Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN, INC. | |
Entity Central Index Key | 0000921299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.01 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-36740 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0357827 | |
Entity Address, Address Line One | 409 Illinois Street | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94158 | |
City Area Code | 415 | |
Local Phone Number | 978-1200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock Shares Outstanding | 92,128,227 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 433,508 | $ 678,393 |
Short-term investments | 110,724 | 8,144 |
Accounts receivable, net ($32,847 and $4,127 from related parties) | 40,543 | 41,883 |
Inventories | 20,764 | 16,530 |
Prepaid expenses and other current assets ($5,015 and $889 from related parties) | 16,155 | 10,160 |
Total current assets | 621,694 | 755,110 |
Restricted time deposits | 2,072 | 2,072 |
Long-term investments | 93,679 | 244 |
Property and equipment, net | 30,933 | 33,647 |
Finance lease right-of-use assets | 27,311 | 29,606 |
Equity method investment in unconsolidated variable interest entity | 2,483 | 2,728 |
Other assets | 9,129 | 3,433 |
Total assets | 787,301 | 826,840 |
Current liabilities: | ||
Accounts payable ($0 and $1,118 to a related party) | 24,061 | 24,789 |
Accrued and other current liabilities ($121 and $24 to a related party) | 119,781 | 119,521 |
Deferred revenue ($4,005 and $2,907 to a related party) | 10,725 | 6,547 |
Finance lease liabilities, current | 12,480 | 12,330 |
Total current liabilities | 167,047 | 163,187 |
Product development obligations | 17,962 | 18,697 |
Deferred revenue, net of current ($14,638 and $4,636 to a related party) | 151,491 | 138,474 |
Finance lease liabilities, non-current | 22,193 | 25,391 |
Other long-term liabilities | 38,335 | 39,642 |
Total liabilities | 397,028 | 385,391 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at March 31, 2021, and December 31, 2020 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at March 31, 2021, and December 31, 2020; 92,080 and 91,441 shares issued and outstanding at March 31, 2021, and December 31, 2020 | 921 | 914 |
Additional paid-in capital | 1,420,471 | 1,399,774 |
Accumulated other comprehensive loss | (4,624) | (4,499) |
Accumulated deficit | (1,045,766) | (974,011) |
Total stockholders’ equity | 371,002 | 422,178 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 390,273 | 441,449 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 787,301 | $ 826,840 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related parties | $ 32,847 | $ 4,127 |
Prepaid expenses and other current assets from related parties | 5,015 | 889 |
Accounts payable to related party | 0 | 1,118 |
Accrued and other current liabilities to related party | 121 | 24 |
Deferred revenue current to related party | 4,005 | 2,907 |
Deferred revenue non-current to related party | $ 14,638 | $ 4,636 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 125,000,000 | 125,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 92,080,000 | 91,441,000 |
Common stock, shares outstanding | 92,080,000 | 91,441,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue: | ||
Total revenue | $ 38,429 | $ 24,401 |
Operating costs and expenses: | ||
Cost of goods sold | $ 3,401 | $ 970 |
Cost, Product and Service [Extensible List] | Product Revenue, Net [Member] | Product Revenue, Net [Member] |
Research and development | $ 74,676 | $ 54,902 |
Selling, general and administrative | 30,779 | 49,603 |
Total operating costs and expenses | 108,856 | 105,475 |
Loss from operations | (70,427) | (81,074) |
Interest and other, net | ||
Interest expense | (501) | (633) |
Interest income and other income (expenses), net | (453) | 3,165 |
Total interest and other, net | (954) | 2,532 |
Loss before income taxes | (71,381) | (78,542) |
Provision for (benefit from) income taxes | 134 | (194) |
Investment loss in unconsolidated variable interest entity | (240) | 0 |
Net loss | $ (71,755) | $ (78,348) |
Net loss per share - basic and diluted | $ (0.78) | $ (0.89) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 91,688 | 88,219 |
License Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 0 | $ 0 |
Development and Other Revenue [Member] | ||
Revenue: | ||
Total revenue | 14,587 | 19,446 |
Product Revenue, Net [Member] | ||
Revenue: | ||
Total revenue | 15,362 | 4,955 |
Drug Product Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 8,480 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Collaboration services and other revenue from a related party | $ 3,611 | $ 4,737 |
Product revenue from a related party | 10,406 | 0 |
Drug product revenue from a related party | $ 4,030 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (71,755) | $ (78,348) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | (70) | 281 |
Available-for-sale investments: | ||
Unrealized gain (loss) on investments, net of tax effect | (55) | 1,649 |
Other comprehensive income, net of taxes | (125) | 1,930 |
Comprehensive loss | $ (71,880) | $ (76,418) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Noncontrolling Interests [Member] |
Balance at Dec. 31, 2019 | $ 535,406 | $ 877 | $ 1,300,725 | $ (747) | $ (784,720) | $ 19,271 |
Balance, Shares at Dec. 31, 2019 | 87,657,489 | |||||
Net loss | (78,348) | $ 0 | 0 | 0 | (78,348) | 0 |
Change in unrealized gain or loss on investments | 1,649 | 0 | 0 | 1,649 | 0 | 0 |
Foreign currency translation adjustments | 281 | 0 | 0 | 281 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 1,725 | $ 12 | 1,713 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,238,141 | |||||
Stock-based compensation | 16,916 | $ 0 | 16,916 | 0 | 0 | 0 |
Balance at Mar. 31, 2020 | 477,629 | $ 889 | 1,319,354 | 1,183 | (863,068) | 19,271 |
Balance, Shares at Mar. 31, 2020 | 88,895,630 | |||||
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 | (71,755) | $ 0 | 0 | 0 | (71,755) | 0 |
Change in unrealized gain or loss on investments | (55) | 0 | 0 | (55) | 0 | 0 |
Foreign currency translation adjustments | (70) | 0 | 0 | (70) | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 1,320 | $ 7 | 1,313 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 639,766 | |||||
Stock-based compensation | 19,384 | $ 0 | 19,384 | 0 | 0 | 0 |
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 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net loss | $ (71,755) | $ (78,348) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 2,723 | 2,868 |
Amortization of finance lease right-of-use assets | 2,616 | 2,594 |
Net accretion of premium and discount on investments | 131 | (143) |
Unrealized loss on equity investments | 0 | 21 |
Investment loss in unconsolidated variable interest entity | 240 | 0 |
Stock-based compensation | 19,384 | 16,916 |
Tax benefit on unrealized gain on available-for-sale securities | 0 | (439) |
Realized loss on sales of available-for-sale securities | 0 | 258 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,336 | (30,085) |
Inventories | (4,288) | (1,521) |
Prepaid expenses and other current assets | (5,457) | (637) |
Other assets | (5,621) | 761 |
Accounts payable | (669) | (3,223) |
Accrued and other liabilities | 252 | (41,224) |
Deferred revenue | 17,196 | 47,996 |
Accrued interest for finance lease liabilities | (29) | (216) |
Other long-term liabilities | (1,043) | 24,936 |
Net cash used in operating activities | (44,984) | (59,486) |
Investing activities | ||
Purchases of property and equipment | (518) | (459) |
Purchases of available-for-sale securities | (196,243) | (38) |
Proceeds from sales of available-for-sale securities | 0 | 10,606 |
Proceeds from maturities of investments | 42 | 45,900 |
Net cash provided by (used in) investing activities | (196,719) | 56,009 |
Financing activities | ||
Repayments of finance lease liabilities | (3,299) | (2,814) |
Repayments of lease obligations | (101) | (101) |
Cash paid for payroll taxes on restricted stock unit releases | (4,757) | (5,279) |
Proceeds from issuance of common stock | 6,077 | 7,004 |
Net cash used in financing activities | (2,080) | (1,190) |
Effect of exchange rate change on cash and cash equivalents | (1,102) | (39) |
Net decrease in cash and cash equivalents | (244,885) | (4,706) |
Total cash and cash equivalents at beginning of period | 678,393 | 126,266 |
Total cash and cash equivalents at end of period | $ 433,508 | $ 121,560 |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 1. Significant Accounting Policies Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”). FibroGen is a leading biopharmaceutical company developing and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (“HIF”) biology, 2-oxoglutarate enzymology, connective tissue growth factor (“CTGF”) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, FibroGen’s most advanced product, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity that is being commercialized in China (tradename: 爱瑞卓 ® The Company’s New Drug Application (“NDA”) filing in the United States (“U.S.”) for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was submitted in December 2019 to the U.S. Food and Drug Administration (“FDA”). In December 2020, the FDA extended the review period of the NDA by three months for FibroGen to submit additional analyses of existing roxadustat clinical data, and set a new Prescription Drug User Fee Act goal date of March 20, 2021. On March 1, 2021, the FDA informed us that the Cardiovascular and Renal Drugs Advisory Committee will hold an advisory committee meeting to review the NDA for roxadustat. The date of the advisory committee meeting has been tentatively set for July 15, 2021. In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was accepted for regulatory review by the European Medicines Agency (“EMA”) in May 2020 and Astellas Pharma Inc. (“Astellas”) expects an approval decision by the EMA mid-2021. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 3 development in China for anemia associated with myelodysplastic syndromes. Roxadustat is in Phase 2 clinical development for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy. Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. All inter-company transactions and balances have been eliminated in consolidation. For any variable interest entity for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting. The Company operates as one 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 U.S. (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020 (“2020 Form 10-K”). Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for China performance obligation (as defined and discussed under Significant Accounting Policies 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. Diluted weighted average shares excluded potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling 7.8 million and 8.7 million, for the three months ended March 31, 2021 and 2020, respectively, as they were anti-dilutive. Risks and Uncertainties The Company’s business is subject to risks and uncertainties, including those related to COVID-19 and the related shelter-in-place, stay-at-home and other similar governmental orders issued in response to the COVID-19 pandemic. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, Starting in the first quarter of 2020, the Company experienced slower enrollment in its clinical trials due to the interruption caused by COVID-19 in the worldwide healthcare system. The future impact of the COVID-19 pandemic on the Company’s business is uncertain. The COVID-19 pandemic may continue to affect enrollment in and initiation of the Company’s clinical trials, and could affect the Company’s supply chain if further social distancing and other business restrictions are put in place by various government entities, particularly in China and the U.S. COVID-19 may affect the health of the Company’s employees limiting the Company’s productivity. The COVID-19 pandemic may also impact the market for the Company’s products and product candidates in the future, affecting sales of the Company’s products. Such possible risks and uncertain impacts from the COVID-19 pandemic could have a material adverse effect on the Company’s drug development, commercialization revenues, and other portions of its business, and in particular, could impact the Company’s assumptions of accounts receivable collectability, fair value measurements of investments, liquidity, and development costs. The extent of the pandemic’s effect on the Company’s operational and financial performance will depend in large part on future developments, particularly with respect to the scope and severity of the pandemic, governmental restrictions put in place to fight the pandemic, and the roll out of vaccines and treatments for COVID-19. Due to the inherent uncertainty of the unprecedented and rapidly evolving situation, the Company is unable to estimate the likely impact of the COVID-19 pandemic on its future operations. Recently Issued and Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recently Issued Accounting Guidance Not Yet Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting ASU 2020 - 04 ” , Reference Rate Reform (Topic 848): Scope The Company has certain lease arrangements that are linked to LIBOR. The Company is in the process of evaluating options for transitioning away from LIBOR and expects to complete by the time LIBOR is phased out. The Company did not elect to apply any of the expedients or exceptions as of and for the period ended March 31, 2021 and is currently evaluating the impact on its consolidated financial statements and related disclosures upon adoption of this guidance. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2020 Form 10-K, except for the following: Product revenue, net Product revenue, net consists of revenues from sales of roxadustat commercial product to Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”), and directly to pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. Falikang is jointly owned by AstraZeneca AB (“AstraZeneca”) and FibroGen Beijing. The Company is not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and the Company lacks the power criterion to direct the activities of Falikang (see Note 3, Variable Interest Entity Sales to Falikang Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang. Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang. Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors. The promises identified under the AstraZeneca China Agreement (as defined in Note 2, Collaboration Agreements and Revenues Collaboration Agreements and Revenues, The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation . Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period. Specifically, the transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which the Company believes those sales would occur. The price per unit is subject to reassessment on a quarterly basis, which may result in cumulative catch up adjustments. The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration: ● ● ● ● o o The non-refundable upfront license fees constitute a fixed consideration. The remainder of the above are variable consideration components, which may be constrained, and included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. The calculation of the above variable consideration includes key estimation areas such as total sales quantity, performance period, gross transfer price and profit share, which require a substantial degree of judgment. Any net transfer price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligations are satisfied. Direct Sales to Distributors The Company sells roxadustat in China directly to a number of pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. These pharmaceutical distributors are the Company’s customers. Hospitals order roxadustat through a distributor and the Company ships the product directly to the distributors. The delivery of roxadustat to a distributor represents a single performance obligation. Distributors are responsible for delivering product to end users, primarily hospitals. Distributors bear inventory risk once they receive and accept the product. Product revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product. The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. As such, product revenue is not adjusted for the effects of a significant financing component. Product revenue is recorded at the net sales prices which includes the following estimates of variable consideration: ● ● ● ● ● The calculation of the above variable consideration is based on gross sales to the distributor, or estimated utilizing best available information from the distributor, maximum known exposures and other available information including estimated channel inventory levels and estimated sales made by the distributor to hospitals, which involve a substantial degree of judgment. The above rebates and discounts all together are eligible to be applied against the distributor’s future sales order, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible and in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the liability for rebates and discounts are presented as reductions of gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The distributor’s legal right of offset is calculated at the individual distributor level. |
Collaboration Agreements and Re
Collaboration Agreements and Revenues | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements and Revenues | 2 . Collaboration Agreements and Revenues Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. The aggregate amount of consideration received through March 31, 2021 totals $105.1 million, excluding drug product revenue that is discussed separately below. In 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Japan Amendment”). Under this amendment, FibroGen would continue to manufacture and supply roxadustat API Drug Product Revenue Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of consideration received under the Europe Agreement through March 31, 2021 totals $540.0 million, excluding drug product revenue that is discussed separately below. Under the Europe Agreement, Astellas has an option to purchase roxadustat bulk drug product in support of commercial supplies. During the three months ended March 31, 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement with Astellas to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to Astellas as pre-commercial supply for process validation purposes during the three months ended March 31, 2021. The Company constrained the consideration of $11.8 million from this shipment, as described in details under Drug Product Revenue AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of April 2020), (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. The aggregate amount of consideration received under the U.S./RoW Agreement through March 31, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Master Supply Agreement under the U.S./RoW Agreement with AstraZeneca (“Master Supply Agreement”) to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to AstraZeneca as commercial supply during the three months ended March 31, 2021 and recognized related drug product revenue of $4.5 million, as described in details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into the China Agreement (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the China Amendment discussed below in the third quarter of 2020, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period. The aggregate amount of such consideration received for milestone and upfront payments through March 31, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen China and AstraZeneca (together with FibroGen China, the “Parties”) entered into the China Amendment, effective July 1, 2020, relating to the development and commercialization of roxadustat in China. While the responsibilities of the Parties under the China Agreement remain largely the same, certain changes were made. Under the China Amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. Under the China Amendment, the interim period is defined as the period from April 1, 2020 to the time when Falikang is fully operational. Falikang became fully operational in January 2021. The calculation for profit or loss share related to sales of roxadustat in China has changed for the period from April 1, 2020 onwards. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses incurred by AstraZeneca are calculated and billed. AstraZeneca’s co-promotion expenses for their sales and marketing efforts are now subject to a cap of a percentage of net sales. Once AstraZeneca has been fully reimbursed for their sales and marketing costs under the cap, AstraZeneca will bill the co-promotion expenses based on actual costs on a prospective basis. In addition, the China Amendment has allowed for a higher cost of manufacturing incurred by FibroGen Beijing to be included in the profit or loss share calculation, subject to an annual cap, among other changes. Since Falikang became fully operational in January 2021, substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in a few provinces in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share. In addition, AstraZeneca now bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity. Development costs continue to be shared 50/50 between the Parties. During the three months ended March 31, 2021, the Company recognized $10.4 million of net product revenue from the sales to Falikang, as described in details under Product Revenue, Net In addition to sales to Falikang, the Company recognized $5.0 million of net product revenue from sales directly to distributors in a few provinces in China, as in Note 2, Collaboration Agreements and Revenues License Revenue and Development Revenue Recognized Under the Collaboration Agreements Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 Japan License revenue $ — $ — Development revenue $ 80 $ 163 The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 100,347 $ — $ 100,347 Development revenue 16,430 75 16,505 Total license and development revenue $ 116,777 $ 75 $ 116,852 The revenue recognized under the Japan Agreement for the three months ended March 31, 2021 included immaterial revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The Company does not expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Japan Agreement. Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 Europe License revenue $ — $ — Development revenue $ 3,531 $ 4,574 The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 487,951 $ — $ 487,951 Development revenue 252,493 825 253,318 Total license and development revenue $ 740,444 $ 825 $ 741,269 The revenue recognized under the Europe Agreement for the three months ended March 31, 2021 included an increase in revenue of $0.4 million resulting from changes to estimated variable consideration. The remainder of the transaction price related to the Europe Agreement includes $24.5 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 U.S. / RoW and China License revenue $ — $ — Development revenue 10,976 14,556 China performance obligation $ — $ 153 The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement with AstraZeneca, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 565,751 4,449 570,200 China performance obligation * 10,406 142,813 153,219 Total license and development revenue $ 918,001 $ 147,262 ** $ 1,065,263 * China performance obligation revenue is recognized as product revenue, as described in details under Product Revenue, Net ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of March 31, 2021, deferred revenue included $143.6 million related to the U.S./RoW and China Agreement, which represents the net of $147.3 million of deferred revenue presented above and a $3.7 million unbilled co-development revenue under the China Amendment with AstraZeneca. The revenue recognized under the U.S./RoW Agreement for the three months ended March 31, 2021 included a reduction in revenue of $4.2 million resulting from changes to estimated variable consideration. The remainder of the transaction price related to the U.S./RoW Agreement and China Agreement includes $49.5 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation. The amount allocated to the U.S./RoW Agreement is expected to be recognized over the remaining development service period. The amount allocated to the China performance obligation is expected to be recognized as the Company transfers control of the commercial products to Falikang. Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Three Months Ended March 31, 2021 2020 Direct Sales: Gross revenue $ 5,429 $ 5,372 Discounts and rebates (562 ) (417 ) Sales returns 89 — Direct sales revenue, net 4,956 4,955 Sales to Falikang: Gross transfer price 24,401 — Profit share (10,064 ) — Net transfer price 14,337 — Constrained for future recognition (3,931 ) — Sales to Falikang revenue, net 10,406 — Total product revenue, net $ 15,362 $ 4,955 Direct Sales Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products, net of various sales rebates and discounts. The total discounts and rebates were $0.6 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively, which primarily consisted of the contractual sales rebate calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The rebates and discounts that the Company’s pharmaceutical distributors have earned are eligible to be applied against future sales orders, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible in the same period that the related revenue is recorded. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The Company’s legal right to offset is calculated at the individual distributor level. The following table includes a roll-forward of the contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at March 31, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (1,422 ) $ 533 $ 47 $ (15,979 ) As of March 31, 2021 and December 31, 2020, the total contract liabilities were $16.0 million and $15.1 million, which were included in accrued and other current liabilities in the condensed consolidated balance sheet. There were no rebates and discounts reflected as reductions to gross accounts receivable as of March 31, 2021 as substantially all direct product sales to distributors were transitioned to Falikang. As of December 31, 2020, the total rebates and discounts as reductions to gross accounts receivable was $0.5 million. 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 product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period . Any net transfer price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligations are satisfied . During the three months ended March 31, 2021, the Company constrained $3.9 million from the net transfer price to Falikang, which was included in the related deferred revenue of China performance obligation. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (15,881 ) $ 10,406 $ (142,813 ) 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 March 31, 2021, approximately $6.0 million of the deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China. The reductions to gross accounts receivable related to product revenue to Falikang was $9.2 million as of March 31, 2021. Drug Product Revenue Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended March 31, 2021 Astellas $ 4,030 AstraZeneca 4,450 Drug product revenue $ 8,480 During the three months ended March 31, 2021, the Company recorded $4.0 million drug product revenue related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018, due to a change in estimated variable consideration. Specifically, the change in estimated variable consideration was based on the API held by Astellas at March 31, 2021 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. This amount was unbilled to Astellas as of March 31, 2021, and recorded under prepaid expenses and other current assets in the condensed consolidated balance sheet. This amount was billed to Astellas in April 2021. During three months ended March 31, 2021, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement, and recognized drug product revenue of $4.5 million. During the three months ended March 31, 2021, the Company shipped bulk drug product from process validation supplies for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas. The Company constrained the consideration of $11.8 million from this shipment due to a high degree of uncertainty associated with the final consideration, which was reflected as deferred revenue as of March 31, 2021. The deferred revenue will be recognized as and when uncertainty is resolved. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Drug product revenue - Astellas - deferred revenue $ (5,984 ) $ (11,759 ) $ — $ (17,743 ) |
Variable Interest Entity
Variable Interest Entity | 3 Months Ended |
Mar. 31, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Variable Interest Entity | 3. Variable Interest Entity Falikang is a distribution entity jointly owned by AstraZeneca and FibroGen Beijing. FibroGen Beijing owns 51.1% of the outstanding shares of Falikang. Pursuant to the guidance under ASC 810, the Company concluded that Falikang qualifies as a variable interest entity (“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 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. Accordingly, the Company records its total investments in Falikang as an equity method investment in an unconsolidated variable interest entity 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 variable interest entity 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 December 31, 2020 Share of Net Loss Currency Translation Balance at March 31, 2021 Falikang 51.1 % $ 2,728 $ (240 ) $ (5 ) $ 2,483 Falikang is considered as a related party to the Company. See Note 9, Related Party Transactions |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): March 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 282,269 $ — $ — $ 282,269 Corporate bonds — 84,538 — 84,538 Commercial paper — 100,958 — 100,958 U.S. government bonds 30,059 — — 30,059 Agency bonds — 14,347 — 14,347 Asset-backed securities — 12,569 — 12,569 Foreign government bonds — 12,194 — 12,194 Equity investments 242 — — 242 Total $ 312,570 $ 224,606 $ — $ 537,176 December 31, 2020 Level 1 Level 2 Level 3 Total Bond and mutual funds $ — $ 8,144 $ — $ 8,144 Equity investments 244 — — 244 Money market funds 590,347 — — 590,347 Total $ 590,591 $ 8,144 $ — $ 598,735 The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. There were no transfers of assets between levels during the three months ended March 31, 2021. The Company’s financial liabilities related to lease obligations as of March 31, 2021 and December 31, 2020 were $1.0 million and $1.1 million, respectively. The fair values of the Company’s financial liabilities are carried at historical cost that were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows. There were no transfers of assets or liabilities between levels for any of the periods presented. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Leases | 5. Leases The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item March 31, 2021 December 31, 2020 Assets Finance: Right-of-use assets - cost $ 50,796 $ 50,477 Accumulated amortization (23,485 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 27,311 29,606 Operating: Right-of-use assets - cost 7,340 3,934 Accumulated amortization (2,264 ) (1,891 ) Operating lease right-of-use assets, net Other assets 5,076 2,043 Total lease assets $ 32,387 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,480 $ 12,330 Operating lease liabilities Accrued and other current liabilities 1,724 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 22,193 25,391 Operating lease liabilities Other long-term liabilities 3,354 853 Total lease liabilities $ 39,751 $ 39,762 During the three months ended March 31, 2021, after FibroGen Beijing’s previous long-term lease agreement expired, the Company entered into a new lease agreement with the landlord for the same pilot plant located in Beijing Yizhuang Biomedical Park of BDA. The new lease term is five year, scheduled to expire in 2026, and is treated as an operating lease. Accordingly, the Company recorded $3.4 million in the operating right-of-use assets and total operating lease liabilities, respectively. The lease contract provides for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs. The components of lease expense were as follows (in thousands): Three Months Ended March 31, Statement of Operations Line Item 2021 2020 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 2,616 $ 2,594 Interest on lease liabilities Interest expense 385 515 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 418 309 Sublease income Selling, general and administrative expenses (300 ) (292 ) Total lease cost $ 3,119 $ 3,126 Supplemental cash flow information related to leases were as follows (in thousands): Three Months Ended March 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 475 $ 149 Operating cash flows from finance leases 385 517 Financing cash flows from finance leases 3,299 2,814 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 322 9 Operating leases $ 3,462 $ — Lease term and discount rate were as follows: March 31, 2021 December 31, 2020 Weighted-average remaining lease term (years): Finance leases 2.6 2.9 Operating leases 4.0 1.8 Weighted-average discount rate: Finance leases 4.39 % 4.39 % Operating leases 4.75 % 4.74 % Maturities of lease liabilities as of March 31, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2021 (remaining nine month period) $ 10,237 $ 1,425 2022 13,898 1,602 2023 12,535 909 2024 — 768 2025 — 766 Beyond 2025 — 65 Total future lease payments 36,670 5,535 Less: Interest (1,997 ) (457 ) Present value of lease liabilities $ 34,673 $ 5,078 |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 6. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): March 31, 2021 December 31, 2020 Cash $ 100,735 $ 88,046 Commercial paper 41,419 — Corporate bonds 9,085 — Money market funds 282,269 590,347 Total cash and cash equivalents $ 433,508 $ 678,393 At March 31, 2021 and December 31, 2020, a total of $76.5 million and $66.0 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations. Investments The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): March 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 75,503 $ 4 $ (54 ) $ 75,453 Commercial paper 59,536 4 (1 ) 59,539 U.S. government bonds 30,060 2 (3 ) 30,059 Agency bonds 14,349 1 (3 ) 14,347 Asset-backed securities 12,573 — (4 ) 12,569 Foreign government bonds 12,195 1 (2 ) 12,194 Equity investments 125 117 — 242 Total investments $ 204,341 $ 129 $ (67 ) $ 204,403 December 31, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Bond and mutual funds $ 8,147 $ — $ (3 ) $ 8,144 Equity investments 125 119 — 244 Total investments $ 8,272 $ 119 $ (3 ) $ 8,388 At March 31, 2021, the available-for-sale investments had contractual maturities range from several months to four years. During the three months ended March 31, 2021, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands): March 31, 2021 December 31, 2020 Raw materials $ 3,308 $ 2,303 Work-in-progress 9,661 8,114 Finished goods 7,795 6,113 Total inventories $ 20,764 $ 16,530 The Company capitalizes inventory costs for FibroGen Beijing’s productions of roxadustat for commercial sales purposes. The Company started capitalizing pre-launch inventory costs in the U.S. in the second quarter of 2020 prior to regulatory approval. As of March 31, 2021 and December 31, 2020, pre-launch inventory capitalized was 37% and 29% of the total inventory balance, respectively. The provision to write-down excess and obsolete inventory was immaterial for the three months ended March 31, 2021 and 2020. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands): March 31, 2021 December 31, 2020 Unbilled contract assets $ 7,721 $ 2,147 Deferred revenues from associated contracts (3,691 ) (2,147 ) Net unbilled contract assets 4,030 — Prepaid assets 9,602 8,353 Other current assets 2,523 1,807 Total prepaid expenses and other current assets $ 16,155 $ 10,160 The unbilled contract assets as of March 31, 2021 included $4.0 million related to a change in estimated variable consideration associated with the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018, and $3.7 million related to unbilled co-development revenue under the China Amendment with AstraZeneca. The unbilled contract assets as of December 31, 2020 were related to unbilled co-development revenue under the China Amendment with AstraZeneca. See Note 2, Collaboration Agreements and Revenues Property and Equipment Property and equipment consisted of the following (in thousands): March 31, 2021 December 31, 2020 Leasehold improvements $ 102,265 $ 102,006 Laboratory equipment 18,541 18,143 Machinery 8,231 8,312 Computer equipment 9,107 9,545 Furniture and fixtures 6,195 6,128 Construction in progress 228 760 Total property and equipment $ 144,567 $ 144,894 Less: accumulated depreciation (113,634 ) (111,247 ) Property and equipment, net $ 30,933 $ 33,647 Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): March 31, 2021 December 31, 2020 Preclinical and clinical trial accruals $ 39,775 $ 44,113 Payroll and related accruals 15,473 22,800 Contract liabilities to pharmaceutical distributors 15,979 15,137 Accrued co-promotion expenses - current 17,431 11,537 Roxadustat profit share to AstraZeneca 7,007 7,007 Property taxes and other taxes 9,242 5,970 Professional services 5,948 4,869 Other 8,926 8,088 Total accrued and other current liabilities $ 119,781 $ 119,521 The profit share liability of $7.0 million to AstraZeneca as of March 31, 2021 and December 31, 2020 represented the profit/loss share between FibroGen Beijing and AstraZeneca that was calculated for the interim period pursuant to the China Amendment. This liability correspondingly reduced the deferred