied on the estimated weighted average net sales price per strength, which is estimated to be realized by Astellas from the end sale of roxadustat in its approved territories. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. Under the U.S./RoW Agreement, the Company and AstraZeneca will equally share in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million (i.e. the Company’s share of development costs is $116.5 million, which was reached in 2015). Development costs incurred by FibroGen during the development period in excess of the $233.0 million (aggregated spend) are fully reimbursed by AstraZeneca. AstraZeneca will pay the Company tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition, the Company will receive a transfer price for shipment of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the combined arrangement in the second quarter of 2019, of which $42.4 million was recognized as revenue during the year ended December 31, 2019 and immaterial amounts were recognized as revenue during the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied. This milestone was fully received in April 2020. The aggregate amount of the considerations received under the U.S./RoW Agreement through December 31, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Commercial Supply Agreement under the U.S./RoW Agreement with AstraZeneca to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to AstraZeneca as commercial supply during 2020, and the first and second quarter of 2021. In August 2021, the FDA Issued a complete response letter regarding roxadustat’s NDA for the treatment of anemia due to CKD in adult patients, stating that it could not be approved in its present form. The Company evaluated the impact of these developments in revising its estimates of variable consideration associated with drug product revenue and updated the estimated transaction price, and recorded $11.2 million as deferred revenue as of December 31, 2021. See details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the China Amendment discussed below in the third quarter of 2020, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period. In December 2019, roxadustat has been included on the updated National Reimbursement Drug List (“NRDL”) released by China’s National Healthcare Security Administration for the treatment of anemia in CKD, covering patients who are non-dialysis dependent as well as those who are dialysis-dependent. The inclusion on the NRDL triggered a total of $22.0 million milestones payable to the Company by AstraZeneca. Accordingly, the total consideration of $22.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the combined arrangement, of which $18.7 million was recognized as revenue during the year ended December 31, 2019. This milestone payment was received during the first quarter of 2020. The Company continued to recognize related revenue during the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied, and the amounts were not material. The aggregate amount of the considerations received for milestone and upfront payments under the China Agreement through December 31, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen Cayman, FibroGen Beijing, and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca (together with FibroGen China, the “Parties”) entered into the China Amendment, effective July 1, 2020, relating to the development and commercialization of roxadustat in China. While the responsibilities of the Parties under the China Agreement remain largely the same, certain changes were made. Under the China Amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. Under the China Amendment, the interim period is defined as the period from April 1, 2020 to the time when Falikang is fully operational. Falikang became fully operational in January 2021. The calculation for profit or loss share related to sales of roxadustat in China has changed for the period from April 1, 2020 onwards. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses incurred by AstraZeneca are calculated and billed. AstraZeneca’s co-promotion expenses for their sales and marketing efforts are now subject to a cap of a percentage of net sales. Once AstraZeneca has been fully reimbursed for their sales and marketing costs under the cap, AstraZeneca will bill the co-promotion expenses based on actual costs on a prospective basis. In addition, the China Amendment has allowed for a higher cost of manufacturing incurred by FibroGen Beijing to be included in the profit or loss share calculation, subject to an annual cap, among other changes. As a result, the interim period during the year ended December 31, 2020 primarily included the following activities: • Co-promotion expenses: The China Amendment revised the payment arrangements and calculation of the historical unpaid co-promotion expenses to AstraZeneca for its sales and marketing efforts associated with the commercial sales for roxadustat in China since the product launch. Under the China Amendment, a portion of the historical unpaid co-promotion expenses was adjusted to reduce the amount owed by FibroGen Beijing and the current period co-promotion expenses are capped at a percentage of net roxadustat sales in China. As a result, in the third quarter of 2020, the Company reversed approximately $84.4 million of previously accrued co-promotion expenses payable, which was recorded as a reduction to selling, general and administrative expenses, where these expenses were initially recorded during the periods from the initiation of commercial activities in the first quarter of 2019 to the second quarter of 2020. The co-promotion expenses for the years ended December 31, 2021 and 2020, capped at a percentage of net roxadustat sales in China, were $4.7 million and $27.2 million, respectively, included in the selling, general and administrative expenses. • Profit share: Profit/loss share between FibroGen Beijing and AstraZeneca is based on a calculation of the current period net roxadustat sales in China and deductible expenses pursuant to the China Agreement. Based on the calculation revised under the China Amendment, profit was achieved during the third and fourth quarter of 2020. As a result, the Company recorded a profit share liability of $7.9 million and $7.0 million to AstraZeneca as of December 31, 2021 and 2020, respectively, in the accrued and other current liabilities, which correspondingly reduced the deferred revenue related to the performance obligation in accordance with the China Agreement. Since Falikang became fully operational in January 2021, substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in a few provinces in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transaction price, which is adjusted for the estimated profit share. In addition, AstraZeneca now bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity. Development costs continue to be shared 50/50 between the Parties. During the year ended December 31, 2021, the Company recognized $35.6 million of net product revenue from the sales to Falikang, as described in details under Product Revenue, Net In addition to sales to Falikang, during the year ended December 31, 2021, the Company recognized $12.1 million of net product revenue from sales directly to distributors in a few provinces in China, as Product Revenue, Net Accounting for the AstraZeneca Agreements The Company evaluated whether the U.S./RoW Agreement and the China Agreement should be accounted for as a single or separate arrangements and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. The key points the Company considered in reaching this conclusion are as follows: 1. While the two agreements were largely negotiated separately, those negotiations proceeded concurrently, and were intended to be completed contemporaneously, presuming AstraZeneca decided to proceed with licenses in all regions available. 2. Throughout negotiations for both agreements, the Company and the counterparties understood and considered the possibility that one arrangement may be executed without the execution of the other arrangement. However, the preference for the Company and the counterparties during the negotiations was to execute both arrangements concurrently. 3. The two agreements were executed as separate agreements because different development, regulatory and commercial approaches required certain terms of the agreements to be structured differently, rather than because the Company or the counterparties considered the agreements to be fundamentally separate negotiations. Accordingly, as the agreements are being accounted for as a single arrangement, upfront and other non-contingent consideration received and to be received has been and will be pooled together and allocated to each of the performance obligations in both the U.S./RoW Agreement and the China Agreement based on their relative SSPs. For each of the AstraZeneca agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundled services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual promised services. There are no right-of-return provisions for the delivered items in the AstraZeneca agreements. As of December 31, 2021, the transaction price for the U.S./RoW Agreement and the China Agreement, excluding manufacturing services that is discussed separately below, included $402.2 million of non-contingent upfront payments, $114.0 million of variable consideration related to payments for milestones considered probable of being achieved, $610.9 million of variable consideration related to co-development billings, offset by $7.0 million of variable consideration related to profit share under the China Amendment. For the AstraZeneca agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings and commercial sale of product. Co-development billings under the U.S./RoW Agreement were allocated entirely to the U.S./RoW co-development services performance obligation, and co-development billings under the China Agreement were allocated entirely to the combined performance obligation under the China Agreement. Commercial sale of product under the U.S./ROW Agreement is entirely allocated to the manufacturing commercial supply of products performance obligation, and commercial sale of product under the China Agreement is allocated entirely to the combined China performance obligation. For revenue recognition purposes, the Company determined that the term s of its collaboration agreements with AstraZeneca begin on the effective date and en |
Equity Method Investment - Vari
Equity Method Investment - Variable Interest Entity | 12 Months Ended |
Dec. 31, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Equity Method Investment - Variable Interest Entity | 4. Falikang is a distribution entity jointly owned by AstraZeneca and FibroGen Beijing. FibroGen Beijing owns 51.1% of the outstanding shares of Falikang. Pursuant to the guidance under ASC 810, the Company concluded that Falikang qualifies as a VIE for U.S. GAAP purposes under ASC 810. As Falikang is a distribution joint venture between FibroGen Beijing and AstraZeneca, and AstraZeneca is the final decision maker for all the roxadustat commercialization activities, the Company lacks the power criterion while AstraZeneca meets both the power and economic criteria under the ASC 810, to direct the activities of Falikang that most significantly impact its performance. Therefore, the Company is not the primary beneficiary of this VIE for U.S. GAAP accounting purposes. As a result, the Company accounts for its investment in Falikang under the equity method, and Falikang is not consolidated into the Company’s consolidated financial statements. Accordingly, the Company records its total investments in Falikang as an equity method investment in an unconsolidated VIE in the consolidated balance sheet. In addition, the Company recognizes its proportionate share of the reported profits or losses of Falikang as investment income (loss) in unconsolidated VIE in the consolidated statement of operations, and as an adjustment to its investment in Falikang in the consolidated balance sheet. Falikang has not incurred material profit or loss to date. The Company may provide shareholder loans to Falikang to meet necessary financial obligations as part of its operations. To date, these loans have been immaterial. The Company’s equity method investment in Falikang was as follows for the year ended December 31, 2021 (in thousands): Entity Ownership Percentage Balance at December 31, 2020 Share of Net Income Currency Translation Balance at December 31, 2021 Falikang 51.1 % $ 2,728 $ 1,007 $ 90 $ 3,825 Falikang is considered as a related party to the Company. See Note 13, Related Party Transactions On an ongoing basis, the Company will re-evaluate the VIE assessment based on changes in facts and circumstances, including but not limited to, the shareholder loans received by Falikang and the execution of any future significant agreements between Falikang and its shareholders and/or other third parties. The Company will assess the impairment of its equity method investment whenever events or changes in circumstances indicate that a decrease in value of the investment has occurred that is other than temporary. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis. The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements. The guidance also requires fair value measurements be classified and disclosed in one of the following three categories: Level 1 : Quoted prices in active markets for identical assets or liabilities. Level 2 : Observable inputs other than quoted prices in active markets for identical assets or liabilities. Level 3 : Unobservable inputs. The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs. The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2). The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The availability of observable data is monitored to assess classification of financial instruments within the fair value hierarchy. Depending upon the availability of such inputs, specific securities may transfer between levels. In such instances, the transfer is reported at the end of the reporting period. The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): December 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 58,801 $ — $ — $ 58,801 Corporate bonds — 182,646 — 182,646 Commercial paper — 69,079 — 69,079 U.S. government bonds 91,522 — — 91,522 Agency bonds — 23,275 — 23,275 Asset-backed securities — 27,087 — 27,087 Foreign government bonds — 9,154 — 9,154 Total $ 150,323 $ 311,241 $ — $ 461,564 December 31, 2020 Level 1 Level 2 Level 3 Total Bond and mutual funds $ — $ 8,144 $ — $ 8,144 Equity investments 244 — — 244 Money market funds 590,347 — — 590,347 Total $ 590,591 $ 8,144 $ — $ 598,735 The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. There were no transfers of assets between levels for the years ended December 31, 2021 and 2020. During the fourth quarter of 2019, there was a $29.8 million transfer of assets from Level 1 to Level 2 as such US treasury notes and bills were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day. The fair value of the Company’s financial liabilities related to lease obligations were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows, which were immaterial as of December 31, 2021 and 2020. There were no transfers of liabilities between levels for the years ended December 31, 2021, 2020 and 2019. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 6. Leases The Company’s long-term property lease with Alexandria for its corporate headquarters in San Francisco, California, had an initial term of 15 years, scheduled to expire in 2023. The original lease was accounted for as a finance lease upon adoption of ASC 842, Leases On June 1, 2021, the Company entered into an amendment with Alexandria to extend the lease to 2028 (“Lease Amendment”). Under the terms of the Lease Amendment, the Company has two optional rights to each extend the lease for an additional five years. The lease contract provides for a fixed annual rent, with scheduled increases of two percent that occur on each anniversary of the rent commencement date through 2023, and with scheduled increases of three percent that occur on each anniversary of the rent commencement date through 2028. This lease requires the Company to pay all costs of ownership, operation, and maintenance of the premises, including without limitation all operating costs, insurance costs, and taxes. Company determined that the Lease Amendment was a lease modification, effective June 1, 2021, and thus reassessed the lease classification, remeasured the related lease liability using an updated discount rate, and adjusted the related right-of-use asset under the lease modification guidance under the ASC 842. Accordingly, on June 1, 2021, the Company determined that the modified lease be accounted for as an operating lease, and therefore derecognized the previous finance lease right-of-use asset of $24.6 million and the related finance lease liability of $32.6 million, and recognized an operating lease right-of-use asset of $93.2 million and the related operating lease liability of $101.2 million. Starting June 1, 2021, the cash payment related to this lease was classified as an operating activity, the impact of which was approximately $7.9 million to the consolidated statement of cash flow for the year ended December 31, 2021. During the first quarter of 2021, after FibroGen Beijing’s previous long-term lease agreement expired, the Company entered into a new lease agreement with the landlord for the same pilot plant located in Beijing Yizhuang Biomedical Park of BDA. The new lease term is five year, scheduled to expire in 2026, and is treated as an operating lease. Accordingly, the Company recorded $3.4 million in the operating right-of-use assets and total operating lease liabilities, respectively. The lease contract provides for fixed quarterly rent payments, and requires the Company to pay operating and maintenance costs. The Company currently has several additional real estate leases for office spaces in Shanghai and Beijing, China, which are treated as operating leases. These leases have lease terms ranging from one to five years, expiring in 2023. These lease contracts provide for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs, and a fixed amount for property management fees. In addition, the Company has several immaterial lease arrangements in China and U.S. for office equipment, scientific devices and automobile leases, with contracted lease terms ranging from one to five years, treated as finance leases or operating leases, respectively. The Company’s lease assets and related lease liabilities were as follows (in thousands): December 31, Balance Sheet Line Item 2021 2020 Assets Finance: Right-of-use assets cost $ 2,165 $ 50,477 Accumulated amortization (1,404 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 761 29,606 Operating: Right-of-use assets cost 100,912 3,934 Accumulated amortization (9,800 ) (1,891 ) Operating lease right-of-use assets, net Operating lease right-of-use assets 91,112 2,043 Total lease assets $ 91,873 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 11 $ 12,330 Operating lease liabilities Operating lease liabilities, current 10,944 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 3 25,391 Operating lease liabilities Operating lease liabilities, non-current 88,776 853 Total lease liabilities $ 99,734 $ 39,762 The components of lease expense were as follows (in thousands): Years Ended December 31, Statement of Operations Line Item 2021 2020 2019 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 4,639 $ 10,369 $ 10,307 Interest on lease liabilities Interest expense 628 1,932 2,373 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 10,722 1,151 891 Sublease income Selling, general and administrative expenses (1,271 ) (1,201 ) (1,385 ) Total lease cost $ 14,718 $ 12,251 $ 12,186 Supplemental cash flow information related to leases were as follows (in thousands): Years Ended December 31, 2021 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 10,022 $ 951 $ 914 Operating cash flows from finance leases 629 1,896 2,196 Financing cash flows from finance leases 5,489 12,620 11,925 Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 450 662 49,909 Operating leases 3,585 1,072 2,736 Non-cash: Increase (decrease) resulting from lease modification: Finance lease right-of-use assets (24,654 ) — — Operating lease right-of-use assets 93,222 — — Finance lease liabilities, current (12,587 ) — — Operating lease liabilities, current 9,221 — — Finance lease liabilities, non-current (20,009 ) — — Operating lease liabilities, non-current $ 91,943 $ — $ — Lease term and discount rate were as follows: December 31, 2021 2020 Weighted-average remaining lease term (years): Finance leases 1.1 2.9 Operating leases 6.8 1.8 Weighted-average discount rate: Finance leases 4.64 % 4.39 % Operating leases 4.75 % 4.74 % Maturities of lease liabilities as of December 31, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2022 $ 12 $ 15,387 2023 3 13,469 2024 — 16,810 2025 — 18,205 2026 — 18,005 Beyond 2026 — 35,877 Total future lease payments 15 117,753 Less: Interest (1 ) (18,033 ) Present value of lease liabilities $ 14 $ 99,720 |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 7. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): December 31, 2021 2020 Cash $ 111,422 $ 88,046 Commercial paper 1,000 — Money market funds 58,801 590,347 Total cash and cash equivalents $ 171,223 $ 678,393 Investments The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 183,136 $ 2 $ (492 ) $ 182,646 Commercial paper 68,079 — — 68,079 U.S. government bonds 91,840 — (318 ) 91,522 Agency bonds 23,339 — (64 ) 23,275 Asset-backed securities 27,105 — (18 ) 27,087 Foreign government bonds 9,165 — (11 ) 9,154 Total investments $ 402,664 $ 2 $ (903 ) $ 401,763 December 31, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Bond and mutual funds $ 8,147 $ — $ (3 ) $ 8,144 Equity investments 125 119 — 244 Total investments $ 8,272 $ 119 $ (3 ) $ 8,388 The contractual maturities of the available-for-sale investments were as follows (in thousands): December 31, 2021 Within one year - Bond and mutual funds $ 233,967 After one year through three years 167,796 Total investments $ 401,763 The Company periodically reviews its available-for-sale investments for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three years ended December 31, 2021, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands): December 31, 2021 2020 Raw materials $ 1,363 $ 2,303 Work-in-progress 21,499 8,114 Finished goods 8,153 6,113 Total inventories $ 31,015 $ 16,530 The Company capitalizes inventory costs for FibroGen Beijing’s production of roxadustat for commercial sales purposes. The Company started capitalizing inventory costs for the U.S. entity in the second quarter of 2020 prior to regulatory approvals in the U.S., Europe and other territories. As of December 31, 2021 and 2020, inventory capitalized for the U.S. entity was 38% and 29% of the total inventory balance, respectively, which will be used for commercial launches in Europe and other territories where the Company has received regulatory approvals. The provision to write-down excess and obsolete inventory was immaterial as of December 31, 2021 and 2020. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Unbilled contract assets $ 66,909 $ 2,147 Deferred revenues from associated contracts (58,909 ) (2,147 ) Net unbilled contract assets 8,000 — Prepaid assets 7,383 8,353 Other current assets 5,070 1,807 Total prepaid expenses and other current assets $ 20,453 $ 10,160 The unbilled contract assets as of December 31, 2021 included $49.8 million related to transfer price true up for bulk drug product under the Europe Agreement with Astellas, $9.1 million related to unbilled co-development revenue under the China Amendment with AstraZeneca, and the $8.0 million unbilled upfront license payment under the Eluminex Agreement. The unbilled contract assets as of December 31, 2020 were related to unbilled co-development revenue under the China Amendment with AstraZeneca. See Note 3, Collaboration Agreements, License Agreement and Revenues Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2021 2020 Leasehold improvements $ 103,352 $ 102,006 Laboratory equipment 19,300 18,143 Machinery 8,339 8,312 Computer equipment 9,670 9,545 Furniture and fixtures 6,201 6,128 Construction in progress 2,423 760 Total property and equipment $ 149,285 $ 144,894 Less: accumulated depreciation (121,008 ) (111,247 ) Property and equipment, net $ 28,277 $ 33,647 Depreciation expense for the years ended December 31, 2021, 2020 and 2019 was $10.2 million, $11.7 million, and $11.1 million, respectively. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Preclinical and clinical trial accruals $ 56,283 $ 44,113 Acquired in-process research and development asset 35,000 — Payroll and related accruals 20,909 22,800 Contract liabilities to pharmaceutical distributors 3,176 15,137 Accrued co-promotion expenses - current 25,746 11,537 Roxadustat profit share to AstraZeneca 7,895 7,007 Property taxes and other taxes 12,610 5,970 Professional services 6,074 4,869 Other 4,895 6,900 Total accrued and other current liabilities $ 172,588 $ 118,333 The acquired IPR&D asset of $35.0 million as of December 31, 2021 was related to the Summary of Significant Accounting Policies - License Acquisition Agreement The profit share liability to AstraZeneca as of December 31, 2021 and 2020 was $7.9 million and $7.0 million, respectively, which represented the profit/loss share between FibroGen Beijing and AstraZeneca that was calculated for the interim period pursuant to the China Amendment. This liability correspondingly reduced the deferred revenue related to the performance obligation in accordance with the China Amendment. Collaboration Agreements, License Agreement and Revenues Other Long-term Liabilities Other long-term liabilities consisted of the following (in thousands): December 31, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 15,236 $ 27,424 Other long-term tax liabilities 9,192 8,675 Other 1,590 2,690 Total other long-term liabilities $ 26,018 $ 38,789 |
