Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN, INC. | |
Entity Central Index Key | 0000921299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.01 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 1-36740 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0357827 | |
Entity Address, Address Line One | 409 Illinois Street | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94158 | |
City Area Code | 415 | |
Local Phone Number | 978-1200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock Shares Outstanding | 90,355,096 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 429,269 | $ 126,266 |
Short-term investments | 256,317 | 407,491 |
Accounts receivable, net ($12,090 and $4,845 from a related party) | 26,519 | 28,455 |
Inventories | 8,582 | 6,887 |
Prepaid expenses and other current assets ($0 and $125,210 from a related party) | 6,481 | 133,391 |
Total current assets | 727,168 | 702,490 |
Restricted time deposits | 2,072 | 2,072 |
Long-term investments | 229 | 61,118 |
Property and equipment, net | 36,984 | 42,743 |
Finance lease right-of-use assets | 34,368 | 39,602 |
Other assets | 6,862 | 9,372 |
Total assets | 807,683 | 857,397 |
Current liabilities: | ||
Accounts payable | 5,015 | 6,088 |
Accrued and other current liabilities ($216 and $36,883 to a related party) | 50,464 | 83,816 |
Deferred revenue | 9,813 | 490 |
Finance lease liabilities, current | 12,279 | 12,351 |
Total current liabilities | 77,571 | 102,745 |
Long-term portion of lease obligations | 940 | 1,141 |
Product development obligations | 16,959 | 16,780 |
Deferred revenue, net of current | 138,242 | 99,449 |
Finance lease liabilities, non-current | 31,586 | 37,610 |
Other long-term liabilities | 127,242 | 64,266 |
Total liabilities | 392,540 | 321,991 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at June 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at March 31, 2020 and December 31, 2019; 90,228 and 87,657 shares issued and outstanding at June 30, 2020 and December 31, 2019 | 902 | 877 |
Additional paid-in capital | 1,344,912 | 1,300,725 |
Accumulated other comprehensive loss | (1,561) | (747) |
Accumulated deficit | (948,381) | (784,720) |
Total stockholders’ equity | 395,872 | 516,135 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 415,143 | 535,406 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 807,683 | $ 857,397 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 12,090 | $ 4,845 |
Prepaid expenses and other current assets from related party | 0 | 125,210 |
Accrued and other current liabilities to related party | $ 216 | $ 36,883 |
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 | 90,228,000 | 87,657,000 |
Common stock, shares outstanding | 90,228,000 | 87,657,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenue: | ||||
Total revenue | $ 42,888 | $ 191,566 | $ 67,288 | $ 215,429 |
Operating costs and expenses: | ||||
Cost of goods sold | $ 3,076 | $ 0 | $ 4,047 | $ 0 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 61,414 | $ 52,008 | $ 116,315 | $ 102,505 |
Selling, general and administrative | 63,535 | 26,739 | 113,138 | 48,948 |
Total operating costs and expenses | 128,025 | 78,747 | 233,500 | 151,453 |
Income (loss) from operations | (85,137) | 112,819 | (166,212) | 63,976 |
Interest and other, net | ||||
Interest expense | (651) | (736) | (1,284) | (1,507) |
Interest income and other, net | 644 | 4,125 | 3,810 | 8,303 |
Total interest and other, net | (7) | 3,389 | 2,526 | 6,796 |
Income (loss) before income taxes | (85,144) | 116,208 | (163,686) | 70,772 |
Provision for (benefit from) income taxes | 169 | 205 | (25) | 180 |
Net income (loss) | $ (85,313) | $ 116,003 | $ (163,661) | $ 70,592 |
Net income (loss) per share: | ||||
Basic | $ (0.95) | $ 1.34 | $ (1.84) | $ 0.82 |
Diluted | $ (0.95) | $ 1.26 | $ (1.84) | $ 0.77 |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 89,451 | 86,445 | 88,835 | 86,077 |
Diluted | 89,451 | 91,728 | 88,835 | 92,069 |
License Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 150,581 | $ 0 | $ 150,581 |
Development and Other Revenue [Member] | ||||
Revenue: | ||||
Total revenue | 18,957 | 40,985 | 38,402 | 64,848 |
Product Revenue, Net [Member] | ||||
Revenue: | ||||
Total revenue | 15,693 | 0 | 20,648 | 0 |
Drug Product Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 8,238 | $ 0 | $ 8,238 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
License and milestone revenue from a related party | $ 0 | $ 117,470 | $ 0 | $ 117,470 |
Collaboration services and other revenue from a related party | 4,766 | 17,223 | 9,503 | 22,082 |
Drug product revenue from a related party | $ 8,238 | $ 0 | $ 8,238 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ (85,313) | $ 116,003 | $ (163,661) | $ 70,592 |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments (Note 1) | (1,615) | (180) | (1,334) | 111 |
Available-for-sale investments: | ||||
Unrealized gain on investments, net of tax effect | (1,129) | 655 | 520 | 1,097 |
Other comprehensive income, net of taxes | (2,744) | 475 | (814) | 1,208 |
Comprehensive income (loss) | $ (88,057) | $ 116,478 | $ (164,475) | $ 71,800 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment [Member] | Common Stock [Member] | Common Stock [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Other Comprehensive Income (Loss) [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] | Noncontrolling Interests [Member] | Noncontrolling Interests [Member]Cumulative Effect, Period of Adoption, Adjustment [Member] |
Balance at Dec. 31, 2018 | $ 528,470 | $ 854 | $ 1,226,453 | $ (2,281) | $ (715,827) | $ 19,271 | ||||||
Balance (ASU 2016-02 [Member]) at Dec. 31, 2018 | $ 8,688 | $ 0 | $ 0 | $ 0 | $ 8,688 | $ 0 | ||||||
Balance (ASU 2018-02 [Member]) at Dec. 31, 2018 | $ 0 | $ 0 | $ 0 | $ 611 | $ (611) | $ 0 | ||||||
Balance, Shares at Dec. 31, 2018 | 85,432,102 | |||||||||||
Net income (loss) | 70,592 | $ 0 | 0 | 0 | 70,592 | 0 | ||||||
Change in unrealized gain or loss on investments | 1,097 | 0 | 0 | 1,097 | 0 | 0 | ||||||
Foreign currency translation adjustments | 111 | 0 | 0 | 111 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 5,272 | $ 14 | 5,258 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,414,970 | |||||||||||
Stock-based compensation | 34,072 | $ 0 | 34,072 | 0 | 0 | 0 | ||||||
Balance at Jun. 30, 2019 | 648,302 | $ 868 | 1,265,783 | (462) | (637,158) | 19,271 | ||||||
Balance, Shares at Jun. 30, 2019 | 86,847,072 | |||||||||||
Balance at Mar. 31, 2019 | 508,494 | $ 861 | 1,242,460 | (937) | (753,161) | 19,271 | ||||||
Balance, Shares at Mar. 31, 2019 | 86,129,564 | |||||||||||
Net income (loss) | 116,003 | $ 0 | 0 | 0 | 116,003 | 0 | ||||||
Change in unrealized gain or loss on investments | 655 | 0 | 0 | 655 | 0 | 0 | ||||||
Foreign currency translation adjustments | (180) | 0 | 0 | (180) | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 5,688 | $ 7 | 5,681 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 717,508 | |||||||||||
Stock-based compensation | 17,642 | $ 0 | 17,642 | 0 | 0 | 0 | ||||||
Balance at Jun. 30, 2019 | 648,302 | $ 868 | 1,265,783 | (462) | (637,158) | 19,271 | ||||||
Balance, Shares at Jun. 30, 2019 | 86,847,072 | |||||||||||
Balance at Dec. 31, 2019 | 535,406 | $ 877 | 1,300,725 | (747) | (784,720) | 19,271 | ||||||
Balance, Shares at Dec. 31, 2019 | 87,657,489 | |||||||||||
Net income (loss) | (163,661) | $ 0 | 0 | 0 | (163,661) | 0 | ||||||
Change in unrealized gain or loss on investments | 520 | 0 | 0 | 520 | 0 | 0 | ||||||
Foreign currency translation adjustments | (1,334) | 0 | 0 | (1,334) | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 9,652 | $ 25 | 9,627 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 2,570,804 | |||||||||||
Stock-based compensation | 34,560 | $ 0 | 34,560 | 0 | 0 | 0 | ||||||
Balance at Jun. 30, 2020 | 415,143 | $ 902 | 1,344,912 | (1,561) | (948,381) | 19,271 | ||||||
Balance, Shares at Jun. 30, 2020 | 90,228,293 | |||||||||||
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 | |||||||||||
Net income (loss) | (85,313) | $ 0 | 0 | 0 | (85,313) | 0 | ||||||
Change in unrealized gain or loss on investments | (1,129) | 0 | 0 | (1,129) | 0 | 0 | ||||||
Foreign currency translation adjustments | (1,615) | 0 | 0 | (1,615) | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid | 7,927 | $ 13 | 7,914 | 0 | 0 | 0 | ||||||
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,332,663 | |||||||||||
Stock-based compensation | 17,644 | $ 0 | 17,644 | 0 | 0 | 0 | ||||||
Balance at Jun. 30, 2020 | $ 415,143 | $ 902 | $ 1,344,912 | $ (1,561) | $ (948,381) | $ 19,271 | ||||||
Balance, Shares at Jun. 30, 2020 | 90,228,293 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities | ||
Net income (loss) | $ (163,661) | $ 70,592 |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 5,737 | 5,523 |
Amortization of finance lease right-of-use assets | 5,247 | 5,140 |
Net accretion of discount on investments | (22) | (2,457) |
Unrealized loss (gain) on equity investments | 15 | (59) |
Gain on disposal of property and equipment | 0 | (10) |
Stock-based compensation | 34,560 | 34,072 |
Tax benefit on unrealized gain on available-for-sale securities | (138) | 0 |
Realized loss on sales of available-for-sale securities | 258 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,903 | 57,231 |
Inventories | (2,016) | (1,981) |
Prepaid expenses and other current assets | 126,874 | (131,803) |
Other assets | 4,025 | (200) |
Accounts payable | (1,060) | (5,079) |
Accrued and other liabilities | (33,501) | 917 |
Deferred revenue | 48,117 | (46,818) |
Accrued interest for finance lease liabilities | (115) | 241 |
Other long-term liabilities | 63,956 | 8,519 |
Net cash provided by (used in) operating activities | 90,179 | (6,172) |
Investing activities | ||
Purchases of property and equipment | (1,185) | (2,206) |
Advanced payment made for acquisition | (1,419) | 0 |
Purchases of available-for-sale securities and term deposit | (38) | (105,511) |
Proceeds from sales of available-for-sale securities | 10,606 | 0 |
Proceeds from maturities of investments | 201,900 | 100,000 |
Net cash provided by (used in) investing activities | 209,864 | (7,717) |
Financing activities | ||
Repayments of finance lease liabilities | (5,992) | (5,850) |
Repayments of lease obligations | (201) | (202) |
Cash paid for payroll taxes on restricted stock unit releases | (6,858) | (8,065) |
Proceeds from issuance of common stock | 16,510 | 13,337 |
Net cash provided by (used in) financing activities | 3,459 | (780) |
Effect of exchange rate change on cash and cash equivalents | (499) | (2) |
Net increase (decrease) in cash and cash equivalents | 303,003 | (14,671) |
Total cash and cash equivalents at beginning of period | 126,266 | 89,258 |
