Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
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, $0.01 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-36740 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0357827 | |
Entity Address, Address Line One | 409 Illinois Street | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94158 | |
City Area Code | 415 | |
Local Phone Number | 978-1200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock Shares Outstanding | 93,741,180 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 167,758 | $ 171,223 |
Short-term investments | 270,375 | 233,967 |
Accounts receivable, net ($26,779 and $10,930 from related parties) | 33,573 | 17,401 |
Inventories | 40,899 | 31,015 |
Prepaid expenses and other current assets | 8,038 | 20,453 |
Total current assets | 520,643 | 474,059 |
Restricted time deposits | 2,072 | 2,072 |
Long-term investments | 45,920 | 167,796 |
Property and equipment, net | 24,505 | 28,277 |
Equity method investment in unconsolidated variable interest entity | 4,494 | 3,825 |
Operating lease right-of-use assets | 84,654 | 91,112 |
Other assets | 4,501 | 6,680 |
Total assets | 686,789 | 773,821 |
Current liabilities: | ||
Accounts payable | 29,360 | 26,097 |
Accrued and other current liabilities ($43,286 and $4 to a related party) | 193,099 | 172,599 |
Deferred revenue ($5,204 and $3,201 to related parties) | 6,897 | 15,857 |
Operating lease liabilities, current | 10,984 | 10,944 |
Total current liabilities | 240,340 | 225,497 |
Product development obligations | 16,439 | 17,613 |
Deferred revenue, net of current ($49,2733 and $25,891 to a related party) | 205,351 | 186,801 |
Operating lease liabilities, non-current | 83,080 | 88,776 |
Other long-term liabilities | 17,832 | 26,021 |
Total liabilities | 563,042 | 544,708 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at June 30, 2022 and December 31, 2021 | ||
Common stock, $0.01 par value; 225,000 shares authorized at June 30, 2022 and December 31, 2021; 93,733 and 92,881 shares issued and outstanding at June 30, 2022 and December 31, 2021 | 937 | 929 |
Additional paid-in capital | 1,509,636 | 1,476,414 |
Accumulated other comprehensive loss | (6,930) | (4,163) |
Accumulated deficit | (1,399,863) | (1,264,034) |
Total stockholders’ equity | 103,780 | 209,146 |
Non-controlling interests | 19,967 | 19,967 |
Total equity | 123,747 | 229,113 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 686,789 | $ 773,821 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Accounts receivable from related parties | $ 26,779 | $ 10,930 |
Accrued and other current liabilities to related party | 43,286 | 4 |
Deferred revenue current to related party | 5,204 | 3,201 |
Deferred revenue non-current to related party | $ 49,733 | $ 25,891 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 125,000 | 125,000 |
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 | 225,000 |
Common stock, shares issued | 93,733 | 92,881 |
Common stock, shares outstanding | 93,733 | 92,881 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 |
Operating costs and expenses: | ||||
Cost of goods sold | $ 6,809 | $ 3,078 | $ 11,048 | $ 6,479 |
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 | $ 70,963 | $ 122,567 | $ 159,981 | $ 197,243 |
General and administrative | 60,820 | 63,334 | ||
Selling, general and administrative | 30,258 | 32,554 | ||
Total operating costs and expenses | 108,030 | 158,199 | 231,849 | 267,056 |
Loss from operations | (78,224) | (133,835) | (141,216) | (204,263) |
Interest and other, net | ||||
Interest expense | (141) | (355) | (238) | (856) |
Interest income and other income (expenses), net | 5,199 | (363) | 4,876 | (817) |
Total interest and other, net | 5,058 | (718) | 4,638 | (1,673) |
Loss before income taxes | (73,166) | (134,553) | (136,578) | (205,936) |
Provision for (benefit from) income taxes | 23 | (3) | 136 | 130 |
Investment income in unconsolidated variable interest entity | 565 | 562 | 885 | 323 |
Net loss | $ (72,624) | $ (133,988) | $ (135,829) | $ (205,743) |
Net loss per share - basic | $ (0.78) | $ (1.45) | $ (1.46) | $ (2.24) |
Net loss per share - diluted | $ (0.78) | $ (1.45) | $ (1.46) | $ (2.24) |
Weighted average number of common shares used to calculate net loss per share - basic | 93,475 | 92,276 | 93,260 | 91,983 |
Weighted average number of common shares used to calculate net loss per share - diluted | 93,475 | 92,276 | 93,260 | 91,983 |
License Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 0 | $ 22,590 | $ 0 |
Development and Other Revenue [Member] | ||||
Revenue: | ||||
Total revenue | 5,457 | 19,641 | 17,219 | 34,228 |
Product Revenue, Net [Member] | ||||
Revenue: | ||||
Total revenue | 23,256 | 13,371 | 42,137 | 28,733 |
Drug Product Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 1,093 | $ 8,648 | $ 8,687 | $ (168) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
License and milestone revenue from a related party | $ 0 | $ 0 | $ 22,590 | $ 0 |
Collaboration services and other revenue from a related party | 1,825 | 2,645 | 7,005 | 6,256 |
Product revenue from a related party | 19,736 | 11,760 | 35,959 | 22,167 |
Drug product revenue from a related party | $ 1,093 | $ (1,974) | $ 8,687 | $ 2,056 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (72,624) | $ (133,988) | $ (135,829) | $ (205,743) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 159 | 40 | 408 | (30) |
Available-for-sale investments: | ||||
Unrealized gain (loss) on investments, net of tax effect | (584) | 17 | (3,175) | (38) |
Other comprehensive gain (loss), net of taxes | (425) | 57 | (2,767) | (68) |
Comprehensive loss | $ (73,049) | $ (133,931) | $ (138,596) | $ (205,811) |
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, 2020 | $ 441,449 | $ 914 | $ 1,399,774 | $ (4,499) | $ (974,011) | $ 19,271 |
Balance, Shares at Dec. 31, 2020 | 91,440,633 | |||||
Net loss | (205,743) | $ 0 | 0 | 0 | (205,743) | 0 |
Change in unrealized gain or loss on investments | (38) | 0 | 0 | (38) | 0 | 0 |
Foreign currency translation adjustments | (30) | 0 | 0 | (30) | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 5,828 | $ 12 | 5,816 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,168,296 | |||||
Stock-based compensation | 38,385 | $ 0 | 38,385 | 0 | 0 | 0 |
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 | |||||
Balance at Mar. 31, 2021 | 390,273 | $ 921 | 1,420,471 | (4,624) | (1,045,766) | 19,271 |
Balance, Shares at Mar. 31, 2021 | 92,080,399 | |||||
Net loss | (133,988) | $ 0 | 0 | 0 | (133,988) | 0 |
Change in unrealized gain or loss on investments | 17 | 17 | ||||
Foreign currency translation adjustments | 40 | 0 | 0 | 40 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 4,508 | $ 5 | 4,503 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 528,530 | |||||
Stock-based compensation | 19,001 | $ 0 | 19,001 | 0 | 0 | 0 |
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 | |||||
Balance at Dec. 31, 2021 | 229,113 | $ 929 | 1,476,414 | (4,163) | (1,264,034) | 19,967 |
Balance, Shares at Dec. 31, 2021 | 92,880,533 | |||||
Net loss | (135,829) | $ 0 | 0 | 0 | (135,829) | 0 |
Change in unrealized gain or loss on investments | (3,175) | 0 | 0 | (3,175) | 0 | 0 |
Foreign currency translation adjustments | 408 | 0 | 0 | 408 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | (580) | $ 8 | (588) | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 852,501 | |||||
Stock-based compensation | 33,810 | $ 0 | 33,810 | 0 | 0 | 0 |
Balance at Jun. 30, 2022 | 123,747 | $ 937 | 1,509,636 | (6,930) | (1,399,863) | 19,967 |
Balance, Shares at Jun. 30, 2022 | 93,733,034 | |||||
Balance at Mar. 31, 2022 | 178,015 | $ 933 | 1,490,859 | (6,505) | (1,327,239) | 19,967 |
Balance, Shares at Mar. 31, 2022 | 93,288,584 | |||||
Net loss | (72,624) | (72,624) | ||||
Change in unrealized gain or loss on investments | (584) | 0 | 0 | (584) | 0 | 0 |
Foreign currency translation adjustments | 159 | 0 | 0 | 159 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 2,123 | $ 4 | 2,119 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 444,450 | |||||
Stock-based compensation | 16,658 | $ 0 | 16,658 | 0 | 0 | 0 |
Balance at Jun. 30, 2022 | $ 123,747 | $ 937 | $ 1,509,636 | $ (6,930) | $ (1,399,863) | $ 19,967 |
Balance, Shares at Jun. 30, 2022 | 93,733,034 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities | ||
Net loss | $ (135,829) | $ (205,743) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 4,966 | 5,242 |
Amortization of finance lease right-of-use assets | 269 | 4,393 |
Net accretion of premium and discount on investments | 1,512 | 767 |
Unrealized loss on equity investments | 0 | 4 |
Investment income in unconsolidated variable interest entity | (885) | (323) |
(Gain) / loss on disposal of property and equipment | (1) | 13 |
Stock-based compensation | 33,810 | 38,385 |
Expense for acquired in-process research and development asset | 0 | 25,000 |
Realized loss on sales of available-for-sale securities | 5 | 8 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (16,200) | 17,868 |
Inventories | (10,858) | (7,861) |
Prepaid expenses and other current assets | 11,596 | 2,231 |
Operating lease right-of-use assets | 6,256 | (1,800) |
Other assets | 1,487 | (3,066) |
Accounts payable | 4,192 | (1,013) |
Accrued and other liabilities | 61,005 | 27,745 |
Operating lease liabilities, current | 108 | 295 |
Deferred revenue | 9,651 | 33,078 |
Accrued interest for finance lease liabilities | 14 | (73) |
Operating lease liabilities, non-current | (5,574) | 1,388 |
Other long-term liabilities | (7,064) | (8,065) |
Net cash used in operating activities | (41,540) | (71,527) |
Investing activities | ||
Purchases of property and equipment | (2,543) | (2,215) |
Payment made for acquired in-process research and development asset | (35,000) | 0 |
Proceeds from sale of property and equipment | 6 | 0 |
Purchases of available-for-sale securities | (59,123) | (266,647) |
Proceeds from sales of available-for-sale securities | 7,382 | 4,000 |
Proceeds from maturities of investments | 132,518 | 10,610 |
Net cash provided by (used in) investing activities | 43,240 | (254,252) |
Financing activities | ||
Repayments of finance lease liabilities | (23) | (5,326) |
Repayments of lease obligations | (201) | (201) |
Cash paid for payroll taxes on restricted stock unit releases | (3,361) | (5,928) |
Proceeds from issuance of common stock | 2,779 | 11,756 |
Net cash provided by (used in) financing activities | (806) | 301 |
Effect of exchange rate change on cash and cash equivalents | (4,359) | 446 |
Net increase (decrease) in cash and cash equivalents | (3,465) | (325,032) |
Total cash and cash equivalents at beginning of period | 171,223 | 678,393 |