revenue related to the performance obligation in accordance with the China Amendment. Other Long-term Liabilities Other long-term liabilities consisted of the following (in thousands): March 31, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 23,295 $ 27,424 Other long-term tax liabilities 9,025 8,675 Operating lease liabilities, non-current 3,354 853 Other 2,661 2,690 Total other long-term liabilities $ 38,335 $ 39,642 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 12,221 $ 10,637 Selling, general and administrative 7,163 6,279 Total stock-based compensation expense $ 19,384 $ 16,916 The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended March 31, 2021 2020 Stock Options Expected term (in years) 5.7 5.7 Expected volatility 58.8 % 68.3 % Risk-free interest rate 0.7 % 0.9 % Expected dividend yield — — Weighted average estimated fair value $ 27.46 $ 17.24 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.5 - 64.4 % 49.5 - 57.7 % Risk-free interest rate 0.1 - 2.2 % 1.5 - 2.9 % Expected dividend yield — — Weighted average estimated fair value $ 16.94 $ 18.57 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes Provision for income tax for the three months ended March 31, 2021 was primarily due to foreign taxes. The benefit from income taxes for the three months ended March 31, 2020 was primarily due to the tax effect arising from other comprehensive income related to available-for-sale securities, partially offset by 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 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 | 3 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related Party Transactions Astellas is an equity investor in the Company and considered a related party. The Company recorded revenue related to collaboration agreements with Astellas of $3.6 million and $4.7 million for the three months ended March 31, 2021 and 2020, respectively. During the three months ended March 31, 2021, the Company also recorded drug product revenue from Astellas of $4.0 million related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018, due to a change in estimated variable consideration. See Note 2, Collaboration Agreements and Revenues The Company’s expense related to collaboration agreements with Astellas was $0.1 million for each of the three months ended March 31, 2021 and 2020, respectively. As of March 31, 2021 and December 31, 2020, accounts receivable from Astellas were $17.5 million and $4.1 million, respectively. As of March 31, 2021 and December 31, 2020, total deferred revenue from Astellas was $18.6 million and $7.5 million, respectively. As of March 31, 2021 and December 31, 2020, amounts due to Astellas were $0.1 million and $1.1 million, respectively. As of March 31, 2021, prepaid expenses and other current assets included $4.0 million of unbilled contract assets from Astellas, representing the above mentioned change in estimated variable consideration related to the API shipments fulfilled in 2018. This amount was billed to Astellas in April 2021. See Note 2, Collaboration Agreements and Revenues In September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which was determined to be an unconsolidated VIE. As such, Falikang is accounted for as an equity method investment, and considered as a related party to the Company. FibroGen Beijing owns 51.1% of Falikang’s equity. See Note 3, Variable Interest Entity For the three months ended March 31, 2021, the net product revenue from Falikang was $10.4 million. See Note 2, Collaboration Agreements and Revenues For the three months ended March 31, 2021, the investment loss in Falikang was $0.2 million. As of March 31, 2021 and December 31, 2020, the Company’s equity method investment in Falikang was $2.5 million and $2.7 million, respectively. See Note 3, Variable Interest Entity As of March 31, 2021, accounts receivable, net, from Falikang was of $15.4 million. As of March 31, 2021 and December 31, 2020, prepaid expenses and other current assets included miscellaneous receivables from Falikang of $1.0 million and $0.9 million, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Contract Obligations As of March 31, 2021, the Company had outstanding total non-cancelable purchase obligations of $93.9 million, including $30.4 million for manufacture and supply of roxadustat, $57.5 million for manufacture and supply of pamrevlumab, and $6.0 million for other purchases. The Company expects to fulfill our 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. Future milestone payments for research and pre-clinical stage development programs consisted of up to approximately $10.9 million in total potential future milestone payments under the Company’s license agreements with Dana-Farber Cancer Institute, University of Miami and Medarex, Inc. These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones. The event triggering such payment or obligation has not yet occurred. Legal Proceedings From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value), to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have material accruals for any currently active legal action in its condensed consolidated balance sheets as of March 31, 2021, as it could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. In April 2021, three putative securities class action complaints were filed against FibroGen and certain of its current and former executive officers (collectively, the “Defendants”) in the United States District Court for the Northern District of California. The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for FDA approval between November 2019 and December 2020. Plaintiffs seek to represent a class of persons or entities that purchased FibroGen securities between November 8, 2019 and April 6, 2021. In May 2021, two additional putative securities class action complaints were filed against Defendants alleging the same claims. One of the lawsuits alleges that Defendants made materially false and misleading statements between October 2017 and December 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between October 18, 2017 and April 6, 2021. The other lawsuit alleges that Defendants made materially false and misleading statements between December 2018 and February 2020 and seeks to represent a class of persons or entities that purchased FibroGen securities between December 20, 2018 and April 6, 2021. All plaintiffs seek unspecified monetary damages and other relief. Motions for lead plaintiff are due on June 11, 2021. Once a lead plaintiff is appointed by the Court, we expect to receive an amended consolidated complaint. We believe that the claims are without merit and we intend to vigorously defend against them. However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against us or any adverse settlement could materially and adversely impact our business, results of operations, financial condition, and prospects. Indemnification Agreements The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the estimated fair value of these arrangements is minimal. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Operations | Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”). FibroGen is a leading biopharmaceutical company developing and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (“HIF”) biology, 2-oxoglutarate enzymology, connective tissue growth factor (“CTGF”) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, FibroGen’s most advanced product, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity that is being commercialized in China (tradename: 爱瑞卓 ® The Company’s New Drug Application (“NDA”) filing in the United States (“U.S.”) for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was submitted in December 2019 to the U.S. Food and Drug Administration (“FDA”). In December 2020, the FDA extended the review period of the NDA by three months for FibroGen to submit additional analyses of existing roxadustat clinical data, and set a new Prescription Drug User Fee Act goal date of March 20, 2021. On March 1, 2021, the FDA informed us that the Cardiovascular and Renal Drugs Advisory Committee will hold an advisory committee meeting to review the NDA for roxadustat. The date of the advisory committee meeting has been tentatively set for July 15, 2021. In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was accepted for regulatory review by the European Medicines Agency (“EMA”) in May 2020 and Astellas Pharma Inc. (“Astellas”) expects an approval decision by the EMA mid-2021. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 3 development in China for anemia associated with myelodysplastic syndromes. Roxadustat is in Phase 2 clinical development for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy. |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. All inter-company transactions and balances have been eliminated in consolidation. For any variable interest entity for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting. The Company operates as one 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 U.S. (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020 (“2020 Form 10-K”). |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for China performance obligation (as defined and discussed under Significant Accounting Policies |
Net Income (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. Diluted weighted average shares excluded potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling 7.8 million and 8.7 million, for the three months ended March 31, 2021 and 2020, respectively, as they were anti-dilutive. |
Risks and Uncertainties | Risks and Uncertainties The Company’s business is subject to risks and uncertainties, including those related to COVID-19 and the related shelter-in-place, stay-at-home and other similar governmental orders issued in response to the COVID-19 pandemic. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, Starting in the first quarter of 2020, the Company experienced slower enrollment in its clinical trials due to the interruption caused by COVID-19 in the worldwide healthcare system. The future impact of the COVID-19 pandemic on the Company’s business is uncertain. The COVID-19 pandemic may continue to affect enrollment in and initiation of the Company’s clinical trials, and could affect the Company’s supply chain if further social distancing and other business restrictions are put in place by various government entities, particularly in China and the U.S. COVID-19 may affect the health of the Company’s employees limiting the Company’s productivity. The COVID-19 pandemic may also impact the market for the Company’s products and product candidates in the future, affecting sales of the Company’s products. Such possible risks and uncertain impacts from the COVID-19 pandemic could have a material adverse effect on the Company’s drug development, commercialization revenues, and other portions of its business, and in particular, could impact the Company’s assumptions of accounts receivable collectability, fair value measurements of investments, liquidity, and development costs. The extent of the pandemic’s effect on the Company’s operational and financial performance will depend in large part on future developments, particularly with respect to the scope and severity of the pandemic, governmental restrictions put in place to fight the pandemic, and the roll out of vaccines and treatments for COVID-19. Due to the inherent uncertainty of the unprecedented and rapidly evolving situation, the Company is unable to estimate the likely impact of the COVID-19 pandemic on its future operations. |
