Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Jan. 31, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | FGEN | ||
Entity Registrant Name | FIBROGEN INC | ||
Entity Central Index Key | 921,299 | ||
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 Common Stock, Shares Outstanding | 85,562,391 | ||
Entity Public Float | $ 3,548.1 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 89,258 | $ 673,658 |
Short-term investments | 532,144 | 62,060 |
Accounts receivable ($47,210 and $4,004 from a related party) | 63,684 | 8,452 |
Prepaid expenses and other current assets | 4,929 | 4,800 |
Total current assets | 690,015 | 748,970 |
Restricted time deposits | 4,145 | 5,181 |
Long-term investments | 55,820 | 10,506 |
Property and equipment, net | 127,198 | 129,476 |
Other assets | 3,420 | 4,517 |
Total assets | 880,598 | 898,650 |
Current liabilities: | ||
Accounts payable | 9,139 | 5,509 |
Accrued liabilities ($444 and $272 to a related party) | 66,123 | 63,781 |
Deferred revenue | 13,771 | 16,670 |
Total current liabilities | 89,033 | 85,960 |
Long-term portion of lease financing obligations | 97,157 | 97,763 |
Product development obligations | 16,798 | 17,244 |
Deferred rent | 3,038 | 3,657 |
Deferred revenue, net of current | 136,109 | 138,241 |
Other long-term liabilities | 9,993 | 8,047 |
Total liabilities | 352,128 | 350,912 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at December 31, 2018 and December 31, 2017 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at December 31, 2018 and December 31, 2017; 85,432 and 82,498 shares issued and outstanding at December 31, 2018 and December 31, 2017 | 854 | 825 |
Additional paid-in capital | 1,226,453 | 1,160,094 |
Accumulated other comprehensive loss | (2,281) | (1,795) |
Accumulated deficit | (715,827) | (630,657) |
Total stockholders’ equity | 509,199 | 528,467 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 528,470 | 547,738 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 880,598 | $ 898,650 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 47,210 | $ 4,004 |
Accrued liabilities to related party | $ 444 | $ 272 |
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 | 85,432,000 | 82,498,000 |
Common stock, shares outstanding | 85,432,000 | 82,498,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue: | |||
Total revenue | $ 212,958 | $ 130,996 | $ 183,189 |
Operating expenses: | |||
Research and development | 235,839 | 196,517 | 187,206 |
General and administrative | 63,812 | 51,760 | 46,025 |
Total operating expenses | 299,651 | 248,277 | 233,231 |
Loss from operations | (86,693) | (117,281) | (50,042) |
Interest and other, net | |||
Interest expense | (10,991) | (9,706) | (10,725) |
Interest income and other, net | 11,568 | 6,433 | 2,628 |
Total interest and other, net | 577 | (3,273) | (8,097) |
Loss before income taxes | (86,116) | (120,554) | (58,139) |
Provision for (benefit from) income taxes | 304 | 321 | (71) |
Net loss | $ (86,420) | $ (120,875) | $ (58,068) |
Net loss per share - basic and diluted | $ (1.03) | $ (1.66) | $ (0.93) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 84,062 | 72,987 | 62,744 |
License Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 22,269 | $ 9,933 | $ 50,607 |
Development and Other Revenue [Member] | |||
Revenue: | |||
Total revenue | 125,913 | 121,063 | 132,582 |
Product Revenue [Member] | |||
Revenue: | |||
Total revenue | $ 64,776 | $ 0 | $ 0 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
License and milestone revenue from a related party | $ 14,323 | $ 0 | $ 9,548 |
Collaboration services and other revenue from a related party | 20,903 | 20,111 | 21,775 |
Product revenue from a related party | $ 64,776 | $ 0 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (86,420) | $ (120,875) | $ (58,068) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments | 771 | (2,022) | 532 |
Available-for-sale investments: | |||
Unrealized gain (loss) on investments, net of tax effect | (7) | 1,259 | 140 |
Reclassification from accumulated other comprehensive loss | 0 | (72) | 19 |
Net change in unrealized gain on available-for-sale investments | (7) | 1,187 | 159 |
Other comprehensive income (loss), net of taxes | 764 | (835) | 691 |
Comprehensive loss | $ (85,656) | $ (121,710) | $ (57,377) |
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, 2015 | $ 153,173 | $ 620 | $ 586,647 | $ (1,651) | $ (451,714) | $ 19,271 |
Balance, Shares at Dec. 31, 2015 | 61,985,079 | |||||
Net loss | (58,068) | $ 0 | 0 | 0 | (58,068) | 0 |
Change in unrealized gain or loss on investments | 159 | 0 | 0 | 159 | 0 | 0 |
Foreign currency translation adjustments | 532 | 0 | 0 | 532 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 7,141 | $ 17 | 7,124 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 1,660,759 | |||||
Stock appreciation rights settled | 0 | $ 0 | 0 | 0 | 0 | 0 |
Stock appreciation rights settled, Shares | 17,855 | |||||
Stock-based compensation | 32,132 | $ 0 | 32,132 | 0 | 0 | 0 |
Warrants exercised | 0 | $ 0 | 0 | 0 | 0 | 0 |
Warrants exercised, Shares | 1,591 | |||||
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 inaccounting principle uponadoption of ASU 2016-01(Note 2) | 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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (86,420) | $ (120,875) | $ (58,068) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation | 6,562 | 6,099 | 6,040 |
Net amortization of premium and discount on investments | (42) | 1,844 | 2,729 |
Unrealized loss on cash equivalents and short-term equity investments | 1,120 | 2 | 0 |
Loss on disposal of property and equipment | 53 | 3 | 0 |
Stock-based compensation | 52,142 | 37,539 | 32,132 |
Realized foreign currency gain | (1,074) | 0 | 0 |
Tax benefit on unrealized gain on available-for-sale securities | 0 | 0 | (211) |
Realized gain on sales of available-for-sale securities | (87) | (143) | (37) |
Changes in operating assets and liabilities: | |||
Accounts receivable ($(43,206), $98 and $353 from related party) | (55,232) | 1,996 | 4,957 |
Prepaid expenses and other current assets | (129) | (1,911) | 1,099 |
Other assets | 1,090 | (2,365) | (136) |
Accounts payable | 3,630 | (714) | (298) |
Accrued liabilities ($172, $(1,343) and $(430) from related party) | 5,606 | 9,196 | 2,965 |
Deferred revenue | (5,031) | 174 | 13,225 |
Lease financing liability | 32 | 1,023 | 814 |
Other long-term liabilities | 1,636 | 1,619 | 1,897 |
Net cash provided by (used in) operating activities | (76,144) | (66,513) | 7,108 |
Investing activities | |||
Purchases of property and equipment | (8,020) | (8,500) | (1,252) |
Proceeds from sale of property and equipment | 184 | 5 | 0 |
Purchases of available-for-sale securities and term deposit | (576,880) | (169) | (9,041) |
Proceeds from sales of available-for-sale securities | 8,167 | 21,109 | 4,298 |
Proceeds from maturities of investments | 54,426 | 57,421 | 12,617 |
Net cash provided by (used in) investing activities | (522,123) | 69,866 | 6,622 |
Financing activities | |||
Borrowings under capital lease obligations | 49 | 0 | 0 |
Repayments of capital lease obligations | (6) | 0 | 0 |
Repayments of lease liability | (403) | (403) | (403) |
Proceeds from follow-on offerings, net of underwriting discounts and commission costs | 0 | 471,205 | 0 |
Cash paid for payroll taxes on restricted stock unit releases | (15,612) | (8,296) | (2,740) |
Proceeds from issuance of common stock | 29,847 | 34,910 | 9,881 |
Payments of deferred offering costs | 0 | (944) | 0 |
Net cash provided by financing activities | 13,875 | 496,472 | 6,738 |
Effect of exchange rate change on cash and cash equivalents | (8) | 51 | (10) |
Net increase (decrease) in cash and cash equivalents | (584,400) | 499,876 | 20,458 |
Total cash and cash equivalents at beginning of period | 673,658 | 173,782 | 153,324 |
Total cash and cash equivalents at end of period | 89,258 | 673,658 | 173,782 |
Supplemental cash flow information: | |||
Interest payments | 218 | 255 | 295 |
Balance in accounts payable and accrued liabilities related to purchases of property and equipment | 276 | 3,781 | 356 |
Deferred offering costs recorded in accounts payable and accrued liabilities | $ 24 | $ 35 | $ 0 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Cash Flows [Abstract] | |||
Accounts receivable from related party | $ (43,206) | $ 98 | $ 353 |
Accrued liabilities from related party | $ 172 | $ (1,343) | $ (430) |
The Company
The Company | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company has applied its pioneering expertise in hypoxia-inducible factor (“HIF”) and connective tissue growth factor (“CTGF”) biology to develop innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat (FG-4592), the Company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat has received approval of its New Drug Application (“NDA”) in anemia associated with chronic kidney disease (“CKD”) in dialysis-dependent patients from the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“China”). In conjunction with our collaboration partners, we have completed the Phase 3 trials of roxadustat intended to support B On April 11, 2017, the Company closed a follow-on offering of its common stock. In this offering, the Company sold 5,228,750 shares of its common stock at a public offering price of $22.95 per share. Net proceeds from this offering were $115.1 million, after deducting underwriting discounts and commissions of $4.9 million. In addition, the offering expenses were approximately $0.6 million in total. On August 24, 2017, the Company completed another follow-on offering of its common stock. In this offering, the Company sold a total of 9,200,000 shares of its common stock at a public offering price of $40.75 per share. Net proceeds from this offering were $356.2 million, after deducting underwriting discounts and commissions of $18.7 million. In addition, the offering expenses were approximately $0.4 million in total. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 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. A portion of cash on hand is invested in a diversified portfolio of investment grade corporate bonds issued by U.S. corporations as rated investment grade corporate bonds. 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, 2018 2017 Astellas Pharma Inc. (“Astellas”)—Related party 74 % 47 % AstraZeneca AB (“AstraZeneca”) 26 % 53 % 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 include money market accounts, various deposit accounts, and money market funds. 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, 2018 and 2017 totaled $4.1 million and $5.2 million, respectively. As of December 31, 2018, a total of $21.9 million of the Company’s cash and cash equivalents is held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. Investments The Company’s investments consist of available-for-sale debt investments, 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 are considered short-term investments. Those investments with maturities greater than 12 months are considered long-term investments. 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). Property and Equipment Property and equipment (except for costs of construction of certain long-lived assets — refer to Note 8) are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, 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. 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 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. Product revenue consists 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 is subject to potential future adjustments. This represents a form of variable consideration. With respect to these sales in 2018, the transaction price will be adjusted at the time the roxadustat listed price is issued by the Japanese Ministry of Health, Labour and Welfare to reflect differences between estimated and actual listed price, yield from the manufacture of bulk product tablets, and bulk product manufacturing costs. The Company evaluates the latest available facts and circumstances, 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 is necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. 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. 