Total cash and cash equivalents at end of period | $ 167,758 | $ 353,361 |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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. The Company applies its pioneering expertise in hypoxia-inducible factor ("HIF") biology, 2-oxoglutarate enzymology, and connective tissue growth factor to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. 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. To date, the Company has retained exclusive worldwide rights for pamrevlumab. Roxadustat is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat (爱瑞卓 ® , EVRENZO TM ) is now approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and those not on dialysis. Astellas Pharma Inc. (“Astellas”) and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, Australia/New Zealand, and Southeast Asia. Roxadustat is in Phase 3 clinical development for anemia associated with myelodysplastic syndromes. The Company has completed a Phase 2 study of roxadustat in chemotherapy-induced anemia and is running a Phase 3 trial of roxadustat chemotherapy-induced anemia in China. The Company has a pipeline of late-stage clinical programs as well as preclinical drug candidates at various stages of development that include both small molecules and biologics. The Company has leveraged its internally developed 2-oxoglutarate and connective tissue growth factor biology expertise as well as in-licensing of additional programs, such as antibodies targeting Galectin-9 protein (“Gal-9”) and C-C Motif Chemokine Receptor 8 (“CCR8”), to further enhance its late-stage preclinical pipeline. FibroGen's goal is to build a diversified pipeline with novel drugs that will address unmet patient needs in oncology, immunology, and fibrosis. 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 the 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 for the year ended December 31, 2021, filed on February 28, 2022 and as amended on March 4, 2022 (“2021 Form 10-K”). Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no impact on previously reported financial position, results of operations, or cash flows. 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 and deferred revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China manufacturing and supply obligation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. 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 2021 Form 10-K, except for the updates to the following: Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees, which are comprised of stock options, service-based restricted stock units ("RSUs"), performance-based RSUs and total shareholder return (“TSR”) awards. The Company measures and recognizes compensation expense for all stock options, service and performance-based restricted stock units granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The determination of the grant date fair value of options using the Black-Scholes valuation model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. To estimate the fair value of the TSR awards, the Company uses the Monte Carlo valuation model to simulate the probabilities of achievement, which requires management to make a number of assumptions including 30-day average price, volatility of the underlying stock and the Company's peers, and the risk-free interest rate. The compensation cost of service-based stock options and restricted stock units is recognized net of any estimated forfeitures on a straight-line basis over the employee requisite service period. Compensation cost for performance-based RSUs is expensed over the respective vesting periods when the achievement of performance criteria is probable. Compensation cost for the TSR awards is recognized over the requisite service period, regardless of when, if ever, the market condition is satisfied. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. Net Loss per Share Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a net loss for each interim period presented. 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 (including service-based RSUs, performance-based RSUs and TSR awards) and shares to be purchased under the employee stock purchase plan totaling 14.2 million and 11.4 million for the three months ended June 30, 2022 and 2021 , and totaling 13.3 million and 9.4 million for the six months ended June 30, 2022 and 2021 , 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, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, intellectual property protection for the Company's proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties. 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” ) , which provides companies with optional financial reporting alternatives to reduce the cost and complexity associated with the accounting for contracts and hedging relationships affected by reference rate reform. This guidance is effective as of March 12, 2020 through December 31, 2022. Subsequently in January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848): Scope , which clarifies ASU 2020-04 and provides certain optional expedients that allow derivative instruments impacted by changes in the interest rate used for margining, discounting or contract price alignment to qualify for certain optional relief. ASU 2021-01 is effective in the same timeframe as ASU2020-04. The relief offered by this guidance, if adopted, is available to companies for the period March 12, 2020 through December 31, 2022. The Company has certain lease arrangements that are linked to the London Inter-Bank Offered Rate ("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 three and six months ended June 30, 2022 and is currently evaluating the impact on its condensed consolidated financial statements and related disclosures upon adoption of this guidance. |
Collaboration Agreements, Licen
Collaboration Agreements, License Agreement and Revenues | 6 Months Ended |
Jun. 30, 2022 | |
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 for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 172.6 million . 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 June 30, 2022 totaled $ 105.1 million , excluding drug product revenue that is discussed separately below. Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Japan License revenue $ — $ — $ — $ — Development revenue $ 79 $ 99 $ 111 $ 179 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 Deferred Total License $ 100,347 $ — $ 100,347 Development revenue 16,709 — 16,709 Total license and development revenue $ 117,056 $ — $ 117,056 There was no rev enue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended June 30, 2022 under the Japan Agreement. The Company does no t expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Japan Agreement. 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”). The related drug product revenue, as described under Drug Product Revenue section below, was immaterial for the three months ended June 30, 2022, $( 2.0 ) million for the three months ended June 30, 2021, and $ 7.6 million and $ 2.1 million for the six months ended June 30, 2022 and 2021, respectively. 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 agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 745.0 million . U nder 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 . On March 21, 2022, EVRENZO ® (roxadustat) was registered with the Russian Ministry of Health. The Company evaluated the regulatory milestone payment associated with the approval in Russia under the Europe Agreement and concluded that this milestone was achieved in the first quarter of 2022. Accordingly, the consideration of $ 25.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Europe Agreement, all of which was recognized as revenue during the first quarter of 2022 from performance obligations satisfied. Such amount was billed and recorded in accounts receivable from Astellas as of March 31, 2022 and received in April 2022. The aggregate amount of consideration received under the Europe Agreement through June 30, 2022 totaled $ 685.0 million , excluding drug product revenue that is discussed separately below. Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Europe License revenue $ — $ — $ 22,590 $ — Development revenue $ 1,746 $ 2,546 $ 6,894 $ 6,077 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 Deferred Total License $ 618,975 $ — $ 618,975 Development revenue 277,536 — 277,536 Total license and development revenue $ 896,511 $ — $ 896,511 There was no rev enue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for three months ended June 30, 2022 under the Europe Agreement. The remainder of the transaction price related to the Europe Agreement includes $ 7.6 million of variable consideration from estimated future co-development billing and is estimated to be recognized over the remaining development service period. 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 EU Supply Agreement under the Europe Agreement with Astellas (“EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The related drug product revenue, as described under Drug Product Revenue section below, was $ 1.1 million for the three and six months ended June 30, 2022, respectively. There was no related drug product revenue for the three and six months ended June 30, 2021. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB ("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 agreed to pay upfront, non-contingent, non-refundable and time-based payments, and potential milestone payments, totaling $ 1.2 billion . AstraZeneca will pay the Comp any tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range . In addition, the Company will receive a transfer price for shipment of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. The aggregate amount of consideration received under the U.S./RoW Agreement through June 30, 2022 totaled $ 439.0 million , excluding drug product revenue that is discussed separately below. While FibroGen and AstraZeneca continue to develop roxadustat in the U.S. for the treatment of anemia in patients with myelodysplastic syndromes, the Company has not been able to agree on a path forward for AstraZeneca to fund further roxadustat development for CKD anemia in the U.S. Therefore, the Company does not expect to receive most or all of the remaining U.S./RoW Agreement milestones from AstraZeneca. 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. There was no related drug product revenue for the three and six months ended June 30, 2022, and the related drug product revenue was $( 6.7 ) million and $( 2.2 ) million for the three and six months ended June 30, 2021, respectively. See Drug Product Revenue section below. 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 and potential milestone payments, totaling $ 376.7 million . 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 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 June 30, 2022 totaled $ 77.2 million . China Amendment In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd. ("FibroGen Beijing"), and FibroGen International (Hong Kong) Limited (collectively “FibroGen China”) and AstraZeneca entered into the China Amendment, relating to the development and commercialization of roxadustat in China. Under the China Amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Beijing Falikang Pharmaceutical Co., Ltd. ("Falikang"), which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca. 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 one province 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. Amounts recognized as revenue under the U.S./RoW Agreement and China Agreement with AstraZeneca were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 U.S. / RoW License revenue $ — $ — $ — $ — Development revenue 3,352 16,993 9,171 27,969 The transaction price relat ed 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 Deferred Total License $ 341,844 $ — $ 341,844 Co-development, information sharing & 612,290 — 612,290 China performance obligation * 71,527 170,514 242,041 Total license and development revenue $ 1,025,661 $ 170,514 ** $ 1,196,175 * China performance obligation revenue is recognized as product revenue, as described under Product Revenue, Net section below. ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of June 30, 2022, deferred revenue included $ 157.3 million related to the U.S./RoW Agreement and China Agreement, which represents the net of $ 170.5 million of deferred revenue presented above and a $ 13.2 million unbilled co-development revenue under the China Amendment with AstraZeneca. There was no revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended June 30, 2022 under the U.S./RoW Agreement. The remainder of the transaction price related to the U.S./R oW Agreement and China Agreement includes $ 18.0 million of variable consideration from estimated future co-development billing and is estimated to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation. The amount allocated to the China performance obligation is expected to be recognized as the Company transfers control of the commercial drug product to Falikang. The net product revenue from the sales to Falikang was $ 19.7 million and $ 11.8 million for the three months ended June 30, 2022 and 2021, and $ 36.0 million and $ 22.2 million for the six months ended June 30, 2022 and 2021, respectively, as described under Product Revenue, Net section below. In addition to sales to Falikang, the net product revenue from direct sales distributors in China was $ 3.5 million and $ 1.6 million for the three months ended June 30, 2022 and 2021, and $ 6.2 million and $ 6.6 million for the six months ended June 30, 2022 and 2021, respectively, as described as direct sales under Product Revenue, Net section below. Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Direct Sales: Gross revenue $ 3,533 $ 2,230 $ 6,362 $ 7,659 Discounts and rebates ( 13 ) ( 618 ) ( 187 ) ( 1,181 ) Sales returns ( 1 ) ( 1 ) 3 88 Direct sales revenue, net 3,519 1,611 6,178 6,566 Sales to Falikang: Gross transaction price 28,281 26,714 51,007 51,115 Profit share ( 10,065 ) ( 9,573 ) ( 18,914 ) ( 19,636 ) Net transaction price 18,216 17,141 32,093 31,479 Decrease (increase) in deferred revenue 1,521 ( 5,381 ) 3,866 ( 9,312 ) Sales to Falikang revenue, net 19,737 11,760 35,959 22,167 Total product revenue, net $ 23,256 $ 13,371 $ 42,137 $ 28,733 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 immaterial for the periods presented. 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 Additions Deduction Currency Balance at Product revenue - Direct sales - contract liabilities $ ( 3,176 ) $ ( 286 ) $ 1,903 $ 157 $ ( 1,402 ) The above contract liabilities 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 wer e $ 0.7 million and $ 1.1 million a s of June 30, 2022 and December 31, 2021, 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 transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligation is satisfied. Following updates to its estimates, the Company recognized $ 1.5 million and $ 3.9 million from the previously deferred revenue of the China performance obligation during the three and six months ended June 30, 2022, respectively. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at Additions Recognized as Revenue Currency Balance at Product revenue - AstraZeneca China $ ( 171,516 ) $ ( 36,184 ) $ 35,959 $ 1,227 $ ( 170,514 ) 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 June 30, 2022 , approximately $ 14.9 million of the above 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. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts, mainly related to profit sharing, are presented as reductions to gross accounts receivable from Falikang, which was $ 6.5 million and $ 13.4 million as of June 30, 2022 and December 31, 2021 , respectively. Drug Product Revenue Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Astellas - Japan Agreement $ 17 $ ( 1,974 ) $ 7,611 $ 2,056 Astellas - Europe Agreement 1,076 — 1,076 — AstraZeneca - U.S. Agreement — ( 6,674 ) — ( 2,224 ) Drug product revenue $ 1,093 $ ( 8,648 ) $ 8,687 $ ( 168 ) During the first quarter of 2022, the Company fulfilled a shipment obligation under the terms of Japan Amendment with Astellas, and recognized related drug product revenue of $ 9.8 million in the same period. In addition, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Japan Amendment with Astellas, and accordingly recorded adjustments to the drug product revenue of $( 2.2 ) million, $( 2.0 ) million and $ 4.0 million for the first quarter of 2022, the second quarter of 2021 and the first quarter of 2021, respectively. Specifically, the change in estimated variable consideration was based on the API held by Astellas at 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 second quarter of 2022, the Company transferred bulk drug product for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas, and recognized the related fully burdened manufacturing costs of $ 1.0 million as drug product revenue, and recorded $ 23.2 million as deferred revenue due to a high degree of uncertainty associated with the final consideration. In addition, the Company recognized royalty revenue of $ 0.1 million as drug product revenue from the deferred revenue under the Europe Agreement during the second quar ter of 2022. The remainder of the deferred revenue will be recognized as and when uncertainty is resolved, based on the performance of roxadustat product sales in the territory. During the first quarter of 2022, the Company billed and received $ 49.2 million from Astellas related to the annual transfer price true up for bulk drug product transferred for commercial purposes. This amount was recorded in deferred revenue and netted against an unbilled contract asset as of December 31, 2021. During the first and second quarter of 2022, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, the Company reclassified $ 43.3 million from deferred revenue to accrued liabilities as of June 30, 2022, representing its best estimate that this amount will be paid in the first quarter of 2023. During the first quarter of 2022, the Company evaluated the current developments in the U.S. market, and updated its estimates of variable consideration associated with bulk drug product shipments to AstraZeneca in prior years as commercial supply. As a result, the Company reclassified $ 11.2 million from the related deferred revenue to accrued liabilities as of June 30, 2022. The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at Additions Recognized as Revenue Reclassified to Accrued Liability / Accounts Payable Balance at Astellas - Japan Agreement $ ( 1,974 ) $ ( 2,226 ) $ — $ 4,200 $ — Astellas - Europe Agreement ( 25,891 ) ( 72,409 ) 90 43,273 ( 54,937 ) AstraZeneca - U.S. Agreement ( 11,171 ) — — 11,171 — Drug product revenue - deferred revenue $ ( 39,036 ) $ ( 74,635 ) $ 90 $ 58,644 $ ( 54,937 ) 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 , as amended and restated on January 21, 2022, Eluminex made an $ 8.0 million upfront payment to FibroGen during the first quarter of 2022, which was recorded as an unbilled contract asset as of December 31, 2021 in the prepaid expenses and other current assets in the condensed consolidated balance sheets. 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 royalties based upon worldwide net sales of cornea products, and low single-digit to mid single-digit royalties based upon worldwide n et sales of other recombinant human collagen type III products that are not cornea products. During the first quarter of 2022, FibroGen and Eluminex entered into a separate contract manufacturing agreement, under which the Company is responsible for supplying the cornea product at 110 % of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex. The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the condensed consolidated statement of operations. Amounts recognized as revenue under the Eluminex were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Eluminex Other revenue - contract manufacturing $ 280 $ — $ 1,042 $ — |
Variable Interest Entity
Variable Interest Entity | 6 Months Ended |
Jun. 30, 2022 | |
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 (“ASC 810”), the Company concluded that Falikang qualifies as a VIE. As Falikang is a distribution entity and AstraZeneca is the final decision maker for all the roxadustat commercialization activities, the Company lacks the power criterion, while AstraZeneca meets both the power and economic criteria under the ASC 810 to direct the activities of Falikang that most significantly impact its performance. Therefore, the Company is not the primary beneficiary of this VIE for accounting purposes. As a result, the Company accounts for its investment in Falikang under the equity method, and Falikang is not consolidated into the Company’s condensed consolidated financial statements. The Company records its total investments in Falikang as an equity method investment in an unconsolidated VIE in the condensed consolidated balance sheet. In addition, the Company recognizes its proportionate share of the reported profits or losses of Falikang as investment gain or loss in unconsolidated VIE in the condensed consolidated statement of operations and as an adjustment to its investment in Falikang in the condensed consolidated balance sheet. Falikang has not incurred material profit or loss to date. The Company may provide shareholder loans to Falikang to meet necessary financial obligations as part of its operations. To date, these loans have been immaterial. The Company’s equity method investment in Falikang was as follows (in thousands): Entity Ownership Percentage Balance at Share of Net Income Currency Balance at Falikang 51.1 % $ 3,825 $ 885 $ ( 216 ) $ 4,494 Falikang is considered a related party to the Company. See Note 7, Related Party Transactions , for related disclosures. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
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): June 30, 2022 Level 1 Level 2 Level 3 Total Money market funds $ 34,123 $ — $ — $ 34,123 Corporate bonds — 125,491 — 125,491 Commercial paper — 55,307 — 55,307 U.S. government bonds 105,383 10,972 — 116,355 Agency bonds — 14,930 — 14,930 Asset-backed securities — 4,741 — 4,741 Foreign government bonds — 4,954 — 4,954 Total $ 139,506 $ 216,395 $ — $ 355,901 December 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 58,801 $ — $ — $ 58,801 Corporate bonds — 182,646 — 182,646 Commercial paper — 69,079 — 69,079 U.S. government bonds 91,522 — — 91,522 Agency bonds — 23,275 — 23,275 Asset-backed securities — 27,087 — 27,087 Foreign government bonds — 9,154 — 9,154 Total $ 150,323 $ 311,241 $ — $ 461,564 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 six months ended June 30, 2022 . |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): June 30, 2022 December 31, 2021 Cash $ 128,152 $ 111,422 Commercial paper 5,483 1,000 Money market funds 34,123 58,801 Total cash and cash equivalents $ 167,758 $ 171,223 At June 30, 2022 and December 31, 2021 , a total of $ 98.8 million and $ 91.2 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): June 30, 2022 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Corporate bonds $ 127,387 $ — $ ( 1,896 ) $ 125,491 Commercial paper 49,824 — — 49,824 U.S. government bonds 118,142 — ( 1,787 ) 116,355 Agency bonds 15,235 — ( 305 ) 14,930 Asset-backed securities 4,751 — ( 10 ) 4,741 Foreign government bonds 5,032 — ( 78 ) 4,954 Total investments $ 320,371 $ — $ ( 4,076 ) $ 316,295 December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Corporate bonds $ 183,136 $ 2 $ ( 492 ) $ 182,646 Commercial paper 68,079 — — 68,079 U.S. government bonds 91,840 — ( 318 ) 91,522 Agency bonds 23,339 — ( 64 ) 23,275 Asset-backed securities 27,105 — ( 18 ) 27,087 Foreign government bonds 9,165 — ( 11 ) 9,154 Total investments $ 402,664 $ 2 $ ( 903 ) $ 401,763 At June 30, 2022 , the available-for-sale investments had contractual maturities range from several months to two years . The Company periodically reviews its available-for-sale investments for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. Based on the results of its review, the Company did no t recognize any other-than-temporary impairment loss during the three and six months ended June 30, 2022 and 2021. Inventories Inventories consisted of the following (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 1,220 $ 1,363 Work-in-progress 34,488 21,499 Finished goods 5,191 8,153 Total inventories $ 40,899 $ 31,015 Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Preclinical and clinical trial accruals $ 66,553 $ 56,283 API and bulk drug product price true-up 54,443 — Acquired in-process research and development asset — 35,000 Payroll and related accruals 13,480 20,909 Accrued co-promotion expenses - current 32,352 25,746 Contract liabilities to pharmaceutical distributors 1,402 3,176 Roxadustat profit share to AstraZeneca 7,497 7,895 Property taxes and other taxes 5,449 12,610 Professional services 4,929 6,074 Other 6,994 4,906 Total accrued and other current liabilities $ 193,099 $ 172,599 The accrued liabilities of $ 54.4 million for API and bulk drug product price true-up as of June 30, 2022 resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Japan Amendment with Astellas, the bulk drug product transferred under the terms of the Europe Agreement and the EU Supply Agreement with Astellas, and the bulk drug product shipments to AstraZeneca under the terms of the Master Supply Agreement. See Note 2, Collaboration Agreements, License Agreement and Revenues, for details. The acquired in-process research and development asset of $ 35.0 million as of December 31, 2021 was related to the upfront payment under an exclusive license and option agreement with HiFiBiO Therapeutics (“HiFiBiO”), which was paid during the six months ended June 30, 2022 . |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes Provisions for (benefit from) income tax for the three and six months ended June 30, 2022 and 2021 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 | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. 