Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN INC | |
Entity Central Index Key | 921,299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 84,978,056 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 566,722 | $ 673,658 |
Short-term investments | 86,009 | 62,060 |
Accounts receivable ($19,434 and $4,004 from a related party) | 23,187 | 8,452 |
Prepaid expenses and other current assets | 2,865 | 4,800 |
Total current assets | 678,783 | 748,970 |
Restricted time deposits | 5,181 | 5,181 |
Long-term investments | 40,602 | 10,506 |
Property and equipment, net | 127,908 | 129,476 |
Other assets | 3,167 | 4,517 |
Total assets | 855,641 | 898,650 |
Current liabilities: | ||
Accounts payable | 10,131 | 5,509 |
Accrued liabilities ($353 and $272 to a related party) | 52,598 | 63,781 |
Deferred revenue | 37,697 | 16,670 |
Total current liabilities | 100,426 | 85,960 |
Long-term portion of lease financing obligations | 97,323 | 97,763 |
Product development obligations | 16,948 | 17,244 |
Deferred rent | 3,197 | 3,657 |
Deferred revenue, net of current | 136,874 | 138,241 |
Other long-term liabilities | 10,291 | 8,047 |
Total liabilities | 365,059 | 350,912 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at September 30, 2018 and December 31, 2017 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2018 and December 31, 2017; 84,847 and 82,498 shares issued and outstanding at September 30, 2018 and December 31, 2017 | 848 | 825 |
Additional paid-in capital | 1,209,813 | 1,160,094 |
Accumulated other comprehensive loss | (2,570) | (1,795) |
Accumulated deficit | (736,780) | (630,657) |
Total stockholders’ equity | 471,311 | 528,467 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 490,582 | 547,738 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 855,641 | $ 898,650 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 19,434 | $ 4,004 |
Accrued liabilities to related party | $ 353 | $ 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 | 84,847,000 | 82,498,000 |
Common stock, shares outstanding | 84,847,000 | 82,498,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue: | ||||
Total revenue | $ 29,027 | $ 40,550 | $ 104,903 | $ 100,260 |
Operating expenses: | ||||
Research and development | 56,443 | 50,336 | 165,555 | 144,049 |
General and administrative | 15,356 | 12,953 | 45,961 | 37,908 |
Total operating expenses | 71,799 | 63,289 | 211,516 | 181,957 |
Loss from operations | (42,772) | (22,739) | (106,613) | (81,697) |
Interest and other, net | ||||
Interest expense | (2,739) | (2,769) | (8,257) | (7,901) |
Interest income and other, net | 3,079 | 1,106 | 7,796 | 2,783 |
Total interest and other, net | 340 | (1,663) | (461) | (5,118) |
Loss before income taxes | (42,432) | (24,402) | (107,074) | (86,815) |
Provision for income taxes | 124 | 57 | 299 | 166 |
Net loss | $ (42,556) | $ (24,459) | $ (107,373) | $ (86,981) |
Net loss per share - basic and diluted | $ (0.50) | $ (0.32) | $ (1.28) | $ (1.24) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 84,508 | 75,891 | 83,713 | 69,899 |
License Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 0 | $ 9,933 | $ 14,323 | $ 9,933 |
Development and Other Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 29,027 | $ 30,617 | $ 90,580 | $ 90,327 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
License and milestone revenue from a related party | $ 0 | $ 0 | $ 14,323 | $ 0 |
Collaboration services and other revenue from a related party | $ 5,131 | $ 5,322 | $ 16,448 | $ 15,106 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (42,556) | $ (24,459) | $ (107,373) | $ (86,981) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 72 | (578) | 503 | (1,827) |
Available-for-sale investments: | ||||
Unrealized gain on investments, net of tax effect | (31) | 403 | (28) | 1,250 |
Reclassification from accumulated other comprehensive loss | 0 | (47) | 0 | (72) |
Net change in unrealized gain on available-for-sale investments | (31) | 356 | (28) | 1,178 |
Other comprehensive income (loss), net of taxes | 41 | (222) | 475 | (649) |
Comprehensive loss | $ (42,515) | $ (24,681) | $ (106,898) | $ (87,630) |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities | ||
Net loss | $ (107,373) | $ (86,981) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 4,693 | 4,582 |
Amortization of premium on investments | 584 | 1,503 |
Unrealized loss (gain) on short-term investments | 1,103 | 3 |
Loss (gain) on disposal of property and equipment | 53 | 3 |
Stock-based compensation | 38,432 | 27,608 |
Realized foreign currency gain | (1,074) | 0 |
Realized gain on sales of available-for-sale securities | (87) | (143) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (14,735) | (13,180) |
Prepaid expenses and other current assets | 1,935 | 33 |
Other assets | 1,350 | (1,657) |
Accounts payable | 4,622 | 184 |
Accrued liabilities | (9,885) | (114) |
Deferred revenue | 19,660 | 2,021 |
Lease financing liability | 35 | 474 |
Other long-term liabilities | 2,008 | 337 |
Net cash used in operating activities | (58,679) | (65,327) |
Investing activities | ||
Purchases of property and equipment | (4,852) | (4,992) |
Proceeds from sale of property and equipment | 184 | 5 |
Purchases of available-for-sale securities | (110,156) | (102) |
Proceeds from sales of available-for-sale securities | 8,167 | 21,109 |
Proceeds from maturities of available-for-sale securities | 47,390 | 33,849 |
Net cash provided by investing activities | (59,267) | 49,869 |
Financing activities | ||
Borrowings under capital lease obligations | 49 | 0 |
Repayments of lease liability | (302) | (302) |
Proceeds from follow-on offerings, net of underwriting discounts and commission costs | 0 | 471,205 |
Cash paid for payroll taxes on restricted stock unit releases | (13,288) | (5,970) |
Proceeds from issuance of common stock | 24,598 | 28,556 |
Payments of deferred offering costs | 0 | (430) |
Net cash provided by financing activities | 11,057 | 493,059 |
Effect of exchange rate change on cash and cash equivalents | (47) | (10) |
Net decrease in cash and cash equivalents | (106,936) | 477,591 |
Total cash and cash equivalents at beginning of period | 673,658 | 173,782 |