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. General and Administrative Expenses General and administrative expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. Other general and administrative expenses include facility-related costs and professional fees, accounting and legal services, other outside services, 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 New Revenue Standards In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue Recognition Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company adopted the new revenue standards as of January 1, 2018 using the full retrospective method, which required the Company to recast the prior reporting periods presented in the consolidated financial statements. The primary impact upon adoption of the new revenue standards relates to the manner in which revenue is recognized for co-development billings and milestone payments under the Company’s collaboration arrangements. Under the new revenue standards, both of these elements of consideration are considered variable consideration which requires the Company to make estimates of when co-development billings become due or when achievement of a particular milestone becomes probable. Payments are included in the transaction price when it becomes probable that inclusion would not lead to a significant revenue reversal. The Company has recast its consolidated statement of operations and balance sheet from amounts previously reported due to the adoption of the new revenue standards. The adoption of the new revenue standards had no impact to the Company’s previously reported consolidated statement of cash flows. Select line items from the Company’s consolidated statement of operations and balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Year Ended December 31, 2017 Year Ended December 31, 2016 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 96,056 $ (86,123 ) $ 9,933 $ 137,352 $ (86,745 ) $ 50,607 Development and other revenue 29,612 91,451 121,063 42,225 90,357 132,582 Total revenue 125,668 5,328 130,996 179,577 3,612 183,189 Net loss (126,203 ) 5,328 (120,875 ) (61,680 ) 3,612 (58,068 ) Net loss per share - basic and diluted $ (1.73 ) $ 0.07 $ (1.66 ) $ (0.98 ) $ 0.05 $ (0.93 ) December 31, 2017 As Previously Reported New Revenue Standards Adjustment As Recast Balance Sheet Deferred revenue, current $ 7,968 $ 8,702 $ 16,670 Deferred revenue, net of current 112,231 26,010 138,241 Accumulated deficit (595,945 ) (34,712 ) (630,657 ) The adoption of the new revenue standards also resulted in the following changes in the accumulated deficit as of December 31, 2016 and 2015: As Previously Reported New Revenue Standards Adjustment As Recast Accumulated Deficit As of December 31, 2016 $ (469,742 ) $ (40,040 ) $ (509,782 ) As of December 31, 2015 $ (408,062 ) $ (43,652 ) $ (451,714 ) 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 ) * Recast to reflect the adoption of the new revenue standards. See above. The adoption of this guidance had no impact to the Company’s consolidated statement of cash flows for the year ended December 31, 2018. ASU 2017-09 In May 2017, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting ASU 2016-16 In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory Recently Issued Accounting Guidance Not Yet Adopted Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax effects from Accumulated Other Comprehensive Income In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In November 2018, the FASB issued 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses ”), which clarifies certain topics included within ASU 2016-13. ASU 2016-13 and ASU 2018-19 are effective for the Leases (Topic 842) Leases (Topic 842): Targeted Improvements (“ ”) , utilize the modified retrospective transition method through a cumulative-effect adjustment at the beginning of the first quarter of 2019. a recognition of approximately $47 million to $62 million in right-of-use assets and approximately $57 million to $67 million in lease liabilities, respectively, upon adoption of this guidance, for its operating leases and facility leases disclosed in Note 8 to its consolidated balance sheets. Accordingly, balances as of December 31, 2018 in property and equipment, net, and long-term portion of lease financing obligations would be removed. The Company |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements | 3. Collaboration Agreements 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). The Japan Agreement also provides for additional development and regulatory approval milestone payments up to $117.5 million, a commercial sales related milestone of $15.0 million and additional consideration based on net sales (as defined) in the low 20% range after commercial launch. 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. 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. 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. 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 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 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. 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, which were fully received in 2014. In addition, the China Agreement provides for AstraZeneca to pay regulatory approval and other approval related milestones of up to $161.0 million. The China Agreement also provides for sales related milestone payments of up to $167.5 million and contingent payments of $20.0 million related to possible future compounds. 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. In September 2016, AstraZeneca approved the protocol related to the development of roxadustat for the treatment of anemia in patients with myelodysplastic syndrome (“MDS”), for which the Company has received approval from then the China Food and Drug Administration (“CFDA,” now known as the National Medicine Products Administration (“NMPA”)) for its clinical trial application for a Phase 2/3 trial and acceptance of its Investigational New Drug Application from the U.S. Food and Drug Administration for a Phase 3 trial. As a result, for revenue recognition purposes, during the third quarter of 2016, the Company extended the estimated joint development service period for the AstraZeneca agreements from the end of 2018 to the end of 2020, to allow for development of MDS. 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. In October 2017, then the CFDA (now known as the NMPA) accepted the Company’s recently submitted New Drug Application (“NDA”) for registration of roxadustat for anemia in dialysis-dependent CKD and non-dialysis-dependent CKD (NDD-CKD) patients. This NDA submission triggered a $15.0 million milestone payment to the Company by AstraZeneca, which became probable of being achieved during the third quarter of 2017, and therefore partially recognized as revenue under the new revenue standards during 2017. 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 fourth quarter of 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, 2018, the transaction price for the Japan Agreement included $40.1 million of non-contingent upfront payments, $37.5 million of variable consideration related to payments for milestones considered probable of being achieved, and $12.1 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, $90.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $180.9 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 is subject to potential future adjustments. This represents a form of variable consideration. The Company evaluates the latest available facts and circumstances to determine whether any adjustments to the estimated transaction price is necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. 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, 2018, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $42.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $621.6 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 of the agreement as services are provided. Items (3)-(4) 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 delivering 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. (5) Manufacturing commercial supplies of products. This promise is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based royalties related predominately to the license of intellectual property under the agreement. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. To date, no such revenue has been recognized. China Agreement: The performance obligation that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: • License to the Company’s technology existing at the effective date of the agreement. The license was delivered at the beginning of the agreement term. However, the China Agreement with AstraZeneca has contractual limitations that might affect AstraZeneca’s ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is distinct in the context of the agreement. In the China Agreement, AstraZeneca does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the arrangement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of AstraZeneca to benefit from the license on its own or together with other resources readily available to AstraZeneca. For the China Agreement, the Company retained manufacturing rights as an essential part of a strategy to pursue domestic regulatory pathway for product approval which requires the regulatory licensure of the manufacturing facility in order to commence commercial shipment. The prospects for the collaboration as a whole would have been substantially different had manufacturing rights been provided to AstraZeneca. Due to certain regulatory restrictions in China, manufacturing services of commercial drug product in China are not readily available to AstraZeneca or any other parties. Therefore, AstraZeneca cannot benefit from the license on its own or together with other readily available resources. Accordingly, all the promises identified, including co-development services, under the China Agreement have been bundled into a single performance obligation and amounts of the transaction price allocable to this performance obligation are deferred until control of the manufactured commercial drug product has begun to transfer to AstraZeneca. Upon commencement of the transfer of control to commercial drug product, revenue would be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Summary of revenue recognized under the collaboration agreements The table below summarizes the accounting treatment for the various performance obligations pursuant to each of the Astellas and AstraZeneca agreements. License amounts identified below are included in the “License revenue” line item in the consolidated statements of operations. All other elements identified below are included in the “Development and other revenue” line item in the consolidated statements of operations . Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2018 2017 * 2016 * Japan License revenue $ 14,323 $ — $ 9,548 Development revenue $ 2,400 $ 1,588 $ 4,288 * Recast to reflect the adoption of the new revenue standards. See Note 2. 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, 2018 Deferred Revenue at December 31, 2018 Total Consideration Through December 31, 2018 License $ 74,089 $ — $ 74,089 Development revenue 13,908 286 14,194 Total license and development revenue $ 87,997 $ 286 $ 88,283 The revenue recognized under the Japan Agreement for the year ended December 31, 2018 included an increase of $14.9 million resulting from changes to estimated variable consideration in the current year relating to performance obligations satisfied or partially satis |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
