Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN, INC. | |
Entity Central Index Key | 0000921299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.01 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-36740 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0357827 | |
Entity Address, Address Line One | 409 Illinois Street | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94158 | |
City Area Code | 415 | |
Local Phone Number | 978-1200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock Shares Outstanding | 92,709,943 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 274,527 | $ 678,393 |
Short-term investments | 211,875 | 8,144 |
Accounts receivable, net ($23,126 and $4,127 from related parties) | 35,994 | 41,883 |
Inventories | 29,315 | 16,530 |
Prepaid expenses and other current assets ($0 and $889 from related parties) | 21,688 | 10,160 |
Total current assets | 573,399 | 755,110 |
Restricted time deposits | 2,072 | 2,072 |
Long-term investments | 142,636 | 244 |
Property and equipment, net | 29,052 | 33,647 |
Finance lease right-of-use assets | 771 | 29,606 |
Equity method investment in unconsolidated variable interest entity | 3,421 | 2,728 |
Operating lease right-of-use assets | 94,055 | 2,043 |
Other assets | 5,107 | 1,390 |
Total assets | 850,513 | 826,840 |
Current liabilities: | ||
Accounts payable ($0 and $1,118 to a related party) | 23,868 | 24,789 |
Accrued and other current liabilities ($18 and $24 to a related party) | 151,346 | 118,333 |
Deferred revenue ($9,113 and $2,907 to a related party) | 23,256 | 6,547 |
Finance lease liabilities, current | 15 | 12,330 |
Operating lease liabilities, current | 10,831 | 1,188 |
Total current liabilities | 209,316 | 163,187 |
Product development obligations | 17,914 | 18,697 |
Deferred revenue, net of current ($10,604 and $4,636 to a related party) | 162,415 | 138,474 |
Finance lease liabilities, non-current | 5 | 25,391 |
Operating lease liabilities, non-current | 91,478 | 853 |
Other long-term liabilities | 24,322 | 38,789 |
Total liabilities | 505,450 | 385,391 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at September 30, 2021, and December 31, 2020 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2021, and December 31, 2020; 92,708 and 91,441 shares issued and outstanding at September 30, 2021, and December 31, 2020 | 927 | 914 |
Additional paid-in capital | 1,458,979 | 1,399,774 |
Accumulated other comprehensive loss | (4,158) | (4,499) |
Accumulated deficit | (1,129,956) | (974,011) |
Total stockholders’ equity | 325,792 | 422,178 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 345,063 | 441,449 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 850,513 | $ 826,840 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related parties | $ 23,126 | $ 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 | 18 | 24 |
Deferred revenue current to related party | 9,113 | 2,907 |
Deferred revenue non-current to related party | $ 10,604 | $ 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 | 92,708,000 | 91,441,000 |
Common stock, shares outstanding | 92,708,000 | 91,441,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 |
Operating costs and expenses: | ||||
Cost of goods sold | $ 3,266 | $ 2,207 | $ 9,746 | $ 6,253 |
Cost, Product and Service [Extensible List] | Product Revenue, Net [Member] | Product Revenue, Net [Member] | Product Revenue, Net [Member] | Product Revenue, Net [Member] |
Research and development | $ 75,880 | $ 58,476 | $ 273,123 | $ 174,792 |
Selling, general and administrative | 25,853 | (48,981) | 89,186 | 64,157 |
Total operating costs and expenses | 104,999 | 11,702 | 372,055 | 245,202 |
Income (loss) from operations | 50,974 | 32,330 | (153,289) | (133,882) |
Interest and other, net | ||||
Interest expense | (109) | (580) | (965) | (1,864) |
Interest income and other income (expenses), net | (1,303) | 1,482 | (2,120) | 5,292 |
Total interest and other, net | (1,412) | 902 | (3,085) | 3,428 |
Income (loss) before income taxes | 49,562 | 33,232 | (156,374) | (130,454) |
Provision for income taxes | 106 | 215 | 235 | 190 |
Investment income (loss) in unconsolidated variable interest entity | 342 | (13) | 664 | (13) |
Net income (loss) | $ 49,798 | $ 33,004 | $ (155,945) | $ (130,657) |
Net income (loss) per share: | ||||
Basic | $ 0.54 | $ 0.36 | $ (1.69) | $ (1.46) |
Diluted | $ 0.54 | $ 0.35 | $ (1.69) | $ (1.46) |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 92,644 | 90,558 | 92,206 | 89,414 |
Diluted | 92,808 | 93,678 | 92,206 | 89,414 |
License Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 116,434 | $ 0 | $ 116,434 | $ 0 |
Development and Other Revenue [Member] | ||||
Revenue: | ||||
Total revenue | 26,097 | 20,663 | 60,325 | 59,065 |
Product Revenue, Net [Member] | ||||
Revenue: | ||||
Total revenue | 13,442 | 22,683 | 42,175 | 43,331 |
Drug Product Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 686 | $ (168) | $ 8,924 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
License and milestone revenue from a related party | $ 108,434 | $ 0 | $ 108,434 | $ 0 |
Collaboration services and other revenue from a related party | 14,127 | 4,736 | 20,383 | 14,239 |
Product revenue from a related party | 10,328 | 0 | 32,495 | 0 |
Drug product revenue from a related party | $ 0 | $ (3,957) | $ 2,056 | $ 4,281 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 49,798 | $ 33,004 | $ (155,945) | $ (130,657) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 396 | (2,038) | 366 | (3,372) |
Available-for-sale investments: | ||||
Unrealized gain (loss) on investments, net of tax effect | 13 | (657) | (25) | (137) |
Other comprehensive income (loss), net of taxes | 409 | (2,695) | 341 | (3,509) |
Comprehensive income (loss) | $ 50,207 | $ 30,309 | $ (155,604) | $ (134,166) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Noncontrolling Interests [Member] |
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 income (loss) | (130,657) | $ 0 | 0 | 0 | (130,657) | 0 |
Change in unrealized gain or loss on investments | (137) | 0 | 0 | (137) | 0 | 0 |
Foreign currency translation adjustments | (3,372) | 0 | 0 | (3,372) | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 17,240 | $ 32 | 17,208 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 3,227,267 | |||||
Stock-based compensation | 52,451 | $ 0 | 52,451 | 0 | 0 | 0 |
Balance at Sep. 30, 2020 | 470,931 | $ 909 | 1,370,384 | (4,256) | (915,377) | 19,271 |
Balance, Shares at Sep. 30, 2020 | 90,884,756 | |||||
Balance at Jun. 30, 2020 | 415,143 | $ 902 | 1,344,912 | (1,561) | (948,381) | 19,271 |
Balance, Shares at Jun. 30, 2020 | 90,228,293 | |||||
Net income (loss) | 33,004 | $ 0 | 0 | 0 | 33,004 | 0 |
Change in unrealized gain or loss on investments | (657) | 0 | 0 | (657) | 0 | 0 |
Foreign currency translation adjustments | (2,038) | 0 | 0 | (2,038) | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 7,588 | $ 7 | 7,581 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 656,463 | |||||
Stock-based compensation | 17,891 | $ 0 | 17,891 | 0 | 0 | 0 |
Balance at Sep. 30, 2020 | 470,931 | $ 909 | 1,370,384 | (4,256) | (915,377) | 19,271 |
Balance, Shares at Sep. 30, 2020 | 90,884,756 | |||||
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 income (loss) | (155,945) | $ 0 | 0 | 0 | (155,945) | 0 |
Change in unrealized gain or loss on investments | (25) | 0 | 0 | (25) | 0 | 0 |
Foreign currency translation adjustments | 366 | 0 | 0 | 366 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 5,129 | $ 13 | 5,116 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,267,319 | |||||
Stock-based compensation | 54,089 | $ 0 | 54,089 | 0 | 0 | 0 |
Balance at Sep. 30, 2021 | 345,063 | $ 927 | 1,458,979 | (4,158) | (1,129,956) | 19,271 |
Balance, Shares at Sep. 30, 2021 | 92,707,952 | |||||
Balance at Jun. 30, 2021 | 279,851 | $ 926 | 1,443,975 | (4,567) | (1,179,754) | 19,271 |
Balance, Shares at Jun. 30, 2021 | 92,608,929 | |||||
Net income (loss) | 49,798 | $ 0 | 0 | 0 | 49,798 | 0 |
Change in unrealized gain or loss on investments | 13 | 0 | 0 | 13 | 0 | 0 |
Foreign currency translation adjustments | 396 | 0 | 0 | 396 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | (699) | $ 1 | (700) | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 99,023 | |||||
Stock-based compensation | 15,704 | $ 0 | 15,704 | 0 | 0 | 0 |
Balance at Sep. 30, 2021 | $ 345,063 | $ 927 | $ 1,458,979 | $ (4,158) | $ (1,129,956) | $ 19,271 |
Balance, Shares at Sep. 30, 2021 | 92,707,952 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities | ||
Net loss | $ (155,945) | $ (130,657) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 7,717 | 8,671 |
Amortization of finance lease right-of-use assets | 4,509 | 7,886 |
Net accretion of premium and discount on investments | 1,447 | 103 |
Unrealized loss on equity investments | 12 | (3) |
Investment (gain) loss in unconsolidated variable interest entity | (664) | 13 |
Loss (gain) on disposal of property and equipment | 232 | (3) |
Stock-based compensation | 54,089 | 52,451 |
Expense for acquired in-process research and development asset | 25,000 | 0 |
Realized loss on sales of available-for-sale securities | 8 | 258 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 6,131 | 2,520 |
Inventories | (12,658) | (5,206) |
Prepaid expenses and other current assets | (11,160) | 121,923 |
Operating lease right-of-use assets | 1,232 | 678 |
Other assets | (3,563) | 6,857 |
Accounts payable | (1,115) | 1,440 |
Accrued and other liabilities | 31,997 | 3,478 |
Operating lease liabilities, current | 410 | (229) |
Deferred revenue | 40,650 | 45,925 |
Accrued interest for finance lease liabilities | (76) | (196) |
Operating lease liabilities, non-current | (1,326) | (479) |
Other long-term liabilities | (14,199) | (26,600) |
Net cash provided by (used in) operating activities | (27,272) | 88,830 |
Investing activities | ||
Purchases of property and equipment | (3,790) | (1,604) |
Payment made for acquired in-process research and development asset | (25,000) | 0 |
Payment made for investment in unconsolidated variable interest entity | 0 | (2,145) |
Purchases of available-for-sale securities | (397,909) | (38) |
Proceeds from sales of available-for-sale securities | 4,000 | 10,606 |
Proceeds from maturities of investments | 46,294 | 301,900 |
Net cash provided by (used in) investing activities | (376,405) | 308,719 |
Financing activities | ||
Repayments of finance lease liabilities | (5,359) | (9,254) |
Repayments of lease obligations | (302) | (302) |
Cash paid for payroll taxes on restricted stock unit releases | (6,734) | (9,007) |
Proceeds from issuance of common stock | 11,863 | 26,247 |
Net cash provided by (used in) financing activities | (532) | 7,684 |
Effect of exchange rate change on cash and cash equivalents | 343 | 969 |
Net increase (decrease) in cash and cash equivalents | (403,866) | 406,202 |
Total cash and cash equivalents at beginning of period | 678,393 | 126,266 |