Total cash and cash equivalents at end of period | $ 429,269 | $ 74,587 |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 1. Significant Accounting Policies Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and are 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”), 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 (“HIF-PH”) activity that has received marketing authorization in China for the treatment of anemia caused by chronic kidney disease (“CKD”) in dialysis and non-dialysis patients. Evrenzo® (roxadustat) is also approved in Japan for the treatment of anemia associated with CKD in dialysis patients. In January 2020, Astellas Pharma Inc. (“Astellas”) submitted a supplemental New Drug Application (“NDA”) in Japan for the treatment of anemia in non-dialysis CKD patients. The Company’s NDA filing in the United States (“U.S.”) for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was accepted by the U.S. Food and Drug Administration (“FDA”) in February 2020. In Europe, the Marketing Authorization Application (“MAA”) 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. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 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 both idiopathic pulmonary fibrosis and pancreatic cancer. Pamrevlumab is also currently in a Phase 2 trial for Duchenne muscular dystrophy and is in Phase 2/3 development in Severe Acute Respiratory Syndrome Coronavirus 2019 Disease (“COVID-19”). 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. (“FibroGen Cayman”). All inter-company transactions and balances have been eliminated in consolidation. 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, 2019 (“2019 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. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. Net Income (Loss) per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Net income (loss) $ (85,313 ) $ 116,003 $ (163,661 ) $ 70,592 Weighted average shares used to compute net income (loss) per share: Basic 89,451 86,445 88,835 86,077 Dilutive effect of potential common shares — 5,283 — 5,992 Diluted 89,451 91,728 88,835 92,069 Net income (loss) per share: Basic $ (0.95 ) $ 1.34 $ (1.84 ) $ 0.82 Diluted $ (0.95 ) $ 1.26 $ (1.84 ) $ 0.77 Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. During the three and six months ended June 30, 2020, the Company reported a net loss. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive. Diluted weighted average shares excluded potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling 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. 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 normal worldwide healthcare system, as well as an impact on its roxadustat sales in China due to the social distancing and other restrictions put in place, particularly during February and March. The future impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. 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 development 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 August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This guidance is intended to provide financial statement users with more decision-useful information about the expected credit losses on financial instrume nts and other commitments to extend credit held by a reporting entity at each reporting date. This guidance requires the measurement of financial assets with a methodology that reflects expected credit losses and requires consideration of a broader range o f reasonable and supportable information to inform credit loss estimates. This guidance requires an impairment model, known as the current expected credit loss model, which is based on expected losses rather than incurred losses. Entities are required to c arry an allowance for expected credit losses for financial assets, including most debt instruments (except those carried at fair value) and trade receivables. In November 2019, the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments-Credit Losses (“ASU 2019-11”) , which has the same effective dates and transition requirements as ASU 2016 - 13 . ASU 2016-13 and ASU 2019-11 were effective for annual reporting periods beginning af ter December 15, 2019 including interim periods. The Company’s investment portfolio primarily consists of U.S. Treasury bills and notes carried at fair value, which is required to follow the impairment model under Topic 326. The Company adopted this guidan ce on January 1, 2020 . Based on the composition of the Company’s trade receivables and investment portfolio, economic conditions and historical credit loss activity, t he adoption of this guidance did not have material impact to the Company’s condensed cons olidated financial statements. Recently Issued Accounting Guidance Not Yet Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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 2019 Form 10-K, except for the following: Foreign currency translation Prior to April 1, 2020, the functional currency of the Company’s subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), was the U.S. dollar. Accordingly, monetary assets and liabilities of FibroGen Beijing in the currencies other than USD were remeasured using exchange rates in effect at the end of the period. Revenues and costs in its local currency, Renminbi Yuan (“CNY”), were remeasured using average exchange rates for the period, except for costs related to those balance sheet items that were remeasured using historical exchange rates. The resulting remeasurement gains and losses were included within interest income and other, net in the consolidated statements of operations as incurred. On April 1, 2020, FibroGen Beijing adopted CNY as its functional currency based on reassessment of the primary economic operational environment of FibroGen Beijing that is mainly associated with its growing manufacturing and product sales activities conducted in CNY. As such, monetary assets and liabilities of FibroGen Beijing in currencies other than CNY are remeasured using exchange rates in effect at the end of the period. The assets and liabilities are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. This change in FibroGen Beijing’s functional currency was accounted for prospectively from April 1, 2020, and the prior condensed consolidated financial statements were not restated. The related currency translation adjustment was $1.3 million as of June 30, 2020. Trade accounts receivable The allowance for doubtful accounts is based on the Company’s assessment of the collectability of customer accounts. The Company makes estimates of expected credit losses for the allowance for doubtful accounts by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, current economic and regulatory conditions that may affect a customer’s ability to pay, and estimates of expected future losses. The Company’s bad debt expense for the three and six months ended June 30, 2020 and the allowance for doubtful accounts as of June 30, 2020 were immaterial. Credit losses – Available-for-sale debt securities The Company periodically assesses its available-for-sale investments for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through interest and other, net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through interest and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income. Changes in the allowance for credit losses are recorded as provision for, or reversal of, credit loss expense. Losses are charged against the allowance when the Company believes the uncollectability of an available-for-sale security is confirmed or when either of the criteria regarding intent or requirement to sell is met. Product revenue, net The Company sells roxadustat in China through a number of pharmaceutical distributors located in China. 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 control of promised goods and when the Company receives payment is based on a general 60-day payment term. As such, product revenue is not adjusted for the effects of a significant financing component. Product drug revenue is recorded at the net sales prices (transaction price) which includes the following estimates of variable consideration: • Price adjustment: In December 2019, China’s National Healthcare Security Administration (“NHSA”) released price guidance for roxadustat under NRDL, effective January 1, 2020. Any channel inventories as of January 1, 2020 that had not been sold to hospitals by distributors, or to patients by hospitals, were eligible for a price adjustment under the price protection. The price adjustment is calculated based on estimated channel inventory levels at January 1, 2020. If price guidance changes in the future, the price adjustment will be calculated in the same manner; • Contractual sales rebate : The contractual sales rebate is calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The contractual sales rebate is recorded as a reduction to revenue at the point of sale to the distributor; • Key account hospital sales rebate : An additional sales rebate is provided to a distributor for product sold to key account hospitals as a percentage of gross sales made by the distributor to eligible hospitals. This additional rebate is recorded as a reduction to revenue at the point of sale to the distributor; • Transfer fee discount : The transfer fee discount is offered to a distributor who has its downstream distributors supply to eligible hospitals. This discount is calculated based on a percentage of gross sales made to the downstream distributors, and recorded as a reduction to revenue as incurred; • Sales return : Distributors can request to return product to the Company only due to quality issues and for product within one year of the product’s expiration date. The Company, at its sole discretion, decides whether to accept such return request; and • Non-key account hospital listing award: A one-time fixed-amount award is offered to a distributor who successfully lists the product with an eligible hospital, and meets certain requirements. The Company considers this particular award to be an upfront payment to a customer within the definitions of ASC 606. The non-key account hospital listing award is capitalized when the distributor meets eligibility requirements, and amortized as reduction to product revenue over future sales orders made by the distributor until exhausted. 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 in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions 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. The distributor’s legal right of offset is calculated at the individual distributor level. |
Collaboration Agreements and Re
Collaboration Agreements and Revenues | 6 Months Ended |
Jun. 30, 2020 | |
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 aggregate amount of consideration received through June 30, 2020 totals $90.1 million. The Japan Agreement also provides for tiered payments based on net sales of roxadustat in the low 20% range after commercial launch. 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 roxadustat in the low 20% range. The aggregate amount of consideration received through June 30, 2020 totals $540.0 million. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE plus hospitalized unstable angina and hospitalized congestive heart failure (“MACE+”) data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for an MAA submission to the EMA, following the Company’s NDA submission to the FDA. These milestones became probable of being achieved in the second quarter of 2019, and the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during 2019, and $0.6 million was recognized as revenue during the six months ended June 30, 2020, from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments were billed to Astellas upon the submission of an MAA in the second quarter of 2020 and the total $130.0 million was received during the same quarter. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca 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, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, and the remaining $50.0 million was received in April 2020 as a result of the NDA submission milestone, (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 through June 30, 2020 totals $439.0 million. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The regulatory milestone payment associated with this NDA submission became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $42.4 million was recognized as revenue during 2019, and $0.4 China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) 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. The aggregate amount of such consideration received through June 30, 2020 totals $77.2 million. In December 2019, roxadustat was included on the updated National Reimbursement Drug List (“NRDL”) released by China’s NHSA for the treatment of anemia in CKD, covering patients who are non-dialysis dependent as well as those who are dialysis-dependent. The inclusion on the NRDL triggered a total of $22.0 million milestones payable to the Company by AstraZeneca. Accordingly, the total consideration of $22.