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 fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): 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 December 31, 2017 Level 1 Level 2 Level 3 Total Corporate bonds $ — $ 53,943 $ — $ 53,943 Bond and mutual funds 18,402 — — 18,402 Equity investments 221 — — 221 Money market funds 569,942 — — 569,942 Total $ 588,565 $ 53,943 $ — $ 642,508 The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands): December 31, 2018 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,105 $ 98,105 December 31, 2017 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,476 $ 98,476 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. There were no transfers of assets or liabilities between levels for the years ended December 31, 2018, 2017 and 2016. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): December 31, 2018 2017 Cash $ 38,783 $ 103,716 US treasury notes and bills 49,934 — Money market funds 541 569,942 Total cash and cash equivalents $ 89,258 $ 673,658 Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2018 2017 Leasehold improvements $ 101,200 $ 93,758 Building shell (Refer to Note 8) 53,880 53,879 Laboratory equipment 16,405 19,497 Machinery 8,382 — Computer equipment 6,473 6,006 Furniture and fixtures 5,690 5,575 Construction in progress 367 10,402 Total property and equipment $ 192,397 $ 189,117 Less: accumulated depreciation (65,199 ) (59,641 ) Property and equipment, net $ 127,198 $ 129,476 Depreciation expense for the years ended December 31, 2018, 2017 and 2016 was $6.6 million, $6.1 million, and $6.0 million, respectively. 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, 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 December 31, 2017 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 53,985 $ 4 $ (46 ) $ 53,943 Bond and mutual funds 17,249 1,153 — 18,402 Equity investments 126 95 — 221 Total investments $ 71,360 $ 1,252 $ (46 ) $ 72,566 The contractual maturities of the available-for-sale investments and term deposit were as follows (in thousands): December 31, 2018 Within one year $ 532,144 After one year through four years 45,102 Total debt investments 577,246 Bond and mutual funds 10,484 Equity investments 234 Total investments $ 587,964 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, 2018, the Company did not recognize any other-than-temporary impairment loss. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2018 2017 Preclinical and clinical trial accruals $ 35,413 $ 32,321 Payroll and related accruals 21,430 18,810 Property taxes and other 1,095 4,201 Professional services 2,648 1,991 Other 5,537 6,458 Total accrued liabilities $ 66,123 $ 63,781 |
Product Development Obligations
Product Development Obligations | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Product Development Obligations | 6. 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 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, 2018 and 2017, the Company had $10.8 million and $11.3 million of principal outstanding, respectively, and $6.0 million and $5.9 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. |
Convertible Note Payable
Convertible Note Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Note Payable | 7. Convertible Note Payable In January 2013, FibroGen China entered into a $0.6 million convertible promissory note. The note bears simple interest at a rate of two percent (2.00%) per annum, accrued on an annual basis in arrears. The outstanding principal balance and unpaid accrued interest on the note is due and payable upon the earlier of (a) the effectiveness of the initial public offering of FibroGen China or (b) the eight year anniversary of the date of the note. The total outstanding principal balance and unpaid accrued interest on the note will be converted into Series A Preferred Stock of FibroGen China at the option of the lender or by the Company at its discretion. As of December 31, 2018 and 2017, the total outstanding principal balance and accrued interest were $0.7 million and $0.6 million, respectively, and recorded in the other long-term liabilities in the consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Operating Leases Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 are as follows (in thousands): Year Ending Operating Leases 2019 $ 444 2020 232 2021 25 2022 16 2023 — Total minimum payments $ 717 Facility Lease Financing Obligations FibroGen, Inc. In September 2006, the Company entered into a long-term property lease with Shorenstein Properties LLC (“Alexandria” or “landlord”) providing the Company with 234,249 square feet of space for an initial term of 15 years. Upon signing, a stand-by letter of credit was established in the amount of $7.3 million which has been included in restricted time deposits. Starting the fourth quarter of 2016, on an annual basis, 1/8 th In connection with this lease, the Company was responsible for approximately 60% of the construction costs for the tenant improvements. The Company is deemed, for accounting purposes only, to be the accounting owner of the entire project including the building shell, even though it is not the legal owner. The balance of the tenant improvements were paid by Alexandria in the form of a tenant improvement allowance of $140.50 per square foot of rentable space, or $32.5 million. In connection with the Company’s accounting for this transaction, the Company capitalized Alexandria’s costs of constructing the building shell which totaled $50.8 million, and recognized a corresponding lease financing obligation. The Company also recognized, as an additional lease financing obligation, the reimbursements totaling $32.5 million from landlord for tenant improvements since these reimbursements are also deemed to be a financing obligation. A portion of the monthly lease payment is allocated to land rent and recorded as an operating lease expense and the non-interest portion of the amortized lease payments to the landlord related to rent of the building is applied to the lease financing liability. FibroGen China In February 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 leased space is 4,820 square meters over an eight (8) year term starting February 1, 2013. In connection with this lease, the Company was responsible for approximately 100% of the construction costs for the tenant improvements. The Company is deemed, for accounting purposes only, to be the accounting owner of the entire project, including the building shell, even though it is not the legal owner. In connection with the Company’s accounting for this transaction, the Company capitalized BDA Management Committee’s costs of constructing the building shell which totaled $3.1 million, and recognized a corresponding lease financing obligation. The Company also recognized, as an additional lease financing obligation, the reimbursements totaling $0.5 million from BYBP for a rent subsidy since this reimbursement is also deemed to be a financing obligation. A portion of the monthly lease payment is allocated to land rent and recorded as an operating lease expense and the non-interest portion of the amortized lease payments to the landlord related to rent of the building is applied to the lease financing liability. Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 are 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 Apart from the property leases with Alexandria and BDA Management Committee, rent expense for leased facilities under operating lease commitments was $3.1 million, $3.0 million, and $2.8 million for the years ended December 31, 2018, 2017 and 2016, respectively. The Company received sublease income of $3.5 million, $3.9 million, and $3.8 million for the years ended December 31, 2018, 2017 and 2016, respectively, which were recorded as a reduction of research and development expenses and general and administrative expenses for the respective periods. 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. |
Equity and Stock-based Compensa
Equity and Stock-based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 and 2017, 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, , , 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 EU 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, 2018 and 2017, 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, 2018 and 2017. 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 RSUs grant and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2018 2017 Common stock outstanding 85,432 82,498 Stock options outstanding 10,430 11,550 RSUs outstanding 1,428 1,562 Common stock warrants outstanding 4 4 Shares reserved for future stock options and RSUs grant 6,041 4,190 Shares reserved for future ESPP offering 2,618 2,024 Total shares of common stock reserved 105,953 101,828 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 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, 2018, the Company has reserved 6,040,725 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, 2018 and 2017, 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, 2017 11,550 $ 14.82 Granted 1,307 53.64 Exercised (2,271 ) 11.20 Expired (7 ) 5.82 Forfeited (149 ) 30.55 Outstanding at December 31, 2018 10,430 20.25 5.47 $ 281,436 Vested and expected to vest, December 31, 2018 10,430 20.25 5.47 281,436 Exercisable at December 31, 2018 7,644 $ 13.83 4.47 $ 248,206 The total intrinsic value of options exercised during the years ended December 31, 2018, 2017 and 2016 was $97.5 million, $111.9 million, and $17.9 million, respectively. The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2017 1,562 $ 24.75 Granted 706 53.69 Vested (727 ) 24.70 Forfeited (113 ) 35.12 Unvested at December 31, 2018 1,428 $ 38.26 Among the vested RSUs during the year ended December 31, 2017, 432,472 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, 2018, 2017 and 2016 was $53.69, $26.59 and $19.37, 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 230,317 shares, 250,834 shares and 266,720 shares purchased by employees under the 2014 Purchased Plan for the years ended December 31, 2018, 2017 and 2016, 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 general and administrative expense for the years ended December 31, 2018, 2017 and 2016 was as follows (in thousands): Years Ended December 31, 2018 2017 2016 Research and development $ 30,491 $ 21,807 $ 19,070 General and administrative 21,651 15,732 13,062 Total stock-based compensation expense $ 52,142 $ 37,539 $ 32,132 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 options was estimated using the following assumptions: Expected Term. Expected Volatility. Risk-Free Interest Rate. Expected Dividend Yield. 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, 2018 2017 2016 Stock Options Expected term (in years) 5.4 5.7 5.3 Expected volatility 67.9 % 71.5 % 69.9 % Risk-free interest rate 2.7 % 2.2 % 1.4 % Expected dividend yield — — — Weighted average estimated fair value $ 32.12 $ 16.96 $ 11.49 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.3 - 75.3 % 52.8 - 77.2 % 61.9 - 80.7 % Risk-free interest rate 0.8 - 2.9 % 0.5 - 1.6 % 0.2 - 1.0 % Expected dividend yield — — — Weighted average estimated fair value $ 16.27 $ 9.41 $ 9.94 As of December 31, 2018, there was $46.6 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 2.24 years. As of December 31, 2018, there was $40.9 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 2.40 years. Warrants The following warrants to purchase shares of Common Stock were issued in connection with certain facility and equipment lease financing arrangements and are outstanding at December 31, 2018: Year of Issuance Number of Shares Exercise Price per Share Reason for Issuance Expiration Date 2000 4,430 $ 15.00 Issued in connection with lease agreement Five years after initial public offering or upon merger or sale of the Company’s assets, whichever occurs first 4,430 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The following 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, 2018 2017 2016 Employee stock options 10,430 11,550 13,660 RSUs outstanding 1,428 1,562 1,211 Warrants 4 4 4 11,862 13,116 14,875 |
FibroGen, Inc. 401(k) Plan
FibroGen, Inc. 401(k) Plan | 12 Months Ended |
Dec. 31, 2018 | |