Total cash and cash equivalents at end of period | $ 274,527 | $ 532,468 |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 1. Significant Accounting Policies Description of Operations 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 to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, FibroGen’s most advanced product, is an oral small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (“HIF-PH”) activity that is approved in the European Union, Great Britain, Japan, South Korea, and Chile for the treatment of anemia caused by chronic kidney disease (“CKD”) in dialysis and non-dialysis patients, 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, a human monoclonal antibody targeting connective tissue growth factor, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy. Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. 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 as one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020 (“2020 Form 10-K”). Use of Estimates The preparation of the condensed 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 Significant Accounting Policies Net Loss per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) $ 49,798 $ 33,004 $ (155,945 ) $ (130,657 ) Weighted average shares used to compute net income (loss) per share: Basic 92,644 90,558 92,206 89,414 Dilutive effect of potential common shares 164 3,120 — — Diluted 92,808 93,678 92,206 89,414 Net income (loss) per share: Basic $ 0.54 $ 0.36 $ (1.69 ) $ (1.46 ) Diluted $ 0.54 $ 0.35 $ (1.69 ) $ (1.46 ) 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 nine months ended September 30, 2021 and 2020, 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 potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling 12.5 million and 4.2 million for the three months ended September 30, 2021 and 2020, and totaling 9.7 million and 8.9 million for the nine months ended September 30, 2021 and 2020, respectively, as they were anti-dilutive. 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 U.S. Food and Drug Administration (“FDA”) or other regulatory authorities, 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 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 period ended September 30, 2021 and is currently evaluating the impact on its consolidated financial statements and related disclosures upon adoption of this guidance. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2020 Form 10-K, except for the updates to the following: 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 recognize 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 Beijing Falikang Pharmaceutical Co., Ltd. (“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 AB (“AstraZeneca”) and FibroGen (China) Medical Technology Development Co., Ltd. (“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 3, 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 2, 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 believes 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: ● ● ● Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020; and ● o o 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 key estimates such as total sales quantity, performance period, gross transfer price and profit share, which require a substantial degree of judgment. Any net transfer 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: ● ● ● Revenue from Contracts with Customers ● Other discounts and rebates, including key account hospital sales reba t e 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 ● 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 substantial degree of 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. License Acquisition Agreement On June 16, 2021, the Company entered into an exclusive license and option agreement with HiFiBiO Therapeutics (“HiFiBiO”) (“HiFiBiO Agreement”), pursuant to which the Company exclusively licensed all product candidates in HiFiBiO’s Galectin-9 program and will have the sole right to develop them worldwide. The Company has also obtained exclusive options to license all product candidates in HiFiBiO’s CXCR5 and CCR8 programs. Under the terms of the HiFiBiO Agreement, the Company will make a $25.0 million upfront payment to HiFiBiO, as well as payments upon option exercise. 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 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 initial upfront payment of $25.0 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 September 30, 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. |
Collaboration Agreements, Licen
Collaboration Agreements, License Agreement and Revenues | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements, License Agreement and Revenues | 2 . Collaboration Agreements, License Agreement and Revenues Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“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 Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. The aggregate amount of consideration received through September 30, 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 active pharmaceutical ingredient (“ API ”) to Astellas for the roxadustat commercial purposes in Japan . The commercial terms of the Japan Agreement relating to the transfer price for roxadustat for commercial use remain substantially the same, reflecting an adjustment for the manufacture of drug product by Astellas rather than FibroGen. The related drug product revenue, as described in details under Drug Product Revenue section below, was $ 2.1 million for the nine months ended September 30 , 2021. 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 ® The aggregate amount of consideration received under the Europe Agreement through September 30, 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. During the first quarter of 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement with Astellas 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 shipped bulk drug product to Astellas as pre-commercial supply for process validation purposes during the first quarter of 2021. The Company continued to record the consideration of $11.8 million from this shipment as deferred revenue as of September 30, 2021, as described in details under Drug Product Revenue 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 (such amounts were fully received as of April 2020), (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. The aggregate amount of consideration received under the U.S./RoW Agreement through September 30, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Master Supply Agreement under the U.S./RoW Agreement with AstraZeneca (“Master Supply Agreement”) 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 (“CRL”) regarding roxadustat’s New Drug Application 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 continued to record $11.2 million as deferred revenue as of September 30, 2021. See details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into the China Agreement (“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. The aggregate amount of such consideration received for milestone and upfront payments through September 30, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen China Anemia Holdings, Ltd., 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. 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 transfer 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 three and nine months ended September 30, 2021, the Company recognized $10.3 million and $32.5 million, respectively, 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 three and nine months ended September 30, 2021, the Company recognized $3.1 million and 9.7 million, respectively, of net product revenue from sales directly to distributors in a few provinces in China, as Product Revenue, Net Eluminex Agreement In July 2021, FibroGen exclusively licensed to Eluminex Biosciences (Suzhou) Limited (“Eluminex”) global rights to its investigational biosynthetic cornea derived from recombinant human collagen Type III. Under the terms of the agreement with Eluminex (the “Eluminex Agreement”), Eluminex will make an $8.0 million upfront payment to FibroGen. In addition, FibroGen may receive up to a total of $64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea. FibroGen will also be eligible to receive mid single-digit to low double-digit of cornea products, and low single-digit to mid single-digit royalties based upon worldwide net sales of other recombinant human collagen type III products that are not cornea products The Company accounted for this agreement under ASC 606 and identified one performance obligation at inception of the agreement related to the granting of the license rights to the investigational biosynthetic cornea derived from recombinant human collagen Type III. The Company based its assessment on the determination that Eluminex can benefit from the granted license on its own by developing and commercializing the underlying product using its own resources. All components of the transaction price in the agreement were allocated to the single performance obligation. Additionally, the Company will be responsible for supplying the cornea product at 110% of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex. Supply of the cornea product will be managed by a separate agreement and is considered a separate performance obligation. During the third quarter of 2021, the $8.0 million upfront license payment was recognized as license revenue for the performance obligation satisfied. This amount was recorded as an unbilled contract asset as of September 30, 2021 in the prepaid expenses and other current assets in the condensed consolidated balance sheets. The remaining future variable consideration related to future manufacturing, clinical, regulatory milestone payments as described above were fully constrained because the Company cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainties of success with these future milestones. For commercial milestones and royalties, the Company determined that the license is the predominant item to which the royalties or sales-based milestones relate and revenue will be recognized when the corresponding milestones and royalties are earned. License Revenue and Development Revenue Recognized Under the Collaboration Agreements and License Agreement Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Japan License revenue $ — $ — $ — $ — Development revenue $ 66 $ 86 $ 245 $ 413 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 September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 100,347 $ — $ 100,347 Development revenue 16,595 — 16,595 Total license and development revenue $ 116,942 $ — $ 116,942 The revenue recognized under the Japan Agreement for the three months ended September 30, 2021 included immaterial revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The Company does not expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Japan Agreement. Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Europe License revenue $ 108,434 $ — $ 108,434 $ — Development revenue $ 14,061 $ 4,651 $ 20,138 $ 13,827 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 September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 596,385 $ — $ 596,385 Development revenue 269,100 — 269,100 Total license and development revenue $ 865,485 $ — $ 865,485 The revenue recognized under the Europe Agreement for the three months ended September 30, 2021 included an increase in revenue of $0.2 million resulting from changes to estimated variable consideration. The remainder of the transaction price related to the Europe Agreement includes $15.6 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 U.S. / RoW and China License revenue $ — $ — $ — $ — Development revenue 11,970 15,220 39,939 43,525 China performance obligation $ — $ 706 $ — $ 1,300 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 with AstraZeneca, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 594,713 1,428 596,141 China performance obligation * 32,495 160,267 192,762 Total license and development revenue $ 969,052 $ 161,695 ** $ 1,130,747 * 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 September 30, 2021, deferred revenue included $154.7 million related to the U.S./RoW and China Agreement, which represents the net of $161.7 million of deferred revenue presented above and a $7.0 million unbilled co-development revenue under the China Amendment with AstraZeneca. The revenue recognized under the U.S./RoW Agreement for the three months ended September 30, 2021 included a reduction in revenue of $0.8 million resulting from changes to estimated variable consideration. The remainder of the transaction price related to the U.S./RoW Agreement and China Agreement includes $35.3 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation. The amount allocated to the U.S./RoW Agreement is expected to be recognized over the remaining development service period. The amount allocated to the China performance obligation is expected to be recognized as the Company transfers control of the commercial products to Falikang. Amounts recognized as revenue under the Eluminex were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Eluminex License revenue $ 8,000 $ — $ 8,000 $ — Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Direct Sales: Gross revenue $ 3,249 $ 27,900 $ 10,908 $ 53,105 Discounts and rebates (133 ) (5,209 ) (1,314 ) (9,721 ) Sales returns (2 ) (8 ) 86 (53 ) Direct sales revenue, net 3,114 22,683 9,680 43,331 Sales to Falikang: Gross transfer price 31,179 — 82,294 — Profit share (12,090 ) — (31,726 ) — Net transfer price 19,089 — 50,568 — Increase in deferred revenue (8,761 ) — (18,073 ) — Sales to Falikang revenue, net 10,328 — 32,495 — Total product revenue, net $ 13,442 $ 22,683 $ 42,175 $ 43,331 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 various sales rebates and discounts. The total discounts and rebates were $0.1 million and $5.2 million for the three months ended September 30, 2021 and 2020, and $1.3 million and $9.7 million for the nine months ended September 30, 2021 and 2020, respectively. The discounts and rebates primarily 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. In addition, the discounts and rebates for the three and nine months ended September 30, 2020 primarily included the non-key account hospital listing award calculated based on eligible non-key account hospital listing to date achieved by each distributor with certain requirements met during the period. 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 Company’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 contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at September 30, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (944 ) $ 5,913 $ (167 ) $ (10,335 ) As of September 30, 2021 and December 31, 2020, the total contract liabilities were $10.3 million and $15.1 million, which were included in accrued and other current liabilities in the condensed consolidated balance sheet. The rebates and discounts reflected as reductions to gross accounts receivable for direct sales was $0.8 million and $0.5 million as of September 30, 2021 and December 31, 2020, 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 transfer price for FibroGen Beijing’s product sales to Falikang is based on a gross transfer 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 transfer 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 three and nine months ended September 30, 2021, following updates to its estimates, the Company deferred $8.8 million and $18.1 million, respectively, from the net transfer 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 September 30, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (55,424 ) $ 32,495 $ (160,267 ) 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 September 30, 2021, approximately $8.5 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 $23.1 million as of September 30, 2021. Drug Product Revenue Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Astellas $ — $ (3,957 ) $ 2,056 $ 4,281 AstraZeneca — 4,643 (2,224 ) 4,643 Drug product revenue $ — $ 686 $ (168 ) $ 8,924 During the second quarter of 2021, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement. Based on the CRL 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, and continued to record $11.2 million as deferred revenue as of September 30, 2021. During the first six months of 2021, the Company updated its estimate of variable consideration and recorded an adjustment of $2.1 million to the drug product revenue related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018. 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 first quarter of 2021, the Company shipped 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 continued to record the consideration of $11.8 million from this shipment as deferred revenue as of September 30, 2021, due to a high degree of uncertainty associated with the final consideration. The deferred revenue will be recognized as and when the uncertainty is resolved. The following table includes a roll-forward of the above- mentioned deferred revenue s that are considered as contract liabilit ies related to drug product (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at September 30, 2021 Astellas - Japan Agreement $ — $ (1,974 ) $ — $ (1,974 ) Astellas - Europe Agreement (5,984 ) (11,759 ) — (17,743 ) AstraZeneca - U.S. Agreement — (11,171 ) — (11,171 ) Drug product revenue - deferred revenue $ (5,984 ) $ (24,904 ) $ — $ (30,888 ) |
Variable Interest Entity
Variable Interest Entity | 9 Months Ended |
Sep. 30, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Variable Interest Entity | 3. Variable Interest Entity 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, Consolidation The Company’s equity method investment in Falikang was as follows (in thousands): Entity Ownership Percentage Balance at December 31, 2020 Share of Net Income Currency Translation Balance at September 30, 2021 Falikang 51.1 % $ 2,728 $ 664 $ 29 $ 3,421 Falikang is considered a related party to the Company. See Note 9, Related Party Transactions |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): September 30, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 171,628 $ — $ — $ 171,628 Corporate bonds — 126,994 — 126,994 Commercial paper — 107,402 — 107,402 U.S. government bonds 73,108 — — 73,108 Agency bonds — 23,399 — 23,399 Asset-backed securities — 27,256 — 27,256 Foreign government bonds — 8,127 — 8,127 Equity investments 225 — — 225 Total $ 244,961 $ 293,178 $ — $ 538,139 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 during the three and nine months ended September 30, 2021. The Company’s financial liabilities related to lease obligations as of September 30, 2021 and December 31, 2020 were immaterial. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | 5. Leases The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item September 30, 2021 December 31, 2020 Assets Finance: Right-of-use assets cost $ 2,033 $ 50,477 Accumulated amortization (1,262 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 771 29,606 Operating: Right-of-use assets cost 100,710 3,934 Accumulated amortization (6,655 ) (1,891 ) Operating lease right-of-use assets, net Operating lease right-of-use assets 94,055 2,043 Total lease assets $ 94,826 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 15 $ 12,330 Operating lease liabilities Operating lease liabilities, current 10,831 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 5 25,391 Operating lease liabilities Operating lease liabilities, non-current 91,478 853 Total lease liabilities $ 102,329 $ 39,762 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 $4.5 million to the condensed consolidated statement of cash flow for the nine months ended September 30, 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 components of lease expense were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Statement of Operations Line Item 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 116 $ 2,639 $ 4,509 $ 7,886 Interest on lease liabilities Interest expense — 462 627 1,511 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 4,273 304 6,435 868 Sublease income Selling, general and administrative expenses (263 ) (301 ) (838 ) (899 ) Total lease cost $ 4,126 $ 3,104 $ 10,733 $ 9,366 Supplemental cash flow information related to leases were as follows (in thousands): Nine Months Ended September 30, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 6,090 $ 812 Operating cash flows from finance leases 628 1,468 Financing cash flows from finance leases 5,359 9,254 Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 330 434 Operating leases 3,509 55 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: September 30, 2021 December 31, 2020 Weighted-average remaining lease term (years): Finance leases 1.2 2.9 Operating leases 7.0 1.8 Weighted-average discount rate: Finance leases 4.58 % 4.39 % Operating leases 4.75 % 4.74 % Maturities of lease liabilities as of September 30, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2021 (remaining three month period) $ 6 $ 3,697 2022 12 15,517 2023 3 13,454 2024 — 16,797 2025 — 18,192 Beyond 2025 — 53,881 Total future lease payments 21 121,538 Less: Interest (1 ) (19,229 ) Present value of lease liabilities $ 20 $ 102,309 |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 6. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): September 30, 2021 December 31, 2020 Cash $ 90,899 $ 88,046 Commercial paper 12,000 — Money market funds 171,628 590,347 Total cash and cash equivalents $ 274,527 $ 678,393 At September 30, 2021 and December 31, 2020, a total of $77.4 million and $66.0 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations. 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): September 30, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 127,005 $ 35 $ (46 ) $ 126,994 Commercial paper 95,402 — — 95,402 U.S. government bonds 73,119 5 (16 ) 73,108 Agency bonds 23,399 4 (4 ) 23,399 Asset-backed securities 27,261 2 (7 ) 27,256 Foreign government bonds 8,127 — — 8,127 Equity investments 118 107 — 225 Total investments $ 354,431 $ 153 $ (73 ) $ 354,511 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 At September 30, 2021, the available-for-sale investments had contractual maturities range from several months to two years. During the three and nine months ended September 30, 2021 and 2020, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ 820 $ 2,303 Work-in-progress 20,662 8,114 Finished goods 7,833 6,113 Total inventories $ 29,315 $ 16,530 The Company capitalizes inventory costs for FibroGen Beijing’s production of roxadustat for commercial sales purposes. The Company started capitalizing inventory costs in the U.S. in the second quarter of 2020 prior to regulatory approvals in the U.S., Europe and other territories. As of September 30, 2021 and December 31, 2020, inventory capitalized in the U.S. was 40% 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 for three and nine months ended September 30, 2021 and 2020. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, 2021 December 31, 2020 Unbilled contract assets $ 15,003 $ 2,147 Deferred revenues from associated contracts (7,003 ) (2,147 ) Net unbilled contract assets 8,000 — Prepaid assets 6,598 8,353 Other current assets 7,090 1,807 Total prepaid expenses and other current assets $ 21,688 $ 10,160 The unbilled contract assets as of September 30, 2021 included the $8.0 million unbilled upfront license payment under the Eluminex Agreement, and $7.0 million related to unbilled co-development revenue under the China Amendment with AstraZeneca. The unbilled contract assets as of December 31, 2020 were related to unbilled co-development revenue under the China Amendment with AstraZeneca. See Note 2, Collaboration Agreements, License Agreement and Revenues Property and Equipment Property and equipment consisted of the following (in thousands): September 30, 2021 December 31, 2020 Leasehold improvements $ 102,843 $ 102,006 Laboratory equipment 18,809 18,143 Machinery 8,234 8,312 Computer equipment 9,262 9,545 Furniture and fixtures 6,175 6,128 Construction in progress 1,920 760 Total property and equipment $ 147,243 $ 144,894 Less: accumulated depreciation (118,191 ) (111,247 ) Property and equipment, net $ 29,052 $ 33,647 Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Preclinical and clinical trial accruals $ 64,212 $ 44,113 Payroll and related accruals 20,121 22,800 Contract liabilities to pharmaceutical distributors 10,335 15,137 Accrued co-promotion expenses - current 27,071 11,537 Roxadustat profit share to AstraZeneca 7,764 7,007 Property taxes and other taxes 11,532 5,970 Professional services 4,565 4,869 Other 5,746 6,900 Total accrued and other current liabilities $ 151,346 $ 118,333 The profit share liability to AstraZeneca as of September 30, 2021 and December 31, 2020 was $7.8 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. Other Long-term Liabilities Other long-term liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 13,514 $ 27,424 Other long-term tax liabilities 9,120 8,675 Other 1,688 2,690 Total other long-term liabilities $ 24,322 $ 38,789 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 8,220 $ 11,236 $ 31,123 $ 32,653 Selling, general and administrative 7,484 6,655 22,966 19,798 Total stock-based compensation expense $ 15,704 $ 17,891 $ 54,089 $ 52,451 The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock Options Expected term (in years) 5.8 5.6 5.7 5.7 Expected volatility 68.1 % 59.0 % 61.8 % 67.7 % Risk-free interest rate 1.2 % 0.3 % 0.9 % 0.8 % Expected dividend yield — — — — Weighted average estimated fair value $ 11.08 $ 22.48 $ 21.45 $ 18.11 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 50.6 - 104.4 % 50.4 - 77.1 % 47.1 - 104.4 % 49.5 - 77.1 % Risk-free interest rate 0.0 - 1.6 % 0.2 - 2.9 % 0.0 - 2.2 % 0.2 - 2.9 % Expected dividend yield — — — — Weighted average estimated fair value $ 12.37 $ 17.00 $ 13.57 $ 17.74 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes Provision for (benefit from) income tax for the three and nine months ended September 30, 2021 and 2020 were primarily due to foreign taxes. Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its net deferred tax assets as it does not currently believe that realization of those assets is more likely than not. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related Party Transactions Astellas is an equity investor in the Company and is considered a related party. The Company recorded revenue related to collaboration agreements with Astellas of $122.6 million and $4.7 million for the three months ended September 30, 2021 and 2020, and $128.8 million and $14.2 million for the nine months ended September 30, 2021 and 2020, respectively. The Company also recorded drug product revenue from Astellas of $2.1 million and $4.3 million for the nine months ended September 30, 2021 and 2020, respectively. See Note 2, Collaboration Agreements, License Agreement and Revenues The Company’s expense related to collaboration agreements with Astellas was immaterial for each of the three and nine months ended September 30, 2021 and 2020. As of September 30, 2021 and December 31, 2020, accounts receivable from Astellas were $2.4 million and $4.1 million, respectively. As of September 30, 2021 and December 31, 2020, total deferred revenue from Astellas was $19.7 million and $7.5 million, respectively. As of September 30, 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 3, Variable Interest Entity For the three and nine months ended September 30, 2021, the net product revenue from Falikang was $10.3 million and $32.5 million, respectively. See Note 2, Collaboration Agreements, License Agreement and Revenues For the three and nine months ended September 30, 2021, the investment income in Falikang was $0.3 million and $0.7 million, respectively. The investment loss in Falikang for the three and nine months ended September 30, 2020 was immaterial. As of September 30, 2021 and December 31, 2020, the Company’s equity method investment in Falikang was $3.4 million and $2.7 million, respectively. See Note 3, Variable Interest Entity As of September 30, 2021 , accounts receivable, net, from Falikang was of $ 20.7 million. As of September 30, 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. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Contract Obligations As of September 30, 2021, the Company had outstanding total non-cancelable purchase obligations of $77.4 million, including $22.0 million for manufacture and supply of roxadustat, $46.5 million for manufacture and supply of pamrevlumab, and $8.9 million for other purchases. 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 September 30, 2021, future milestone payments for research and pre-clinical stage development programs consisted of up to approximately $359.1 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (for Galectin-9), 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 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 material accruals for any currently active legal action in its condensed consolidated balance sheets as of September 30, 2021, as it 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 lead plaintiff. Plaintiff filed its consolidated amended complaint on October 29, 2021. Defendants’ motion to dismiss the consolidated amended complaint is due December 20, 2021. 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 the Company’s officers and directors, as well as the Company as nominal defendant, and asserts state and federal claims based on some of the same alleged misstatements as the securities class action complaints. 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. 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. 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Description of Operations | Description of Operations 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 to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, FibroGen’s most advanced product, is an oral small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (“HIF-PH”) activity that is approved in the European Union, Great Britain, Japan, South Korea, and Chile for the treatment of anemia caused by chronic kidney disease (“CKD”) in dialysis and non-dialysis patients, 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, a human monoclonal antibody targeting connective tissue growth factor, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy. |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. 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 as one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020 (“2020 Form 10-K”). |
Use of Estimates | Use of Estimates The preparation of the condensed 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 Significant Accounting Policies |
Net Income (Loss) per Share | Net Loss per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) $ 49,798 $ 33,004 $ (155,945 ) $ (130,657 ) Weighted average shares used to compute net income (loss) per share: Basic 92,644 90,558 92,206 89,414 Dilutive effect of potential common shares 164 3,120 — — Diluted 92,808 93,678 92,206 89,414 Net income (loss) per share: Basic $ 0.54 $ 0.36 $ (1.69 ) $ (1.46 ) Diluted $ 0.54 $ 0.35 $ (1.69 ) $ (1.46 ) 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 nine months ended September 30, 2021 and 2020, 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 potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling 12.5 million and 4.2 million for the three months ended September 30, 2021 and 2020, and totaling 9.7 million and 8.9 million for the nine months ended September 30, 2021 and 2020, respectively, as they were anti-dilutive. |
Risks and Uncertainties | 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 U.S. Food and Drug Administration (“FDA”) or other regulatory authorities, |
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 |
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 period ended September 30, 2021 and is currently evaluating the impact on its consolidated financial statements and related disclosures upon adoption of this guidance. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2020 Form 10-K, except for the updates to the following: 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 recognize 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 Beijing Falikang Pharmaceutical Co., Ltd. (“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 AB (“AstraZeneca”) and FibroGen (China) Medical Technology Development Co., Ltd. (“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 3, 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 2, 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 believes 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: ● ● ● Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020; and ● o o 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 key estimates such as total sales quantity, performance period, gross transfer price and profit share, which require a substantial degree of judgment. Any net transfer 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: ● ● ● Revenue from Contracts with Customers ● Other discounts and rebates, including key account hospital sales reba t e 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 ● 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 substantial degree of 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. License Acquisition Agreement On June 16, 2021, the Company entered into an exclusive license and option agreement with HiFiBiO Therapeutics (“HiFiBiO”) (“HiFiBiO Agreement”), pursuant to which the Company exclusively licensed all product candidates in HiFiBiO’s Galectin-9 program and will have the sole right to develop them worldwide. The Company has also obtained exclusive options to license all product candidates in HiFiBiO’s CXCR5 and CCR8 programs. Under the terms of the HiFiBiO Agreement, the Company will make a $25.0 million upfront payment to HiFiBiO, as well as payments upon option exercise. 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 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 initial upfront payment of $25.0 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 September 30, 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. |
Collaboration Agreements, License Agreement and Revenues | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“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 Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. The aggregate amount of consideration received through September 30, 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 active pharmaceutical ingredient (“ API ”) to Astellas for the roxadustat commercial purposes in Japan . The commercial terms of the Japan Agreement relating to the transfer price for roxadustat for commercial use remain substantially the same, reflecting an adjustment for the manufacture of drug product by Astellas rather than FibroGen. The related drug product revenue, as described in details under Drug Product Revenue section below, was $ 2.1 million for the nine months ended September 30 , 2021. 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 ® The aggregate amount of consideration received under the Europe Agreement through September 30, 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. During the first quarter of 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement with Astellas 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 shipped bulk drug product to Astellas as pre-commercial supply for process validation purposes during the first quarter of 2021. The Company continued to record the consideration of $11.8 million from this shipment as deferred revenue as of September 30, 2021, as described in details under Drug Product Revenue 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 (such amounts were fully received as of April 2020), (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. The aggregate amount of consideration received under the U.S./RoW Agreement through September 30, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Master Supply Agreement under the U.S./RoW Agreement with AstraZeneca (“Master Supply Agreement”) 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 (“CRL”) regarding roxadustat’s New Drug Application 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 continued to record $11.2 million as deferred revenue as of September 30, 2021. See details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into the China Agreement (“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. The aggregate amount of such consideration received for milestone and upfront payments through September 30, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen China Anemia Holdings, Ltd., 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. 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 transfer 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 three and nine months ended September 30, 2021, the Company recognized $10.3 million and $32.5 million, respectively, 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 three and nine months ended September 30, 2021, the Company recognized $3.1 million and 9.7 million, respectively, of net product revenue from sales directly to distributors in a few provinces in China, as Product Revenue, Net |