Total cash and cash equivalents at end of period | $ 566,722 | $ 651,373 |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 1. Significant Accounting Policies Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics agents to treat serious unmet medical needs. The Company’s focus in the areas of fibrosis and hypoxia-inducible factor (“HIF”) biology has generated multiple programs targeting various therapeutic areas. The Company’s most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (“HIF-PHs”) in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (“CKD”) and myelodysplastic syndromes (“MDS”). Pamrevlumab, or FG-3019, is the Company’s monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), pancreatic cancer and Duchenne muscular dystrophy (“DMD”). The Company is taking a global approach with respect to the development and future commercialization of its product candidates, and this includes development and commercialization in the People’s Republic of China (“China”). The Company is capitalizing on its extensive experience in fibrosis and HIF biology and clinical development to advance a pipeline of innovative medicines for the treatment of anemia, fibrotic disease cancer, corneal blindness and other serious unmet medical needs. Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. (“FibroGen 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. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the United States Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2017 (“2017 Form 10-K”). The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2017 Form 10-K, except for the following: 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 2 “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 2 “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; 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 amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangements. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 2 “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. Investments The Company’s investments consist of available-for-sale debt investments and marketable equity investments. Those investments with maturities 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. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, estimates of accruals related to clinical trial costs, valuation allowances for deferred tax assets, and valuation and recognition of stock-based compensation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. 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 period presented in the condensed 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 condensed consolidated statement of operations and condensed 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 condensed consolidated statement of cash flows. Select line items from the Company’s condensed consolidated statement of operations and condensed balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 19,997 $ (10,064 ) $ 9,933 $ 60,930 $ (50,997 ) $ 9,933 Development and other revenue 7,275 23,342 30,617 22,230 68,097 90,327 Total revenue 27,272 13,278 40,550 83,160 17,100 100,260 Net loss (37,737 ) 13,278 (24,459 ) (104,081 ) 17,100 (86,981 ) Net loss per share - basic and diluted $ (0.50 ) $ 0.18 $ (0.32 ) $ (1.49 ) $ 0.25 $ (1.24 ) 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 resulted in an increase in revenue of $5.3 million and $3.6 million for the years ended December 31, 2017 and 2016, respectively, and an increase in the opening accumulated deficit of $43.7 million as of January 1, 2016. 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 condensed consolidated statement of operations or condensed consolidated statement of cash flows for the nine months ended September 30, 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 In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In 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 February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements (“ ”) , |
Collaboration Agreements
Collaboration Agreements | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements | 2. 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, which amounts were fully received as of February 2009. Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events, which amounts were fully received as of July 2016, (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. 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 is 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, of which $14.9 million was recognized as revenue during the second quarter of 2018 from performance obligations satisfied or partially satisfied. FibroGen and Astellas are currently negotiating an amendment to the Japan Agreement that will allow Astellas to manufacture roxadustat drug product for commercialization in Japan, and for which FibroGen would continue to manufacture and deliver to Astellas roxadustat active pharmaceutical ingredient (“API”). The commercial terms of the Japan Agreement would remain substantially the same. In the second quarter of 2018, FibroGen delivered roxadustat API to Astellas under a material transfer agreement for Astellas to conduct commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. The associated consideration of $20.9 million was recorded as deferred revenue because Astellas’ right to use the material was limited as of September 30, 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). Under the Europe Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $425.0 million in potential milestone payments, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Clinical milestone payments of $40.0 million and $50.0 million were received in 2010 and 2012, respectively. 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. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million, which were fully received in various amounts through June 2016. Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. Under the U.S./RoW Agreement, the Company and AstraZeneca shared 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 during the fourth quarter of 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 paid upfront, non-contingent and non-refundable payments totaling $28.2 million, which were fully received in 2014. Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. In October 2017, the State Drug Administration in China, now known as the National Medicine Products Administration, accepted the Company’s 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. The Company evaluated this milestone based on variable consideration requirements under the new revenue standards and concluded that the milestone was probable of being achieved in the third quarter of 2017. Accordingly, consideration associated with this milestone was included in the transaction price and allocated to performance obligations under the China Agreement in the same period. 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 September 30, 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 $12.6 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 $183.0 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 which is currently estimated to continue through the end of 2019. 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. 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 September 30, 2018, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $30.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $669.7 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 which is estimated to continue through the end of 2020. (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 condensed consolidated statements of operations. All other elements identified below are included in the “Development and other revenue” line item in the condensed consolidated statements of operations. Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * Japan License revenue $ — $ — $ 14,323 $ — Development revenue $ 474 $ 517 $ 2,065 $ 1,130 * Recast to reflect the adoption of the new revenue standards. See Note 1. 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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 74,089 $ — $ 74,089 Development revenue 13,572 386 13,958 Total license and development revenue $ 87,661 $ 386 $ 88,047 The true-up relating to prior periods resulting from changes to estimated variable consideration was immaterial in the quarter ended September 30, 2018. The remainder of the transaction price related to the Japan Agreement includes $2.1 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * Europe License revenue $ — $ — $ — $ — Development revenue $ 4,658 $ 4,805 $ 14,384 $ 13,976 * Recast to reflect the adoption of the new revenue standards. See Note 1. 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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 370,481 $ — $ 370,481 Development revenue 198,717 4,350 203,067 Total license and development revenue $ 569,198 $ 4,350 $ 573,548 The revenue recognized under the Europe Agreement in the quarter ended September 30, 2018 included a decrease in revenue of $0.1 million as true-up relating to prior periods resulting from changes to estimated variable consideration in the current period. The remainder of the transaction price related to the Europe Agreement includes $19.4 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * U.S. / RoW and China License revenue $ — $ 9,933 $ — $ 9,933 Development revenue 23,895 25,295 74,096 75,218 China performance obligation $ — $ — $ — $ — * Recast to reflect the adoption of the new revenue standards. See Note 1. 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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 286,216 $ — $ 286,216 Co-development, information sharing |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): September 30, 2018 Level 1 Level 2 Level 3 Total Corporate bonds $ — $ 6,009 $ — $ 6,009 Bond and mutual funds 10,446 — — 10,446 Equity investments 223 — — 223 Money market funds 495,131 — — 495,131 Certificate of deposits — 109,933 — 109,933 Total $ 505,800 $ 115,942 $ — $ 621,742 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 Our 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): September 30, 2018 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,209 $ 98,209 December 31, 2017 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,476 $ 98,476 The fair values of the Company’s financial liabilities were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows. There were no transfers of assets or liabilities between levels for any of the periods presented. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): September 30, 2018 December 31, 2017 Cash $ 71,591 $ 103,716 Money market funds 495,131 569,942 Total cash and cash equivalents $ 566,722 $ 673,658 At September 30, 2018 and December 31, 2017, a total of $25.5 million and $32.3 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations. Investments The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale investments by major investments type are summarized in the tables below (in thousands): September 30, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 6,011 $ — $ (2 ) $ 6,009 Certificate of deposits 110,000 — (67 ) 109,933 Bond and mutual funds 10,399 47 — 10,446 Equity investments 125 98 — 223 Total investments $ 126,535 $ 145 $ (69 ) $ 126,611 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 At September 30, 2018, all of the available-for-sale investments had contractual maturities within one year. The Company periodically reviews its available-for-sale investments for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three and nine months ended September 30, 2018 and 2017, the Company did not recognize any other-than-temporary impairment loss. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, 2018 December 31, 2017 Preclinical and clinical trial accruals $ 22,606 $ 32,321 Payroll and related accruals 16,626 18,810 Property taxes and other 1,900 4,201 Professional services 1,835 1,991 Other 9,631 6,458 Total accrued liabilities $ 52,598 $ 63,781 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 5. Stock-Based Compensation Stock-based compensation expense was allocated to research and development and general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 8,465 $ 5,538 $ 22,729 $ 16,060 General and administrative 5,858 4,090 15,703 11,548 Total stock-based compensation expense $ 14,323 $ 9,628 $ 38,432 $ 27,608 The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Stock Options Expected term (in years) 5.3 5.3 5.4 5.7 Expected volatility 68.1 % 69.5 % 67.8 % 71.5 % Risk-free interest rate 2.9 % 1.9 % 2.7 % 2.2 % Expected dividend yield — — — — Weighted average estimated fair value $ 35.99 $ 26.47 $ 32.37 $ 16.63 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.3 - 72.8 % 52.8 - 76.0 % 47.3 - 75.3 % 52.8 - 77.2 % Risk-free interest rate 1.0 - 2.6 % 0.6 - 1.3 % 0.8 - 2.6 % 0.5 - 1.3 % Expected dividend yield — — — — Weighted average estimated fair value $ 20.10 $ 9.67 $ 15.27 $ 9.15 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes The provisions for income taxes for the three and nine months ended September 30, 2018 and 2017 were due to foreign taxes. Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception and expected continuing net loss, the Company has established and continues to maintain a full valuation allowance against its deferred tax assets as it does not currently believe that realization of those assets is more likely than not. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions Astellas is an equity investor in the Company and considered a related party. The Company recorded revenue related to collaboration agreements with Astellas of $5.1 million and $5.3 million during the three months ended September 30, 2018 and 2017, respectively, and $30.8 million and $15.1 million during the nine months ended September 30, 2018 and 2017, respectively. The related party revenue for the nine months ended September 30, 2018 included $14.9 million of a $15.0 million regulatory milestone under the Japan Agreement that was included in the transaction price during the second quarter of 2018. See Note 2 and below for details. The related party revenue was recast for the three and nine months ended September 30, 2017 as a result of adoption of the new revenue standards. See Note 1 for details. The Company recorded expense related to collaboration agreements with Astellas of $0.4 million and $0.2 million during the three months ended September 30, 2018 and 2017, respectively, and $1.1 million and $0.8 million during the nine months ended September 30, 2018 and 2017, respectively. As of September 30, 2018 and December 31, 2017, accounts receivable from Astellas were $19.4 million and $4.0 million, respectively, and amounts due to Astellas were $0.4 million and $0.3 million, respectively. The accounts receivable from Astellas as of June 30, 2018 included $20.9 million related to a sale of roxadustat API to Astellas during the second quarter of 2018, which was received during the three months ended September 30, 2018. The sale was made pursuant to a material transfer agreement in anticipation of the execution of an amendment to the Japan Agreement allowing Astellas to manufacture roxadustat drug product, which is expected to be finalized in the fourth quarter of 2018. The sale enables Astellas to conduct the commercial scale manufacturing validation for roxadustat drug product in anticipation of commercial launch in Japan. The associated consideration was recorded as deferred revenue because Astellas’ right to use the material was limited as of September 30, 2018. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Description of Operations | Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics agents to treat serious unmet medical needs. The Company’s focus in the areas of fibrosis and hypoxia-inducible factor (“HIF”) biology has generated multiple programs targeting various therapeutic areas. The Company’s most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (“HIF-PHs”) in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (“CKD”) and myelodysplastic syndromes (“MDS”). Pamrevlumab, or FG-3019, is the Company’s monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), pancreatic cancer and Duchenne muscular dystrophy (“DMD”). The Company is taking a global approach with respect to the development and future commercialization of its product candidates, and this includes development and commercialization in the People’s Republic of China (“China”). The Company is capitalizing on its extensive experience in fibrosis and HIF biology and clinical development to advance a pipeline of innovative medicines for the treatment of anemia, fibrotic disease cancer, corneal blindness and other serious unmet medical needs. |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. (“FibroGen 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. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the United States Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2017 (“2017 Form 10-K”). The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2017 Form 10-K, except for the following: |
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 2 “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 2 “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; 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 amount of variable consideration from co-development billings requires the Company to make estimates of future research and development efforts, which involves significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective. Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestone payments are therefore included in the transaction price when achievement of the milestone becomes probable. For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangements. The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services. Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 2 “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. |
Investments | Investments The Company’s investments consist of available-for-sale debt investments and marketable equity investments. Those investments with maturities 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. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue, estimates of accruals related to clinical trial costs, valuation allowances for deferred tax assets, and valuation and recognition of stock-based compensation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. |