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 $2.9 million, $2.5 million and $2.3 million were made during years ended December 31, 2018, 2017 and 2016, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 * 2016 * Domestic $ (38,472 ) $ (80,735 ) $ (25,342 ) Foreign (47,644 ) (39,819 ) (32,797 ) Loss before provision for income taxes $ (86,116 ) $ (120,554 ) $ (58,139 ) * Recast to reflect the adoption of the new revenue standards. See Note 2. The provision for (benefit from) income taxes consists of the following (in thousands): Years Ended December 31, 2018 2017 2016 Current: Federal $ — $ — $ — State 2 2 2 Foreign 302 319 139 Total current 304 321 141 Deferred: Federal — — (212 ) State — — — Foreign — — — Total deferred — — (212 ) Total provision for (benefit from) income taxes $ 304 $ 321 $ (71 ) The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate: Years Ended December 31, 2018 2017 2016 Tax at statutory federal rate 21.0 % 34.0 % 34.0 % State tax — % — % — % Stock-based compensation expense 14.5 % 18.5 % (7.9 )% 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 (23.2 )% (43.8 )% (12.9 )% Foreign net operating losses not benefitted (11.6 )% (6.7 )% (13.0 )% Orphan drug credit 0.0 % (2.0 )% — % Other (1.1 )% (0.3 )% (0.1 )% Total (0.4 )% (0.3 )% 0.1 % Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2018 2017 Federal and state net operating loss carryforwards $ 91,683 $ 71,256 Tax credit carryforwards 45,885 39,488 Foreign net operating loss carryforwards 21,295 15,052 Stock-based compensation 9,281 7,835 Lease obligations 2,511 2,737 Reserves and accruals 6,072 4,851 Deferred revenue 16,454 18,103 Fixed assets 356 — Other 450 420 Subtotal 193,987 159,742 Less: Valuation allowance (193,987 ) (159,540 ) Net deferred tax assets — 202 Fixed assets — (181 ) Other — (21 ) Net deferred tax liabilities — (202 ) 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 $34.4 million, $30.5 million and $12.3 million for the years ended December 31, 2018, 2017 and 2016, 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, 2018, the Company had net operating loss carryforwards available to offset future taxable income of approximately $400.3 million and $148.1 million for federal and state tax purposes, respectively. These carryforwards will begin to expire in 2026 for federal and 2019 for state purposes, if not utilized before these dates. The Company also had foreign net operating loss carryforwards of approximately $86.3 million which expire between 2019 and 2028 if not utilized. At December 31, 2018, the Company had approximately $46.4 million of federal and $26.3 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 2019 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 as. 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. Due to the adoption of ASU 2016-09 in 2017, the Company recorded a retrospective increase of $19.5 million in the deferred tax assets for previously unrecognized excess tax benefits that existed as of December 31, 2016, and a corresponding increase of $19.5 million in the valuation allowance against these deferred tax assets. In addition, all excess tax benefits and deficiencies are recognized as income tax expense and will result in increased volatility in the Company’s income tax. 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, 2018 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 $28.0 million as of December 31, 2018. Approximately $0.5 million of unrecognized tax benefits, if recognized, would affect the effective tax rate. The interest accrued as of December 31, 2018 and 2017 was immaterial. A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2018 is as follows (in thousands): Federal Balance as of December 31, 2015 $ 24,213 Decrease due to prior positions (7,109 ) Increase due to current year position 2,550 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 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 2009 to 2018. The Company is not currently under audit in any tax jurisdiction. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016, the Company recorded revenue related to collaboration agreements with Astellas of $100.0 million, $20.1 million, and $31.3 million, respectively. The related party revenue for the year ended December 31, 2018 included $64.8 million product revenue for API to conduct commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. See Note 3 and below for details. The related party revenue was recast for each of the years ended December 31, 2017 and 2016 as a result of adoption of the new revenue standards. See Note 2 for details. During the years ended December 31, 2018, 2017 and 2016, the Company recorded expense related to collaboration agreements with Astellas of $1.5 million, $1.0 million and $6.4 million, respectively. As of December 31, 2018 and 2017, accounts receivable from Astellas were $47.2 million and $4.0 million, respectively, and amounts due to Astellas were $0.4 million and $0.3 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. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 2016 Europe $ 112,916 $ 110,861 $ 151,736 Japan (related party) 100,002 20,111 31,323 All other 40 24 130 Total revenue $ 212,958 $ 130,996 $ 183,189 Geographic Long-Lived Assets Property and equipment, net by geographic location are as follows (in thousands): December 31, 2018 2017 United States $ 103,539 $ 107,228 China 23,659 22,248 Total property and equipment $ 127,198 $ 129,476 Customer Concentration Substantially all of the Company’s revenues to date have been generated from the following collaboration partners that respectively accounted for more than 10% of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2018 2017 2016 2018 2017 Astellas—Related party 47 % 15 % 17 % 74 % 47 % AstraZeneca 53 % 85 % 83 % 26 % 53 % |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2018 | |
Valuation And Qualifying Accounts [Abstract] | |
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, 2018 $ 159,540 $ 34,447 $ — $ — $ 193,987 Year ended December 31, 2017 $ 128,995 $ 11,039 $ 19,506 $ — $ 159,540 Year ended December 31, 2016 $ 116,718 $ 12,277 $ — $ — $ 128,995 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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 |
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. A portion of cash on hand is invested in a diversified portfolio of investment grade corporate bonds issued by U.S. corporations as rated investment grade corporate bonds. 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, 2018 2017 Astellas Pharma Inc. (“Astellas”)—Related party 74 % 47 % AstraZeneca AB (“AstraZeneca”) 26 % 53 % 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 include money market accounts, various deposit accounts, and money market funds. 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, 2018 and 2017 totaled $4.1 million and $5.2 million, respectively. As of December 31, 2018, a total of $21.9 million of the Company’s cash and cash equivalents is held outside of the U.S. in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations. |
Investments | Investments The Company’s investments consist of available-for-sale debt investments, 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 are considered short-term investments. Those investments with maturities greater than 12 months are considered long-term investments. 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). |
Property and Equipment | Property and Equipment Property and equipment (except for costs of construction of certain long-lived assets — refer to Note 8) are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Computer equipment, laboratory equipment, 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. |
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 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. Product revenue consists 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 is subject to potential future adjustments. This represents a form of variable consideration. With respect to these sales in 2018, the transaction price will be adjusted at the time the roxadustat listed price is issued by the Japanese Ministry of Health, Labour and Welfare to reflect differences between estimated and actual listed price, yield from the manufacture of bulk product tablets, and bulk product manufacturing costs. The Company evaluates the latest available facts and circumstances, 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 is necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. 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. |
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. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. Other general and administrative expenses include facility-related costs and professional fees, accounting and legal services, other outside services, 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 options was estimated using the following assumptions: Expected Term. Expected Volatility. Risk-Free Interest Rate. Expected Dividend Yield. |
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 New Revenue Standards In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue Recognition Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company adopted the new revenue standards as of January 1, 2018 using the full retrospective method, which required the Company to recast the prior reporting periods presented in the consolidated financial statements. The primary impact upon adoption of the new revenue standards relates to the manner in which revenue is recognized for co-development billings and milestone payments under the Company’s collaboration arrangements. Under the new revenue standards, both of these elements of consideration are considered variable consideration which requires the Company to make estimates of when co-development billings become due or when achievement of a particular milestone becomes probable. Payments are included in the transaction price when it becomes probable that inclusion would not lead to a significant revenue reversal. The Company has recast its consolidated statement of operations and balance sheet from amounts previously reported due to the adoption of the new revenue standards. The adoption of the new revenue standards had no impact to the Company’s previously reported consolidated statement of cash flows. Select line items from the Company’s consolidated statement of operations and balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Year Ended December 31, 2017 Year Ended December 31, 2016 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 96,056 $ (86,123 ) $ 9,933 $ 137,352 $ (86,745 ) $ 50,607 Development and other revenue 29,612 91,451 121,063 42,225 90,357 132,582 Total revenue 125,668 5,328 130,996 179,577 3,612 183,189 Net loss (126,203 ) 5,328 (120,875 ) (61,680 ) 3,612 (58,068 ) Net loss per share - basic and diluted $ (1.73 ) $ 0.07 $ (1.66 ) $ (0.98 ) $ 0.05 $ (0.93 ) December 31, 2017 As Previously Reported New Revenue Standards Adjustment As Recast Balance Sheet Deferred revenue, current $ 7,968 $ 8,702 $ 16,670 Deferred revenue, net of current 112,231 26,010 138,241 Accumulated deficit (595,945 ) (34,712 ) (630,657 ) The adoption of the new revenue standards also resulted in the following changes in the accumulated deficit as of December 31, 2016 and 2015: As Previously Reported New Revenue Standards Adjustment As Recast Accumulated Deficit As of December 31, 2016 $ (469,742 ) $ (40,040 ) $ (509,782 ) As of December 31, 2015 $ (408,062 ) $ (43,652 ) $ (451,714 ) 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 ) * Recast to reflect the adoption of the new revenue standards. See above. The adoption of this guidance had no impact to the Company’s consolidated statement of cash flows for the year ended December 31, 2018. ASU 2017-09 In May 2017, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting ASU 2016-16 In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory |
Recently Issued Accounting Guidance Not Yet Adopted | Recently Issued Accounting Guidance Not Yet Adopted Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax effects from Accumulated Other Comprehensive Income In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In November 2018, the FASB issued 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses ”), which clarifies certain topics included within ASU 2016-13. ASU 2016-13 and ASU 2018-19 are effective for the Leases (Topic 842) Leases (Topic 842): Targeted Improvements (“ ”) , utilize the modified retrospective transition method through a cumulative-effect adjustment at the beginning of the first quarter of 2019. a recognition of approximately $47 million to $62 million in right-of-use assets and approximately $57 million to $67 million in lease liabilities, respectively, upon adoption of this guidance, for its operating leases and facility leases disclosed in Note 8 to its consolidated balance sheets. Accordingly, balances as of December 31, 2018 in property and equipment, net, and long-term portion of lease financing obligations would be removed. The Company |
