Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Jan. 31, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | FGEN | ||
Entity Registrant Name | FIBROGEN, INC. | ||
Entity Central Index Key | 0000921299 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36740 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 77-0357827 | ||
Entity Address, Address Line One | 409 Illinois Street | ||
Entity Address, City or Town | San Francisco | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94158 | ||
City Area Code | 415 | ||
Local Phone Number | 978-1200 | ||
Entity Common Stock, Shares Outstanding | 87,999,804 | ||
Entity Public Float | $ 2,463.8 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K incorporate information by reference from the definitive proxy statement for the registrant’s 2020 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than after 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 126,266 | $ 89,258 |
Short-term investments | 407,491 | 532,144 |
Accounts receivable, net ($4,845 and $47,210 from a related party) | 28,455 | 63,684 |
Inventories | 6,887 | 0 |
Prepaid expenses and other current assets ($125,210 and $0 from a related party) | 133,391 | 4,929 |
Total current assets | 702,490 | 690,015 |
Restricted time deposits | 2,072 | 4,145 |
Long-term investments | 61,118 | 55,820 |
Property and equipment, net | 42,743 | 127,198 |
Finance lease right-of-use assets | 39,602 | 0 |
Other assets | 9,372 | 3,420 |
Total assets | 857,397 | 880,598 |
Current liabilities: | ||
Accounts payable | 6,088 | 9,139 |
Accrued and other current liabilities ($36,883 and $444 to a related party) | 83,816 | 66,123 |
Deferred revenue | 490 | 13,771 |
Finance lease liabilities, current | 12,351 | 0 |
Total current liabilities | 102,745 | 89,033 |
Long-term portion of lease obligations | 1,141 | 97,157 |
Product development obligations | 16,780 | 16,798 |
Deferred rent | 3,038 | |
Deferred revenue, net of current | 99,449 | 136,109 |
Finance lease liabilities, non-current | 37,610 | 0 |
Other long-term liabilities | 64,266 | 9,993 |
Total liabilities | 321,991 | 352,128 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at December 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at December 31, 2019 and December 31, 2018; 87,657 and 85,432 shares issued and outstanding at December 31, 2019 and December 31, 2018 | 877 | 854 |
Additional paid-in capital | 1,300,725 | 1,226,453 |
Accumulated other comprehensive loss | (747) | (2,281) |
Accumulated deficit | (784,720) | (715,827) |
Total stockholders’ equity | 516,135 | 509,199 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 535,406 | 528,470 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 857,397 | $ 880,598 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 4,845,000 | $ 47,210,000 |
Prepaid expenses and other current assets from related party | 125,210,000 | 0 |
Accrued and other current liabilities to related party | $ 36,883,000 | $ 444,000 |
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 | 87,657,000 | 85,432,000 |
Common stock, shares outstanding | 87,657,000 | 85,432,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | |||
Total revenue | $ 256,577 | $ 212,958 | $ 130,996 |
Operating costs and expenses: | |||
Cost of goods sold | $ 1,147 | $ 0 | $ 0 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 209,265 | $ 235,839 | $ 196,517 |
Selling, general and administrative | 135,479 | 63,812 | 51,760 |
Total operating costs and expenses | 345,891 | 299,651 | 248,277 |
Loss from operations | (89,314) | (86,693) | (117,281) |
Interest and other, net | |||
Interest expense | (2,876) | (10,991) | (9,706) |
Interest income and other, net | 15,548 | 11,568 | 6,433 |
Total interest and other, net | 12,672 | 577 | (3,273) |
Loss before income taxes | (76,642) | (86,116) | (120,554) |
Provision for income taxes | 328 | 304 | 321 |
Net loss | $ (76,970) | $ (86,420) | $ (120,875) |
Net loss per share - basic and diluted | $ (0.89) | $ (1.03) | $ (1.66) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 86,633 | 84,062 | 72,987 |
License Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 177,086 | $ 22,269 | $ 9,933 |
Development and Other Revenue [Member] | |||
Revenue: | |||
Total revenue | 114,115 | 125,913 | 121,063 |
Product Revenue [Member] | |||
Revenue: | |||
Total revenue | $ (34,624) | $ 64,776 | $ 0 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
License and milestone revenue from a related party | $ 129,405 | $ 14,323 | $ 0 |
Collaboration services and other revenue from a related party | 29,393 | 20,903 | 20,111 |
Product revenue from a related party | $ (36,324) | $ 64,776 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (76,970) | $ (86,420) | $ (120,875) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments | 331 | 771 | (2,022) |
Available-for-sale investments: | |||
Unrealized gain (loss) on investments, net of tax effect | 592 | (7) | 1,259 |
Reclassification from accumulated other comprehensive loss | 0 | 0 | (72) |
Net change in unrealized gain on available-for-sale investments | 592 | (7) | 1,187 |
Other comprehensive income (loss), net of taxes | 923 | 764 | (835) |
Comprehensive loss | $ (76,047) | $ (85,656) | $ (121,710) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Noncontrolling Interests [Member] |
Balance at Dec. 31, 2016 | $ 135,069 | $ 637 | $ 625,903 | $ (960) | $ (509,782) | $ 19,271 |
Balance, Shares at Dec. 31, 2016 | 63,665,284 | |||||
Net loss | (120,875) | $ 0 | 0 | 0 | (120,875) | 0 |
Change in unrealized gain or loss on investments | 1,187 | 0 | 0 | 1,187 | 0 | 0 |
Foreign currency translation adjustments | (2,022) | 0 | 0 | (2,022) | 0 | 0 |
Follow-on Offerings, net of underwriting discounts, commission and issuance costs | 470,226 | $ 144 | 470,082 | 0 | 0 | 0 |
Follow-on Offerings, net of underwriting discounts, commission and issuance costs, Shares | 14,428,750 | |||||
Shares issued from stock plans, net of payroll taxes paid | 26,614 | $ 44 | 26,570 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 4,404,094 | |||||
Stock-based compensation | 37,539 | $ 0 | 37,539 | 0 | 0 | 0 |
Balance at Dec. 31, 2017 | 547,738 | $ 825 | 1,160,094 | (1,795) | (630,657) | 19,271 |
Balance, Shares at Dec. 31, 2017 | 82,498,128 | |||||
Impact of change in accounting principle upon adoption | ASU 2016-01 [Member] | 0 | $ 0 | 0 | (1,250) | 1,250 | 0 |
Net loss | (86,420) | 0 | 0 | 0 | (86,420) | 0 |
Change in unrealized gain or loss on investments | (7) | 0 | 0 | (7) | 0 | 0 |
Foreign currency translation adjustments | 771 | 0 | 0 | 771 | 0 | 0 |
Adjustment to issuance costs for Follow-on Offerings | 11 | 0 | 11 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 14,235 | $ 29 | 14,206 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 2,933,974 | |||||
Stock-based compensation | 52,142 | $ 0 | 52,142 | 0 | 0 | 0 |
Balance at Dec. 31, 2018 | 528,470 | $ 854 | 1,226,453 | (2,281) | (715,827) | 19,271 |
Balance, Shares at Dec. 31, 2018 | 85,432,102 | |||||
Impact of change in accounting principle upon adoption | ASU 2016-02 [Member] | 8,688 | $ 0 | 0 | 0 | 8,688 | 0 |
Impact of change in accounting principle upon adoption | ASU 2018-02 [Member] | 0 | 0 | 0 | 611 | (611) | 0 |
Net loss | (76,970) | 0 | 0 | 0 | (76,970) | 0 |
Change in unrealized gain or loss on investments | 592 | 0 | 0 | 592 | 0 | 0 |
Foreign currency translation adjustments | 331 | 0 | 0 | 331 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 7,962 | $ 23 | 7,939 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 2,220,957 | |||||
Warrants exercised | 66 | $ 0 | 66 | 0 | 0 | 0 |
Warrants exercised, Shares | 4,430 | |||||
Stock-based compensation | 66,267 | $ 0 | 66,267 | 0 | 0 | 0 |
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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities | |||
Net loss | $ (76,970) | $ (86,420) | $ (120,875) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 11,147 | 6,562 | 6,099 |
Amortization of finance lease right-of-use assets | 10,307 | 0 | 0 |
Net amortization (accretion) of premium (discount) on investments | (3,667) | (42) | 1,844 |
Unrealized loss (gain) on cash equivalents and short-term equity investments | (88) | 1,120 | 2 |
Loss (gain) on disposal of property and equipment | (42) | 53 | 3 |
Stock-based compensation | 66,267 | 52,142 | 37,539 |
Realized foreign currency gain | 0 | (1,074) | 0 |
Realized gain on sales of available-for-sale securities | 0 | (87) | (143) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net ($42,365, $(43,486) and $98 from a related party) | 35,229 | (55,232) | 1,996 |
Inventories | (6,887) | 0 | 0 |
Prepaid expenses and other current assets ($(125,210), $0 and $0 from a related party) | (128,598) | (129) | (1,911) |
Other assets | (3,253) | 1,090 | (2,365) |
Accounts payable | (3,051) | 3,630 | (714) |
Accrued and other liabilities ($36,439, $172 and $(1,343) from a related party) | 18,288 | 5,606 | 9,196 |
Deferred revenue | (49,941) | (5,031) | 174 |
Lease obligations | 0 | 32 | 1,023 |
Accrued interest for finance lease liabilities | 194 | 0 | 0 |
Other long-term liabilities | 52,360 | 1,636 | 1,619 |
Net cash used in operating activities | (78,705) | (76,144) | (66,513) |
Investing activities | |||
Purchases of property and equipment | (5,762) | (8,020) | (8,500) |
Proceeds from sale of property and equipment | 7 | 184 | 5 |
Purchases of available-for-sale securities and term deposit | (411,299) | (576,880) | (169) |
Proceeds from sales of available-for-sale securities | 0 | 8,167 | 21,109 |
Proceeds from maturities of investments | 537,072 | 54,426 | 57,421 |
Net cash provided by (used in) investing activities | 120,018 | (522,123) | 69,866 |
Financing activities | |||
Borrowings under capital lease obligations | 0 | 49 | 0 |
Repayments of capital lease obligations | 0 | (6) | 0 |
Repayments of finance lease liabilities | (11,925) | 0 | 0 |
Repayments of lease obligations | (403) | (403) | (403) |
Proceeds from follow-on offerings, net of underwriting discounts and commission costs | 0 | 0 | 471,205 |
Cash paid for payroll taxes on restricted stock unit releases | (12,750) | (15,612) | (8,296) |
Proceeds from issuance of common stock | 20,778 | 29,847 | 34,910 |
Payments of deferred offering costs | 0 | 0 | (944) |
Net cash provided by (used in) financing activities | (4,300) | 13,875 | 496,472 |
Effect of exchange rate change on cash and cash equivalents | (5) | (8) | 51 |
Net increase (decrease) in cash and cash equivalents | 37,008 | (584,400) | 499,876 |
Total cash and cash equivalents at beginning of period | 89,258 | 673,658 | 173,782 |
Total cash and cash equivalents at end of period | 126,266 | 89,258 | 673,658 |
Supplemental cash flow information: | |||
Interest payments | 174 | 218 | 255 |
Balance in accounts payable and accrued liabilities related to purchases of property and equipment | 460 | 276 | 3,781 |
Deferred offering costs recorded in accounts payable and accrued liabilities | $ 0 | $ 24 | $ 35 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Cash Flows [Abstract] | |||
Accounts receivable from related party | $ 42,365 | $ (43,486) | $ 98 |
Prepaid expenses and other current assets from related party | (125,210) | 0 | 0 |
Accrued and other liabilities from related party | $ 36,439 | $ 172 | $ (1,343) |
The Company
The Company | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company 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. In September 2019, roxadustat (Evrenzo ® for the treatment of anemia patients with dialysis-dependent CKD and non-dialysis-dependent CKD was accepted by Astellas is in the process of preparing in the second quarter of 2020 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. (“FibroGen China”). All inter-company transactions and balances have been eliminated in consolidation. The Company operates in one segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. Foreign Currency Translation The reporting currency of the Company and its subsidiaries is the United States (“U.S.”) dollar. The functional currency of FibroGen Europe is the Euro. The assets and liabilities of FibroGen Europe are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. The functional currency of FibroGen, Inc. and all other subsidiaries is the U.S. dollar. Accordingly, monetary assets and liabilities in the non-functional currency of these subsidiaries are remeasured using exchange rates in effect at the end of the period. Revenues and costs in local currency are remeasured using average exchange rates for the period, except for costs related to those balance sheet items that are remeasured using historical exchange rates. The resulting remeasurement gains and losses are included within interest income and other, net in the consolidated statements of operations as incurred and have not been material for all periods presented. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue. 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. Concentration of Credit Risk and Other Risks and Uncertainties The Company is subject to risks associated with concentration of credit for cash and cash equivalents. Outside of short-term operating needs, the majority of cash on hand is invested in US treasury instruments. Any remaining cash is deposited with major financial institutions in the U.S., Finland, China and the Cayman Islands. At times, such deposits may be in excess of insured limits. The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2019 2018 Astellas Pharma Inc. (“Astellas”)—Related party 17 % 74 % AstraZeneca AB (“AstraZeneca”) 81 % 26 % The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Cash, Cash Equivalents and Restricted Time Deposits The Company considers all highly liquid investments with maturities of three months or less and that are used in the Company’s cash management activities at the date of purchase to be cash equivalents. Cash and cash equivalents also include money market accounts and various deposit accounts. Restricted time deposits include an irrevocable standby letter of credit as security deposit for a long-term property lease with the Company’s landlord. Restricted time deposits as of December 31, 2019 and 2018 totaled $2.1 million and $4.1 million, respectively. As of December 31, 2019 and 2018, a total of $11.9 million and $21.9 million, respectively, of the Company’s cash and cash equivalents was held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. Investments As of December 31, 2019, the Company’s investments consist of US treasuries, diversified bond funds, marketable equity investments, a term deposit and a certificate of deposit. Those investments with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered short-term investments. Those investments with maturities greater than 12 months (365 days) are considered long-term investments. When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses for available-for-sale debt investments that are deemed temporary in nature are recorded in accumulated other comprehensive income (loss) as a separate component of stockholder’ equity. Marketable equity securities are equity securities with readily determinable fair value, and are measured and recorded at fair value. Realized and unrealized gains or losses resulting from changes in value and sale of the Company’s marketable equity investments are recorded in other income (expenses) in the consolidated statement of operations. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums and discounts are amortized (accreted) over the life of the related security as an adjustment to its yield. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value (refer to Note 4). Inventories Inventories are stated at the lower of cost or net realizable value. The cost of inventories is determined using full absorption and standard costing, which approximates cost based on a first-in, first-out method. The Company reviews the standard cost of raw materials, work-in-process and finished goods annually and more often as appropriate to ensure that its inventories approximate current actual cost. The cost of inventories includes direct material cost, direct labor and manufacturing overhead. The Company periodically reviews its inventories to identify obsolete, slow-moving, excess or otherwise unsaleable items. If obsolete, excess or unsaleable items are observed and there are no alternate uses for the inventory, an inventory valuation reserve is recorded through a charge to cost of goods sold on the Company’s consolidated statements of operations. The establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, requires judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others. Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, machinery and furniture and fixtures are depreciated over three to five years. Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter. Leases The Company determines if an arrangement is or contains a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company reassesses the incremental borrowing rate periodically for application to any new leases or lease modifications, which approximates the rate at which the Company would borrow, on a secured basis, in the country where the lease was executed. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. Revenue Recognition Revenues under collaboration agreements Substantially all of the Company’s revenues to date have been generated from its collaboration agreements. The Company’s collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct. Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services. The Company’s process for identifying performance obligations and an enumeration of each obligation for each agreement is outlined in Note 3 “Collaboration Agreements.” Determining the performance obligations within a collaboration agreement often involves significant judgment and is specific to the facts and circumstances contained in each agreement. The Company has identified the following material promises under its collaboration agreements: (1) license of FibroGen technology, (2) the performance of co-development services, including manufacturing of clinical supplies and other services during the development period, and (3) manufacture of commercial supply. The evaluation as to whether these promises are distinct, and therefore represent separate performance obligations, is described in more details in Note 3 “Collaboration Agreements.” For revenue recognition purposes, the Company determines that the term of its collaboration agreements begin on the effective date and ends upon the completion of all performance obligations contained in the agreements. In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the existence of what it considers to be substantive termination penalties on the part of the counterparty create sufficient incentive for the counterparty to avoid exercising its right to terminate the agreement unless in exceptionally rare situations. The transaction price for each collaboration agreement is determined based on the amount of consideration the Company expects to be entitled for satisfying all performance obligations within the agreement. The Company’s collaboration agreements include payments to the Company of one or more of the following: non-refundable upfront license fees; co-development billings; development, regulatory, and commercial milestone payments; payments from sales of active pharmaceutical ingredient (“API”); and royalties on net sales of licensed products. Upfront license fees are non-contingent and non-refundable in nature and are included in the transaction price at the point when the license fees become due to the Company. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration. Determining the reimbursable amount of research and development efforts requires detailed analysis of the terms of the collaboration agreements and the nature of the research and development efforts incurred. Determining the amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangements. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 3 “Collaboration Agreements.” For each performance obligation identified within an arrangement, the Company determines the period over which the promised services are transferred and the performance obligation is satisfied. Service revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of co-development services and certain other related performance obligations, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The Company believes this measure of progress provides a faithful depiction of the transfer of services because other measures do not measure as accurately how the Company transfers its performance obligations to its collaboration partners. API product revenue Product revenue in 2018 consisted of sales of commercial-grade API used in support of pre-commercial validation work. In 2018, the Company recorded revenue from commercial-grade API sales to Astellas based on a transaction price that was subject to potential future adjustments, which represented a form of variable consideration. The Company evaluated the latest available facts and circumstances in 2018, including listed prices of comparable drug products in Japan and historical bulk drug product manufacturing yields and costs, to determine whether any adjustments to the estimated transaction price was necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the estimated transaction price. With respect to these sales in 2018, a change in estimated variable consideration occurred in 2019 at the time the actual listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare, which resulted in a total difference of $36.3 million between the estimated and the actual listed price and yield from the manufacture of bulk product tablets. Drug product revenue, net During 2019, the Company started selling 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 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. The Company established a bad debt allowance based on its judgment to consider factors such as the age of the receivables. Bad debt expense is included in selling, general and administrative expenses on the consolidated statements of operations. There was no bad debt allowance provided as of December 31, 2019. 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 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 accrued at the point of sale to the distributor, and applied to future sales orders made by the distributor under the Company’s discretion; • 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 accrued at the point of sale to the distributor and applied to future sales orders made by the distributor under the Company’s discretion; • 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 accrued at the point of sale to the distributor; • Sales return : Distributors can request to return product to the Company only due to quality issues and for product within one year of its expiration date. The Company, at its sole discretion, decides whether to accept such return request. The sales return allowance provided as of December 31, 2019 was immaterial; 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 the sales volume and timing requirements. The non-key account hospital listing award is accrued when the distributor meets eligibility requirements, and applied against future sales orders made by the distributor. The Company considers this particular award to be a material right within the definitions of ASC 606 and therefore have treated it as a separate performance obligation. The above allowances are recorded as reductions of gross accounts receivable from the distributor in the same period that the related revenue is recorded, with the exception of the non-key account hospital listing award, which is accrued when the distributor meets the eligibility requirements. The calculation of such allowances are 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. Research and Development Expenses Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development costs include employee-related expenses, expenses incurred under agreements with clinical research organizations (“CROs”), other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. All research and development costs are expensed as incurred. Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services including co-promotional expenses, recruiting fees and expenses associated with obtaining and maintaining patents. Income Taxes The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for expected future consequences of temporary differences between the financial reporting and income tax bases of assets and liabilities using enacted tax rates. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and also for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, the Company must establish a valuation allowance. The calculation of the Company’s current provision for income taxes involves the use of estimates, assumptions and judgments while taking into account current tax laws, interpretation of current tax laws and possible outcomes of future tax audits. The Company has established reserves to address potential exposures related to tax positions that could be challenged by tax authorities. Although the Company believes its estimates, assumptions and judgments to be reasonable, any changes in tax law or its interpretation of tax laws and the resolutions of potential tax audits could significantly impact the amounts provided for income taxes in the Company’s consolidated financial statements. The calculation of the Company’s deferred tax asset balance involves the use of estimates, assumptions and judgments while taking into account estimates of the amounts and type of future taxable income. Actual future operating results and the underlying amount and type of income could differ materially from the Company’s estimates, assumptions and judgments thereby impacting the Company’s financial position and results of operations. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes The Company includes interest and penalties related to unrecognized tax benefits within income tax expense in the Consolidated Statements of Operations. Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees and non-employee consultants. Compensation expense relating to non-employee stock options has not been material for all the periods presented. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. As such, the fair value of the unvested portion of the options granted to non-employees is re-measured each period. The resulting increase in value, if any, is recognized as expense during the period the related services are rendered on a straight-line basis. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated Common Stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. Comprehensive Income (Loss) The Company is required to report all components of comprehensive income (loss), including net loss, in the consolidated financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation adjustments. Comprehensive gains (losses) have been reflected in the consolidated statements of comprehensive income (loss) for all periods presented. Recently Issued and Adopted Accounting Guidance ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements The Company adopted the above guidance under ASC 842 as of January 1, 2019, using the modified retrospective transition method, through a cumulative-effect adjustment at the beginning of the first quarter of 2019. The Company elected the optional transition method under the guidance, which allowed it to continue applying previous lease guidance (ASC 840) for the comparative prior year periods presentation in the year of adoption. Accordingly, the Company recognized a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has a limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short-term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC |
Collaboration Agreements and Re
Collaboration Agreements and Revenues | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements and Revenues | 3. Collaboration Agreements and Revenues Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range after commercial launch. The aggregate amount of such consideration received through December 31, 2019 totals $90.1 million. In September 2019, Japan’s Ministry of Health, Labour and Welfare approved Evrenzo® (generic name: roxadustat; tradename Evrenzo® in Japan) for the treatment of anemia associated with CKD in dialysis patients. This approval triggered a $12.5 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $12.5 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the third quarter of 2019, substantially all of which was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. During the second quarter of 2018, Astellas reported positive results from the final phase 3 CKD-dialysis trial of roxadustat in Japan, indicating that Astellas was ready to make an NDA submission for the treatment of anemia with roxadustat in CKD-dialysis patients in 2018. The Company evaluated the regulatory milestone payment associated with NDA submission in Japan based on variable consideration requirements under the current revenue standards and concluded that this milestone became probable of being achieved in the second quarter of 2018. Accordingly, the consideration of $15.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the second quarter of 2018, substantially all of which was recognized as revenue during the year ended December 31, 2018 from performance obligations satisfied or partially satisfied. On November 30, 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that will allow 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 API. The commercial terms of the Japan Agreement relating to the transfer price for roxadustat for commercial use remain substantially the same, reflecting an adjustment for the manufacture of drug product by Astellas rather than FibroGen. This amendment obligates Astellas to purchase API from the Company, of which $20.9 million was delivered to Astellas in the second quarter of 2018 under a material transfer agreement to conduct commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. The remaining $43.9 million of API was delivered to Astellas in December 2018. The transaction price of such API product was adjusted in 2019 at the time the listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare to reflect a total difference of $36.3 million between estimated and actual listed price and yield from the manufacture of bulk product tablets. Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of such consideration received through December 31, 2019 totals $410.0 million. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE+ 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 in the second quarter of 2020, following the Company’s NDA submission to the FDA that was accepted for review in February 2020. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments are not billable to Astellas until the submission of an MAA, therefore this $130.0 million remained as an unbilled contract asset as of December 31, 2019. In the fourth quarter of 2018, the Company’s was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50-50 between the Company’s two partners. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe 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 CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (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 such consideration received through December 31, 2019 totals $389.0 million. Under the U.S./RoW Agreement, the Company and AstraZeneca will share equally in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million (i.e. the Company’s share of development costs is $116.5 million, which was reached in 2015). Development costs incurred by FibroGen during the development period in excess of the $233.0 million (aggregated spend) are fully reimbursed by AstraZeneca. AstraZeneca will pay the Company tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition, the Company will receive a transfer price for delivery of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $42.4 million was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. On December 23, 2019, the Company submitted such NDA, which was accepted by FDA in February 2020. According to the U.S/RoW Agreement, this milestone payment is not billable to AstraZeneca until the NDA is accepted by the FDA, therefore this $50.0 million remained as an unbilled contract asset as of December 31, 2019, and will be billed during the first quarter of 2020. 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 December 31, 2019 totals $55.2 million. In December 2019, roxadustat has been included on the updated NRDL released by China’s NHSA for the treatment of anemia in CKD, covering patients who are non-dialysis dependent dialysis-dependent As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50-50 between the Company’s two partners. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been 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 CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen China”), received marketing authorization from the NMPA for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca . Approximately $9.9 million of the total $12.0 million milestone payables was recognized as revenue during the year ended December 31, 2018 from performance obligations satisfied or partially satisfied. Accounting for the Astellas Agreements For each of the Astellas agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundles of services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual services. There are no right-of-return provisions for the delivered items in the Astellas agreements. As of December 31, 2019, the transaction price for the Japan Agreement included $40.1 million of non-contingent upfront payments, $50.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $11.4 million of variable consideration related to co-development billings. The transaction price for the Europe Agreement included $320.0 million of non-contingent upfront payments, $220.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $229.2 million of variable consideration related to co-development billings. For revenue recognition purposes, the Company determined that the term of each collaboration agreement with Astellas begins on the effective date and ends upon the completion of all performance obligations contained in the agreement. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and loss of product rights, along with non-refundable upfront payments already remitted by Astellas, create significant disincentive for Astellas to exercise its right to terminate the agreements. For the Astellas agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings allocated entirely to co-development services performance obligations. For the technology license under the Japan Agreement and Europe Agreement, SSP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. SSP also considered certain future royalty payments associated with commercial performance of the Company’s compounds, transfer prices and expected gross margins. The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For both of the Astellas agreements, the license was delivered at the beginning of the agreement term. In both cases, the Company concluded at the time of the agreement that its collaboration partner, Astellas, would have the knowledge and capabilities to fully exploit the licenses without the Company’s further involvement. However, the Japan Agreement has contractual limitations that might affect Astellas’ ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is capable of being distinct. In the Japan Agreement, Astellas does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the agreement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of Astellas to benefit from the license together with other resources readily available to Astellas. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work in either agreement would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Manufacturing rights. In the case of the Japan Agreement, the Company retained manufacturing rights largely because of the way the parties chose for FibroGen to be compensated under the agreement. At the time the agreement was signed, the Company believed that it was more advantageous upon commercialization to have a transfer price revenue model in place as opposed to a traditional sales-based model. The manufacturing process does not require specialized knowledge or expertise uniquely held by FibroGen, and notwithstanding contractual restrictions, Astellas could employ manufacturing services from readily available third parties in order to benefit from the license. Therefore, along with the foregoing paragraph, the Company determined that the license in Japan is a distinct performance obligation despite the retention of manufacturing rights by the Company. In summary, the Company concludes that item (1) represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to Astellas . (2) Co-development services (Europe Agreement). This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is considered distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. Co-development services are expected to continue over the development period that is currently estimated to continue through the end of 2019. In addition, the Company concluded that the new indication related to CIA approved in January 2019 represents a modification to the Europe agreements at that time and will be accounted for separately, for which the development service period is estimated to continue through the end of 2023. There was no provision for co-development services in the Japan Agreement. (3) License to the Company’s technology developed during the term of the agreement and development (referred to as “when and if available”) and information sharing services. These promises are generally satisfied throughout the term of the agreements. (4) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (5) Committee service . This promise is satisfied throughout the course of the agreements as meetings are attended. Items (3)-(5) are bundled into a single performance obligation which is distinct given the fact that all are highly interrelated during the development period (pre-commercial phase of development) such that satisfying them independently is not practicable. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. (6) Manufacturing commercial supplies of products. This promised service is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based payments related predominately to the license of intellectual property under both Astellas agreements. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. To date, no such revenue has been recognized. In 2018, the Company recorded revenue from commercial-grade API sales to Astellas to conduct commercial scale manufacturing validation based on a transaction price that was subject to potential future adjustments. This represents a form of variable consideration. The Company evaluated the latest available facts and circumstances in 2018, including listed prices of comparable drug products in Japan and historical bulk drug product manufacturing yields and costs, to determine whether any adjustments to the estimated transaction price was necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. The transaction price was later adjusted in 2019 at the time the listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare to reflect the difference between estimated and actual listed price and yield from the manufacture of bulk product tablets. Accounting for the AstraZeneca Agreements The Company evaluated whether the U.S./RoW Agreement and China Agreement should be accounted for as a single or separate arrangements and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. The key points the Company considered in reaching this conclusion are as follows: 1. While the two agreements were largely negotiated separately, those negotiations proceeded concurrently, and were intended to be completed contemporaneously, presuming AstraZeneca 2. Throughout negotiations for both agreements, the Company and the counterparties understood and considered the possibility that one arrangement may be executed without the execution of the other arrangement. However, the preference for the Company and the counterparties during the negotiations was to execute both arrangements concurrently. 3. The two agreements were executed as separate agreements because different development, regulatory and commercial approaches required certain terms of the agreements to be structured differently, rather than because the Company or the counterparties considered the agreements to be fundamentally separate negotiations. Accordingly, as the agreements are being accounted for as a single arrangement, upfront and other non-contingent consideration received and to be received has been and will be pooled together and allocated to each of the performance obligations in both the U.S./RoW Agreement and China Agreement based on their relative SSPs. For each of the AstraZeneca agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundled services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual promised services. There are no right-of-return provisions for the delivered items in the AstraZeneca agreements. As of December 31, 2019, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $114.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $598.8 million of variable consideration related to co-development billings. For the AstraZeneca agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings. Co-development billings under the U.S./RoW Agreement were allocated entirely to the U.S./RoW co-development services performance obligation, and co-development billings under the China Agreement were allocated entirely to the combined performance obligation under the China Agreement. For revenue recognition purposes, the Company determined that the term of its collaboration agreements with AstraZeneca begin on the effective date and ends upon the completion of all performance obligations contained in the agreements. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and the loss of product rights, along with non-refundable upfront payments already remitted by AstraZeneca, represent substantive termination penalties that create significant disincentive for AstraZeneca to exercise its right to terminate the agreement. For the technology license under the AstraZeneca U.S./RoW Agreement, SSP was determined based on a two-step process. The first step involved determining an implied royalty rate that would result in the net present value of future cash flows to equal to zero (i.e. where the implied royalty rate on the transaction would equal the target return for the investment). This results in an upper bound estimation of the magnitude of royalties that a hypothetical acquirer would reasonably pay for the forecasted cash flow stream. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. The second step involved applying the implied royalty rate, which was determined to be 40%, against the probability-adjusted projected net revenues by territory and determining the value of the license as the net present value of future cash flows after adjusting for taxes. The discount rate utilized was 17.5%. U.S./RoW Agreement: The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For the U.S./RoW Agreement, the license was delivered at the beginning of the agreement term. The Company concluded that AstraZeneca has the knowledge and capabilities to fully exploit the license under the U.S./RoW Agreement without the Company’s further involvement. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Therefore, the Company has concluded that the license is distinct and represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to AstraZeneca. (2) Co-development services. This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. Co-development services are expected to continue over the development period that is currently estimated to continue through the end of 2020. In addition, the Company concluded that the addition of the new indications related to CIA, ACI and MM approved during the fourth quarter of 2018 represents a modification to the collaboration agreements and will be accounted for separately, for which the joint development service period is estimated to continue through the end of 2024. (3) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (4) Information sharing and committee service. These pro |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis. The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements. The guidance also requires fair value measurements be classified and disclosed in one of the following three categories: Level 1 : Quoted prices in active markets for identical assets or liabilities. Level 2 : Observable inputs other than quoted prices in active markets for identical assets or liabilities. Level 3 : Unobservable inputs. The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs. The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2). The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The availability of observable data is monitored to assess classification of financial instruments within the fair value hierarchy. Depending upon the availability of such inputs, specific securities may transfer between levels. In such instances, the transfer is reported at the end of the reporting period. The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Total US 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 December 31, 2018 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 292,317 $ 224,953 $ — $ 517,270 Bond and mutual funds 10,484 — — 10,484 Equity investments 234 — — 234 Money market funds 541 — — 541 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,910 — 29,910 Total $ 303,576 $ 334,863 $ — $ 638,439 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. During the fourth quarter of 2019, there was a $29.8 million transfer of assets from Level 1 to Level 2 as such US treasury notes and bills were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day. There were no transfers of assets between levels for the years ended December 31, 2018 and 2017. The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,544 $ 1,544 December 31, 2018 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 98,105 $ 98,105 The fair value 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. As of December 31, 2018, the Company had $96.2 million in lease obligations related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these liabilities previously recognized under ASC 840 build-to-suit designation. Refer to Note 2 for details. There were no transfers of liabilities between levels for the years ended December 31, 2019, 2018 and 2017. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | 5. Leases The Company currently has two building leases treated as finance leases. In 2006, the Company entered into a long-term property lease with Alexandria for its corporate headquarters in San Francisco, California, with an initial term of 15 years, scheduled to expire in 2023. The Company has an option to extend the lease for an additional 10 years through 2033. The lease contract provides for a fixed annual rent, with scheduled increases of two percent that occur on each anniversary of the rent commencement date. This lease requires the Company to pay all costs of ownership, operation, and maintenance of the premises, including without limitation all operating costs, insurance costs, and taxes. In 2013, the Company entered into a long-term property lease with Beijing Economic-Technological Development Area (“BDA”) Management Committee for a pilot plant located in Beijing Yizhuang Biomedical Park (“BYBP”) of BDA. The building is leased for an initial lease term of eight years, scheduled to expire in 2021. Renewal options are not specified within the lease contract. The lease contract provides for fixed quarterly rent payments, with scheduled increases that occur as detailed in the lease contract. This lease requires the Company to pay all operating and maintenance costs, and a fixed amount for property management fees. The Company currently has seven additional real estate leases for space within a building, which are treated as operating leases. These leases have lease terms ranging from two to four years. These lease contracts provide for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs, and a fixed amount for property management fees. In addition, the Company has several immaterial lease arrangements for office equipment, scientific devices and automobile leases, with contracted lease terms ranging from two to five years, treated as finance leases or operating leases, respectively. The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item December 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,909 Accumulated amortization (10,307 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 39,602 Operating: Right-of-use assets - cost 2,736 Accumulated amortization (805 ) Operating lease right-of-use assets, net Other assets 1,931 Total lease assets $ 41,533 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,351 Operating lease liabilities Accrued and other current liabilities 983 Non-current: Finance lease liabilities Finance lease liabilities, non-current 37,610 Operating lease liabilities Other long-term liabilities 942 Total lease liabilities $ 51,886 The components of lease expense were as follows (in thousands): Statement of Operations Line Item Year Ended December 31, 2019 Finance lease cost: Amortization of right-of-use assets Research and development, Selling, general and administrative expenses $ 10,307 Interest on lease liabilities Interest expense 2,373 Operating lease cost Research and development, Selling, general and administrative expenses 891 Sublease income Selling, general and administrative expenses (1,385 ) Total lease cost $ 12,186 Supplemental cash flow information related to leases were as follows (in thousands): Year Ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 914 Operating cash flows from finance leases 2,196 Financing cash flows from finance leases 11,925 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 49,909 Operating leases $ 2,736 Lease term and discount rate were as follows at December 31, 2019: December 31, 2019 Weighted-average remaining lease term (years): Finance leases 3.6 Operating leases 2.1 Weighted-average discount rate: Finance leases 4.42 % Operating leases 4.75 % Maturities of lease liabilities are as follows: Year Ending Finance Leases Operating Leases 2020 $ 14,078 $ 1,043 2021 13,676 668 2022 13,878 307 2023 12,523 — Total future lease payments 54,155 2,018 Less: Interest (4,194 ) (93 ) Present value of lease liabilities $ 49,961 $ 1,925 The following information was previously disclosed under ASC 840 as of December 31, 2018: Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands): Year Ending Operating Leases 2019 $ 444 2020 232 2021 25 2022 16 2023 — Total minimum payments $ 717 Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands): Year Ending Lease financing obligations 2019 $ 14,379 2020 14,664 2021 14,179 2022 14,335 2023 12,872 Total minimum payments $ 70,429 |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 6. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): December 31, 2019 2018 Cash $ 40,715 $ 38,783 US treasury notes and bills — 49,934 Money market funds 85,551 541 Total cash and cash equivalents $ 126,266 $ 89,258 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): December 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US 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 December 31, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 467,296 $ 109 $ (69 ) $ 467,336 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (90 ) 29,910 Bond and mutual funds 10,464 20 — 10,484 Equity investments 125 109 — 234 Total investments $ 587,885 $ 238 $ (159 ) $ 587,964 The contractual maturities of the available-for-sale investments and term deposit were as follows (in thousands): December 31, 2019 Within one year $ 407,491 After one year through four years 50,047 Total debt investments 457,538 Bond and mutual funds 10,816 Equity investments 255 Total investments $ 468,609 The Company periodically reviews its available-for-sale investments and term deposit for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three years ended December 31, 2019, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands): December 31, 2019 Raw materials $ 325 Work-in-progress 2,264 Finished goods 4,298 Total inventories $ 6,887 The Company started capitalizing inventory costs in June 2019 when FibroGen China began productions of roxadustat for commercial sales purposes. The provision to write-down excess and obsolete inventory was nominal for the year ended December 31, 2019. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2019 2018 Unbilled contract assets $ 180,000 $ — Deferred revenues from associated contracts (54,790 ) — Net unbilled contract assets 125,210 — Prepaid assets 6,464 2,705 Other current assets 1,717 2,224 Total prepaid expenses and other current assets $ 133,391 $ 4,929 The unbilled contract assets as of December 31, 2019 were related to two regulatory milestones totaling $130.0 million under the Europe Agreement with Astellas associated with the planned MAA submission in Europe, and 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. See Note 3 for details. Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2019 2018 Leasehold improvements $ 101,548 $ 101,200 Building shell — 53,880 Laboratory equipment 17,329 16,405 Machinery 8,217 8,382 Computer equipment 8,399 6,473 Furniture and fixtures 5,822 5,690 Construction in progress 1,792 367 Total property and equipment $ 143,107 $ 192,397 Less: accumulated depreciation (100,364 ) (65,199 ) Property and equipment, net $ 42,743 $ 127,198 As of December 31, 2018, the Company had $53.9 million building shell cost and $13.5 million accumulated depreciation related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these assets previously recognized under ASC 840 build-to-suit designation. Up to December 31, 2018, the leasehold improvements related to these building leases were depreciated over the life of the building under ASC 840. Upon the adoption of ASC 842, these leasehold improvements should have a useful life based on the lease term. As a result, at the adoption date, the Company recorded a cumulative adjustment of $38.9 million to the opening accumulated depreciation for these leasehold improvements so that their net balance equals the undepreciated amount had the useful life of the leasehold improvements always been equal to the lease terms. Refer to Note 2 for details. Depreciation expense for the years ended December 31, 2019, 2018 and 2017 was $11.1 million, $6.6 million, and $6.1 million, respectively. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2019 2018 Preclinical and clinical trial accruals $ 16,279 $ 35,413 API product price adjustment 36,324 — Payroll and related accruals 19,784 21,430 Property taxes and other 2,044 1,095 Professional services 4,842 2,648 Other 4,543 5,537 Total accrued liabilities $ 83,816 $ 66,123 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. Refer to Note 3 for details. Other Long-term Liabilities Other long-term liabilities consisted of the following (in thousands): December 31, 2019 2018 Accrued long-term co-promotional expenses $ 53,071 $ — Other long-term tax liabilities 8,913 8,138 Operating lease liabilities, non-current 942 — Other 1,340 1,855 Total other long-term liabilities $ 64,266 $ 9,993 The a ccrued long-term co-promotional expenses as of December 31, 2019 was related to the estimated amount payable to AstraZeneca for its sales and marketing efforts related to the commercial launch for roxadustat in China. The payment for such amount is not expected to occur within the next yea |
Product Development Obligations
Product Development Obligations | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Product Development Obligations | 7. Product Development Obligations The Technology Development Center of the Republic of Finland (“TEKES”) product development obligations consist of 11 separate advances (each in the form of a note agreement) received by FibroGen Europe between 1996 and 2008 from TEKES. These advances are granted on a project by project basis to fund various product development efforts undertaken by FibroGen Europe only. Each separate note is denominated in EUR and bears interest (not compounded) calculated as one percentage point less than the Bank of Finland rate in effect at the time of the note, but no less than 3.0%. If the research work funded by TEKES does not result in an economically profitable business or does not meet its technological objectives, TEKES may, on application from FibroGen Europe, forgive each of these loans, including accrued interest, either in full or in part. As of December 31, 2019 and 2018, the Company had USD equivalent of $10.6 million and $10.8 million of principal outstanding, respectively, and $6.2 million and $6.0 million of interest accrued, respectively, which were presented in the product development obligations line on the consolidated balance sheets. The Company is not a guarantor of these loans, and these loans are not repayable by FibroGen Europe until it has distributable funds. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Lease Obligations In 2006, upon signing the Company’s above-mentioned long-term property lease agreement with Alexandria, a stand-by letter of credit $7.3 million was established which has been included in restricted time deposits on the Company’s consolidated balance sheet. Starting the fourth quarter of 2016, on an annual basis, a portion of this letter of credit was released. As a result, the restriction of a $2.1 million was removed during the year ended December 31, 2019. The agreement also included an expansion option to occupy part of an adjacent building, for which the Company gave notice to its landlord that it would not exercise this expansion option. This resulted in a $5.0 million payment liability to the landlord which is being financed over the remaining lease term of its lease. The related balance was $1.5 million as of December 31, 2019, with $0.4 million included in accrued and other current liabilities, and $1.1 million included in long-term portion of lease obligations on the Company’s consolidated balance sheet. Legal Proceedings The Company a party to various legal actions that arose in the ordinary course of its business. The Company recognizes accruals for any legal action when it concludes that a loss is probable and reasonably estimable. The Company did not have any material accruals for any currently active legal action in its consolidated balance sheets as of December 31, 2019 and 2018, 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 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. 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. Some of the Company’s license agreements provide for periodic maintenance fees over specified time periods, as well as payments by the Company upon the achievement of development, regulatory and commercial milestones. Future milestone payments for research and pre-clinical stage development programs consisted of up to approximately $11.0 million in total potential future milestone payments under the Company’s license agreements with Dana-Farber Cancer Institute, University of Miami and Medarex, Inc. These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones. The event triggering such payment or obligation has not yet occurred. |
Equity and Stock-based Compensa
Equity and Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity and Stock-based Compensation | 9. Equity and Stock-based Compensation Subsidiary Stock and Non-Controlling Interests FibroGen Europe As of December 31, 2019 and 2018, respectively, FibroGen Europe had a total of 42,619,022 shares of Preferred Stock outstanding, of which there were 1,700,845 shares of Series A Preferred Stock, 1,875,000 shares of Series B Preferred Stock, 1,599,503 shares of Series C Preferred Stock, 1,520,141 shares of Series D Preferred Stock, 459,565 shares of Series E Preferred Stock, 5,714,332 shares of Series F Preferred Stock, 9,927,500 shares of Series G Preferred Stock and 19,822,136 shares of Series H Preferred Stock, all of which shares no longer have any right to be exchanged for FibroGen, Inc. Common Stock. The holders of FibroGen Europe’s shares of Preferred Stock (“Preferred Shares”) have the following rights, preferences and privileges: Dividend Rights — When the assets of FibroGen Europe are distributed (except for distribution in a liquidation), Preferred Shares shall have the same rights to dividend or other forms of distribution as shares of Common Stock of FibroGen Europe. In the event of a merger, holders of Preferred Shares do not have the right to demand FibroGen Europe to redeem all or part of their Preferred Shares. FibroGen Europe may repurchase shares of Common Stock or Preferred Shares for consideration. Pre-emptive Right — Preferred Shares shall have pre-emptive subscription right in accordance with the Finnish Limited Liability Companies Act if additional shares are issued, option rights are given, or convertible loan is taken, provided , however , that the foregoing pre-emptive right does not apply to a directed share issue, for which two thirds (2/3) of the voting shares represented at a general meeting of shareholders approve for an important legitimate cause. Redemption Right — If a Preferred Share can be redeemed by a majority shareholder owning more than ninety percent (90%) of the shares of FibroGen Europe in accordance with the provisions of the Finnish Limited Liability Companies Act, the minority holders of Preferred Shares have the right to request redemption of their shares. Voting Right — Each share has one vote. Preferred Shares have voting rights only in situations that are specifically provided in the Articles of Association, which include a merger transaction and directed share issue. In addition, Preferred Shares have right to vote in a general shareholder meeting for amending the Articles of Association if the amendment will affect the rights of Preferred Shares. Conversion Right (1-for-1 basis into Common Stock of FibroGen Europe): • Voluntary conversion right: Preferred Shares can be converted into common shares upon the written request of a shareholder provided that the conversion is feasible within the maximum and minimum amounts of shares of classes of FibroGen Europe as set forth in its Articles of Association. Such request can be withdrawn before the notification of conversion is filed with the Finnish Trade Register. • Compulsory conversion right: Preferred Shares will be converted into common shares if (i) FibroGen Europe’s shares are listed in a stock exchange or other trading system in the European Economic Area, or (ii) FibroGen Europe’s recombinant collagen and gelatin production technology is being put into commercial use in the area of Europe and certain other European states. Commercial use means there is income generated from the first commercial sale of the products incorporating the above mentioned technology and does not include license fees, development financing, milestone payments or income from test products or equipment used in research. The board of directors of FibroGen Europe shall notify the shareholders of the compulsory conversion in writing, and the shareholders shall request to convert their shares within the timeframe provided in the notification. Should the shareholders fail to make the conversion request within the time limit, FibroGen Europe may redeem the shares of such shareholders. Liquidation Right — In the event of a dissolution of FibroGen Europe, holders of Preferred Shares are entitled to be paid in an amount equal to the subscription price of the shares before any distribution is made to holders of common shares. Among holders of Preferred Shares, holders of shares of Series F Preferred Stock are entitled to be paid in an amount equal to the subscription price of Series F Preferred Stock before any distribution is made to holders of other Preferred Shares. FibroGen China FibroGen China had 6,758,000 Series A Preference Shares outstanding as of December 31, 2019 and 2018, respectively. The holders of the FibroGen China Series A Preference Shares have the following rights, preferences and privileges: Liquidation — In the event of liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, including by means of a merger, the holders of FibroGen China Series A Preference Shares are entitled to be paid an amount equal to the product of the number of shares held by a holder of shares of FibroGen China Series A Preference Shares and the original issue price of $1.00 (subject to equitable adjustment for any stock dividend, combination, split, reclassification, recapitalization) plus all declared and unpaid dividends thereon. Conversion — Each share of FibroGen China Series A Preference Shares is convertible into the number of fully paid and non-assessable shares of Common Stock of FibroGen China that results from dividing the original issue price by the conversion price in effect at the time of the conversion, subject to adjustments for stock splits, stock dividends, reclassifications and like events. The FibroGen China Series A Preference Shares have a conversion price that is equal to the original issuance price such that the conversion ratio to FibroGen China Common Stock is 1:1 as of all periods presented. Voting — The holders of FibroGen China Series A Preference Shares are entitled to vote together with the FibroGen China Common Stock holders on all matters submitted for a vote of the stockholders. The holder of each share of FibroGen China Series A Preference Shares has the number of votes equal to the number of shares of FibroGen China Common Stock into which it is convertible. Dividends — The holders of FibroGen China Series A Preference Shares are entitled to receive cash dividends when and if declared, at a rate of 6%. Non-Controlling Interests Non-controlling interest positions related to the issuance of subsidiary stock as described above are reported as a separate component of consolidated equity from the equity attributable to the Company’s stockholders at December 31, 2019 and 2018. In addition, the Company does not allocate losses to the non-controlling interests as the outstanding shares representing the non-controlling interest do not represent a residual equity interest in the subsidiary. Upon the initial public offering and as described above, all eligible FibroGen Europe preferred shares were exchanged for 958,996 shares of FibroGen Common Stock. No other FibroGen Europe shares have the right to be exchanged for FibroGen, Inc. Common Stock. Common Stock Each share of Common Stock is entitled to one vote. The holders of Common Stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. Shares of Common Stock outstanding, shares of stock plans outstanding and shares reserved for future issuance related to stock options and RSU grants and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2019 2018 Common stock outstanding 87,657 85,432 Stock options outstanding 10,018 10,430 RSUs outstanding 1,483 1,428 Common stock warrants outstanding — 4 Shares reserved for future stock options and RSUs grant 7,725 6,041 Shares reserved for future ESPP offering 3,337 2,618 Total shares of common stock reserved 110,220 105,953 Stock Plans Stock Option and RSU Plans Under the Company’s Amended and Restated 2005 Stock Plan (“2005 Stock Plan”), the Company may issue shares of Common Stock and options to purchase Common Stock and other forms of equity incentives to employees, directors and consultants. Options granted under the 2005 Stock Plan may be incentive stock options or nonqualified stock options. Incentive stock options (“ISO”) may be granted only to employees and officers of the Company. Nonqualified stock options (“NSO”) and stock purchase rights may be granted to employees, directors and consultants. The board of directors has the authority to determine to whom options will be granted, the number of options, the term and the exercise price. Options are to be granted at an exercise price not less than fair market value for an ISO or an NSO. Options generally vest over four years. Options expire no more than 10 years after the date of grant. Upon the effective date of the registration statement related to the Company’s initial public offering, the 2005 Plan was amended to cease the grant of any additional awards thereunder, although the Company will continue to issue common stock upon the exercise of previously granted stock options under the 2005 Plan. In September 2014, the Company adopted a 2014 Equity Incentive Plan (the “2014 Plan”) which became effective on November 13, 2014. The 2014 Plan is the successor equity compensation plan to the 2005 Plan. The 2014 Plan will terminate on November 12, 2024. The 2014 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, stock appreciation rights, performance stock awards, performance cash awards, restricted stock units and other stock awards to employees, directors and consultants. Stock options granted must be at prices not less than 100% of the fair market value at date of grant. Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule (25% vesting on the first anniversary of the vesting base date and quarterly thereafter over the next 3 years). Options generally expire ten years from the date of grant unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant. Unvested options exercised are subject to the Company’s repurchase right. Shares reserved for issuance increases on January 1 of each year commencing on January 1, 2016 and ending on January 1, 2024 by the lesser of (i) the amount equal to 4% of the number of shares issued and outstanding on December 31 immediately prior to the date of increase or (ii) such lower number of shares as may be determined by the board of directors. As of December 31, 2019, the Company has reserved 7,724,691 shares of its common stock that remains unissued for issuance under the 2014 Plan. Issuance of shares upon share option exercise or share unit conversion is made through issuance of new shares authorized under the plan. Certain Common Stock option holders have the right to exercise unvested options, subject to a right held by the Company to repurchase the stock, at the original exercise price, in the event of voluntary or involuntary termination of employment of the stockholder. The shares are generally released from repurchase provisions ratably over four years. The Company accounts for the cash received in consideration for the early exercised options as a liability. At December 31, 2019 and 2018, no shares of Common Stock were subject to repurchase by the Company. Stock option transactions, including forfeited options granted under the 2014 Plan as well as prior plans, are summarized below: Shares (In thousands) Weighted Average Exercise per Share Weighted Average Remaining Contractual Life (In Years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2018 10,430 $ 20.25 Granted 1,909 53.75 Exercised (1,642 ) 10.15 Expired (21 ) 50.40 Forfeited (658 ) 44.65 Outstanding at December 31, 2019 10,018 26.63 5.17 $ 193,226 Vested and expected to vest, December 31, 2019 10,018 26.63 5.17 193,226 Exercisable at December 31, 2019 7,318 $ 18.63 3.89 $ 183,707 The total intrinsic value of options exercised during the years ended December 31, 2019, 2018 and 2017 was $59.2 million, $97.5 million, and $111.9 million, respectively. The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2018 1,428 $ 38.26 Granted 1,110 54.74 Vested (715 ) 37.71 Forfeited (340 ) 46.15 Unvested at December 31, 2019 1,483 $ 49.05 Among the vested RSUs during the year ended December 31, 2019, 448,647 shares were released and issued, while the remaining was withheld for the related payroll taxes. The estimated weighted-average fair value of the awards granted during the years ended December 31, 2019, 2018 and 2017 was $54.74, $53.69 and $26.59, respectively. ESPP In September 2014, the Company adopted a 2014 ESPP that became effective on November 13, 2014. The 2014 ESPP is designed to enable eligible employees to periodically purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan or IRS limitations. At the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last day of the offering period. Purchases are accomplished through participation in discrete offering periods. The 2014 ESPP is intended to qualify as an ESPP under Section 423 of the Internal Revenue Code. The Company has reserved 1,600,000 shares of its common stock for issuance under the 2014 ESPP and shares reserved for issuance increases January 1 of each year commencing January 1, 2016 by the lesser of (i) a number of shares equal to 1% of the total number of outstanding shares of common stock on December 31 immediately prior to the date of increase; (ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors. There were 135,115 shares, 230,317 shares and 250,834 shares purchased by employees under the 2014 Purchased Plan for the years ended December 31, 2019, 2018 and 2017, respectively. The expected term of 2014 ESPP shares is the average of the remaining purchase periods under each offering period. Stock-Based Compensation Stock-based compensation expense allocated to research and development and selling, general and administrative expense for the years ended December 31, 2019, 2018 and 2017 was as follows (in thousands): Years Ended December 31, 2019 2018 2017 Research and development $ 41,015 $ 30,491 $ 21,807 Selling, general and administrative 25,252 21,651 15,732 Total stock-based compensation expense $ 66,267 $ 52,142 $ 37,539 The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. Prior to the Company’s initial public offering, the Company, in making its determinations of the fair value of its Common Stock, considered a variety of quantitative and qualitative factors, including (i) net present value of the Company’s projected earnings, (ii) fair market value of the stock of comparable publicly-traded companies, (iii) any third party transactions involving the Company’s convertible preferred stock, (iv) liquidation preferences of the Company’s preferred stock and the likelihood of conversion of the preferred stock, (v) changes in the Company’s business operations, financial condition and results of operations over time, including cash balances and burn-rate, (vi) the status of new product development, and (vii) general financial market conditions. Subsequent to the IPO, the fair market value of common stock is based on the closing price of the Company’s common stock as reported on the NASDAQ Global Select Market on the date of the grant. The fair value of employee stock-based compensation was estimated using the following assumptions: • Expected Term. Expressed as a weighted-average, the expected life of the options is based on the average period the stock options are expected to be outstanding and was based on the Company’s historical information of the option exercise patterns and post-vesting termination behavior as well as contractual terms of the instruments. • Expected Volatility. The Company considers its historical volatility data for volatility considerations for its ESPP. The expected volatility for all other stock-based compensation is currently based upon the historical volatility of comparable public entities. In evaluating comparable companies, the Company considered factors such as industry, stage of life cycle, size and duration as a public company. • Risk-Free Interest Rate. Expressed as a weighted-average, the risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. • Expected Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future. The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows: Years Ended December 31, 2019 2018 2017 Stock Options Expected term (in years) 5.3 5.4 5.7 Expected volatility 68.0 % 67.9 % 71.5 % Risk-free interest rate 2.4 % 2.7 % 2.2 % Expected dividend yield — — — Weighted average estimated fair value $ 31.98 $ 32.12 $ 16.96 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 48.1 - 62.1 % 47.3 - 75.3 % 52.8 - 77.2 % Risk-free interest rate 1.3 - 2.9 % 0.8 - 2.9 % 0.5 - 1.6 % Expected dividend yield — — — Weighted average estimated fair value $ 19.27 $ 16.27 $ 9.41 As of December 31, 2019, there was $57.5 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period of 2.32 years. As of December 31, 2019, there was $52.9 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested RSUs granted that will be recognized on a straight-line basis over the weighted-average period of 2.36 years. Warrants During the year ended December 31, 2019, a warrant to purchase 4,430 shares of our common stock was exercised and there was no warrant to purchase shares of Common Stock outstanding at December 31, 2019. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The following weighted impacts of outstanding securities were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the three years presented (in thousands): Years Ended December 31, 2019 2018 2017 Employee stock options 7,602 7,815 8,936 RSUs 1,187 820 799 ESPP 260 195 206 Warrants 1 4 4 9,050 8,834 9,945 |