Product Revenue, Net | Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Direct Sales: Gross revenue $ 3,249 $ 27,900 $ 10,908 $ 53,105 Discounts and rebates (133 ) (5,209 ) (1,314 ) (9,721 ) Sales returns (2 ) (8 ) 86 (53 ) Direct sales revenue, net 3,114 22,683 9,680 43,331 Sales to Falikang: Gross transfer price 31,179 — 82,294 — Profit share (12,090 ) — (31,726 ) — Net transfer price 19,089 — 50,568 — Increase in deferred revenue (8,761 ) — (18,073 ) — Sales to Falikang revenue, net 10,328 — 32,495 — Total product revenue, net $ 13,442 $ 22,683 $ 42,175 $ 43,331 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 various sales rebates and discounts. The total discounts and rebates were $0.1 million and $5.2 million for the three months ended September 30, 2021 and 2020, and $1.3 million and $9.7 million for the nine months ended September 30, 2021 and 2020, respectively. The discounts and rebates primarily 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. In addition, the discounts and rebates for the three and nine months ended September 30, 2020 primarily included the non-key account hospital listing award calculated based on eligible non-key account hospital listing to date achieved by each distributor with certain requirements met during the period. 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 Company’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 contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at September 30, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (944 ) $ 5,913 $ (167 ) $ (10,335 ) As of September 30, 2021 and December 31, 2020, the total contract liabilities were $10.3 million and $15.1 million, which were included in accrued and other current liabilities in the condensed consolidated balance sheet. The rebates and discounts reflected as reductions to gross accounts receivable for direct sales was $0.8 million and $0.5 million as of September 30, 2021 and December 31, 2020, 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 transfer price for FibroGen Beijing’s product sales to Falikang is based on a gross transfer 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 transfer 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 three and nine months ended September 30, 2021, following updates to its estimates, the Company deferred $8.8 million and $18.1 million, respectively, from the net transfer 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 September 30, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (55,424 ) $ 32,495 $ (160,267 ) 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 September 30, 2021, approximately $8.5 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 $23.1 million as of September 30, 2021. |
Drug Product Revenue | Drug Product Revenue Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Astellas $ — $ (3,957 ) $ 2,056 $ 4,281 AstraZeneca — 4,643 (2,224 ) 4,643 Drug product revenue $ — $ 686 $ (168 ) $ 8,924 During the second quarter of 2021, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement. Based on the CRL 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, and continued to record $11.2 million as deferred revenue as of September 30, 2021. During the first six months of 2021, the Company updated its estimate of variable consideration and recorded an adjustment of $2.1 million to the drug product revenue related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018. 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 first quarter of 2021, the Company shipped 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 continued to record the consideration of $11.8 million from this shipment as deferred revenue as of September 30, 2021, due to a high degree of uncertainty associated with the final consideration. The deferred revenue will be recognized as and when the uncertainty is resolved. The following table includes a roll-forward of the above- mentioned deferred revenue s that are considered as contract liabilit ies related to drug product (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at September 30, 2021 Astellas - Japan Agreement $ — $ (1,974 ) $ — $ (1,974 ) Astellas - Europe Agreement (5,984 ) (11,759 ) — (17,743 ) AstraZeneca - U.S. Agreement — (11,171 ) — (11,171 ) Drug product revenue - deferred revenue $ (5,984 ) $ (24,904 ) $ — $ (30,888 ) |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation | The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) $ 49,798 $ 33,004 $ (155,945 ) $ (130,657 ) Weighted average shares used to compute net income (loss) per share: Basic 92,644 90,558 92,206 89,414 Dilutive effect of potential common shares 164 3,120 — — Diluted 92,808 93,678 92,206 89,414 Net income (loss) per share: Basic $ 0.54 $ 0.36 $ (1.69 ) $ (1.46 ) Diluted $ 0.54 $ 0.35 $ (1.69 ) $ (1.46 ) |
Collaboration Agreements, Lic_2
Collaboration Agreements, License Agreement and Revenues (Tables) | 9 Months Ended |
Sep. 30, 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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Direct Sales: Gross revenue $ 3,249 $ 27,900 $ 10,908 $ 53,105 Discounts and rebates (133 ) (5,209 ) (1,314 ) (9,721 ) Sales returns (2 ) (8 ) 86 (53 ) Direct sales revenue, net 3,114 22,683 9,680 43,331 Sales to Falikang: Gross transfer price 31,179 — 82,294 — Profit share (12,090 ) — (31,726 ) — Net transfer price 19,089 — 50,568 — Increase in deferred revenue (8,761 ) — (18,073 ) — Sales to Falikang revenue, net 10,328 — 32,495 — Total product revenue, net $ 13,442 $ 22,683 $ 42,175 $ 43,331 |
Summary of Amounts Recognized as Revenue | Amounts recognized as revenue under the Eluminex were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Eluminex License revenue $ 8,000 $ — $ 8,000 $ — |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at September 30, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (944 ) $ 5,913 $ (167 ) $ (10,335 ) |
Schedule of Drug Product Revenue | Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Astellas $ — $ (3,957 ) $ 2,056 $ 4,281 AstraZeneca — 4,643 (2,224 ) 4,643 Drug product revenue $ — $ 686 $ (168 ) $ 8,924 |
Drug Product Revenue [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the above- mentioned deferred revenue s that are considered as contract liabilit ies related to drug product (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at September 30, 2021 Astellas - Japan Agreement $ — $ (1,974 ) $ — $ (1,974 ) Astellas - Europe Agreement (5,984 ) (11,759 ) — (17,743 ) AstraZeneca - U.S. Agreement — (11,171 ) — (11,171 ) Drug product revenue - deferred revenue $ (5,984 ) $ (24,904 ) $ — $ (30,888 ) |
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 September 30, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (55,424 ) $ 32,495 $ (160,267 ) |
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): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Japan License revenue $ — $ — $ — $ — Development revenue $ 66 $ 86 $ 245 $ 413 |
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 September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 100,347 $ — $ 100,347 Development revenue 16,595 — 16,595 Total license and development revenue $ 116,942 $ — $ 116,942 |
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): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 Europe License revenue $ 108,434 $ — $ 108,434 $ — Development revenue $ 14,061 $ 4,651 $ 20,138 $ 13,827 |
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 September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 596,385 $ — $ 596,385 Development revenue 269,100 — 269,100 Total license and development revenue $ 865,485 $ — $ 865,485 |
U.S./RoW and China [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2021 2020 2021 2020 U.S. / RoW and China License revenue $ — $ — $ — $ — Development revenue 11,970 15,220 39,939 43,525 China performance obligation $ — $ 706 $ — $ 1,300 |
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 with AstraZeneca, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through September 30, 2021 Deferred Revenue at September 30, 2021 Total Consideration Through September 30, 2021 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 594,713 1,428 596,141 China performance obligation * 32,495 160,267 192,762 Total license and development revenue $ 969,052 $ 161,695 ** $ 1,130,747 * 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 September 30, 2021, deferred revenue included $154.7 million related to the U.S./RoW and China Agreement, which represents the net of $161.7 million of deferred revenue presented above and a $7.0 million unbilled co-development revenue under the China Amendment with AstraZeneca. |
Variable Interest Entity (Table
Variable Interest Entity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Summary of Equity Method Investment | The Company’s equity method investment in Falikang was as follows (in thousands): Entity Ownership Percentage Balance at December 31, 2020 Share of Net Income Currency Translation Balance at September 30, 2021 Falikang 51.1 % $ 2,728 $ 664 $ 29 $ 3,421 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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): September 30, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 171,628 $ — $ — $ 171,628 Corporate bonds — 126,994 — 126,994 Commercial paper — 107,402 — 107,402 U.S. government bonds 73,108 — — 73,108 Agency bonds — 23,399 — 23,399 Asset-backed securities — 27,256 — 27,256 Foreign government bonds — 8,127 — 8,127 Equity investments 225 — — 225 Total $ 244,961 $ 293,178 $ — $ 538,139 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) | 9 Months Ended |