Product Development Obligations
Product Development Obligations | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Product Development Obligations | 8. Product Development Obligations The Technology Development Center of the Republic of Finland (“TEKES”) product development obligations consist of 11 separate advances (each in the form of a note agreement) received by FibroGen Europe between 1996 and 2008 from TEKES. These advances are granted on a project-by-project basis to fund various product development efforts undertaken by FibroGen Europe only. Each separate note is denominated in EUR and bears interest (not compounded) calculated as one percentage point less than the Bank of Finland rate in effect at the time of the note, but no less than 3.0%. If the research work funded by TEKES does not result in an economically profitable business or does not meet its technological objectives, TEKES may, on application from FibroGen Europe, forgive each of these loans, including accrued interest, either in full or in part. As of December 31, 2021 and 2020, the Company had U.S. Dollar equivalent of $10.7 million and $11.6 million of principal outstanding, respectively, and $6.9 million and $7.1 million of interest accrued, respectively, which were presented in the product development obligations line on the consolidated balance sheets. The Company is not a guarantor of these loans, and these loans are not repayable by FibroGen Europe until it has distributable funds. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Contract Obligations As of December 31, 2021, the Company had the following outstanding non-cancelable purchase obligations (in thousands): Purchase Obligations Due In The Year Ending December 31, 2022 2023 Total (in thousands) Manufacture and supply of pamrevlumab $ 25,480 $ 19,918 $ 45,398 Manufacture and supply of roxadustat 14,591 3,920 18,511 Other purchases 9,353 — 9,353 Total purchase obligations $ 49,424 $ 23,838 $ 73,262 The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded. Some of the Company’s license agreements provide for periodic maintenance fees over specified time periods, as well as payments by the Company upon the achievement of development, regulatory and commercial milestones. As of December 31, 2021, future milestone payments for research and pre-clinical stage development programs consisted of up to approximately $704.1 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (for Galectin-9 and CCR8), Medarex, Inc. and others. These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones. The event triggering such payment or obligation has not yet occurred. Legal Proceedings and Other Matters From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value), to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any currently active legal action in its consolidated balance sheets as of December 31, 2021, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. In April 2021, three putative securities class action complaints were filed against FibroGen and certain of its current and former executive officers (collectively, the “Defendants”) in the U.S. District Court for the Northern District of California. The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for FDA approval between November 2019 and December 2020. Plaintiffs seek to represent a class of persons or entities that purchased FibroGen securities between November 8, 2019 and April 6, 2021. In May 2021, two additional putative securities class action complaints were filed against Defendants alleging the same claims. One of the lawsuits alleges that Defendants made materially false and misleading statements between October 2017 and December 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between October 18, 2017 and April 6, 2021. The other lawsuit alleges that Defendants made materially false and misleading statements between December 2018 and February 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between December 20, 2018 and April 6, 2021. All plaintiffs seek unspecified monetary damages and other relief. On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs. Plaintiffs filed their consolidated amended complaint on October 29, 2021 and a corrected consolidated amended complaint on November 19, 2021 (the “Complaint”). The Complaint alleges false and misleading statements between December 2018 and June 2021 and seeks to represent a class of persons or entities that purchased FibroGen securities between December 20, 2018 and July 15, 2021. Defendants filed motions to dismiss the Complaint on January 14, 2021. Plaintiffs’ opposition to Defendants’ motions to dismiss is due March 4, 2022 and Defendants’ reply briefs are due April 8, 2022. A hearing on Defendants’ motions to dismiss has been set for April 28, 2022. On July 30, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names as defendants ten of FibroGen’s current and former officers and directors, as well as FibroGen as nominal defendant, and asserts state and federal claims based on some of the same alleged misstatements as the securities class action complaint. The complaint seeks unspecified damages, attorneys’ fees, and other costs. The parties have agreed to stay the action pending resolution of a forthcoming motion to dismiss the securities class action. On December 27, 2021, a second purported shareholder derivative complaint was filed in the U.S. District Court for the District of Delaware. The complaint names seventeen of FibroGen’s current and former officers and directors as defendants , as well as FibroGen as nominal defendant, and asserts state and federal claims based on some of the same alleged misstatements as the securities class action complaint, as well as allegations of insider trading against certain defendants. The complaint seeks unspecified damages, attorneys’ fees, and other costs. Defendants have not been served in the second action. The Company believes that the claims are without merit and it intends to vigorously defend against them. However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against FibroGen or any adverse settlement could materially and adversely impact its business, results of operations, financial condition, and prospects. In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data. The Company is fully cooperating with the SEC. The Company cannot predict with any degree of certainty the outcome of the SEC’s investigation or determine the extent of any potential liabilities. The Company also cannot predict whether there will be any loss as a result of the investigation nor can it provide an estimate of the possible loss or range of loss. Any adverse outcome in this matter or any related proceeding could expose the Company to substantial damages, penalties, or reputational harm that may have a material adverse impact on the Company’s business, results of operations, financial condition, growth prospects, and price of its common stock. Indemnification Agreements The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the estimated fair value of these arrangements is minimal. |
Equity and Stock-based Compensa
Equity and Stock-based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity and Stock-based Compensation | 10. Equity and Stock-based Compensation Common Stock Each share of Common Stock is entitled to one vote. The holders of Common Stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. Shares of Common Stock outstanding, shares of stock plans outstanding and shares reserved for future issuance related to stock options and RSU grants and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2021 2020 Common stock outstanding 92,881 91,441 Stock options outstanding 8,967 9,290 RSUs outstanding 2,304 1,893 Shares reserved for future stock options and RSUs grant 10,253 7,910 Shares reserved for future ESPP offering 4,771 4,070 Total shares of common stock reserved 119,176 114,604 Stock Plans Stock Option and RSU Plans Under the Company’s Amended and Restated 2005 Stock Plan (“2005 Stock Plan”), the Company may issue shares of Common Stock and options to purchase Common Stock and other forms of equity incentives to employees, directors and consultants. Options granted under the 2005 Stock Plan may be incentive stock options or nonqualified stock options. Incentive stock options may be granted only to employees and officers of the Company. Nonqualified stock options and stock purchase rights may be granted to employees, directors and consultants. The board of directors has the authority to determine to whom options will be granted, the number of options, the term and the exercise price. Options are to be granted at an exercise price not less than fair market value for an incentive stock option or a nonqualified stock option. Options generally vest over four years. Options expire no more than 10 years after the date of grant. Upon the effective date of the registration statement related to the Company’s initial public offering, the 2005 Plan was amended to cease the grant of any additional awards thereunder, although the Company will continue to issue common stock upon the exercise of previously granted stock options under the 2005 Plan. In September 2014, the Company adopted a 2014 Equity Incentive Plan (the “2014 Plan”) which became effective on November 13, 2014. The 2014 Plan is the successor equity compensation plan to the 2005 Plan. The 2014 Plan will terminate on November 12, 2024. The 2014 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, stock appreciation rights, performance stock awards, performance cash awards, restricted stock units and other stock awards to employees, directors and consultants. Stock options granted must be at prices not less than 100% of the fair market value at date of grant. Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule (25% vesting on the first anniversary of the vesting base date and quarterly thereafter over the next 3 years). Options generally expire ten years from the date of grant unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant. Unvested options exercised are subject to the Company’s repurchase right. Shares reserved for issuance increases on January 1 of each year commencing on January 1, 2016 and ending on January 1, 2024 by the lesser of (i) the amount equal to 4% of the number of shares issued and outstanding on December 31 immediately prior to the date of increase or (ii) such lower number of shares as may be determined by the board of directors. As of December 31, 2021, the Company has reserved 10,252,944 shares of its common stock that remains unissued for issuance under the 2014 Plan. Issuance of shares upon share option exercise or share unit conversion is made through issuance of new shares authorized under the plan. Certain Common Stock option holders have the right to exercise unvested options, subject to a right held by the Company to repurchase the stock, at the original exercise price, in the event of voluntary or involuntary termination of employment of the stockholder. The shares are generally released from repurchase provisions ratably over four years. The Company accounts for the cash received in consideration for the early exercised options as a liability. At December 31, 2021 and 2020, no shares of Common Stock were subject to repurchase by the Company. Stock option transactions, including forfeited options granted under the 2014 Plan as well as prior plans, are summarized below: Shares (In thousands) Weighted Average Exercise per Share Weighted Average Remaining Contractual Life (In Years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2020 9,290 $ 32.94 Granted 3,452 35.58 Exercised (688 ) 13.89 Expired (1,259 ) 35.40 Forfeited (1,828 ) 34.07 Outstanding at December 31, 2021 8,967 34.84 6.41 $ 2,622 Vested and expected to vest, December 31, 2021 8,535 34.76 6.28 2,460 Exercisable at December 31, 2021 5,241 $ 32.80 4.78 $ 1,408 The total intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019 was $13.1 million, $89.6 million, and $59.2 million, respectively. The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2020 1,893 $ 37.60 Granted 1,808 30.19 Vested (828 ) 37.66 Forfeited (569 ) 42.28 Unvested at December 31, 2021 2,304 $ 30.60 Among the vested RSUs during the year ended December 31, 2021, 538,607 shares were released and issued, while the remaining was withheld for the related payroll taxes. The estimated weighted-average fair value of the awards granted during the years ended December 31, 2021, 2020 and 2019 was $30.19, $29.99 and $54.74, respectively. ESPP In September 2014, the Company adopted a 2014 ESPP that became effective on November 13, 2014. The 2014 ESPP is designed to enable eligible employees to periodically purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan or IRS limitations. At the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last day of the offering period. Purchases are accomplished through participation in discrete offering periods. The 2014 ESPP is intended to qualify as an ESPP under Section 423 of the Internal Revenue Code. The Company has reserved 1,600,000 shares of its common stock for issuance under the 2014 ESPP and shares reserved for issuance increases January 1 of each year commencing January 1, 2016 by the lesser of (i) a number of shares equal to 1% of the total number of outstanding shares of common stock on December 31 immediately prior to the date of increase; (ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors. There were 213,505 shares, 143,876 shares and 135,115 shares purchased by employees under the 2014 Purchased Plan for the years ended December 31, 2021, 2020 and 2019, respectively. The expected term of 2014 ESPP shares is the average of the remaining purchase periods under each offering period. Stock-Based Compensation Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense for the years ended December 31, 2021, 2020 and 2019 was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Research and development $ 40,547 $ 46,229 $ 41,015 Selling, general and administrative 30,614 26,491 25,252 Total stock-based compensation expense $ 71,161 $ 72,720 $ 66,267 The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the Nasdaq Global Select Market on the date of the grant. The fair value of employee stock-based compensation is estimated using the following assumptions: • Expected Term. Expressed as a weighted-average, the expected life of the options is based on the average period the stock options are expected to be outstanding and was based on the Company’s historical information of the option exercise patterns and post-vesting termination behavior as well as contractual terms of the instruments. • Expected Volatility. The Company considers its historical volatility data for volatility considerations for its ESPP. Historically, the expected volatility for all other stock-based compensation was based upon a blend of the Company’s and comparable public entities’ historical volatility. Since the third quarter of 2020, the expected volatility for all other stock-based compensation is currently based upon the Company’s historical volatility data. • Risk-Free Interest Rate. Expressed as a weighted-average, the risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. • Expected Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future. The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows: Years Ended December 31, 2021 2020 2019 Stock Options Expected term (in years) 5.7 5.7 5.3 Expected volatility 61.9 % 67.1 % 68.0 % Risk-free interest rate 0.8 % 0.8 % 2.4 % Expected dividend yield — — — Weighted average estimated fair value $ 20.21 $ 18.36 $ 31.98 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.1 - 104.4 % 47.5 - 77.1 % 48.1 - 62.1 % Risk-free interest rate 0.0 - 2.2 % 0.1 - 2.9 % 1.3 - 2.9 % Expected dividend yield — — — Weighted average estimated fair value $ 12.40 $ 17.53 $ 19.27 As of December 31, 2021, there was $56.4 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period of 2.57 years. As of December 31, 2021, there was $52.3 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested RSUs granted that will be recognized on a straight-line basis over the weighted-average period of 2.29 years. Warrants During the year ended December 31, 2019, a warrant to purchase 4,430 shares of our common stock was exercised and there was no warrant to purchase shares of Common Stock outstanding at December 31, 2021 and 2020. Subsidiary Stock and Non-Controlling Interests FibroGen Europe As of December 31, 2021 and 2020, respectively, FibroGen Europe had a total of 42,619,022 shares of Preferred Stock outstanding, of which there were 1,700,845 shares of Series A Preferred Stock, 1,875,000 shares of Series B Preferred Stock, 1,599,503 shares of Series C Preferred Stock, 1,520,141 shares of Series D Preferred Stock, 459,565 shares of Series E Preferred Stock, 5,714,332 shares of Series F Preferred Stock, 9,927,500 shares of Series G Preferred Stock and 19,822,136 shares of Series H Preferred Stock, all of which shares no longer have any right to be exchanged for FibroGen, Inc. Common Stock. The holders of FibroGen Europe’s shares of Preferred Stock (“Preferred Shares”) have the following rights, preferences and privileges: Dividend Rights — When the assets of FibroGen Europe are distributed (except for distribution in a liquidation), Preferred Shares shall have the same rights to dividend or other forms of distribution as shares of Common Stock of FibroGen Europe. In the event of a merger, holders of Preferred Shares do not have the right to demand FibroGen Europe to redeem all or part of their Preferred Shares. FibroGen Europe may repurchase shares of Common Stock or Preferred Shares for consideration. Pre-emptive Right — Preferred Shares shall have pre-emptive subscription right in accordance with the Finnish Limited Liability Companies Act if additional shares are issued, option rights are given, or convertible loan is taken, , , that the foregoing pre-emptive right does not apply to a directed share issue, for which two thirds (2/3) of the voting shares represented at a general meeting of shareholders approve for an important legitimate cause. Redemption Right — If a Preferred Share can be redeemed by a majority shareholder owning more than ninety percent (90%) of the shares of FibroGen Europe in accordance with the provisions of the Finnish Limited Liability Companies Act, the minority holders of Preferred Shares have the right to request redemption of their shares. Voting Right — Each share has one vote. Preferred Shares have voting rights only in situations that are specifically Conversion Right (1-for-1 basis into Common Stock of FibroGen Europe): • Voluntary conversion right: Preferred Shares can be converted into common shares upon the written request of a shareholder provided that the conversion is feasible within the maximum and minimum amounts of shares of classes of FibroGen Europe as set forth in its Articles of Association. Such request can be withdrawn before the notification of conversion is filed with the Finnish Trade Register. • Compulsory conversion right: Preferred Shares will be converted into common shares if (i) FibroGen Europe’s shares are listed in a stock exchange or other trading system in the European Economic Area, or (ii) FibroGen Europe’s recombinant collagen and gelatin production technology is being put into commercial use in the area of Europe and certain other European states. Commercial use means there is income generated from the first commercial sale of the products incorporating the above-mentioned technology and does not include license fees, development financing, milestone payments or income from test products or equipment used in research. The board of directors of FibroGen Europe shall notify the shareholders of the compulsory conversion in writing, and the shareholders shall request to convert their shares within the timeframe provided in the notification. Should the shareholders fail to make the conversion request within the time limit, FibroGen Europe may redeem the shares of such shareholders. Liquidation Right — In the event of a dissolution of FibroGen Europe, holders of Preferred Shares are entitled to be paid in an amount equal to the subscription price of the shares before any distribution is made to holders of common shares. Among holders of Preferred Shares, holders of shares of Series F Preferred Stock are entitled to be paid in an amount equal to the subscription price of Series F Preferred Stock before any distribution is made to holders of other Preferred Shares. FibroGen Cayman FibroGen Cayman had 6,758,000 Series A Preference Shares outstanding as of December 31, 2021 and 2020, respectively. The holders of the FibroGen Cayman Series A Preference Shares have the following rights, preferences and privileges: Liquidation — In the event of liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, including by means of a merger, the holders of FibroGen Cayman Series A Preference Shares are entitled to be paid an amount equal to the product of the number of shares held by a holder of shares of FibroGen Cayman Series A Preference Shares and the original issue price of $1.00 (subject to equitable adjustment for any stock dividend, combination, split, reclassification, recapitalization) plus all declared and unpaid dividends thereon. Conversion — Each share of FibroGen Cayman Series A Preference Shares is convertible into the number of fully paid and non-assessable shares of Common Stock of FibroGen Cayman that results from dividing the original issue price by the conversion price in effect at the time of the conversion, subject to adjustments for stock splits, stock dividends, reclassifications and like events. The FibroGen Cayman Series A Preference Shares have a conversion price that is equal to the original issuance price such that the conversion ratio to FibroGen Cayman Common Stock is 1:1 as of all periods presented. Voting — The holders of FibroGen Cayman Series A Preference Shares are entitled to vote together with the FibroGen Cayman Common Stockholders on all matters submitted for a vote of the stockholders. The holder of each share of FibroGen Cayman Series A Preference Shares has the number of votes equal to the number of shares of FibroGen Cayman Common Stock into which it is convertible. Dividends — The holders of FibroGen Cayman Series A Preference Shares are entitled to receive cash dividends when and if declared, at a rate of 6%. Non-Controlling Interests Non-controlling interest positions related to the issuance of subsidiary stock as described above are reported as a separate component of consolidated equity from the equity attributable to the Company’s stockholders at December 31, 2021 and 2020. In addition, the Company does not allocate losses to the non-controlling interests as the outstanding shares representing the non-controlling interest do not represent a residual equity interest in the subsidiary. In January 2013, FibroGen Cayman entered into a $0.6 million convertible promissory note. The note bears simple interest at a rate of two percent (2.00%) per annum, accrued on an annual basis in arrears. The outstanding principal balance and unpaid accrued interest on the note is due and payable upon the earlier of (a) the effectiveness of the initial public offering of FibroGen Cayman or (b) the eight year anniversary of the date of the note. As of December 31, 2020, the total outstanding principal balance and accrued interest were $0.7 million and recorded in the other long-term liabilities in the consolidated balance sheets. During the year ended December 31, 2021, at the option of the lender, the $0.7 million total outstanding principal balance and unpaid accrued interest on the note were converted into Series A Preferred Stock of FibroGen Cayman, and was recorded as an addition to the non-controlling interest of the Company. Upon the initial public offering and as described above, all eligible FibroGen Europe preferred shares were exchanged for 958,996 shares of FibroGen Common Stock. No other FibroGen Europe shares have the right to be exchanged for FibroGen, Inc. Common Stock. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. Net Loss Per Share Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. During the years ended December 31, 2021, 2020 and 2019, the Company reported a net loss. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive. Diluted weighted average shares excluded the following potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan for the three years presented as they were anti-dilutive (in thousands): Years Ended December 31, 2021 2020 2019 Employee stock options 8,461 6,694 7,602 RSUs 1,538 564 1,187 ESPP 417 306 260 Warrants — — 1 10,416 7,564 9,050 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 1 2 . Income Taxes The components of loss before income taxes are as follows (in thousands): Years Ended December 31, 2021 2020 2019 Domestic $ (268,499 ) $ (195,617 ) $ 2,538 Foreign (22,184 ) 6,888 (79,180 ) Loss before provision for income taxes $ (290,683 ) $ (188,729 ) $ (76,642 ) The provision for income taxes consists of the following (in thousands): Years Ended December 31, 2021 2020 2019 Current: Federal $ — $ — $ — State — — — Foreign 347 360 328 Total current 347 360 328 Deferred: Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 347 $ 360 $ 328 The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate: Years Ended December 31, 2021 2020 2019 Tax at statutory federal rate 21.0 % 21.0 % 21.0 % State tax — % — % — % Stock-based compensation expense (1.8 )% 2.4 % 6.3 % Benefit due to intercompany transfer of assets — % 41.7 % — % Valuation allowance on intercompany transfer of assets — % (41.7 )% — % Net operating losses not benefitted (16.8 )% (23.2 )% (2.9 )% Foreign net operating losses not benefitted (1.6 )% 0.7 % (21.7 )% Deduction limitation on executive compensation (0.3 )% (0.8 )% (2.5 )% Other (0.6 )% (0.3 )% (0.6 )% Total (0.1 )% (0.2 )% (0.4 )% Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2021 2020 Federal and state net operating loss carryforwards $ 167,135 $ 134,033 Tax credit carryforwards 78,832 62,465 Foreign net operating loss carryforwards 38,117 32,417 Stock-based compensation 10,050 10,399 Lease obligations 20,415 8,243 Reserves and accruals 6,067 5,875 Deferred revenue 20,101 13,550 Intangible assets 84,625 75,915 Other 825 — Subtotal 426,167 342,897 Less: Valuation allowance (409,810 ) (337,824 ) Net deferred tax assets 16,357 5,073 Fixed assets (16,357 ) (5,073 ) Other — — Net deferred tax liabilities (16,357 ) (5,073 ) Total net deferred tax assets $ — $ — A valuation allowance has been provided to reduce the deferred tax assets to an amount management believes is more likely than not to be realized. Expected realization of the deferred tax assets for which a valuation allowance has not been recognized is based on upon the reversal of existing temporary differences and future taxable income. The valuation allowance increased by $72.0 million, $124.0 million and $19.9 million for the years ended December 31, 2021, 2020 and 2019, respectively. Due to uncertainty surrounding the realization of the favorable tax attributes in the future tax returns, the Company has established a valuation allowance against its otherwise recognizable net deferred tax assets. The Company intends to continue maintaining a full valuation allowance on its deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance. However, given the anticipated future foreign earnings, the Company believes that there is a reasonable possibility that within the next 12 months, sufficient positive evidence may become available to reach a conclusion that a portion of the valuation allowance may no longer be needed. Release of the valuation allowance would result in the recognition of certain deferred tax assets and a decrease to income tax expense for the period the release is recorded. The exact timing and amount of the valuation allowance release are subject to change on the basis of the level of profitability that the Company is able to actually achieve. During 2020, the Company transferred certain intellectual property rights relating to its Chinese business between its wholly owned subsidiaries that are based in different tax jurisdictions. The transferor entity was not subject to income taxes in its local jurisdiction. The acquiring entity of the intellectual property is entitled to amortize the acquisition price of the intangible assets for tax purposes. In accordance with ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory At December 31, 2021, the Company had net operating loss carryforwards available to offset future taxable income of approximately $764.1 million and $134.6 million for federal and state tax purposes, respectively. These carryforwards will begin to expire in 2026 for federal and 2022 for state purposes, if not utilized before these dates. The Company also had foreign net operating loss carryforwards of approximately $198.7 million, which expire between 2022 and 2031 if not utilized. At December 31, 2021, the Company had approximately $87.8 million of federal and $36.6 million of California research and development tax credit and other tax credit carryforwards available to offset future taxable income. The federal credits begin to expire in 2022 and the California research credits have no expiration dates. Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change” for tax purposes, as defined in IRC Section 382. The Company reviewed its stock ownership for year ended December 31, 2021 and concluded no ownership changes occurred which would result in a reduction of its net operating loss or in its research and development credits expiring unused. If additional ownership change occurs, the utilization of net operating loss and credit carryforwards could be significantly reduced. Uncertain Tax Positions The Company had unrecognized tax benefits of approximately $57.7 million as of December 31, 2021. Approximately $0.7 million of unrecognized tax benefits, if recognized, would affect the effective tax rate. The interest accrued as of December 31, 2021 and 2020 was immaterial. A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2021 is as follows (in thousands): Federal and State Balance as of December 31, 2018 $ 27,956 Decrease due to prior positions (111 ) Increase due to current year position 4,418 Balance as of December 31, 2019 32,263 Decrease due to prior positions (137 ) Increase due to current year position 16,448 Balance as of December 31, 2020 48,574 Decrease due to prior positions (245 ) Increase due to current year position 8,415 Foreign exchange rate differential 927 Balance as of December 31, 2021 $ 57,671 Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business. The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months that would affect the Company’s effective tax rate. The Company classifies interest and penalties as a component of tax expense, if any. The Company files income tax returns in the U.S. federal jurisdiction, U.S. state and other foreign jurisdictions. The U.S. federal and U.S. state taxing authorities may choose to audit tax returns for tax years beyond the statute of limitation period due to significant tax attribute carryforwards from prior years, making adjustments only to carryforward attributes. The foreign statute of limitation generally remains open from 2012 to 2021. The Company is not currently under audit in any tax jurisdiction. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 1 3 . Related Party Transactions Astellas is an equity investor in the Company and considered a related party. During the years ended December 31, 2021, 2020 and 2019, the Company recorded license and development revenue related to collaboration agreements with Astellas of $130.4 million, $33.5 million, and $158.8 million, respectively. During the years ended December 31, 2021, 2020 and 2019, the Company also recorded drug product revenue from Astellas of $3.2 million, $4.3 million, and $(36.3) million, respectively. See Note 3, Collaboration Agreements, License Agreement and Revenues During the years ended December 31, 2021, 2020 and 2019, the Company recorded expense related to collaboration agreements with Astellas of $0.2 million, $0.5 million and $2.8 million, respectively. As of December 31, 2021 and 2020, accounts receivable from Astellas were $10.9 million and $4.1 million, respectively. As of December 31, 2021 and 2020, total deferred revenue from Astellas were $27.9 million and $7.5 million, respectively. As of December 31, 2021, the amount due to Astellas was immaterial. As of December 31, 2020, amount due to Astellas was $1.1 million. Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company. FibroGen Beijing owns 51.1% of Falikang’s equity. See Note 4, Equity method investment - Variable Interest Entity For the year ended December 31, 2021, the net product revenue from Falikang was $35.6 million. See Note 3, Collaboration Agreements, License Agreement and Revenues For the years ended December 31, 2021 and 2020, the investment income (loss) in Falikang was $1.0 million and $(0.2) million, respectively. As of December 31, 2021 and 2020, the Company’s equity method investment in Falikang was $3.8 million and $2.7 million, respectively. See Note 4, Equity method investment - Variable Interest Entity As of December 31, 2021, accounts receivable, net, from Falikang was zero. As of December 31, 2021, the advanced payment from Falikang, classified as deferred revenue, was $1.2 million. As of December 31, 2021, there was no miscellaneous receivables from Falikang. As of December 31, 2020, prepaid expenses and other current assets included miscellaneous receivables from Falikang of $0.9 million. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Segment and Geographic Information | 1 4 . Segment and Geographic Information The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews financial information presented for the Company’s various clinical trial programs as well as results on a consolidated basis. License revenues and development revenues received are not allocated to various programs for purposes of determining a profit measure and resource allocation decisions are made by the CODM based primarily on consolidated results. As such, the Company has concluded that it operates as one segment. Supplemental enterprise-wide information has been presented below. Geographic Revenues To provide a more meaningful disclosure along with the developments in its business, the Company changed its methodology of summarizing geographic revenues to be by the region that the revenue is generated, from the previously reported by the bill-to region. Accordingly, the information for the year ended December 31, 2020 and 2019 were recalculated. Geographic revenues, which are based on the region that revenue is generated, are as follows (in thousands): Years Ended December 31, 2021 2020 2019 Europe $ 131,243 $ 17,954 $ 145,641 Japan 2,305 19,824 (23,167 ) China 55,640 73,361 20,967 United States 46,121 65,180 113,134 All other — — 2 Total revenue $ 235,309 $ 176,319 $ 256,577 Geographic Assets Geographic information for inventory is as follows (in thousands): December 31, 2021 2020 By geographic location: United States $ 5,522 $ 1,080 China 25,493 15,450 Total inventory $ 31,015 $ 16,530 By inventory ownership: United States $ 11,695 $ 4,715 China 19,320 11,815 Total inventory $ 31,015 $ 16,530 Property and equipment, net by geographic location are as follows (in thousands): December 31, 2021 2020 United States $ 15,002 $ 20,673 China 13,275 12,974 Total property and equipment $ 28,277 $ 33,647 Finance lease right-of-use assets and operating lease right-of-use assets, net by geographic location are as follows (in thousands): December 31, 2021 2020 United States $ 730 $ 29,551 China 31 55 Total finance lease right-of-use assets $ 761 $ 29,606 United States $ 87,113 $ 47 China 3,999 1,996 Total operating lease right-of-use assets $ 91,112 $ 2,043 Customer Concentration The Company’s revenues to date have been generated from the following collaboration partners and distribution entity that respectively accounted for 10% or more of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2021 2020 2019 2021 2020 Astellas—Related party 57 % 21 % 48 % 63 % 10 % AstraZeneca 20 % 37 % 52 % 34 % 26 % Falikang—Related party 15 % — % — % — % — % The Company started selling roxadustat in China since late 2019 through a growing number of pharmaceutical distributors located in China. In January 2021, Falikang became fully operational and substantially all direct product sales to distributors in China were made by Falikang, while FibroGen Beijing continued to sell product directly in a few provinces in China during 2021. The aggregate revenue from FibroGen Beijing’s direct sales to distributors for the year ended December 31, 2021 and the aggregate accounts receivable from direct sales to distributors as of December 31, 2021 were immaterial. For the year ended December 31, 2020, the aggregate revenue from distributors represented 42% of the consolidated revenue, with no individual distributor representing over 10% of the total revenue. As of December 31, 2020, the aggregate accounts receivable from distributors represented 64% of the consolidated accounts receivable, with no material balance from any individual distributor. The aggregate revenue from distributors for the year ended December 31, 2019 and the aggregate accounts receivable from distributors as of December 31, 2019 were immaterial. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2021 | |
Valuation And Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Schedule II: Valuation and Qualifying Accounts (in thousands) Charged Charged to Other Balance at (Credited) Accounts - Beginning of to Statement Liabilities Deductions, Balance at Year of Operation and Equity Net End of Year Valuation allowances for deferred tax assets Year ended December 31, 2021 $ 337,824 $ 71,986 $ — $ — $ 409,810 Year ended December 31, 2020 $ 213,847 $ 123,977 $ — $ — $ 337,824 Year ended December 31, 2019 $ 193,987 $ 19,860 $ — $ — $ 213,847 Allowances for rebates and discounts Year ended December 31, 2021 $ 548 $ 44,258 $ (734 ) $ (29,629 ) $ 14,443 Year ended December 31, 2020 $ 1,102 $ 16,497 $ (14,867 ) $ (2,184 ) $ 548 Year ended December 31, 2019 $ — $ 1,102 $ — $ — $ 1,102 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. (“FibroGen Cayman”). All inter-company transactions and balances have been eliminated in consolidation. For any variable interest entity (“VIE”) for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting. The Company operates in one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications and recalculations had no impact on previously reported financial position, results of operations, or cash flows. |
Foreign Currency Translation | Foreign Currency Translation The reporting currency of the Company and its subsidiaries is the U.S. dollar. The functional currency of FibroGen Europe is the Euro. The assets and liabilities of FibroGen Europe are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Prior to April 1, 2020, the functional currency of the Company’s subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), was the U.S. dollar. On April 1, 2020, FibroGen Beijing adopted CNY as its functional currency based on reassessment of the primary economic operational environment of FibroGen Beijing that is mainly associated with its growing manufacturing and product sales activities conducted in CNY. As such, monetary assets and liabilities of FibroGen Beijing in currencies other than CNY are remeasured using exchange rates in effect at the end of the period. The assets and liabilities of FibroGen Beijing are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. This change in FibroGen Beijing’s functional currency was accounted for prospectively from April 1, 2020, and the prior consolidated financial statements were not restated. The related currency translation adjustment was $ 1.3 million at April 1, 2020 upon adoption. The functional currency of FibroGen, Inc. and all other subsidiaries is the U.S. dollar. Accordingly, monetary assets and liabilities in the non-functional currency of these subsidiaries are remeasured using exchange rates in effect at the end of the period. Revenues and costs in local currency are remeasured using average exchange rates for the period, except for costs related to those balance sheet items that are remeasured using historical exchange rates. The resulting remeasurement gains and losses are included within interest income and other, net in the consolidated statements of operations as incurred and have not been material for all periods presented. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China performance obligation (as defined and discussed under Revenue Recognition |
Concentration of Credit Risk | Concentration of Credit Risk The Company is subject to risks associated with concentration of credit for cash and cash equivalents. Outside of short-term operating needs, the majority of cash on hand is invested in U.S. treasuries and money market funds. Any remaining cash is deposited with major financial institutions in the U.S., Finland, China and the Cayman Islands. At times, such deposits may be in excess of insured limits. The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2021 2020 Astellas Pharma Inc. (“Astellas”)—Related party 63 % 10 % AstraZeneca AB (“AstraZeneca”) 34 % 26 % As of December 31, 2021, the accounts receivable related to roxadustat sales in China from Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”) and direct sales to distributors were not material. As of December 31, 2020, the aggregate accounts receivable related to roxadustat sales in China from distributors represented 64% of the consolidated accounts receivable, with no material balance from any individual distributor. |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. |
Cash, Cash Equivalents and Restricted Time Deposits | Cash, Cash Equivalents and Restricted Time Deposits The Company considers all highly liquid investments with maturities of three months or less and that are used in the Company’s cash management activities at the date of purchase to be cash equivalents. Cash and cash equivalents also include money market accounts and various deposit accounts. Restricted time deposits include an irrevocable standby letter of credit as security deposit for a long-term property lease with the Company’s landlord. Restricted time deposits as of December 31, 2021 and 2020 totaled $2.1 million and $2.1 million, respectively. As of December 31, 2021 and 2020, a total of $91.2 million and $66.0 million, respectively, of the Company’s cash and cash equivalents was held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. |
Investments | Investments As of December 31, 2021, the Company’s investments consist primarily of diversified bonds, commercial paper, and asset-backed securities. Those investments with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered short-term investments. Those investments with maturities greater than 12 months (365 days) from the balance sheet date are considered long-term investments. When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses for available-for-sale debt investments that are deemed temporary in nature are recorded in accumulated other comprehensive income (loss) as a separate component of stockholder’ equity. Marketable equity securities are equity securities with readily determinable fair value, and are measured and recorded at fair value. Realized and unrealized gains or losses resulting from changes in value and sale of the Company’s marketable equity investments are recorded in other income (expenses) in the consolidated statement of operations. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums and discounts are amortized (accreted) over the life of the related security as an adjustment to its yield. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value (See Note 5, Fair Value Measurements |
Trade Accounts Receivable | Trade accounts receivable The allowance for doubtful accounts is based on the Company’s assessment of the collectability of customer accounts. The Company makes estimates of expected credit losses for the allowance for doubtful accounts by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, current economic and regulatory conditions that may affect a customer’s ability to pay, and estimates of expected future losses. The Company’s bad debt expense for the years ended December 31, 2021, 2020 and 2019 and the allowance for doubtful accounts as of December 31, 2021 and 2020 were immaterial. |
Credit Losses – Available-For-Sale Debt Securities | Credit losses – Available-for-sale debt securities The Company periodically assesses its available-for-sale investments for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through interest and other, net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through interest and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income. Changes in the allowance for credit losses are recorded as provision for, or reversal of, credit loss expense. Losses are charged against the allowance when the Company believes that an available-for-sale security is confirmed uncollectable or when either of the criteria regarding intent or requirement to sell is met. |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value, on a first-in, first-out, or FIFO, basis. The cost of the Company’s inventories in China is determined using full absorption and standard costing method. The Company reviews the standard cost of raw materials, work-in-process and finished goods annually and more often as appropriate to ensure that its inventories approximate current actual cost. The cost of the Company’s inventories in the U.S. uses actual costs to determine its cost basis. The cost of inventories includes direct material cost, direct labor and manufacturing overhead. When the technical feasibility of the Company’s future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment, the Company capitalizes pre-launch inventory costs prior to regulatory approval. A number of factors are considered, including the status in the validation process in significant jurisdictions, regulatory application and approval process, and terms and condition for future sale of such inventory or future alternative use. The pre-launch inventory cost includes purchase cost of raw materials, cost paid to contract manufacturers for inventory manufacturing, freight and custom charges, and certain direct internal labor and overhead expenses. The Company periodically reviews its inventories to identify obsolete, slow-moving, excess or otherwise unsaleable items. If obsolete, excess or unsaleable items are observed and there are no alternate uses for the inventory, an inventory valuation adjustment is recorded through a charge to cost of goods sold on the Company’s consolidated statements of operations. The establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, requires judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, machinery and furniture and fixtures are depreciated over three to five years. Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter. |
Equity Method Investment - Variable Interest Entity | Equity method investment - Variable Interest Entity Under the Accounting Standards Codification (“ASC”) 810, Consolidation On an ongoing basis, the Company re-evaluates the VIE assessment based on potential changes in facts and circumstances, including but not limited to, the shareholder loans to the entity and the execution of any future significant agreements between the entity and its shareholders and/or other third parties. |
Leases | Leases The Company determines if an arrangement is or contains a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company reassesses the incremental borrowing rate periodically for application to any new leases or lease modifications, which approximates the rate at which the Company would borrow, on a secured basis, in the country where the lease was executed. For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate, and adjusts the related ROU asset under the lease modification guidance under the ASC 842. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in operating lease ROU assets, operating lease liabilities, current and non-current on the Company’s consolidated balance sheets. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. The Company’s impairment of long-lived assets for the years ended December 31, 2021, 2020 and 2019 were immaterial. |