FibroGen, Inc. 401(k) Plan
FibroGen, Inc. 401(k) Plan | 12 Months Ended |
Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
FibroGen, Inc. 401(k) Plan | 11. FibroGen, Inc. 401(k) Plan Substantially all of the Company’s full-time United States of America-based employees are eligible to make contributions to the Company’s 401(k) Plan. Under this plan, participating employees may defer up to 60% of their pretax salary during the year, but not more than statutory limits. The Company may elect to match employee contributions. Matching contributions of $3.0 million, $2.9 million and $2.5 million were made during years ended December 31, 2019, 2018 and 2017, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes The components of loss before income taxes are as follows (in thousands): Years Ended December 31, 2019 2018 2017 Domestic $ 2,538 $ (38,472 ) $ (80,735 ) Foreign (79,180 ) (47,644 ) (39,819 ) Loss before provision for income taxes $ (76,642 ) $ (86,116 ) $ (120,554 ) The provision for income taxes consists of the following (in thousands): Years Ended December 31, 2019 2018 2017 Current: Federal $ — $ — $ — State — 2 2 Foreign 328 302 319 Total current 328 304 321 Deferred: Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 328 $ 304 $ 321 The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate: Years Ended December 31, 2019 2018 2017 Tax at statutory federal rate 21.0 % 21.0 % 34.0 % State tax — % — % — % Stock-based compensation expense 6.3 % 14.5 % 18.5 % Change in deferred tax assets due to rate change — % — % 43.9 % Change in valuation allowance due to rate change — % — % (43.9 )% Net operating losses not benefitted (2.9 )% (23.2 )% (43.8 )% Foreign net operating losses not benefitted (21.7 )% (11.6 )% (6.7 )% Orphan drug credit — % — % (2.0 )% Deduction limitation on executive compensation (2.5 )% (0.5 )% — % Other (0.6 )% (0.6 )% (0.3 )% Total (0.4 )% (0.4 )% (0.3 )% Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2019 2018 Federal and state net operating loss carryforwards $ 91,267 $ 91,683 Tax credit carryforwards 52,243 45,885 Foreign net operating loss carryforwards 37,786 21,295 Stock-based compensation 11,159 9,281 Lease obligations 10,698 2,511 Reserves and accruals 5,353 6,072 Deferred revenue 13,323 16,454 Fixed assets — 356 Other 284 450 Subtotal 222,113 193,987 Less: Valuation allowance (213,847 ) (193,987 ) Net deferred tax assets 8,266 — Fixed assets (8,266 ) — Other — — Net deferred tax liabilities (8,266 ) — Total net deferred tax assets $ — $ — A valuation allowance has been provided to reduce the deferred tax assets to an amount management believes is more likely than not to be realized. Expected realization of the deferred tax assets for which a valuation allowance has not been recognized is based on upon the reversal of existing temporary differences and future taxable income. The valuation allowance increased by $19.9 million, $34.4 million and $30.5 million for the years ended December 31, 2019, 2018 and 2017, respectively. Due to uncertainty surrounding the realization of the favorable tax attributes in the future tax returns, the Company has established a valuation allowance against its otherwise recognizable net deferred tax assets. At December 31, 2019, the Company had net operating loss carryforwards available to offset future taxable income of approximately $404.6 million and $129.4 million for federal and state tax purposes, respectively. These carryforwards will begin to expire in 2026 for federal and 2020 for state purposes, if not utilized before these dates. The Company also had foreign net operating loss carryforwards of approximately $152.2 million which expire between 2020 and 2029 if not utilized. At December 31, 2019, the Company had approximately $54.1 million of federal and $29.4 million of California research and development tax credit and other tax credit carryforwards available to offset future taxable income. The federal credits begin to expire in 2020 and the California research credits have no expiration dates. On December 22, 2017, the Tax Cuts and Jobs Act (“Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings. In the fourth quarter of 2018, the Company completed its analysis to determine the effect of the Tax Act and no material adjustments were recognized as of December 31, 2018. Developing interpretations of the provisions of the Tax Act, changes to U.S. Treasury regulations, administrative interpretations or court decisions interpreting the Tax Act in the future periods may require further adjustments to the Company’s analysis. Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change” for tax purposes, as defined in IRC Section 382. The Company reviewed its stock ownership for year ended December 31, 2019 and concluded no ownership changes occurred which would result in a reduction of its net operating loss or in its research and development credits expiring unused. If additional ownership change occurs, the utilization of net operating loss and credit carryforwards could be significantly reduced. Uncertain Tax Positions The Company had unrecognized tax benefits of approximately $32.3 million as of December 31, 2019. Approximately $0.5 million of unrecognized tax benefits, if recognized, would affect the effective tax rate. The interest accrued as of December 31, 2019 and 2018 was immaterial. A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2019 is as follows (in thousands): Federal Balance as of December 31, 2016 $ 19,654 Increase due to prior positions 303 Increase due to current year position 5,448 Decrease due to U.S. tax rate change (2,044 ) Balance as of December 31, 2017 23,361 Increase due to prior positions 379 Increase due to current year position 4,216 Balance as of December 31, 2018 27,956 Decrease due to prior positions (111 ) Increase due to current year position 4,418 Balance as of December 31, 2019 $ 32,263 Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business. The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months that would affect the Company’s effective tax rate. The Company classifies interest and penalties as a component of tax expense, if any. The Company files income tax returns in the U.S. federal jurisdiction, U.S. state and other foreign jurisdictions. The U.S. federal and U.S. state taxing authorities may choose to audit tax returns for tax years beyond the statute of limitation period due to significant tax attribute carryforwards from prior years, making adjustments only to carryforward attributes. The foreign statute of limitation generally remains open from 2010 to 2019. The Company is not currently under audit in any tax jurisdiction. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. Related Party Transactions Astellas is an equity investor in the Company and considered a related party. During the years ended December 31, 2019, 2018 and 2017, the Company recorded revenue related to collaboration agreements with Astellas of $122.5 million, $100.0 million, and $20.1 million, respectively. The related party revenue for the year ended December 31, 2019 included a change in estimated variable consideration that resulted in a $36.3 million reduction to revenue related to the product revenue of $64.8 million for API recorded in 2018. See Note 3 and below for details. During the years ended December 31, 2019, 2018 and 2017, the Company recorded expense related to collaboration agreements with Astellas of $2.8 million, $1.5 million and $1.0 million, respectively. As of December 31, 2019 and 2018, accounts receivable from Astellas were $4.8 million and $47.2 million, respectively, and amounts due to Astellas were $36.9 million and $0.4 million, respectively. The amounts due are included in accrued liabilities on the consolidated balance sheets. The accounts receivable from Astellas as of December 31, 2018 included $43.8 million related to the delivery of roxadustat API to Astellas during the fourth quarter of 2018. The sale of API was pursuant to the Japan Amendment allowing Astellas to manufacture roxadustat drug product for commercialization in Japan. The amount was received during the first quarter of 2019. 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. Refer to Note 3 for details. Prepaid expenses and other current assets as of December 31, 2019 included $125.2 million of net unbilled contract assets, 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. See Note 3 for details. According to the Europe Agreement, this $130.0 million is not billable to Astellas until the submission of an MAA, therefore the net contract asset was included in the prepaid expenses and other current assets line on the Company’s consolidated balance sheet as of December 31, 2019. There was no such contract asset balance as of December 31, 2018. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment and Geographic Information | 14. Segment and Geographic Information The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”). The CODM reviews financial information presented for the Company’s various clinical trial programs as well as results on a consolidated basis. License revenues and development revenues received are not allocated to various programs for purposes of determining a profit measure and resource allocation decisions are made by the CODM based primarily on consolidated results. As such, the Company has concluded that it operates as one segment. Supplemental enterprise-wide information has been presented below. Geographic Revenues Geographic revenues, which are based on the bill-to region, are as follows (in thousands): Years Ended December 31, 2019 2018 2017 Europe $ 132,400 $ 112,916 $ 110,861 Japan (related party) 122,475 100,002 20,111 All other 1,702 40 24 Total revenue $ 256,577 $ 212,958 $ 130,996 Revenues to other regions include the Company commercial sales of roxadustat drug product in China starting in the third quarter of 2019. See Note 3 for details. Geographic Long-Lived Assets Property and equipment, net by geographic location are as follows (in thousands): December 31, 2019 2018 United States $ 27,325 $ 103,539 China 15,418 23,659 Total property and equipment $ 42,743 $ 127,198 Finance lease right-of-use assets and operating lease right-of-use assets, net by geographic location are as follows (in thousands): December 31, 2019 2018 United States $ 39,237 $ — China 365 — Total finance lease right-of-use assets $ 39,602 $ — United States $ 75 $ — China 1,856 — Total operating lease right-of-use assets $ 1,931 $ — Customer Concentration Substantially all of the Company’s revenues to date have been generated from the following collaboration partners that respectively accounted for 10% or more of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2019 2018 2017 2019 2018 Astellas—Related party 48 % 47 % 15 % 17 % 74 % AstraZeneca 52 % 53 % 85 % 81 % 26 % |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2019 | |
Valuation And Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Schedule II: Valuation and Qualifying Accounts (in thousands) Charged Charged Balance at (Credited) to Other Beginning of to Statement Accounts - Deductions, Balance at Year of Operation Equity Net End of Year Valuation allowances for deferred tax assets Year ended December 31, 2019 $ 193,987 $ 19,860 $ — $ — $ 213,847 Year ended December 31, 2018 $ 159,540 $ 34,447 $ — $ — $ 193,987 Year ended December 31, 2017 $ 128,995 $ 11,039 $ 19,506 $ — $ 159,540 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. (“FibroGen China”). All inter-company transactions and balances have been eliminated in consolidation. The Company operates in one segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. |
Foreign Currency Translation | Foreign Currency Translation The reporting currency of the Company and its subsidiaries is the United States (“U.S.”) dollar. The functional currency of FibroGen Europe is the Euro. The assets and liabilities of FibroGen Europe are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. The functional currency of FibroGen, Inc. and all other subsidiaries is the U.S. dollar. Accordingly, monetary assets and liabilities in the non-functional currency of these subsidiaries are remeasured using exchange rates in effect at the end of the period. Revenues and costs in local currency are remeasured using average exchange rates for the period, except for costs related to those balance sheet items that are remeasured using historical exchange rates. The resulting remeasurement gains and losses are included within interest income and other, net in the consolidated statements of operations as incurred and have not been material for all periods presented. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue. 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. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties The Company is subject to risks associated with concentration of credit for cash and cash equivalents. Outside of short-term operating needs, the majority of cash on hand is invested in US treasury instruments. Any remaining cash is deposited with major financial institutions in the U.S., Finland, China and the Cayman Islands. At times, such deposits may be in excess of insured limits. The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2019 2018 Astellas Pharma Inc. (“Astellas”)—Related party 17 % 74 % AstraZeneca AB (“AstraZeneca”) 81 % 26 % The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. |
Cash, Cash Equivalents and Restricted Time Deposits | Cash, Cash Equivalents and Restricted Time Deposits The Company considers all highly liquid investments with maturities of three months or less and that are used in the Company’s cash management activities at the date of purchase to be cash equivalents. Cash and cash equivalents also include money market accounts and various deposit accounts. Restricted time deposits include an irrevocable standby letter of credit as security deposit for a long-term property lease with the Company’s landlord. Restricted time deposits as of December 31, 2019 and 2018 totaled $2.1 million and $4.1 million, respectively. As of December 31, 2019 and 2018, a total of $11.9 million and $21.9 million, respectively, of the Company’s cash and cash equivalents was held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. |
Investments | Investments As of December 31, 2019, the Company’s investments consist of US treasuries, diversified bond funds, marketable equity investments, a term deposit and a certificate of deposit. Those investments with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered short-term investments. Those investments with maturities greater than 12 months (365 days) are considered long-term investments. When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses for available-for-sale debt investments that are deemed temporary in nature are recorded in accumulated other comprehensive income (loss) as a separate component of stockholder’ equity. Marketable equity securities are equity securities with readily determinable fair value, and are measured and recorded at fair value. Realized and unrealized gains or losses resulting from changes in value and sale of the Company’s marketable equity investments are recorded in other income (expenses) in the consolidated statement of operations. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums and discounts are amortized (accreted) over the life of the related security as an adjustment to its yield. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Carrying amounts of certain of the Company’s financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value (refer to Note 4). |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value. The cost of inventories is determined using full absorption and standard costing, which approximates cost based on a first-in, first-out method. The Company reviews the standard cost of raw materials, work-in-process and finished goods annually and more often as appropriate to ensure that its inventories approximate current actual cost. The cost of inventories includes direct material cost, direct labor and manufacturing overhead. The Company periodically reviews its inventories to identify obsolete, slow-moving, excess or otherwise unsaleable items. If obsolete, excess or unsaleable items are observed and there are no alternate uses for the inventory, an inventory valuation reserve is recorded through a charge to cost of goods sold on the Company’s consolidated statements of operations. The establishment of inventory valuation reserves, together with the calculation of the amount of such reserves, requires judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, machinery and furniture and fixtures are depreciated over three to five years. Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter. |
Leases | Leases The Company determines if an arrangement is or contains a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company reassesses the incremental borrowing rate periodically for application to any new leases or lease modifications, which approximates the rate at which the Company would borrow, on a secured basis, in the country where the lease was executed. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. |
Revenue Recognition | Revenue Recognition Revenues under collaboration agreements Substantially all of the Company’s revenues to date have been generated from its collaboration agreements. The Company’s collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct. Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services. The Company’s process for identifying performance obligations and an enumeration of each obligation for each agreement is outlined in Note 3 “Collaboration Agreements.” Determining the performance obligations within a collaboration agreement often involves significant judgment and is specific to the facts and circumstances contained in each agreement. The Company has identified the following material promises under its collaboration agreements: (1) license of FibroGen technology, (2) the performance of co-development services, including manufacturing of clinical supplies and other services during the development period, and (3) manufacture of commercial supply. The evaluation as to whether these promises are distinct, and therefore represent separate performance obligations, is described in more details in Note 3 “Collaboration Agreements.” For revenue recognition purposes, the Company determines that the term of its collaboration agreements begin on the effective date and ends upon the completion of all performance obligations contained in the agreements. In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the existence of what it considers to be substantive termination penalties on the part of the counterparty create sufficient incentive for the counterparty to avoid exercising its right to terminate the agreement unless in exceptionally rare situations. The transaction price for each collaboration agreement is determined based on the amount of consideration the Company expects to be entitled for satisfying all performance obligations within the agreement. The Company’s collaboration agreements include payments to the Company of one or more of the following: non-refundable upfront license fees; co-development billings; development, regulatory, and commercial milestone payments; payments from sales of active pharmaceutical ingredient (“API”); and royalties on net sales of licensed products. Upfront license fees are non-contingent and non-refundable in nature and are included in the transaction price at the point when the license fees become due to the Company. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration. Determining the reimbursable amount of research and development efforts requires detailed analysis of the terms of the collaboration agreements and the nature of the research and development efforts incurred. Determining the amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangements. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 3 “Collaboration Agreements.” For each performance obligation identified within an arrangement, the Company determines the period over which the promised services are transferred and the performance obligation is satisfied. Service revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of co-development services and certain other related performance obligations, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The Company believes this measure of progress provides a faithful depiction of the transfer of services because other measures do not measure as accurately how the Company transfers its performance obligations to its collaboration partners. API product revenue Product revenue in 2018 consisted of sales of commercial-grade API used in support of pre-commercial validation work. In 2018, the Company recorded revenue from commercial-grade API sales to Astellas based on a transaction price that was subject to potential future adjustments, which represented a form of variable consideration. The Company evaluated the latest available facts and circumstances in 2018, including listed prices of comparable drug products in Japan and historical bulk drug product manufacturing yields and costs, to determine whether any adjustments to the estimated transaction price was necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the estimated transaction price. With respect to these sales in 2018, a change in estimated variable consideration occurred in 2019 at the time the actual listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare, which resulted in a total difference of $36.3 million between the estimated and the actual listed price and yield from the manufacture of bulk product tablets. Drug product revenue, net During 2019, the Company started selling 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 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. The Company established a bad debt allowance based on its judgment to consider factors such as the age of the receivables. Bad debt expense is included in selling, general and administrative expenses on the consolidated statements of operations. There was no bad debt allowance provided as of December 31, 2019. 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 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 accrued at the point of sale to the distributor, and applied to future sales orders made by the distributor under the Company’s discretion; • 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 accrued at the point of sale to the distributor and applied to future sales orders made by the distributor under the Company’s discretion; • 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 accrued at the point of sale to the distributor; • Sales return : Distributors can request to return product to the Company only due to quality issues and for product within one year of its expiration date. The Company, at its sole discretion, decides whether to accept such return request. The sales return allowance provided as of December 31, 2019 was immaterial; 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 the sales volume and timing requirements. The non-key account hospital listing award is accrued when the distributor meets eligibility requirements, and applied against future sales orders made by the distributor. The Company considers this particular award to be a material right within the definitions of ASC 606 and therefore have treated it as a separate performance obligation. The above allowances are recorded as reductions of gross accounts receivable from the distributor in the same period that the related revenue is recorded, with the exception of the non-key account hospital listing award, which is accrued when the distributor meets the eligibility requirements. The calculation of such allowances are 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. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development costs include employee-related expenses, expenses incurred under agreements with clinical research organizations (“CROs”), other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. All research and development costs are expensed as incurred. |