Sep. 30, 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): Balance Sheet Line Item September 30, 2021 December 31, 2020 Assets Finance: Right-of-use assets cost $ 2,033 $ 50,477 Accumulated amortization (1,262 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 771 29,606 Operating: Right-of-use assets cost 100,710 3,934 Accumulated amortization (6,655 ) (1,891 ) Operating lease right-of-use assets, net Operating lease right-of-use assets 94,055 2,043 Total lease assets $ 94,826 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 15 $ 12,330 Operating lease liabilities Operating lease liabilities, current 10,831 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 5 25,391 Operating lease liabilities Operating lease liabilities, non-current 91,478 853 Total lease liabilities $ 102,329 $ 39,762 |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Statement of Operations Line Item 2021 2020 2021 2020 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 116 $ 2,639 $ 4,509 $ 7,886 Interest on lease liabilities Interest expense — 462 627 1,511 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 4,273 304 6,435 868 Sublease income Selling, general and administrative expenses (263 ) (301 ) (838 ) (899 ) Total lease cost $ 4,126 $ 3,104 $ 10,733 $ 9,366 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Nine Months Ended September 30, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 6,090 $ 812 Operating cash flows from finance leases 628 1,468 Financing cash flows from finance leases 5,359 9,254 Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 330 434 Operating leases 3,509 55 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: September 30, 2021 December 31, 2020 Weighted-average remaining lease term (years): Finance leases 1.2 2.9 Operating leases 7.0 1.8 Weighted-average discount rate: Finance leases 4.58 % 4.39 % Operating leases 4.75 % 4.74 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities as of September 30, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2021 (remaining three month period) $ 6 $ 3,697 2022 12 15,517 2023 3 13,454 2024 — 16,797 2025 — 18,192 Beyond 2025 — 53,881 Total future lease payments 21 121,538 Less: Interest (1 ) (19,229 ) Present value of lease liabilities $ 20 $ 102,309 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 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): September 30, 2021 December 31, 2020 Cash $ 90,899 $ 88,046 Commercial paper 12,000 — Money market funds 171,628 590,347 Total cash and cash equivalents $ 274,527 $ 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): September 30, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 127,005 $ 35 $ (46 ) $ 126,994 Commercial paper 95,402 — — 95,402 U.S. government bonds 73,119 5 (16 ) 73,108 Agency bonds 23,399 4 (4 ) 23,399 Asset-backed securities 27,261 2 (7 ) 27,256 Foreign government bonds 8,127 — — 8,127 Equity investments 118 107 — 225 Total investments $ 354,431 $ 153 $ (73 ) $ 354,511 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 |
Schedule of Inventory | Inventories consisted of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ 820 $ 2,303 Work-in-progress 20,662 8,114 Finished goods 7,833 6,113 Total inventories $ 29,315 $ 16,530 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, 2021 December 31, 2020 Unbilled contract assets $ 15,003 $ 2,147 Deferred revenues from associated contracts (7,003 ) (2,147 ) Net unbilled contract assets 8,000 — Prepaid assets 6,598 8,353 Other current assets 7,090 1,807 Total prepaid expenses and other current assets $ 21,688 $ 10,160 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): September 30, 2021 December 31, 2020 Leasehold improvements $ 102,843 $ 102,006 Laboratory equipment 18,809 18,143 Machinery 8,234 8,312 Computer equipment 9,262 9,545 Furniture and fixtures 6,175 6,128 Construction in progress 1,920 760 Total property and equipment $ 147,243 $ 144,894 Less: accumulated depreciation (118,191 ) (111,247 ) Property and equipment, net $ 29,052 $ 33,647 |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Preclinical and clinical trial accruals $ 64,212 $ 44,113 Payroll and related accruals 20,121 22,800 Contract liabilities to pharmaceutical distributors 10,335 15,137 Accrued co-promotion expenses - current 27,071 11,537 Roxadustat profit share to AstraZeneca 7,764 7,007 Property taxes and other taxes 11,532 5,970 Professional services 4,565 4,869 Other 5,746 6,900 Total accrued and other current liabilities $ 151,346 $ 118,333 |
Schedule of Other Long-term Liabilities | Other long-term liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 13,514 $ 27,424 Other long-term tax liabilities 9,120 8,675 Other 1,688 2,690 Total other long-term liabilities $ 24,322 $ 38,789 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Recorded Stock-Based Compensation Expense | Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 8,220 $ 11,236 $ 31,123 $ 32,653 Selling, general and administrative 7,484 6,655 22,966 19,798 Total stock-based compensation expense $ 15,704 $ 17,891 $ 54,089 $ 52,451 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan | The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock Options Expected term (in years) 5.8 5.6 5.7 5.7 Expected volatility 68.1 % 59.0 % 61.8 % 67.7 % Risk-free interest rate 1.2 % 0.3 % 0.9 % 0.8 % Expected dividend yield — — — — Weighted average estimated fair value $ 11.08 $ 22.48 $ 21.45 $ 18.11 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 50.6 - 104.4 % 50.4 - 77.1 % 47.1 - 104.4 % 49.5 - 77.1 % Risk-free interest rate 0.0 - 1.6 % 0.2 - 2.9 % 0.0 - 2.2 % 0.2 - 2.9 % Expected dividend yield — — — — Weighted average estimated fair value $ 12.37 $ 17.00 $ 13.57 $ 17.74 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) shares in Millions | Jun. 16, 2021USD ($) | Sep. 30, 2021shares | Sep. 30, 2020shares | Sep. 30, 2021Segmentshares | Sep. 30, 2020shares |
Accounting Policy [Line Items] | |||||
Number of reportable segment | Segment | 1 | ||||
Anti-dilutive shares outstanding | shares | 12.5 | 4.2 | 9.7 | 8.9 | |
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. | ||||
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 | ||||
Maximum additional future option, clinical, regulatory, and commercial milestone payments | 1,100,000,000 | ||||
Contingent consideration | $ 0 |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Earnings Per Share [Abstract] | ||||
Net income (loss) | $ 49,798 | $ 33,004 | $ (155,945) | $ (130,657) |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 92,644 | 90,558 | 92,206 | 89,414 |
Dilutive effect of potential common shares | 164 | 3,120 | 0 | 0 |
Diluted | 92,808 | 93,678 | 92,206 | 89,414 |
Net income (loss) per share: | ||||
Basic | $ 0.54 | $ 0.36 | $ (1.69) | $ (1.46) |
Diluted | $ 0.54 | $ 0.35 | $ (1.69) | $ (1.46) |
Collaboration Agreements, Lic_3
Collaboration Agreements, License Agreement and Revenues - Astellas Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 35 Months Ended | 45 Months Ended | ||||
Apr. 30, 2006 | Jun. 30, 2005 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Feb. 28, 2009 | Feb. 28, 2009 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 | |||||
Deferred Revenue | 23,256 | 23,256 | $ 6,547 | ||||||
Drug Product Revenue [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue | 0 | $ 686 | (168) | $ 8,924 | |||||
Deferred Revenue | 11,200 | $ 11,200 | |||||||
Astellas Agreement [Member] | Japan [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront, non-contingent and time-based payments received | $ 40,100 | ||||||||
Potential milestone payments | $ 132,500 | ||||||||
Commercial sales milestone | 15,000 | ||||||||
Additional consideration based on net sales description | the low 20% range of the list price | ||||||||
Aggregate consideration received excluding drug product revenue | 105,100 | $ 105,100 | |||||||
Astellas Agreement [Member] | Japan [Member] | Clinical and Development Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | 22,500 | ||||||||
Astellas Agreement [Member] | Japan [Member] | Regulatory Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 95,000 | ||||||||
Astellas Agreement [Member] | Japan [Member] | Drug Product Revenue [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue | 2,100 | $ 2,100 | |||||||
Astellas Agreement [Member] | Europe [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront, non-contingent and time-based payments received | $ 320,000 | ||||||||
Potential milestone payments | 120,000 | ||||||||
Additional consideration based on net sales description | low 20% range | ||||||||
Aggregate consideration received excluding drug product revenue | 660,000 | $ 660,000 | |||||||
Development and regulatory approval milestones | $ 425,000 | ||||||||
Percentage of joint development costs committed to fund | 50.00% | ||||||||
Transaction price and allocated to performance obligations | 120,000 | 120,000 | |||||||
Astellas Agreement [Member] | Europe [Member] | Clinical and Development Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 90,000 | ||||||||
Astellas Agreement [Member] | Europe [Member] | Regulatory Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 335,000 | ||||||||
Astellas Agreement [Member] | Europe [Member] | Drug Product Revenue [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Deferred Revenue | $ 11,800 | $ 11,800 |
Collaboration Agreements, Lic_4
Collaboration Agreements, License Agreement and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) $ in Thousands | Jul. 30, 2013 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | $ 23,256 | $ 23,256 | $ 6,547 | |||
Revenue recognized | 155,973 | $ 44,032 | 218,766 | $ 111,320 | ||
Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue recognized | 13,442 | 22,683 | 42,175 | 43,331 | ||
Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | 11,200 | 11,200 | ||||
Revenue recognized | 0 | 686 | (168) | 8,924 | ||
AstraZeneca Agreements [Member] | Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | 11,200 | 11,200 | ||||
Revenue recognized | 0 | 4,643 | (2,224) | 4,643 | ||
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 | |||||
Aggregate consideration received excluding drug product revenue | 439,000 | 439,000 | ||||
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 | |||||
Deferred Revenue | 7,800 | 7,800 | $ 7,000 | |||
Proceeds from upfront, non-contingent and non-refundable payments | 28,200 | |||||
Commercial sales and other events milestone | 187,500 | |||||
Aggregate consideration received for milestone and upfront payments | 77,200 | 77,200 | ||||
Revenue recognized | 0 | 706 | 0 | 1,300 | ||
AstraZeneca Agreements [Member] | China [Member] | Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue recognized | 10,300 | 32,500 | ||||
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] | ||||||
Revenue recognized | 3,114 | $ 22,683 | 9,680 | $ 43,331 | ||
Direct Sales [Member] | China [Member] | Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue recognized | $ 3,100 | $ 9,700 |
Collaboration Agreements, Lic_5
Collaboration Agreements, License Agreement and Revenues - Eluminex Agreement - Additional Information 2 (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2021USD ($)PerformanceObligation | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 | |
Eluminex [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Aggregate consideration received for milestone and upfront payments | $ 8,000 | 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 |
License Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 116,434 | 0 | 116,434 | 0 |
Development Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 26,097 | 20,663 | 60,325 | 59,065 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 108,434 | 0 | 108,434 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 66 | 86 | 245 | 413 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 14,061 | 4,651 | 20,138 | 13,827 |
AstraZeneca Agreements [Member] | China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 706 | 0 | 1,300 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 11,970 | $ 15,220 | $ 39,939 | $ 43,525 |
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 | Sep. 30, 2021 | Dec. 31, 2020 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 7,003 | $ 2,147 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 116,942 | |
Deferred Revenue | 0 | |
Total Consideration | 116,942 | |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 16,595 | |
Deferred Revenue | 0 | |
Total Consideration | 16,595 | |
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] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 865,485 | |
Deferred Revenue | 0 | |
Total Consideration | 865,485 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 269,100 | |