Recently Issued and Adopted Accounting Guidance | Recently Issued and Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Recently Issued Accounting Guidance Not Yet Adopted | Recently Issued Accounting Guidance Not Yet Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting ASU 2020 - 04 ” , Reference Rate Reform (Topic 848): Scope The Company has certain lease arrangements that are linked to LIBOR. The Company is in the process of evaluating options for transitioning away from LIBOR and expects to complete by the time LIBOR is phased out. The Company did not elect to apply any of the expedients or exceptions as of and for the period ended March 31, 2021 and is currently evaluating the impact on its consolidated financial statements and related disclosures upon adoption of this guidance. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2020 Form 10-K, except for the following: Product revenue, net Product revenue, net consists of revenues from sales of roxadustat commercial product to Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”), and directly to pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. Falikang is jointly owned by AstraZeneca AB (“AstraZeneca”) and FibroGen Beijing. The Company is not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and the Company lacks the power criterion to direct the activities of Falikang (see Note 3, Variable Interest Entity Sales to Falikang Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang. Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang. Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors. The promises identified under the AstraZeneca China Agreement (as defined in Note 2, Collaboration Agreements and Revenues Collaboration Agreements and Revenues, The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation . Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period. Specifically, the transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which the Company believes those sales would occur. The price per unit is subject to reassessment on a quarterly basis, which may result in cumulative catch up adjustments. The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration: ● ● ● ● o o The non-refundable upfront license fees constitute a fixed consideration. The remainder of the above are variable consideration components, which may be constrained, and included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. The calculation of the above variable consideration includes key estimation areas such as total sales quantity, performance period, gross transfer price and profit share, which require a substantial degree of judgment. Any net transfer price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligations are satisfied. Direct Sales to Distributors The Company sells roxadustat in China directly to a number of pharmaceutical distributors located in a few provinces in China that are not covered by Falikang. These pharmaceutical distributors are the Company’s customers. Hospitals order roxadustat through a distributor and the Company ships the product directly to the distributors. The delivery of roxadustat to a distributor represents a single performance obligation. Distributors are responsible for delivering product to end users, primarily hospitals. Distributors bear inventory risk once they receive and accept the product. Product revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product. The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. As such, product revenue is not adjusted for the effects of a significant financing component. Product revenue is recorded at the net sales prices which includes the following estimates of variable consideration: ● ● ● ● ● The calculation of the above variable consideration is based on gross sales to the distributor, or estimated utilizing best available information from the distributor, maximum known exposures and other available information including estimated channel inventory levels and estimated sales made by the distributor to hospitals, which involve a substantial degree of judgment. The above rebates and discounts all together are eligible to be applied against the distributor’s future sales order, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible and in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the liability for rebates and discounts are presented as reductions of gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The distributor’s legal right of offset is calculated at the individual distributor level. |
Collaboration Arrangements and Revenues | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. The aggregate amount of consideration received through March 31, 2021 totals $105.1 million, excluding drug product revenue that is discussed separately below. In 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Japan Amendment”). Under this amendment, FibroGen would continue to manufacture and supply roxadustat API Drug Product Revenue Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of consideration received under the Europe Agreement through March 31, 2021 totals $540.0 million, excluding drug product revenue that is discussed separately below. Under the Europe Agreement, Astellas has an option to purchase roxadustat bulk drug product in support of commercial supplies. During the three months ended March 31, 2021, the Company entered into an Astellas EU Supply Agreement (“EU Supply Agreement”) under the Europe Agreement with Astellas to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to Astellas as pre-commercial supply for process validation purposes during the three months ended March 31, 2021. The Company constrained the consideration of $11.8 million from this shipment, as described in details under Drug Product Revenue AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of April 2020), (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. The aggregate amount of consideration received under the U.S./RoW Agreement through March 31, 2021 totals $439.0 million, excluding drug product revenue that is discussed separately below. In 2020, the Company entered into Master Supply Agreement under the U.S./RoW Agreement with AstraZeneca (“Master Supply Agreement”) to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The Company shipped bulk drug product to AstraZeneca as commercial supply during the three months ended March 31, 2021 and recognized related drug product revenue of $4.5 million, as described in details under Drug Product Revenue China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into the China Agreement (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the China Amendment discussed below in the third quarter of 2020, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period. The aggregate amount of such consideration received for milestone and upfront payments through March 31, 2021 totals $77.2 million. China Amendment In July 2020, FibroGen China and AstraZeneca (together with FibroGen China, the “Parties”) entered into the China Amendment, effective July 1, 2020, relating to the development and commercialization of roxadustat in China. While the responsibilities of the Parties under the China Agreement remain largely the same, certain changes were made. Under the China Amendment, in September 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. Under the China Amendment, the interim period is defined as the period from April 1, 2020 to the time when Falikang is fully operational. Falikang became fully operational in January 2021. The calculation for profit or loss share related to sales of roxadustat in China has changed for the period from April 1, 2020 onwards. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses incurred by AstraZeneca are calculated and billed. AstraZeneca’s co-promotion expenses for their sales and marketing efforts are now subject to a cap of a percentage of net sales. Once AstraZeneca has been fully reimbursed for their sales and marketing costs under the cap, AstraZeneca will bill the co-promotion expenses based on actual costs on a prospective basis. In addition, the China Amendment has allowed for a higher cost of manufacturing incurred by FibroGen Beijing to be included in the profit or loss share calculation, subject to an annual cap, among other changes. Since Falikang became fully operational in January 2021, substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in a few provinces in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share. In addition, AstraZeneca now bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity. Development costs continue to be shared 50/50 between the Parties. During the three months ended March 31, 2021, the Company recognized $10.4 million of net product revenue from the sales to Falikang, as described in details under Product Revenue, Net In addition to sales to Falikang, the Company recognized $5.0 million of net product revenue from sales directly to distributors in a few provinces in China, as in Note 2, Collaboration Agreements and Revenues |
Product Revenue, Net | Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Three Months Ended March 31, 2021 2020 Direct Sales: Gross revenue $ 5,429 $ 5,372 Discounts and rebates (562 ) (417 ) Sales returns 89 — Direct sales revenue, net 4,956 4,955 Sales to Falikang: Gross transfer price 24,401 — Profit share (10,064 ) — Net transfer price 14,337 — Constrained for future recognition (3,931 ) — Sales to Falikang revenue, net 10,406 — Total product revenue, net $ 15,362 $ 4,955 Direct Sales Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those products, net of various sales rebates and discounts. The total discounts and rebates were $0.6 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively, which primarily consisted of the contractual sales rebate calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The rebates and discounts that the Company’s pharmaceutical distributors have earned are eligible to be applied against future sales orders, limited to certain maximums until such rebates and discounts are exhausted. These rebates and discounts are recorded as contract liabilities at the time they become eligible in the same period that the related revenue is recorded. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The Company’s legal right to offset is calculated at the individual distributor level. The following table includes a roll-forward of the contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at March 31, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (1,422 ) $ 533 $ 47 $ (15,979 ) As of March 31, 2021 and December 31, 2020, the total contract liabilities were $16.0 million and $15.1 million, which were included in accrued and other current liabilities in the condensed consolidated balance sheet. There were no rebates and discounts reflected as reductions to gross accounts receivable as of March 31, 2021 as substantially all direct product sales to distributors were transitioned to Falikang. As of December 31, 2020, the total rebates and discounts as reductions to gross accounts receivable was $0.5 million. 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 product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period . Any net transfer price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized over future periods as the performance obligations are satisfied . During the three months ended March 31, 2021, the Company constrained $3.9 million from the net transfer price to Falikang, which was included in the related deferred revenue of China performance obligation. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (15,881 ) $ 10,406 $ (142,813 ) 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 March 31, 2021, approximately $6.0 million of the deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China. The reductions to gross accounts receivable related to product revenue to Falikang was $9.2 million as of March 31, 2021. |
Drug Product Revenue | Drug Product Revenue Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended March 31, 2021 Astellas $ 4,030 AstraZeneca 4,450 Drug product revenue $ 8,480 During the three months ended March 31, 2021, the Company recorded $4.0 million drug product revenue related to the API shipments fulfilled under the terms of the Japan Amendment with Astellas in 2018, due to a change in estimated variable consideration. Specifically, the change in estimated variable consideration was based on the API held by Astellas at March 31, 2021 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. This amount was unbilled to Astellas as of March 31, 2021, and recorded under prepaid expenses and other current assets in the condensed consolidated balance sheet. This amount was billed to Astellas in April 2021. During three months ended March 31, 2021, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement, and recognized drug product revenue of $4.5 million. During the three months ended March 31, 2021, the Company shipped bulk drug product from process validation supplies for commercial purposes under the terms of the Europe Agreement and the EU Supply Agreement with Astellas. The Company constrained the consideration of $11.8 million from this shipment due to a high degree of uncertainty associated with the final consideration, which was reflected as deferred revenue as of March 31, 2021. The deferred revenue will be recognized as and when uncertainty is resolved. The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Drug product revenue - Astellas - deferred revenue $ (5,984 ) $ (11,759 ) $ — $ (17,743 ) |
Collaboration Agreements and _2