Collaboration Arrangements | 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, 2018, the transaction price for the Japan Agreement included $40.1 million of non-contingent upfront payments, $37.5 million of variable consideration related to payments for milestones considered probable of being achieved, and $12.1 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, $90.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $180.9 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 is subject to potential future adjustments. This represents a form of variable consideration. The Company evaluates the latest available facts and circumstances to determine whether any adjustments to the estimated transaction price is necessary. As of December 31, 2018, no new facts or circumstances were available to warrant an adjustment to the transaction price. 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, 2018, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $42.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $621.6 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 of the agreement as services are provided. Items (3)-(4) 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 delivering 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. (5) Manufacturing commercial supplies of products. This promise is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based royalties related predominately to the license of intellectual property under the agreement. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. To date, no such revenue has been recognized. China Agreement: The performance obligation that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows: • License to the Company’s technology existing at the effective date of the agreement. The license was delivered at the beginning of the agreement term. However, the China Agreement with AstraZeneca has contractual limitations that might affect AstraZeneca’s ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is distinct in the context of the agreement. In the China Agreement, AstraZeneca does not have the right to manufacture commercial supplies of the drug. In order to determine whether this characteristic of the arrangement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of AstraZeneca to benefit from the license on its own or together with other resources readily available to AstraZeneca. For the China Agreement, the Company retained manufacturing rights as an essential part of a strategy to pursue domestic regulatory pathway for product approval which requires the regulatory licensure of the manufacturing facility in order to commence commercial shipment. The prospects for the collaboration as a whole would have been substantially different had manufacturing rights been provided to AstraZeneca. Due to certain regulatory restrictions in China, manufacturing services of commercial drug product in China are not readily available to AstraZeneca or any other parties. Therefore, AstraZeneca cannot benefit from the license on its own or together with other readily available resources. Accordingly, all the promises identified, including co-development services, under the China Agreement have been bundled into a single performance obligation and amounts of the transaction price allocable to this performance obligation are deferred until control of the manufactured commercial drug product has begun to transfer to AstraZeneca. Upon commencement of the transfer of control to commercial drug product, revenue would be recognized in a pattern consistent with estimated deliveries of the commercial drug product. |
Product Revenue | Product Revenue 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. |
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, 2018. |
Deferred Revenue | Deferred Revenue Deferred revenue represents amounts 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. The long term portion of deferred revenue also 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, which is not expected to occur within the next year. |
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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Astellas Pharma Inc. (“Astellas”)—Related party 74 % 47 % AstraZeneca AB (“AstraZeneca”) 26 % 53 % |
Schedule of Adoption of New Revenue Standards | Select line items from the Company’s consolidated statement of operations and balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Year Ended December 31, 2017 Year Ended December 31, 2016 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 96,056 $ (86,123 ) $ 9,933 $ 137,352 $ (86,745 ) $ 50,607 Development and other revenue 29,612 91,451 121,063 42,225 90,357 132,582 Total revenue 125,668 5,328 130,996 179,577 3,612 183,189 Net loss (126,203 ) 5,328 (120,875 ) (61,680 ) 3,612 (58,068 ) Net loss per share - basic and diluted $ (1.73 ) $ 0.07 $ (1.66 ) $ (0.98 ) $ 0.05 $ (0.93 ) December 31, 2017 As Previously Reported New Revenue Standards Adjustment As Recast Balance Sheet Deferred revenue, current $ 7,968 $ 8,702 $ 16,670 Deferred revenue, net of current 112,231 26,010 138,241 Accumulated deficit (595,945 ) (34,712 ) (630,657 ) |
Schedule of Impacts to Accumulated Other Comprehensive Loss and Accumulated Deficit Upon Adoption of 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 ) * Recast to reflect the adoption of the new revenue standards. See above. |
Accumulated Deficit [Member] | |
Accounting Policy [Line Items] | |
Schedule of Adoption of New Revenue Standards | The adoption of the new revenue standards also resulted in the following changes in the accumulated deficit as of December 31, 2016 and 2015: As Previously Reported New Revenue Standards Adjustment As Recast Accumulated Deficit As of December 31, 2016 $ (469,742 ) $ (40,040 ) $ (509,782 ) As of December 31, 2015 $ (408,062 ) $ (43,652 ) $ (451,714 ) |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Japan [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2018 2017 * 2016 * Japan License revenue $ 14,323 $ — $ 9,548 Development revenue $ 2,400 $ 1,588 $ 4,288 * Recast to reflect the adoption of the new revenue standards. See Note 2. |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands): Japan Agreement Cumulative Revenue Through December 31, 2018 Deferred Revenue at December 31, 2018 Total Consideration Through December 31, 2018 License $ 74,089 $ — $ 74,089 Development revenue 13,908 286 14,194 Total license and development revenue $ 87,997 $ 286 $ 88,283 |
Europe [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2018 2017 * 2016 * Europe License revenue $ — $ — $ — Development revenue $ 18,503 $ 18,523 $ 17,487 * Recast to reflect the adoption of the new revenue standards. See Note 2. |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement, along with any associated deferred revenue as follows (in thousands): Europe Agreement Cumulative Revenue Through December 31, 2018 Deferred Revenue at December 31, 2018 Total Consideration Through December 31, 2018 License $ 370,481 $ — $ 370,481 Development revenue 202,836 3,225 206,061 Total license and development revenue $ 573,317 $ 3,225 $ 576,542 |
U.S./RoW and China [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW and China Agreements were as follows (in thousands): Years Ended December 31, Agreement Performance Obligation 2018 2017 * 2016 * U.S. / RoW and China License revenue $ 7,946 $ 9,933 $ 41,059 Development revenue $ 104,970 $ 100,928 $ 110,677 China performance obligation $ — $ — $ — * Recast to reflect the adoption of the new revenue standards. See Note 2 . |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands): U.S. / RoW and China Agreements Cumulative Revenue Through December 31, 2018 Deferred Revenue at December 31, 2018 Total Consideration Through December 31, 2018 License $ 294,163 $ — $ 294,163 Co-development, information sharing & committee services 408,637 20,521 429,158 China performance obligation — 125,848 125,848 Total license and development revenue $ 702,800 $ 146,369 $ 849,169 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 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 December 31, 2017 Level 1 Level 2 Level 3 Total Corporate bonds $ — $ 53,943 $ — $ 53,943 Bond and mutual funds 18,402 — — 18,402 Equity investments 221 — — 221 Money market funds 569,942 — — 569,942 Total $ 588,565 $ 53,943 $ — $ 642,508 |
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, 2018 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,105 $ 98,105 December 31, 2017 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,476 $ 98,476 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Cash $ 38,783 $ 103,716 US treasury notes and bills 49,934 — Money market funds 541 569,942 Total cash and cash equivalents $ 89,258 $ 673,658 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2018 2017 Leasehold improvements $ 101,200 $ 93,758 Building shell (Refer to Note 8) 53,880 53,879 Laboratory equipment 16,405 19,497 Machinery 8,382 — Computer equipment 6,473 6,006 Furniture and fixtures 5,690 5,575 Construction in progress 367 10,402 Total property and equipment $ 192,397 $ 189,117 Less: accumulated depreciation (65,199 ) (59,641 ) Property and equipment, net $ 127,198 $ 129,476 |
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, 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 December 31, 2017 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 53,985 $ 4 $ (46 ) $ 53,943 Bond and mutual funds 17,249 1,153 — 18,402 Equity investments 126 95 — 221 Total investments $ 71,360 $ 1,252 $ (46 ) $ 72,566 |
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, 2018 Within one year $ 532,144 After one year through four years 45,102 Total debt investments 577,246 Bond and mutual funds 10,484 Equity investments 234 Total investments $ 587,964 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2018 2017 Preclinical and clinical trial accruals $ 35,413 $ 32,321 Payroll and related accruals 21,430 18,810 Property taxes and other 1,095 4,201 Professional services 2,648 1,991 Other 5,537 6,458 Total accrued liabilities $ 66,123 $ 63,781 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
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 are 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 are 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 |
Equity and Stock-based Compen_2
Equity and Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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 RSUs grant and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands): December 31, 2018 2017 Common stock outstanding 85,432 82,498 Stock options outstanding 10,430 11,550 RSUs outstanding 1,428 1,562 Common stock warrants outstanding 4 4 Shares reserved for future stock options and RSUs grant 6,041 4,190 Shares reserved for future ESPP offering 2,618 2,024 Total shares of common stock reserved 105,953 101,828 |
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, 2017 11,550 $ 14.82 Granted 1,307 53.64 Exercised (2,271 ) 11.20 Expired (7 ) 5.82 Forfeited (149 ) 30.55 Outstanding at December 31, 2018 10,430 20.25 5.47 $ 281,436 Vested and expected to vest, December 31, 2018 10,430 20.25 5.47 281,436 Exercisable at December 31, 2018 7,644 $ 13.83 4.47 $ 248,206 |
Summary of RSU Activity | The following table summarizes RSU activity: Shares (In thousands) Fair Value at Grant Unvested at December 31, 2017 1,562 $ 24.75 Granted 706 53.69 Vested (727 ) 24.70 Forfeited (113 ) 35.12 Unvested at December 31, 2018 1,428 $ 38.26 |
Schedule of Allocated Stock-Based Compensation Expense | Stock-based compensation expense allocated to research and development and general and administrative expense for the years ended December 31, 2018, 2017 and 2016 was as follows (in thousands): Years Ended December 31, 2018 2017 2016 Research and development $ 30,491 $ 21,807 $ 19,070 General and administrative 21,651 15,732 13,062 Total stock-based compensation expense $ 52,142 $ 37,539 $ 32,132 |
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, 2018 2017 2016 Stock Options Expected term (in years) 5.4 5.7 5.3 Expected volatility 67.9 % 71.5 % 69.9 % Risk-free interest rate 2.7 % 2.2 % 1.4 % Expected dividend yield — — — Weighted average estimated fair value $ 32.12 $ 16.96 $ 11.49 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.3 - 75.3 % 52.8 - 77.2 % 61.9 - 80.7 % Risk-free interest rate 0.8 - 2.9 % 0.5 - 1.6 % 0.2 - 1.0 % Expected dividend yield — — — Weighted average estimated fair value $ 16.27 $ 9.41 $ 9.94 |