Clinical Trial Accruals | Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Selling, General and Administrative Expenses | Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services including co-promotional expenses, recruiting fees and expenses associated with obtaining and maintaining patents. |
Income Taxes | Income Taxes The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for expected future consequences of temporary differences between the financial reporting and income tax bases of assets and liabilities using enacted tax rates. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and also for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, the Company must establish a valuation allowance. The calculation of the Company’s current provision for income taxes involves the use of estimates, assumptions and judgments while taking into account current tax laws, interpretation of current tax laws and possible outcomes of future tax audits. The Company has established reserves to address potential exposures related to tax positions that could be challenged by tax authorities. Although the Company believes its estimates, assumptions and judgments to be reasonable, any changes in tax law or its interpretation of tax laws and the resolutions of potential tax audits could significantly impact the amounts provided for income taxes in the Company’s consolidated financial statements. The calculation of the Company’s deferred tax asset balance involves the use of estimates, assumptions and judgments while taking into account estimates of the amounts and type of future taxable income. Actual future operating results and the underlying amount and type of income could differ materially from the Company’s estimates, assumptions and judgments thereby impacting the Company’s financial position and results of operations. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes The Company includes interest and penalties related to unrecognized tax benefits within income tax expense in the Consolidated Statements of Operations. |
Stock-Based Compensation | Stock-Based Compensation The Company maintains equity incentive plans under which incentive and nonqualified stock options are granted to employees and non-employee consultants. Compensation expense relating to non-employee stock options has not been material for all the periods presented. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. As such, the fair value of the unvested portion of the options granted to non-employees is re-measured each period. The resulting increase in value, if any, is recognized as expense during the period the related services are rendered on a straight-line basis. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated Common Stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. Prior to the Company’s initial public offering, the Company, in making its determinations of the fair value of its Common Stock, considered a variety of quantitative and qualitative factors, including (i) net present value of the Company’s projected earnings, (ii) fair market value of the stock of comparable publicly-traded companies, (iii) any third party transactions involving the Company’s convertible preferred stock, (iv) liquidation preferences of the Company’s preferred stock and the likelihood of conversion of the preferred stock, (v) changes in the Company’s business operations, financial condition and results of operations over time, including cash balances and burn-rate, (vi) the status of new product development, and (vii) general financial market conditions. Subsequent to the IPO, the fair market value of common stock is based on the closing price of the Company’s common stock as reported on the NASDAQ Global Select Market on the date of the grant. The fair value of employee stock-based compensation was estimated using the following assumptions: • Expected Term. Expressed as a weighted-average, the expected life of the options is based on the average period the stock options are expected to be outstanding and was based on the Company’s historical information of the option exercise patterns and post-vesting termination behavior as well as contractual terms of the instruments. • Expected Volatility. The Company considers its historical volatility data for volatility considerations for its ESPP. The expected volatility for all other stock-based compensation is currently based upon the historical volatility of comparable public entities. In evaluating comparable companies, the Company considered factors such as industry, stage of life cycle, size and duration as a public company. • Risk-Free Interest Rate. Expressed as a weighted-average, the risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. • Expected Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) The Company is required to report all components of comprehensive income (loss), including net loss, in the consolidated financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation adjustments. Comprehensive gains (losses) have been reflected in the consolidated statements of comprehensive income (loss) for all periods presented. |
Recently Issued and Adopted Accounting Guidance | Recently Issued and Adopted Accounting Guidance ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements The Company adopted the above guidance under ASC 842 as of January 1, 2019, using the modified retrospective transition method, through a cumulative-effect adjustment at the beginning of the first quarter of 2019. The Company elected the optional transition method under the guidance, which allowed it to continue applying previous lease guidance (ASC 840) for the comparative prior year periods presentation in the year of adoption. Accordingly, the Company recognized a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has a limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short-term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC 840 build-to-suit guidance. In addition, as a result of applying the transition guidance, the Company also recorded an adjustment to the accumulated depreciation of related leasehold improvements to reflect a change in estimated useful life from the building life to the shorter of the building life and remaining lease term. Differences between the assets and liabilities derecognized were recorded to the opening balance of retained earnings. The impacts to the select line items from the Company’s consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands): Balance Sheet Line Item Nature of Adjustment New Lease Guidance Adoption Adjustment Assets Property and equipment, net Derecognition - build-to-suit lease assets - building shell, cost $ (53,880 ) Derecognition - build-to-suit lease assets - building shell, accumulated depreciation 13,476 Change of useful life - leasehold improvements, accumulated depreciation (38,877 ) Finance lease right-of-use assets Recognition - finance lease ROU assets 49,597 Other assets Recognition - operating lease ROU assets 730 Liabilities Accrued and other current liabilities Derecognition - deferred rent, current (619 ) Derecognition - build-to-suit lease liabilities, current (545 ) Recognition - operating lease liabilities, current 404 Finance lease liabilities, current Recognition - finance lease liabilities, current 11,499 Long-term portion of lease obligations Derecognition - build-to-suit lease liabilities, non-current (95,613 ) Deferred rent Derecognition - deferred rent, non-current (3,038 ) Finance lease liabilities, non-current Recognition - finance lease liabilities, non-current 49,884 Other long-term liabilities Recognition - operating lease liabilities, non-current 250 Stockholders’ equity Accumulated deficit Cumulative decrease to accumulated deficit $ 8,688 The adoption of this guidance did not have a material impact to the Company’s consolidated statement of operations or consolidated statement of cash flows for the year ended December 31, 2019 . ASU 2018-02 In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2018 $ (2,281 ) $ (715,827 ) Impact of change in accounting principle upon adoption of ASU 2018-02 611 (611 ) Opening balance as of January 1, 2019 $ (1,670 ) $ (716,438 ) The adoption of this guidance had no impact to the Company’s consolidated statement of operations or consolidated statement of cash flows for the year ended December 31, 2019. ASU 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. ASU 2016-01 In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10) Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2017 $ (1,795 ) $ (630,657 ) Impact of change in accounting principle upon adoption of ASU 2016-01 (1,250 ) 1,250 Opening balance as of January 1, 2018 $ (3,045 ) $ (629,407 ) The adoption of this guidance had no impact to the Company’s consolidated statement of cash flows for the year ended December 31, 2018. |
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 In August 2018, the FASB issued 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. This guidance requires capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This guidance should be applied either retrospectively or prospectively, and is effective for annual reporting periods beginning after December 15, 2019 including interim periods, with early adoption permitted. The Company will adopt this guidance on January 1, 2020 and does not anticipate a material impact to its consolidated financial statements upon adoption of this guidance. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments U.S. Treasury bills and notes |
Collaboration Arrangements and Revenues | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range after commercial launch. The aggregate amount of such consideration received through December 31, 2019 totals $90.1 million. In September 2019, Japan’s Ministry of Health, Labour and Welfare approved Evrenzo® (generic name: roxadustat; tradename Evrenzo® in Japan) for the treatment of anemia associated with CKD in dialysis patients. This approval triggered a $12.5 million milestone payable to the Company by Astellas under the Japan Agreement. Accordingly, the consideration of $12.5 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the third quarter of 2019, substantially all of which was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. During the second quarter of 2018, Astellas reported positive results from the final phase 3 CKD-dialysis trial of roxadustat in Japan, indicating that Astellas was ready to make an NDA submission for the treatment of anemia with roxadustat in CKD-dialysis patients in 2018. The Company evaluated the regulatory milestone payment associated with NDA submission in Japan based on variable consideration requirements under the current revenue standards and concluded that this milestone became probable of being achieved in the second quarter of 2018. Accordingly, the consideration of $15.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Japan Agreement in the second quarter of 2018, substantially all of which was recognized as revenue during the year ended December 31, 2018 from performance obligations satisfied or partially satisfied. On November 30, 2018, FibroGen and Astellas entered into an amendment to the Japan Agreement that will allow 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 API. The commercial terms of the Japan Agreement relating to the transfer price for roxadustat for commercial use remain substantially the same, reflecting an adjustment for the manufacture of drug product by Astellas rather than FibroGen. This amendment obligates Astellas to purchase API from the Company, of which $20.9 million was delivered to Astellas in the second quarter of 2018 under a material transfer agreement to conduct commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. The remaining $43.9 million of API was delivered to Astellas in December 2018. The transaction price of such API product was adjusted in 2019 at the time the listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare to reflect a total difference of $36.3 million between estimated and actual listed price and yield from the manufacture of bulk product tablets. Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of such consideration received through December 31, 2019 totals $410.0 million. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE+ 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 in the second quarter of 2020, following the Company’s NDA submission to the FDA that was accepted for review in February 2020. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $128.8 million was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. According to the Europe Agreement, these milestone payments are not billable to Astellas until the submission of an MAA, therefore this $130.0 million remained as an unbilled contract asset as of December 31, 2019. In the fourth quarter of 2018, the Company’s was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50-50 between the Company’s two partners. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe 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 CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (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 such consideration received through December 31, 2019 totals $389.0 million. Under the U.S./RoW Agreement, the Company and AstraZeneca will share equally in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million (i.e. the Company’s share of development costs is $116.5 million, which was reached in 2015). Development costs incurred by FibroGen during the development period in excess of the $233.0 million (aggregated spend) are fully reimbursed by AstraZeneca. AstraZeneca will pay the Company tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition, the Company will receive a transfer price for delivery of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $42.4 million was recognized as revenue during the year ended December 31, 2019 from performance obligations satisfied or partially satisfied. On December 23, 2019, the Company submitted such NDA, which was accepted by FDA in February 2020. According to the U.S/RoW Agreement, this milestone payment is not billable to AstraZeneca until the NDA is accepted by the FDA, therefore this $50.0 million remained as an unbilled contract asset as of December 31, 2019, and will be billed during the first quarter of 2020. 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 December 31, 2019 totals $55.2 million. In December 2019, roxadustat has been included on the updated NRDL released by China’s NHSA for the treatment of anemia in CKD, covering patients who are non-dialysis dependent dialysis-dependent As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50-50 between the Company’s two partners. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been 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 CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen China”), received marketing authorization from the NMPA for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca . Approximately $9.9 million of the total $12.0 million milestone payables was recognized as revenue during the year ended December 31, 2018 from performance obligations satisfied or partially satisfied. Accounting for the Astellas Agreements For each of the Astellas agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundles of services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual services. There are no right-of-return provisions for the delivered items in the Astellas agreements. As of December 31, 2019, the transaction price for the Japan Agreement included $40.1 million of non-contingent upfront payments, $50.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $11.4 million of variable consideration related to co-development billings. The transaction price for the Europe Agreement included $320.0 million of non-contingent upfront payments, $220.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $229.2 million of variable consideration related to co-development billings. For revenue recognition purposes, the Company determined that the term of each collaboration agreement with Astellas begins on the effective date and ends upon the completion of all performance obligations contained in the agreement. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and loss of product rights, along with non-refundable upfront payments already remitted by Astellas, create significant disincentive for Astellas to exercise its right to terminate the agreements. For the Astellas agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings allocated entirely to co-development services performance obligations. For the technology license under the Japan Agreement and Europe Agreement, SSP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. SSP also considered certain future royalty payments associated with commercial performance of the Company’s compounds, transfer prices and expected gross margins. The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For both of the Astellas agreements, the license was delivered at the beginning of the agreement term. In both cases, the Company concluded at the time of the agreement that its collaboration partner, Astellas, would have the knowledge and capabilities to fully exploit the licenses without the Company’s further involvement. However, the Japan Agreement has contractual limitations that might affect Astellas’ ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is capable of being distinct. In the Japan Agreement, Astellas does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the agreement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of Astellas to benefit from the license together with other resources readily available to Astellas. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work in either agreement would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Manufacturing rights. In the case of the Japan Agreement, the Company retained manufacturing rights largely because of the way the parties chose for FibroGen to be compensated under the agreement. At the time the agreement was signed, the Company believed that it was more advantageous upon commercialization to have a transfer price revenue model in place as opposed to a traditional sales-based model. The manufacturing process does not require specialized knowledge or expertise uniquely held by FibroGen, and notwithstanding contractual restrictions, Astellas could employ manufacturing services from readily available third parties in order to benefit from the license. Therefore, along with the foregoing paragraph, the Company determined that the license in Japan is a distinct performance obligation despite the retention of manufacturing rights by the Company. In summary, the Company concludes that item (1) represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to Astellas . (2) Co-development services (Europe Agreement). This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is considered distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. Co-development services are expected to continue over the development period that is currently estimated to continue through the end of 2019. In addition, the Company concluded that the new indication related to CIA approved in January 2019 represents a modification to the Europe agreements at that time and will be accounted for separately, for which the development service period is estimated to continue through the end of 2023. There was no provision for co-development services in the Japan Agreement. (3) License to the Company’s technology developed during the term of the agreement and development (referred to as “when and if available”) and information sharing services. These promises are generally satisfied throughout the term of the agreements. (4) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (5) Committee service . This promise is satisfied throughout the course of the agreements as meetings are attended. Items (3)-(5) are bundled into a single performance obligation which is distinct given the fact that all are highly interrelated during the development period (pre-commercial phase of development) such that satisfying them independently is not practicable. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. The measure of progress is updated each reporting period. (6) Manufacturing commercial supplies of products. This promised service is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based payments related predominately to the license of intellectual property under both Astellas agreements. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. To date, no such revenue has been recognized. In 2018, the Company recorded revenue from commercial-grade API sales to Astellas to conduct commercial scale manufacturing validation based on a transaction price that was subject to potential future adjustments. This represents a form of variable consideration. The Company evaluated the latest available facts and circumstances in 2018, including listed prices of comparable drug products in Japan and historical bulk drug product manufacturing yields and costs, to determine whether any adjustments to the estimated transaction price was necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. The transaction price was later adjusted in 2019 at the time the listed price for roxadustat was issued by the Japanese Ministry of Health, Labour and Welfare to reflect the difference between estimated and actual listed price and yield from the manufacture of bulk product tablets. Accounting for the AstraZeneca Agreements The Company evaluated whether the U.S./RoW Agreement and China Agreement should be accounted for as a single or separate arrangements and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. The key points the Company considered in reaching this conclusion are as follows: 1. While the two agreements were largely negotiated separately, those negotiations proceeded concurrently, and were intended to be completed contemporaneously, presuming AstraZeneca 2. Throughout negotiations for both agreements, the Company and the counterparties understood and considered the possibility that one arrangement may be executed without the execution of the other arrangement. However, the preference for the Company and the counterparties during the negotiations was to execute both arrangements concurrently. 3. The two agreements were executed as separate agreements because different development, regulatory and commercial approaches required certain terms of the agreements to be structured differently, rather than because the Company or the counterparties considered the agreements to be fundamentally separate negotiations. Accordingly, as the agreements are being accounted for as a single arrangement, upfront and other non-contingent consideration received and to be received has been and will be pooled together and allocated to each of the performance obligations in both the U.S./RoW Agreement and China Agreement based on their relative SSPs. For each of the AstraZeneca agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundled services that are distinct. Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual promised services. There are no right-of-return provisions for the delivered items in the AstraZeneca agreements. As of December 31, 2019, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $114.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $598.8 million of variable consideration related to co-development billings. For the AstraZeneca agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings. Co-development billings under the U.S./RoW Agreement were allocated entirely to the U.S./RoW co-development services performance obligation, and co-development billings under the China Agreement were allocated entirely to the combined performance obligation under the China Agreement. For revenue recognition purposes, the Company determined that the term of its collaboration agreements with AstraZeneca begin on the effective date and ends upon the completion of all performance obligations contained in the agreements. The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the requirement to continue funding development for a substantive period of time and the loss of product rights, along with non-refundable upfront payments already remitted by AstraZeneca, represent substantive termination penalties that create significant disincentive for AstraZeneca to exercise its right to terminate the agreement. For the technology license under the AstraZeneca U.S./RoW Agreement, SSP was determined based on a two-step process. The first step involved determining an implied royalty rate that would result in the net present value of future cash flows to equal to zero (i.e. where the implied royalty rate on the transaction would equal the target return for the investment). This results in an upper bound estimation of the magnitude of royalties that a hypothetical acquirer would reasonably pay for the forecasted cash flow stream. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. The second step involved applying the implied royalty rate, which was determined to be 40%, against the probability-adjusted projected net revenues by territory and determining the value of the license as the net present value of future cash flows after adjusting for taxes. The discount rate utilized was 17.5%. U.S./RoW Agreement: The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: (1) License to the Company’s technology existing at the effective date of the agreements. For the U.S./RoW Agreement, the license was delivered at the beginning of the agreement term. The Company concluded that AstraZeneca has the knowledge and capabilities to fully exploit the license under the U.S./RoW Agreement without the Company’s further involvement. Finally, the Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. Therefore, the Company has concluded that the license is distinct and represents a performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to AstraZeneca. (2) Co-development services. This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Revenue is recognized over time based on progress toward complete satisfaction of the performance obligation. The Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred. Co-development services are expected to continue over the development period that is currently estimated to continue through the end of 2020. In addition, the Company concluded that the addition of the new indications related to CIA, ACI and MM approved during the fourth quarter of 2018 represents a modification to the collaboration agreements and will be accounted for separately, for which the joint development service period is estimated to continue through the end of 2024. (3) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period. (4) Information sharing and committee service. These promises are satisfied throughout the course |