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 $ 1.8 million and $ 2.6 million for the three months ended June 30, 2022 and 2021 , and $ 29.6 million and $ 6.3 million for the six months ended June 30, 2022 and 2021 , respectively. The Company also recorded drug product revenue from Astellas of $ 1.1 million and $( 2.0 ) million for the three months ended June 30, 2022 and 2021, and $ 8.7 million and $ 2.1 million for the six months ended June 30, 2022 and 2021, respectively. See Note 2, Collaboration Agreements, License Agreement and Revenues , for details. The Company’s expense related to collaboration agreements with Astellas was immaterial for each of the three and six months ended June 30, 2022 and 2021. As of June 30, 2022 and December 31, 2021 , accounts receivable from Astellas were $ 26.1 million and $ 10.9 million, respectively. As of June 30, 2022 and December 31, 2021 , total deferred revenue from Astellas was $ 54.9 million and $ 27.9 million, respectively. As of June 30, 2022 , the amount due to Astellas was $ 43.3 million. As of December 31, 2021, amount due to Astellas was immaterial. 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 details. The net product revenue from Falikang was $ 19.7 million and $ 11.8 million for the three months ended June 30, 2022 and 2021, and $ 36.0 million and $ 22.2 million for the six months ended June 30, 2022 and 2021, respectively. See Note 2, Collaboration Agreements, License Agreement and Revenues , for details. The investment income in Falikang was $ 0.6 million for each of the three months ended June 30, 2022 and 2021, and $ 0.9 million and $ 0.3 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022 and December 31, 2021, the Company’s equity method investment in Falikang was $ 4.5 million and $ 3.8 million , respectively. See Note 3, Variable Interest Entity , for details. As of June 30, 2022 , accounts receivable, net, from Falikang was of $ 0.7 million. As of December 31, 2021 , accounts receivable, net, from Falikang was zero . The total deferred revenue from Falikang was zero as of June 30, 2022 . The total deferred revenue from Falikang was $ 1.2 million as of December 31, 2021 . |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Contract Obligations As of June 30, 2022, the Company had $ 94.1 million of operating lease liabilities. As of June 30, 2022 , the Company had outstanding total non-cancelable purchase obligations of $ 57.7 million, including $ 33.2 million for manufacture and supply of pamrevlumab, $ 9.2 million for manufacture and supply of roxadustat, and $ 15.3 million for other purchases and programs. 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 June 30, 2022 , future milestone payments for research and preclinical stage development programs consisted of up to approximately $ 697.9 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (for Gal-9 and CCR8), Medarex, Inc. and others. These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones. The event triggering such payment or obligation has not yet occurred. Legal Proceedings and Other Matters From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any active legal action in its condensed consolidated balance sheets as of June 30, 2022, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. In April 2021, three putative securities class action complaints were filed against FibroGen and certain of its current and former executive officers (collectively, the “Defendants”) in the U.S. District Court for the Northern District of California. The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for U.S. Food and Drug Administration approval between November 2019 and December 2020. Plaintiffs seek to represent a class of persons or entities that purchased FibroGen securities between November 8, 2019 and April 6, 2021. In May 2021, two additional putative securities class action complaints were filed against Defendants alleging the same claims. One of the lawsuits alleges that Defendants made materially false and misleading statements between October 2017 and December 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between October 18, 2017 and April 6, 2021. The other lawsuit alleges that Defendants made materially false and misleading statements between December 2018 and February 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between December 20, 2018 and April 6, 2021. All plaintiffs seek unspecified monetary damages and other relief. On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs. Plaintiffs filed their consolidated amended complaint on October 29, 2021 and a corrected consolidated amended complaint on November 19, 2021 (the “Complaint”). The Complaint alleges false and misleading statements between December 2018 and June 2021 and seeks to represent a class of persons or entities that purchased FibroGen securities between December 20, 2018 and July 15, 2021. Defendants filed motions to dismiss the Complaint on January 14, 2022. Plaintiffs’ opposition to Defendants’ motions to dismiss was due March 4, 2022 and Defendants’ reply briefs were due April 8, 2022. On July 15, 2022, the court issued an order denying Defendants’ motions to dismiss. Defendants’ answer to the Complaint is due September 13, 2022. On July 30, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names as defendants ten of FibroGen’s current and former officers and directors, as well as FibroGen as nominal defendant, and asserts state and federal claims based on some of the same alleged misstatements as the securities class action complaint. The complaint seeks unspecified damages, attorneys’ fees, and other costs. The action remains stayed at this time. On December 27, 2021, a second purported shareholder derivative complaint was filed in the U.S. District Court for the District of Delaware. The complaint names seventeen of FibroGen’s current and former officers and directors as defendants, as well as FibroGen as nominal defendant, and asserts state and federal claims based on some of the same alleged misstatements as the securities class action complaint, as well as allegations of insider trading against certain defendants. The complaint seeks unspecified damages, attorneys’ fees, and other costs. The action remains stayed at this time. On April 14, 2022, a third purported shareholder derivative complaint was filed in the Delaware Court of Chancery. It names the same defendants as the second purported shareholder derivative action and asserts similar claims based upon similar allegations. The complaint seeks unspecified damages, attorneys’ fees, and other costs. Defendants have not been served in the third action. The Company believes that the claims are without merit and it intends to vigorously defend against them. However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against FibroGen or any adverse settlement could materially and adversely impact its business, results of operations, financial condition, and prospects. In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data. The Company is fully cooperating with the SEC. The Company cannot predict with any degree of certainty the outcome of the SEC’s investigation or determine the extent of any potential liabilities. The Company also cannot predict whether there will be any loss as a result of the investigation nor can it provide an estimate of the possible loss or range of loss. Any adverse outcome in this matter or any related proceeding could expose the Company to substantial damages, penalties, or reputational harm that may have a material adverse impact on the Company’s business, results of operations, financial condition, growth prospects, and price of its common stock. On August 3, 2022, the Company's Board of Directors received two litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits. The Company may in the future receive such additional demands. 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. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | 9. Subsequent Event On July 26, 2022, the Company received a written evidence from China’s State Taxation Administration, which confirms the transfer of certain intellectual property rights in 2020 relating to the Company’s Chinese business between its wholly owned subsidiaries is exempted from value added tax (“VAT”). The Company evaluated this subsequent event and concluded that it required adjustment and disclosure in the condensed consolidated financial statements. Specifically, the Company released the previously accrued input VAT and output VAT (with a zero net impact to the condensed consolidated balance sheet), the related VAT surcharge, and the estimated late payment fees. As a result, for the three months ended June 30, 2022, the Company recorded a reduction of $ 8.2 million to the accrued and other current liabilities, and a reduction of $ 2.3 million to the other assets in the condensed consolidated balance sheet, and a reduction of $ 6.0 million to other expenses in the condensed consolidated statement of operations. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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. The Company applies its pioneering expertise in hypoxia-inducible factor ("HIF") biology, 2-oxoglutarate enzymology, and connective tissue growth factor to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. 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. To date, the Company has retained exclusive worldwide rights for pamrevlumab. Roxadustat is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat (爱瑞卓 ® , EVRENZO TM ) is now approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and those not on dialysis. Astellas Pharma Inc. (“Astellas”) and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, Australia/New Zealand, and Southeast Asia. Roxadustat is in Phase 3 clinical development for anemia associated with myelodysplastic syndromes. The Company has completed a Phase 2 study of roxadustat in chemotherapy-induced anemia and is running a Phase 3 trial of roxadustat chemotherapy-induced anemia in China. The Company has a pipeline of late-stage clinical programs as well as preclinical drug candidates at various stages of development that include both small molecules and biologics. The Company has leveraged its internally developed 2-oxoglutarate and connective tissue growth factor biology expertise as well as in-licensing of additional programs, such as antibodies targeting Galectin-9 protein (“Gal-9”) and C-C Motif Chemokine Receptor 8 (“CCR8”), to further enhance its late-stage preclinical pipeline. FibroGen's goal is to build a diversified pipeline with novel drugs that will address unmet patient needs in oncology, immunology, and fibrosis. |