Revenue Recognition | Revenue Recognition Revenues under collaboration agreements The Company’s collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct. Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services. The Company’s process for identifying performance obligations and an enumeration of each obligation for each agreement is outlined in Note 3, Collaboration Agreements, License Agreement and Revenues The Company has identified the following material promises under its collaboration agreements: (1) license of FibroGen technology, (2) the performance of co-development services, including manufacturing of clinical supplies and other services during the development period, and (3) manufacture of commercial supply. The evaluation as to whether these promises are distinct, and therefore represent separate performance obligations, is described in more detail in Note 3, Collaboration Agreements, License Agreement and Revenues For revenue recognition purposes, the Company determines that the terms of its collaboration agreements begin on the effective date and end upon the completion of all performance obligations contained in the agreements. In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the existence of what it considers to be substantive termination penalties on the part of the counterparty create sufficient incentive for the counterparty to avoid exercising its right to terminate the agreement unless in exceptionally rare situations. The transaction price for each collaboration agreement is determined based on the amount of consideration the Company expects to be entitled for satisfying all performance obligations within the agreement. The Company’s collaboration agreements include payments to the Company of one or more of the following: non-refundable upfront license fees; co-development billings; development, regulatory, and commercial milestone payments; payments from sales of active pharmaceutical ingredient (“API”); payments from sales of bulk drug product and royalties on net sales of licensed products. Upfront license fees are non-contingent and non-refundable in nature and are included in the transaction price at the point when the license fees become due to the Company. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration. Determining the reimbursable amount of research and development efforts requires detailed analysis of the terms of the collaboration agreements and the nature of the research and development efforts incurred. Determining the amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, royalty revenue resulting from its collaboration arrangements was immaterial. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 3, Collaboration Agreements, License Agreement and Revenues For each performance obligation identified within an arrangement, the Company determines the period over which the promised services are transferred and the performance obligation is satisfied. Service revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. License revenue Under a license agreement, if the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company uses judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Product revenue, net Product revenue, net consists of revenues from sales of roxadustat commercial product to Falikang, and directly to pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. Falikang is jointly owned by AstraZeneca and FibroGen Beijing. The Company is not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and the Company lacks the power criterion to direct the activities of Falikang (see Note 4, Equity method investment - Variable Interest Entity Sales to Falikang Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang. Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang. Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors. The promises identified under the AstraZeneca China Agreement (as defined in Note 3, Collaboration Agreements, License Agreement and Revenues Collaboration Agreements, License Agreement and Revenues, The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation . Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period. Specifically, the transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which the Company determined it is likely those sales would occur. The price per unit is subject to reassessment on a quarterly basis, which may result in cumulative catch up adjustments due to changes in estimates. The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration: ● Non-refundable upfront license fees; development, regulatory, and commercial milestone payments based on the China Agreement allocated to the China performance obligation; ● Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under the China Agreement; ● Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020; and ● Net transaction price from product sales to Falikang from January 1, 2021 onwards. The net transaction price includes the following elements: o Gross transaction price: The gross transaction price is based on a percentage of Falikang’s net sales to its distributors, which takes into account Falikang’s operating expenses and its payments to AstraZeneca for roxadustat sales and marketing efforts, capped at a percentage of Falikang’s net roxadustat sales. o Profit share: The gross transaction price is then adjusted for an estimated amount to achieve the 50/50 profit share from current period roxadustat net sales in China. The adjustments to date have been a reduction to the transaction price and the related accounts receivable from Falikang. The non-refundable upfront license fees constitute a fixed consideration. The remainder of the above are variable consideration components, which may be constrained, and included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. The calculation of the above variable consideration includes significant assumptions such as total sales quantity, performance period, gross transaction price and profit share, which require a significant judgment. Any net transaction price in excess of the revenue recognized is deferred, and will be recognized over future periods as the performance obligations are satisfied. Direct Sales to Distributors The Company sells roxadustat in China directly to a number of pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. These pharmaceutical distributors are the Company’s customers. Hospitals order roxadustat through a distributor and the Company ships the product directly to the distributors. The delivery of roxadustat to a distributor represents a single performance obligation. Distributors are responsible for delivering product to end users, primarily hospitals. Distributors bear inventory risk once they receive and accept the product. Product revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration that the Company expects to be entitled to in exchange for the product. The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. As such, product revenue is not adjusted for the effects of a significant financing component. Product revenue is recorded at the net sales prices that includes the following estimates of variable consideration: ● Price adjustment: When China’s National Healthcare Security Administration releases price guidance for roxadustat under the National Reimbursement Drug List, any channel inventories that have not been sold through by distributors, or to patients by hospitals and retailers, would be eligible for a price adjustment under the price protection. The price adjustment is calculated based on estimated channel inventory levels; ● Contractual sales rebate: The contractual sales rebate is calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The contractual sales rebate is recorded as a reduction to revenue at the point of sale to the distributor; ● Non-key account hospital listing award: A one-time fixed-amount award is offered to a distributor who successfully lists the product with an eligible hospital, and who meets certain requirements. For the year ended December 31, 2020, the non-key account hospital listing award was capitalized when the distributor meets eligibility requirements, and amortized as reduction to product revenue over future sales orders made by the distributor until exhausted. For the year ended December 31, 2021, the non-key account hospital listing award was immaterial and recorded as a reduction to revenue when distributor meets eligibility requirements; ● Other discounts and rebates, including key account hospital sales rebate and transfer fee discount, are generally based on a percentage of eligible gross sales made by the distributor and recorded as a reduction to revenue at the point of sale to the distributor; and ● Sales returns: Distributors can request to return product to the Company only due to quality issues or for product purchased within one year prior to the product’s expiration date. The calculation of the above variable consideration is based on gross sales to the distributor, or estimated utilizing best available information from the distributor, maximum known exposures and other available information including estimated channel inventory levels and estimated sales made by the distributor to hospitals, which involve a significant judgment. The above rebates and discounts all together are eligible to be applied against the distributor’s future sales order, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible and in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the liability for rebates and discounts are presented as reductions of gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The distributor’s legal right of offset is calculated at the individual distributor level. Drug product revenue Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca and Astellas in support of pre-commercial preparation prior to the New Drug Application (“NDA”) or Marketing Authorization Application approval, and to Astellas for ongoing commercial launch in Japan and Europe. Drug product revenue is recognized when the Company fulfills the inventory transfer obligations. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment. The Company reviews new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material. Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known. The total amount constrained as of December 31, 2021 was $88.8 million related to the drug product shipments to Astellas and AstraZeneca. As each of the Company’s collaboration agreements provide for annual true up to the considerations paid for its commercial supplies, the Company will re-evaluate the transaction price in each reporting period and record adjustment to revenue as uncertain events are resolved or other changes in circumstances occur. |
License Acquisition Agreement | License Acquisition Agreement In June 2021, the Company entered into an exclusive license and option agreement (the “HiFiBiO Agreement”) with HiFiBiO Therapeutics (“HiFiBiO”), pursuant to which the Company exclusively licensed all product candidates in HiFiBiO’s Galectin-9 program. Pursuant to its option, the Company has also exclusively licensed all product candidates in HiFiBiO’s CCR8 program in December 2021. The Company has declined to exercise its option to HiFiBiO’s CXCR5 program, however, it is pursuing a replacement option program as specified under the HiFiBiO Agreement. Under the terms of the HiFiBiO Agreement, the Company has paid a $25.0 million upfront payment to HiFiBiO during the year ended December 31, 2021, and recorded a $35.0 million upfront payment for the CCR8 option exercise in accrued liabilities as of December 31, 2021, which was paid during the first quarter of 2022. In addition, HiFiBiO may receive up to a total of an additional $1.1 billion in future option, clinical, regulatory, and commercial milestone payments across all three potential programs. HiFiBiO will also be eligible to receive royalties based upon worldwide net sales. The acquisition of these licenses was accounted for as an asset acquisition. The above-mentioned upfront payments of $60.0 million related to the license and options acquisition meets the definition of an in-process research and development asset (“IPR&D asset”) under the ASC 730, Research and Development Contingent consideration payments will be evaluated and recognized when they become probable and reasonably estimable. The related IPR&D asset will only be capitalized if it has an alternative future use other than in a particular research and development project. Otherwise, amounts allocated to IPR&D asset that have no alternative use will be expensed. As of December 31, 2021, all programs were at the early stage of development and the contingencies related to the milestone payments had not been resolved, therefore no contingent consideration was recognized. The Company will reassess the probability of future option payments and contingent payments on a quarterly basis. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of above-mentioned expense for acquired IPR&D asset, independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development costs include employee-related expenses, expenses incurred under agreements with clinical research organizations, other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. All research and development costs are expensed as incurred. |
Clinical Trial Accruals | Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Selling, General and Administrative Expenses | Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services including co-promotional expenses associated with our commercialization efforts in China, recruiting fees and expenses associated with obtaining and maintaining patents. |
Income Taxes | Income Taxes The Company utilizes the asset and liability method of accounting for income taxes, which requires the recognition of deferred tax assets and liabilities for expected future consequences of temporary differences between the financial reporting and income tax bases of assets and liabilities using enacted tax rates. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, the Company must establish a valuation allowance. The calculation of the Company’s current provision for income taxes involves the use of estimates, assumptions and judgments while taking into account current tax laws, interpretation of current tax laws and possible outcomes of future tax audits. The Company has established reserves to address potential exposures related to tax positions that could be challenged by tax authorities. Although the Company believes its estimates, assumptions and judgments to be reasonable, any changes in tax law or its interpretation of tax laws and the resolutions of potential tax audits could significantly impact the amounts provided for income taxes in the Company’s consolidated financial statements. The calculation of the Company’s deferred tax asset balance involves the use of estimates, assumptions and judgments while taking into account estimates of the amounts and type of future taxable income. Actual future operating results and the underlying amount and type of income could differ materially from the Company’s estimates, assumptions and judgments thereby impacting the Company’s financial position and results of operations. During 2020, the Company transferred certain intellectual property rights relating to its Chinese business between its wholly owned subsidiaries that are based in different tax jurisdictions. See Note 12, Income Taxes The accuracy of these estimates could be affected by unforeseen events or actual results, and the sustainability of the Company’s future tax benefits is dependent upon the acceptance of these valuation estimates and assumptions by the taxing authorities. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes The Company includes interest and penalties related to unrecognized tax benefits within income tax expense in the Consolidated Statements of Operations. |
Stock-Based Compensation | Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees and non-employee consultants. Compensation expense relating to non-employee stock options has not been material for all the periods presented. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated Common Stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the Nasdaq Global Select Market on the date of the grant. The fair value of employee stock-based compensation is estimated using the following assumptions: • Expected Term. Expressed as a weighted-average, the expected life of the options is based on the average period the stock options are expected to be outstanding and was based on the Company’s historical information of the option exercise patterns and post-vesting termination behavior as well as contractual terms of the instruments. • Expected Volatility. The Company considers its historical volatility data for volatility considerations for its ESPP. Historically, the expected volatility for all other stock-based compensation was based upon a blend of the Company’s and comparable public entities’ historical volatility. Since the third quarter of 2020, the expected volatility for all other stock-based compensation is currently based upon the Company’s historical volatility data. • Risk-Free Interest Rate. Expressed as a weighted-average, the risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. • Expected Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) The Company is required to report all components of comprehensive income (loss), including net loss, in the consolidated financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation adjustments. Comprehensive gains (losses) have been reflected in the consolidated statements of comprehensive income (loss) for all periods presented. |
Recently Issued and Adopted Accounting Guidance | Recently Issued and Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments-Credit Losses , In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income |
Recently Issued Accounting Guidance Not Yet Adopted | Recently Issued Accounting Guidance Not Yet Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting ASU 2020 - 04 ” , Reference Rate Reform (Topic 848): Scope The Company has certain lease arrangements that are linked to LIBOR. The Company is in the process of evaluating options for transitioning away from LIBOR and expects to complete this analysis by the time LIBOR is phased out. The Company did not elect to apply any of the expedients or exceptions as of and for the year ended 31, 2021 and is currently evaluating the impact on its consolidated financial statements and related disclosures upon adoption of this guidance. |
Collaboration Arrangements and Revenues | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by the Japanese Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. During the fourth quarter of 2020, the Japanese Ministry of Health, Labour and Welfare approved EVRENZO® (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis. This approval triggered a $15.0 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $15.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the fourth quarter of 2020, substantially all of which was recognized as revenue during the year ended December 31, 2020 from performance obligations satisfied or partially satisfied. In September 2019, the Japanese Ministry of Health, Labour and Welfare approved EVRENZO® (generic name: roxadustat; tradename EVRENZO® in Japan) for the treatment of anemia associated with CKD in dialysis patients. This approval triggered a $12.5 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $12.5 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the third quarter of 2019, substantially all of which was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. The aggregate amount of the considerations received under the Japan Agreement, through December 31, 2021 totals $105.1 million, excluding drug product revenue that is discussed separately below. In 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Japan Amendment”). Under this amendment, FibroGen would continue to manufacture and supply roxadustat API Drug Product Revenue Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. During the third quarter of 2021, the European Commission approved EVRENZO ® During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiovascular event (“MACE”) and MACE+ data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for a Marketing Authorization Application (“MAA”) submission to the European Medicines Agency in the second quarter of 2020, following the Company’s NDA submission to the FDA that was accepted for review in February 2020. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during the year ended December 31, 2019 and immaterial amounts for the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments are billable to Astellas upon the submission of an MAA, therefore this $130.0 million was an unbilled contract asset as of December 31, 2019, and billed to Astellas upon the submission of an MAA in the second quarter of 2020 with the total $130.0 million received during the same quarter. The aggregate amount of the considerations received under the Europe Agreement through December 31, 2021 totals $660.0 million, excluding drug product revenue that is discussed separately below. Under the Europe Agreement, Astellas has an option to purchase roxadustat bulk drug product in support of commercial supplies. The Company fulfilled an inventory transfer obligation under the terms of the Europe Agreement in the fourth quarter of 2020. During the first quarter of 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company transferred bulk drug product to Astellas as pre-commercial supply for process validation purposes during the first quarter and commercial product during the fourth quarter of 2021. The Company recognized the related fully burdened manufacturing costs of $1.0 million as drug product revenue during the year ended December 21, 2021, and recorded the consideration of $25.9 million from these inventory transfers as deferred revenue as of December 31, 2021. See details under Drug Product Revenue Accounting for the Astellas Agreements For each of the Astellas agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundles of services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual services. There are no right-of-return provisions for the delivered items in the Astellas agreements. As of December 31, 2021, the transaction price for the Japan Agreement, excluding manufacturing services that is discussed separately below, included $40.1 million of non-contingent upfront payments, $65.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $11.9 million of variable consideration related to co-development billings. The transaction price for the Europe Agreement, excluding manufacturing services that is discussed separately below, included $320.0 million of non-contingent upfront payments, $340.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $219.9 million of variable consideration related to co-development billings. For revenue recognition purposes, the Company determined that the term of each collaboration agreement with Astellas begins on the effective date and ends upon the completion of all performance obligations contained in the agreement. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and loss of product rights, along with non-refundable upfront payments already remitted by Astellas, create significant disincentive for Astellas to exercise its right to terminate the agreements. For the Astellas agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings allocated entirely to co-development services performance obligations. For the technology license under the Japan Agreement and the Europe Agreement, SSP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. SSP also considered certain future royalty payments associated with commercial performance of the Company’s compounds, transfer prices and expected gross margins. The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For both of the Astellas agreements, the license was delivered at the beginning of the agreement term. In both cases, the Company concluded at the time of the agreement that its collaboration partner, Astellas, would have the knowledge and capabilities to fully exploit the licenses without the Company’s further involvement. However, the Japan Agreement has contractual limitations that might affect Astellas’ ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is capable of being distinct. In the Japan Agreement, Astellas does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the agreement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of Astellas to benefit from the license together with other resources readily available to Astellas. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work in either agreement would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Manufacturing rights. In the case of the Japan Agreement, the Company retained manufacturing rights largely because of the way the parties chose for FibroGen to be compensated under the agreement. At the time the agreement was signed, the Company believed that it was more advantageous upon commercialization to have a transfer price revenue model in place as opposed to a traditional sales-based model. The manufacturing process does not require specialized knowledge or expertise uniquely held by FibroGen, and notwithstanding contractual restrictions, Astellas could employ manufacturing services from readily available third parties in order to benefit from the license. Therefore, along with the foregoing paragraph, the Company determined that the license in Japan is a distinct performance obligation despite the retention of manufacturing rights by the Company. In summary, the Company concludes that item (1) represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to Astellas. (2) Co-development services (Europe Agreement). This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is considered distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. Co-development services related to CKD continued over its development period through August 2021. In addition, the Company accounts for the indications related to chemotherapy-induced anemia and myelodysplastic syndromes separately through the end of 2021 and the third quarter of 2024, respectively. There was no provision for co-development services in the Japan Agreement. (3) License to the Company’s technology developed during the term of the agreement and development (referred to as “when and if available”) and information sharing services. These promises are generally satisfied throughout the term of the agreements. (4) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (5) Committee service . This promise is satisfied throughout the course of the agreements as meetings are attended. Items (2)-(5) are bundled into a single performance obligation that is distinct given the fact that all are highly interrelated during the development period (pre-commercial phase of development) such that satisfying them independently is not practicable. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. (6) Manufacturing commercial supplies of products. This promised service is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based payments related predominately to the license of intellectual property under both Astellas agreements. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. Under the Japan Amendment, the drug product revenue represents variable consideration and is estimated based on the quantity of product shipped, actual listed price for roxadustat issued by the Japanese Ministry of Health, Labour and Welfare and possible future changes to the listed price, adjusted for the timing of and estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk drug product tablets, and estimated yield from the manufacture of bulk product tablets, among others. Under the Europe Agreement, the drug product revenue amount represents variable consideration and is estimated based on the quantity of product transferred and an estimated price. The estimated price is based on the contractual transfer price percentage applied on the estimated weighted average net sales price per strength, which is estimated to be realized by Astellas from the end sale of roxadustat in its approved territories. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. Under the U.S./RoW Agreement, the Company and AstraZeneca will equally share in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million (i.e. the Company’s share of development costs is $116.5 million, which was reached in 2015). Development costs incurred by FibroGen during the development period in excess of the $233.0 million (aggregated spend) are fully reimbursed by AstraZeneca. AstraZeneca will pay the Company tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition, the Company will receive a transfer price for shipment of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the combined arrangement in the second quarter of 2019, of which $42.4 million was recognized as revenue during the year ended December 31, 2019 and immaterial amounts were recognized as revenue during the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied. This milestone was fully received in April 2020. The aggregate amount of the considerations received under the U.S./RoW Agreement through December 31, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Commercial Supply Agreement under the U.S./RoW Agreement with AstraZeneca to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to AstraZeneca as commercial supply during 2020, and the first and second quarter of 2021. In August 2021, the FDA Issued a complete response letter regarding roxadustat’s NDA for the treatment of anemia due to CKD in adult patients, stating that it could not be approved in its present form. The Company evaluated the impact of these developments in revising its estimates of variable consideration associated with drug product revenue and updated the estimated transaction price, and recorded $11.2 million as deferred revenue as of December 31, 2021. See details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the China Amendment discussed below in the third quarter of 2020, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period. In December 2019, roxadustat has been included on the updated National Reimbursement Drug List (“NRDL”) released by China’s National Healthcare Security Administration for the treatment of anemia in CKD, covering patients who are non-dialysis dependent as well as those who are dialysis-dependent. The inclusion on the NRDL triggered a total of $22.0 million milestones payable to the Company by AstraZeneca. Accordingly, the total consideration of $22.