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 period presented in the condensed 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 condensed consolidated statement of operations and condensed 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 condensed consolidated statement of cash flows. Select line items from the Company’s condensed consolidated statement of operations and condensed balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 19,997 $ (10,064 ) $ 9,933 $ 60,930 $ (50,997 ) $ 9,933 Development and other revenue 7,275 23,342 30,617 22,230 68,097 90,327 Total revenue 27,272 13,278 40,550 83,160 17,100 100,260 Net loss (37,737 ) 13,278 (24,459 ) (104,081 ) 17,100 (86,981 ) Net loss per share - basic and diluted $ (0.50 ) $ 0.18 $ (0.32 ) $ (1.49 ) $ 0.25 $ (1.24 ) 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 resulted in an increase in revenue of $5.3 million and $3.6 million for the years ended December 31, 2017 and 2016, respectively, and an increase in the opening accumulated deficit of $43.7 million as of January 1, 2016. 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 condensed consolidated statement of operations or condensed consolidated statement of cash flows for the nine months ended September 30, 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 In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In 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 February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements (“ ”) , |
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 September 30, 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 $12.6 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 $183.0 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 which is currently estimated to continue through the end of 2019. 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. 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 September 30, 2018, the transaction price for the U.S./RoW Agreement and China Agreement included $402.2 million of non-contingent upfront payments, $30.0 million of variable consideration related to payments for milestones considered probable of being achieved, and $669.7 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 which is estimated to continue through the end of 2020. (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. |
Other Revenues | Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. |
Deferred Revenue | Deferred Revenue Deferred revenue represents amounts billed 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. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Adoption of New Revenue Standards | Select line items from the Company’s condensed consolidated statement of operations and condensed balance sheet, which reflect the adoption of the new revenue standards are as follows (in thousands): Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017 As Previously Reported New Revenue Standards Adjustment As Recast As Previously Reported New Revenue Standards Adjustment As Recast Statement of Operations License revenue $ 19,997 $ (10,064 ) $ 9,933 $ 60,930 $ (50,997 ) $ 9,933 Development and other revenue 7,275 23,342 30,617 22,230 68,097 90,327 Total revenue 27,272 13,278 40,550 83,160 17,100 100,260 Net loss (37,737 ) 13,278 (24,459 ) (104,081 ) 17,100 (86,981 ) Net loss per share - basic and diluted $ (0.50 ) $ 0.18 $ (0.32 ) $ (1.49 ) $ 0.25 $ (1.24 ) 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. |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Japan [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * Japan License revenue $ — $ — $ 14,323 $ — Development revenue $ 474 $ 517 $ 2,065 $ 1,130 * Recast to reflect the adoption of the new revenue standards. See Note 1. |
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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 74,089 $ — $ 74,089 Development revenue 13,572 386 13,958 Total license and development revenue $ 87,661 $ 386 $ 88,047 |
Europe [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * Europe License revenue $ — $ — $ — $ — Development revenue $ 4,658 $ 4,805 $ 14,384 $ 13,976 * Recast to reflect the adoption of the new revenue standards. See Note 1. |
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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 370,481 $ — $ 370,481 Development revenue 198,717 4,350 203,067 Total license and development revenue $ 569,198 $ 4,350 $ 573,548 |
U.S./RoW and China [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, Agreement Performance Obligation 2018 2017 * 2018 2017 * U.S. / RoW and China License revenue $ — $ 9,933 $ — $ 9,933 Development revenue 23,895 25,295 74,096 75,218 China performance obligation $ — $ — $ — $ — * Recast to reflect the adoption of the new revenue standards. See Note 1. |
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 September 30, 2018 Deferred Revenue at September 30, 2018 Total Consideration Through September 30, 2018 License $ 286,216 $ — $ 286,216 Co-development, information sharing & committee services 377,765 29,163 406,928 China performance obligation — 119,744 119,744 Total license and development revenue $ 663,981 $ 148,907 $ 812,888 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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): September 30, 2018 Level 1 Level 2 Level 3 Total Corporate bonds $ — $ 6,009 $ — $ 6,009 Bond and mutual funds 10,446 — — 10,446 Equity investments 223 — — 223 Money market funds 495,131 — — 495,131 Certificate of deposits — 109,933 — 109,933 Total $ 505,800 $ 115,942 $ — $ 621,742 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): September 30, 2018 Level 1 Level 2 Level 3 Total Lease financing obligations $ — $ — $ 98,209 $ 98,209 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) | 9 Months Ended |
Sep. 30, 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): September 30, 2018 December 31, 2017 Cash $ 71,591 $ 103,716 Money market funds 495,131 569,942 Total cash and cash equivalents $ 566,722 $ 673,658 |
Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments | The Company’s investments consist of available-for-sale debt investments and marketable equity investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale investments by major investments type are summarized in the tables below (in thousands): September 30, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Corporate bonds $ 6,011 $ — $ (2 ) $ 6,009 Certificate of deposits 110,000 — (67 ) 109,933 Bond and mutual funds 10,399 47 — 10,446 Equity investments 125 98 — 223 Total investments $ 126,535 $ 145 $ (69 ) $ 126,611 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 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): September 30, 2018 December 31, 2017 Preclinical and clinical trial accruals $ 22,606 $ 32,321 Payroll and related accruals 16,626 18,810 Property taxes and other 1,900 4,201 Professional services 1,835 1,991 Other 9,631 6,458 Total accrued liabilities $ 52,598 $ 63,781 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Allocated Stock-Based Compensation Expense | Stock-based compensation expense was allocated to research and development and general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 8,465 $ 5,538 $ 22,729 $ 16,060 General and administrative 5,858 4,090 15,703 11,548 Total stock-based compensation expense $ 14,323 $ 9,628 $ 38,432 $ 27,608 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan | The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Stock Options Expected term (in years) 5.3 5.3 5.4 5.7 Expected volatility 68.1 % 69.5 % 67.8 % 71.5 % Risk-free interest rate 2.9 % 1.9 % 2.7 % 2.2 % Expected dividend yield — — — — Weighted average estimated fair value $ 35.99 $ 26.47 $ 32.37 $ 16.63 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected volatility 47.3 - 72.8 % 52.8 - 76.0 % 47.3 - 75.3 % 52.8 - 77.2 % Risk-free interest rate 1.0 - 2.6 % 0.6 - 1.3 % 0.8 - 2.6 % 0.5 - 1.3 % Expected dividend yield — — — — Weighted average estimated fair value $ 20.10 $ 9.67 $ 15.27 $ 9.15 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) $ in Millions | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2018Segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2016USD ($) | |
Accounting Policy [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Short term investments Maturity | 12 months | |||
Long term Investments Maturity | 12 months | |||
U.S. federal statutory income tax rate | 21.00% | 35.00% | ||
ASU 2014-09 [Member] | Accumulated Deficit [Member] | ||||
Accounting Policy [Line Items] | ||||
Increase in accumulative deficit | $ 43.7 | |||
New Revenue Standards [Member] | Revenue [Member] | ||||
Accounting Policy [Line Items] | ||||
Increase (reduction) in revenue | $ 5.3 | $ 3.6 |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Adoption of New Revenue Standards (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Statement of Operations | |||||
Total revenue | $ 29,027 | $ 40,550 | $ 104,903 | $ 100,260 | |
Net loss | $ (42,556) | $ (24,459) | $ (107,373) | $ (86,981) | |
Net loss per share - basic and diluted | $ (0.50) | $ (0.32) | $ (1.28) | $ (1.24) | |
Balance Sheet | |||||
Deferred revenue | $ 37,697 | $ 37,697 | $ 16,670 | ||
Deferred revenue, net of current | 136,874 | 136,874 | 138,241 | ||
Accumulated deficit | (736,780) | (736,780) | (630,657) | ||
License Revenue [Member] | |||||
Statement of Operations | |||||
Total revenue | 0 | $ 9,933 | 14,323 | $ 9,933 | |
Development and Other Revenue [Member] | |||||
Statement of Operations | |||||
Total revenue | $ 29,027 | 30,617 | $ 90,580 | 90,327 | |
As Previously Reported [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | 27,272 | 83,160 | |||
Net loss | $ (37,737) | $ (104,081) | |||
Net loss per share - basic and diluted | $ (0.50) | $ (1.49) | |||
Balance Sheet | |||||
Deferred revenue | 7,968 | ||||
Deferred revenue, net of current | 112,231 | ||||
Accumulated deficit | (595,945) | ||||
As Previously Reported [Member] | License Revenue [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | $ 19,997 | $ 60,930 | |||
As Previously Reported [Member] | Development and Other Revenue [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | 7,275 | 22,230 | |||
New Revenue Standards Adjustment [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | 13,278 | 17,100 | |||
Net loss | $ 13,278 | $ 17,100 | |||
Net loss per share - basic and diluted | $ 0.18 | $ 0.25 | |||
Balance Sheet | |||||
Deferred revenue | 8,702 | ||||
Deferred revenue, net of current | 26,010 | ||||
Accumulated deficit | $ (34,712) | ||||
New Revenue Standards Adjustment [Member] | License Revenue [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | $ (10,064) | $ (50,997) | |||
New Revenue Standards Adjustment [Member] | Development and Other Revenue [Member] | ASU 2014-09 [Member] | |||||
Statement of Operations | |||||
Total revenue | $ 23,342 | $ 68,097 |
Summary of Significant Accounti
Summary of Significant Accounting Policies - Schedule of Impacts to Accumulated Other Comprehensive Loss and Accumulated Deficit Upon Adoption of Guidance (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | $ (2,570) | $ (1,795) | |
Accumulated deficit | $ (736,780) | $ (630,657) | |
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) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 35 Months Ended | 45 Months Ended | ||||
Jul. 31, 2016 | Apr. 30, 2006 | Jun. 30, 2005 | Jun. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2012 | Dec. 31, 2010 | Feb. 28, 2009 | Feb. 28, 2009 | Dec. 31, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Deferred revenue | $ 37,697 | $ 16,670 | ||||||||
Astellas Agreement [Member] | Japan [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront, non-contingent and time-based payments received | $ 40,100 | |||||||||
Potential milestone payments | $ 132,500 | |||||||||
Commercial sales milestone | 15,000 | |||||||||
Milestones revenue | $ 22,500 | |||||||||
Consideration associated with milestone included in transaction price | $ 15,000 | |||||||||
Changes in revenue due to prior period adjustment | $ 14,900 | |||||||||
Deferred revenue | 20,900 | |||||||||
Astellas Agreement [Member] | Japan [Member] | Clinical and Development Milestone [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments | 22,500 | |||||||||
Astellas Agreement [Member] | Japan [Member] | Regulatory Milestone [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments | $ 95,000 | |||||||||
Astellas Agreement [Member] | Europe [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront, non-contingent and time-based payments received | $ 320,000 | |||||||||
Potential milestone payments | $ 425,000 | |||||||||
Changes in revenue due to prior period adjustment | $ (100) | |||||||||
Clinical development milestones | $ 50,000 | $ 40,000 | ||||||||
Percentage of joint development costs committed to fund | 50.00% | |||||||||
Additional consideration based on net sales description | Low 20% range | |||||||||
Astellas Agreement [Member] | Europe [Member] | Clinical and Development Milestone [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments | $ 90,000 | |||||||||