Deferred Revenue | 0 | |
Total Consideration | 269,100 | |
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 | |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 160,267 | $ 137,338 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 969,052 | |
Deferred Revenue | 161,695 | |
Total Consideration | 1,130,747 | |
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 | 594,713 | |
Deferred Revenue | 1,428 | |
Total Consideration | 596,141 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 32,495 | |
Deferred Revenue | 160,267 | |
Total Consideration | $ 192,762 |
Collaboration Agreements, Lic_8
Collaboration Agreements, License Agreement and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) $ in Millions | 3 Months Ended |
Sep. 30, 2021USD ($) | |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 15.6 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue from changes to estimated variable consideration | 0.2 |
U.S./RoW and China [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | 35.3 |
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue from changes to estimated variable consideration | $ 0.8 |
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 (Parenthetical) (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($10,604 and $4,636 to a related party) | $ 162,415 | $ 138,474 |
Deferred Revenue | 7,003 | 2,147 |
Net unbilled co-development revenue | 8,000 | 0 |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 160,267 | $ 137,338 |
Net unbilled co-development revenue | 7,000 | |
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($10,604 and $4,636 to a related party) | 154,700 | |
Deferred Revenue | 161,700 | |
Net unbilled co-development revenue | $ 7,000 |
Collaboration Agreements, Li_10
Collaboration Agreements, License Agreement and Revenues - Summary of Amounts Recognized as Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 |
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 | 0 | 116,434 | 0 |
License Revenue [Member] | Eluminex [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 8,000 | $ 0 | $ 8,000 | $ 0 |
Collaboration Agreements, Li_11
Collaboration Agreements, License Agreement and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 |
Discounts and Rebates [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 100 | 5,200 | 1,300 | 9,700 |
Product Revenue, Net [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 13,442 | 22,683 | 42,175 | 43,331 |
Product Revenue, Net [Member] | Direct Sales [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Gross revenue | 3,249 | 27,900 | 10,908 | 53,105 |
Total revenue | 3,114 | 22,683 | 9,680 | 43,331 |
Product Revenue, Net [Member] | Direct Sales [Member] | Discounts and Rebates [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (133) | (5,209) | (1,314) | (9,721) |
Product Revenue, Net [Member] | Direct Sales [Member] | Sales Returns [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (2) | (8) | 86 | (53) |
Product Revenue, Net [Member] | Sales To Falikang [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 10,328 | 0 | 32,495 | 0 |
Gross transfer price | 31,179 | 0 | 82,294 | 0 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Profit Share [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (12,090) | 0 | (31,726) | 0 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Net Transfer Price [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 19,089 | 0 | 50,568 | 0 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Increase in Deferred Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ (8,761) | $ 0 | $ (18,073) | $ 0 |
Collaboration Agreements, Li_12
Collaboration Agreements, License Agreement and Revenues - Product Revenue, Net - Additional Information 1 (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 | |
Discounts and Rebates [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | 100 | $ 5,200 | 1,300 | $ 9,700 | |
Rebates and Discounts [Member] | Gross Accounts Receivable [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | 800 | $ 500 | |||
Rebates and Discounts [Member] | Contract Liabilities [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | 10,300 | $ 15,100 | |||
Constrained for Future Recognition [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | $ 8,800 | $ 18,100 |
Collaboration Agreements, Li_13
Collaboration Agreements, License Agreement and Revenues - Roll-forward of Related Contract Liabilities (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | $ (2,147) |
Balance at September 30, 2021 | (7,003) |
AstraZeneca Agreements [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (137,338) |
Additions | (55,424) |
Recognized as Revenue | 32,495 |
Balance at September 30, 2021 | (160,267) |
Product Revenue, Net [Member] | Direct Sales [Member] | Contract Liabilities [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (15,137) |
Additions | (944) |
Deduction | 5,913 |
Currency Translation and Other | (167) |
Balance at September 30, 2021 | (10,335) |
Drug Product Revenue [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (5,984) |
Additions | (24,904) |
Recognized as Revenue | 0 |
Balance at September 30, 2021 | (30,888) |
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) |
Recognized as Revenue | 0 |
Balance at September 30, 2021 | (11,171) |
Drug Product Revenue [Member] | Astellas Agreement [Member] | Japan [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | 0 |
Additions | (1,974) |
Recognized as Revenue | 0 |
Balance at September 30, 2021 | (1,974) |
Drug Product Revenue [Member] | Astellas Agreement [Member] | Europe [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (5,984) |
Additions | (11,759) |
Recognized as Revenue | 0 |
Balance at September 30, 2021 | $ (17,743) |
Collaboration Agreements, Li_14
Collaboration Agreements, License Agreement and Revenues - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | $ 7,003 | $ 2,147 |
Product Revenue, Net [Member] | Beijing Falikang Pharmaceutical Co Ltd | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Reductions to gross accounts receivable | 23,100 | |
AstraZeneca Agreements [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | 160,267 | $ 137,338 |
AstraZeneca Agreements [Member] | China [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | $ 8,500 |
Collaboration Agreements, Li_15
Collaboration Agreements, License Agreement and Revenues - Drug Product Revenue - Summary of Drug Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue recognized | $ 155,973 | $ 44,032 | $ 218,766 | $ 111,320 |
Drug Product Revenue [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue recognized | 0 | 686 | (168) | 8,924 |
Drug Product Revenue [Member] | Astellas Agreement [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue recognized | 0 | (3,957) | 2,056 | 4,281 |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Revenue recognized | $ 0 | $ 4,643 | $ (2,224) | $ 4,643 |
Collaboration Agreements, Li_16
Collaboration Agreements, License Agreement and Revenues - Drug Product Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | $ 23,256 | $ 23,256 | $ 6,547 | |||
Drug product revenue recognized | 155,973 | $ 44,032 | 218,766 | $ 111,320 | ||
Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | 11,200 | 11,200 | ||||
Drug product revenue recognized | 0 | 686 | (168) | 8,924 | ||
Drug Product Revenue [Member] | Astellas Agreement [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Drug product revenue recognized | 0 | $ (3,957) | 2,056 | $ 4,281 | ||
Drug Product Revenue [Member] | Europe [Member] | Astellas Agreement [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Deferred Revenue | $ 11,800 | $ 11,800 | ||||
Drug Product Revenue [Member] | API Shipment [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Drug product revenue recognized | $ 2,100 |
Variable Interest Entity - Addi
Variable Interest Entity - Additional Information (Detail) | Sep. 30, 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% |
Variable Interest Entity - Summ
Variable Interest Entity - Summary of Equity Method Investment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Acquisition And Variable Interest Entity [Line Items] | ||||
Beginning balance | $ 2,728 | |||
Investment income (loss) in unconsolidated variable interest entity | $ 342 | $ (13) | 664 | $ (13) |
Ending balance | $ 3,421 | $ 3,421 | ||
Beijing Falikang Pharmaceutical Co. Ltd [Member] | ||||
Acquisition And Variable Interest Entity [Line Items] | ||||
Ownership Percentage | 51.10% | 51.10% | ||
Beginning balance | $ 2,728 | |||
Investment income (loss) in unconsolidated variable interest entity | 664 | |||
Currency Translation | 29 | |||
Ending balance | $ 3,421 | $ 3,421 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 354,511 | $ 8,388 |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 126,994 | |
Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 95,402 | |
Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 27,256 | |
Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,127 | |
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 | 225 | 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 | 538,139 | 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 | 171,628 | 590,347 |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 126,994 | |
Fair Value, Measurements, Recurring [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 107,402 | |
Fair Value, Measurements, Recurring [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 73,108 | |
Fair Value, Measurements, Recurring [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 23,399 | |
Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 27,256 | |
Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,127 | |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 8,144 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 225 | 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 | 244,961 | 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 | 171,628 | 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 | 73,108 | |
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 | 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 | 225 | 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 | 293,178 | 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 | 126,994 | |
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 | 107,402 | |
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 | 23,399 | |
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 | 27,256 | |
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 | 8,127 | |
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 | 0 | 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 | 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 | 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 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | |
Fair Value Disclosures [Abstract] | ||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 |
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 |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Right-of-use assets cost | $ 2,033 | $ 50,477 |
Accumulated amortization | (1,262) | (20,871) |
Finance lease right-of-use assets, net | 771 | 29,606 |
Right-of-use assets cost | 100,710 | 3,934 |
Accumulated amortization | (6,655) | (1,891) |
Operating lease right-of-use assets, net | 94,055 | 2,043 |
Total lease assets | 94,826 | 31,649 |
Finance lease liabilities | 15 | 12,330 |
Operating lease liabilities | 10,831 | 1,188 |
Finance lease liabilities | 5 | 25,391 |
Operating lease liabilities | 91,478 | 853 |
Total lease liabilities | $ 102,329 | $ 39,762 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | Jun. 01, 2021USD ($)Option | Mar. 31, 2021USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) |
Lessee Lease Description [Line Items] | |||||
Finance lease right-of-use assets | $ 771 | $ 29,606 | |||