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 the 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 for the year ended December 31, 2021, filed on February 28, 2022 and as amended on March 4, 2022 (“2021 Form 10-K”). Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no impact on previously reported financial position, results of operations, or cash flows. |
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 and deferred revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China manufacturing and supply obligation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. |
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. The Company applies its pioneering expertise in hypoxia-inducible factor ("HIF") biology, 2-oxoglutarate enzymology, and connective tissue growth factor to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. 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. To date, the Company has retained exclusive worldwide rights for pamrevlumab. Roxadustat is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat (爱瑞卓 ® , EVRENZO TM ) is now approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and those not on dialysis. Astellas Pharma Inc. (“Astellas”) and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, Australia/New Zealand, and Southeast Asia. Roxadustat is in Phase 3 clinical development for anemia associated with myelodysplastic syndromes. The Company has completed a Phase 2 study of roxadustat in chemotherapy-induced anemia and is running a Phase 3 trial of roxadustat chemotherapy-induced anemia in China. The Company has a pipeline of late-stage clinical programs as well as preclinical drug candidates at various stages of development that include both small molecules and biologics. The Company has leveraged its internally developed 2-oxoglutarate and connective tissue growth factor biology expertise as well as in-licensing of additional programs, such as antibodies targeting Galectin-9 protein (“Gal-9”) and C-C Motif Chemokine Receptor 8 (“CCR8”), to further enhance its late-stage preclinical pipeline. FibroGen's goal is to build a diversified pipeline with novel drugs that will address unmet patient needs in oncology, immunology, and fibrosis. 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 the 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 for the year ended December 31, 2021, filed on February 28, 2022 and as amended on March 4, 2022 (“2021 Form 10-K”). Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no impact on previously reported financial position, results of operations, or cash flows. 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 and deferred revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China manufacturing and supply obligation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. 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 2021 Form 10-K, except for the updates to the following: Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees, which are comprised of stock options, service-based restricted stock units ("RSUs"), performance-based RSUs and total shareholder return (“TSR”) awards. The Company measures and recognizes compensation expense for all stock options, service and performance-based restricted stock units granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The determination of the grant date fair value of options using the Black-Scholes valuation model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. To estimate the fair value of the TSR awards, the Company uses the Monte Carlo valuation model to simulate the probabilities of achievement, which requires management to make a number of assumptions including 30-day average price, volatility of the underlying stock and the Company's peers, and the risk-free interest rate. The compensation cost of service-based stock options and restricted stock units is recognized net of any estimated forfeitures on a straight-line basis over the employee requisite service period. Compensation cost for performance-based RSUs is expensed over the respective vesting periods when the achievement of performance criteria is probable. Compensation cost for the TSR awards is recognized over the requisite service period, regardless of when, if ever, the market condition is satisfied. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. Net Loss per Share Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a net loss for each interim period presented. 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 (including service-based RSUs, performance-based RSUs and TSR awards) and shares to be purchased under the employee stock purchase plan totaling 14.2 million and 11.4 million for the three months ended June 30, 2022 and 2021 , and totaling 13.3 million and 9.4 million for the six months ended June 30, 2022 and 2021 , 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, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, intellectual property protection for the Company's proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties. 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” ) , which provides companies with optional financial reporting alternatives to reduce the cost and complexity associated with the accounting for contracts and hedging relationships affected by reference rate reform. This guidance is effective as of March 12, 2020 through December 31, 2022. Subsequently in January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848): Scope , which clarifies ASU 2020-04 and provides certain optional expedients that allow derivative instruments impacted by changes in the interest rate used for margining, discounting or contract price alignment to qualify for certain optional relief. ASU 2021-01 is effective in the same timeframe as ASU2020-04. The relief offered by this guidance, if adopted, is available to companies for the period March 12, 2020 through December 31, 2022. The Company has certain lease arrangements that are linked to the London Inter-Bank Offered Rate ("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 three and six months ended June 30, 2022 and is currently evaluating the impact on its condensed consolidated financial statements and related disclosures upon adoption of this guidance. |
Stock-Based Compensation | Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees, which are comprised of stock options, service-based restricted stock units ("RSUs"), performance-based RSUs and total shareholder return (“TSR”) awards. The Company measures and recognizes compensation expense for all stock options, service and performance-based restricted stock units granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The determination of the grant date fair value of options using the Black-Scholes valuation model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. To estimate the fair value of the TSR awards, the Company uses the Monte Carlo valuation model to simulate the probabilities of achievement, which requires management to make a number of assumptions including 30-day average price, volatility of the underlying stock and the Company's peers, and the risk-free interest rate. The compensation cost of service-based stock options and restricted stock units is recognized net of any estimated forfeitures on a straight-line basis over the employee requisite service period. Compensation cost for performance-based RSUs is expensed over the respective vesting periods when the achievement of performance criteria is probable. Compensation cost for the TSR awards is recognized over the requisite service period, regardless of when, if ever, the market condition is satisfied. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. |
Net Loss per Share | Net Loss per Share Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a net loss for each interim period presented. 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 (including service-based RSUs, performance-based RSUs and TSR awards) and shares to be purchased under the employee stock purchase plan totaling 14.2 million and 11.4 million for the three months ended June 30, 2022 and 2021 , and totaling 13.3 million and 9.4 million for the six months ended June 30, 2022 and 2021 , 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, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, intellectual property protection for the Company's proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties. |
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” ) , which provides companies with optional financial reporting alternatives to reduce the cost and complexity associated with the accounting for contracts and hedging relationships affected by reference rate reform. This guidance is effective as of March 12, 2020 through December 31, 2022. Subsequently in January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848): Scope , which clarifies ASU 2020-04 and provides certain optional expedients that allow derivative instruments impacted by changes in the interest rate used for margining, discounting or contract price alignment to qualify for certain optional relief. ASU 2021-01 is effective in the same timeframe as ASU2020-04. The relief offered by this guidance, if adopted, is available to companies for the period March 12, 2020 through December 31, 2022. The Company has certain lease arrangements that are linked to the London Inter-Bank Offered Rate ("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 three and six months ended June 30, 2022 and is currently evaluating the impact on its condensed consolidated financial statements and related disclosures upon adoption of this guidance. |
Collaboration Agreements, License Agreement and Revenues | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 172.6 million . 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 June 30, 2022 totaled $ 105.1 million , excluding drug product revenue that is discussed separately below. |
Product Revenue, Net | Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Direct Sales: Gross revenue $ 3,533 $ 2,230 $ 6,362 $ 7,659 Discounts and rebates ( 13 ) ( 618 ) ( 187 ) ( 1,181 ) Sales returns ( 1 ) ( 1 ) 3 88 Direct sales revenue, net 3,519 1,611 6,178 6,566 Sales to Falikang: Gross transaction price 28,281 26,714 51,007 51,115 Profit share ( 10,065 ) ( 9,573 ) ( 18,914 ) ( 19,636 ) Net transaction price 18,216 17,141 32,093 31,479 Decrease (increase) in deferred revenue 1,521 ( 5,381 ) 3,866 ( 9,312 ) Sales to Falikang revenue, net 19,737 11,760 35,959 22,167 Total product revenue, net $ 23,256 $ 13,371 $ 42,137 $ 28,733 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 immaterial for the periods presented. 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 Additions Deduction Currency Balance at Product revenue - Direct sales - contract liabilities $ ( 3,176 ) $ ( 286 ) $ 1,903 $ 157 $ ( 1,402 ) The above contract liabilities 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 wer e $ 0.7 million and $ 1.1 million a s of June 30, 2022 and December 31, 2021, 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 transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligation is satisfied. Following updates to its estimates, the Company recognized $ 1.5 million and $ 3.9 million from the previously deferred revenue of the China performance obligation during the three and six months ended June 30, 2022, respectively. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at Additions Recognized as Revenue Currency Balance at Product revenue - AstraZeneca China $ ( 171,516 ) $ ( 36,184 ) $ 35,959 $ 1,227 $ ( 170,514 ) 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 June 30, 2022 , approximately $ 14.9 million of the above 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. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts, mainly related to profit sharing, are presented as reductions to gross accounts receivable from Falikang, which was $ 6.5 million and $ 13.4 million as of June 30, 2022 and December 31, 2021 , respectively. |