Product Revenue | Product Revenue, Net Years Ended December 31, 2019 2018 (dollars in thousands) Product revenue, net: API product $ (36,324 ) $ 64,776 Drug product Gross revenue 2,803 — Price adjustment (936 ) — Sales rebates and other discounts (167 ) — Drug product revenue, net 1,700 — Total product revenue, net $ (34,624 ) $ 64,776 As described above, the Japan Amendment obligates Astellas to purchase API from the Company to conduct commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. The Company fulfilled all the delivery obligations under the term of the Japan Amendment during the year ended December 31, 2018, and recognized the related product revenue of $64.8 million in the same period In addition, the Company started commercial sales of roxadustat drug product in China in the third quarter of 2019. Drug 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 price adjustment, contractual sales rebate and other discounts. For the year ended December 31, 2019, a $0.9 million of price adjustment was recorded based on government-listed price guidance and estimated channel inventory levels. The contractual sales rebate and other discounts were immaterial for the year ended December 31, 2019. |
Other Revenues | Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for each of the three years ended December 31, 2019. |
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 December 31, 2018, such deferred revenue was included in long-term deferred revenue. As of December 31, 2019, following receipt of the Chinese Good Manufacturing Practices license by FibroGen Beijing in the second quarter of 2019, approximately $0.8 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, as a result of the transfer of control of commercial drug product in China. |
Fair Value Measurements | Fair Value Measurements In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis. The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements. The guidance also requires fair value measurements be classified and disclosed in one of the following three categories: Level 1 : Quoted prices in active markets for identical assets or liabilities. Level 2 : Observable inputs other than quoted prices in active markets for identical assets or liabilities. Level 3 : Unobservable inputs. The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs. The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2). The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The availability of observable data is monitored to assess classification of financial instruments within the fair value hierarchy. Depending upon the availability of such inputs, specific securities may transfer between levels. In such instances, the transfer is reported at the end of the reporting period. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policy [Line Items] | |
Schedule of Significant Balance of Accounts Receivable | The Company has not experienced any loss on its deposits of cash and cash equivalents. Included in current assets are significant balances of accounts receivable as follows: December 31, 2019 2018 Astellas Pharma Inc. (“Astellas”)—Related party 17 % 74 % AstraZeneca AB (“AstraZeneca”) 81 % 26 % |
ASU 2016-02 [Member] | |
Accounting Policy [Line Items] | |
Schedule of Impacts Upon Adoption of New Guidance | The impacts to the select line items from the Company’s consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands): Balance Sheet Line Item Nature of Adjustment New Lease Guidance Adoption Adjustment Assets Property and equipment, net Derecognition - build-to-suit lease assets - building shell, cost $ (53,880 ) Derecognition - build-to-suit lease assets - building shell, accumulated depreciation 13,476 Change of useful life - leasehold improvements, accumulated depreciation (38,877 ) Finance lease right-of-use assets Recognition - finance lease ROU assets 49,597 Other assets Recognition - operating lease ROU assets 730 Liabilities Accrued and other current liabilities Derecognition - deferred rent, current (619 ) Derecognition - build-to-suit lease liabilities, current (545 ) Recognition - operating lease liabilities, current 404 Finance lease liabilities, current Recognition - finance lease liabilities, current 11,499 Long-term portion of lease obligations Derecognition - build-to-suit lease liabilities, non-current (95,613 ) Deferred rent Derecognition - deferred rent, non-current (3,038 ) Finance lease liabilities, non-current Recognition - finance lease liabilities, non-current 49,884 Other long-term liabilities Recognition - operating lease liabilities, non-current 250 Stockholders’ equity Accumulated deficit Cumulative decrease to accumulated deficit $ 8,688 |
ASU 2018-02 [Member] | |
Accounting Policy [Line Items] | |
Schedule of Impacts Upon Adoption of New Guidance | The impacts, based on the aggregate portfolio approach, to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands): Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2018 $ (2,281 ) $ (715,827 ) Impact of change in accounting principle upon adoption of ASU 2018-02 611 (611 ) Opening balance as of January 1, 2019 $ (1,670 ) $ (716,438 ) |
ASU 2016-01 [Member] | |
Accounting Policy [Line Items] | |
Schedule of Impacts Upon Adoption of New Guidance | The impacts to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands): Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2017 $ (1,795 ) $ (630,657 ) Impact of change in accounting principle upon adoption of ASU 2016-01 (1,250 ) 1,250 Opening balance as of January 1, 2018 $ (3,045 ) $ (629,407 ) |
Collaboration Agreements and _2
Collaboration Agreements and Revenues (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | Product Revenue, Net Years Ended December 31, 2019 2018 (dollars in thousands) Product revenue, net: API product $ (36,324 ) $ 64,776 Drug product Gross revenue 2,803 — Price adjustment (936 ) — Sales rebates and other discounts (167 ) — Drug product revenue, net 1,700 — Total product revenue, net $ (34,624 ) $ 64,776 |
Japan [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement with Astellas were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2019 2018 2017 Japan License revenue $ 11,935 $ 14,323 $ — Development revenue $ 1,222 $ 2,400 $ 1,588 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through December 31, 2019 Deferred Revenue at December 31, 2019 Total Consideration Through December 31, 2019 License $ 86,024 $ — $ 86,024 Development revenue 15,130 375 15,505 Total license and development revenue $ 101,154 $ 375 $ 101,529 |
Europe [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement with Astellas were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2019 2018 2017 Europe License revenue $ 117,470 $ — $ — Development revenue $ 28,172 $ 18,503 $ 18,523 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through December 31, 2019 Deferred Revenue at December 31, 2019 Total Consideration Through December 31, 2019 License $ 487,951 $ — $ 487,951 Development revenue 231,008 4,790 235,798 Total license and development revenue $ 718,959 $ 4,790 * $ 723,749 * Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the condensed consolidated balance sheets. As of December 31, 2019, prepaid expenses and other current assets included a net unbilled contract asset of $125.2 million related to the Europe Agreement, which represents the net of the above-mentioned unbilled contract asset of $130.0 million, and $4.8 million of deferred revenue presented above. |
U.S./RoW and China [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW and China Agreements with AstraZeneca were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2019 2018 2017 U.S. / RoW and China License revenue $ 47,681 $ 7,946 $ 9,933 Development revenue 84,629 104,970 100,928 China performance obligation $ 90 $ — $ — |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through December 31, 2019 Deferred Revenue at December 31, 2019 Total Consideration Through December 31, 2019 License $ 341,844 $ — $ 341,844 Co-development, information sharing & committee services 493,266 8,452 501,718 China performance obligation 90 140,872 140,962 Total license and development revenue $ 835,200 $ 149,324 * $ 984,524 * Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the condensed consolidated balance sheets. As of December 31, 2019, long-term deferred revenue included $99.3 million related to the U.S./RoW and China Agreement, which represents the net of $149.3 million of deferred revenue presented above and the above-mentioned $50.0 million unbilled contract asset. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): December 31, 2019 Level 1 Level 2 Level 3 Total US 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 December 31, 2018 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 292,317 $ 224,953 $ — $ 517,270 Bond and mutual funds 10,484 — — 10,484 Equity investments 234 — — 234 Money market funds 541 — — 541 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,910 — 29,910 Total $ 303,576 $ 334,863 $ — $ 638,439 |
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): December 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,544 $ 1,544 December 31, 2018 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 98,105 $ 98,105 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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 December 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,909 Accumulated amortization (10,307 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 39,602 Operating: Right-of-use assets - cost 2,736 Accumulated amortization (805 ) Operating lease right-of-use assets, net Other assets 1,931 Total lease assets $ 41,533 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 12,351 Operating lease liabilities Accrued and other current liabilities 983 Non-current: Finance lease liabilities Finance lease liabilities, non-current 37,610 Operating lease liabilities Other long-term liabilities 942 Total lease liabilities $ 51,886 |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Statement of Operations Line Item Year Ended December 31, 2019 Finance lease cost: Amortization of right-of-use assets Research and development, Selling, general and administrative expenses $ 10,307 Interest on lease liabilities Interest expense 2,373 Operating lease cost Research and development, Selling, general and administrative expenses 891 Sublease income Selling, general and administrative expenses (1,385 ) Total lease cost $ 12,186 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Year Ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 914 Operating cash flows from finance leases 2,196 Financing cash flows from finance leases 11,925 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 49,909 Operating leases $ 2,736 |
Schedule of Lease Term and Discount Rate | Lease term and discount rate were as follows at December 31, 2019: December 31, 2019 Weighted-average remaining lease term (years): Finance leases 3.6 Operating leases 2.1 Weighted-average discount rate: Finance leases 4.42 % Operating leases 4.75 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities are as follows: Year Ending Finance Leases Operating Leases 2020 $ 14,078 $ 1,043 2021 13,676 668 2022 13,878 307 2023 12,523 — Total future lease payments 54,155 2,018 Less: Interest (4,194 ) (93 ) Present value of lease liabilities $ 49,961 $ 1,925 |
Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations | Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands): Year Ending Operating Leases 2019 $ 444 2020 232 2021 25 2022 16 2023 — Total minimum payments $ 717 |
Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations | Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands): Year Ending Lease financing obligations 2019 $ 14,379 2020 14,664 2021 14,179 2022 14,335 2023 12,872 Total minimum payments $ 70,429 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): December 31, 2019 2018 Cash $ 40,715 $ 38,783 US treasury notes and bills — 49,934 Money market funds 85,551 541 Total cash and cash equivalents $ 126,266 $ 89,258 |
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): December 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US 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 December 31, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 467,296 $ 109 $ (69 ) $ 467,336 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (90 ) 29,910 Bond and mutual funds 10,464 20 — 10,484 Equity investments 125 109 — 234 Total investments $ 587,885 $ 238 $ (159 ) $ 587,964 |
Summary of Contractual Maturities Available-for-Sale Investments and Term Deposit | The contractual maturities of the available-for-sale investments and term deposit were as follows (in thousands): December 31, 2019 Within one year $ 407,491 After one year through four years 50,047 Total debt investments 457,538 Bond and mutual funds 10,816 Equity investments 255 Total investments $ 468,609 |
Schedule of Inventory | Inventories consisted of the following (in thousands): December 31, 2019 Raw materials $ 325 Work-in-progress 2,264 Finished goods 4,298 Total inventories $ 6,887 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2019 2018 Unbilled contract assets $ 180,000 $ — Deferred revenues from associated contracts (54,790 ) — Net unbilled contract assets 125,210 — Prepaid assets 6,464 2,705 Other current assets 1,717 2,224 Total prepaid expenses and other current assets $ 133,391 $ 4,929 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2019 2018 Leasehold improvements $ 101,548 $ 101,200 Building shell — 53,880 Laboratory equipment 17,329 16,405 Machinery 8,217 8,382 Computer equipment 8,399 6,473 Furniture and fixtures 5,822 5,690 Construction in progress 1,792 367 Total property and equipment $ 143,107 $ 192,397 Less: accumulated depreciation (100,364 ) (65,199 ) Property and equipment, net $ 42,743 $ 127,198 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2019 2018 Preclinical and clinical trial accruals $ 16,279 $ 35,413 API product price adjustment 36,324 — Payroll and related accruals 19,784 21,430 Property taxes and other 2,044 1,095 Professional services 4,842 2,648 Other 4,543 5,537 Total accrued liabilities $ 83,816 $ 66,123 |
Schedule of Other Long-term Liabilities | Other long-term liabilities consisted of the following (in thousands): December 31, 2019 2018 Accrued long-term co-promotional expenses $ 53,071 $ — Other long-term tax liabilities 8,913 8,138 Operating lease liabilities, non-current 942 — Other 1,340 1,855 Total other long-term liabilities $ 64,266 $ 9,993 |
Equity and Stock-based Compen_2
Equity and Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | Shares of Common Stock outstanding, shares of stock plans outstanding and shares reserved for future issuance related to stock options and RSU grants and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2019 2018 Common stock outstanding 87,657 85,432 Stock options outstanding 10,018 10,430 RSUs outstanding 1,483 1,428 Common stock warrants outstanding — 4 Shares reserved for future stock options and RSUs grant 7,725 6,041 Shares reserved for future ESPP offering 3,337 2,618 Total shares of common stock reserved 110,220 105,953 |
Summary of Stock Option Transactions | Stock option transactions, including forfeited options granted under the 2014 Plan as well as prior plans, are summarized below: Shares (In thousands) Weighted Average Exercise per Share Weighted Average Remaining Contractual Life (In Years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2018 10,430 $ 20.25 Granted 1,909 53.75 Exercised (1,642 ) 10.15 Expired (21 ) 50.40 Forfeited (658 ) 44.65 Outstanding at December 31, 2019 10,018 26.63 5.17 $ 193,226 Vested and expected to vest, December 31, 2019 10,018 26.63 5.17 193,226 Exercisable at December 31, 2019 7,318 $ 18.63 3.89 $ 183,707 |
Summary of RSU Activity | The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2018 1,428 $ 38.26 Granted 1,110 54.74 Vested (715 ) 37.71 Forfeited (340 ) 46.15 Unvested at December 31, 2019 1,483 $ 49.05 |
Schedule of Allocated Stock-Based Compensation Expense | Stock-based compensation expense allocated to research and development and selling, general and administrative expense for the years ended December 31, 2019, 2018 and 2017 was as follows (in thousands): Years Ended December 31, 2019 2018 2017 Research and development $ 41,015 $ 30,491 $ 21,807 Selling, general and administrative 25,252 21,651 15,732 Total stock-based compensation expense $ 66,267 $ 52,142 $ 37,539 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Employee Stock Purchase Plans | The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows: Years Ended December 31, 2019 2018 2017 Stock Options Expected term (in years) 5.3 5.4 5.7 Expected volatility 68.0 % 67.9 % 71.5 % Risk-free interest rate 2.4 % 2.7 % 2.2 % Expected dividend yield — — — Weighted average estimated fair value $ 31.98 $ 32.12 $ 16.96 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 48.1 - 62.1 % 47.3 - 75.3 % 52.8 - 77.2 % Risk-free interest rate 1.3 - 2.9 % 0.8 - 2.9 % 0.5 - 1.6 % Expected dividend yield — — — Weighted average estimated fair value $ 19.27 $ 16.27 $ 9.41 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Weighted Impacts of Outstanding Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following weighted impacts of outstanding securities were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the three years presented (in thousands): Years Ended December 31, 2019 2018 2017 Employee stock options 7,602 7,815 8,936 RSUs 1,187 820 799 ESPP 260 195 206 Warrants 1 4 4 9,050 8,834 9,945 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Loss Before Income Taxes | The components of loss before income taxes are as follows (in thousands): Years Ended December 31, 2019 2018 2017 Domestic $ 2,538 $ (38,472 ) $ (80,735 ) Foreign (79,180 ) (47,644 ) (39,819 ) Loss before provision for income taxes $ (76,642 ) $ (86,116 ) $ (120,554 ) |
Schedule of Components of Provision For Income Taxes | The provision for income taxes consists of the following (in thousands): Years Ended December 31, 2019 2018 2017 Current: Federal $ — $ — $ — State — 2 2 Foreign 328 302 319 Total current 328 304 321 Deferred: Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 328 $ 304 $ 321 |
Schedule of Reconciliation Between Statutory Federal Income Tax Rate and Effective Tax Rate | The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate: Years Ended December 31, 2019 2018 2017 Tax at statutory federal rate 21.0 % 21.0 % 34.0 % State tax — % — % — % Stock-based compensation expense 6.3 % 14.5 % 18.5 % Change in deferred tax assets due to rate change — % — % 43.9 % Change in valuation allowance due to rate change — % — % (43.9 )% Net operating losses not benefitted (2.9 )% (23.2 )% (43.8 )% Foreign net operating losses not benefitted (21.7 )% (11.6 )% (6.7 )% Orphan drug credit — % — % (2.0 )% Deduction limitation on executive compensation (2.5 )% (0.5 )% — % Other (0.6 )% (0.6 )% (0.3 )% Total (0.4 )% (0.4 )% (0.3 )% |
Schedule of Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2019 2018 Federal and state net operating loss carryforwards $ 91,267 $ 91,683 Tax credit carryforwards 52,243 45,885 Foreign net operating loss carryforwards 37,786 21,295 Stock-based compensation 11,159 9,281 Lease obligations 10,698 2,511 Reserves and accruals 5,353 6,072 Deferred revenue 13,323 16,454 Fixed assets — 356 Other 284 450 Subtotal 222,113 193,987 Less: Valuation allowance (213,847 ) (193,987 ) Net deferred tax assets 8,266 — Fixed assets (8,266 ) — Other — — Net deferred tax liabilities (8,266 ) — Total net deferred tax assets $ — $ — |
Schedule of Reconciliation of the Beginning and Ending Amounts of Unrecognized Income Tax Benefits | A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2019 is as follows (in thousands): Federal Balance as of December 31, 2016 $ 19,654 Increase due to prior positions 303 Increase due to current year position 5,448 Decrease due to U.S. tax rate change (2,044 ) Balance as of December 31, 2017 23,361 Increase due to prior positions 379 Increase due to current year position 4,216 Balance as of December 31, 2018 27,956 Decrease due to prior positions (111 ) Increase due to current year position 4,418 Balance as of December 31, 2019 $ 32,263 |
Segment and Geographic Inform_2
Segment and Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Schedule of Revenue by Geographic Area | Geographic revenues, which are based on the bill-to region, are as follows (in thousands): Years Ended December 31, 2019 2018 2017 Europe $ 132,400 $ 112,916 $ 110,861 Japan (related party) 122,475 100,002 20,111 All other 1,702 40 24 Total revenue $ 256,577 $ 212,958 $ 130,996 |
Schedule of Long Lived Assets by Geographic Area | Property and equipment, net by geographic location are as follows (in thousands): December 31, 2019 2018 United States $ 27,325 $ 103,539 China 15,418 23,659 Total property and equipment $ 42,743 $ 127,198 |
Summary of Finance and Operating Lease Right of Use Assets by Geographical Location | Finance lease right-of-use assets and operating lease right-of-use assets, net by geographic location are as follows (in thousands): December 31, 2019 2018 United States $ 39,237 $ — China 365 — Total finance lease right-of-use assets $ 39,602 $ — United States $ 75 $ — China 1,856 — Total operating lease right-of-use assets $ 1,931 $ — |
Schedule of Customer Concentration by Collaboration Partners | Substantially all of the Company’s revenues to date have been generated from the following collaboration partners that respectively accounted for 10% or more of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2019 2018 2017 2019 2018 Astellas—Related party 48 % 47 % 15 % 17 % 74 % AstraZeneca 52 % 53 % 85 % 81 % 26 % |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Nov. 30, 2018USD ($) | Dec. 31, 2019USD ($)Segment | Dec. 31, 2018USD ($) | Dec. 31, 2017 |
Accounting Policy [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Highly liquid investment maturity period | three months or less | |||
Restricted time deposits | $ 2,072,000 | $ 4,145,000 | ||
Cash and cash equivalents | $ 126,266,000 | $ 89,258,000 | ||
Short term investments maturity | 12 months | |||
Long term Investments Maturity | 12 months | |||
Impairment of long-lived assets | $ 0 | |||
U.S. federal statutory income tax rate | 21.00% | 21.00% | 34.00% | |
Japan [Member] | Astellas Agreement [Member] | ||||
Accounting Policy [Line Items] | ||||
Difference in estimated and actual listed price | $ 36,300,000 | $ 36,300,000 | ||
U.S. federal statutory income tax rate | 21.00% | 35.00% | ||
Minimum [Member] | Computer Equipment [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 3 years | |||
Minimum [Member] | Laboratory Equipment [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 3 years | |||
Minimum [Member] | Machinery [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 3 years | |||
Minimum [Member] | Furniture and Fixtures [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 3 years | |||
Maximum [Member] | ||||
Accounting Policy [Line Items] | ||||
U.S. federal statutory income tax rate | 35.00% | |||
Maximum [Member] | Computer Equipment [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 5 years | |||
Maximum [Member] | Laboratory Equipment [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 5 years | |||
Maximum [Member] | Machinery [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 5 years | |||
Maximum [Member] | Furniture and Fixtures [Member] | ||||
Accounting Policy [Line Items] | ||||
Property and equipment estimated useful life | 5 years | |||
Foreign subsidiaries [Member] | ||||
Accounting Policy [Line Items] | ||||
Cash and cash equivalents | $ 11,900,000 | $ 21,900,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Significant Balance of Accounts Receivable (Detail) - Accounts Receivable [Member] - Credit Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Astellas Agreement [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 17.00% | 74.00% |