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the China Agreement during fourth quarter of 2019. This milestone payment was received during the first quarter of 2020. AstraZeneca and Astellas approved the development of roxadustat for the treatment of chemotherapy-induced anemia in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition, in December 2018, anemia of chronic inflammation and multiple myeloma was approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of chemotherapy-induced anemia, anemia of chronic inflammation and multiple myeloma under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On July 8, 2020, FibroGen Cayman, FibroGen Beijing and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca (together with FibroGen China, the “Parties”) entered into an amendment, effective July 1, 2020, to the China Agreement, relating to the development and commercialization of roxadustat in China. See Note 10 for details. Summary of Revenue Recognized Under the Collaboration Agreements The table below summarizes the accounting treatment for the various performance obligations pursuant to each of the Astellas and AstraZeneca agreements. License amounts identified below are included in the “License revenue” line item in the condensed consolidated statements of operations. All other elements identified below are included in the “Development and other revenue” line item in the condensed consolidated statements of operations. Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 Japan License revenue $ — $ — $ — $ — Development revenue $ 164 $ 369 $ 327 $ 615 The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 86,024 $ — $ 86,024 Development revenue 15,458 183 15,641 Total license and development revenue $ 101,482 $ 183 $ 101,665 The revenue recognized under the Japan Agreement for the three months ended June 30, 2020 included an increase in revenue of $0.1 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Japan Agreement includes no further variable consideration from estimated future co-development billing. Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 Europe License revenue $ — $ 117,470 $ — $ 117,470 Development revenue $ 4,602 $ 16,854 $ 9,176 $ 21,467 The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 487,951 $ — $ 487,951 Development revenue 240,184 2,338 242,522 Total license and development revenue $ 728,135 $ 2,338 $ 730,473 The revenue recognized under the Europe Agreement for the three months ended June 30, 2020 included an increase in revenue of $1.6 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Europe Agreement includes $31.7 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 Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 U.S. / RoW and China License revenue $ — $ 33,111 $ — $ 33,111 Development revenue 13,750 23,762 28,305 42,766 China performance obligation $ 441 $ — $ 594 $ — The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 521,572 4,547 526,119 China performance obligation 684 140,973 141,657 Total license and development revenue $ 864,100 $ 145,520 $ 1,009,620 The revenue recognized under the U.S./RoW Agreement for the three months ended June 30, 2020 included a decrease of $0.2 million in revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the U.S./RoW Agreement and China Agreement includes $90.1 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, which are expected to be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Product Revenue, Net The Company started roxadustat commercial sales in China in the third quarter of 2019. Product revenue 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. Product revenue, net was as follows (in thousands): Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 Gross revenue $ 19,833 $ 25,205 Non-key account hospital listing award (2,566 ) (2,566 ) Contractual sales rebate (1,372 ) (1,748 ) Other discounts and rebates (202 ) (243 ) Product revenue, net $ 15,693 $ 20,648 In the second quarter of 2020, the Company amended the agreement with its pharmaceutical distributors, which triggered accounting modifications particularly related to non-key account hospital listing award. During the three months ended June 30, 2020, a $2.6 million of non-key account hospital listing award was recorded as a reduction to the revenue, which was calculated based on eligible non-key account hospital listing to date achieved by each distributor with certain requirements met during the period. For the three and six months ended June 30, 2020, the contractual sales rebate was $1.4 million and $1.7 million, respectively, which were calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. All other rebates and discounts, including sales return allowance were immaterial for the period. The rebates and discounts that the Company’s pharmaceutical distributors have earned are eligible to be applied against their 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 in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable. The distributor’s legal right of 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, 2019 Additions Deduction Currency Translation and Other Gross Contract Liabilities Balance Balance Presented Net Against Accounts Receivable Balance at June 30, 2020 Contract liabilities $ (1,102 ) $ (4,907 ) $ 16 $ 9 $ (5,984 ) $ 5,595 $ (389 ) As of June 30, 2020, the total rebates and discounts as reductions to gross accounts receivable was $5.6 million, and the total contract liabilities was $0.4 million, which was included in accrued and other current liabilities in the condensed consolidated balance sheet. The above-mentioned contra-accounts receivable items related to product revenue consisted of the following (in thousands): June 30, 2020 December 31, 2019 Price adjustment $ 935 $ 936 Contractual sales rebate 1,878 148 Non-key account hospital listing award 2,567 — Other discounts and rebates 260 18 Provision for credit loss 84 — Total reductions to gross accounts receivable $ 5,724 $ 1,102 Drug Product Revenue 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 deliver to Astellas roxadustat active pharmaceutical ingredient (“API”) for the roxadustat commercial launch in Japan. During the three months ended June 30, 2020, the Company fulfilled the delivery obligations under the term of the Japan Amendment, and recognized the related drug product revenue of $8.2 million in the same period. The amount represents variable consideration and was estimated based on the quantity of product shipped, actual listed price for roxadustat issued by the Japanese Ministry of Health, Labour and Welfare and possible future changes to the listed price, adjusted for estimated yield and the related cost to convert the API to bulk product tablets. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known. Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. The long-term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying performance obligations. Deferred revenue includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China. As of June 30, 2020, approximately $2.7 million of the related deferred revenue 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. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total U.S. treasury notes and bills $ 176,028 $ 50,151 $ — $ 226,179 Equity investments 229 — — 229 Money market funds 230,561 — — 230,561 Certificate of deposit — 30,138 — 30,138 Total $ 406,818 $ 80,289 $ — $ 487,107 December 31, 2019 Level 1 Level 2 Level 3 Total U.S. treasury notes and bills $ 347,383 $ 80,123 $ — $ 427,506 Bond and mutual funds 10,816 — — 10,816 Equity investments 255 — — 255 Money market funds 85,551 — — 85,551 Certificate of deposit — 30,032 — 30,032 Total $ 444,005 $ 110,155 $ — $ 554,160 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. The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,343 $ 1,343 December 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,544 $ 1,544 The fair values of the Company’s financial liabilities 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 | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Leases | 4. Leases The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item June 30, 2020 December 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,903 $ 49,909 Accumulated amortization (15,535 ) (10,307 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 34,368 39,602 Operating: Right-of-use assets - cost 2,647 2,736 Accumulated amortization (1,270 ) (805 ) Operating lease right-of-use assets, net Other assets 1,377 1,931 Total lease assets $ 35,745 $ 41,533 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,279 $ 12,351 Operating lease liabilities Accrued and other current liabilities 801 983 Non-current: Finance lease liabilities Finance lease liabilities, non-current 31,586 37,610 Operating lease liabilities Other long-term liabilities 572 942 Total lease liabilities $ 45,238 $ 51,886 The components of lease expense were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Statement of Operations Line Item 2020 2019 2020 2019 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 2,653 $ 2,571 $ 5,247 $ 5,140 Interest on lease liabilities Interest expense 534 609 1,049 1,249 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 255 163 564 289 Sublease income Selling, general and administrative expenses (306 ) (237 ) (598 ) (824 ) Total lease cost $ 3,136 $ 3,106 $ 6,262 $ 5,854 Supplemental cash flow information related to leases were as follows (in thousands): Six Months Ended June 30, 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 433 $ 191 Operating cash flows from finance leases 1,010 1,053 Financing cash flows from finance leases 5,992 5,850 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 144 49,676 Operating leases $ 5 $ 1,212 Lease term and discount rate were as follows: June 30, 2020 December 31, 2019 Weighted-average remaining lease term (years): Finance leases 3.4 3.6 Operating leases 1.8 2.1 Weighted-average discount rate: Finance leases 4.39 % 4.42 % Operating leases 4.73 % 4.75 % Maturities of lease liabilities as of June 30, 2020 are as follows (in thousands): Year Ending Finance Leases Operating Leases 2020 (Remaining six month period) $ 7,047 $ 463 2021 13,680 663 2022 13,883 305 2023 12,523 — Total future lease payments 47,133 1,431 Less: Interest (3,268 ) (58 ) Present value of lease liabilities $ 43,865 $ 1,373 |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): June 30, 2020 December 31, 2019 Cash $ 198,708 $ 40,715 Money market funds 230,561 85,551 Total cash and cash equivalents $ 429,269 $ 126,266 At June 30, 2020 and December 31, 2019, a total of $32.8 million and $11.9 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, marketable equity investments, term deposit and certificate of deposit. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. treasury notes and bills $ 225,117 $ 1,062 $ — $ 226,179 Certificates of deposit 30,000 138 — 30,138 Equity investments 125 104 — 229 Total investments $ 255,242 $ 1,304 $ — $ 256,546 December 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. treasury notes and bills $ 426,995 $ 536 $ (25 ) $ 427,506 Certificates of deposit 30,000 32 — 30,032 Bond and mutual funds 10,730 86 — 10,816 Equity investments 125 130 — 255 Total investments $ 467,850 $ 784 $ (25 ) $ 468,609 At June 30, 2020, all of the available-for-sale investments had contractual maturities within one year. During the three and six months ended June 30, 2020 and 2019, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 327 $ 325 Work-in-progress 3,815 2,264 Finished goods 4,440 4,298 Total inventories $ 8,582 $ 6,887 The provision to write-down excess and obsolete inventory was immaterial for the three and six months ended June 30, 2020. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands): June 30, 2020 December 31, 2019 Unbilled contract assets $ — $ 180,000 Deferred revenues from associated contracts — (54,790 ) Net unbilled contract assets — 125,210 Prepaid assets 4,429 6,464 Other current assets 2,052 1,717 Total prepaid expenses and other current assets $ 6,481 $ 133,391 The unbilled contract assets as of December 31, 2019 included two regulatory milestones totaling $130.0 million under the Europe Agreement with Astellas associated with the planned MAA submission in Europe. The MAA was submitted in the second quarter of 2020. Therefore the $130 million milestones were billed in the same quarter. The unbilled contract assets as of December 31, 2019 also included a $50.0 million regulatory milestone under the U.S./RoW Agreement with AstraZeneca associated with the NDA submission in the U.S, which was submitted in December 2019 and accepted for review in February 2020. Therefore, the $50.0 million milestone was billed during the first quarter of 2020. See Note 2 for details. Property and Equipment Property and equipment consisted of the following (in thousands): June 30, 2020 December 31, 2019 Leasehold improvements $ 100,159 $ 101,548 Laboratory equipment 17,362 17,329 Machinery 7,660 8,217 Computer equipment 8,930 8,399 Furniture and fixtures 5,873 5,822 Construction in progress 1,225 1,792 Total property and equipment $ 141,209 $ 143,107 Less: accumulated depreciation (104,225 ) (100,364 ) Property and equipment, net $ 36,984 $ 42,743 Accrued Liabilities Accrued liabilities consisted of the following (in thousands): June 30, 2020 December 31, 2019 Preclinical and clinical trial accruals $ 21,691 $ 16,279 API product price adjustment — 36,324 Payroll and related accruals 14,266 19,784 Property taxes and other 1,145 2,044 Professional services 5,653 4,842 Other 7,709 4,543 Total accrued liabilities $ 50,464 $ 83,816 The amount of $36.3 million accrued as of December 31, 2019 was related to the change in estimated variable consideration of API product at the time the roxadustat listed price was issued by the Japanese Ministry of Health, Labour and Welfare. The amount was fully paid during the first quarter of 2020. Other Long-term Liabilities Other long-term liabilities consisted of the following (in thousands): June 30, 2020 December 31, 2019 Accrued long-term co-promotional expenses $ 116,230 $ 53,071 Other long-term tax liabilities 8,653 8,913 Operating lease liabilities, non-current 572 942 Other 1,787 1,340 Total other long-term liabilities $ 127,242 $ 64,266 The accrued long-term co-promotional expenses of $116.2 million and $53.1 million as of June 30, 2020 and December 31, 2019, respectively, were related to the estimated amount payable to AstraZeneca for its sales and marketing efforts associated with the commercial launch and sales for roxadustat in China. The payment for such amount is not expected to occur within the next year. On July 8, 2020, the Parties into an amendment to the China Agreement, relating to the development and commercialization of roxadustat in China. As a result, such accrued long-term co-promotional expenses will be reduced by approximately $82 million in the third quarter of 2020. See Note 10 for details. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation Stock-based compensation expense was recorded to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 10,780 $ 10,450 $ 21,417 $ 20,028 Selling, general and administrative 6,864 7,192 13,143 14,044 Total stock-based compensation expense $ 17,644 $ 17,642 $ 34,560 $ 34,072 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 June 30, Six Months Ended June 30, 2020 2019 2020 2019 Stock Options Expected term (in years) 5.5 5.3 5.7 5.3 Expected volatility 69.2 % 68.2 % 68.4 % 67.9 % Risk-free interest rate 0.4 % 2.0 % 0.8 % 2.5 % Expected dividend yield — — — — Weighted average estimated fair value $ 21.72 $ 24.40 $ 17.75 $ 33.20 ESPPs Expected term (in years) 0.5 – 2.0 0.5 – 2.0 0.5 – 2.0 0.5 – 2.0 Expected volatility 49.5 – 77.1 % 48.1 – 62.1 % 49.5 – 77.1 % 48.1 – 62.1 % Risk-free interest rate 0.2 – 2.9 % 1.3 – 2.9 % 0.2 – 2.9 % 1.3 – 2.9 % Expected dividend yield — — — — Weighted average estimated fair value $ 17.82 $ 19.07 $ 18.11 $ 19.65 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes Provision for (benefit from) income tax for the three and six months ended June 30, 2020 were primarily due to the tax effect arising from other comprehensive income related to available-for-sale securities, and foreign taxes. Provisions for income tax for the three and six months ended June 30, 2019 were primarily due to foreign taxes. Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its deferred tax assets as it does not currently believe that realization of those assets is more likely than not. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 8. 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 $4.8 million and $134.7 million for the three months ended June 30, 2020 and 2019, respectively, and $9.5 million and $139.6 million for the six months ended June 30, 2020 and 2019, respectively. For the three and six months ended June 30, 2020, the Company also recorded $8.2 million drug product revenue from Astellas. The Company recorded expense related to collaboration agreements with Astellas of $0.2 million and $0.8 million during the three months ended June 30, 2020 and 2019, respectively, and $0.3 million and $1.3 million during the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020 and December 31, 2019, accounts receivable from Astellas were $12.1 million and $4.8 million, respectively, and amounts due to Astellas were $0.2 million and $36.9 million, respectively. The amounts due to Astellas as of December 31, 2019 included $36.3 million of a change in estimated variable consideration related to the API product revenue recognized in 2018, at the time the roxadustat listed price was issued by the Japanese Ministry of Health, Labour and Welfare. Such amount was fully paid during the first quarter of 2020. Prepaid expenses and other current assets as of December 31, 2019 included $125.2 million of net unbilled contract assets, respectively, representing a $130.0 million unbilled contract asset related to two regulatory milestones under the Europe Agreement with Astellas associated with the planned MAA submission to the EMA, net of $4.8 million of associated deferred revenue. According to the Europe Agreement, this $130.0 million was billed to Astellas upon the submission of an MAA in the second quarter of 2020. See Note 2 for details. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Contract Obligations As of June 30, 2020, the Company had outstanding total non-cancelable contract obligations of $26.2 million, including $14.2 million for manufacture and supply of roxadustat, $10.9 million for future milestone payments for research and pre-clinical stage development programs, and $1.1 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. Legal Proceedings From time to time, the Company is a party to various legal actions, both inside and outside the United States, 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 June 30, 2020, as it could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. Indemnification Agreements The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the estimated fair value of these arrangements is minimal. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Event | 10. Subsequent Event On July 8, 2020, FibroGen Cayman, FibroGen Beijing, and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca AB (“AstraZeneca”, and together with FibroGen China, the “Parties”) entered into an amendment, effective July 1, 2020, to the China Agreement, relating to the development and commercialization of roxadustat in China (the “Amendment”). The Amendment provides for the establishment of a jointly owned entity (the “Distribution Entity”) that will perform roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. FibroGen Beijing will continue to hold all of the regulatory licenses issued by China regulatory authorities and will continue to be primarily responsible for regulatory, clinical, manufacturing, medical affairs and pharmacovigilance. In July 2020, the Company closed the acquisition of an entity for the purpose of the establishment of the Distribution Entity. While the responsibilities of the Parties under the China Agreement remain largely the same, certain changes were made. The Parties have changed the method under which commercial expenses incurred by AstraZeneca are billed, and the collaboration has been adjusted to more fully account for the cost of manufacturing incurred by FibroGen Beijing. The Company is in the process of evaluating the accounting impacts resulting from the Amendment and the establishment of the Distribution Entity, which is expected to be significant to its consolidated financial statements starting the third quarter of 2020. Among others, the accrued long-term co-promotional expenses related to the estimated amount payable to AstraZeneca for its sales and marketing efforts associated with the commercial launch and sales for roxadustat will be reduced by approximately $82 million in the third quarter of 2020. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Description of Operations | Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and are 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”), 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 (“HIF-PH”) activity that has received marketing authorization in China for the treatment of anemia caused by chronic kidney disease (“CKD”) in dialysis and non-dialysis patients. Evrenzo® (roxadustat) is also approved in Japan for the treatment of anemia associated with CKD in dialysis patients. In January 2020, Astellas Pharma Inc. (“Astellas”) submitted a supplemental New Drug Application (“NDA”) in Japan for the treatment of anemia in non-dialysis CKD patients. The Company’s NDA filing in the United States (“U.S.”) for roxadustat for the treatment of anemia in dialysis and non-dialysis CKD patients was accepted by the U.S. Food and Drug Administration (“FDA”) in February 2020. In Europe, the Marketing Authorization Application (“MAA”) 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. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 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 both idiopathic pulmonary fibrosis and pancreatic cancer. Pamrevlumab is also currently in a Phase 2 trial for Duchenne muscular dystrophy and is in Phase 2/3 development in Severe Acute Respiratory Syndrome Coronavirus 2019 Disease (“COVID-19”). |
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. (“FibroGen Cayman”). All inter-company transactions and balances have been eliminated in consolidation. 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, 2019 (“2019 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. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. |
Net Income (Loss) per Share | Net Income (Loss) per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Net income (loss) $ (85,313 ) $ 116,003 $ (163,661 ) $ 70,592 Weighted average shares used to compute net income (loss) per share: Basic 89,451 86,445 88,835 86,077 Dilutive effect of potential common shares — 5,283 — 5,992 Diluted 89,451 91,728 88,835 92,069 Net income (loss) per share: Basic $ (0.95 ) $ 1.34 $ (1.84 ) $ 0.82 Diluted $ (0.95 ) $ 1.26 $ (1.84 ) $ 0.77 Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. During the three and six months ended June 30, 2020, the Company reported a net loss. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive. Diluted weighted average shares excluded potential common shares related to stock options, restricted stock units and shares to be purchased under the employee stock purchase plan totaling |
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. 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 normal worldwide healthcare system, as well as an impact on its roxadustat sales in China due to the social distancing and other restrictions put in place, particularly during February and March. The future impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. 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 development 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 August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This guidance is intended to provide financial statement users with more decision-useful information about the expected credit losses on financial instrume nts and other commitments to extend credit held by a reporting entity at each reporting date. This guidance requires the measurement of financial assets with a methodology that reflects expected credit losses and requires consideration of a broader range o f reasonable and supportable information to inform credit loss estimates. This guidance requires an impairment model, known as the current expected credit loss model, which is based on expected losses rather than incurred losses. Entities are required to c arry an allowance for expected credit losses for financial assets, including most debt instruments (except those carried at fair value) and trade receivables. In November 2019, the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments-Credit Losses (“ASU 2019-11”) , which has the same effective dates and transition requirements as ASU 2016 - 13 . ASU 2016-13 and ASU 2019-11 were effective for annual reporting periods beginning af ter December 15, 2019 including interim periods. The Company’s investment portfolio primarily consists of U.S. Treasury bills and notes carried at fair value, which is required to follow the impairment model under Topic 326. The Company adopted this guidan ce on January 1, 2020 . Based on the composition of the Company’s trade receivables and investment portfolio, economic conditions and historical credit loss activity, t he adoption of this guidance did not have material impact to the Company’s condensed cons olidated financial statements. |