Drug Product Revenue | Drug Product Revenue Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Astellas - Japan Agreement $ 17 $ ( 1,974 ) $ 7,611 $ 2,056 Astellas - Europe Agreement 1,076 — 1,076 — AstraZeneca - U.S. Agreement — ( 6,674 ) — ( 2,224 ) Drug product revenue $ 1,093 $ ( 8,648 ) $ 8,687 $ ( 168 ) During the first quarter of 2022, the Company fulfilled a shipment obligation under the terms of Japan Amendment with Astellas, and recognized related drug product revenue of $ 9.8 million in the same period. In addition, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Japan Amendment with Astellas, and accordingly recorded adjustments to the drug product revenue of $( 2.2 ) million, $( 2.0 ) million and $ 4.0 million for the first quarter of 2022, the second quarter of 2021 and the first quarter of 2021, respectively. Specifically, the change in estimated variable consideration was based on the API held by Astellas at 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 second quarter of 2022, the Company transferred bulk drug product for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas, and recognized the related fully burdened manufacturing costs of $ 1.0 million as drug product revenue, and recorded $ 23.2 million as deferred revenue due to a high degree of uncertainty associated with the final consideration. In addition, the Company recognized royalty revenue of $ 0.1 million as drug product revenue from the deferred revenue under the Europe Agreement during the second quar ter of 2022. The remainder of the deferred revenue will be recognized as and when uncertainty is resolved, based on the performance of roxadustat product sales in the territory. During the first quarter of 2022, the Company billed and received $ 49.2 million from Astellas related to the annual transfer price true up for bulk drug product transferred for commercial purposes. This amount was recorded in deferred revenue and netted against an unbilled contract asset as of December 31, 2021. During the first and second quarter of 2022, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, the Company reclassified $ 43.3 million from deferred revenue to accrued liabilities as of June 30, 2022, representing its best estimate that this amount will be paid in the first quarter of 2023. During the first quarter of 2022, the Company evaluated the current developments in the U.S. market, and updated its estimates of variable consideration associated with bulk drug product shipments to AstraZeneca in prior years as commercial supply. As a result, the Company reclassified $ 11.2 million from the related deferred revenue to accrued liabilities as of June 30, 2022. The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at Additions Recognized as Revenue Reclassified to Accrued Liability / Accounts Payable Balance at Astellas - Japan Agreement $ ( 1,974 ) $ ( 2,226 ) $ — $ 4,200 $ — Astellas - Europe Agreement ( 25,891 ) ( 72,409 ) 90 43,273 ( 54,937 ) AstraZeneca - U.S. Agreement ( 11,171 ) — — 11,171 — Drug product revenue - deferred revenue $ ( 39,036 ) $ ( 74,635 ) $ 90 $ 58,644 $ ( 54,937 ) |
Collaboration Agreements, Lic_2
Collaboration Agreements, License Agreement and Revenues (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Direct Sales: Gross revenue $ 3,533 $ 2,230 $ 6,362 $ 7,659 Discounts and rebates ( 13 ) ( 618 ) ( 187 ) ( 1,181 ) Sales returns ( 1 ) ( 1 ) 3 88 Direct sales revenue, net 3,519 1,611 6,178 6,566 Sales to Falikang: Gross transaction price 28,281 26,714 51,007 51,115 Profit share ( 10,065 ) ( 9,573 ) ( 18,914 ) ( 19,636 ) Net transaction price 18,216 17,141 32,093 31,479 Decrease (increase) in deferred revenue 1,521 ( 5,381 ) 3,866 ( 9,312 ) Sales to Falikang revenue, net 19,737 11,760 35,959 22,167 Total product revenue, net $ 23,256 $ 13,371 $ 42,137 $ 28,733 |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the contract liabilities (in thousands): Balance at Additions Deduction Currency Balance at Product revenue - Direct sales - contract liabilities $ ( 3,176 ) $ ( 286 ) $ 1,903 $ 157 $ ( 1,402 ) |
Schedule of Drug Product Revenue | Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Astellas - Japan Agreement $ 17 $ ( 1,974 ) $ 7,611 $ 2,056 Astellas - Europe Agreement 1,076 — 1,076 — AstraZeneca - U.S. Agreement — ( 6,674 ) — ( 2,224 ) Drug product revenue $ 1,093 $ ( 8,648 ) $ 8,687 $ ( 168 ) |
Summary of Amounts Recognized as Revenue | Amounts recognized as revenue under the Eluminex were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Eluminex Other revenue - contract manufacturing $ 280 $ — $ 1,042 $ — |
Drug Product Revenue [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at Additions Recognized as Revenue Reclassified to Accrued Liability / Accounts Payable Balance at Astellas - Japan Agreement $ ( 1,974 ) $ ( 2,226 ) $ — $ 4,200 $ — Astellas - Europe Agreement ( 25,891 ) ( 72,409 ) 90 43,273 ( 54,937 ) AstraZeneca - U.S. Agreement ( 11,171 ) — — 11,171 — Drug product revenue - deferred revenue $ ( 39,036 ) $ ( 74,635 ) $ 90 $ 58,644 $ ( 54,937 ) |
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 Additions Recognized as Revenue Currency Balance at Product revenue - AstraZeneca China $ ( 171,516 ) $ ( 36,184 ) $ 35,959 $ 1,227 $ ( 170,514 ) |
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 for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Japan License revenue $ — $ — $ — $ — Development revenue $ 79 $ 99 $ 111 $ 179 |
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 Deferred Total License $ 100,347 $ — $ 100,347 Development revenue 16,709 — 16,709 Total license and development revenue $ 117,056 $ — $ 117,056 |
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 for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 Europe License revenue $ — $ — $ 22,590 $ — Development revenue $ 1,746 $ 2,546 $ 6,894 $ 6,077 |
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 Deferred Total License $ 618,975 $ — $ 618,975 Development revenue 277,536 — 277,536 Total license and development revenue $ 896,511 $ — $ 896,511 |
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 Agreement and China Agreement with AstraZeneca were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2022 2021 2022 2021 U.S. / RoW License revenue $ — $ — $ — $ — Development revenue 3,352 16,993 9,171 27,969 |
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 relat ed 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 Deferred Total License $ 341,844 $ — $ 341,844 Co-development, information sharing & 612,290 — 612,290 China performance obligation * 71,527 170,514 242,041 Total license and development revenue $ 1,025,661 $ 170,514 ** $ 1,196,175 * China performance obligation revenue is recognized as product revenue, as described under Product Revenue, Net section below. ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of June 30, 2022, deferred revenue included $ 157.3 million related to the U.S./RoW Agreement and China Agreement, which represents the net of $ 170.5 million of deferred revenue presented above and a $ 13.2 million unbilled co-development revenue under the China Amendment with AstraZeneca. |
Variable Interest Entity (Table
Variable Interest Entity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 Share of Net Income Currency Balance at Falikang 51.1 % $ 3,825 $ 885 $ ( 216 ) $ 4,494 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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): June 30, 2022 Level 1 Level 2 Level 3 Total Money market funds $ 34,123 $ — $ — $ 34,123 Corporate bonds — 125,491 — 125,491 Commercial paper — 55,307 — 55,307 U.S. government bonds 105,383 10,972 — 116,355 Agency bonds — 14,930 — 14,930 Asset-backed securities — 4,741 — 4,741 Foreign government bonds — 4,954 — 4,954 Total $ 139,506 $ 216,395 $ — $ 355,901 December 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 58,801 $ — $ — $ 58,801 Corporate bonds — 182,646 — 182,646 Commercial paper — 69,079 — 69,079 U.S. government bonds 91,522 — — 91,522 Agency bonds — 23,275 — 23,275 Asset-backed securities — 27,087 — 27,087 Foreign government bonds — 9,154 — 9,154 Total $ 150,323 $ 311,241 $ — $ 461,564 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): June 30, 2022 December 31, 2021 Cash $ 128,152 $ 111,422 Commercial paper 5,483 1,000 Money market funds 34,123 58,801 Total cash and cash equivalents $ 167,758 $ 171,223 |
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): June 30, 2022 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Corporate bonds $ 127,387 $ — $ ( 1,896 ) $ 125,491 Commercial paper 49,824 — — 49,824 U.S. government bonds 118,142 — ( 1,787 ) 116,355 Agency bonds 15,235 — ( 305 ) 14,930 Asset-backed securities 4,751 — ( 10 ) 4,741 Foreign government bonds 5,032 — ( 78 ) 4,954 Total investments $ 320,371 $ — $ ( 4,076 ) $ 316,295 December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Corporate bonds $ 183,136 $ 2 $ ( 492 ) $ 182,646 Commercial paper 68,079 — — 68,079 U.S. government bonds 91,840 — ( 318 ) 91,522 Agency bonds 23,339 — ( 64 ) 23,275 Asset-backed securities 27,105 — ( 18 ) 27,087 Foreign government bonds 9,165 — ( 11 ) 9,154 Total investments $ 402,664 $ 2 $ ( 903 ) $ 401,763 |
Schedule of Inventory | Inventories consisted of the following (in thousands): June 30, 2022 December 31, 2021 Raw materials $ 1,220 $ 1,363 Work-in-progress 34,488 21,499 Finished goods 5,191 8,153 Total inventories $ 40,899 $ 31,015 |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Preclinical and clinical trial accruals $ 66,553 $ 56,283 API and bulk drug product price true-up 54,443 — Acquired in-process research and development asset — 35,000 Payroll and related accruals 13,480 20,909 Accrued co-promotion expenses - current 32,352 25,746 Contract liabilities to pharmaceutical distributors 1,402 3,176 Roxadustat profit share to AstraZeneca 7,497 7,895 Property taxes and other taxes 5,449 12,610 Professional services 4,929 6,074 Other 6,994 4,906 Total accrued and other current liabilities $ 193,099 $ 172,599 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Detail) shares in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 shares | Jun. 30, 2021 shares | Jun. 30, 2022 Segment shares | Jun. 30, 2021 shares | |
Accounting Policy [Line Items] | ||||
Number of reportable segment | Segment | 1 | |||
Anti-dilutive shares outstanding | shares | 14.2 | 11.4 | 13.3 | 9.4 |
Collaboration Agreements, Lic_3
Collaboration Agreements, License Agreement and Revenues - Astellas Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Apr. 30, 2006 | Jun. 30, 2005 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total revenue | $ 29,806,000 | $ 24,364,000 | $ 90,633,000 | $ 62,793,000 | ||||
Deferred Revenue | 6,897,000 | 6,897,000 | $ 15,857,000 | |||||
Drug Product Revenue [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total revenue | 1,093,000 | 8,648,000 | 8,687,000 | (168,000) | ||||
Japan [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price, variable consideration from estimated future co-development billing | 0 | |||||||