Collaboration Agreements and Revenues (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands): Three Months Ended March 31, 2021 2020 Direct Sales: Gross revenue $ 5,429 $ 5,372 Discounts and rebates (562 ) (417 ) Sales returns 89 — Direct sales revenue, net 4,956 4,955 Sales to Falikang: Gross transfer price 24,401 — Profit share (10,064 ) — Net transfer price 14,337 — Constrained for future recognition (3,931 ) — Sales to Falikang revenue, net 10,406 — Total product revenue, net $ 15,362 $ 4,955 |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the contract liabilities (in thousands): Balance at December 31, 2020 Additions Deduction Currency Translation and Other Balance at March 31, 2021 Product revenue - Direct sales - contract liabilities $ (15,137 ) $ (1,422 ) $ 533 $ 47 $ (15,979 ) |
Schedule of Drug Product Revenue | Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands): Three Months Ended March 31, 2021 Astellas $ 4,030 AstraZeneca 4,450 Drug product revenue $ 8,480 |
Drug Product Revenue [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Drug product revenue - Astellas - deferred revenue $ (5,984 ) $ (11,759 ) $ — $ (17,743 ) |
AstraZeneca Agreements [Member] | |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2020 Additions Recognized as Revenue Balance at March 31, 2021 Product revenue - AstraZeneca China performance obligation - deferred revenue $ (137,338 ) $ (15,881 ) $ 10,406 $ (142,813 ) |
Japan [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 Japan License revenue $ — $ — Development revenue $ 80 $ 163 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 100,347 $ — $ 100,347 Development revenue 16,430 75 16,505 Total license and development revenue $ 116,777 $ 75 $ 116,852 |
Europe [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 Europe License revenue $ — $ — Development revenue $ 3,531 $ 4,574 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 487,951 $ — $ 487,951 Development revenue 252,493 825 253,318 Total license and development revenue $ 740,444 $ 825 $ 741,269 |
U.S./RoW and China [Member] | |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2021 2020 U.S. / RoW and China License revenue $ — $ — Development revenue 10,976 14,556 China performance obligation $ — $ 153 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement with AstraZeneca, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through March 31, 2021 Deferred Revenue at March 31, 2021 Total Consideration Through March 31, 2021 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 565,751 4,449 570,200 China performance obligation * 10,406 142,813 153,219 Total license and development revenue $ 918,001 $ 147,262 ** $ 1,065,263 * China performance obligation revenue is recognized as product revenue, as described in details under Product Revenue, Net ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of March 31, 2021, deferred revenue included $143.6 million related to the U.S./RoW and China Agreement, which represents the net of $147.3 million of deferred revenue presented above and a $3.7 million unbilled co-development revenue under the China Amendment with AstraZeneca. |
Variable Interest Entity (Table
Variable Interest Entity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Acquisition And Variable Interest Entity [Abstract] | |
Summary of Equity Method Investment | The Company’s equity method investment in Falikang was as follows (in thousands): Entity Ownership Percentage Balance at December 31, 2020 Share of Net Loss Currency Translation Balance at March 31, 2021 Falikang 51.1 % $ 2,728 $ (240 ) $ (5 ) $ 2,483 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): March 31, 2021 Level 1 Level 2 Level 3 Total Money market funds $ 282,269 $ — $ — $ 282,269 Corporate bonds — 84,538 — 84,538 Commercial paper — 100,958 — 100,958 U.S. government bonds 30,059 — — 30,059 Agency bonds — 14,347 — 14,347 Asset-backed securities — 12,569 — 12,569 Foreign government bonds — 12,194 — 12,194 Equity investments 242 — — 242 Total $ 312,570 $ 224,606 $ — $ 537,176 December 31, 2020 Level 1 Level 2 Level 3 Total Bond and mutual funds $ — $ 8,144 $ — $ 8,144 Equity investments 244 — — 244 Money market funds 590,347 — — 590,347 Total $ 590,591 $ 8,144 $ — $ 598,735 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Schedule of Lease Assets and Related Lease Liabilities | The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item March 31, 2021 December 31, 2020 Assets Finance: Right-of-use assets - cost $ 50,796 $ 50,477 Accumulated amortization (23,485 ) (20,871 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 27,311 29,606 Operating: Right-of-use assets - cost 7,340 3,934 Accumulated amortization (2,264 ) (1,891 ) Operating lease right-of-use assets, net Other assets 5,076 2,043 Total lease assets $ 32,387 $ 31,649 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,480 $ 12,330 Operating lease liabilities Accrued and other current liabilities 1,724 1,188 Non-current: Finance lease liabilities Finance lease liabilities, non-current 22,193 25,391 Operating lease liabilities Other long-term liabilities 3,354 853 Total lease liabilities $ 39,751 $ 39,762 |
Components of Lease Expense | During the three months ended March 31, 2021, after FibroGen Beijing’s previous long-term lease agreement expired, the Company entered into a new lease agreement with the landlord for the same pilot plant located in Beijing Yizhuang Biomedical Park of BDA. The new lease term is five year, scheduled to expire in 2026, and is treated as an operating lease. Accordingly, the Company recorded $3.4 million in the operating right-of-use assets and total operating lease liabilities, respectively. The lease contract provides for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs. The components of lease expense were as follows (in thousands): Three Months Ended March 31, Statement of Operations Line Item 2021 2020 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 2,616 $ 2,594 Interest on lease liabilities Interest expense 385 515 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 418 309 Sublease income Selling, general and administrative expenses (300 ) (292 ) Total lease cost $ 3,119 $ 3,126 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Three Months Ended March 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 475 $ 149 Operating cash flows from finance leases 385 517 Financing cash flows from finance leases 3,299 2,814 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 322 9 Operating leases $ 3,462 $ — |
Schedule of Lease Term and Discount Rate | Lease term and discount rate were as follows: March 31, 2021 December 31, 2020 Weighted-average remaining lease term (years): Finance leases 2.6 2.9 Operating leases 4.0 1.8 Weighted-average discount rate: Finance leases 4.39 % 4.39 % Operating leases 4.75 % 4.74 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities as of March 31, 2021 are as follows (in thousands): Year Ending December 31, Finance Leases Operating Leases 2021 (remaining nine month period) $ 10,237 $ 1,425 2022 13,898 1,602 2023 12,535 909 2024 — 768 2025 — 766 Beyond 2025 — 65 Total future lease payments 36,670 5,535 Less: Interest (1,997 ) (457 ) Present value of lease liabilities $ 34,673 $ 5,078 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): March 31, 2021 December 31, 2020 Cash $ 100,735 $ 88,046 Commercial paper 41,419 — Corporate bonds 9,085 — Money market funds 282,269 590,347 Total cash and cash equivalents $ 433,508 $ 678,393 |
Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Investments | The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): March 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 75,503 $ 4 $ (54 ) $ 75,453 Commercial paper 59,536 4 (1 ) 59,539 U.S. government bonds 30,060 2 (3 ) 30,059 Agency bonds 14,349 1 (3 ) 14,347 Asset-backed securities 12,573 — (4 ) 12,569 Foreign government bonds 12,195 1 (2 ) 12,194 Equity investments 125 117 — 242 Total investments $ 204,341 $ 129 $ (67 ) $ 204,403 December 31, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Bond and mutual funds $ 8,147 $ — $ (3 ) $ 8,144 Equity investments 125 119 — 244 Total investments $ 8,272 $ 119 $ (3 ) $ 8,388 |
Schedule of Inventory | Inventories consisted of the following (in thousands): March 31, 2021 December 31, 2020 Raw materials $ 3,308 $ 2,303 Work-in-progress 9,661 8,114 Finished goods 7,795 6,113 Total inventories $ 20,764 $ 16,530 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): March 31, 2021 December 31, 2020 Unbilled contract assets $ 7,721 $ 2,147 Deferred revenues from associated contracts (3,691 ) (2,147 ) Net unbilled contract assets 4,030 — Prepaid assets 9,602 8,353 Other current assets 2,523 1,807 Total prepaid expenses and other current assets $ 16,155 $ 10,160 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): March 31, 2021 December 31, 2020 Leasehold improvements $ 102,265 $ 102,006 Laboratory equipment 18,541 18,143 Machinery 8,231 8,312 Computer equipment 9,107 9,545 Furniture and fixtures 6,195 6,128 Construction in progress 228 760 Total property and equipment $ 144,567 $ 144,894 Less: accumulated depreciation (113,634 ) (111,247 ) Property and equipment, net $ 30,933 $ 33,647 |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in thousands): March 31, 2021 December 31, 2020 Preclinical and clinical trial accruals $ 39,775 $ 44,113 Payroll and related accruals 15,473 22,800 Contract liabilities to pharmaceutical distributors 15,979 15,137 Accrued co-promotion expenses - current 17,431 11,537 Roxadustat profit share to AstraZeneca 7,007 7,007 Property taxes and other taxes 9,242 5,970 Professional services 5,948 4,869 Other 8,926 8,088 Total accrued and other current liabilities $ 119,781 $ 119,521 |
Schedule of Other Long-term Liabilities | Other long-term liabilities consisted of the following (in thousands): March 31, 2021 December 31, 2020 Accrued long-term co-promotion expenses $ 23,295 $ 27,424 Other long-term tax liabilities 9,025 8,675 Operating lease liabilities, non-current 3,354 853 Other 2,661 2,690 Total other long-term liabilities $ 38,335 $ 39,642 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Recorded Stock-Based Compensation Expense | Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 12,221 $ 10,637 Selling, general and administrative 7,163 6,279 Total stock-based compensation expense $ 19,384 $ 16,916 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan | The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended March 31, 2021 2020 Stock Options Expected term (in years) 5.7 5.7 Expected volatility 58.8 % 68.3 % Risk-free interest rate 0.7 % 0.9 % Expected dividend yield — — Weighted average estimated fair value $ 27.46 $ 17.24 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.5 - 64.4 % 49.5 - 57.7 % Risk-free interest rate 0.1 - 2.2 % 1.5 - 2.9 % Expected dividend yield — — Weighted average estimated fair value $ 16.94 $ 18.57 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Detail) shares in Millions | 3 Months Ended | |
Mar. 31, 2021Segmentshares | Mar. 31, 2020shares | |
Accounting Policy [Line Items] | ||
Number of operating segment | Segment | 1 | |
Anti-dilutive shares outstanding | shares | 7.8 | 8.7 |
Description of payment term | The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms. | |
Description of sales return | Distributors can request to return product to the Company only due to quality issues or for product purchased within one year prior to the product’s expiration date. | |
AstraZeneca Agreements [Member] | ||
Accounting Policy [Line Items] | ||
Profit share percent | 50.00% |
Collaboration Agreements and _3
Collaboration Agreements and Revenues - Astellas Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 35 Months Ended | 45 Months Ended | ||
Apr. 30, 2006 | Jun. 30, 2005 | Mar. 31, 2021 | Mar. 31, 2020 | Feb. 28, 2009 | Feb. 28, 2009 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 38,429 | $ 24,401 | ||||
Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 8,480 | |||||
Astellas Agreement [Member] | Japan [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront, non-contingent and time-based payments received | $ 40,100 | |||||
Potential milestone payments | $ 132,500 | |||||
Commercial sales milestone | 15,000 | |||||
Additional consideration based on net sales description | the low 20% range of the list price | |||||
Aggregate consideration received excluding drug product revenue | $ 105,100 | |||||
Astellas Agreement [Member] | Japan [Member] | Clinical and Development Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | 22,500 | |||||
Astellas Agreement [Member] | Japan [Member] | Regulatory Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 95,000 | |||||