AstraZeneca Agreements [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 81.00% | 26.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Impacts to Consolidated Balance Sheet Upon Adoption of 842 Guidance (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Assets | |||
Property and equipment, net | $ 42,743 | $ 127,198 | |
Finance lease right-of-use assets | 39,602 | 0 | |
Liabilities, stockholders’ equity and non-controlling interests | |||
Finance lease liabilities, current | 12,351 | 0 | |
Deferred rent | 3,038 | ||
Finance lease liabilities, non-current | 37,610 | 0 | |
Accumulated deficit | (784,720) | $ (715,827) | $ (630,657) |
Derecognition Build to Suit Lease Assets [Member] | Building Shell [Member] | |||
Assets | |||
Property and equipment, net | (53,880) | ||
Derecognition Build to Suit Lease Assets Accumulated Depreciation [Member] | Building Shell [Member] | |||
Assets | |||
Property and equipment, net | 13,476 | ||
Leasehold Improvements Accumulated Depreciation [Member] | |||
Assets | |||
Property and equipment, net | (38,877) | ||
Recognition Finance Lease Assets [Member] | |||
Assets | |||
Finance lease right-of-use assets | 49,597 | ||
Recognition Operating Lease Assets [Member] | |||
Assets | |||
Other assets | 730 | ||
Derecognition Deferred Rent Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Accrued and other current liabilities | (619) | ||
Derecognition Build to Suit Lease Liabilities Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Accrued and other current liabilities | (545) | ||
Recognition Operating Lease Liabilities Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Accrued and other current liabilities | 404 | ||
Recognition Finance Lease Liabilities Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Finance lease liabilities, current | 11,499 | ||
Derecognition Build to Suit Lease Liabilities Non Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Long-term portion of lease obligations | (95,613) | ||
Derecognition Deferred Rent Non Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Deferred rent | (3,038) | ||
Recognition Finance Lease Liabilities Non Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Finance lease liabilities, non-current | 49,884 | ||
Recognition Operating Lease Liabilities Non Current [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Other long-term liabilities | 250 | ||
Cumulative Decrease to Accumulated Deficit [Member] | |||
Liabilities, stockholders’ equity and non-controlling interests | |||
Accumulated deficit | $ 8,688 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Impacts to Accumulated Other Comprehensive Loss and Accumulated Deficit Upon Adoption of Guidance (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | $ (747) | $ (2,281) | $ (1,795) | ||
Accumulated deficit | $ (784,720) | $ (715,827) | $ (630,657) | ||
ASU 2018-02 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | $ (1,670) | ||||
Accumulated deficit | (716,438) | ||||
ASU 2016-01 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | $ (3,045) | ||||
Accumulated deficit | (629,407) | ||||
Impact of change in accounting principle upon adoption of ASU 2018-02 [Member] | ASU 2018-02 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | 611 | ||||
Accumulated deficit | $ (611) | ||||
Impact of change in accounting principle upon adoption of ASU 2016-01 [Member] | ASU 2016-01 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | (1,250) | ||||
Accumulated deficit | $ 1,250 |
Collaboration Agreements and _3
Collaboration Agreements and Revenues - Astellas Agreements - Additional Information (Detail) - USD ($) $ in Thousands | Nov. 30, 2018 | Sep. 30, 2019 | Dec. 31, 2018 | Apr. 30, 2006 | Jun. 30, 2005 | Jun. 30, 2018 | Dec. 31, 2019 | Feb. 28, 2009 | Feb. 28, 2009 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Unbilled contract asset | $ 0 | $ 180,000 | |||||||
Europe [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Unbilled contract asset | $ 130,000 | ||||||||
Astellas Agreement [Member] | Japan [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront, non-contingent and time-based payments received | $ 40,100 | ||||||||
Potential milestone payments | $ 12,500 | $ 132,500 | |||||||
Commercial sales milestone | 15,000 | ||||||||
Additional consideration based on net sales description | low 20% range | ||||||||
Aggregate consideration received | $ 90,100 | ||||||||
Transaction price and allocated to performance obligations | $ 12,500 | ||||||||
Consideration associated with milestone included in transaction price | $ 15,000 | ||||||||
Contract with customer, liability, revenue recognized | $ 43,900 | $ 20,900 | |||||||
Difference in estimated and actual listed price | $ 36,300 | $ 36,300 | |||||||
Astellas Agreement [Member] | Japan [Member] | Clinical and Development Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | 22,500 | ||||||||
Astellas Agreement [Member] | Japan [Member] | Regulatory Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 95,000 | ||||||||
Astellas Agreement [Member] | Europe [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront, non-contingent and time-based payments received | $ 320,000 | ||||||||
Additional consideration based on net sales description | low 20% range | ||||||||
Aggregate consideration received | $ 410,000 | ||||||||
Transaction price and allocated to performance obligations | 130,000 | ||||||||
Development and regulatory approval milestones | $ 425,000 | ||||||||
Percentage of joint development costs committed to fund | 50.00% | ||||||||
Revenue during period from performance obligations | 128,800 | ||||||||
Unbilled contract asset | $ 130,000 | ||||||||
Estimated joint development extended service period | 2023 | ||||||||
Astellas Agreement [Member] | Europe [Member] | Clinical and Development Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 90,000 | ||||||||
Astellas Agreement [Member] | Europe [Member] | Regulatory Milestone [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | $ 335,000 |
Collaboration Agreements and _4
Collaboration Agreements and Revenues - AstraZeneca Agreements - Additional Information 1 (Detail) - USD ($) $ in Thousands | Dec. 29, 2018 | Dec. 17, 2018 | Jul. 30, 2013 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2015 | 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 | ||||||
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 | $ 389,000 | ||||||
Shared development costs | $ 233,000 | ||||||
Additional consideration based on net sales description | low 20% range | ||||||
Unbilled contract asset | $ 50,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | FibroGen, Inc. [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Shared development costs | 116,500 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Clinical and Development Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 65,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Regulatory Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 325,000 | ||||||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | Deferred Approval Milestone [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 160,000 | ||||||
AstraZeneca Agreements [Member] | 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] | China [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payments | 348,500 | 22,000 | |||||
Aggregate consideration received | 55,200 | ||||||
Proceeds from upfront, non-contingent and non-refundable payments | 28,200 | ||||||
Commercial sales and other events milestone | 187,500 | ||||||
Contract with customer, liability, revenue recognized | $ 18,700 | ||||||
Estimated joint development extended service period | 2024 | ||||||
Milestone payment, revenue recognition | $ 6,000 | $ 6,000 | $ 12,000 | $ 9,900 | |||
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 - Accounting for the Astellas Agreements - Additional Information 2 (Detail) | 12 Months Ended | ||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 256,577,000 | $ 212,958,000 | $ 130,996,000 |
Astellas Agreement [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Co-development services, currently estimated continuation year | 2023 | ||
Astellas Agreement [Member] | Manufacturing Commercial Supplies of Products [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 0 | ||
Astellas Agreement [Member] | Minimum [Member] | Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Discount rate applied | 17.5 | ||
Astellas Agreement [Member] | Maximum [Member] | Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Discount rate applied | 20 | ||
Astellas Agreement [Member] | Japan [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Non-contingent upfront payments received | $ 40,100,000 | ||
Variable consideration related to payments for milestones considered probable of being achieved | 50,000,000 | ||
Variable consideration related to co-development billings | 11,400,000 | ||
Provision for co-development services | 0 | ||
Astellas Agreement [Member] | Europe [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Non-contingent upfront payments received | 320,000,000 | ||
Variable consideration related to payments for milestones considered probable of being achieved | 220,000,000 | ||
Variable consideration related to co-development billings | $ 229,200,000 |
Collaboration Agreements and _6
Collaboration Agreements and Revenues - Accounting for the AstraZeneca Agreements - Additional Information 3 (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 256,577,000 | $ 212,958,000 | $ 130,996,000 |
AstraZeneca Agreements [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Royalty rate against projected net revenues | 40.00% | ||
Co-development services, currently estimated continuation year | 2024 | ||
AstraZeneca Agreements [Member] | Manufacturing Commercial Supplies of Products [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 0 | ||
AstraZeneca Agreements [Member] | Measurement Input Discount Rate [Member] | Discounted Cash Flow [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Discount rate applied | 17.5 | ||
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Non-contingent upfront payments received | $ 402,200,000 | ||
Variable consideration related to payments for milestones considered probable of being achieved | 114,000,000 | ||
Variable consideration related to co-development billings | $ 598,800,000 |
Collaboration Agreements and _7
Collaboration Agreements and Revenues - Summary of Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | $ 256,577 | $ 212,958 | $ 130,996 |
License Revenue [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 177,086 | 22,269 | 9,933 |
Development Revenue [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 114,115 | 125,913 | 121,063 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 11,935 | 14,323 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 117,470 | 0 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 1,222 | 2,400 | 1,588 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 28,172 | 18,503 | 18,523 |
AstraZeneca Agreements [Member] | China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 90 | 0 | 0 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 47,681 | 7,946 | 9,933 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | $ 84,629 | $ 104,970 | $ 100,928 |
Collaboration Agreements and _8
Collaboration Agreements and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Revenue | $ 54,790 | $ 0 |
Astellas Agreement [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 101,154 | |
Deferred Revenue | 375 | |
Total Consideration | 101,529 | |
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] | Japan [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 15,130 | |
Deferred Revenue | 375 | |
Total Consideration | 15,505 | |
Astellas Agreement [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 718,959 | |
Deferred Revenue | 4,790 | |
Total Consideration | 723,749 | |
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 | |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 231,008 | |
Deferred Revenue | 4,790 | |
Total Consideration | 235,798 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 835,200 | |
Deferred Revenue | 149,324 | |
Total Consideration | 984,524 | |
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 | 493,266 | |
Deferred Revenue | 8,452 | |
Total Consideration | 501,718 | |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Cumulative Revenue | 90 | |
Deferred Revenue | 140,872 | |
Total Consideration | $ 140,962 |
Collaboration Agreements and _9
Collaboration Agreements and Revenues - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
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 | 12,100,000 |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | 45,400,000 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 124,700,000 |
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 | 130,400,000 |
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | $ 62,600,000 |
Collaboration Agreements and_10
Collaboration Agreements and Revenues - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Parenthetical) (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Unbilled contract asset | $ 180,000 | $ 0 |
Deferred revenue | 54,790 | 0 |
Net unbilled contract asset | 125,210 | 0 |
Long-term deferred revenue | 99,449 | $ 136,109 |
Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Unbilled contract asset | 130,000 | |
Astellas Agreement [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Unbilled contract asset | 130,000 | |
Deferred revenue | 4,790 | |
Astellas Agreement [Member] | Europe [Member] | Prepaid Expenses and Other Current Assets [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Net unbilled contract asset | 125,200 | |
AstraZeneca Agreements [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Unbilled contract asset | 50,000 | |
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Unbilled contract asset | 50,000 | |
Deferred revenue | 149,300 | |
Net unbilled contract asset | 50,000 | |
Long-term deferred revenue | $ 99,300 |
Collaboration Agreements and_11
Collaboration Agreements and Revenues - Summary of Product Revenue, Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation Of Revenue [Line Items] | |||
Total product revenue, net | $ 256,577 | $ 212,958 | $ 130,996 |
API Product [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue, net | (36,324) | 64,776 | |
Drug Product [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue, net | 1,700 | 0 | |
Gross revenue | 2,803 | 0 | |
Price adjustment | (936) | 0 | |
Sales rebates and other discounts | (167) | 0 | |
Product Revenue [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue, net | $ (34,624) | $ 64,776 | $ 0 |
Collaboration Agreements and_12
Collaboration Agreements and Revenues - Product Revenue - Additional Information 5 (Detail) - Astellas Agreement [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Contract with customer, liability, revenue recognized | $ 43.9 | $ 20.9 | ||
Product Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Contract with customer, liability, revenue recognized | $ 64.8 | |||
Change in estimated variable consideration | $ 36.3 | |||
Roxadustat Drug [Member] | China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Amount adjusted based on government listed price and estimated channel inventory levels | $ 0.9 |
Collaboration Agreements and_13
Collaboration Agreements and Revenues - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 54,790 | $ 0 |
AstraZeneca Agreements [Member] | China [Member] | ||
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 800 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 468,609 | $ 587,964 |
US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 427,506 | 467,336 |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,816 | 10,484 |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 255 | 234 |
Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | |
Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,032 | 29,910 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 554,160 | 638,439 |
Fair Value, Measurements, Recurring [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 427,506 | 517,270 |
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 | 10,484 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 255 | 234 |
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 | 85,551 | 541 |
Fair Value, Measurements, Recurring [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | |
Fair Value, Measurements, Recurring [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 30,032 | 29,910 |
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 | 444,005 | 303,576 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 347,383 | 292,317 |
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 | 10,484 |
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 | 255 | 234 |
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 | 85,551 | 541 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
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 | 110,155 | 334,863 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,123 | 224,953 |
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 | 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] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | |
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 | 30,032 | 29,910 |
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] | US 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 | 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] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 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 - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Transfers of assets from level 1 to 2 | $ 29,800,000 | $ 0 | $ 0 |
Transfers of assets from level 2 to 1 | 0 | 0 | |
Transfers of assets into level 3 | 0 | 0 | |
Transfers of assets out of level 3 | 0 | 0 | |
Transfers of liabilities from level 1 to 2 | 0 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 | 0 |
Transfers of liabilities out of level 3 | 0 | 0 | $ 0 |
Lease obligations [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Liabilities fair value disclosure | $ 1,544,000 | 98,105,000 | |
Lease obligations [Member] | Building [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Liabilities fair value disclosure | $ 96,200,000 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Values of Financial Liabilities Carried at Historical Cost (Detail) - Lease obligations [Member] - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,544 | $ 98,105 |
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 | $ 1,544 | $ 98,105 |
Leases - Additional Information
Leases - Additional Information (Detail) - Lease | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2013 | Dec. 31, 2006 | |
Minimum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 2 years | ||
Maximum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 4 years | ||
Shorenstein Properties LLC [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, finance lease, initial lease term | 15 years | ||
Lessee, finance lease, expiration period | 2023 | ||
Lessee, finance lease, option to extend the additional lease term | 10 years | ||
Lessee, finance lease, additional lease expiration period | 2033 | ||
Percentage increases on each anniversary of rent commencement date | 2.00% | ||
Lessee, finance lease, existence of option to extend | true | ||
Lessee, finance lease, option to extend | The Company has an option to extend the lease for an additional 10 years through 2033. | ||
Beijing Economic-Technological Development Area [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, finance lease, initial lease term | 8 years | ||
Lessee, finance lease, expiration period | 2021 | ||
Lessee, finance lease, existence of option to extend | false | ||
Building [Member] | |||
Lessee Lease Description [Line Items] | |||
Number of finance leases | 2 | ||
Number of operating leases | 7 | ||
Office Equipment [Member] | Minimum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 2 years | ||
Office Equipment [Member] | Maximum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 5 years |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
Right-of-use assets - cost | $ 49,909 | |
Accumulated amortization | (10,307) | |
Finance lease right-of-use assets, net | 39,602 | $ 0 |
Right-of-use assets - cost | 2,736 | |
Accumulated amortization | (805) | |
Operating lease right-of-use assets, net | 1,931 | 0 |
Total lease assets | 41,533 | |
Finance lease liabilities | 12,351 | 0 |
Operating lease liabilities | 983 | |
Finance lease liabilities | 37,610 | 0 |
Operating lease liabilities | 942 | $ 0 |
Total lease liabilities | $ 51,886 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Finance lease cost: | |||
Amortization of right-of-use assets | $ 10,307 | $ 0 | $ 0 |
Interest on lease liabilities | 2,373 | ||
Operating lease cost | 891 | ||
Sublease income | (1,385) | ||
Total lease cost | $ 12,186 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash paid for amounts included in the measurement of lease liabilities: | |||
Operating cash flows from operating leases | $ 914 | ||
Operating cash flows from finance leases | 2,196 | ||
Financing cash flows from finance leases | 11,925 | $ 0 | $ 0 |
Right-of-use assets obtained in exchange for new lease liabilities: | |||
Finance leases | 49,909 | ||
Operating leases | $ 2,736 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Dec. 31, 2019 |
Weighted-average remaining lease term (years): | |
Finance leases | 3 years 7 months 6 days |
Operating leases | 2 years 1 month 6 days |
Weighted-average discount rate: | |
Finance leases | 4.42% |
Operating leases | 4.75% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Dec. 31, 2019USD ($) |
Finance Leases | |
2020 | $ 14,078 |
2021 | 13,676 |
2022 | 13,878 |
2023 | 12,523 |
Total future lease payments | 54,155 |
Less: Interest | (4,194) |
Present value of lease liabilities | 49,961 |
Operating Leases | |
2020 | 1,043 |
2021 | 668 |
2022 | 307 |
2023 | 0 |
Total future lease payments | 2,018 |
Less: Interest | (93) |
Present value of lease liabilities | $ 1,925 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 444 |
2020 | 232 |
2021 | 25 |
2022 | 16 |
2023 | 0 |
Total minimum payments | $ 717 |
Leases - Schedule of Future M_2
Leases - Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 14,379 |
2020 | 14,664 |
2021 | 14,179 |
2022 | 14,335 |
2023 | 12,872 |
Total minimum payments | $ 70,429 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 40,715 | $ 38,783 |
US treasury notes and bills | 0 | 49,934 |
Money market funds | 85,551 | 541 |
Total cash and cash equivalents | $ 126,266 | $ 89,258 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 467,850 | $ 587,885 |
Gross Unrealized Holding Gains | 784 | 238 |
Gross Unrealized Holding Losses | (25) | (159) |
Fair Value | 468,609 | 587,964 |
US treasury notes and bills [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 426,995 | 467,296 |
Gross Unrealized Holding Gains | 536 | 109 |
Gross Unrealized Holding Losses | (25) | (69) |
Fair Value | 427,506 | 467,336 |
Term deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 80,000 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Fair Value | 80,000 | |
Certificate of deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,000 | 30,000 |
Gross Unrealized Holding Gains | 32 | 0 |
Gross Unrealized Holding Losses | 0 | (90) |
Fair Value | 30,032 | 29,910 |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,730 | 10,464 |
Gross Unrealized Holding Gains | 86 | 20 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 10,816 | 10,484 |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 125 |
Gross Unrealized Holding Gains | 130 | 109 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 255 | $ 234 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Contractual Maturities Available-for-Sale Investments and Term Deposit (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Available For Sale Securities Debt Maturities [Abstract] | ||
Within one year | $ 407,491 | |
After one year through four years | 50,047 | |
Total debt investments | 457,538 | |
Bond and mutual funds | 10,816 | |
Equity investments | 255 | |
Total investments | $ 468,609 | $ 587,964 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule Of Investments [Abstract] | ||
Raw materials | $ 325 | |
Work-in-progress | 2,264 | |
Finished goods | 4,298 | |
Total inventories | $ 6,887 | $ 0 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 180,000 | $ 0 |
Deferred revenues from associated contracts | (54,790) | 0 |
Net unbilled contract assets | 125,210 | 0 |
Prepaid assets | 6,464 | 2,705 |
Other current assets | 1,717 | 2,224 |
Total prepaid expenses and other current assets | $ 133,391 | $ 4,929 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019USD ($)Milestone | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | ||||
Number of regulatory milestones | Milestone | 2 | |||
Unbilled contract assets | $ 180,000 | $ 0 | ||
Building shell cost | 143,107 | 192,397 | ||
Accumulated depreciation | 100,364 | 65,199 | ||
Depreciation expense | 11,147 | 6,562 | $ 6,099 | |
API product price change in estimated variable consideration | 36,324 | 0 | ||
Accrued long-term co-promotional expenses | 53,071 | 0 | ||
Building shell [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Building shell cost | 0 | 53,880 | ||
Building [Member] | Build to suit arrangements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Accumulated depreciation | 13,500 | |||