Schedule of Warrants to Purchase Shares of Common Stock | The following warrants to purchase shares of Common Stock were issued in connection with certain facility and equipment lease financing arrangements and are outstanding at December 31, 2018: Year of Issuance Number of Shares Exercise Price per Share Reason for Issuance Expiration Date 2000 4,430 $ 15.00 Issued in connection with lease agreement Five years after initial public offering or upon merger or sale of the Company’s assets, whichever occurs first 4,430 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following 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, 2018 2017 2016 Employee stock options 10,430 11,550 13,660 RSUs outstanding 1,428 1,562 1,211 Warrants 4 4 4 11,862 13,116 14,875 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 * 2016 * Domestic $ (38,472 ) $ (80,735 ) $ (25,342 ) Foreign (47,644 ) (39,819 ) (32,797 ) Loss before provision for income taxes $ (86,116 ) $ (120,554 ) $ (58,139 ) |
Schedule of Components of Provision For (Benefit From) Income Taxes | The provision for (benefit from) income taxes consists of the following (in thousands): Years Ended December 31, 2018 2017 2016 Current: Federal $ — $ — $ — State 2 2 2 Foreign 302 319 139 Total current 304 321 141 Deferred: Federal — — (212 ) State — — — Foreign — — — Total deferred — — (212 ) Total provision for (benefit from) income taxes $ 304 $ 321 $ (71 ) |
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, 2018 2017 2016 Tax at statutory federal rate 21.0 % 34.0 % 34.0 % State tax — % — % — % Stock-based compensation expense 14.5 % 18.5 % (7.9 )% 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 (23.2 )% (43.8 )% (12.9 )% Foreign net operating losses not benefitted (11.6 )% (6.7 )% (13.0 )% Orphan drug credit 0.0 % (2.0 )% — % Other (1.1 )% (0.3 )% (0.1 )% Total (0.4 )% (0.3 )% 0.1 % |
Schedule of Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2018 2017 Federal and state net operating loss carryforwards $ 91,683 $ 71,256 Tax credit carryforwards 45,885 39,488 Foreign net operating loss carryforwards 21,295 15,052 Stock-based compensation 9,281 7,835 Lease obligations 2,511 2,737 Reserves and accruals 6,072 4,851 Deferred revenue 16,454 18,103 Fixed assets 356 — Other 450 420 Subtotal 193,987 159,742 Less: Valuation allowance (193,987 ) (159,540 ) Net deferred tax assets — 202 Fixed assets — (181 ) Other — (21 ) Net deferred tax liabilities — (202 ) 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, 2018 is as follows (in thousands): Federal Balance as of December 31, 2015 $ 24,213 Decrease due to prior positions (7,109 ) Increase due to current year position 2,550 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 |
Segment and Geographic Inform_2
Segment and Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 2016 Europe $ 112,916 $ 110,861 $ 151,736 Japan (related party) 100,002 20,111 31,323 All other 40 24 130 Total revenue $ 212,958 $ 130,996 $ 183,189 |
Schedule of Long Lived Assets by Geographic Area | Property and equipment, net by geographic location are as follows (in thousands): December 31, 2018 2017 United States $ 103,539 $ 107,228 China 23,659 22,248 Total property and equipment $ 127,198 $ 129,476 |
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 more than 10% of the Company’s total revenue and accounts receivable: Percentage of Revenue Percentage of Accounts Receivable Years Ended December 31, December 31, 2018 2017 2016 2018 2017 Astellas—Related party 47 % 15 % 17 % 74 % 47 % AstraZeneca 53 % 85 % 83 % 26 % 53 % |
The Company - Additional Inform
The Company - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Aug. 24, 2017 | Apr. 11, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Business Description [Line Items] | |||||
Net proceeds from offering | $ 29,847 | $ 34,910 | $ 9,881 | ||
Follow On Offering | |||||
Business Description [Line Items] | |||||
Common stock shares sold | 9,200,000 | 5,228,750 | |||
Public offering price | $ 40.75 | $ 22.95 | |||
Net proceeds from offering | $ 356,200 | $ 115,100 | |||
Underwriting discounts and commissions | 18,700 | 4,900 | |||
Offering expenses | $ 400 | $ 600 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) | Dec. 31, 2016 |
Accounting Policy [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Highly liquid investment maturity period | three months or less | |||
Restricted time deposits | $ 4,145,000 | $ 5,181,000 | ||
Cash and cash equivalents | $ 89,258,000 | $ 673,658,000 | ||
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% | 34.00% | 34.00% | |
ASU 2018-02 [Member] | Accumulated Deficit [Member] | Subsequent Event [Member] | ||||
Accounting Policy [Line Items] | ||||
Cumulative effect on accumulated deficit | $ 600,000 | |||
Minimum [Member] | ASU 2016-02 [Member] | ||||
Accounting Policy [Line Items] | ||||
Right-of-use assets | $ 47,000,000 | |||
Lease liabilities | $ 57,000,000 | |||
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] | 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] | ASU 2016-02 [Member] | ||||
Accounting Policy [Line Items] | ||||
Right-of-use assets | $ 62,000,000 | |||
Lease liabilities | $ 67,000,000 | |||
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] | 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 | $ 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, 2018 | Dec. 31, 2017 | |
Astellas Agreement [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 74.00% | 47.00% |
AstraZeneca Agreements [Member] | ||
Accounting Policy [Line Items] | ||
Concentration risk, percentage | 26.00% | 53.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Adoption of New Revenue Standards (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Operations | ||||
Total revenue | $ 212,958 | $ 130,996 | $ 183,189 | |
Net loss | $ (86,420) | $ (120,875) | $ (58,068) | |
Net loss per share - basic and diluted | $ (1.03) | $ (1.66) | $ (0.93) | |
Balance Sheet | ||||
Deferred revenue | $ 13,771 | $ 16,670 | ||
Deferred revenue, net of current | 136,109 | 138,241 | ||
Accumulated deficit | (715,827) | (630,657) | $ (509,782) | $ (451,714) |
License Revenue [Member] | ||||
Statement of Operations | ||||
Total revenue | 22,269 | 9,933 | 50,607 | |
Development and Other Revenue [Member] | ||||
Statement of Operations | ||||
Total revenue | $ 125,913 | 121,063 | 132,582 | |
As Previously Reported [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | 125,668 | 179,577 | ||
Net loss | $ (126,203) | $ (61,680) | ||
Net loss per share - basic and diluted | $ (1.73) | $ (0.98) | ||
Balance Sheet | ||||
Deferred revenue | $ 7,968 | |||
Deferred revenue, net of current | 112,231 | |||
Accumulated deficit | (595,945) | $ (469,742) | (408,062) | |
As Previously Reported [Member] | License Revenue [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | 96,056 | 137,352 | ||
As Previously Reported [Member] | Development and Other Revenue [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | 29,612 | 42,225 | ||
New Revenue Standards Adjustment [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | 5,328 | 3,612 | ||
Net loss | $ 5,328 | $ 3,612 | ||
Net loss per share - basic and diluted | $ 0.07 | $ 0.05 | ||
Balance Sheet | ||||
Deferred revenue | $ 8,702 | |||
Deferred revenue, net of current | 26,010 | |||
Accumulated deficit | (34,712) | $ (40,040) | $ (43,652) | |
New Revenue Standards Adjustment [Member] | License Revenue [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | (86,123) | (86,745) | ||
New Revenue Standards Adjustment [Member] | Development and Other Revenue [Member] | ASU 2014-09 [Member] | ||||
Statement of Operations | ||||
Total revenue | $ 91,451 | $ 90,357 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Adoption of New Revenue Standards Changes in Accumulated Deficit (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Accumulated deficit | $ (715,827) | $ (630,657) | $ (509,782) | $ (451,714) |
As Previously Reported [Member] | ASU 2014-09 [Member] | ||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Accumulated deficit | (595,945) | (469,742) | (408,062) | |
New Revenue Standards Adjustment [Member] | ASU 2014-09 [Member] | ||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Accumulated deficit | $ (34,712) | $ (40,040) | $ (43,652) |
Summary of Significant Accoun_8
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, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | $ (2,281) | $ (1,795) | |||
Accumulated deficit | $ (715,827) | $ (630,657) | $ (509,782) | $ (451,714) | |
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 2016-01 [Member] | ASU 2016-01 [Member] | |||||
Accounting Policy [Line Items] | |||||
Accumulated other comprehensive loss | (1,250) | ||||
Accumulated deficit | $ 1,250 |
Collaboration Agreements - Aste
Collaboration Agreements - Astellas Agreements - Additional Information (Detail) - Astellas Agreement [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | 35 Months Ended | 45 Months Ended | ||
Dec. 31, 2018 | Apr. 30, 2006 | Jun. 30, 2005 | Jun. 30, 2018 | Dec. 31, 2018 | Feb. 28, 2009 | Feb. 28, 2009 | |
Japan [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront, non-contingent and time-based payments received | $ 40.1 | ||||||
Development and regulatory approval milestones | $ 117.5 | ||||||
Commercial sales milestone | $ 15 | ||||||
Additional consideration based on net sales description | Low 20% range | ||||||
Consideration associated with milestone included in transaction price | $ 15 | ||||||
Contract with customer liability, revenue recognized | $ 43.9 | $ 20.9 | |||||
Europe [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront, non-contingent and time-based payments received | $ 320 | ||||||
Development and regulatory approval milestones | $ 425 | ||||||
Additional consideration based on net sales description | 0 | ||||||
Percentage of joint development costs committed to fund | 50.00% | ||||||
Estimated joint development extended service period | 2,023 |
Collaboration Agreements - Astr
Collaboration Agreements - AstraZeneca Agreements - Additional Information 1 (Detail) - AstraZeneca Agreements [Member] - USD ($) $ in Millions | Dec. 29, 2018 | Dec. 17, 2018 | Jul. 30, 2013 | Dec. 31, 2018 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2015 |
U.S./RoW [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Expected upfront, non-contingent and time-based payments | $ 374 | |||||||
Development and regulatory approval milestones | 550 | |||||||
Commercial sales milestone | 325 | |||||||
Shared development costs | $ 233 | |||||||
Additional consideration based on net sales description | Low 20% range | |||||||
U.S./RoW [Member] | FibroGen, Inc. [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Shared development costs | $ 116.5 | |||||||
China [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Development and regulatory approval milestones | 161 | |||||||
Commercial sales milestone | 167.5 | |||||||
Proceeds from upfront payments | 28.2 | |||||||
Contingent payment | $ 20 | |||||||
Estimated joint development service period | 2,018 | |||||||
Estimated joint development extended service period | 2,020 | 2,024 | ||||||
Milestone payment, revenue recognition | $ 6 | $ 6 | $ 9.9 | $ 15 | $ 12 |
Collaboration Agreements - Acco
Collaboration Agreements - Accounting for the Astellas Agreements - Additional Information 2 (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 212,958,000 | $ 130,996,000 | $ 183,189,000 |
Astellas Agreement [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Co-development services, currently estimated continuation year | 2,023 | ||
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 | 37,500,000 | ||
Variable consideration related to co-development billings | 12,100,000 | ||
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 | 90,000,000 | ||
Variable consideration related to co-development billings | $ 180,900,000 |
Collaboration Agreements - Ac_2
Collaboration Agreements - Accounting for the AstraZeneca Agreements - Additional Information 3 (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Manufacturing commercial supplies of products, revenue recognized | $ 212,958,000 | $ 130,996,000 | $ 183,189,000 |
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 | 2,024 | ||
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 | 42,000,000 | ||
Variable consideration related to co-development billings | $ 621,600,000 |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | $ 212,958 | $ 130,996 | $ 183,189 |
License Revenue [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 22,269 | 9,933 | 50,607 |
Development Revenue [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 125,913 | 121,063 | 132,582 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 14,323 | 0 | 9,548 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 0 | 0 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 2,400 | 1,588 | 4,288 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 18,503 | 18,523 | 17,487 |