Astellas Agreement [Member] | Japan [Member] | Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 4,000 | |||||
Astellas Agreement [Member] | Europe [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront, non-contingent and time-based payments received | $ 320,000 | |||||
Additional consideration based on net sales description | low 20% range | |||||
Aggregate consideration received excluding drug product revenue | $ 540,000 | |||||
Development and regulatory approval milestones | $ 425,000 | |||||
Percentage of joint development costs committed to fund | 50.00% | |||||
Astellas Agreement [Member] | Europe [Member] | Clinical and Development Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 90,000 | |||||
Astellas Agreement [Member] | Europe [Member] | Regulatory Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 335,000 | |||||
Astellas Agreement [Member] | Europe [Member] | Drug Product Revenue [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Consideration constrained related to drug product shipment | $ 11,800 |
Collaboration Agreements and _4
Collaboration Agreements and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) $ in Thousands | Jul. 30, 2013 | Mar. 31, 2021 | Mar. 31, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | $ 38,429 | $ 24,401 | |
Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 15,362 | 4,955 | |
Drug Product Revenue [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 8,480 | ||
AstraZeneca Agreements [Member] | Drug Product Revenue [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 4,450 | ||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Upfront, non-contingent, non-refundable and time-based payments | $ 374,000 | ||
Potential milestone payments | 875,000 | ||
Commercial sales milestone | 325,000 | ||
Aggregate consideration received excluding drug product revenue | 439,000 | ||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Clinical and Development Milestone [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | 65,000 | ||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Regulatory Milestone [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | 325,000 | ||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Deferred Approval Milestone [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | 160,000 | ||
AstraZeneca Agreements [Member] | China [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | 348,500 | ||
Drug product revenue | 0 | 153 | |
Proceeds from upfront, non-contingent and non-refundable payments | 28,200 | ||
Commercial sales and other events milestone | 187,500 | ||
Aggregate consideration received for milestone and upfront payments | 77,200 | ||
AstraZeneca Agreements [Member] | China [Member] | Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 10,400 | ||
AstraZeneca Agreements [Member] | China [Member] | Clinical and Development Milestone [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | 15,000 | ||
AstraZeneca Agreements [Member] | China [Member] | Regulatory Milestone [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential milestone payments | $ 146,000 | ||
Direct Sales [Member] | Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | 4,956 | $ 4,955 | |
Direct Sales [Member] | China [Member] | Product Revenue, Net [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Drug product revenue | $ 5,000 |
Collaboration Agreements and _5
Collaboration Agreements and Revenues - Summary of License Revenue and Development Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | $ 38,429 | $ 24,401 |
License Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 14,587 | 19,446 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 80 | 163 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 3,531 | 4,574 |
AstraZeneca Agreements [Member] | China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 153 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | $ 10,976 | $ 14,556 |
Collaboration Agreements and _6
Collaboration Agreements and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 3,691 | $ 2,147 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 116,777 | |
Deferred Revenue | 75 | |
Total Consideration | 116,852 | |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 16,430 | |
Deferred Revenue | 75 | |
Total Consideration | 16,505 | |
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 | 740,444 | |
Deferred Revenue | 825 | |
Total Consideration | 741,269 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 252,493 | |
Deferred Revenue | 825 | |
Total Consideration | 253,318 | |
Astellas Agreement [Member] | Europe [Member] | License Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 487,951 | |
Deferred Revenue | 0 | |
Total Consideration | 487,951 | |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 142,813 | $ 137,338 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 918,001 | |
Deferred Revenue | 147,262 | |
Total Consideration | 1,065,263 | |
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 | 565,751 | |
Deferred Revenue | 4,449 | |
Total Consideration | 570,200 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 10,406 | |
Deferred Revenue | 142,813 | |
Total Consideration | $ 153,219 |
Collaboration Agreements and _7
Collaboration Agreements and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 24.5 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue from changes to estimated variable consideration | 0.4 |
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 | 49.5 |
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue from changes to estimated variable consideration | $ 4.2 |
Collaboration Agreements and _8
Collaboration Agreements and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Parenthetical) (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($14,638 and $4,636 to a related party) | $ 151,491 | $ 138,474 |
Deferred Revenue | 3,691 | 2,147 |
Net unbilled co-development revenue | 4,030 | 0 |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | 142,813 | $ 137,338 |
Net unbilled co-development revenue | 3,700 | |
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred revenue, net of current ($14,638 and $4,636 to a related party) | 143,600 | |
Deferred Revenue | 147,300 | |
Net unbilled co-development revenue | $ 3,700 |
Collaboration Agreements and _9
Collaboration Agreements and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 38,429 | $ 24,401 |
Discounts and Rebates [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 600 | 400 |
Constrained for Future Recognition [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 3,900 | |
Product [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 15,362 | 4,955 |
Product [Member] | Direct Sales [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Gross revenue | 5,429 | 5,372 |
Total revenue | 4,956 | 4,955 |
Product [Member] | Direct Sales [Member] | Discounts and Rebates [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | (562) | (417) |
Product [Member] | Direct Sales [Member] | Sales Returns [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 89 | 0 |
Product [Member] | Sales To Falikang [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 10,406 | 0 |
Gross transfer price | 24,401 | 0 |
Product [Member] | Sales To Falikang [Member] | Profit Share [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | (10,064) | 0 |
Product [Member] | Sales To Falikang [Member] | Net Transfer Price [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 14,337 | 0 |
Product [Member] | Sales To Falikang [Member] | Constrained for Future Recognition [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ (3,931) | $ 0 |
Collaboration Agreements and_10
Collaboration Agreements and Revenues - Product Revenue, Net - Additional Information 1 (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | $ 38,429,000 | $ 24,401,000 | |
Discounts and Rebates [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 600,000 | $ 400,000 | |
Rebates and Discounts [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 0 | ||
Rebates and Discounts [Member] | Gross Accounts Receivable [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | $ 500,000 | ||
Rebates and Discounts [Member] | Contract Liabilities [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | 16,000,000 | $ 15,100,000 | |
Constrained for Future Recognition [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Total revenue | $ 3,900,000 |
Collaboration Agreements and_11
Collaboration Agreements and Revenues - Roll-forward of Related Contract Liabilities (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | $ (2,147) |
Balance at March 31, 2021 | (3,691) |
AstraZeneca Agreements [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (137,338) |
Additions | (15,881) |
Balance at March 31, 2021 | (142,813) |
Recognized as Revenue | 10,406 |
Product Revenue, Net [Member] | Direct Sales [Member] | Contract Liabilities [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (15,137) |
Additions | (1,422) |
Deduction | 533 |
Currency Translation and Other | 47 |
Balance at March 31, 2021 | (15,979) |
Drug Product Revenue [Member] | Astellas Agreement [Member] | |
Contract with Customer Liability [Line Items] | |
Balance at December 31, 2020 | (5,984) |
Additions | (11,759) |
Balance at March 31, 2021 | (17,743) |
Recognized as Revenue | $ 0 |
Collaboration Agreements and_12
Collaboration Agreements and Revenues - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | $ 3,691 | $ 2,147 |
Product Revenue, Net [Member] | Beijing Falikang Pharmaceutical Co Ltd | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Reductions to gross accounts receivable | 9,200 | |
AstraZeneca Agreements [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | 142,813 | $ 137,338 |
AstraZeneca Agreements [Member] | China [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred revenue | $ 6,000 |
Collaboration Agreements and_13
Collaboration Agreements and Revenues - Drug Product Revenue - Summary of Drug Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue | $ 38,429 | $ 24,401 |
Drug Product Revenue [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue | 8,480 | |
Drug Product Revenue [Member] | Astellas Agreement | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue | 4,030 | |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue | $ 4,450 |
Collaboration Agreements and_14
Collaboration Agreements and Revenues - Drug Product Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue recognized | $ 38,429 | $ 24,401 |
Drug Product Revenue [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue recognized | 8,480 | |
Drug Product Revenue [Member] | AstraZeneca Agreements [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue recognized | 4,450 | |
Drug Product Revenue [Member] | Astellas Agreement | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue recognized | 4,030 | |
Drug Product Revenue [Member] | Astellas Agreement | Europe [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Consideration constrained related to drug product shipment | 11,800 | |
Drug Product Revenue [Member] | API Shipment [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Drug product revenue recognized | $ 4,000 |
Variable Interest Entity - Addi
Variable Interest Entity - Additional Information (Detail) | Mar. 31, 2021 |
Beijing Kangda Yongfu Pharmaceutical Co., LTD [Member] | Beijing Falikang Pharmaceutical Co Ltd | FibroGen Beijing [Member] | AstraZenecaAB [Member] | |
Acquisition And Variable Interest Entity [Line Items] | |
Percentage of outstanding shares acquired | 51.10% |
Variable Interest Entity - Summ
Variable Interest Entity - Summary of Equity Method Investment (Detail) - Beijing Falikang Pharmaceutical Co. Ltd [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Acquisition And Variable Interest Entity [Line Items] | |
Ownership Percentage | 51.10% |
Beginning balance | $ 2,728 |
Share of Net Loss | (240) |
Currency Translation | (5) |
Ending balance | $ 2,483 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 204,403 | $ 8,388 |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 75,453 | |
Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 59,539 | |
Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 12,569 | |
Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 12,194 | |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 8,144 | |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 242 | 244 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 537,176 | 598,735 |
Fair Value, Measurements, Recurring [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 282,269 | 590,347 |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 84,538 | |