Recently Issued Accounting Guidance Not Yet Adopted | Recently Issued Accounting Guidance Not Yet Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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 2019 Form 10-K, except for the following: Foreign currency translation Prior to April 1, 2020, the functional currency of the Company’s subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), was the U.S. dollar. Accordingly, monetary assets and liabilities of FibroGen Beijing in the currencies other than USD were remeasured using exchange rates in effect at the end of the period. Revenues and costs in its local currency, Renminbi Yuan (“CNY”), were remeasured using average exchange rates for the period, except for costs related to those balance sheet items that were remeasured using historical exchange rates. The resulting remeasurement gains and losses were included within interest income and other, net in the consolidated statements of operations as incurred. On April 1, 2020, FibroGen Beijing adopted CNY as its functional currency based on reassessment of the primary economic operational environment of FibroGen Beijing that is mainly associated with its growing manufacturing and product sales activities conducted in CNY. As such, monetary assets and liabilities of FibroGen Beijing in currencies other than CNY are remeasured using exchange rates in effect at the end of the period. The assets and liabilities are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. This change in FibroGen Beijing’s functional currency was accounted for prospectively from April 1, 2020, and the prior condensed consolidated financial statements were not restated. The related currency translation adjustment was $1.3 million as of June 30, 2020. Trade accounts receivable The allowance for doubtful accounts is based on the Company’s assessment of the collectability of customer accounts. The Company makes estimates of expected credit losses for the allowance for doubtful accounts by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, current economic and regulatory conditions that may affect a customer’s ability to pay, and estimates of expected future losses. The Company’s bad debt expense for the three and six months ended June 30, 2020 and the allowance for doubtful accounts as of June 30, 2020 were immaterial. Credit losses – Available-for-sale debt securities The Company periodically assesses its available-for-sale investments for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through interest and other, net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through interest and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income. Changes in the allowance for credit losses are recorded as provision for, or reversal of, credit loss expense. Losses are charged against the allowance when the Company believes the uncollectability of an available-for-sale security is confirmed or when either of the criteria regarding intent or requirement to sell is met. Product revenue, net The Company sells roxadustat in China through a number of pharmaceutical distributors located in China. 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 control of promised goods and when the Company receives payment is based on a general 60-day payment term. As such, product revenue is not adjusted for the effects of a significant financing component. Product drug revenue is recorded at the net sales prices (transaction price) which includes the following estimates of variable consideration: • Price adjustment: In December 2019, China’s National Healthcare Security Administration (“NHSA”) released price guidance for roxadustat under NRDL, effective January 1, 2020. Any channel inventories as of January 1, 2020 that had not been sold to hospitals by distributors, or to patients by hospitals, were eligible for a price adjustment under the price protection. The price adjustment is calculated based on estimated channel inventory levels at January 1, 2020. If price guidance changes in the future, the price adjustment will be calculated in the same manner; • Contractual sales rebate : The contractual sales rebate is calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. The contractual sales rebate is recorded as a reduction to revenue at the point of sale to the distributor; • Key account hospital sales rebate : An additional sales rebate is provided to a distributor for product sold to key account hospitals as a percentage of gross sales made by the distributor to eligible hospitals. This additional rebate is recorded as a reduction to revenue at the point of sale to the distributor; • Transfer fee discount : The transfer fee discount is offered to a distributor who has its downstream distributors supply to eligible hospitals. This discount is calculated based on a percentage of gross sales made to the downstream distributors, and recorded as a reduction to revenue as incurred; • Sales return : Distributors can request to return product to the Company only due to quality issues and for product within one year of the product’s expiration date. The Company, at its sole discretion, decides whether to accept such return request; and • Non-key account hospital listing award: A one-time fixed-amount award is offered to a distributor who successfully lists the product with an eligible hospital, and meets certain requirements. The Company considers this particular award to be an upfront payment to a customer within the definitions of ASC 606. The non-key account hospital listing award is capitalized when the distributor meets eligibility requirements, and amortized as reduction to product revenue over future sales orders made by the distributor until exhausted. 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 in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions 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. 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 aggregate amount of consideration received through June 30, 2020 totals $90.1 million. The Japan Agreement also provides for tiered payments based on net sales of roxadustat in the low 20% range after commercial launch. 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 roxadustat in the low 20% range. The aggregate amount of consideration received through June 30, 2020 totals $540.0 million. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE plus hospitalized unstable angina and hospitalized congestive heart failure (“MACE+”) data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for an MAA submission to the EMA, following the Company’s NDA submission to the FDA. These milestones became probable of being achieved in the second quarter of 2019, and the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during 2019, and $0.6 million was recognized as revenue during the six months ended June 30, 2020, from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments were billed to Astellas upon the submission of an MAA in the second quarter of 2020 and the total $130.0 million was received during the same quarter. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca 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, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, and the remaining $50.0 million was received in April 2020 as a result of the NDA submission milestone, (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 through June 30, 2020 totals $439.0 million. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The regulatory milestone payment associated with this NDA submission became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $42.4 million was recognized as revenue during 2019, and $0.4 China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) 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. The aggregate amount of such consideration received through June 30, 2020 totals $77.2 million. In December 2019, roxadustat was included on the updated National Reimbursement Drug List (“NRDL”) released by China’s NHSA for the treatment of anemia in CKD, covering patients who are non-dialysis dependent as well as those who are dialysis-dependent. The inclusion on the NRDL triggered a total of $22.0 million milestones payable to the Company by AstraZeneca. Accordingly, the total consideration of $22.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the China Agreement during fourth quarter of 2019. This milestone payment was received during the first quarter of 2020. AstraZeneca and Astellas approved the development of roxadustat for the treatment of chemotherapy-induced anemia in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition, in December 2018, anemia of chronic inflammation and multiple myeloma was approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of chemotherapy-induced anemia, anemia of chronic inflammation and multiple myeloma under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On July 8, 2020, FibroGen Cayman, FibroGen Beijing and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca (together with FibroGen China, the “Parties”) entered into an amendment, effective July 1, 2020, to the China Agreement, relating to the development and commercialization of roxadustat in China. See Note 10 for details. |
Product Revenue | Product Revenue, Net The Company started roxadustat commercial sales in China in the third quarter of 2019. Product revenue 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. Product revenue, net was as follows (in thousands): Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 Gross revenue $ 19,833 $ 25,205 Non-key account hospital listing award (2,566 ) (2,566 ) Contractual sales rebate (1,372 ) (1,748 ) Other discounts and rebates (202 ) (243 ) Product revenue, net $ 15,693 $ 20,648 In the second quarter of 2020, the Company amended the agreement with its pharmaceutical distributors, which triggered accounting modifications particularly related to non-key account hospital listing award. During the three months ended June 30, 2020, a $2.6 million of non-key account hospital listing award was recorded as a reduction to the revenue, which was calculated based on eligible non-key account hospital listing to date achieved by each distributor with certain requirements met during the period. For the three and six months ended June 30, 2020, the contractual sales rebate was $1.4 million and $1.7 million, respectively, which were calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor. All other rebates and discounts, including sales return allowance were immaterial for the period. The rebates and discounts that the Company’s pharmaceutical distributors have earned are eligible to be applied against their 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 in the same period that the related revenue is recorded. Due to the distributor’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable. The distributor’s legal right of 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, 2019 Additions Deduction Currency Translation and Other Gross Contract Liabilities Balance Balance Presented Net Against Accounts Receivable Balance at June 30, 2020 Contract liabilities $ (1,102 ) $ (4,907 ) $ 16 $ 9 $ (5,984 ) $ 5,595 $ (389 ) As of June 30, 2020, the total rebates and discounts as reductions to gross accounts receivable was $5.6 million, and the total contract liabilities was $0.4 million, which was included in accrued and other current liabilities in the condensed consolidated balance sheet. The above-mentioned contra-accounts receivable items related to product revenue consisted of the following (in thousands): June 30, 2020 December 31, 2019 Price adjustment $ 935 $ 936 Contractual sales rebate 1,878 148 Non-key account hospital listing award 2,567 — Other discounts and rebates 260 18 Provision for credit loss 84 — Total reductions to gross accounts receivable $ 5,724 $ 1,102 |
