Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN INC | |
Entity Central Index Key | 0000921299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 86,221,978 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 81,673 | $ 89,258 |
Short-term investments | 483,726 | 532,144 |
Accounts receivable ($3,898 and $47,210 from a related party) | 6,023 | 63,684 |
Prepaid expenses and other current assets | 7,578 | 4,929 |
Total current assets | 579,000 | 690,015 |
Restricted time deposits | 4,145 | 4,145 |
Long-term investments | 132,203 | 55,820 |
Property and equipment, net | 45,828 | 127,198 |
Finance lease right-of-use assets | 47,029 | 0 |
Other assets | 4,192 | 3,420 |
Total assets | 812,397 | 880,598 |
Current liabilities: | ||
Accounts payable | 3,772 | 9,139 |
Accrued and other current liabilities ($519 and $444 to a related party) | 66,278 | 66,123 |
Deferred revenue | 12,104 | 13,771 |
Finance lease liabilities, current | 11,766 | 0 |
Total current liabilities | 93,920 | 89,033 |
Long-term portion of lease obligations | 1,443 | 97,157 |
Product development obligations | 16,545 | 16,798 |
Deferred rent | 0 | 3,038 |
Deferred revenue, net of current | 135,196 | 136,109 |
Finance lease liabilities, non-current | 46,818 | 0 |
Other long-term liabilities | 9,981 | 9,993 |
Total liabilities | 303,903 | 352,128 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.01 par value; 225,000 shares authorized at March 31, 2019 and December 31, 2018; 86,130 and 85,432 shares issued and outstanding at March 31, 2019 and December 31, 2018 | 861 | 854 |
Additional paid-in capital | 1,242,460 | 1,226,453 |
Accumulated other comprehensive loss | (937) | (2,281) |
Accumulated deficit | (753,161) | (715,827) |
Total stockholders’ equity | 489,223 | 509,199 |
Non-controlling interests | 19,271 | 19,271 |
Total equity | 508,494 | 528,470 |
Total liabilities, stockholders’ equity and non-controlling interests | $ 812,397 | $ 880,598 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 3,898 | $ 47,210 |
Accrued and other current liabilities to related party | $ 519 | $ 444 |
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 | 86,130,000 | 85,432,000 |
Common stock, shares outstanding | 86,130,000 | 85,432,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenue: | ||
Total revenue | $ 23,863 | $ 31,925 |
Operating expenses: | ||
Research and development | 50,496 | 56,974 |
Selling, general and administrative | 22,210 | 15,550 |
Total operating expenses | 72,706 | 72,524 |
Loss from operations | (48,843) | (40,599) |
Interest and other, net | ||
Interest expense | (770) | (2,769) |
Interest income and other, net | 4,177 | 2,071 |
Total interest and other, net | 3,407 | (698) |
Loss before income taxes | (45,436) | (41,297) |
Provision for (benefit from) income taxes | (25) | 99 |
Net loss | $ (45,411) | $ (41,396) |
Net loss per share - basic and diluted | $ (0.53) | $ (0.50) |
Weighted average number of common shares used to calculate net loss per share - basic and diluted | 85,704 | 82,863 |
License Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 0 | $ 0 |
Development and Other Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 23,863 | $ 31,925 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Astellas Agreement [Member] | ||
Collaboration services and other revenue from a related party | $ 4,859 | $ 5,172 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (45,411) | $ (41,396) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | 291 | (527) |
Available-for-sale investments: | ||
Unrealized gain (loss) on investments, net of tax effect | 442 | (50) |
Net change in unrealized gain on available-for-sale investments | 442 | (50) |
Other comprehensive income (loss), net of taxes | 733 | (577) |
Comprehensive loss | $ (44,678) | $ (41,973) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Noncontrolling Interests [Member] |
Balance at Dec. 31, 2017 | $ 547,738 | $ 825 | $ 1,160,094 | $ (1,795) | $ (630,657) | $ 19,271 |
Balance, Shares at Dec. 31, 2017 | 82,498,128 | |||||
Impact of change in accounting principle upon adoption | ASU 2016-01 [Member] | 0 | $ 0 | 0 | (1,250) | 1,250 | 0 |
Net loss | (41,396) | 0 | 0 | 0 | (41,396) | 0 |
Change in unrealized gain or loss on investments | (50) | 0 | 0 | (50) | 0 | 0 |
Foreign currency translation adjustments | (527) | 0 | 0 | (527) | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | 2,146 | $ 9 | 2,137 | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 922,497 | |||||