AstraZeneca Agreements [Member] | China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 0 | 0 | 0 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | 7,946 | 9,933 | 41,059 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Total revenue | $ 104,970 | $ 100,928 | $ 110,677 |
Collaboration Agreements - Tran
Collaboration Agreements - Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Astellas Agreement [Member] | Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | $ 87,997 |
Deferred Revenue | 286 |
Total Consideration | 88,283 |
Astellas Agreement [Member] | Japan [Member] | License Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 74,089 |
Deferred Revenue | 0 |
Total Consideration | 74,089 |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 13,908 |
Deferred Revenue | 286 |
Total Consideration | 14,194 |
Astellas Agreement [Member] | Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 573,317 |
Deferred Revenue | 3,225 |
Total Consideration | 576,542 |
Astellas Agreement [Member] | Europe [Member] | License Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 370,481 |
Deferred Revenue | 0 |
Total Consideration | 370,481 |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 202,836 |
Deferred Revenue | 3,225 |
Total Consideration | 206,061 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 702,800 |
Deferred Revenue | 146,369 |
Total Consideration | 849,169 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | License Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 294,163 |
Deferred Revenue | 0 |
Total Consideration | 294,163 |
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 | 408,637 |
Deferred Revenue | 20,521 |
Total Consideration | 429,158 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | China performance obligation [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 0 |
Deferred Revenue | 125,848 |
Total Consideration | $ 125,848 |
Collaboration Agreements - Su_2
Collaboration Agreements - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 1.4 |
Japan [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 14.9 |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | 14.3 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 0.6 |
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 | 197.4 |
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 | $ 20.2 |
Collaboration Agreements - Prod
Collaboration Agreements - Product Revenue - Additional Information 5 (Detail) - Astellas Agreement [Member] - Japan [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with customer liability, revenue recognized | $ 43.9 | $ 20.9 | |
Product Revenue [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Contract with customer liability, revenue recognized | $ 64.8 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 587,964 | $ 72,566 |
US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 467,336 | |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,484 | 18,402 |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 234 | 221 |
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 | 29,910 | |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 53,943 | |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 638,439 | 642,508 |
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 | 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 | 10,484 | 18,402 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 234 | 221 |
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 | 541 | 569,942 |
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 | 29,910 | |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 53,943 | |
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 | 303,576 | 588,565 |
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 | 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 | 10,484 | 18,402 |
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 | 234 | 221 |
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 | 541 | 569,942 |
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 | |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 334,863 | 53,943 |
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 | 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 | 29,910 | |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 53,943 | |
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 | |
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 | |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Values of Financial Liabilities Carried at Historical Cost (Detail) - Lease financing obligations [Member] - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 98,105 | $ 98,476 |
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 | $ 98,105 | $ 98,476 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 | $ 0 |
Transfers of assets from level 2 to 1 | 0 | 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 assets into level 3 | 0 | 0 | 0 |
Transfers of assets out of level 3 | 0 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 | $ 0 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 38,783 | $ 103,716 |
US treasury notes and bills | 49,934 | 0 |
Money market funds | 541 | 569,942 |
Total cash and cash equivalents | $ 89,258 | $ 673,658 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 192,397 | $ 189,117 |
Less: accumulated depreciation | (65,199) | (59,641) |
Property and equipment, net | 127,198 | 129,476 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 101,200 | 93,758 |
Building shell [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 53,880 | 53,879 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 16,405 | 19,497 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,382 | 0 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,473 | 6,006 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 5,690 | 5,575 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 367 | $ 10,402 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |||
Depreciation | $ 6,562 | $ 6,099 | $ 6,040 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 587,885 | $ 71,360 |
Gross Unrealized Holding Gains | 238 | 1,252 |
Gross Unrealized Holding Losses | (159) | (46) |
Fair Value | 587,964 | 72,566 |
US treasury notes and bills [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 467,296 | |
Gross Unrealized Holding Gains | 109 | |
Gross Unrealized Holding Losses | (69) | |
Fair Value | 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 | |
Certificates of deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,000 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (90) | |
Fair Value | 29,910 | |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 53,985 | |
Gross Unrealized Holding Gains | 4 | |
Gross Unrealized Holding Losses | (46) | |
Fair Value | 53,943 | |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,464 | 17,249 |
Gross Unrealized Holding Gains | 20 | 1,153 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 10,484 | 18,402 |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 126 |
Gross Unrealized Holding Gains | 109 | 95 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 234 | $ 221 |
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, 2018 | Dec. 31, 2017 |
Investments Schedule [Abstract] | ||
Within one year | $ 532,144 | |
After one year through four years | 45,102 | |
Total debt investments | 577,246 | |
Bond and mutual funds | 10,484 | |
Equity investments | 234 | |
Total investments | $ 587,964 | $ 72,566 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 35,413 | $ 32,321 |
Payroll and related accruals | 21,430 | 18,810 |
Property taxes and other | 1,095 | 4,201 |
Professional services | 2,648 | 1,991 |
Other | 5,537 | 6,458 |
Total accrued liabilities | $ 66,123 | $ 63,781 |
Product Development Obligatio_2
Product Development Obligations - Additional Information (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2018USD ($)DevelopmentObligation | Dec. 31, 2017USD ($) | |
Debt Instrument [Line Items] | ||
Number of product development obligations | DevelopmentObligation | 11 | |
Accrued product development costs excluding interest | $ 10.8 | $ 11.3 |
Accrued Interest | $ 6 | $ 5.9 |
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% |
Convertible Note Payable - Addi
Convertible Note Payable - Additional Information (Detail) - FibroGen China [Member] - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2013 | Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | |||
Convertible promissory note | $ 0.6 | ||
Interest rate of convertible promissory note | 2.00% | ||
Anniversary date of promissory note | 8 years | ||
Other Long Term Liabilities [Member] | |||
Debt Instrument [Line Items] | |||
Total outstanding principal balance and accrued interest | $ 0.7 | $ 0.6 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,019 | $ 444 |
2,020 | 232 |
2,021 | 25 |
2,022 | 16 |
2,023 | 0 |
Total minimum payments | $ 717 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Feb. 28, 2013USD ($)ft² | Sep. 30, 2006USD ($)ft²$ / ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jun. 30, 2012USD ($) | |
Commitments And Contingencies [Line Items] | |||||||||
Restricted time deposits | $ 4,145 | $ 5,181 | $ 4,145 | $ 5,181 | |||||
FibroGen, Inc. [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Land subject to leases | ft² | 234,249 | ||||||||
Initial term of lease contract | 15 years | ||||||||
Restricted time deposits | $ 7,300 | ||||||||
Percentage of letter of credit released | 0.125% | ||||||||
Description of lessee leasing arrangements, operating leases | The agreement included an expansion option to occupy part of an adjacent building within 31 months of the lease commencement date of November 20, 2008. | ||||||||
Lease incentive receivable from land lord through expansion option not used | $ 5,000 | ||||||||
Percentage of construction costs for tenant improvement | 60.00% | ||||||||
Tenant improvement price per square foot of rental space | $ / ft² | 140.50 | ||||||||
Tenant improvements allowance of rental space | $ 32,500 | ||||||||
Cost of construction capitalized | 50,800 | ||||||||
Reimbursements from landlord for tenant improvements | $ 32,500 | ||||||||
FibroGen, Inc. [Member] | Reclassified from Restricted Cash to Short-term Investments [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Prior period reclassification adjustment | $ 1,000 | $ 1,000 | $ 1,000 | ||||||
FibroGen China [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Land subject to leases | ft² | 4,820 | ||||||||
Initial term of lease contract | 8 years | ||||||||
Percentage of construction costs for tenant improvement | 100.00% | ||||||||
Cost of construction capitalized | $ 3,100 | ||||||||
Reimbursements from landlord for tenant improvements | $ 500 | ||||||||
Lease starting date | Feb. 1, 2013 | ||||||||
Rent expenses for leased facilities | $ 3,100 | 3,000 | $ 2,800 | ||||||
FibroGen China [Member] | Research and Development Expenses and General and Administrative Expenses [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Sublease income received | $ 3,500 | $ 3,900 | $ 3,800 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,019 | $ 14,379 |
2,020 | 14,664 |
2,021 | 14,179 |
2,022 | 14,335 |
2,023 | 12,872 |
Total minimum payments | $ 70,429 |
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, 2018 | Dec. 31, 2017 | 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 | 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, 2018 | |
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 shares in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Class Of Stock [Line Items] | ||
Common stock outstanding | 85,432 | 82,498 |
Stock options outstanding | 10,430 | 11,550 |
RSUs outstanding | 1,428 | 1,562 |
Common stock warrants outstanding | 4 | 4 |
Shares reserved for future stock options and RSUs grant | 6,041 | 4,190 |
Total shares of common stock reserved | 105,953 | 101,828 |
ESPP [Member] | ||
Class Of Stock [Line Items] | ||
Shares reserved for future ESPP offering | 2,618 | 2,024 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total intrinsic value of options exercised | $ 248,206 | |||
RSUs released and issued net of shares withheld for taxes | 432,472 | |||
Weighted-average fair value of awards granted | $ 53.69 | $ 26.59 | $ 19.37 | |
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 | 6,040,725 | |||