Drug Product Revenue | Drug Product Revenue 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 deliver to Astellas roxadustat active pharmaceutical ingredient (“API”) for the roxadustat commercial launch in Japan. During the three months ended June 30, 2020, the Company fulfilled the delivery obligations under the term of the Japan Amendment, and recognized the related drug product revenue of $8.2 million in the same period. The amount represents variable consideration and was estimated based on the quantity of product shipped, actual listed price for roxadustat issued by the Japanese Ministry of Health, Labour and Welfare and possible future changes to the listed price, adjusted for estimated yield and the related cost to convert the API to bulk product tablets. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known. |
Other Revenues | Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. |
Deferred Revenue | Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. The long-term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying performance obligations. Deferred revenue includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China. As of June 30, 2020, approximately $2.7 million of the related deferred revenue 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. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation | The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Net income (loss) $ (85,313 ) $ 116,003 $ (163,661 ) $ 70,592 Weighted average shares used to compute net income (loss) per share: Basic 89,451 86,445 88,835 86,077 Dilutive effect of potential common shares — 5,283 — 5,992 Diluted 89,451 91,728 88,835 92,069 Net income (loss) per share: Basic $ (0.95 ) $ 1.34 $ (1.84 ) $ 0.82 Diluted $ (0.95 ) $ 1.26 $ (1.84 ) $ 0.77 |
Collaboration Agreements and _2
Collaboration Agreements and Revenues (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | Product revenue, net was as follows (in thousands): Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 Gross revenue $ 19,833 $ 25,205 Non-key account hospital listing award (2,566 ) (2,566 ) Contractual sales rebate (1,372 ) (1,748 ) Other discounts and rebates (202 ) (243 ) Product revenue, net $ 15,693 $ 20,648 |
Roll-forward of Contract Liabilities | The following table includes a roll-forward of the contract liabilities (in thousands): Balance at December 31, 2019 Additions Deduction Currency Translation and Other Gross Contract Liabilities Balance Balance Presented Net Against Accounts Receivable Balance at June 30, 2020 Contract liabilities $ (1,102 ) $ (4,907 ) $ 16 $ 9 $ (5,984 ) $ 5,595 $ (389 ) |
Summary of Contra-Accounts Receivable Items Related to Product Revenue | The above-mentioned contra-accounts receivable items related to product revenue consisted of the following (in thousands): June 30, 2020 December 31, 2019 Price adjustment $ 935 $ 936 Contractual sales rebate 1,878 148 Non-key account hospital listing award 2,567 — Other discounts and rebates 260 18 Provision for credit loss 84 — Total reductions to gross accounts receivable $ 5,724 $ 1,102 |
Japan [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 Japan License revenue $ — $ — $ — $ — Development revenue $ 164 $ 369 $ 327 $ 615 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 86,024 $ — $ 86,024 Development revenue 15,458 183 15,641 Total license and development revenue $ 101,482 $ 183 $ 101,665 |
Europe [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 Europe License revenue $ — $ 117,470 $ — $ 117,470 Development revenue $ 4,602 $ 16,854 $ 9,176 $ 21,467 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 487,951 $ — $ 487,951 Development revenue 240,184 2,338 242,522 Total license and development revenue $ 728,135 $ 2,338 $ 730,473 |
U.S./RoW and China [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Agreement Performance Obligation 2020 2019 2020 2019 U.S. / RoW and China License revenue $ — $ 33,111 $ — $ 33,111 Development revenue 13,750 23,762 28,305 42,766 China performance obligation $ 441 $ — $ 594 $ — |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through June 30, 2020 Deferred Revenue at June 30, 2020 Total Consideration Through June 30, 2020 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 521,572 4,547 526,119 China performance obligation 684 140,973 141,657 Total license and development revenue $ 864,100 $ 145,520 $ 1,009,620 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total U.S. treasury notes and bills $ 176,028 $ 50,151 $ — $ 226,179 Equity investments 229 — — 229 Money market funds 230,561 — — 230,561 Certificate of deposit — 30,138 — 30,138 Total $ 406,818 $ 80,289 $ — $ 487,107 December 31, 2019 Level 1 Level 2 Level 3 Total U.S. treasury notes and bills $ 347,383 $ 80,123 $ — $ 427,506 Bond and mutual funds 10,816 — — 10,816 Equity investments 255 — — 255 Money market funds 85,551 — — 85,551 Certificate of deposit — 30,032 — 30,032 Total $ 444,005 $ 110,155 $ — $ 554,160 |
Fair Values of Financial Liabilities Carried at Historical Cost | The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands): June 30, 2020 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,343 $ 1,343 December 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,544 $ 1,544 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020 December 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,903 $ 49,909 Accumulated amortization (15,535 ) (10,307 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 34,368 39,602 Operating: Right-of-use assets - cost 2,647 2,736 Accumulated amortization (1,270 ) (805 ) Operating lease right-of-use assets, net Other assets 1,377 1,931 Total lease assets $ 35,745 $ 41,533 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,279 $ 12,351 Operating lease liabilities Accrued and other current liabilities 801 983 Non-current: Finance lease liabilities Finance lease liabilities, non-current 31,586 37,610 Operating lease liabilities Other long-term liabilities 572 942 Total lease liabilities $ 45,238 $ 51,886 |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Statement of Operations Line Item 2020 2019 2020 2019 Finance lease cost: Amortization of right-of-use assets Cost of goods sold; Research and development; Selling, general and administrative expenses $ 2,653 $ 2,571 $ 5,247 $ 5,140 Interest on lease liabilities Interest expense 534 609 1,049 1,249 Operating lease cost Cost of goods sold; Research and development; Selling, general and administrative expenses 255 163 564 289 Sublease income Selling, general and administrative expenses (306 ) (237 ) (598 ) (824 ) Total lease cost $ 3,136 $ 3,106 $ 6,262 $ 5,854 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Six Months Ended June 30, 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 433 $ 191 Operating cash flows from finance leases 1,010 1,053 Financing cash flows from finance leases 5,992 5,850 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 144 49,676 Operating leases $ 5 $ 1,212 |
Schedule of Lease Term and Discount Rate | Lease term and discount rate were as follows: June 30, 2020 December 31, 2019 Weighted-average remaining lease term (years): Finance leases 3.4 3.6 Operating leases 1.8 2.1 Weighted-average discount rate: Finance leases 4.39 % 4.42 % Operating leases 4.73 % 4.75 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities as of June 30, 2020 are as follows (in thousands): Year Ending Finance Leases Operating Leases 2020 (Remaining six month period) $ 7,047 $ 463 2021 13,680 663 2022 13,883 305 2023 12,523 — Total future lease payments 47,133 1,431 Less: Interest (3,268 ) (58 ) Present value of lease liabilities $ 43,865 $ 1,373 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): June 30, 2020 December 31, 2019 Cash $ 198,708 $ 40,715 Money market funds 230,561 85,551 Total cash and cash equivalents $ 429,269 $ 126,266 |
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, marketable equity investments, term deposit and certificate of deposit. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): June 30, 2020 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. treasury notes and bills $ 225,117 $ 1,062 $ — $ 226,179 Certificates of deposit 30,000 138 — 30,138 Equity investments 125 104 — 229 Total investments $ 255,242 $ 1,304 $ — $ 256,546 December 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. treasury notes and bills $ 426,995 $ 536 $ (25 ) $ 427,506 Certificates of deposit 30,000 32 — 30,032 Bond and mutual funds 10,730 86 — 10,816 Equity investments 125 130 — 255 Total investments $ 467,850 $ 784 $ (25 ) $ 468,609 |
Schedule of Inventory | Inventories consisted of the following (in thousands): June 30, 2020 December 31, 2019 Raw materials $ 327 $ 325 Work-in-progress 3,815 2,264 Finished goods 4,440 4,298 Total inventories $ 8,582 $ 6,887 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): June 30, 2020 December 31, 2019 Unbilled contract assets $ — $ 180,000 Deferred revenues from associated contracts — (54,790 ) Net unbilled contract assets — 125,210 Prepaid assets 4,429 6,464 Other current assets 2,052 1,717 Total prepaid expenses and other current assets $ 6,481 $ 133,391 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): June 30, 2020 December 31, 2019 Leasehold improvements $ 100,159 $ 101,548 Laboratory equipment 17,362 17,329 Machinery 7,660 8,217 Computer equipment 8,930 8,399 Furniture and fixtures 5,873 5,822 Construction in progress 1,225 1,792 Total property and equipment $ 141,209 $ 143,107 Less: accumulated depreciation (104,225 ) (100,364 ) Property and equipment, net $ 36,984 $ 42,743 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): June 30, 2020 December 31, 2019 Preclinical and clinical trial accruals $ 21,691 $ 16,279 API product price adjustment — 36,324 Payroll and related accruals 14,266 19,784 Property taxes and other 1,145 2,044 Professional services 5,653 4,842 Other 7,709 4,543 Total accrued liabilities $ 50,464 $ 83,816 |
Schedule of Other Long-term Liabilities | Other long-term liabilities consisted of the following (in thousands): June 30, 2020 December 31, 2019 Accrued long-term co-promotional expenses $ 116,230 $ 53,071 Other long-term tax liabilities 8,653 8,913 Operating lease liabilities, non-current 572 942 Other 1,787 1,340 Total other long-term liabilities $ 127,242 $ 64,266 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Recorded Stock-Based Compensation Expense | Stock-based compensation expense was recorded to research and development and selling, general and administrative expense as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 10,780 $ 10,450 $ 21,417 $ 20,028 Selling, general and administrative 6,864 7,192 13,143 14,044 Total stock-based compensation expense $ 17,644 $ 17,642 $ 34,560 $ 34,072 |
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 June 30, Six Months Ended June 30, 2020 2019 2020 2019 Stock Options Expected term (in years) 5.5 5.3 5.7 5.3 Expected volatility 69.2 % 68.2 % 68.4 % 67.9 % Risk-free interest rate 0.4 % 2.0 % 0.8 % 2.5 % Expected dividend yield — — — — Weighted average estimated fair value $ 21.72 $ 24.40 $ 17.75 $ 33.20 ESPPs Expected term (in years) 0.5 – 2.0 0.5 – 2.0 0.5 – 2.0 0.5 – 2.0 Expected volatility 49.5 – 77.1 % 48.1 – 62.1 % 49.5 – 77.1 % 48.1 – 62.1 % Risk-free interest rate 0.2 – 2.9 % 1.3 – 2.9 % 0.2 – 2.9 % 1.3 – 2.9 % Expected dividend yield — — — — Weighted average estimated fair value $ 17.82 $ 19.07 $ 18.11 $ 19.65 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020USD ($)shares | Jun. 30, 2019shares | Jun. 30, 2020USD ($)Segmentshares | Jun. 30, 2019shares | |
Accounting Policies [Abstract] | ||||
Number of operating segment | Segment | 1 | |||
Anti-dilutive shares outstanding | shares | 9.2 | 4.4 | 9 | 3.4 |
Currency translation adjustment | $ | $ 1.3 | $ 1.3 | ||
Description of payment term | The period between the transfer control of promised goods and when the Company receives payment is based on a general 60-day payment term. | |||