Finance lease liability | 20 | ||||
Operating lease right-of-use assets | 94,055 | $ 2,043 | |||
Operating lease liability | 102,309 | ||||
Cash payment related to lease | 6,090 | $ 812 | |||
ASC 842 [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Finance lease right-of-use assets | 24,654 | 0 | |||
Operating lease right-of-use assets | $ 93,222 | $ 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, existence of option to extend | true | ||||
Lessee, finance lease, additional lease expiration period | 2028 | ||||
Percentage increases on each anniversary of rent commencement date 2023 | 2.00% | ||||
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 | ||||
Lessee, finance lease, option to extend the additional lease term | 5 years | ||||
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 | $ 4,500 | ||||
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 - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Finance lease cost: | ||||
Amortization of right-of-use assets | $ 116 | $ 2,639 | $ 4,509 | $ 7,886 |
Interest on lease liabilities | 0 | 462 | 627 | 1,511 |
Operating lease cost | 4,273 | 304 | 6,435 | 868 |
Sublease income | (263) | (301) | (838) | (899) |
Total lease cost | $ 4,126 | $ 3,104 | $ 10,733 | $ 9,366 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | |||
Operating cash flows from operating leases | $ 6,090 | $ 812 | |
Operating cash flows from finance leases | 628 | 1,468 | |
Financing cash flows from finance leases | 5,359 | 9,254 | |
Non-cash: Right-of-use assets obtained in exchange for new lease liabilities: | |||
Finance leases | 330 | 434 | |
Operating leases | 3,509 | 55 | |
Non-cash: Increase (decrease) resulting from lease modification: | |||
Finance lease right-of-use assets | (771) | $ (29,606) | |
Operating lease right-of-use assets | 94,055 | 2,043 | |
Finance lease liabilities, current | (15) | (12,330) | |
Operating lease liabilities, current | 10,831 | 1,188 | |
Finance lease liabilities, non-current | (5) | (25,391) | |
Operating lease liabilities, non-current | 91,478 | $ 853 | |
ASC 842 [Member] | |||
Non-cash: Increase (decrease) resulting from lease modification: | |||
Finance lease right-of-use assets | (24,654) | 0 | |
Operating lease right-of-use assets | 93,222 | 0 | |
Finance lease liabilities, current | (12,587) | 0 | |
Operating lease liabilities, current | 9,221 | 0 | |
Finance lease liabilities, non-current | (20,009) | 0 | |
Operating lease liabilities, non-current | $ 91,943 | $ 0 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Sep. 30, 2021 | Dec. 31, 2020 |
Weighted-average remaining lease term (years): | ||
Finance leases | 1 year 2 months 12 days | 2 years 10 months 24 days |
Operating leases | 7 years | 1 year 9 months 18 days |
Weighted-average discount rate: | ||
Finance leases | 4.58% | 4.39% |
Operating leases | 4.75% | 4.74% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2021USD ($) |
Finance Leases | |
2021 (remaining three month period) | $ 6 |
2022 | 12 |
2023 | 3 |
2024 | 0 |
2025 | 0 |
Beyond 2025 | 0 |
Total future lease payments | 21 |
Less: Interest | (1) |
Present value of lease liabilities | 20 |
Operating Leases | |
2021 (remaining three month period) | 3,697 |
2022 | 15,517 |
2023 | 13,454 |
2024 | 16,797 |
2025 | 18,192 |
Beyond 2025 | 53,881 |
Total future lease payments | 121,538 |
Less: Interest | (19,229) |
Present value of lease liabilities | $ 102,309 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 90,899 | $ 88,046 |
Commercial paper | 12,000 | 0 |
Money market funds | 171,628 | 590,347 |
Total cash and cash equivalents | $ 274,527 | $ 678,393 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2021 | Jul. 31, 2021 | Dec. 31, 2020 | |
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 274,527,000 | $ 274,527,000 | $ 678,393,000 | |
Other-than-temporary impairment loss | 0 | 0 | ||
Net unbilled co-development revenue | 8,000,000 | 8,000,000 | 0 | |
Profit share liability | 23,256,000 | 23,256,000 | $ 6,547,000 | |
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 | $ 7,000,000 | $ 7,000,000 | ||
U.S. [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Percentage of pre-launch inventory capitalized of aggregate inventory balance | 40.00% | 40.00% | 29.00% | |
China [Member] | AstraZeneca Agreements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Unbilled upfront payment | $ 77,200,000 | $ 77,200,000 | ||
Profit share liability | 7,800,000 | $ 7,800,000 | $ 7,000,000 | |
Maximum [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Contractual maturities of available-for-sale investments | 2 years | |||
Foreign subsidiaries [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 77,400,000 | $ 77,400,000 | $ 66,000,000 |
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 | Sep. 30, 2021 | Dec. 31, 2020 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 354,431 | $ 8,272 |
Gross Unrealized Holding Gains | 153 | 119 |
Gross Unrealized Holding Losses | (73) | (3) |
Fair Value | 354,511 | 8,388 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 127,005 | |
Gross Unrealized Holding Gains | 35 | |
Gross Unrealized Holding Losses | (46) | |
Fair Value | 126,994 | |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 95,402 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 95,402 | |
U.S. government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 73,119 | |
Gross Unrealized Holding Gains | 5 | |
Gross Unrealized Holding Losses | (16) | |
Fair Value | 73,108 | |
Agency bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 23,399 | |
Gross Unrealized Holding Gains | 4 | |
Gross Unrealized Holding Losses | (4) | |
Fair Value | 23,399 | |
Asset-backed securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 27,261 | |
Gross Unrealized Holding Gains | 2 | |
Gross Unrealized Holding Losses | (7) | |
Fair Value | 27,256 | |
Foreign government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,127 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 8,127 | |
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 | 118 | 125 |
Gross Unrealized Holding Gains | 107 | 119 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 225 | $ 244 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Schedule Of Investments [Abstract] | ||
Raw materials | $ 820 | $ 2,303 |
Work-in-progress | 20,662 | 8,114 |
Finished goods | 7,833 | 6,113 |
Total inventories | $ 29,315 | $ 16,530 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 15,003 | $ 2,147 |
Deferred revenues from associated contracts | (7,003) | (2,147) |
Net unbilled contract assets | 8,000 | 0 |
Prepaid assets | 6,598 | 8,353 |
Other current assets | 7,090 | 1,807 |
Total prepaid expenses and other current assets | $ 21,688 | $ 10,160 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 147,243 | $ 144,894 |
Less: accumulated depreciation | (118,191) | (111,247) |
Property and equipment, net | 29,052 | 33,647 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 102,843 | 102,006 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 18,809 | 18,143 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,234 | 8,312 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 9,262 | 9,545 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,175 | 6,128 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,920 | $ 760 |
Balance Sheet Components - Sc_5
Balance Sheet Components - Schedule of Accrued and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 64,212 | $ 44,113 |
Payroll and related accruals | 20,121 | 22,800 |
Contract liabilities to pharmaceutical distributors | 10,335 | 15,137 |
Accrued co-promotion expenses - current | 27,071 | 11,537 |
Roxadustat profit share to AstraZeneca | 7,764 | 7,007 |
Property taxes and other taxes | 11,532 | 5,970 |
Professional services | 4,565 | 4,869 |
Other | 5,746 | 6,900 |
Total accrued and other current liabilities | $ 151,346 | $ 118,333 |
Balance Sheet Components - Sc_6
Balance Sheet Components - Schedule of Other Long-term Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Other Liabilities Noncurrent [Abstract] | ||
Accrued long-term co-promotion expenses | $ 13,514 | $ 27,424 |
Other long-term tax liabilities | 9,120 | 8,675 |
Other | 1,688 | 2,690 |
Total other long-term liabilities | $ 24,322 | $ 38,789 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Recorded Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 15,704 | $ 17,891 | $ 54,089 | $ 52,451 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 8,220 | 11,236 | 31,123 | 32,653 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 7,484 | $ 6,655 | $ 22,966 | $ 19,798 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee stock options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 9 months 18 days | 5 years 7 months 6 days | 5 years 8 months 12 days | 5 years 8 months 12 days |
Expected volatility | 68.10% | 59.00% | 61.80% | 67.70% |
Risk-free interest rate | 1.20% | 0.30% | 0.90% | 0.80% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 11.08 | $ 22.48 | $ 21.45 | $ 18.11 |
2014 Employee Share Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility, minimum | 50.60% | 50.40% | 47.10% | 49.50% |
Expected volatility, maximum | 104.40% | 77.10% | 104.40% | 77.10% |
Risk-free interest rate, minimum | 0.00% | 0.20% | 0.00% | 0.20% |
Risk-free interest rate, maximum | 1.60% | 2.90% | 2.20% | 2.90% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 12.37 | $ 17 | $ 13.57 | $ 17.74 |
2014 Employee Share Purchase Plan [Member] | Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
2014 Employee Share Purchase Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 2 years | 2 years | 2 years | 2 years |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | |||||
Accounts receivable from related party | $ 23,126,000 | $ 23,126,000 | $ 4,127,000 | ||
Accrued liabilities to related party | 18,000 | 18,000 | 24,000 | ||
Deferred revenue | 7,003,000 | 7,003,000 | 2,147,000 | ||
Investment income | (342,000) | $ 13,000 | (664,000) | $ 13,000 | |
Equity method investments | 3,421,000 | 3,421,000 | 2,728,000 | ||
Astellas [Member] | |||||
Related Party Transaction [Line Items] | |||||
Drug product revenue from a related party | 2,100,000 | 4,300,000 | |||
Astellas [Member] | Collaborative Arrangement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | 122,600,000 | $ 4,700,000 | 128,800,000 | $ 14,200,000 | |
Accounts receivable from related party | 2,400,000 | 2,400,000 | 4,100,000 | ||
Accrued liabilities to related party | 1,100,000 | ||||
Deferred revenue | 19,700,000 | 19,700,000 | 7,500,000 | ||
Falikang [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts receivable from related party | 20,700,000 | 20,700,000 | |||
Investment income | 300,000 | 700,000 | |||
Equity method investments | 3,400,000 | $ 3,400,000 | 2,700,000 | ||
Percentage of outstanding shares owned | 51.10% | ||||
Miscellaneous receivables | 0 | $ 0 | $ 900,000 | ||
Falikang [Member] | Collaborative Arrangement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | $ 10,300,000 | $ 32,500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 1 Months Ended | 9 Months Ended | |
May 31, 2021PutativeClassAction | Apr. 30, 2021PutativeClassAction | Sep. 30, 2021USD ($) | |
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | $ 77.4 | ||
Putative securities class action complaints filed | PutativeClassAction | 2 | 3 | |
Manufacture and Supply of Roxadustat [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 22 | ||
Manufacture and Supply of Pamrevlumab [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 46.5 | ||
Other Purchases [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 8.9 | ||
Research and Pre-Clinical Stage Development Programs [Member] | |||
Commitments And Contingencies [Line Items] | |||
Maximum future milestone payments | $ 359.1 |