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, 2018, the Company has reserved 6,040,725 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 | $ 97,500 | $ 111,900 | $ 17,900 | |
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, 2018USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Outstanding, Beginning Balance, Shares | shares | 11,550 |
Granted, Shares | shares | 1,307 |
Exercised, Shares | shares | (2,271) |
Expired, Shares | shares | (7) |
Forfeited, Shares | shares | (149) |
Outstanding, Ending Balance, Shares | shares | 10,430 |
Vested and expected to vest, Shares | shares | 10,430 |
Exercisable, Shares | shares | 7,644 |
Outstanding, Beginning Balance, Weighted Average Exercise per Share | $ / shares | $ 14.82 |
Granted, Weighted Average Exercise per Share | $ / shares | 53.64 |
Exercised, Weighted Average Exercise per Share | $ / shares | 11.20 |
Expired, Weighted Average Exercise per Share | $ / shares | 5.82 |
Forfeited, Weighted Average Exercise per Share | $ / shares | 30.55 |
Outstanding, Ending Balance, Weighted Average Exercise per Share | $ / shares | 20.25 |
Vested and expected to vest, Weighted Average Exercise per Share | $ / shares | 20.25 |
Exercisable, Weighted Average Exercise per Share | $ / shares | $ 13.83 |
Outstanding, Weighted Average Remaining Contractual Life | 5 years 5 months 19 days |
Vested and expected to vest, Weighted Average Remaining Contractual Life | 5 years 5 months 19 days |
Exercisable, Weighted Average Remaining Contractual Life | 4 years 5 months 19 days |
Outstanding, Aggregate Intrinsic Value | $ | $ 281,436 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 281,436 |
Exercisable, Aggregate Intrinsic Value | $ | $ 248,206 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,562 | ||
Unvested, Shares, Ending Balance | 1,428 | 1,562 | |
Granted, Fair value at Grant | $ 53.69 | $ 26.59 | $ 19.37 |
Restricted Stock Unit [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested, Shares, Beginning Balance | 1,562 | ||
Granted, Shares | 706 | ||
Vested, Shares | (727) | ||
Forfeited, Shares | (113) | ||
Unvested, Shares, Ending Balance | 1,428 | 1,562 | |
Unvested, Fair value at Grant, Beginning Balance | $ 24.75 | ||
Granted, Fair value at Grant | 53.69 | ||
Vested, Fair value at Grant | 24.70 | ||
Forfeited, Fair value at Grant | 35.12 | ||
Unvested, Fair value at Grant, Ending Balance | $ 38.26 | $ 24.75 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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 | 230,317 | 250,834 | 266,720 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 52,142 | $ 37,539 | $ 32,132 |
Research and development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 30,491 | 21,807 | 19,070 |
General and administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 21,651 | $ 15,732 | $ 13,062 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee stock options [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 4 months 24 days | 5 years 8 months 12 days | 5 years 3 months 18 days |
Expected volatility | 67.90% | 71.50% | 69.90% |
Risk-free interest rate | 2.70% | 2.20% | 1.40% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 32.12 | $ 16.96 | $ 11.49 |
Employee stock purchase plans [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected volatility, minimum | 47.30% | 52.80% | 61.90% |
Expected volatility, maximum | 75.30% | 77.20% | 80.70% |
Risk-free interest rate, minimum | 0.80% | 0.50% | 0.20% |
Risk-free interest rate, maximum | 2.90% | 1.60% | 1.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 16.27 | $ 9.41 | $ 9.94 |
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, 2018USD ($) | |
Stock Option Awards [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 46.6 |
Non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period | 2 years 2 months 26 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 24 days |
Unrecognized compensation costs | $ 40.9 |
Equity and Stock-based Compe_13
Equity and Stock-based Compensation - Schedule of Warrants to Purchase Shares of Common Stock (Detail) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Number of Shares | 4,430 |
Year of Issuance 2000 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Year of Issuance | 2,000 |
Number of Shares | 4,430 |
Exercise Price per Share | $ / shares | $ 15 |
Reason for Issuance | Issued in connection with lease agreement |
Expiration Date | Five years after initial public offering or upon merger or sale of the Company’s assets, whichever occurs first |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 11,862 | 13,116 | 14,875 |
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 | 10,430 | 11,550 | 13,660 |
RSUs outstanding [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 1,428 | 1,562 | 1,211 |
Warrants [Member] | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of net loss per share | 4 | 4 | 4 |
FibroGen, Inc. 401(k) Plan - Ad
FibroGen, Inc. 401(k) Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Compensation And Retirement Disclosure [Abstract] | |||
Defined contribution plan, maximum annual contributions per employee, percent | 60.00% | ||
Defined contribution plan, employer matching contributions | $ 2.9 | $ 2.5 | $ 2.3 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Components Of Income Tax Expense Benefit Continuing Operations [Abstract] | |||
Domestic | $ (38,472) | $ (80,735) | $ (25,342) |
Foreign | (47,644) | (39,819) | (32,797) |
Loss before income taxes | $ (86,116) | $ (120,554) | $ (58,139) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Provision For (Benefit From) Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 2 | 2 | 2 |
Foreign | 302 | 319 | 139 |
Total current | 304 | 321 | 141 |
Deferred: | |||
Federal | 0 | 0 | (212) |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | (212) |
Total provision for (benefit from) income taxes | $ 304 | $ 321 | $ (71) |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Tax at statutory federal rate | 21.00% | 34.00% | 34.00% |
State tax | 0.00% | 0.00% | 0.00% |
Stock-based compensation expense | 14.50% | 18.50% | (7.90%) |
Change in deferred tax assets due to rate change | 0.00% | 43.90% | 0.00% |
Change in valuation allowance due to rate change | 0.00% | (43.90%) | 0.00% |
Net operating losses not benefitted | (23.20%) | (43.80%) | (12.90%) |
Foreign net operating losses not benefitted | (11.60%) | (6.70%) | (13.00%) |
Orphan drug credit | 0.00% | (2.00%) | 0.00% |
Other | (1.10%) | (0.30%) | (0.10%) |
Total | (0.40%) | (0.30%) | 0.10% |
Income Taxes - Schedule of Sign
Income Taxes - Schedule of Significant Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Components Of Deferred Tax Assets And Liabilities [Abstract] | ||
Federal and state net operating loss carryforwards | $ 91,683 | $ 71,256 |
Tax credit carryforwards | 45,885 | 39,488 |
Foreign net operating loss carryforwards | 21,295 | 15,052 |
Stock-based compensation | 9,281 | 7,835 |
Lease obligations | 2,511 | 2,737 |
Reserves and accruals | 6,072 | 4,851 |
Deferred revenue | 16,454 | 18,103 |
Fixed assets | 356 | 0 |
Other | 450 | 420 |
Subtotal | 193,987 | 159,742 |
Less: Valuation allowance | (193,987) | (159,540) |
Net deferred tax assets | 0 | 202 |
Fixed assets | 0 | (181) |
Other | 0 | (21) |
Net deferred tax liabilities | 0 | (202) |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | |||
Increase in valuation allowance | $ 34,400,000 | $ 30,500,000 | $ 12,300,000 |
Federal and state net operating loss carryforwards | 91,683,000 | 71,256,000 | |
Foreign net operating loss carryforwards | $ 21,295,000 | $ 15,052,000 | |
Tax at statutory federal rate | 21.00% | 34.00% | 34.00% |
Percentage of ownership changes | 0.00% | ||
Unrecognized tax benefits | $ 28,000,000 | ||
Unrecognized tax benefits that would affect effective tax rate | 500,000 | ||
Accrued interest, unrecognized tax benefits | $ 0 | $ 0 | |
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 | 2,009 | ||
Latest Tax Year [Member] | |||
Income Taxes [Line Items] | |||
Foreign statute of limitation generally remains open in the year | 2,018 | ||
ASU 2016-09 [Member] | |||
Income Taxes [Line Items] | |||
Increase in valuation allowance | $ 19,500,000 | ||
Retrospective increase in deferred tax assets for previously unrecognized excess tax benefits | 19,500,000 | ||
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 | $ 86,300,000 | ||
Foreign net operating loss [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards expiration year | 2,019 | ||
Foreign net operating loss [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards expiration year | 2,028 | ||
Federal [Member] | |||
Income Taxes [Line Items] | |||
Federal and state net operating loss carryforwards | $ 400,300,000 | ||
Operating loss carryforwards expiration year | 2,026 | ||
Other tax credit carryforwards | $ 46,400,000 | ||
Other tax credit carryforwards expiration year | 2,019 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Federal and state net operating loss carryforwards | $ 148,100,000 | ||
Operating loss carryforwards expiration year | 2,019 | ||
State [Member] | California [Member] | |||
Income Taxes [Line Items] | |||
Other tax credit carryforwards | $ 26,300,000 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Contingency [Line Items] | |||
Ending Balance | $ 28,000 | ||
Federal and State [Member] | |||
Income Tax Contingency [Line Items] | |||
Beginning balance | 23,361 | $ 19,654 | $ 24,213 |
Decrease due to prior positions | (2,044) | (7,109) | |
Increase due to current year position | 4,216 | 5,448 | 2,550 |
Increase due to prior positions | 379 | 303 | |
Ending Balance | $ 27,956 | $ 23,361 | $ 19,654 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Related Party Transaction [Line Items] | |||
Accounts receivable from related party | $ 47,210 | $ 4,004 | |
Accrued liabilities to related party | 444 | 272 | |
Astellas [Member] | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | 100,000 | 20,100 | $ 31,300 |
Expense related to collaboration agreements | 1,500 | 1,000 | $ 6,400 |
Accounts receivable from related party | 47,200 | 4,000 | |
Accrued liabilities to related party | 400 | $ 300 | |
API Shipment [Member] | Astellas [Member] | Astellas Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Accrued liabilities to related party | 43,800 | ||
Product Revenue [Member] | API Shipment [Member] | Astellas [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | $ 64,800 |
Segment and Geographic Inform_3
Segment and Geographic Information - Additional information (Detail) | 12 Months Ended |
Dec. 31, 2018Segment | |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 212,958 | $ 130,996 | $ 183,189 |
Europe [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 112,916 | 110,861 | 151,736 |
Japan [Member] | Related Party [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | 100,002 | 20,111 | 31,323 |
All other [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue recognized | $ 40 | $ 24 | $ 130 |
Segment and Geographic Inform_5
Segment and Geographic Information - Schedule of Long Lived Assets by Geographic Area (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 127,198 | $ 129,476 |
United States [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | 103,539 | 107,228 |
China [Member] | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Property and equipment, net | $ 23,659 | $ 22,248 |
Segment and Geographic Inform_6
Segment and Geographic Information - Schedule of Customer Concentration by Collaboration Partners (Detail) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Percentage of Revenue [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 47.00% | 15.00% | 17.00% |
Percentage of Revenue [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 53.00% | 85.00% | 83.00% |
Percentage of Accounts Receivable [Member] | Astellas-Related party [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 74.00% | 47.00% | |
Percentage of Accounts Receivable [Member] | AstraZeneca [Member] | |||
Entity Wide Revenue Major Customer [Line Items] | |||
Concentration risk, percentage | 26.00% | 53.00% |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Year | $ 159,540 | $ 128,995 | $ 116,718 |
Charged (Credited) to Statement of Operation | 34,447 | 11,039 | 12,277 |
Charged to Other Accounts - Equity | 0 | 19,506 | 0 |
Deductions, Net | 0 | 0 | 0 |
Balance at End of Year | $ 193,987 | $ 159,540 | $ 128,995 |