Description of sales return | Distributors can request to return product to the Company only due to quality issues and for product within one year of the product’s expiration date. |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Earnings Per Share [Abstract] | ||||
Net income (loss) | $ (85,313) | $ 116,003 | $ (163,661) | $ 70,592 |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 89,451 | 86,445 | 88,835 | 86,077 |
Dilutive effect of potential common shares | 0 | 5,283 | 0 | 5,992 |
Diluted | 89,451 | 91,728 | 88,835 | 92,069 |
Net income (loss) per share: | ||||
Basic | $ (0.95) | $ 1.34 | $ (1.84) | $ 0.82 |
Diluted | $ (0.95) | $ 1.26 | $ (1.84) | $ 0.77 |
Collaboration Agreements and _3
Collaboration Agreements and Revenues - Astellas Agreements - Additional Information (Detail) - Astellas Agreement [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 35 Months Ended | 45 Months Ended | |||
Apr. 30, 2006 | Jun. 30, 2005 | Jun. 30, 2020 | Jun. 30, 2020 | Feb. 28, 2009 | Feb. 28, 2009 | Dec. 31, 2019 | Jun. 30, 2019 | |
Japan [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront, non-contingent and time-based payments received | $ 40.1 | |||||||
Potential milestone payments | $ 132.5 | |||||||
Commercial sales milestone | 15 | |||||||
Additional consideration based on net sales description | low 20% range | |||||||
Aggregate consideration received | $ 90.1 | $ 90.1 | ||||||
Japan [Member] | Clinical and Development Milestone [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential milestone payments | 22.5 | |||||||
Japan [Member] | Regulatory Milestone [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential milestone payments | $ 95 | |||||||
Europe [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront, non-contingent and time-based payments received | $ 320 | |||||||
Additional consideration based on net sales description | low 20% range | |||||||
Aggregate consideration received | 540 | $ 540 | ||||||
Development and regulatory approval milestones | $ 425 | |||||||
Percentage of joint development costs committed to fund | 50.00% | |||||||
Transaction price and allocated to performance obligations | $ 130 | |||||||
Revenue during period from performance obligations | 0.6 | $ 0.6 | $ 128.8 | |||||
Milestone payment received | $ 130 | |||||||
Europe [Member] | Clinical and Development Milestone [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential milestone payments | $ 90 | |||||||
Europe [Member] | Regulatory Milestone [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential milestone payments | $ 335 |
Collaboration Agreements and _4
Collaboration Agreements and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) $ in Thousands | Jul. 30, 2013 | Apr. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2020 | Dec. 31, 2015 | Mar. 31, 2020 | Jun. 30, 2019 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Unbilled contract asset | $ 180,000 | $ 0 | |||||
AstraZeneca Agreements [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Transaction price and allocated to performance obligations | $ 50,000 | ||||||
Revenue during period from performance obligations | 42,400 | 400 | |||||
Unbilled contract asset | $ 50,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront, non-contingent, non-refundable and time-based payments | $ 374,000 | ||||||
Potential milestone payments | 875,000 | ||||||
Commercial sales milestone | 325,000 | ||||||
Aggregate consideration received | 439,000 | ||||||
Unbilled contract asset | 50,000 | ||||||
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] | U.S./RoW [Member] | Development Milestones [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Receipt of development milestone payment | $ 15,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | NDA Submission Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Receipt of development milestone payment | $ 50,000 | ||||||
AstraZeneca Agreements [Member] | China [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 348,500 | 22,000 | |||||
Aggregate consideration received | $ 77,200 | ||||||
Transaction price and allocated to performance obligations | $ 22,000 | ||||||
Proceeds from upfront, non-contingent and non-refundable payments | 28,200 | ||||||
Commercial sales and other events milestone | 187,500 | ||||||
Estimated joint development extended service period | 2024 | ||||||
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 |
Collaboration Agreements and _5
Collaboration Agreements and Revenues - Summary of Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 42,888 | $ 191,566 | $ 67,288 | $ 215,429 |
License Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 150,581 | 0 | 150,581 |
Development Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 18,957 | 40,985 | 38,402 | 64,848 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 117,470 | 0 | 117,470 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 164 | 369 | 327 | 615 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 4,602 | 16,854 | 9,176 | 21,467 |
AstraZeneca Agreements [Member] | China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 441 | 0 | 594 | 0 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 33,111 | 0 | 33,111 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 13,750 | $ 23,762 | $ 28,305 | $ 42,766 |
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 | Jun. 30, 2020 | Dec. 31, 2019 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 0 | $ 54,790 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 101,482 | |
Deferred Revenue | 183 | |
Total Consideration | 101,665 | |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 15,458 | |
Deferred Revenue | 183 | |
Total Consideration | 15,641 | |
Astellas Agreement [Member] | Japan [Member] | License Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 86,024 | |
Deferred Revenue | 0 | |
Total Consideration | 86,024 | |
Astellas Agreement [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 728,135 | |
Deferred Revenue | 2,338 | |
Total Consideration | 730,473 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 240,184 | |
Deferred Revenue | 2,338 | |
Total Consideration | 242,522 | |
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] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 864,100 | |
Deferred Revenue | 145,520 | |
Total Consideration | 1,009,620 | |
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 | 521,572 | |
Deferred Revenue | 4,547 | |
Total Consideration | 526,119 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 684 | |
Deferred Revenue | 140,973 | |
Total Consideration | $ 141,657 |
Collaboration Agreements and _7
Collaboration Agreements and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 0 |
Japan [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 100,000 |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | 31,700,000 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 1,600,000 |
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 | 90,100,000 |
U.S./RoW and China [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | $ (200,000) |
Collaboration Agreements and _8
Collaboration Agreements and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 42,888 | $ 191,566 | $ 67,288 | $ 215,429 |
Non-key Account Hospital Listing Award [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 2,600 | |||
Contractual Sales Rebate [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 1,400 | 1,700 | ||
Product [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Gross revenue | 19,833 | 25,205 | ||
Total revenue | 15,693 | $ 0 | 20,648 | $ 0 |
Product [Member] | Non-key Account Hospital Listing Award [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (2,566) | (2,566) | ||
Product [Member] | Contractual Sales Rebate [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (1,372) | (1,748) | ||
Product [Member] | Other Discounts and Rebates [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ (202) | $ (243) |
Collaboration Agreements and _9
Collaboration Agreements and Revenues - Product Revenue, Net - Additional Information 1 (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total revenue | $ 42,888 | $ 191,566 | $ 67,288 | $ 215,429 |
Non-key Account Hospital Listing Award [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total revenue | 2,600 | |||
Contractual Sales Rebate [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total revenue | $ 1,400 | 1,700 | ||
Rebates and Discounts [Member] | Gross Accounts Receivable [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total revenue | 5,600 | |||
Rebates and Discounts [Member] | Contract Liabilities [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Total revenue | $ 400 |
Collaboration Agreements and_10
Collaboration Agreements and Revenues - Roll-forward of Contract Liabilities (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Contract with Customer Liability [Line Items] | |
Beginning balance | $ (54,790) |
Ending balance | 0 |
Product [Member] | |
Contract with Customer Liability [Line Items] | |
Beginning balance | (1,102) |
Additions | (4,907) |
Deduction | 16 |
Currency Translation and Other | 9 |
Gross Contract Liabilities Balance | (5,984) |
Balance Presented Net Against Accounts Receivable | 5,595 |
Ending balance | $ (389) |
Collaboration Agreements and_11
Collaboration Agreements and Revenues - Summary of Contra-Accounts Receivable Items Related to Product Revenue (Detail) - Product [Member] - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | $ 5,724 | $ 1,102 |
Price Adjustment | ||
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | 935 | 936 |
Contractual Sales Rebate [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | 1,878 | 148 |
Non-key Account Hospital Listing Award [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | 2,567 | 0 |
Other Discounts and Rebates [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | 260 | 18 |
Provision for Credit Loss [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total reductions to gross accounts receivable | $ 84 | $ 0 |
Collaboration Agreements and_12
Collaboration Agreements and Revenues - Drug Product Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | $ 42,888 | $ 191,566 | $ 67,288 | $ 215,429 |
Astellas Agreement [Member] | Drug Product Revenue [Member] | Japan [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Drug product revenue recognized | $ 8,200 |
Collaboration Agreements and_13
Collaboration Agreements and Revenues - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 0 | $ 54,790 |
AstraZeneca Agreements [Member] | China [Member] | ||
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 2,700 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 256,546 | $ 468,609 |
U.S. treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 226,179 | 427,506 |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,816 | |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 229 | 255 |
Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,138 | 30,032 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 487,107 | 554,160 |
Fair Value, Measurements, Recurring [Member] | U.S. treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 226,179 | 427,506 |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,816 | |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 229 | 255 |
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 | 230,561 | 85,551 |
Fair Value, Measurements, Recurring [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,138 | 30,032 |
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 | 406,818 | 444,005 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | U.S. treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 176,028 | 347,383 |
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 | 10,816 | |
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 | 229 | 255 |
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 | 230,561 | 85,551 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 80,289 | 110,155 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | U.S. treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 50,151 | 80,123 |
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 | |