Fair Value, Measurements, Recurring [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 100,958 | |
Fair Value, Measurements, Recurring [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,059 | |
Fair Value, Measurements, Recurring [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 14,347 | |
Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 12,569 | |
Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 12,194 | |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 8,144 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 242 | 244 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 312,570 | 590,591 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 282,269 | 590,347 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,059 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 242 | 244 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 224,606 | 8,144 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 84,538 | |
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 | 100,958 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 14,347 | |
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 | 12,569 | |
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 | 12,194 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 8,144 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Commercial paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | U.S. government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Agency bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Asset-backed securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Foreign government bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
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 |
Liabilities fair value disclosure | 1,000,000 | 1,100,000 |
Transfers of liabilities from level 1 to 2 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Right-of-use assets - cost | $ 50,796 | $ 50,477 |
Accumulated amortization | (23,485) | (20,871) |
Finance lease right-of-use assets, net | 27,311 | 29,606 |
Right-of-use assets - cost | 7,340 | 3,934 |
Accumulated amortization | (2,264) | (1,891) |
Operating lease right-of-use assets, net | 5,076 | 2,043 |
Total lease assets | 32,387 | 31,649 |
Finance lease liabilities | 12,480 | 12,330 |
Operating lease liabilities | 1,724 | 1,188 |
Finance lease liabilities | 22,193 | 25,391 |
Operating lease liabilities | 3,354 | 853 |
Total lease liabilities | $ 39,751 | $ 39,762 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | ||
Operating right-of-use asset | $ 5,076 | $ 2,043 |
Operating lease liability | $ 5,078 | |
Beijing Economic-Technological Development Area [Member] | ||
Lessee Lease Description [Line Items] | ||
Lessee, operating lease, lease term | 5 years | |
Lessee, operating lease, expiration period | 2026 | |
Operating right-of-use asset | $ 3,400 | |
Operating lease liability | $ 3,400 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Finance lease cost: | ||
Amortization of right-of-use assets | $ 2,616 | $ 2,594 |
Interest on lease liabilities | 385 | 515 |
Operating lease cost | 418 | 309 |
Sublease income | (300) | (292) |
Total lease cost | $ 3,119 | $ 3,126 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 475 | $ 149 |
Operating cash flows from finance leases | 385 | 517 |
Financing cash flows from finance leases | 3,299 | 2,814 |
Right-of-use assets obtained in exchange for new lease liabilities: | ||
Finance leases | 322 | 9 |
Operating leases | $ 3,462 | $ 0 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Mar. 31, 2021 | Dec. 31, 2020 |
Weighted-average remaining lease term (years): | ||
Finance leases | 2 years 7 months 6 days | 2 years 10 months 24 days |
Operating leases | 4 years | 1 year 9 months 18 days |
Weighted-average discount rate: | ||
Finance leases | 4.39% | 4.39% |
Operating leases | 4.75% | 4.74% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Finance Leases | |
2021 (remaining nine month period) | $ 10,237 |
2022 | 13,898 |
2023 | 12,535 |
2024 | 0 |
2025 | 0 |
Beyond 2025 | 0 |
Total future lease payments | 36,670 |
Less: Interest | (1,997) |
Present value of lease liabilities | 34,673 |
Operating Leases | |
2021 (remaining nine month period) | 1,425 |
2022 | 1,602 |
2023 | 909 |
2024 | 768 |
2025 | 766 |
Beyond 2025 | 65 |
Total future lease payments | 5,535 |
Less: Interest | (457) |
Present value of lease liabilities | $ 5,078 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 100,735 | $ 88,046 |
Commercial paper | 41,419 | 0 |
Corporate bonds | 9,085 | 0 |
Money market funds | 282,269 | 590,347 |
Total cash and cash equivalents | $ 433,508 | $ 678,393 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Cash and cash equivalents | $ 433,508,000 | $ 678,393,000 |
Other-than-temporary impairment loss | $ 0 | |
Percentage of pre-launch inventory capitalized of aggregate inventory balance | 37.00% | 29.00% |
Net unbilled co-development revenue | $ 4,030,000 | $ 0 |
Profit share liability | 10,725,000 | 6,547,000 |
Astellas Agreement [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Unbilled contract assets, change in estimated variable consideration | 4,000,000 | |
AstraZeneca Agreements [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Net unbilled co-development revenue | 3,700,000 | |
AstraZeneca Agreements [Member] | China [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Profit share liability | $ 7,000,000 | 7,000,000 |
Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Contractual maturities of available-for-sale investments | 4 years | |
Foreign subsidiaries [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cash and cash equivalents | $ 76,500,000 | $ 66,000,000 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 204,341 | $ 8,272 |
Gross Unrealized Holding Gains | 129 | 119 |
Gross Unrealized Holding Losses | (67) | (3) |
Fair Value | 204,403 | 8,388 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 75,503 | |
Gross Unrealized Holding Gains | 4 | |
Gross Unrealized Holding Losses | (54) | |
Fair Value | 75,453 | |
Commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 59,536 | |
Gross Unrealized Holding Gains | 4 | |
Gross Unrealized Holding Losses | (1) | |
Fair Value | 59,539 | |
U.S. government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,060 | |
Gross Unrealized Holding Gains | 2 | |
Gross Unrealized Holding Losses | (3) | |
Fair Value | 30,059 | |
Agency bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 14,349 | |
Gross Unrealized Holding Gains | 1 | |
Gross Unrealized Holding Losses | (3) | |
Fair Value | 14,347 | |
Asset-backed securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,573 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (4) | |
Fair Value | 12,569 | |
Foreign government bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,195 | |
Gross Unrealized Holding Gains | 1 | |
Gross Unrealized Holding Losses | (2) | |
Fair Value | 12,194 | |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,147 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (3) | |
Fair Value | 8,144 | |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 125 |
Gross Unrealized Holding Gains | 117 | 119 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 242 | $ 244 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule Of Investments [Abstract] | ||
Raw materials | $ 3,308 | $ 2,303 |
Work-in-progress | 9,661 | 8,114 |
Finished goods | 7,795 | 6,113 |
Total inventories | $ 20,764 | $ 16,530 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 7,721 | $ 2,147 |
Deferred revenues from associated contracts | (3,691) | (2,147) |
Net unbilled contract assets | 4,030 | 0 |
Prepaid assets | 9,602 | 8,353 |
Other current assets | 2,523 | 1,807 |
Total prepaid expenses and other current assets | $ 16,155 | $ 10,160 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 144,567 | $ 144,894 |
Less: accumulated depreciation | (113,634) | (111,247) |
Property and equipment, net | 30,933 | 33,647 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 102,265 | 102,006 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 18,541 | 18,143 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,231 | 8,312 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 9,107 | 9,545 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,195 | 6,128 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 228 | $ 760 |
Balance Sheet Components - Sc_5
Balance Sheet Components - Schedule of Accrued and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 39,775 | $ 44,113 |
Payroll and related accruals | 15,473 | 22,800 |
Contract liabilities to pharmaceutical distributors | 15,979 | 15,137 |
Accrued co-promotion expenses - current | 17,431 | 11,537 |
Roxadustat profit share to AstraZeneca | 7,007 | 7,007 |
Property taxes and other taxes | 9,242 | 5,970 |
Professional services | 5,948 | 4,869 |
Other | 8,926 | 8,088 |
Total accrued and other current liabilities | $ 119,781 | $ 119,521 |
Balance Sheet Components - Sc_6
Balance Sheet Components - Schedule of Other Long-term Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Noncurrent [Abstract] | ||
Accrued long-term co-promotion expenses | $ 23,295 | $ 27,424 |
Other long-term tax liabilities | 9,025 | 8,675 |
Operating lease liabilities, non-current | 3,354 | 853 |
Other | 2,661 | 2,690 |
Total other long-term liabilities | $ 38,335 | $ 39,642 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Recorded Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 19,384 | $ 16,916 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 12,221 | 10,637 |
Selling, general and administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 7,163 | $ 6,279 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Employee stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 8 months 12 days | 5 years 8 months 12 days |
Expected volatility | 58.80% | 68.30% |
Risk-free interest rate | 0.70% | 0.90% |
Expected dividend yield | 0.00% | 0.00% |
Weighted average estimated fair value | $ 27.46 | $ 17.24 |
2014 Employee Share Purchase Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 47.50% | 49.50% |
Expected volatility, maximum | 64.40% | 57.70% |
Risk-free interest rate, minimum | 0.10% | 1.50% |
Risk-free interest rate, maximum | 2.20% | 2.90% |
Expected dividend yield | 0.00% | 0.00% |
Weighted average estimated fair value | $ 16.94 | $ 18.57 |
2014 Employee Share Purchase Plan [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 6 months | 6 months |
2014 Employee Share Purchase Plan [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 2 years | 2 years |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Sep. 30, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | ||||
Accounts receivable from related party | $ 32,847 | $ 4,127 | ||
Accrued liabilities to related party | 121 | 24 | ||
Deferred revenue | 3,691 | 2,147 | ||
Unbilled contract asset | 7,721 | 2,147 | ||
Astellas [Member] | API Shipment [Member] | ||||
Related Party Transaction [Line Items] | ||||
Drug product revenue from a related party | 4,000 | |||
Unbilled contract asset | 4,000 | |||
Astellas [Member] | Collaborative Arrangement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Revenue related to collaboration agreements | 3,600 | $ 4,700 | ||
Expense related to collaboration agreements | 100 | $ 100 | ||
Accounts receivable from related party | 17,500 | 4,100 | ||
Accrued liabilities to related party | 100 | 1,100 | ||
Deferred revenue | 18,600 | 7,500 | ||
Falikang [Member] | ||||
Related Party Transaction [Line Items] | ||||
Accounts receivable from related party | 15,400 | |||
Investment loss | 200 | |||
Equity method investments | 2,500 | 2,700 | ||
Percentage of outstanding shares owned | 51.10% | |||
Miscellaneous receivables | 1,000 | $ 900 | ||
Falikang [Member] | Collaborative Arrangement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Revenue related to collaboration agreements | $ 10,400 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 1 Months Ended | 3 Months Ended | |
May 31, 2021PutativeClassAction | Apr. 30, 2021PutativeClassAction | Mar. 31, 2021USD ($) | |
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | $ 93.9 | ||
Subsequent Event [Member] | |||
Commitments And Contingencies [Line Items] | |||
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 | 30.4 | ||
Manufacture and Supply of Pamrevlumab [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 57.5 | ||
Other Purchases [Member] | |||
Commitments And Contingencies [Line Items] | |||
Outstanding non-cancelable purchase obligations | 6 | ||
Research and Pre-Clinical Stage Development Programs [Member] | |||
Commitments And Contingencies [Line Items] | |||
Maximum future milestone payments | $ 10.9 |