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the combined arrangement, of which $18.7 million was recognized as revenue during the year ended December 31, 2019. This milestone payment was received during the first quarter of 2020. The Company continued to recognize related revenue during the years ended December 31, 2021 and 2020, from performance obligations satisfied or partially satisfied, and the amounts were not material. The aggregate amount of the considerations received for milestone and upfront payments under the China Agreement through December 31, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen Cayman, FibroGen Beijing, and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca (together with FibroGen China, the “Parties”) entered into the China Amendment, effective July 1, 2020, relating to the development and commercialization of roxadustat in China. While the responsibilities of the Parties under the China Agreement remain largely the same, certain changes were made. Under the China Amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. Under the China Amendment, the interim period is defined as the period from April 1, 2020 to the time when Falikang is fully operational. Falikang became fully operational in January 2021. The calculation for profit or loss share related to sales of roxadustat in China has changed for the period from April 1, 2020 onwards. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses incurred by AstraZeneca are calculated and billed. AstraZeneca’s co-promotion expenses for their sales and marketing efforts are now subject to a cap of a percentage of net sales. Once AstraZeneca has been fully reimbursed for their sales and marketing costs under the cap, AstraZeneca will bill the co-promotion expenses based on actual costs on a prospective basis. In addition, the China Amendment has allowed for a higher cost of manufacturing incurred by FibroGen Beijing to be included in the profit or loss share calculation, subject to an annual cap, among other changes. As a result, the interim period during the year ended December 31, 2020 primarily included the following activities: • Co-promotion expenses: The China Amendment revised the payment arrangements and calculation of the historical unpaid co-promotion expenses to AstraZeneca for its sales and marketing efforts associated with the commercial sales for roxadustat in China since the product launch. Under the China Amendment, a portion of the historical unpaid co-promotion expenses was adjusted to reduce the amount owed by FibroGen Beijing and the current period co-promotion expenses are capped at a percentage of net roxadustat sales in China. As a result, in the third quarter of 2020, the Company reversed approximately $84.4 million of previously accrued co-promotion expenses payable, which was recorded as a reduction to selling, general and administrative expenses, where these expenses were initially recorded during the periods from the initiation of commercial activities in the first quarter of 2019 to the second quarter of 2020. The co-promotion expenses for the years ended December 31, 2021 and 2020, capped at a percentage of net roxadustat sales in China, were $4.7 million and $27.2 million, respectively, included in the selling, general and administrative expenses. • Profit share: Profit/loss share between FibroGen Beijing and AstraZeneca is based on a calculation of the current period net roxadustat sales in China and deductible expenses pursuant to the China Agreement. Based on the calculation revised under the China Amendment, profit was achieved during the third and fourth quarter of 2020. As a result, the Company recorded a profit share liability of $7.9 million and $7.0 million to AstraZeneca as of December 31, 2021 and 2020, respectively, in the accrued and other current liabilities, which correspondingly reduced the deferred revenue related to the performance obligation in accordance with the China Agreement. Since Falikang became fully operational in January 2021, substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in a few provinces in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transaction price, which is adjusted for the estimated profit share. In addition, AstraZeneca now bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity. Development costs continue to be shared 50/50 between the Parties. During the year ended December 31, 2021, the Company recognized $35.6 million of net product revenue from the sales to Falikang, as described in details under Product Revenue, Net In addition to sales to Falikang, during the year ended December 31, 2021, the Company recognized $12.1 million of net product revenue from sales directly to distributors in a few provinces in China, as Product Revenue, Net Accounting for the AstraZeneca Agreements The Company evaluated whether the U.S./RoW Agreement and the China Agreement should be accounted for as a single or separate arrangements and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. The key points the Company considered in reaching this conclusion are as follows: 1. While the two agreements were largely negotiated separately, those negotiations proceeded concurrently, and were intended to be completed contemporaneously, presuming AstraZeneca decided to proceed with licenses in all regions available. 2. Throughout negotiations for both agreements, the Company and the counterparties understood and considered the possibility that one arrangement may be executed without the execution of the other arrangement. However, the preference for the Company and the counterparties during the negotiations was to execute both arrangements concurrently. 3. The two agreements were executed as separate agreements because different development, regulatory and commercial approaches required certain terms of the agreements to be structured differently, rather than because the Company or the counterparties considered the agreements to be fundamentally separate negotiations. Accordingly, as the agreements are being accounted for as a single arrangement, upfront and other non-contingent consideration received and to be received has been and will be pooled together and allocated to each of the performance obligations in both the U.S./RoW Agreement and the China Agreement based on their relative SSPs. For each of the AstraZeneca agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundled services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual promised services. There are no right-of-return provisions for the delivered items in the AstraZeneca agreements. As of December 31, 2021, the transaction price for the U.S./RoW Agreement and the China Agreement, excluding manufacturing services that is discussed separately below, included $402.2 million of non-contingent upfront payments, $114.0 million of variable consideration related to payments for milestones considered probable of being achieved, $610.9 million of variable consideration related to co-development billings, offset by $7.0 million of variable consideration related to profit share under the China Amendment. For the AstraZeneca agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings and commercial sale of product. Co-development billings under the U.S./RoW Agreement were allocated entirely to the U.S./RoW co-development services performance obligation, and co-development billings under the China Agreement were allocated entirely to the combined performance obligation under the China Agreement. Commercial sale of product under the U.S./ROW Agreement is entirely allocated to the manufacturing commercial supply of products performance obligation, and commercial sale of product under the China Agreement is allocated entirely to the combined China performance obligation. For revenue recognition purposes, the Company determined that the term s of its collaboration agreements with AstraZeneca begin on the effective date and end upon the completion of all performance obligations containe |
Product Revenue, Net | Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Direct Sales: Gross revenue $ 13,727 $ 89,027 2,803 Price adjustment (982 ) — (936 ) Non-key account hospital listing award 95 (9,325 ) — Contractual sales rebate (832 ) (6,189 ) (149 ) Other discounts and rebates (21 ) (923 ) (18 ) Sales returns 83 (92 ) — Direct sales revenue, net 12,070 72,498 1,700 Sales to Falikang: Gross transaction price 97,531 — — Profit share (34,759 ) — — Net transaction price 62,772 — — Increase in deferred revenue (27,204 ) — — Sales to Falikang revenue, net 35,568 — — Total product revenue, net $ 47,638 $ 72,498 $ 1,700 Direct Sales Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those products, net of sales rebates and discounts. The total discounts and rebates were $1.7 million, $16.4 million and $1.1 million for the years ended December 31, 2021, 2020 and 2019, respectively. The discounts and rebates for the years ended December 31, 2021 and 2019 primarily consisted of $1.0 million and $0.9 million, respectively, of price adjustments recorded based on government-listed price guidance and estimated channel inventory levels. The discounts and rebates also consisted of the contractual sales rebate calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The contractual sales rebate was $0.8 million, $6.2 million and $0.1 million, respectively, for the years ended December 31, 2021, 2020 and 2019. In addition, in the second quarter of 2020, the Company amended the agreement with its pharmaceutical distributors, which triggered accounting modifications particularly related to the non-key account hospital listing award. For the year ended December 31, 2020, the non-key account hospital listing award was $9.3 million, which was recorded as a reduction to the revenue and calculated based on eligible non-key account hospital listings to date achieved by each distributor with certain requirements met during the period. All other rebates and discounts, including sales return allowance were immaterial for the periods presented. The rebates and discounts that the Company’s pharmaceutical distributors have earned are eligible to be applied against future sales orders, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The Company’s legal right to offset is calculated at the individual distributor level. The following table includes a roll-forward of the related contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at December 31, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (1,371 ) $ 13,645 $ (313 ) $ (3,176 ) As of December 31, 2021 and 2020, the total contract liabilities was $3.2 million and $15.1 million, respectively, which was included in accrued and other current liabilities in the consolidated balance sheet. As of December 31, 2021 and 2020, the total rebates and discounts reflected as reductions to gross accounts receivable for direct sales was $1.1 million and $0.5 million, respectively. Sales to Falikang – China Performance Obligation Since Falikang became fully operational in January 2021, substantially all direct roxadustat product sales to distributors in China are made by Falikang. FibroGen Beijing manufactures and supplies commercial product to Falikang. The net transaction price for FibroGen Beijing’s product sales to Falikang is based on a gross transaction price, which is adjusted to account for the 50/50 profit share for the period. The roxadustat sales to Falikang marked the beginning of the Company’s China performance obligation under the Company’s agreements with AstraZeneca . Product revenue is based on the transaction price of the China performance obligation. Revenue is recognized when control of the product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period . Any net transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligations are satisfied . During the year ended December 31, 2021, following updates to its estimates, the Company deferred $27.2 million from the net transaction price to Falikang, which was included in the related deferred revenue of the China performance obligation. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at December 31, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (69,746 ) $ 35,568 $ (171,516 ) Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca. As of December 31, 2021, approximately $10.6 million of the deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China. The reductions to gross accounts receivable related to product revenue to Falikang was $13.4 million as of December 31, 2021. |
Drug Product Revenue | Drug Product Revenue Drug product revenue was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Astellas $ 3,186 $ 4,281 $ (36,324 ) AstraZeneca (2,224 ) 4,625 — Drug product revenue $ 962 $ 8,906 $ (36,324 ) During the second quarter of 2020, the Company fulfilled shipment obligations under the terms of Japan Amendment with Astellas, and recognized related drug product revenue of $8.2 million in the same period. During the years ended December 31, 2021, 2020 and 2019, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018 and 2020, and recorded an adjustment to the drug product revenue of $2.1 million, $(4.0) million and $(36.3) million for the years ended December 31, 2021, 2020 and 2019, respectively. Specifically, the change in estimated variable consideration was based on the API held by Astellas at the period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk product tablets, and estimated yield from the manufacture of bulk product tablets, among others. During the fourth quarter of 2021, the Company transferred bulk drug product for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas, and recognized the related fully burdened manufacturing costs of $1.0 million as drug product revenue, and recorded $8.3 million as deferred revenue as of December 31, 2021, due to a high degree of uncertainty associated with the final consideration. During the first quarter of 2021, the Company transferred bulk drug product from process validation supplies for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas. The Company recorded the consideration of $11.8 million from this inventory transfer as deferred revenue as of December 31, 2021, due to a high degree of uncertainty associated with the final consideration. During the fourth quarter of 2020, the Company transferred bulk drug product from process validation supplies for commercial purposes under the terms of the Europe Agreement with Astellas. As a result, the Company recorded $6.0 million as deferred revenue as of December 31, 2020, due to a high degree of uncertainty associated with the final consideration. The Company recognized royalty revenue of $0.2 million from this deferred revenue during the year ended December 31, 2021. The remainder of the deferred revenue will be recognized as and when uncertainty is resolved. During the fourth quarter of 2021, the Company updated its estimate of variable consideration related to the bulk drug product inventory transfers fulfilled under the terms of the Europe Agreement and the EU Supply Agreement with Astellas, and recorded an unbilled contract asset of $49.8 million, which was offset by related deferred revenue under the Europe Agreement and EU Supply Agreement. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, among others. During the first half of 2021 and during the year ended December 31, 2020, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement. Based on the complete response letter issued by the FDA in August 2021, the Company evaluated the impact of these developments in revising its estimates of variable consideration associated with drug product revenue. As a result, the Company updated the estimated transaction price for these shipments, and recorded $11.2 million as deferred revenue as of December 31, 2021. The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance Presented Net Against Contract Asset Balance at December 31, 2021 Astellas - Japan Agreement $ — $ (1,974 ) $ — $ — $ (1,974 ) Astellas - Europe Agreement (5,984 ) (69,874 ) 179 49,788 (25,891 ) AstraZeneca - U.S. Agreement — (11,171 ) — — (11,171 ) Drug product revenue - deferred revenue $ (5,984 ) $ (83,019 ) $ 179 $ 49,788 $ (39,036 ) |
Fair Value Measurements | Fair Value Measurements In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis. The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements. The guidance also requires fair value measurements be classified and disclosed in one of the following three categories: Level 1 : Quoted prices in active markets for identical assets or liabilities. Level 2 : Observable inputs other than quoted prices in active markets for identical assets or liabilities. Level 3 : Unobservable inputs. The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs. The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2). The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The availability of observable data is monitored to assess classification of financial instruments within the fair value hierarchy. Depending upon the availability of such inputs, specific securities may transfer between levels. In such instances, the transfer is reported at the end of the reporting period. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Significant Balance of Accounts Receivable | The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2021 2020 Astellas Pharma Inc. (“Astellas”)—Related party 63 % 10 % AstraZeneca AB (“AstraZeneca”) 34 % 26 % |
Collaboration Agreements,Lice_2
Collaboration Agreements,License Agreement and Revenues (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Direct Sales: Gross revenue $ 13,727 $ 89,027 2,803 Price adjustment (982 ) — (936 ) Non-key account hospital listing award 95 (9,325 ) — Contractual sales rebate (832 ) (6,189 ) (149 ) Other discounts and rebates (21 ) (923 ) (18 ) Sales returns 83 (92 ) — Direct sales revenue, net 12,070 72,498 1,700 Sales to Falikang: Gross transaction price 97,531 — — Profit share (34,759 ) — — Net transaction price 62,772 — — Increase in deferred revenue (27,204 ) — — Sales to Falikang revenue, net 35,568 — — Total product revenue, net $ 47,638 $ 72,498 $ 1,700 |
Summary of Amounts Recognized as Revenue | Amounts recognized as revenue under the Eluminex were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2021 2020 2019 Eluminex License revenue $ 8,000 $ — $ — |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the related contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at December 31, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (1,371 ) $ 13,645 $ (313 ) $ (3,176 ) |
Schedule of Drug Product Revenue | Drug product revenue was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Astellas $ 3,186 $ 4,281 $ (36,324 ) AstraZeneca (2,224 ) 4,625 — Drug product revenue $ 962 $ 8,906 $ (36,324 ) |
AstraZeneca Agreements [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at December 31, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (69,746 ) $ 35,568 $ (171,516 ) |
Drug Product Revenue [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance Presented Net Against Contract Asset Balance at December 31, 2021 Astellas - Japan Agreement $ — $ (1,974 ) $ — $ — $ (1,974 ) Astellas - Europe Agreement (5,984 ) (69,874 ) 179 49,788 (25,891 ) AstraZeneca - U.S. Agreement — (11,171 ) — — (11,171 ) Drug product revenue - deferred revenue $ (5,984 ) $ (83,019 ) $ 179 $ 49,788 $ (39,036 ) |
Japan [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2021 2020 2019 Japan License revenue $ — $ 14,323 $ 11,935 Development revenue $ 248 $ 1,220 $ 1,222 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through December 31, 2021 Deferred Revenue at December 31, 2021 Total Consideration Through December 31, 2021 License $ 100,347 $ — $ 100,347 Development revenue 16,598 — 16,598 Total license and development revenue $ 116,945 $ — $ 116,945 |
Europe [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2021 2020 2019 Europe License revenue $ 108,434 $ — $ 117,470 Development revenue $ 21,679 $ 17,954 $ 28,172 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through December 31, 2021 Deferred Revenue at December 31, 2021 Total Consideration Through December 31, 2021 License $ 596,385 $ — $ 596,385 Development revenue 270,641 — 270,641 Total license and development revenue $ 867,026 $ — $ 867,026 |
U.S./RoW and China [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the U.S./RoW and China Agreements with AstraZeneca were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2021 2020 2019 U.S. / RoW and China License revenue $ — $ — $ 47,681 Development revenue 48,345 61,508 84,629 China performance obligation $ — $ (90 ) $ 90 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through December 31, 2021 Deferred Revenue at December 31, 2021 Total Consideration Through December 31, 2021 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 603,119 — 603,119 China performance obligation * 35,568 171,516 207,084 Total license and development revenue $ 980,531 $ 171,516 ** $ 1,152,047 * China performance obligation revenue is recognized as product revenue, as described in details under Product Revenue, Net * * Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of December 31, 2021, deferred revenue included $162.4 million related to the U.S./RoW and China Agreement, which represents the net of $171.5 million of deferred revenue presented above and a $9.1 million unbilled co-development revenue under the China Amendment with AstraZeneca. |
Equity Method Investment - Va_2
Equity Method Investment - Variable Interest Entity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Summary of Equity Method Investment | The Company’s equity method investment in Falikang was as follows for the year ended December 31, 2021 (in thousands): Entity Ownership Percentage Balance at December 31, 2020 Share of Net Income Currency Translation Balance at December 31, 2021 Falikang 51.1 % $ 2,728 $ 1,007 $ 90 $ 3,825 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): December 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 58,801 $ — $ — $ 58,801 Corporate bonds — 182,646 — 182,646 Commercial paper — 69,079 — 69,079 U.S. government bonds 91,522 — — 91,522 Agency bonds — 23,275 — 23,275 Asset-backed securities — 27,087 — 27,087 Foreign government bonds — 9,154 — 9,154 Total $ 150,323 $ 311,241 $ — $ 461,564 December 31, 2020 Level 1 Level 2 Level 3 Total Bond and mutual funds $ — $ 8,144 $ — $ 8,144 Equity investments 244 — — 244 Money market funds 590,347 — — 590,347 Total $ 590,591 $ 8,144 $ — $ 598,735 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Lease Assets and Related Lease Liabilities | The Company’s lease assets and related lease liabilities were as follows (in thousands): December 31, Balance Sheet Line Item 2021 2020 Assets Finance: Right-of-use assets cost $ 2,165 $ 50,477 Accumulated amortization (1,404 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 761 29,606 Operating: Right-of-use assets cost 100,912 3,934 Accumulated amortization (9,800 ) (1,891 ) Operating lease right-of-use assets, net Operating lease right-of-use assets 91,112 2,043 Total lease assets $ 91,873 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 11 $ 12,330 Operating lease liabilities Operating lease liabilities, current 10,944 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 3 25,391 Operating lease liabilities Operating lease liabilities, non-current 88,776 853 Total lease liabilities $ 99,734 $ 39,762 |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Years Ended December 31, Statement of Operations Line Item 2021 2020 2019 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 4,639 $ 10,369 $ 10,307 Interest on lease liabilities Interest expense 628 1,932 2,373 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 10,722 1,151 891 Sublease income Selling, general and administrative expenses (1,271 ) (1,201 ) (1,385 ) Total lease cost $ 14,718 $ 12,251 $ 12,186 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Years Ended December 31, 2021 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 10,022 $ 951 $ 914 Operating cash flows from finance leases 629 1,896 2,196 Financing cash flows from finance leases 5,489 12,620 11,925 Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 450 662 49,909 Operating leases 3,585 1,072 2,736 Non-cash: Increase (decrease) resulting from lease modification: Finance lease right-of-use assets (24,654 ) — — Operating lease right-of-use assets 93,222 — — Finance lease liabilities, current (12,587 ) — — Operating lease liabilities, current 9,221 — — Finance lease liabilities, non-current (20,009 ) — — Operating lease liabilities, non-current $ 91,943 $ — $ — |
Schedule of Lease Term and Discount Rate | Lease term and discount rate were as follows: December 31, 2021 2020 Weighted-average remaining lease term (years): Finance leases 1.1 2.9 Operating leases 6.8 1.8 Weighted-average discount rate: Finance leases 4.64 % 4.39 % Operating leases 4.75 % 4.74 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities as of December 31, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2022 $ 12 $ 15,387 2023 3 13,469 2024 — 16,810 2025 — 18,205 2026 — 18,005 Beyond 2026 — 35,877 Total future lease payments 15 117,753 Less: Interest (1 ) (18,033 ) Present value of lease liabilities $ 14 $ 99,720 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): December 31, 2021 2020 Cash $ 111,422 $ 88,046 Commercial paper 1,000 — Money market funds 58,801 590,347 Total cash and cash equivalents $ 171,223 $ 678,393 |
Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Investments | The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 183,136 $ 2 $ (492 ) $ 182,646 Commercial paper 68,079 — — 68,079 U.S. government bonds 91,840 — (318 ) 91,522 Agency bonds 23,339 — (64 ) 23,275 Asset-backed securities 27,105 — (18 ) 27,087 Foreign government bonds 9,165 — (11 ) 9,154 Total investments $ 402,664 $ 2 $ (903 ) $ 401,763 December 31, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Bond and mutual funds $ 8,147 $ — $ (3 ) $ 8,144 Equity investments 125 119 — 244 Total investments $ 8,272 $ 119 $ (3 ) $ 8,388 |
Summary of Contractual Maturities of Available-for-Sale Investments | The contractual maturities of the available-for-sale investments were as follows (in thousands): December 31, 2021 Within one year - Bond and mutual funds $ 233,967 After one year through three years 167,796 Total investments $ 401,763 |
Schedule of Inventory | Inventories consisted of the following (in thousands): December 31, 2021 2020 Raw materials $ 1,363 $ 2,303 Work-in-progress 21,499 8,114 Finished goods 8,153 6,113 Total inventories $ 31,015 $ 16,530 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Unbilled contract assets $ 66,909 $ 2,147 Deferred revenues from associated contracts (58,909 ) (2,147 ) Net unbilled contract assets 8,000 — Prepaid assets 7,383 8,353 Other current assets 5,070 1,807 Total prepaid expenses and other current assets $ 20,453 $ 10,160 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2021 2020 Leasehold improvements $ 103,352 $ 102,006 Laboratory equipment 19,300 18,143 Machinery 8,339 8,312 Computer equipment 9,670 9,545 Furniture and fixtures 6,201 6,128 Construction in progress 2,423 760 Total property and equipment $ 149,285 $ 144,894 Less: accumulated depreciation (121,008 ) (111,247 ) Property and equipment, net $ 28,277 $ 33,647 |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Preclinical and clinical trial accruals $ 56,283 $ 44,113 Acquired in-process research and development asset 35,000 — Payroll and related accruals 20,909 22,800 Contract liabilities to pharmaceutical distributors 3,176 15,137 Accrued co-promotion expenses - current 25,746 11,537 Roxadustat profit share to AstraZeneca 7,895 7,007 Property taxes and other taxes 12,610 5,970 Professional services 6,074 4,869 Other 4,895 6,900 Total accrued and other current liabilities $ 172,588 $ 118,333 |
Schedule of Other Long-term Liabilities | Other long-term liabilities consisted of the following (in thousands): December 31, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 15,236 $ 27,424 Other long-term tax liabilities 9,192 8,675 Other 1,590 2,690 Total other long-term liabilities $ 26,018 $ 38,789 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Outstanding Non-cancelable Purchase Obligations | As of December 31, 2021, the Company had the following outstanding non-cancelable purchase obligations (in thousands): Purchase Obligations Due In The Year Ending December 31, 2022 2023 Total (in thousands) Manufacture and supply of pamrevlumab $ 25,480 $ 19,918 $ 45,398 Manufacture and supply of roxadustat 14,591 3,920 18,511 Other purchases 9,353 — 9,353 Total purchase obligations $ 49,424 $ 23,838 $ 73,262 |
Equity and Stock-based Compen_2
Equity and Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | Shares of Common Stock outstanding, shares of stock plans outstanding and shares reserved for future issuance related to stock options and RSU grants and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2021 2020 Common stock outstanding 92,881 91,441 Stock options outstanding 8,967 9,290 RSUs outstanding 2,304 1,893 Shares reserved for future stock options and RSUs grant 10,253 7,910 Shares reserved for future ESPP offering 4,771 4,070 Total shares of common stock reserved 119,176 114,604 |
Summary of Stock Option Transactions | Stock option transactions, including forfeited options granted under the 2014 Plan as well as prior plans, are summarized below: Shares (In thousands) Weighted Average Exercise per Share Weighted Average Remaining Contractual Life (In Years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2020 9,290 $ 32.94 Granted 3,452 35.58 Exercised (688 ) 13.89 Expired (1,259 ) 35.40 Forfeited (1,828 ) 34.07 Outstanding at December 31, 2021 8,967 34.84 6.41 $ 2,622 Vested and expected to vest, December 31, 2021 8,535 34.76 6.28 2,460 Exercisable at December 31, 2021 5,241 $ 32.80 4.78 $ 1,408 |
Summary of RSU Activity | The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2020 1,893 $ 37.60 Granted 1,808 30.19 Vested (828 ) 37.66 Forfeited (569 ) 42.28 Unvested at December 31, 2021 2,304 $ 30.60 |
Schedule of Recorded Stock-Based Compensation Expense | Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense for the years ended December 31, 2021, 2020 and 2019 was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Research and development $ 40,547 $ 46,229 $ 41,015 Selling, general and administrative 30,614 26,491 25,252 Total stock-based compensation expense $ 71,161 $ 72,720 $ 66,267 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Employee Stock Purchase Plans | The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows: Years Ended December 31, 2021 2020 2019 Stock Options Expected term (in years) 5.7 5.7 5.3 Expected volatility 61.9 % 67.1 % 68.0 % Risk-free interest rate 0.8 % 0.8 % 2.4 % Expected dividend yield — — — Weighted average estimated fair value $ 20.21 $ 18.36 $ 31.98 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.1 - 104.4 % 47.5 - 77.1 % 48.1 - 62.1 % Risk-free interest rate 0.0 - 2.2 % 0.1 - 2.9 % 1.3 - 2.9 % Expected dividend yield — — — Weighted average estimated fair value $ 12.40 $ 17.53 $ 19.27 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Weighted Impacts of Outstanding Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. During the years ended December 31, 2021, 2020 and 2019, the Company reported a net loss. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive. Diluted weighted average shares excluded the following potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan for the three years presented as they were anti-dilutive (in thousands): Years Ended December 31, 2021 2020 2019 Employee stock options 8,461 6,694 7,602 RSUs 1,538 564 1,187 ESPP 417 306 260 Warrants — — 1 10,416 7,564 9,050 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Loss Before Income Taxes | The components of loss before income taxes are as follows (in thousands): Years Ended December 31, 2021 2020 2019 Domestic $ (268,499 ) $ (195,617 ) $ 2,538 Foreign (22,184 ) 6,888 (79,180 ) Loss before provision for income taxes $ (290,683 ) $ (188,729 ) $ (76,642 ) |
Schedule of Components of Provision For Income Taxes | The provision for income taxes consists of the following (in thousands): Years Ended December 31, 2021 2020 2019 Current: Federal $ — $ — $ — State — — — Foreign 347 360 328 Total current 347 360 328 Deferred: Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 347 $ 360 $ 328 |
Schedule of Reconciliation Between Statutory Federal Income Tax Rate and Effective Tax Rate | The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate: Years Ended December 31, 2021 2020 2019 Tax at statutory federal rate 21.0 % 21.0 % 21.0 % State tax — % — % — % Stock-based compensation expense (1.8 )% 2.4 % 6.3 % Benefit due to intercompany transfer of assets — % 41.7 % — % Valuation allowance on intercompany transfer of assets — % (41.7 )% — % Net operating losses not benefitted (16.8 )% (23.2 )% (2.9 )% Foreign net operating losses not benefitted (1.6 )% 0.7 % (21.7 )% Deduction limitation on executive compensation (0.3 )% (0.8 )% (2.5 )% Other (0.6 )% (0.3 )% (0.6 )% Total (0.1 )% (0.2 )% (0.4 )% |
Schedule of Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2021 2020 Federal and state net operating loss carryforwards $ 167,135 $ 134,033 Tax credit carryforwards 78,832 62,465 Foreign net operating loss carryforwards 38,117 32,417 Stock-based compensation 10,050 10,399 Lease obligations 20,415 8,243 Reserves and accruals 6,067 5,875 Deferred revenue 20,101 13,550 Intangible assets 84,625 75,915 Other 825 — Subtotal 426,167 342,897 Less: Valuation allowance (409,810 ) (337,824 ) Net deferred tax assets 16,357 5,073 Fixed assets (16,357 ) (5,073 ) Other — — Net deferred tax liabilities (16,357 ) (5,073 ) Total net deferred tax assets $ — $ — |
Schedule of Reconciliation of the Beginning and Ending Amounts of Unrecognized Income Tax Benefits | A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2021 is as follows (in thousands): Federal and State Balance as of December 31, 2018 $ 27,956 Decrease due to prior positions (111 ) Increase due to current year position 4,418 Balance as of December 31, 2019 32,263 Decrease due to prior positions (137 ) Increase due to current year position 16,448 Balance as of December 31, 2020 48,574 Decrease due to prior positions (245 ) Increase due to current year position 8,415 Foreign exchange rate differential 927 Balance as of December 31, 2021 $ 57,671 |
Segment and Geographic Inform_2
Segment and Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Schedule of Revenue by Geographic Area | To provide a more meaningful disclosure along with the developments in its business, the Company changed its methodology of summarizing geographic revenues to be by the region that the revenue is generated, from the previously reported by the bill-to region. Accordingly, the information for the year ended December 31, 2020 and 2019 were recalculated. Geographic revenues, which are based on the region that revenue is generated, are as follows (in thousands): Years Ended December 31, 2021 2020 2019 Europe $ 131,243 $ 17,954 $ 145,641 Japan 2,305 19,824 (23,167 ) China 55,640 73,361 20,967 United States 46,121 65,180 113,134 All other — — 2 Total revenue $ 235,309 $ 176,319 $ 256,577 |
Schedule of Inventory by Geographic Area | Geographic information for inventory is as follows (in thousands): December 31, 2021 2020 By geographic location: United States $ 5,522 $ 1,080 China 25,493 15,450 Total inventory $ 31,015 $ 16,530 By inventory ownership: United States $ 11,695 $ 4,715 China 19,320 11,815 Total inventory $ 31,015 $ 16,530 |
Schedule of Long Lived Assets by Geographic Area | Property and equipment, net by geographic location are as follows (in thousands): December 31, 2021 2020 United States $ 15,002 $ 20,673 China 13,275 12,974 Total property and equipment $ 28,277 $ 33,647 |
Summary of Finance and Operating Lease Right of Use Assets by Geographical Location | Finance lease right-of-use assets and operating lease right-of-use assets, net by geographic location are as follows (in thousands): December 31, 2021 2020 United States $ 730 $ 29,551 China 31 55 Total finance lease right-of-use assets $ 761 $ 29,606 United States $ 87,113 $ 47 China 3,999 1,996 Total operating lease right-of-use assets $ 91,112 $ 2,043 |
Schedule of Customer Concentration by Collaboration Partners and Distribution Entity | The Company’s revenues to date have been generated from the following collaboration partners and distribution entity that respectively accounted for 10% or more of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2021 2020 2019 2021 2020 Astellas—Related party 57 % 21 % 48 % 63 % 10 % AstraZeneca 20 % 37 % 52 % 34 % 26 % Falikang—Related party 15 % — % — % — % — % |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Jun. 16, 2021USD ($) | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Apr. 01, 2020USD ($) | Jan. 01, 2019USD ($) |
Accounting Policy [Line Items] | |||||
Number of operating segment | Segment | 1 | ||||
Currency translation adjustment | $ 1,300,000 | ||||
Highly liquid investment maturity period | three months or less | ||||
Restricted time deposits | $ 2,100,000 | $ 2,100,000 | |||
Cash and cash equivalents | $ 171,223,000 | 678,393,000 | |||
Short term investments maturity | 12 months | ||||
Long term Investments Maturity | 12 months | ||||
Impairment of long-lived assets | $ 0 | ||||
Description of payment term | The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. | ||||
Description of sales return | Distributors can request to return product to the Company only due to quality issues or for product purchased within one year prior to the product’s expiration date. | ||||
Accumulated deficit | $ (1,264,034,000) | (974,011,000) | |||
Accumulated other comprehensive loss | (4,163,000) | (4,499,000) | |||
ASU 2018-02 [Member] | Impact of change in accounting principle upon adoption of ASU 2018-02 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated deficit | $ 600,000 | ||||
Accumulated other comprehensive loss | (600,000) | ||||
Cumulative Effect, Period of Adoption, Adjustment [Member] | ASU 2016-02 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated deficit | $ (8,700,000) | ||||
Astellas and AstraZeneca [Member] | |||||
Accounting Policy [Line Items] | |||||
Amount constrained related to drug product shipment | $ 88,800,000 | ||||
AstraZeneca Agreements [Member] | |||||
Accounting Policy [Line Items] | |||||
Profit share percent | 50.00% | ||||
HiFiBiO Agreement [Member] | |||||
Accounting Policy [Line Items] | |||||
Initial upfront payment | $ 25,000,000 | $ 25,000,000 | |||
Maximum additional future option, clinical, regulatory, and commercial milestone payments | $ 1,100,000 | ||||
HiFiBiO Agreement [Member] | IPR&D Asset [Member] | |||||
Accounting Policy [Line Items] | |||||
Initial upfront payment | 60,000,000 | ||||
HiFiBiO Agreement [Member] | Accrued Liabilities | |||||
Accounting Policy [Line Items] | |||||
Initial upfront payment | $ 35,000,000 | ||||
Minimum [Member] | Computer Equipment [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 3 years | ||||
Minimum [Member] | Laboratory Equipment [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 3 years | ||||
Minimum [Member] | Machinery [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 3 years | ||||
Minimum [Member] | Furniture and Fixtures [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 3 years | ||||
Maximum [Member] | Computer Equipment [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 5 years | ||||
Maximum [Member] | Laboratory Equipment [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 5 years | ||||
Maximum [Member] | Machinery [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 5 years | ||||
Maximum [Member] | Furniture and Fixtures [Member] | |||||
Accounting Policy [Line Items] | |||||
Property and equipment estimated useful life | 5 years | ||||
Foreign subsidiaries [Member] | |||||
Accounting Policy [Line Items] | |||||
Cash and cash equivalents | $ 91,200,000 | $ 66,000,000 | |||
Accounts Receivable from Distributors [Member] | Credit Concentration Risk [Member] | Roxadustat [Member] | |||||
Accounting Policy [Line Items] | |||||
Concentration risk, percentage | 64.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Significant Balance of Accounts Receivable (Detail) - Accounts Receivable [Member] - Credit Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Astellas Agreement [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 63.00% | 10.00% |
AstraZeneca Agreements [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 34.00% | 26.00% |
Collaboration Agreements, Licen
Collaboration Agreements, License Agreement and Revenues - Astellas Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 35 Months Ended | 45 Months Ended | |||||||
Dec. 31, 2020 | Sep. 30, 2019 | Apr. 30, 2006 | Jun. 30, 2005 | Sep. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2009 | Feb. 28, 2009 | Jun. 30, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue | $ 235,309,000 | $ 176,319,000 | $ 256,577,000 | |||||||||
Unbilled contract asset | $ 2,147,000 | 66,909,000 | 2,147,000 | |||||||||
Deferred Revenue | 6,547,000 | 15,857,000 | 6,547,000 | |||||||||
Drug Product Revenue [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue | $ 962,000 | 8,906,000 | (36,324,000) | |||||||||
Japan [Member] | Drug Product Revenue [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue | $ 8,200,000 | |||||||||||
Astellas Agreement [Member] | Japan [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Upfront, non-contingent and time-based payments received | $ 40,100,000 | |||||||||||
Potential milestone payments | 15,000,000 | $ 12,500,000 | $ 132,500,000 | |||||||||
Commercial sales milestone | 15,000,000 | |||||||||||
Additional consideration based on net sales description | the low 20% range of the list price | |||||||||||
Transaction price and allocated to performance obligations | $ 15,000,000 | $ 12,500,000 | 15,000,000 | |||||||||
Aggregate considerations received excluding drug product revenue | $ 105,100,000 | |||||||||||
Astellas Agreement [Member] | Japan [Member] | Drug Product Revenue [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue | $ 2,100,000 | $ 4,300,000 | (36,300,000) | |||||||||
Astellas Agreement [Member] | Japan [Member] | Clinical and Development Milestone [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Potential milestone payments | 22,500,000 | |||||||||||
Astellas Agreement [Member] | Japan [Member] | Regulatory Milestone [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Potential milestone payments | $ 95,000,000 | |||||||||||
Astellas Agreement [Member] | Europe [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Upfront, non-contingent and time-based payments received | $ 320,000,000 | |||||||||||
Potential milestone payments | $ 120,000 | |||||||||||
Additional consideration based on net sales description | low 20% range | |||||||||||
Transaction price and allocated to performance obligations | $ 120,000 | $ 130,000,000 | ||||||||||
Aggregate considerations received excluding drug product revenue | $ 660,000,000 | |||||||||||
Development and regulatory approval milestones | $ 425,000,000 | |||||||||||
Percentage of joint development costs committed to fund | 50.00% | |||||||||||
Revenue related to collaboration agreements | 128,800,000 | |||||||||||
Unbilled contract asset | $ 130,000,000 | |||||||||||
Milestone payment received | $ 130,000,000 | |||||||||||
Astellas Agreement [Member] | Europe [Member] | Drug Product Revenue [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Burdened manufacturing costs | 1,000,000 | |||||||||||
Deferred Revenue | $ 25,900,000 | |||||||||||
Astellas Agreement [Member] | Europe [Member] | Clinical and Development Milestone [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Potential milestone payments | $ 90,000,000 | |||||||||||
Astellas Agreement [Member] | Europe [Member] | Regulatory Milestone [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Potential milestone payments | $ 335,000,000 |
Collaboration Agreements, Lic_2
Collaboration Agreements, License Agreement and Revenues - Accounting for the Astellas Agreements - Additional Information 2 (Detail) - Astellas Agreement [Member] | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Co-development services related to CKD continued over development period | 2021-08 |
Minimum [Member] | Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Discount rate applied | 17.5 |
Maximum [Member] | Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Discount rate applied | 20 |
Japan [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Non-contingent upfront payments received | $ 40,100,000 |
Variable consideration related to payments for milestones considered probable of being achieved | 65,000,000 |
Variable consideration related to co-development billings | 11,900,000 |
Provision for co-development services | 0 |
Europe [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Non-contingent upfront payments received | 320,000,000 |
Variable consideration related to payments for milestones considered probable of being achieved | 340,000,000 |
Variable consideration related to co-development billings | $ 219,900,000 |
Collaboration Agreements, Lic_3
Collaboration Agreements, License Agreement and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) $ in Thousands | Jul. 30, 2013 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2015 | Jun. 30, 2019 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | $ 6,547 | $ 15,857 | $ 6,547 | ||||
Deferred revenue ($3,201 and $2,907 to related parties) | 6,547 | 15,857 | 6,547 | ||||
Total revenue | 235,309 | 176,319 | $ 256,577 | ||||
Product Revenue, Net [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | 47,638 | 72,498 | 1,700 | ||||
Drug Product Revenue [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | 962 | 8,906 | (36,324) | ||||
AstraZeneca Agreements [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Transaction price and allocated to performance obligations | $ 50,000 | ||||||
Revenue during period from performance obligations | 42,400 | ||||||
Milestone payment received | 35,568 | ||||||
AstraZeneca Agreements [Member] | Selling, General and Administrative Expenses [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Reversal of accrued co-promotion expenses | 84,400 | ||||||
Co-promotion expenses | 4,700 | 27,200 | |||||
AstraZeneca Agreements [Member] | Drug Product Revenue [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | 11,200 | ||||||
Deferred revenue ($3,201 and $2,907 to related parties) | 11,200 | ||||||
Total revenue | $ (2,224) | 4,625 | 0 | ||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront, non-contingent, non-refundable and time-based payments | $ 374,000 | ||||||
Potential milestone payments | 875,000 | ||||||
Commercial sales milestone | 325,000 | ||||||
Shared development costs | $ 233,000 | ||||||
Additional consideration based on net sales description | low 20% range | ||||||
Aggregate considerations received excluding drug product revenue | $ 439,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | FibroGen, Inc. [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Shared development costs | $ 116,500 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Clinical and Development Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 65,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Regulatory Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 325,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Deferred Approval Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 160,000 | ||||||
AstraZeneca Agreements [Member] | China [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 348,500 | 22,000 | |||||
Transaction price and allocated to performance obligations | 22,000 | ||||||
Deferred Revenue | 7,000 | 7,900 | 7,000 | ||||
Proceeds from upfront, non-contingent and non-refundable payments | 28,200 | ||||||
Commercial sales and other events milestone | 187,500 | ||||||
Aggregate considerations received | 77,200 | ||||||
Milestone payment received | 18,700 | ||||||
Deferred revenue ($3,201 and $2,907 to related parties) | 7,000 | 7,900 | 7,000 | ||||
Total revenue | 0 | (90) | 90 | ||||
AstraZeneca Agreements [Member] | China [Member] | Product Revenue, Net [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | 35,600 | ||||||
AstraZeneca Agreements [Member] | China [Member] | Accrued and Other Current Liabilities [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | 7,000 | 7,900 | 7,000 | ||||
Deferred revenue ($3,201 and $2,907 to related parties) | $ 7,000 | 7,900 | 7,000 | ||||
AstraZeneca Agreements [Member] | China [Member] | Clinical and Development Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 15,000 | ||||||
AstraZeneca Agreements [Member] | China [Member] | Regulatory Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | $ 146,000 | ||||||
Direct Sales [Member] | Product Revenue, Net [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | 12,070 | $ 72,498 | $ 1,700 | ||||
Direct Sales [Member] | China [Member] | Product Revenue, Net [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | $ 12,100 |
Collaboration Agreements, Lic_4
Collaboration Agreements, License Agreement and Revenues - Accounting for the AstraZeneca Agreements - Additional Information 3 (Detail) - AstraZeneca Agreements [Member] $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Royalty rate against projected net revenues | 40.00% |
Co-development services related to CDK continued over development year | 2024 |
Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Discount rate applied | 17.5 |
U.S./RoW and China [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Non-contingent upfront payments received | $ 402.2 |
Variable consideration related to payments for milestones considered probable of being achieved | 114 |
Variable consideration related to co-development billings | 610.9 |
Variable consideration related to profit share | $ 7 |
Collaboration Agreements, Lic_5
Collaboration Agreements, License Agreement and Revenues - Eluminex Agreement - Additional Information 2 (Detail) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2021USD ($)PerformanceObligation | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 | |
Eluminex [Member] | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Upfront payment | $ 8,000 | 8,000 | ||
Future manufacturing clinical regulatory and commercial milestone payments | 64,000 | |||
Commercial milestone | $ 36,000 | |||
Total revenue | $ 8,000 | |||
Eluminex [Member] | ASC 606 [Member] | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Number of identified performance obligation at inception of agreement | PerformanceObligation | 1 | |||
Eluminex [Member] | Cornea Products [Member] | ASC 606 [Member] | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Percentage of product manufacturing costs until manufacturing technology fully transferred | 110.00% |
Collaboration Agreements, Lic_6
Collaboration Agreements, License Agreement and Revenues - Summary of License Revenue and Development Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 |