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 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] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,138 | 30,032 |
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] | U.S. treasury notes and bills [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] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 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] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | $ 0 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Values of Financial Liabilities Carried at Historical Cost (Detail) - Lease obligations [Member] - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,343 | $ 1,544 |
Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,343 | $ 1,544 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
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 liabilities from level 1 to 2 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 |
Transfers of assets into level 3 | 0 | 0 |
Transfers of assets out of level 3 | 0 | 0 |
Transfers of liabilities 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 | Jun. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Right-of-use assets - cost | $ 49,903 | $ 49,909 |
Accumulated amortization | (15,535) | (10,307) |
Finance lease right-of-use assets, net | 34,368 | 39,602 |
Right-of-use assets - cost | 2,647 | 2,736 |
Accumulated amortization | (1,270) | (805) |
Operating lease right-of-use assets, net | 1,377 | 1,931 |
Total lease assets | 35,745 | 41,533 |
Finance lease liabilities | 12,279 | 12,351 |
Operating lease liabilities | 801 | 983 |
Finance lease liabilities | 31,586 | 37,610 |
Operating lease liabilities | 572 | 942 |
Total lease liabilities | $ 45,238 | $ 51,886 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Finance lease cost: | ||||
Amortization of right-of-use assets | $ 2,653 | $ 2,571 | $ 5,247 | $ 5,140 |
Interest on lease liabilities | 534 | 609 | 1,049 | 1,249 |
Operating lease cost | 255 | 163 | 564 | 289 |
Sublease income | (306) | (237) | (598) | (824) |
Total lease cost | $ 3,136 | $ 3,106 | $ 6,262 | $ 5,854 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 433 | $ 191 |
Operating cash flows from finance leases | 1,010 | 1,053 |
Financing cash flows from finance leases | 5,992 | 5,850 |
Right-of-use assets obtained in exchange for new lease liabilities: | ||
Finance leases | 144 | 49,676 |
Operating leases | $ 5 | $ 1,212 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Jun. 30, 2020 | Dec. 31, 2019 |
Weighted-average remaining lease term (years): | ||
Finance leases | 3 years 4 months 24 days | 3 years 7 months 6 days |
Operating leases | 1 year 9 months 18 days | 2 years 1 month 6 days |
Weighted-average discount rate: | ||
Finance leases | 4.39% | 4.42% |
Operating leases | 4.73% | 4.75% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Jun. 30, 2020USD ($) |
Finance Leases | |
2020 (Remaining six month period) | $ 7,047 |
2021 | 13,680 |
2022 | 13,883 |
2023 | 12,523 |
Total future lease payments | 47,133 |
Less: Interest | (3,268) |
Present value of lease liabilities | 43,865 |
Operating Leases | |
2020 (Remaining six month period) | 463 |
2021 | 663 |
2022 | 305 |
2023 | 0 |
Total future lease payments | 1,431 |
Less: Interest | (58) |
Present value of lease liabilities | $ 1,373 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 198,708 | $ 40,715 |
Money market funds | 230,561 | 85,551 |
Total cash and cash equivalents | $ 429,269 | $ 126,266 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) | Dec. 31, 2019USD ($)Milestone | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Mar. 31, 2020USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |||||||
Cash and cash equivalents | $ 126,266,000 | $ 429,269,000 | $ 429,269,000 | ||||
Contractual maturities of available-for-sale investments | 1 year | ||||||
Other-than-temporary impairment loss | 0 | $ 0 | $ 0 | $ 0 | |||
Number of regulatory milestones | Milestone | 2 | ||||||
Unbilled contract assets | $ 180,000,000 | 0 | 0 | ||||
Billed contract assets | $ 50,000,000 | ||||||
API product price change in estimated variable consideration | 36,324,000 | 0 | 0 | ||||
Accrued long-term co-promotional expenses | 53,071,000 | 116,230,000 | 116,230,000 | ||||
Europe [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Unbilled contract assets | 130,000,000 | 130,000,000 | |||||
Astellas Agreement [Member] | Europe [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Unbilled contract assets | 130,000,000 | ||||||
Billed contract assets | 130,000,000 | 130,000,000 | |||||
AstraZeneca Agreements [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Unbilled contract assets | $ 50,000,000 | ||||||
Accrued long-term co-promotional expenses | 53,100,000 | 116,200,000 | 116,200,000 | ||||
AstraZeneca Agreements [Member] | Scenario Forecast [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Accrued long-term co-promotional expenses | $ 82,000,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Unbilled contract assets | 50,000,000 | ||||||
Foreign subsidiaries [Member] | |||||||
Schedule of Available-for-sale Securities [Line Items] | |||||||
Cash and cash equivalents | $ 11,900,000 | $ 32,800,000 | $ 32,800,000 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 255,242 | $ 467,850 |
Gross Unrealized Holding Gains | 1,304 | 784 |
Gross Unrealized Holding Losses | 0 | (25) |
Fair Value | 256,546 | 468,609 |
U.S. treasury notes and bills [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 225,117 | 426,995 |
Gross Unrealized Holding Gains | 1,062 | 536 |
Gross Unrealized Holding Losses | 0 | (25) |
Fair Value | 226,179 | 427,506 |
Certificate of deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,000 | 30,000 |
Gross Unrealized Holding Gains | 138 | 32 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 30,138 | 30,032 |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,730 | |
Gross Unrealized Holding Gains | 86 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 10,816 | |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 125 |
Gross Unrealized Holding Gains | 104 | 130 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 229 | $ 255 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Schedule Of Investments [Abstract] | ||
Raw materials | $ 327 | $ 325 |
Work-in-progress | 3,815 | 2,264 |
Finished goods | 4,440 | 4,298 |
Total inventories | $ 8,582 | $ 6,887 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 0 | $ 180,000 |
Deferred revenues from associated contracts | 0 | (54,790) |
Net unbilled contract assets | 0 | 125,210 |
Prepaid assets | 4,429 | 6,464 |
Other current assets | 2,052 | 1,717 |
Total prepaid expenses and other current assets | $ 6,481 | $ 133,391 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 141,209 | $ 143,107 |
Less: accumulated depreciation | (104,225) | (100,364) |
Property and equipment, net | 36,984 | 42,743 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 100,159 | 101,548 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 17,362 | 17,329 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 7,660 | 8,217 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,930 | 8,399 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 5,873 | 5,822 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,225 | $ 1,792 |
Balance Sheet Components - Sc_5
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 21,691 | $ 16,279 |
API product price adjustment | 0 | 36,324 |
Payroll and related accruals | 14,266 | 19,784 |
Property taxes and other | 1,145 | 2,044 |
Professional services | 5,653 | 4,842 |
Other | 7,709 | 4,543 |
Total accrued liabilities | $ 50,464 | $ 83,816 |
Balance Sheet Components - Sc_6
Balance Sheet Components - Schedule of Other Long-term Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Other Liabilities Noncurrent [Abstract] | ||
Accrued long-term co-promotional expenses | $ 116,230 | $ 53,071 |
Other long-term tax liabilities | 8,653 | 8,913 |
Operating lease liabilities, non-current | 572 | 942 |
Other | 1,787 | 1,340 |
Total other long-term liabilities | $ 127,242 | $ 64,266 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Recorded Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 17,644 | $ 17,642 | $ 34,560 | $ 34,072 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 10,780 | 10,450 | 21,417 | 20,028 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 6,864 | $ 7,192 | $ 13,143 | $ 14,044 |
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 | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Employee stock options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 6 months | 5 years 3 months 18 days | 5 years 8 months 12 days | 5 years 3 months 18 days |
Expected volatility | 69.20% | 68.20% | 68.40% | 67.90% |
Risk-free interest rate | 0.40% | 2.00% | 0.80% | 2.50% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 21.72 | $ 24.40 | $ 17.75 | $ 33.20 |
2014 Employee Share Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility, minimum | 49.50% | 48.10% | 49.50% | 48.10% |
Expected volatility, maximum | 77.10% | 62.10% | 77.10% | 62.10% |
Risk-free interest rate, minimum | 0.20% | 1.30% | 0.20% | 1.30% |
Risk-free interest rate, maximum | 2.90% | 2.90% | 2.90% | 2.90% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 17.82 | $ 19.07 | $ 18.11 | $ 19.65 |
2014 Employee Share Purchase Plan [Member] | Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
2014 Employee Share Purchase Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 2 years | 2 years | 2 years | 2 years |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | ||||||
Accounts receivable from related party | $ 12,090 | $ 12,090 | $ 4,845 | |||
Accrued liabilities to related party | 216 | 216 | 36,883 | |||
Unbilled contract asset | 0 | 0 | 180,000 | |||
Net unbilled contract asset | 0 | 0 | 125,210 | |||
Deferred revenue | 0 | 0 | 54,790 | |||
Europe [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Unbilled contract asset | 130,000 | 130,000 | ||||
Astellas Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Drug product revenue from a related party | 8,238 | $ 0 | 8,238 | $ 0 | ||
Astellas Agreement [Member] | Japan [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Deferred revenue | 183 | 183 | ||||
Astellas Agreement [Member] | Europe [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Unbilled contract asset | 130,000 | |||||
Deferred revenue | 2,338 | 2,338 | ||||
Astellas [Member] | Europe [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Unbilled contract asset | 130,000 | 130,000 | ||||
Net unbilled contract asset | 0 | 0 | 125,200 | |||
Deferred revenue | 0 | 0 | 4,800 | |||
Astellas [Member] | Collaborative Arrangement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Revenue related to collaboration agreements | 4,800 | 134,700 | 9,500 | 139,600 | ||
Drug product revenue from a related party | 8,200 | 8,200 | ||||
Expense related to collaboration agreements | 200 | $ 800 | 300 | $ 1,300 | ||
Accounts receivable from related party | 12,100 | 12,100 | 4,800 | |||
Accrued liabilities to related party | $ 200 | $ 200 | $ 36,900 | |||
Astellas [Member] | Astellas Agreement [Member] | Japan [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Accrued liabilities to related party | $ 36,300 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Commitments And Contingencies [Line Items] | |
Outstanding non-cancelable contract obligations | $ 26.2 |
Manufacture and Supply of Roxadustat [Member] | |
Commitments And Contingencies [Line Items] | |
Outstanding non-cancelable contract obligations | 14.2 |
Research and Pre-Clinical Stage Development Programs [Member] | |
Commitments And Contingencies [Line Items] | |
Future milestone payments | 10.9 |
Other Purchases [Member] | |
Commitments And Contingencies [Line Items] | |
Outstanding non-cancelable contract obligations | $ 1.1 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Subsequent Event [Line Items] | |||
Accrued long-term co-promotional expenses | $ 116,230 | $ 53,071 | |
AstraZeneca Agreements [Member] | |||
Subsequent Event [Line Items] | |||
Accrued long-term co-promotional expenses | $ 116,200 | $ 53,100 | |
Scenario Forecast [Member] | AstraZeneca Agreements [Member] | |||
Subsequent Event [Line Items] | |||
Accrued long-term co-promotional expenses | $ 82,000 |