Leasehold improvements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Building shell cost | 101,548 | $ 101,200 | ||
Leasehold improvements [Member] | Accounting standards update 2016-02 [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Accumulated depreciation | $ 38,900 | |||
Europe [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Unbilled contract assets | 130,000 | |||
Astellas Agreement [Member] | Europe [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Unbilled contract assets | 130,000 | |||
AstraZeneca Agreements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Unbilled contract assets | 50,000 | |||
Accrued long-term co-promotional expenses | 53,100 | |||
AstraZeneca Agreements [Member] | U.S./RoW [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Unbilled contract assets | $ 50,000 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 143,107 | $ 192,397 |
Less: accumulated depreciation | (100,364) | (65,199) |
Property and equipment, net | 42,743 | 127,198 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 101,548 | 101,200 |
Building shell [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 0 | 53,880 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 17,329 | 16,405 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,217 | 8,382 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,399 | 6,473 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 5,822 | 5,690 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,792 | $ 367 |
Balance Sheet Components - Sc_5
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 16,279 | $ 35,413 |
API product price adjustment | 36,324 | 0 |
Payroll and related accruals | 19,784 | 21,430 |
Property taxes and other | 2,044 | 1,095 |
Professional services | 4,842 | 2,648 |
Other | 4,543 | 5,537 |
Total accrued liabilities | $ 83,816 | $ 66,123 |
Balance Sheet Components - Sc_6
Balance Sheet Components - Schedule of Other Long-term Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Other Liabilities Noncurrent [Abstract] | ||
Accrued long-term co-promotional expenses | $ 53,071 | $ 0 |
Other long-term tax liabilities | 8,913 | 8,138 |
Operating lease liabilities | 942 | 0 |
Other | 1,340 | 1,855 |
Total other long-term liabilities | $ 64,266 | $ 9,993 |
Product Development Obligatio_2
Product Development Obligations - Additional Information (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2019USD ($)DevelopmentObligation | Dec. 31, 2018USD ($) | |
Debt Instrument [Line Items] | ||
Number of product development obligations | DevelopmentObligation | 11 | |
Accrued product development costs excluding interest | $ 10.6 | $ 10.8 |
Accrued Interest | $ 6.2 | $ 6 |
Bank of Finland Interest Rate [Member] | ||
Debt Instrument [Line Items] | ||
Percentage points deducted to reference rate to compute effective interest rate | 1.00% | |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate on product development advances | 3.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2006 | |
Commitments And Contingencies [Line Items] | |||
Restricted time deposits | $ 2,072 | $ 4,145 | |
Lease obligation liability | 1,925 | ||
Research and Pre-Clinical Stage Development Programs [Member] | |||
Commitments And Contingencies [Line Items] | |||
Maximum future milestone payments | 11,000 | ||
FibroGen, Inc. [Member] | |||
Commitments And Contingencies [Line Items] | |||
Restricted time deposits | $ 7,300 | ||
Prior period reclassification adjustment | $ 2,100 | ||
Description of lessee leasing arrangements, operating leases | The agreement also included an expansion option to occupy part of an adjacent building, for which the Company gave notice to its landlord that it would not exercise this expansion option | ||
Lease incentive receivable from land lord through expansion option not used | $ 5,000 | ||
Lease obligation liability | 1,500 | ||
FibroGen, Inc. [Member] | Accrued and Other Current Liabilities [Member] | |||
Commitments And Contingencies [Line Items] | |||
Lease obligation liability | 400 | ||
FibroGen, Inc. [Member] | Long Term Portion of Lease Obligations [Member] | |||
Commitments And Contingencies [Line Items] | |||
Lease obligation liability | $ 1,100 |
Equity and Stock-based Compen_3
Equity and Stock-based Compensation - Subsidiary Stock and Non-Controlling Interests - Additional information (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Nov. 19, 2014 | |
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 0 | 0 | |
IPO [Member] | |||
Class Of Stock [Line Items] | |||
Conversion rights, shares issued upon conversion of each preferred share | 958,996 | ||
FibroGen Europe [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 42,619,022 | 42,619,022 | |
Preferred stock redemption percentage | Redemption Right — If a Preferred Share can be redeemed by a majority shareholder owning more than ninety percent (90%) of the shares of FibroGen Europe in accordance with the provisions of the Finnish Limited Liability Companies Act, the minority holders of Preferred Shares have the right to request redemption of their shares. | ||
Minimum percentage of shareholder's approval to call for redemption of preferred shares | 90.00% | ||
Preferred stock, voting rights | one vote | ||
Conversion rights, shares issued upon conversion of each preferred share | 1 | ||
FibroGen Europe [Member] | Series A [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,700,845 | 1,700,845 | |
FibroGen Europe [Member] | Series B [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,875,000 | 1,875,000 | |
FibroGen Europe [Member] | Series C [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,599,503 | 1,599,503 | |
FibroGen Europe [Member] | Series D [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,520,141 | 1,520,141 | |
FibroGen Europe [Member] | Series E [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 459,565 | 459,565 | |
FibroGen Europe [Member] | Series F [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 5,714,332 | 5,714,332 | |
FibroGen Europe [Member] | Series G [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 9,927,500 | 9,927,500 | |
FibroGen Europe [Member] | Series H [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 19,822,136 | 19,822,136 | |
FibroGen China [Member] | |||
Class Of Stock [Line Items] | |||
Conversion rights, shares issued upon conversion of each preferred share | 1 | ||
FibroGen China [Member] | Series A [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares outstanding | 6,758,000 | 6,758,000 | |
Preferred shares issued, price per share | $ 1 | ||
Cash dividend percentage | 6.00% |
Equity and Stock-based Compen_4
Equity and Stock-based Compensation - Common Stock - Additional information (Detail) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Common stock voting rights | one vote |
Equity and Stock-based Compen_5
Equity and Stock-based Compensation - Summary of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2019 | Dec. 31, 2018 |
Class Of Stock [Line Items] | ||
Common stock outstanding | 87,657,000 | 85,432,000 |
Stock options outstanding | 10,018,000 | 10,430,000 |
RSUs outstanding | 1,483,000 | 1,428,000 |
Common stock warrants outstanding | 0 | 4,000 |
Shares reserved for future stock options and RSUs grant | 7,725,000 | 6,041,000 |
Total shares of common stock reserved | 110,220,000 | 105,953,000 |
ESPP [Member] | ||
Class Of Stock [Line Items] | ||
Shares reserved for future ESPP offering | 3,337,000 | 2,618,000 |
Equity and Stock-based Compen_6
Equity and Stock-based Compensation - Stock Plans - Additional information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total intrinsic value of options exercised | $ 183,707 | |||
RSUs released and issued net of shares withheld for taxes | 448,647 | |||
Weighted-average fair value of awards granted | $ 54.74 | $ 53.69 | $ 26.59 | |
2005 Stock Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period of stock options | 4 years | |||
2005 Stock Plan | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expiration period of stock options | 10 years | |||
2014 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period of stock options | 5 years | |||
Expiration period of stock options | 10 years | |||
Termination date of equity incentive plan | Nov. 12, 2024 | |||
Option vesting term | Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule (25% vesting on the first anniversary of the vesting base date and quarterly thereafter over the next 3 years). | |||
Number of common stock reserved for issuance | 7,724,691 | |||
Common stock reserved for future issuance, Description | Shares reserved for issuance increases on January 1 of each year commencing on January 1, 2016 and ending on January 1, 2024 by the lesser of (i) the amount equal to 4% of the number of shares issued and outstanding on December 31 immediately prior to the date of increase or (ii) such lower number of shares as may be determined by the board of directors. As of December 31, 2019, the Company has reserved 7,724,691 shares of its common stock that remains unissued for issuance under the 2014 Plan. | |||
Percentage of common stock reserved for future issuance | 4.00% | |||
Number of common stock repurchased | 0 | 0 | ||
Total intrinsic value of options exercised | $ 59,200 | $ 97,500 | $ 111,900 | |
2014 Equity Incentive Plan | First Anniversary [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of vesting rights | 25.00% | |||
2014 Equity Incentive Plan | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of fair value exercise price grant date | 100.00% |
Equity and Stock-based Compen_7
Equity and Stock-based Compensation - Stock Plans - Summary of Stock Option Transactions (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Outstanding, Beginning Balance, Shares | shares | 10,430 |
Granted, Shares | shares | 1,909 |
Exercised, Shares | shares | (1,642) |
Expired, Shares | shares | (21) |
Forfeited, Shares | shares | (658) |
Outstanding, Ending Balance, Shares | shares | 10,018 |
Vested and expected to vest, Shares | shares | 10,018 |
Exercisable, Shares | shares | 7,318 |
Outstanding, Beginning Balance, Weighted Average Exercise per Share | $ / shares | $ 20.25 |
Granted, Weighted Average Exercise per Share | $ / shares | 53.75 |
Exercised, Weighted Average Exercise per Share | $ / shares | 10.15 |
Expired, Weighted Average Exercise per Share | $ / shares | 50.40 |
Forfeited, Weighted Average Exercise per Share | $ / shares | 44.65 |
Outstanding, Ending Balance, Weighted Average Exercise per Share | $ / shares | 26.63 |
Vested and expected to vest, Weighted Average Exercise per Share | $ / shares | 26.63 |
Exercisable, Weighted Average Exercise per Share | $ / shares | $ 18.63 |
Outstanding, Weighted Average Remaining Contractual Life | 5 years 2 months 1 day |
Vested and expected to vest, Weighted Average Remaining Contractual Life | 5 years 2 months 1 day |
Exercisable, Weighted Average Remaining Contractual Life | 3 years 10 months 20 days |
Outstanding, Aggregate Intrinsic Value | $ | $ 193,226 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 193,226 |
Exercisable, Aggregate Intrinsic Value | $ | $ 183,707 |
Equity and Stock-based Compen_8
Equity and Stock-based Compensation - Summary of RSU Activity (Detail) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,428 | ||
Unvested, Shares, Ending Balance | 1,483 | 1,428 | |
Granted, Fair value at Grant | $ 54.74 | $ 53.69 | $ 26.59 |
Restricted Stock Unit [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,428 | ||
Granted, Shares | 1,110 | ||
Vested, Shares | (715) | ||
Forfeited, Shares | (340) | ||
Unvested, Shares, Ending Balance | 1,483 | 1,428 | |
Unvested, Fair value at Grant, Beginning Balance | $ 38.26 | ||
Granted, Fair value at Grant | 54.74 | ||
Vested, Fair value at Grant | 37.71 | ||
Forfeited, Fair value at Grant | 46.15 | ||
Unvested, Fair value at Grant, Ending Balance | $ 49.05 | $ 38.26 |
Equity and Stock-based Compen_9
Equity and Stock-based Compensation - Employee Stock Purchase Plan - Additional information (Detail) - 2014 ESPP [Member] - shares | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Purchase of common stock shares at discount | 15.00% | |||
Percentage of fair value exercise price grant date | 85.00% | |||
Number of common stock reserved for issuance | 1,600,000 | |||
Common stock reserved for future issuance, Description | The Company has reserved 1,600,000 shares of its common stock for issuance under the 2014 ESPP and shares reserved for issuance increases January 1 of each year commencing January 1, 2016 by the lesser of (i) a number of shares equal to 1% of the total number of outstanding shares of common stock on December 31 immediately prior to the date of increase; (ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors. | |||
Percentage of common stock reserved for future issuance | 1.00% | |||
Increase in number of shares of common stock reserved for future issuance, shares | 1,200,000 | |||
Shares purchased by employees | 135,115 | 230,317 | 250,834 |
Equity and Stock-based Compe_10
Equity and Stock-based Compensation - Schedule of Allocated Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 66,267 | $ 52,142 | $ 37,539 |
Research and development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 41,015 | 30,491 | 21,807 |
Selling, general and administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 25,252 | $ 21,651 | $ 15,732 |
Equity and Stock-based Compe_11
Equity and Stock-based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Employee Stock Purchase Plans (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee stock options [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 3 months 18 days | 5 years 4 months 24 days | 5 years 8 months 12 days |
Expected volatility | 68.00% | 67.90% | 71.50% |
Risk-free interest rate | 2.40% | 2.70% | 2.20% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 31.98 | $ 32.12 | $ 16.96 |
Employee stock purchase plans [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected volatility, minimum | 48.10% | 47.30% | 52.80% |
Expected volatility, maximum | 62.10% | 75.30% | 77.20% |
Risk-free interest rate, minimum | 1.30% | 0.80% | 0.50% |
Risk-free interest rate, maximum | 2.90% | 2.90% | 1.60% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 19.27 | $ 16.27 | $ 9.41 |
Employee stock purchase plans [Member] | Minimum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | 6 months | 6 months |
Employee stock purchase plans [Member] | Maximum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 2 years | 2 years | 2 years |
Equity and Stock-based Compe_12
Equity and Stock-based Compensation - Stock-Based Compensation - Additional information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Stock Option Awards [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 57.5 |
Non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period | 2 years 3 months 25 days |
Restricted Stock Unit [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period | 2 years 4 months 9 days |
Unrecognized compensation costs | $ 52.9 |
Equity and Stock-based Compe_13
Equity and Stock-based Compensation - Warrants - Additional information (Detail) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Shareholders Equity And Stock Based Compensation [Abstract] | ||
Warrants to purchase common stock exercised | 4,430 | |
Warrants to purchase common stock outstanding | 0 | 4,000 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Weighted Impacts of Outstanding Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 9,050 | 8,834 | 9,945 |
Employee stock options [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 7,602 | 7,815 | 8,936 |
RSUs [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 1,187 | 820 | 799 |
ESPP [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 260 | 195 | 206 |
Warrants [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 1 | 4 | 4 |
FibroGen, Inc. 401(k) Plan - Ad
FibroGen, Inc. 401(k) Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Compensation And Retirement Disclosure [Abstract] | |||
Defined contribution plan, maximum annual contributions per employee, percent | 60.00% | ||
Defined contribution plan, employer matching contributions | $ 3 | $ 2.9 | $ 2.5 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Components Of Income Tax Expense Benefit Continuing Operations [Abstract] | |||
Domestic | $ 2,538 | $ (38,472) | $ (80,735) |
Foreign | (79,180) | (47,644) | (39,819) |
Loss before income taxes | $ (76,642) | $ (86,116) | $ (120,554) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Provision For Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 2 | 2 |
Foreign | 328 | 302 | 319 |
Total current | 328 | 304 | 321 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | 0 |
Total provision for income taxes | $ 328 | $ 304 | $ 321 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation Between Statutory Federal Income Tax Rate and Effective Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Tax at statutory federal rate | 21.00% | 21.00% | 34.00% |
State tax | 0.00% | 0.00% | 0.00% |
Stock-based compensation expense | 6.30% | 14.50% | 18.50% |
Change in deferred tax assets due to rate change | 0.00% | 0.00% | 43.90% |
Change in valuation allowance due to rate change | 0.00% | 0.00% | (43.90%) |
Net operating losses not benefitted | (2.90%) | (23.20%) | (43.80%) |
Foreign net operating losses not benefitted | (21.70%) | (11.60%) | (6.70%) |
Orphan drug credit | 0.00% | 0.00% | (2.00%) |
Deduction limitation on executive compensation | (2.50%) | (0.50%) | 0.00% |
Other | (0.60%) | (0.60%) | (0.30%) |
Total | (0.40%) | (0.40%) | (0.30%) |
Income Taxes - Schedule of Sign
Income Taxes - Schedule of Significant Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Components Of Deferred Tax Assets And Liabilities [Abstract] | ||
Federal and state net operating loss carryforwards | $ 91,267 | $ 91,683 |
Tax credit carryforwards | 52,243 | 45,885 |
Foreign net operating loss carryforwards | 37,786 | 21,295 |
Stock-based compensation | 11,159 | 9,281 |
Lease obligations | 10,698 | 2,511 |
Reserves and accruals | 5,353 | 6,072 |
Deferred revenue | 13,323 | 16,454 |
Fixed assets | 0 | 356 |
Other | 284 | 450 |
Subtotal | 222,113 | 193,987 |
Less: Valuation allowance | (213,847) | (193,987) |
Net deferred tax assets | 8,266 | 0 |
Fixed assets | (8,266) | 0 |
Other | 0 | 0 |
Net deferred tax liabilities | (8,266) | 0 |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | |||
Increase in valuation allowance | $ 19,900,000 | $ 34,400,000 | $ 30,500,000 |
Federal and state net operating loss carryforwards | 91,267,000 | 91,683,000 | |
Foreign net operating loss carryforwards | $ 37,786,000 | $ 21,295,000 | |
Tax at statutory federal rate | 21.00% | 21.00% | 34.00% |
Percentage of ownership changes | 0.00% | ||
Unrecognized tax benefits | $ 32,300,000 | ||
Accrued interest, unrecognized tax benefits | 0 | $ 0 | |
Unrecognized tax benefits that would affect effective tax rate | $ 500,000 | ||
Unrecognized tax benefits description | The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months that would affect the Company’s effective tax rate. | ||
Earliest Tax Year [Member] | |||
Income Taxes [Line Items] | |||
Foreign statute of limitation generally remains open in the year | 2010 | ||
Latest Tax Year [Member] | |||
Income Taxes [Line Items] | |||
Foreign statute of limitation generally remains open in the year | 2019 | ||
Maximum [Member] | |||
Income Taxes [Line Items] | |||
Tax at statutory federal rate | 35.00% | ||
Foreign net operating loss [Member] | |||
Income Taxes [Line Items] | |||
Foreign net operating loss carryforwards | $ 152,200,000 | ||
Foreign net operating loss [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards expiration year | 2020 | ||
Foreign net operating loss [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards expiration year | 2029 | ||
Federal [Member] | |||
Income Taxes [Line Items] | |||
Federal and state net operating loss carryforwards | $ 404,600,000 | ||
Operating loss carryforwards expiration year | 2026 | ||
Other tax credit carryforwards | $ 54,100,000 | ||
Other tax credit carryforwards expiration year | 2020 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Federal and state net operating loss carryforwards | $ 129,400,000 | ||
Operating loss carryforwards expiration year | 2020 | ||
State [Member] | California [Member] | |||
Income Taxes [Line Items] | |||
Other tax credit carryforwards | $ 29,400,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of the Beginning and Ending Amounts of Unrecognized Income Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Contingency [Line Items] | |||
Ending Balance | $ 32,300 | ||
Federal and State [Member] | |||
Income Tax Contingency [Line Items] | |||
Beginning balance | 27,956 | $ 23,361 | $ 19,654 |
Increase due to prior positions | 379 | 303 | |
Increase due to current year position | 4,418 | 4,216 | 5,448 |
Decrease due to prior positions | (111) | (2,044) | |
Ending Balance | $ 32,263 | $ 27,956 | $ 23,361 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | |||
Accounts receivable from related party | $ 4,845,000 | $ 47,210,000 | |
Accrued liabilities to related party | 36,883,000 | 444,000 | |
Unbilled contract asset | 180,000,000 | 0 | |
Due from Related Parties, Current | 125,210,000 | 0 | |
Net unbilled contract asset | 125,210,000 | 0 | |
Deferred revenue | 54,790,000 | 0 | |
Europe [Member] | |||
Related Party Transaction [Line Items] | |||
Unbilled contract asset | 130,000,000 | ||
Astellas Agreement [Member] | Japan [Member] | |||
Related Party Transaction [Line Items] | |||
Deferred revenue | 375,000 | ||
Astellas Agreement [Member] | Europe [Member] | |||
Related Party Transaction [Line Items] | |||
Unbilled contract asset | 130,000,000 | ||
Deferred revenue | 4,790,000 | ||
Astellas [Member] | Europe [Member] | |||
Related Party Transaction [Line Items] | |||
Unbilled contract asset | 130,000,000 | ||
Net unbilled contract asset | 125,200,000 | ||
Deferred revenue | 4,800,000 | ||
Astellas [Member] | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | 122,500,000 | 100,000,000 | $ 20,100,000 |
Expense related to collaboration agreements | 2,800,000 | 1,500,000 | $ 1,000,000 |
Accounts receivable from related party | 4,800,000 | 47,200,000 | |
Accrued liabilities to related party | 36,900,000 | 400,000 | |
Astellas [Member] | Astellas Agreement [Member] | Japan [Member] | |||
Related Party Transaction [Line Items] | |||
Accrued liabilities to related party | 36,300 | ||
API Shipment [Member] | Astellas [Member] | Astellas Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Accrued liabilities to related party | 43,800,000 | ||
Product Revenue [Member] | API Shipment [Member] | Astellas [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | $ (36,300,000) | $ 64,800,000 |
Segment and Geographic Inform_3
Segment and Geographic Information - Additional information (Detail) | 12 Months Ended |
Dec. 31, 2019Segment | |
Segment Reporting [Abstract] | |
Number of operating segment | 1 |
Segment and Geographic Inform_4
Segment and Geographic Information - Schedule of Revenue by Geographic Area (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 256,577 | $ 212,958 | $ 130,996 |
Europe [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 132,400 | 112,916 | 110,861 |
Japan [Member] | Related Party [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 122,475 | 100,002 | 20,111 |
All other [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 1,702 | $ 40 | $ 24 |
Segment and Geographic Inform_5
Segment and Geographic Information - Schedule of Long Lived Assets by Geographic Area (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 42,743 | $ 127,198 |
United States [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | 27,325 | 103,539 |
China [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 15,418 | $ 23,659 |
Segment and Geographic Inform_6
Segment and Geographic Information - Summary of Finance and Operating Lease Right of Use Assets by Geographical Location (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Total finance lease right-of-use assets | $ 39,602 | $ 0 |
Total operating lease right-of-use assets | 1,931 | 0 |
United States [Member] | ||
Total finance lease right-of-use assets | 39,237 | 0 |
Total operating lease right-of-use assets | 75 | 0 |
China [Member] | ||
Total finance lease right-of-use assets | 365 | 0 |
Total operating lease right-of-use assets | $ 1,856 | $ 0 |
Segment and Geographic Inform_7
Segment and Geographic Information - Schedule of Customer Concentration by Collaboration Partners (Detail) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Percentage of Revenue [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 48.00% | 47.00% | 15.00% |
Percentage of Revenue [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 52.00% | 53.00% | 85.00% |
Percentage of Accounts Receivable [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 17.00% | 74.00% | |
Percentage of Accounts Receivable [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 81.00% | 26.00% |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Detail) - Valuation Allowances for Deferred Tax Assets [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | $ 193,987 | $ 159,540 | $ 128,995 |
Charged (Credited) to Statement of Operation | 19,860 | 34,447 | 11,039 |
Charged to Other Accounts - Equity | 0 | 0 | 19,506 |
Deductions, Net | 0 | 0 | 0 |
Balance at End of Year | $ 213,847 | $ 193,987 | $ 159,540 |