Japan [Member] | Drug Product Revenue [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total revenue | $ 9,800,000 | |||||||
Europe [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price, variable consideration from estimated future co-development billing | $ 7,600,000 | |||||||
Astellas Agreement [Member] | Japan [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront, non-contingent and time-based payments received | $ 172,600,000 | |||||||
Additional consideration based on net sales description | the low 20% range of the list price | |||||||
Aggregate consideration received excluding drug product revenue | 105,100,000 | $ 105,100,000 | ||||||
Revenue resulting from changes to estimated variable consideration | 0 | |||||||
Astellas Agreement [Member] | Japan [Member] | Drug Product Revenue [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Total revenue | (2,000,000) | $ 7,600,000 | 2,100,000 | |||||
Astellas Agreement [Member] | Europe [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront, non-contingent and time-based payments received | $ 745,000,000 | |||||||
Additional consideration based on net sales description | low 20% range | |||||||
Aggregate consideration received excluding drug product revenue | 685,000,000 | $ 685,000,000 | ||||||
Total revenue | 1,100,000 | $ 0 | $ 1,100,000 | $ 0 | ||||
Percentage of joint development costs committed to fund | 50% | |||||||
Transaction price and allocated to performance obligations | $ 25,000,000 | |||||||
Changes in revenue from changes to estimated variable consideration | $ 0 |
Collaboration Agreements, Lic_4
Collaboration Agreements, License Agreement and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jul. 30, 2013 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 29,806,000 | $ 24,364,000 | $ 90,633,000 | $ 62,793,000 | ||
Deferred Revenue | 6,897,000 | 6,897,000 | $ 15,857,000 | |||
Drug product revenue recognized | 29,806,000 | 24,364,000 | 90,633,000 | 62,793,000 | ||
Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 23,256,000 | 13,371,000 | 42,137,000 | 28,733,000 | ||
Drug product revenue recognized | 23,256,000 | 13,371,000 | 42,137,000 | 28,733,000 | ||
Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 1,093,000 | 8,648,000 | 8,687,000 | (168,000) | ||
Drug product revenue recognized | 1,093,000 | 8,648,000 | $ 8,687,000 | (168,000) | ||
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 | $ 1,200,000,000 | |||||
Additional consideration based on net sales description | low 20% range | |||||
Aggregate consideration received excluding drug product revenue | 439,000,000 | $ 439,000,000 | ||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 0 | (6,700,000) | 0 | (2,200,000) | ||
Drug product revenue recognized | 0 | (6,700,000) | 0 | (2,200,000) | ||
AstraZeneca Agreements [Member] | China [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront, non-contingent, non-refundable and time-based payments | $ 376,700,000 | |||||
Aggregate considerations received | 77,200,000 | |||||
AstraZeneca Agreements [Member] | China [Member] | Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 19,700,000 | 11,800,000 | 36,000,000 | 22,200,000 | ||
Drug product revenue recognized | 19,700,000 | 11,800,000 | 36,000,000 | 22,200,000 | ||
Direct Sales [Member] | Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 3,519,000 | 1,611,000 | 6,178,000 | 6,566,000 | ||
Drug product revenue recognized | 3,519,000 | 1,611,000 | 6,178,000 | 6,566,000 | ||
Direct Sales [Member] | China [Member] | Product Revenue, Net [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 3,500,000 | 1,600,000 | 6,200,000 | 6,600,000 | ||
Drug product revenue recognized | $ 3,500,000 | $ 1,600,000 | $ 6,200,000 | $ 6,600,000 |
Collaboration Agreements, Lic_5
Collaboration Agreements, License Agreement and Revenues - Summary of License Revenue and Development Revenue Recognized under Agreement (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 29,806,000 | $ 24,364,000 | $ 90,633,000 | $ 62,793,000 |
License Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 22,590,000 | 0 |
Development Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 5,457,000 | 19,641,000 | 17,219,000 | 34,228,000 |
Astellas Agreement [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 1,100,000 | 0 | 1,100,000 | 0 |
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 | 0 | 0 | 22,590,000 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 79,000 | 99,000 | 111,000 | 179,000 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 1,746,000 | 2,546,000 | 6,894,000 | 6,077,000 |
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 | $ 3,352,000 | $ 16,993,000 | $ 9,171,000 | $ 27,969,000 |
Collaboration Agreements, Lic_6
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | $ 117,056 | |
Deferred Revenue | 0 | |
Total Consideration | 117,056 | |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 16,709 | |
Deferred Revenue | 0 | |
Total Consideration | 16,709 | |
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 | 896,511 | |
Deferred Revenue | 0 | |
Total Consideration | 896,511 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 277,536 | |
Deferred Revenue | 0 | |
Total Consideration | 277,536 | |
Astellas Agreement [Member] | Europe [Member] | License Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 618,975 | |
Deferred Revenue | 0 | |
Total Consideration | 618,975 | |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 170,514 | $ 171,516 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 1,025,661 | |
Deferred Revenue | 170,514 | |
Total Consideration | 1,196,175 | |
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 | 612,290 | |
Deferred Revenue | 0 | |
Total Consideration | 612,290 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 71,527 | |
Deferred Revenue | 170,514 | |
Total Consideration | $ 242,041 |
Collaboration Agreements, Lic_7
Collaboration Agreements, License Agreement and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 7,600,000 | |
Europe [Member] | Astellas Agreement [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Changes in revenue from changes to estimated variable consideration | $ 0 | |
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 | 18,000,000 | |
Changes in revenue from changes to estimated variable consideration | $ 0 |
Collaboration Agreements, Lic_8
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($49,2733 and $25,891 to a related party) | $ 205,351 | $ 186,801 |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 170,514 | $ 171,516 |
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($49,2733 and $25,891 to a related party) | 157,300 | |
Deferred Revenue | 170,500 | |
Net unbilled co-development revenue | $ 13,200 |
Collaboration Agreements, Lic_9
Collaboration Agreements, License Agreement and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 |
Product Revenue, Net [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 23,256 | 13,371 | 42,137 | 28,733 |
Product Revenue, Net [Member] | Direct Sales [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Gross revenue | 3,533 | 2,230 | 6,362 | 7,659 |
Total revenue | 3,519 | 1,611 | 6,178 | 6,566 |
Product Revenue, Net [Member] | Direct Sales [Member] | Discounts and Rebates [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (13) | (618) | (187) | (1,181) |
Product Revenue, Net [Member] | Direct Sales [Member] | Sales Returns [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 1 | 1 | 3 | 88 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 19,737 | 11,760 | 35,959 | 22,167 |
Gross transfer price | 28,281 | 26,714 | 51,007 | 51,115 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Profit Share [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (10,065) | (9,573) | (18,914) | (19,636) |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Net Transfer Price [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 18,216 | 17,141 | 32,093 | 31,479 |
Product Revenue, Net [Member] | Sales To Falikang [Member] | Increase in Deferred Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ (1,521) | $ (5,381) | $ 3,866 | $ (9,312) |
Collaboration Agreements, Li_10
Collaboration Agreements, License Agreement and Revenues - Product Revenue, Net - Additional Information 1 (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 | |
Rebates and Discounts [Member] | Gross Accounts Receivable [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | 700 | $ 1,100 | |||
Constrained for Future Recognition [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total revenue | $ 1,500 | $ 3,900 |
Collaboration Agreements, Li_11
Collaboration Agreements, License Agreement and Revenues - Roll-forward of Related Contract Liabilities (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
AstraZeneca Agreements [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | $ (171,516) |
Additions | (36,184) |
Currency Translation and Other | 1,227 |
Recognized as Revenue | 35,959 |
Balance at June 30, 2022 | (170,514) |
Product Revenue, Net [Member] | Direct Sales [Member] | Contract Liabilities [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | (3,176) |
Additions | (286) |
Deduction | 1,903 |
Currency Translation and Other | 157 |
Balance at June 30, 2022 | (1,402) |
Drug Product Revenue [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | (39,036) |
Additions | (74,635) |
Reclassified to Accrued Liability | 58,644 |
Recognized as Revenue | 90 |
Balance at June 30, 2022 | (54,937) |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | U.S. [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | (11,171) |
Additions | 0 |
Reclassified to Accrued Liability | 11,171 |
Recognized as Revenue | 0 |
Balance at June 30, 2022 | 0 |
Drug Product Revenue [Member] | Astellas Agreement [Member] | Japan [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | (1,974) |
Additions | (2,226) |
Reclassified to Accrued Liability | 4,200 |
Recognized as Revenue | 0 |
Balance at June 30, 2022 | 0 |
Drug Product Revenue [Member] | Astellas Agreement [Member] | Europe [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2021 | (25,891) |
Additions | (72,409) |
Reclassified to Accrued Liability | 43,273 |
Recognized as Revenue | 90 |
Balance at June 30, 2022 | $ (54,937) |
Collaboration Agreements, Li_12
Collaboration Agreements, License Agreement and Revenues - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Product Revenue, Net [Member] | Beijing Falikang Pharmaceutical Co Ltd | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Reductions to gross accounts receivable | $ 6,500 | $ 13,400 |
AstraZeneca Agreements [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | 170,514 | $ 171,516 |
AstraZeneca Agreements [Member] | China [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | $ 14,900 |
Collaboration Agreements, Li_13
Collaboration Agreements, License Agreement and Revenues - Drug Product Revenue - Summary of Drug Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 | |
Drug Product Revenue [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | 1,093 | 8,648 | 8,687 | (168) | |
Drug Product Revenue [Member] | Japan [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | $ 9,800 | ||||
Drug Product Revenue [Member] | Astellas Agreement [Member] | Japan [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | 17 | (1,974) | 7,611 | 2,056 | |
Drug Product Revenue [Member] | Astellas Agreement [Member] | Europe [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | 1,076 | 0 | 1,076 | 0 | |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | U.S. [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Drug product revenue recognized | $ 0 | $ (6,674) | $ 0 | $ (2,224) |
Collaboration Agreements, Li_14
Collaboration Agreements, License Agreement and Revenues - Drug Product Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | $ 6,897 | $ 6,897 | $ 15,857 | ||||