License Revenue [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 116,434 | 14,323 | 177,086 |
Development Revenue [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 70,275 | 80,592 | 114,115 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 0 | 14,323 | 11,935 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 108,434 | 0 | 117,470 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 248 | 1,220 | 1,222 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 21,679 | 17,954 | 28,172 |
AstraZeneca Agreements [Member] | China [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 0 | (90) | 90 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 0 | 0 | 47,681 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | $ 48,345 | $ 61,508 | $ 84,629 |
Collaboration Agreements, Lic_7
Collaboration Agreements, License Agreement and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 58,909 | $ 2,147 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 116,945 | |
Deferred Revenue | 0 | |
Total Consideration | 116,945 | |
Astellas Agreement [Member] | Japan [Member] | License Revenue [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 100,347 | |
Deferred Revenue | 0 | |
Total Consideration | 100,347 | |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 16,598 | |
Deferred Revenue | 0 | |
Total Consideration | 16,598 | |
Astellas Agreement [Member] | Europe [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 867,026 | |
Deferred Revenue | 0 | |
Total Consideration | 867,026 | |
Astellas Agreement [Member] | Europe [Member] | License Revenue [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 596,385 | |
Deferred Revenue | 0 | |
Total Consideration | 596,385 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 270,641 | |
Deferred Revenue | 0 | |
Total Consideration | $ 270,641 |
Collaboration Agreements, Lic_8
Collaboration Agreements, License Agreement and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Japan [Member] | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Transaction price, variable consideration from estimated future co-development billing | $ 0 |
Europe [Member] | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Transaction price, variable consideration from estimated future co-development billing | 12,900,000 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 1,000,000 |
U.S./RoW and China [Member] | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Transaction price, variable consideration from estimated future co-development billing | 30,900,000 |
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | $ 4,800,000 |
Collaboration Agreements, Lic_9
Collaboration Agreements, License Agreement and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations Deferred Revenue (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 58,909 | $ 2,147 |
AstraZeneca Agreements [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred Revenue | 171,516 | $ 137,338 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 980,531 | |
Deferred Revenue | 171,516 | |
Total Consideration | 1,152,047 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | License Revenue [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 341,844 | |
Deferred Revenue | 0 | |
Total Consideration | 341,844 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | Co-development, information sharing & committee services [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 603,119 | |
Deferred Revenue | 0 | |
Total Consideration | 603,119 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 35,568 | |
Deferred Revenue | 171,516 | |
Total Consideration | $ 207,084 |
Collaboration Agreements, Li_10
Collaboration Agreements, License Agreement and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations Deferred Revenue (Parenthetical) (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current | $ 186,801 | $ 138,474 |
Deferred Revenue | 58,909 | 2,147 |
Net unbilled co-development revenue | 8,000 | 0 |
AstraZeneca Agreements [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred Revenue | 171,516 | $ 137,338 |
Net unbilled co-development revenue | 9,100 | |
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current | 162,400 | |
Deferred Revenue | 171,500 | |
Net unbilled co-development revenue | $ 9,100 |
Collaboration Agreements,Lice_3
Collaboration Agreements,License Agreement and Revenues - Summary of Amounts Recognized as Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 |
Eluminex [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 8,000 | ||
License Revenue [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | 116,434 | 14,323 | 177,086 |
License Revenue [Member] | Eluminex [Member] | |||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |||
Total revenue | $ 8,000 | $ 0 | $ 0 |
Collaboration Agreements,Lice_4
Collaboration Agreements,License Agreement and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 |
Non-key Account Hospital Listing Award [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 0 | 9,300 | 0 |
Contractual Sales Rebate [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 800 | 6,200 | 100 |
Product Revenue, Net [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 47,638 | 72,498 | 1,700 |
Product Revenue, Net [Member] | Direct Sales [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Gross revenue | 13,727 | 89,027 | 2,803 |
Total revenue | 12,070 | 72,498 | 1,700 |
Product Revenue, Net [Member] | Direct Sales [Member] | Price Adjustment [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | (982) | 0 | (936) |
Product Revenue, Net [Member] | Direct Sales [Member] | Non-key Account Hospital Listing Award [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 95 | (9,325) | 0 |
Product Revenue, Net [Member] | Direct Sales [Member] | Contractual Sales Rebate [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | (832) | (6,189) | (149) |
Product Revenue, Net [Member] | Direct Sales [Member] | Other Discounts and Rebates [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | (21) | (923) | (18) |
Product Revenue, Net [Member] | Direct Sales [Member] | Sales Returns [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 83 | (92) | 0 |
Product Revenue, Net [Member] | Sales To Falikang | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 35,568 | 0 | 0 |
Gross transaction price | 97,531 | 0 | 0 |
Product Revenue, Net [Member] | Sales To Falikang | Profit Share | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | (34,759) | 0 | 0 |
Product Revenue, Net [Member] | Sales To Falikang | Net Transfer Price | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 62,772 | 0 | 0 |
Product Revenue, Net [Member] | Sales To Falikang | Increase In Deferred Revenue | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | $ (27,204) | $ 0 | $ 0 |
Collaboration Agreements,Lice_5
Collaboration Agreements,License Agreement and Revenues - Product Revenue, Net - Additional Information 1 (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | $ 235,309 | $ 176,319 | $ 256,577 |
Contract with Customer, Liability [Abstract] | |||
Deferred Revenue | 58,909 | 2,147 | |
Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 47,638 | 72,498 | 1,700 |
Product Revenue, Net [Member] | Beijing Falikang Pharmaceutical Co Ltd | |||
Contract with Customer, Liability [Abstract] | |||
Reductions to gross accounts receivable | 13,400 | ||
AstraZeneca Agreements [Member] | |||
Contract with Customer, Liability [Abstract] | |||
Deferred Revenue | 171,516 | 137,338 | |
AstraZeneca Agreements [Member] | China [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 0 | (90) | 90 |
Contract with Customer, Liability [Abstract] | |||
Deferred Revenue | 10,600 | ||
AstraZeneca Agreements [Member] | China [Member] | Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 35,600 | ||
Contractual Sales Rebate [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 800 | 6,200 | 100 |
Discounts And Rebates | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 1,700 | 16,400 | 1,100 |
Discounts And Rebates Current | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 1,000 | 900 | |
Non-key Account Hospital Listing Award [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 0 | 9,300 | $ 0 |
Rebates and Discounts [Member] | Gross Accounts Receivable [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 1,100 | 500 | |
Rebates and Discounts [Member] | Contract Liabilities [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 3,200 | $ 15,100 | |
Constrained for Future Recognition [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | $ 27,200 |
Collaboration Agreements,Lice_6
Collaboration Agreements,License Agreement and Revenues - Roll-forward of Related Contract Liabilities (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | $ (2,147) |
Balance at December 31, 2021 | (58,909) |
AstraZeneca Agreements [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (137,338) |
Additions | (69,746) |
Balance at December 31, 2021 | (171,516) |
Milestone payment received | 35,568 |
Product [Member] | Direct Sales [Member] | Contract Liabilities [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (15,137) |
Additions | (1,371) |
Deduction | 13,645 |
Currency Translation and Other | (313) |
Balance at December 31, 2021 | (3,176) |
Drug Product Revenue [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (5,984) |
Additions | (83,019) |
Balance at December 31, 2021 | (39,036) |
Milestone payment received | 179 |
Balance Presented Net Against Contract Asset | 49,788 |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | U.S. [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | 0 |
Additions | (11,171) |
Balance at December 31, 2021 | (11,171) |
Milestone payment received | 0 |
Balance Presented Net Against Contract Asset | 0 |
Drug Product Revenue [Member] | Astellas Agreement | Japan [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | 0 |
Additions | (1,974) |
Balance at December 31, 2021 | (1,974) |
Milestone payment received | 0 |
Balance Presented Net Against Contract Asset | 0 |
Drug Product Revenue [Member] | Astellas Agreement | Europe [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (5,984) |
Additions | (69,874) |
Balance at December 31, 2021 | (25,891) |
Milestone payment received | 179 |
Balance Presented Net Against Contract Asset | $ 49,788 |
Collaboration Agreements,Lice_7
Collaboration Agreements,License Agreement and Revenues - Drug Product Revenue - Summary of Drug Product Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | $ 235,309 | $ 176,319 | $ 256,577 |
Drug Product Revenue [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 962 | 8,906 | (36,324) |
Drug Product Revenue [Member] | Astellas Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 3,186 | 4,281 | (36,324) |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | $ (2,224) | $ 4,625 | $ 0 |
Collaboration Agreements,Lice_8
Collaboration Agreements,License Agreement and Revenues - Drug Product Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | $ 235,309 | $ 176,319 | $ 256,577 | |
Deferred Revenue | 15,857 | 6,547 | ||
Royalty Revenue [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Deferred Revenue | 200 | |||
Drug Product Revenue [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | 962 | 8,906 | (36,324) | |
Drug Product Revenue [Member] | Astellas Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | 3,186 | 4,281 | $ (36,324) | |
Drug Product Revenue [Member] | Japan [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | $ 8,200 | |||
Drug Product Revenue [Member] | Europe [Member] | Astellas Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Deferred Revenue | 11,800 | |||
Bulk Drug Product | Europe [Member] | Astellas Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Deferred Revenue | $ 6,000 | |||
Bulk Drug Product | Europe [Member] | E U Supply And Astellas Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | 8,300 | |||
Burdened manufacturing costs | $ 1,000 |
Collaboration Agreements,Lice_9
Collaboration Agreements,License Agreement and Revenues - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue recognized | $ 235,309 | $ 176,319 | $ 256,577 |
Unbilled contract asset | 66,909 | 2,147 | |
Drug Product Revenue [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue recognized | 962 | 8,906 | (36,324) |
Drug Product Revenue [Member] | API Shipment [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue recognized | 2,100 | $ (4,000) | $ (36,300) |
Bulk Drug Product | Europe [Member] | E U Supply And Astellas Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue recognized | 8,300 | ||
Unbilled contract asset | 49,800 | ||
Bulk Drug Product | Astra Zeneca | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue recognized | $ 11,200 |
Equity method investment - Va_3
Equity method investment - Variable Interest Entity - Additional Information (Detail) | Dec. 31, 2021 |
Beijing Kangda Yongfu Pharmaceutical Co., LTD [Member] | Beijing Falikang Pharmaceutical Co Ltd | FibroGen Beijing [Member] | AstraZenecaAB [Member] | |
Acquisition And Variable Interest Entity [Line Items] | |
Percentage of outstanding shares acquired | 51.10% |
Equity method investment - Va_4
Equity method investment - Variable Interest Entity - Summary of Equity Method Investment (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Acquisition And Variable Interest Entity [Line Items] | |||
Beginning balance | $ 2,728 | ||
Investment income (loss) in unconsolidated variable interest entity | 1,007 | $ (202) | $ 0 |
Ending balance | $ 3,825 | 2,728 | |
Beijing Falikang Pharmaceutical Co. Ltd [Member] | |||
Acquisition And Variable Interest Entity [Line Items] | |||
Ownership Percentage | 51.10% | ||
Beginning balance | $ 2,728 | ||
Investment income (loss) in unconsolidated variable interest entity | 1,007 | ||
Currency Translation | 90 | ||
Ending balance | $ 3,825 | $ 2,728 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 401,763 | $ 8,388 |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 182,646 | |
Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 68,079 | |
Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 27,087 | |
Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 9,154 | |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,144 | |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 244 | |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 461,564 | 598,735 |
Fair Value, Measurements, Recurring [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 58,801 | 590,347 |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 182,646 | |
Fair Value, Measurements, Recurring [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 69,079 | |
Fair Value, Measurements, Recurring [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 91,522 | |
Fair Value, Measurements, Recurring [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 23,275 | |
Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 27,087 | |
Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 9,154 | |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,144 | |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 244 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 150,323 | 590,591 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 58,801 | 590,347 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 91,522 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 244 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 311,241 | 8,144 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 182,646 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 69,079 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 23,275 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 27,087 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 9,154 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,144 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 | $ 29,800,000 |
Transfers of assets from level 2 to 1 | 0 | 0 | |
Transfers of assets into level 3 | 0 | 0 | |
Transfers of assets out of level 3 | 0 | 0 | |
Transfers of liabilities from level 1 to 2 | 0 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | Jun. 01, 2021USD ($)Option | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Lessee Lease Description [Line Items] | |||||
Finance lease right-of-use assets | $ 761 | $ 29,606 | |||
Finance lease liability | 14 | ||||
Operating lease right-of-use assets | 91,112 | 2,043 | |||
Operating lease liability | 99,720 | ||||
Cash payment related to lease | $ 10,022 | 951 | $ 914 | ||
Minimum [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, lease term | 1 year | ||||
Maximum [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, lease term | 5 years | ||||
Office Spaces | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, expiration period | 2023 | ||||
Office Equipment [Member] | Minimum [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, lease term | 1 year | ||||
Office Equipment [Member] | Maximum [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, operating lease, lease term | 5 years | ||||
ASC 842 [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Finance lease right-of-use assets | $ 24,654 | 0 | 0 | ||
Operating lease right-of-use assets | $ 93,222 | $ 0 | $ 0 | ||
Shorenstein Properties LLC [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, finance lease, initial lease term | 15 years | ||||
Lessee, finance lease, expiration period | 2023 | ||||
Shorenstein Properties LLC [Member] | Lease Amendment [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lessee, finance lease, option to extend the additional lease term | 5 years | ||||
Lessee, finance lease, additional lease expiration period | 2028 | ||||
Percentage increases on each anniversary of rent commencement date 2023 | 2.00% | ||||
Lessee, finance lease, existence of option to extend | true | ||||
Lessee, finance lease, option to extend | Under the terms of the Lease Amendment, the Company has two optional rights to each extend the lease for an additional five years. | ||||
Optional rights to extend lease | Option | 2 | ||||
Rent increase commencement year first option | 2023 | ||||
Percentage increases on each anniversary of rent commencement date 2028 | 3.00% | ||||
Rent increase commencement year second option | 2028 | ||||
Shorenstein Properties LLC [Member] | Lease Amendment [Member] | ASC 842 [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Finance lease right-of-use assets | $ 24,600 | ||||
Finance lease liability | 32,600 | ||||
Operating lease right-of-use assets | 93,200 | ||||
Operating lease liability | $ 101,200 | ||||
Cash payment related to lease | $ 7,900 | ||||
Beijing Economic-Technological Development Area [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Operating lease right-of-use assets | $ 3,400 | ||||
Operating lease liability | $ 3,400 | ||||
Lessee, operating lease, lease term | 5 years | ||||
Lessee, operating lease, expiration period | 2026 |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Right-of-use assets cost | $ 2,165 | $ 50,477 |
Accumulated amortization | (1,404) | (20,871) |
Finance lease right-of-use assets, net | 761 | 29,606 |
Right-of-use assets cost | 100,912 | 3,934 |
Accumulated amortization | (9,800) | (1,891) |
Operating lease right-of-use assets, net | 91,112 | 2,043 |
Total lease assets | 91,873 | 31,649 |
Finance lease liabilities | 11 | 12,330 |
Operating lease liabilities | 10,944 | 1,188 |
Finance lease liabilities | 3 | 25,391 |
Operating lease liabilities | 88,776 | 853 |
Total lease liabilities | $ 99,734 | $ 39,762 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finance lease cost: | |||
Amortization of right-of-use assets | $ 4,639 | $ 10,369 | $ 10,307 |
Interest on lease liabilities | 628 | 1,932 | 2,373 |
Operating lease cost | 10,722 | 1,151 | 891 |
Sublease income | (1,271) | (1,201) | (1,385) |
Total lease cost | $ 14,718 | $ 12,251 | $ 12,186 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash paid for amounts included in the measurement of lease liabilities: | |||
Operating cash flows from operating leases | $ 10,022 | $ 951 | $ 914 |
Operating cash flows from finance leases | 629 | 1,896 | 2,196 |
Financing cash flows from finance leases | 5,489 | 12,620 | 11,925 |
Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: | |||
Finance leases | 450 | 662 | 49,909 |
Operating leases | 3,585 | 1,072 | 2,736 |
Non-cash: Increase (decrease) resulting from lease modification: | |||
Finance lease right-of-use assets | (761) | (29,606) | |
Operating lease right-of-use assets | 91,112 | 2,043 | |
Finance lease liabilities, current | (11) | (12,330) | |
Operating lease liabilities, current | 10,944 | 1,188 | |
Finance lease liabilities, non-current | (3) | (25,391) | |
Operating lease liabilities, non-current | 88,776 | 853 | |
ASC 842 [Member] | |||
Non-cash: Increase (decrease) resulting from lease modification: | |||
Finance lease right-of-use assets | (24,654) | 0 | 0 |
Operating lease right-of-use assets | 93,222 | 0 | 0 |
Finance lease liabilities, current | (12,587) | 0 | 0 |
Operating lease liabilities, current | 9,221 | 0 | 0 |
Finance lease liabilities, non-current | (20,009) | 0 | 0 |
Operating lease liabilities, non-current | $ 91,943 | $ 0 | $ 0 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Dec. 31, 2021 | Dec. 31, 2020 |
Weighted-average remaining lease term (years): | ||
Finance leases | 1 year 1 month 6 days | 2 years 10 months 24 days |
Operating leases | 6 years 9 months 18 days | 1 year 9 months 18 days |
Weighted-average discount rate: | ||
Finance leases | 4.64% | 4.39% |
Operating leases | 4.75% | 4.74% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Finance Leases | |
2022 | $ 12 |
2023 | 3 |
2024 | 0 |
2025 | 0 |
2026 | 0 |
Beyond 2026 | 0 |
Total future lease payments | 15 |
Less: Interest | (1) |
Present value of lease liabilities | 14 |
Operating Leases | |
2022 | 15,387 |
2023 | 13,469 |
2024 | 16,810 |
2025 | 18,205 |
2026 | 18,005 |
Beyond 2026 | 35,877 |
Total future lease payments | 117,753 |
Less: Interest | (18,033) |
Present value of lease liabilities | $ 99,720 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 111,422 | $ 88,046 |
Commercial paper | 1,000 | 0 |
Money market funds | 58,801 | 590,347 |
Total cash and cash equivalents | $ 171,223 | $ 678,393 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 402,664 | $ 8,272 |
Gross Unrealized Holding Gains | 2 | 119 |
Gross Unrealized Holding Losses | (903) | (3) |
Fair Value | 401,763 | 8,388 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 183,136 | |
Gross Unrealized Holding Gains | 2 | |
Gross Unrealized Holding Losses | (492) | |
Fair Value | 182,646 | |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 68,079 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 68,079 | |
U.S. government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 91,840 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (318) | |
Fair Value | 91,522 | |
Agency bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 23,339 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (64) | |
Fair Value | 23,275 | |
Asset-backed securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 27,105 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (18) | |
Fair Value | 27,087 | |
Foreign government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 9,165 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (11) | |
Fair Value | $ 9,154 | |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,147 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (3) | |
Fair Value | 8,144 | |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | |
Gross Unrealized Holding Gains | 119 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | $ 244 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Contractual Maturities of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Available For Sale Securities Debt Maturities [Abstract] | ||
Within one year - Bond and mutual funds | $ 233,967 | |
After one year through three years | 167,796 | |
Total investments | $ 401,763 | $ 8,388 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 31, 2021 | |
Schedule of Available-for-sale Securities [Line Items] | |||||
Other-than-temporary impairment loss | $ 0 | ||||
Net unbilled co-development revenue | 8,000,000 | $ 8,000,000 | $ 0 | ||
Depreciation expense | 10,170,000 | 11,678,000 | $ 11,147,000 | ||
Profit share liability | 15,857,000 | 15,857,000 | 6,547,000 | ||
Acquired in-process research and development asset | 35,000,000 | 35,000,000 | $ 0 | ||
Eluminex [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Unbilled upfront payment | 8,000,000 | 8,000,000 | $ 8,000,000 | ||
AstraZeneca Agreements [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Net unbilled co-development revenue | 9,100,000 | 9,100,000 | |||
HiFiBiO Agreement [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Acquired in-process research and development asset | $ 35,000,000 | $ 35,000,000 | |||
U.S. [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Percentage of pre-launch inventory capitalized of aggregate inventory balance | 38.00% | 38.00% | 29.00% | ||
Europe [Member] | Astellas Agreement [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Transfer price true up | $ 49,800,000 | $ 49,800,000 | |||
China [Member] | AstraZeneca Agreements [Member] | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Profit share liability | $ 7,900,000 | $ 7,900,000 | $ 7,000,000 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule Of Investments [Abstract] | ||
Raw materials | $ 1,363 | $ 2,303 |
Work-in-progress | 21,499 | 8,114 |
Finished goods | 8,153 | 6,113 |
Total inventories | $ 31,015 | $ 16,530 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 66,909 | $ 2,147 |
Deferred revenues from associated contracts | (58,909) | (2,147) |
Net unbilled contract assets | 8,000 | 0 |
Prepaid assets | 7,383 | 8,353 |
Other current assets | 5,070 | 1,807 |
Total prepaid expenses and other current assets | $ 20,453 | $ 10,160 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 149,285 | $ 144,894 |
Less: accumulated depreciation | (121,008) | (111,247) |