Astellas Agreement [Member] | Europe [Member] | Regulatory Milestone [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Potential milestone payments | $ 335,000 |
Collaboration Agreements - Astr
Collaboration Agreements - AstraZeneca Agreements - Additional Information 1 (Detail) - AstraZeneca Agreements [Member] - USD ($) $ in Millions | Jul. 30, 2013 | Dec. 31, 2015 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2015 |
U.S./RoW [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Upfront, non-contingent, non-refundable and time-based payments | $ 374 | ||||
Potential milestone payments | 875 | ||||
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 | ||||
U.S./RoW [Member] | Clinical and Development Milestone [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | 65 | ||||
U.S./RoW [Member] | Regulatory Milestone [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | 325 | ||||
U.S./RoW [Member] | Deferred Approval Milestone [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | 160 | ||||
U.S./RoW [Member] | Development Milestones [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Receipt of development milestone payment | $ 15 | ||||
China [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | 348.5 | ||||
Proceeds from upfront, non-contingent and non-refundable payments | 28.2 | ||||
Commercial sales and other events milestone | 187.5 | ||||
Milestone payment, revenue recognition | $ 15 | ||||
China [Member] | Clinical and Development Milestone [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | 15 | ||||
China [Member] | Regulatory Milestone [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payments | $ 146 |
Collaboration Agreements - Acco
Collaboration Agreements - Accounting for the Astellas Agreements - Additional Information 2 (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Manufacturing commercial supplies of products, revenue recognized | $ 29,027,000 | $ 40,550,000 | $ 104,903,000 | $ 100,260,000 |
Astellas Agreement [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Co-development services, currently estimated continuation year | 2,019 | |||
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 | 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 | 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 | 12,600,000 | |||
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 | $ 183,000,000 |
Collaboration Agreements - Ac_2
Collaboration Agreements - Accounting for the AstraZeneca Agreements - Additional Information 3 (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Manufacturing commercial supplies of products, revenue recognized | $ 29,027,000 | $ 40,550,000 | $ 104,903,000 | $ 100,260,000 |
AstraZeneca Agreements [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Right-of-return provisions for delivered items | $ 0 | |||
Royalty rate against projected net revenues | 40.00% | 40.00% | ||
Co-development services, currently estimated continuation year | 2,020 | |||
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 | 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 | 30,000,000 | |||
Variable consideration related to co-development billings | $ 669,700,000 |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 29,027 | $ 40,550 | $ 104,903 | $ 100,260 |
License Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 9,933 | 14,323 | 9,933 |
Development and Other Revenue [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 29,027 | 30,617 | 90,580 | 90,327 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 14,323 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
Astellas Agreement [Member] | Development and Other Revenue [Member] | Japan [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 474 | 517 | 2,065 | 1,130 |
Astellas Agreement [Member] | Development and Other Revenue [Member] | Europe [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 4,658 | 4,805 | 14,384 | 13,976 |
AstraZeneca Agreements [Member] | China [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 0 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | 0 | 9,933 | 0 | 9,933 |
AstraZeneca Agreements [Member] | Development and Other Revenue [Member] | U.S./RoW [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total revenue | $ 23,895 | $ 25,295 | $ 74,096 | $ 75,218 |
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 | Sep. 30, 2018USD ($) |
Astellas Agreement [Member] | Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | $ 87,661 |
Deferred Revenue | 386 |
Total Consideration | 88,047 |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 13,572 |
Deferred Revenue | 386 |
Total Consideration | 13,958 |
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] | Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 569,198 |
Deferred Revenue | 4,350 |
Total Consideration | 573,548 |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 198,717 |
Deferred Revenue | 4,350 |
Total Consideration | 203,067 |
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 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 663,981 |
Deferred Revenue | 148,907 |
Total Consideration | 812,888 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | License Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 286,216 |
Deferred Revenue | 0 |
Total Consideration | 286,216 |
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 | 377,765 |
Deferred Revenue | 29,163 |
Total Consideration | 406,928 |
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 | 119,744 |
Total Consideration | $ 119,744 |
Collaboration Agreements - Su_2
Collaboration Agreements - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2018 | |
Japan [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 2.1 | ||
Japan [Member] | Astellas Agreement [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Changes in revenue due to prior period adjustment | $ 14.9 | ||
Europe [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 19.4 | ||
Europe [Member] | Astellas Agreement [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Changes in revenue due to prior period adjustment | (0.1) | ||
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 | 223.7 | ||
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Changes in revenue due to prior period adjustment | $ (0.1) |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 126,611 | $ 72,566 |
Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 6,009 | 53,943 |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,446 | 18,402 |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 223 | 221 |
Certificate of deposits [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 109,933 | |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 621,742 | 642,508 |
Fair Value, Measurements, Recurring [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 6,009 | 53,943 |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,446 | 18,402 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 223 | 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 | 495,131 | 569,942 |
Fair Value, Measurements, Recurring [Member] | Certificate of deposits [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 109,933 | |
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 | 505,800 | 588,565 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,446 | 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 | 223 | 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 | 495,131 | 569,942 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Certificate of deposits [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 | 115,942 | 53,943 |
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 | 6,009 | 53,943 |
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] | Certificate of deposits [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 109,933 | |
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] | Corporate bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | 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] | Certificate of deposits [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 | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 98,209 | $ 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 | $ 98,209 | $ 98,476 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | ||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 |
Transfers of assets from level 2 to 1 | 0 | 0 |
Transfers of liabilities from level 1 to 2 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 |
Transfers of assets into level 3 | 0 | 0 |
Transfers of assets out of level 3 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 71,591 | $ 103,716 |
Money market funds | 495,131 | 569,942 |
Total cash and cash equivalents | $ 566,722 | $ 673,658 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||||||
Cash and cash equivalents | $ 566,722,000 | $ 566,722,000 | $ 566,722,000 | $ 673,658,000 | ||
Contractual maturities of available-for-sale investments | 1 year | |||||
Other-than-temporary impairment loss | 0 | $ 0 | 0 | $ 0 | ||
Foreign subsidiaries [Member] | ||||||
Schedule of Available-for-sale Securities [Line Items] | ||||||
Cash and cash equivalents | $ 25,500,000 | $ 25,500,000 | $ 25,500,000 | $ 32,300,000 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 126,535 | $ 71,360 |
Gross Unrealized Holding Gains | 145 | 1,252 |
Gross Unrealized Holding Losses | (69) | (46) |
Fair Value | 126,611 | 72,566 |
Corporate bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 6,011 | 53,985 |
Gross Unrealized Holding Gains | 0 | 4 |
Gross Unrealized Holding Losses | (2) | (46) |
Fair Value | 6,009 | 53,943 |
Certificate of deposits [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 110,000 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | (67) | |
Fair Value | 109,933 | |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,399 | 17,249 |
Gross Unrealized Holding Gains | 47 | 1,153 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 10,446 | 18,402 |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 126 |
Gross Unrealized Holding Gains | 98 | 95 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 223 | $ 221 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 22,606 | $ 32,321 |
Payroll and related accruals | 16,626 | 18,810 |
Property taxes and other | 1,900 | 4,201 |
Professional services | 1,835 | 1,991 |
Other | 9,631 | 6,458 |
Total accrued liabilities | $ 52,598 | $ 63,781 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Allocated Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 14,323 | $ 9,628 | $ 38,432 | $ 27,608 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 8,465 | 5,538 | 22,729 | 16,060 |
General and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 5,858 | $ 4,090 | $ 15,703 | $ 11,548 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Employee stock options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months 19 days | 5 years 3 months 19 days | 5 years 4 months 24 days | 5 years 8 months 12 days |
Expected volatility | 68.10% | 69.50% | 67.80% | 71.50% |
Risk-free interest rate | 2.90% | 1.90% | 2.70% | 2.20% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 35.99 | $ 26.47 | $ 32.37 | $ 16.63 |
2014 Employee Share Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility, minimum | 47.30% | 52.80% | 47.30% | 52.80% |
Expected volatility, maximum | 72.80% | 76.00% | 75.30% | 77.20% |
Risk-free interest rate, minimum | 1.00% | 0.60% | 0.80% | 0.50% |
Risk-free interest rate, maximum | 2.60% | 1.30% | 2.60% | 1.30% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 20.10 | $ 9.67 | $ 15.27 | $ 9.15 |
2014 Employee Share Purchase Plan [Member] | Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
2014 Employee Share Purchase Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 2 years | 2 years | 2 years | 2 years |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | |||||
Accounts receivable from related party | $ 19,434 | $ 19,434 | $ 4,004 | ||
Accrued liabilities to related party | 353 | 353 | 272 | ||
Astellas [Member] | Collaborative Arrangement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | 5,100 | $ 5,300 | 30,800 | $ 15,100 | |
Expense related to collaboration agreements | 400 | $ 200 | 1,100 | $ 800 | |
Accounts receivable from related party | 19,400 | 19,400 | 4,000 | ||
Accrued liabilities to related party | 400 | 400 | $ 300 | ||
Astellas [Member] | Astellas Agreement [Member] | API Shipment [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accrued liabilities to related party | 20,900 | 20,900 | |||
Unbilled Revenues [Member] | Astellas [Member] | Regulatory Milestone [Member] | |||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | $ 14,900 | $ 15,000 |