Drug product revenue recognized | 29,806 | $ 24,364 | 90,633 | $ 62,793 | |||
Royalty Revenue [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | 100 | 100 | |||||
Drug Product Revenue [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | 1,093 | 8,648 | 8,687 | (168) | |||
Drug Product Revenue [Member] | Europe [Member] | Astellas Agreement [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | 1,076 | 0 | 1,076 | 0 | |||
Drug Product Revenue [Member] | Japan [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | $ 9,800 | ||||||
Drug Product Revenue [Member] | Japan [Member] | Astellas Agreement [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | 17 | (1,974) | 7,611 | $ 2,056 | |||
Drug Product Revenue [Member] | API Shipment [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | (2,200) | $ (2,000) | $ 4,000 | ||||
Bulk Drug Product [Member] | Astellas Agreement [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | 43,300 | ||||||
Bulk Drug Product [Member] | Astra Zeneca Agreements [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Drug product revenue recognized | 11,200 | ||||||
Bulk Drug Product [Member] | E U Supply And Astellas Agreement [Member] | Europe [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred Revenue | 23,200 | $ 23,200 | |||||
Billed Contracts Receivable | $ 49,200 | ||||||
Burdened manufacturing costs | $ 1,000 |
Collaboration Agreements, Li_15
Collaboration Agreements, License Agreement and Revenues - Eluminex Agreement - Additional Information 2 (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jul. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Total revenue | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 | ||
Eluminex [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Aggregate consideration received for milestone and upfront payments | $ 8,000 | |||||
Future manufacturing clinical regulatory and commercial milestone payments | 64,000 | |||||
Commercial milestone | $ 36,000 | |||||
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% |
Collaboration Agreements, Li_16
Collaboration Agreements, License Agreement and Revenues - Summary of Amounts Recognized as Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 29,806 | $ 24,364 | $ 90,633 | $ 62,793 |
License Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 22,590 | 0 |
License Revenue [Member] | Eluminex [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 280 | $ 0 | $ 1,042 | $ 0 |
Variable Interest Entity - Addi
Variable Interest Entity - Additional Information (Detail) | Jun. 30, 2022 |
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Acquisition And Variable Interest Entity [Line Items] | ||||
Beginning balance | $ 3,825 | |||
Share of Net Income | $ 565 | $ 562 | 885 | $ 323 |
Ending balance | $ 4,494 | $ 4,494 | ||
Beijing Falikang Pharmaceutical Co. Ltd [Member] | ||||
Acquisition And Variable Interest Entity [Line Items] | ||||
Ownership Percentage | 51.10% | 51.10% | ||
Beginning balance | $ 3,825 | |||
Share of Net Income | 885 | |||
Currency Translation | (216) | |||
Ending balance | $ 4,494 | $ 4,494 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 316,295 | $ 401,763 |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 125,491 | 182,646 |
Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 49,824 | 68,079 |
Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,741 | 27,087 |
Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,954 | 9,154 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 355,901 | 461,564 |
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 | 34,123 | 58,801 |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 125,491 | 182,646 |
Fair Value, Measurements, Recurring [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 55,307 | 69,079 |
Fair Value, Measurements, Recurring [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 116,355 | 91,522 |
Fair Value, Measurements, Recurring [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 14,930 | 23,275 |
Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,741 | 27,087 |
Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,954 | 9,154 |
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 | 139,506 | 150,323 |
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 | 34,123 | 58,801 |
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 | 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 | 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 | 105,383 | 91,522 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 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 | 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 | 0 |
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 | 216,395 | 311,241 |
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 | 125,491 | 182,646 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 55,307 | 69,079 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,972 | 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 | 14,930 | 23,275 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,741 | 27,087 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 4,954 | 9,154 |
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 | 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 | 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 | 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 | 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 | 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 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Operating lease right-of-use assets, net | $ 84,654 | $ 91,112 |
Operating lease liabilities | 10,984 | 10,944 |
Operating lease liabilities | $ 83,080 | $ 88,776 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Lessee Lease Description [Line Items] | ||
Operating lease right-of-use assets | $ 84,654 | $ 91,112 |
Operating lease liability | $ 94,100 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Finance lease cost: | ||
Amortization of right-of-use assets | $ 269 | $ 4,393 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Financing cash flows from finance leases | $ 23 | $ 5,326 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Millions | Jun. 30, 2022 USD ($) |
Operating Leases | |
Present value of lease liabilities | $ 94.1 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] | ||
Cash | $ 128,152 | $ 111,422 |
Commercial paper | 5,483 | 1,000 |
Money market funds | 34,123 | 58,801 |
Total cash and cash equivalents | $ 167,758 | $ 171,223 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Jul. 31, 2021 | |
Schedule of Available-for-sale Securities [Line Items] | ||||||
Cash and cash equivalents | $ 167,758,000 | $ 167,758,000 | $ 171,223,000 | |||
Other-than-temporary impairment loss | 0 | $ 0 | 0 | $ 0 | ||
API and bulk drug product price true-up | 54,443,000 | 54,443,000 | ||||
Acquired In Process Research And Development Asset | 35,000,000 | |||||
Profit share liability | 6,897,000 | $ 6,897,000 | 15,857,000 | |||
Eluminex [Member] | ||||||
Schedule of Available-for-sale Securities [Line Items] | ||||||
Unbilled upfront payment | $ 8,000,000 | |||||
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 | $ 98,800,000 | $ 98,800,000 | $ 91,200,000 |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 320,371 | $ 402,664 |
Gross Unrealized Holding Gains | 0 | 2 |
Gross Unrealized Holding Losses | (4,076) | (903) |
Fair Value | 316,295 | 401,763 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 127,387 | 183,136 |
Gross Unrealized Holding Gains | 0 | 2 |
Gross Unrealized Holding Losses | (1,896) | (492) |
Fair Value | 125,491 | 182,646 |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 49,824 | 68,079 |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 49,824 | 68,079 |
U.S. government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 118,142 | 91,840 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | (1,787) | (318) |
Fair Value | 116,355 | 91,522 |
Agency bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 15,235 | 23,339 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | (305) | (64) |
Fair Value | 14,930 | 23,275 |
Asset-backed securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,751 | 27,105 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | (10) | (18) |
Fair Value | 4,741 | 27,087 |
Foreign government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 5,032 | 9,165 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | (78) | (11) |
Fair Value | $ 4,954 | $ 9,154 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of Investments [Abstract] | ||
Raw materials | $ 1,220 | $ 1,363 |
Work-in-progress | 34,488 | 21,499 |
Finished goods | 5,191 | 8,153 |
Total inventories | $ 40,899 | $ 31,015 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 66,553 | $ 56,283 |
API and bulk drug product price true-up | 54,443 | |
Acquired in-process research and development asset | 35,000 | |
Payroll and related accruals | 13,480 | 20,909 |
Accrued co-promotion expenses - current | 1,402 | 3,176 |
Contract liabilities to pharmaceutical distributors | 7,497 | 7,895 |
Roxadustat profit share to AstraZeneca | 32,352 | 25,746 |
Property taxes and other taxes | 5,449 | 12,610 |
Professional services | 4,929 | 6,074 |
Other | 6,994 | 4,906 |
Total accrued and other current liabilities | $ 193,099 | $ 172,599 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||||
Accounts Receivable, Related Parties, Current | $ 26,779 | $ 26,779 | $ 10,930 | ||
Accrued liabilities to related party | 43,286 | 43,286 | 4 | ||
Investment income (loss) | (565) | $ (562) | (885) | $ (323) | |
Equity method investments | 4,494 | 4,494 | 3,825 | ||
Astellas [Member] | |||||
Related Party Transaction [Line Items] | |||||
Drug product revenue from a related party | 1,100 | (2,000) | 8,700 | 2,100 | |
Astellas [Member] | Collaborative Arrangement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | 1,800 | 2,600 | 29,600 | 6,300 | |
Accounts Receivable, Related Parties, Current | 26,100 | 26,100 | 10,900 | ||
Accrued liabilities to related party | 43,300 | 43,300 | |||
Contract with Customer, Liability | 54,900 | 54,900 | 27,900 | ||
Falikang [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts Receivable, Related Parties, Current | 700 | 700 | 0 | ||
Investment income (loss) | 600 | 600 | (900) | (300) | |
Equity method investments | 4,500 | $ 4,500 | 3,800 | ||
Percentage of outstanding shares owned | 51.10% | ||||
Deferred revenue | 0 | $ 0 | $ 1,200 | ||
Falikang [Member] | Collaborative Arrangement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | $ 19,700 | $ 11,800 | $ 36,000 | $ 22,200 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 1 Months Ended | 6 Months Ended | |
May 31, 2021 PutativeClassAction | Apr. 30, 2021 PutativeClassAction | Jun. 30, 2022 USD ($) | |
Commitments And Contingencies [Line Items] | |||
Operating lease liability | $ 94.1 | ||
Outstanding non-cancelable purchase obligations | 57.7 | ||
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 | 9.2 | ||
Manufacture and Supply of Pamrevlumab [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 33.2 | ||
Other Purchases [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 15.3 | ||
Research and Pre-Clinical Stage Development Programs [Member] | |||
Commitments And Contingencies [Line Items] | |||
Maximum future milestone payments | $ 697.9 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | |
Subsequent Event [Line Items] | |||
Reduction of accrued and other current liabilities | $ 61,005 | $ 27,745 | |
Intellectual Property Rights [Member] | |||
Subsequent Event [Line Items] | |||
Reduction of accrued and other current liabilities | $ 8,200 | ||
Reduction of other assets | 2,300 | ||
Reduction of other expenses | $ 6,000 |