Property and equipment, net | 28,277 | 33,647 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 103,352 | 102,006 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 19,300 | 18,143 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,339 | 8,312 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 9,670 | 9,545 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,201 | 6,128 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,423 | $ 760 |
Balance Sheet Components - Sc_5
Balance Sheet Components - Schedule of Accrued and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 56,283 | $ 44,113 |
Acquired in-process research and development asset | 35,000 | 0 |
Payroll and related accruals | 20,909 | 22,800 |
Contract liabilities to pharmaceutical distributors | 3,176 | 15,137 |
Accrued co-promotion expenses - current | 25,746 | 11,537 |
Roxadustat profit share to AstraZeneca | 7,895 | 7,007 |
Property taxes and other taxes | 12,610 | 5,970 |
Professional services | 6,074 | 4,869 |
Other | 4,895 | 6,900 |
Total accrued and other current liabilities | $ 172,588 | $ 118,333 |
Balance Sheet Components - Sc_6
Balance Sheet Components - Schedule of Other Long-term Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Noncurrent [Abstract] | ||
Accrued long-term co-promotion expenses | $ 15,236 | $ 27,424 |
Other long-term tax liabilities | 9,192 | 8,675 |
Other | 1,590 | 2,690 |
Total other long-term liabilities | $ 26,018 | $ 38,789 |
Product Development Obligatio_2
Product Development Obligations - Additional Information (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2021USD ($)DevelopmentObligation | Dec. 31, 2020USD ($) | |
Debt Instrument [Line Items] | ||
Number of product development obligations | DevelopmentObligation | 11 | |
Accrued product development costs excluding interest | $ 10.7 | $ 11.6 |
Accrued Interest | $ 6.9 | $ 7.1 |
Bank of Finland Interest Rate [Member] | ||
Debt Instrument [Line Items] | ||
Percentage points deducted to reference rate to compute effective interest rate | 1.00% | |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate on product development advances | 3.00% |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Outstanding Non-cancelable Purchase Obligations (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligations due 2022 | $ 49,424 |
Purchase obligations due 2023 | 23,838 |
Total purchase obligations | 73,262 |
Manufacture and Supply of Roxadustat [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligations due 2022 | 14,591 |
Purchase obligations due 2023 | 3,920 |
Total purchase obligations | 18,511 |
Manufacture and Supply of Pamrevlumab [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligations due 2022 | 25,480 |
Purchase obligations due 2023 | 19,918 |
Total purchase obligations | 45,398 |
Other Purchases [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligations due 2022 | 9,353 |
Purchase obligations due 2023 | 0 |
Total purchase obligations | $ 9,353 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 1 Months Ended | 12 Months Ended | |
May 31, 2021PutativeClassAction | Apr. 30, 2021PutativeClassAction | Dec. 31, 2021USD ($) | |
Commitments And Contingencies [Line Items] | |||
Putative securities class action complaints filed | PutativeClassAction | 2 | 3 | |
Research and Pre-Clinical Stage Development Programs [Member] | |||
Commitments And Contingencies [Line Items] | |||
Maximum future milestone payments | $ | $ 704.1 |
Equity and Stock-based Compen_3
Equity and Stock-based Compensation - Common Stock - Additional information (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common stock voting rights | one vote |
Equity and Stock-based Compen_4
Equity and Stock-based Compensation - Summary of Common Stock Reserved for Future Issuance (Detail) - shares shares in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||
Common stock outstanding | 92,881 | 91,441 |
Stock options outstanding | 8,967 | 9,290 |
RSUs outstanding | 2,304 | 1,893 |
Shares reserved for future stock options and RSUs grant | 10,253 | 7,910 |
Total shares of common stock reserved | 119,176 | 114,604 |
ESPP [Member] | ||
Class Of Stock [Line Items] | ||
Shares reserved for future ESPP offering | 4,771 | 4,070 |
Equity and Stock-based Compen_5
Equity and Stock-based Compensation - Stock Plans - Additional information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total intrinsic value of options exercised | $ 1,408 | |||
RSUs released and issued net of shares withheld for taxes | 538,607 | |||
Weighted-average fair value of awards granted | $ 30.19 | $ 29.99 | $ 54.74 | |
2005 Stock Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period of stock options | 4 years | |||
2005 Stock Plan | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expiration period of stock options | 10 years | |||
2014 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period of stock options | 5 years | |||
Expiration period of stock options | 10 years | |||
Termination date of equity incentive plan | Nov. 12, 2024 | |||
Option vesting term | Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule (25% vesting on the first anniversary of the vesting base date and quarterly thereafter over the next 3 years). | |||
Number of common stock reserved for issuance | 10,252,944 | |||
Common stock reserved for future issuance, Description | Shares reserved for issuance increases on January 1 of each year commencing on January 1, 2016 and ending on January 1, 2024 by the lesser of (i) the amount equal to 4% of the number of shares issued and outstanding on December 31 immediately prior to the date of increase or (ii) such lower number of shares as may be determined by the board of directors. As of December 31, 2021, the Company has reserved 10,252,944 shares of its common stock that remains unissued for issuance under the 2014 Plan. | |||
Percentage of common stock reserved for future issuance | 4.00% | |||
Number of common stock repurchased | 0 | 0 | ||
Total intrinsic value of options exercised | $ 13,100 | $ 89,600 | $ 59,200 | |
2014 Equity Incentive Plan | First Anniversary [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of vesting rights | 25.00% | |||
2014 Equity Incentive Plan | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of fair value exercise price grant date | 100.00% |
Equity and Stock-based Compen_6
Equity and Stock-based Compensation - Stock Plans - Summary of Stock Option Transactions (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Outstanding, Beginning Balance, Shares | shares | 9,290 |
Granted, Shares | shares | 3,452 |
Exercised, Shares | shares | (688) |
Expired, Shares | shares | (1,259) |
Forfeited, Shares | shares | (1,828) |
Outstanding, Ending Balance, Shares | shares | 8,967 |
Vested and expected to vest, Shares | shares | 8,535 |
Exercisable, Shares | shares | 5,241 |
Outstanding, Beginning Balance, Weighted Average Exercise per Share | $ / shares | $ 32.94 |
Granted, Weighted Average Exercise per Share | $ / shares | 35.58 |
Exercised, Weighted Average Exercise per Share | $ / shares | 13.89 |
Expired, Weighted Average Exercise per Share | $ / shares | 35.40 |
Forfeited, Weighted Average Exercise per Share | $ / shares | 34.07 |
Outstanding, Ending Balance, Weighted Average Exercise per Share | $ / shares | 34.84 |
Vested and expected to vest, Weighted Average Exercise per Share | $ / shares | 34.76 |
Exercisable, Weighted Average Exercise per Share | $ / shares | $ 32.80 |
Outstanding, Weighted Average Remaining Contractual Life | 6 years 4 months 28 days |
Vested and expected to vest, Weighted Average Remaining Contractual Life | 6 years 3 months 10 days |
Exercisable, Weighted Average Remaining Contractual Life | 4 years 9 months 10 days |
Outstanding, Aggregate Intrinsic Value | $ | $ 2,622 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 2,460 |
Exercisable, Aggregate Intrinsic Value | $ | $ 1,408 |
Equity and Stock-based Compen_7
Equity and Stock-based Compensation - Summary of RSU Activity (Detail) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,893 | ||
Unvested, Shares, Ending Balance | 2,304 | 1,893 | |
Granted, Fair value at Grant | $ 30.19 | $ 29.99 | $ 54.74 |
Restricted Stock Unit [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,893 | ||
Granted, Shares | 1,808 | ||
Vested, Shares | (828) | ||
Forfeited, Shares | (569) | ||
Unvested, Shares, Ending Balance | 2,304 | 1,893 | |
Unvested, Fair value at Grant, Beginning Balance | $ 37.60 | ||
Granted, Fair value at Grant | 30.19 | ||
Vested, Fair value at Grant | 37.66 | ||
Forfeited, Fair value at Grant | 42.28 | ||
Unvested, Fair value at Grant, Ending Balance | $ 30.60 | $ 37.60 |
Equity and Stock-based Compen_8
Equity and Stock-based Compensation - Employee Stock Purchase Plan - Additional information (Detail) - 2014 ESPP [Member] - shares | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Purchase of common stock shares at discount | 15.00% | |||
Percentage of fair value exercise price grant date | 85.00% | |||
Number of common stock reserved for issuance | 1,600,000 | |||
Common stock reserved for future issuance, Description | The Company has reserved 1,600,000 shares of its common stock for issuance under the 2014 ESPP and shares reserved for issuance increases January 1 of each year commencing January 1, 2016 by the lesser of (i) a number of shares equal to 1% of the total number of outstanding shares of common stock on December 31 immediately prior to the date of increase; (ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors. | |||
Percentage of common stock reserved for future issuance | 1.00% | |||
Increase in number of shares of common stock reserved for future issuance, shares | 1,200,000 | |||
Shares purchased by employees | 213,505 | 143,876 | 135,115 |
Equity and Stock-based Compen_9
Equity and Stock-based Compensation - Schedule of Recorded Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 71,161 | $ 72,720 | $ 66,267 |
Research and development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 40,547 | 46,229 | 41,015 |
Selling, general and administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 30,614 | $ 26,491 | $ 25,252 |
Equity and Stock-based Compe_10
Equity and Stock-based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Employee Stock Purchase Plans (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee stock options [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 8 months 12 days | 5 years 8 months 12 days | 5 years 3 months 18 days |
Expected volatility | 61.90% | 67.10% | 68.00% |
Risk-free interest rate | 0.80% | 0.80% | 2.40% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 20.21 | $ 18.36 | $ 31.98 |
Employee stock purchase plans [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected volatility, minimum | 47.10% | 47.50% | 48.10% |
Expected volatility, maximum | 104.40% | 77.10% | 62.10% |
Risk-free interest rate, minimum | 0.00% | 0.10% | 1.30% |
Risk-free interest rate, maximum | 2.20% | 2.90% | 2.90% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 12.40 | $ 17.53 | $ 19.27 |
Employee stock purchase plans [Member] | Minimum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | 6 months | 6 months |
Employee stock purchase plans [Member] | Maximum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 2 years | 2 years | 2 years |
Equity and Stock-based Compe_11
Equity and Stock-based Compensation - Stock-Based Compensation - Additional information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Stock Option Awards [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 56.4 |
Non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period | 2 years 6 months 25 days |
Restricted Stock Unit [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period | 2 years 3 months 14 days |
Unrecognized compensation costs | $ 52.3 |
Equity and Stock-based Compe_12
Equity and Stock-based Compensation - Warrants - Additional information (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shareholders Equity And Stock Based Compensation [Abstract] | |||
Warrants to purchase common stock exercised | 4,430 | ||
Warrants to purchase common stock outstanding | 0 | 0 |
Equity and Stock-based Compe_13
Equity and Stock-based Compensation - Subsidiary Stock and Non-Controlling Interests - Additional information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Nov. 19, 2014 | Jan. 31, 2013 | |
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 0 | 0 | ||
IPO [Member] | ||||
Class Of Stock [Line Items] | ||||
Conversion rights, shares issued upon conversion of each preferred share | 958,996 | |||
FibroGen Europe [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 42,619,022 | 42,619,022 | ||
Preferred stock redemption percentage | Redemption Right — If a Preferred Share can be redeemed by a majority shareholder owning more than ninety percent (90%) of the shares of FibroGen Europe in accordance with the provisions of the Finnish Limited Liability Companies Act, the minority holders of Preferred Shares have the right to request redemption of their shares. | |||
Minimum percentage of shareholder's approval to call for redemption of preferred shares | 90.00% | |||
Preferred stock, voting rights | one vote | |||
Conversion rights, shares issued upon conversion of each preferred share | 1 | |||
FibroGen Europe [Member] | Series A [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 1,700,845 | 1,700,845 | ||
FibroGen Europe [Member] | Series B [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 1,875,000 | 1,875,000 | ||
FibroGen Europe [Member] | Series C [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 1,599,503 | 1,599,503 | ||
FibroGen Europe [Member] | Series D [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 1,520,141 | 1,520,141 | ||
FibroGen Europe [Member] | Series E [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 459,565 | 459,565 | ||
FibroGen Europe [Member] | Series F [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 5,714,332 | 5,714,332 | ||
FibroGen Europe [Member] | Series G [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 9,927,500 | 9,927,500 | ||
FibroGen Europe [Member] | Series H [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 19,822,136 | 19,822,136 | ||
FibroGen Cayman [Member] | ||||
Class Of Stock [Line Items] | ||||
Conversion rights, shares issued upon conversion of each preferred share | 1 | |||
Convertible promissory note | $ 0.7 | $ 0.7 | $ 0.6 | |
Convertible promissory note interest rate | 2.00% | |||
Conditions of payment of interest, convertible promissory note | 0 | |||
FibroGen Cayman [Member] | Series A [Member] | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, shares outstanding | 6,758,000 | 6,758,000 | ||
Preferred shares issued, price per share | $ 1 | |||
Cash dividend percentage | 6.00% |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Weighted Impacts of Outstanding Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 10,416 | 7,564 | 9,050 |
Employee stock options [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 8,461 | 6,694 | 7,602 |
RSUs [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 1,538 | 564 | 1,187 |
ESPP [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 417 | 306 | 260 |
Warrants [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 0 | 0 | 1 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Components Of Income Tax Expense Benefit Continuing Operations [Abstract] | |||
Domestic | $ (268,499) | $ (195,617) | $ 2,538 |
Foreign | (22,184) | 6,888 | (79,180) |
Loss before provision for income taxes | $ (290,683) | $ (188,729) | $ (76,642) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Provision For Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 347 | 360 | 328 |
Total current | 347 | 360 | 328 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | 0 |
Total provision for income taxes | $ 347 | $ 360 | $ 328 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation Between Statutory Federal Income Tax Rate and Effective Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Tax at statutory federal rate | 21.00% | 21.00% | 21.00% |
State tax | 0.00% | 0.00% | 0.00% |
Stock-based compensation expense | (1.80%) | 2.40% | 6.30% |
Benefit due to intercompany transfer of assets | 0.00% | 41.70% | 0.00% |
Valuation allowance on intercompany transfer of assets | 0.00% | (41.70%) | 0.00% |
Net operating losses not benefitted | (16.80%) | (23.20%) | (2.90%) |
Foreign net operating losses not benefitted | (1.60%) | 0.70% | (21.70%) |
Deduction limitation on executive compensation | (0.30%) | (0.80%) | (2.50%) |
Other | (0.60%) | (0.30%) | (0.60%) |
Total | (0.10%) | (0.20%) | (0.40%) |
Income Taxes - Schedule of Sign
Income Taxes - Schedule of Significant Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Components Of Deferred Tax Assets And Liabilities [Abstract] | ||
Federal and state net operating loss carryforwards | $ 167,135 | $ 134,033 |
Tax credit carryforwards | 78,832 | 62,465 |
Foreign net operating loss carryforwards | 38,117 | 32,417 |
Stock-based compensation | 10,050 | 10,399 |
Lease obligations | 20,415 | 8,243 |
Reserves and accruals | 6,067 | 5,875 |
Deferred revenue | 20,101 | 13,550 |
Intangible assets | 84,625 | 75,915 |
Other | 825 | 0 |
Subtotal | 426,167 | 342,897 |
Less: Valuation allowance | (409,810) | (337,824) |
Net deferred tax assets | 16,357 | 5,073 |
Fixed assets | (16,357) | (5,073) |
Other | 0 | 0 |
Net deferred tax liabilities | (16,357) | (5,073) |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes [Line Items] | ||||
Increase in valuation allowance | $ 72,000,000 | $ 124,000,000 | $ 19,900,000 | |
Deferred tax asset for temporary difference | 78,700,000 | |||
Federal and state net operating loss carryforwards | 167,135,000 | 134,033,000 | ||
Foreign net operating loss carryforwards | $ 38,117,000 | $ 32,417,000 | ||
Percentage of ownership changes | 0.00% | |||
Unrecognized tax benefits | $ 57,700,000 | |||
Accrued interest, unrecognized tax benefits | 0 | $ 0 | ||
Unrecognized tax benefits that would affect effective tax rate | $ 700,000 | |||
Unrecognized tax benefits description | The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months that would affect the Company’s effective tax rate. | |||
Earliest Tax Year [Member] | ||||
Income Taxes [Line Items] | ||||
Foreign statute of limitation generally remains open in the year | 2012 | |||
Latest Tax Year [Member] | ||||
Income Taxes [Line Items] | ||||
Foreign statute of limitation generally remains open in the year | 2021 | |||
Foreign net operating loss [Member] | ||||
Income Taxes [Line Items] | ||||
Foreign net operating loss carryforwards | $ 198,700,000 | |||
Foreign net operating loss [Member] | Minimum [Member] | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards expiration year | 2022 | |||
Foreign net operating loss [Member] | Maximum [Member] | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards expiration year | 2031 | |||
Federal [Member] | ||||
Income Taxes [Line Items] | ||||
Federal and state net operating loss carryforwards | $ 764,100,000 | |||
Operating loss carryforwards expiration year | 2026 | |||
Other tax credit carryforwards | $ 87,800,000 | |||
Other tax credit carryforwards expiration year | 2022 | |||
State [Member] | ||||
Income Taxes [Line Items] | ||||
Federal and state net operating loss carryforwards | $ 134,600,000 | |||
Operating loss carryforwards expiration year | 2022 | |||
State [Member] | California [Member] | ||||
Income Taxes [Line Items] | ||||
Other tax credit carryforwards | $ 36,600,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of the Beginning and Ending Amounts of Unrecognized Income Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Contingency [Line Items] | |||
Ending Balance | $ 57,700 | ||
Federal and State [Member] | |||
Income Tax Contingency [Line Items] | |||
Beginning balance | 48,574 | $ 32,263 | $ 27,956 |
Decrease due to prior positions | (245) | (137) | (111) |
Increase due to current year position | 8,415 | 16,448 | 4,418 |
Foreign exchange rate differential | 927 | ||
Ending Balance | $ 57,671 | $ 48,574 | $ 32,263 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | |||
Accounts receivable from related parties | $ 10,930,000 | $ 4,127,000 | |
Deferred revenue | 58,909,000 | 2,147,000 | |
Accrued liabilities to related party | 4,000 | 24,000 | |
Investment income (loss) | 1,007,000 | (202,000) | $ 0 |
Equity method investment in unconsolidated variable interest entity | 3,825,000 | 2,728,000 | |
Astellas [Member] | |||
Related Party Transaction [Line Items] | |||
Drug product revenue from a related party | 3,200,000 | 4,300,000 | (36,300,000) |
Astellas [Member] | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Expense related to collaboration agreements | 200,000 | 500,000 | 2,800,000 |
Accounts receivable from related parties | 10,900,000 | 4,100,000 | |
Deferred revenue | 27,900,000 | 7,500,000 | |
Accrued liabilities to related party | 1,100,000 | ||
Falikang | |||
Related Party Transaction [Line Items] | |||
Accounts receivable from related parties | 0 | ||
Deferred revenue | $ 1,200,000 | ||
Percentage of outstanding shares owned | 51.10% | ||
Investment income (loss) | $ 1,000,000 | (200,000) | |
Equity method investment in unconsolidated variable interest entity | 3,800,000 | 2,700,000 | |
Miscellaneous receivables | 0 | 900,000 | |
Falikang | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | 35,600,000 | ||
License and Development [Member] | Astellas [Member] | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | $ 130,400,000 | $ 33,500,000 | $ 158,800,000 |
Segment and Geographic Inform_3
Segment and Geographic Information - Additional information (Detail) - Segment | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of operating segment | 1 | |
Customer Concentration Risk [Member] | Percentage of Revenue [Member] | Roxadustat [Member] | ||
Concentration risk, percentage | 42.00% | |
Customer Concentration Risk [Member] | Percentage of Accounts Receivable [Member] | Roxadustat [Member] | ||
Concentration risk, percentage | 64.00% |
Segment and Geographic Inform_4
Segment and Geographic Information - Schedule of Revenue by Geographic Area (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 235,309 | $ 176,319 | $ 256,577 |
Europe [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 131,243 | 17,954 | 145,641 |
Japan [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 2,305 | 19,824 | (23,167) |
China [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 55,640 | 73,361 | 20,967 |
United States [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 46,121 | 65,180 | 113,134 |
All other [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 0 | $ 0 | $ 2 |
Segment and Geographic Inform_5
Segment and Geographic Information - Schedule of Inventory by Geographic Area (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Segment Reporting Information [Line Items] | ||
Total inventory | $ 31,015 | $ 16,530 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Total inventory | 5,522 | 1,080 |
China [Member] | ||
Segment Reporting Information [Line Items] | ||
Total inventory | $ 25,493 | $ 15,450 |
Segment and Geographic Inform_6
Segment and Geographic Information - Schedule of Inventory by Inventory Ownership (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Segment Reporting Information [Line Items] | ||
Total inventory | $ 31,015 | $ 16,530 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Total inventory | 11,695 | 4,715 |
China [Member] | ||
Segment Reporting Information [Line Items] | ||
Total inventory | $ 19,320 | $ 11,815 |
Segment and Geographic Inform_7
Segment and Geographic Information - Schedule of Long Lived Assets by Geographic Area (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 28,277 | $ 33,647 |
United States [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | 15,002 | 20,673 |
China [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 13,275 | $ 12,974 |
Segment and Geographic Inform_8
Segment and Geographic Information - Summary of Finance and Operating Lease Right of Use Assets by Geographical Location (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Total finance lease right-of-use assets | $ 761 | $ 29,606 |
Total operating lease right-of-use assets | 91,112 | 2,043 |
United States [Member] | ||
Total finance lease right-of-use assets | 730 | 29,551 |
Total operating lease right-of-use assets | 87,113 | 47 |
China [Member] | ||
Total finance lease right-of-use assets | 31 | 55 |
Total operating lease right-of-use assets | $ 3,999 | $ 1,996 |
Segment and Geographic Inform_9
Segment and Geographic Information - Schedule of Customer Concentration by Collaboration Partners and Distribution Entity (Detail) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Percentage of Revenue [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 57.00% | 21.00% | 48.00% |
Percentage of Revenue [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 20.00% | 37.00% | 52.00% |
Percentage of Revenue [Member] | Falikang—Related party | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 15.00% | 0.00% | 0.00% |
Percentage of Accounts Receivable [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 63.00% | 10.00% | |
Percentage of Accounts Receivable [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 34.00% | 26.00% | |
Percentage of Accounts Receivable [Member] | Falikang—Related party | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 0.00% | 0.00% |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Valuation Allowances for Deferred Tax Assets [Member] | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | $ 337,824 | $ 213,847 | $ 193,987 |
Charged (Credited) to Statement of Operation | 71,986 | 123,977 | 19,860 |
Charged to Other Accounts - Liabilities and Equity | 0 | 0 | 0 |
Deductions, Net | 0 | 0 | 0 |
Balance at End of Year | 409,810 | 337,824 | 213,847 |
Valuation Allowance for Rebates and Discounts [Member] | |||
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | 548 | 1,102 | 0 |
Charged (Credited) to Statement of Operation | 44,258 | 16,497 | 1,102 |
Charged to Other Accounts - Liabilities and Equity | (734) | (14,867) | 0 |
Deductions, Net | (29,629) | (2,184) | 0 |
Balance at End of Year | $ 14,443 | $ 548 | $ 1,102 |