Stock-based compensation | 10,878 | $ 0 | 10,878 | 0 | 0 | 0 |
Balance at Mar. 31, 2018 | 518,789 | $ 834 | 1,173,109 | (3,622) | (670,803) | 19,271 |
Balance, Shares at Mar. 31, 2018 | 83,420,625 | |||||
Balance at Dec. 31, 2018 | 528,470 | $ 854 | 1,226,453 | (2,281) | (715,827) | 19,271 |
Balance, Shares at Dec. 31, 2018 | 85,432,102 | |||||
Impact of change in accounting principle upon adoption | ASU 2016-02 [Member] | 8,688 | $ 0 | 0 | 0 | 8,688 | 0 |
Impact of change in accounting principle upon adoption | ASU 2018-02 [Member] | 0 | 0 | 0 | 611 | (611) | 0 |
Net loss | (45,411) | 0 | 0 | 0 | (45,411) | 0 |
Change in unrealized gain or loss on investments | 442 | 0 | 0 | 442 | 0 | 0 |
Foreign currency translation adjustments | 291 | 0 | 0 | 291 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid | (416) | $ 7 | (423) | 0 | 0 | 0 |
Shares issued from stock plans, net of payroll taxes paid, Shares | 697,462 | |||||
Stock-based compensation | 16,430 | $ 0 | 16,430 | 0 | 0 | 0 |
Balance at Mar. 31, 2019 | $ 508,494 | $ 861 | $ 1,242,460 | $ (937) | $ (753,161) | $ 19,271 |
Balance, Shares at Mar. 31, 2019 | 86,129,564 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities | ||
Net loss | $ (45,411) | $ (41,396) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 2,744 | 1,519 |
Amortization of finance lease right-of-use assets | 2,569 | 0 |
Net amortization of premium and discount on investments | (1,350) | 277 |
Unrealized gain on cash equivalents and short-term equity investments | (51) | (165) |
Gain on disposal of property and equipment | (10) | 0 |
Stock-based compensation | 16,430 | 10,878 |
Tax benefit on unrealized gain on available-for-sale securities | (118) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 57,661 | (1,523) |
Prepaid expenses and other current assets | (2,785) | 1,380 |
Other assets | (51) | (364) |
Accounts payable | (5,367) | (1,960) |
Accrued and other liabilities | 736 | (1,066) |
Deferred revenue | (2,580) | (5) |
Lease obligations | 0 | 14 |
Accrued interest for finance lease liabilities | 219 | 0 |
Other long-term liabilities | (156) | 448 |
Net cash provided by (used in) operating activities | 22,480 | (31,963) |
Investing activities | ||
Purchases of property and equipment | (483) | (1,837) |
Purchases of available-for-sale securities and term deposit | (76,004) | (44) |
Proceeds from maturities of investments | 50,000 | 17,180 |
Net cash provided by (used in) investing activities | (26,487) | 15,299 |
Financing activities | ||
Repayments of finance lease liabilities | (3,017) | 0 |
Repayments of lease obligations | (101) | (101) |
Cash paid for payroll taxes on restricted stock unit releases | (5,988) | (6,813) |
Proceeds from issuance of common stock | 5,572 | 8,959 |
Net cash provided by (used in) financing activities | (3,534) | 2,045 |
Effect of exchange rate change on cash and cash equivalents | (44) | (32) |
Net decrease in cash and cash equivalents | (7,585) | (14,651) |
Total cash and cash equivalents at beginning of period | 89,258 | 673,658 |
Total cash and cash equivalents at end of period | $ 81,673 | $ 659,007 |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
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 leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company has applied its pioneering expertise in hypoxia-inducible factor (“HIF”) and connective tissue growth factor (“CTGF”) biology to develop innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat (FG-4592), the Company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat has received approval of its New Drug Application (“NDA”) in anemia associated with chronic kidney disease (“CKD”) in dialysis-dependent patients from the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“China”). In conjunction with our collaboration partners, we have completed the Phase 3 trials of roxadustat intended to support B 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, 2018 (“2018 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 2018 Form 10-K, except for the following: Leases The Company determines if an arrangement is a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company will reassess the incremental borrowing rate periodically for application to any new leases or lease modifications or if any company-specific or general business conditions warrant. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. 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 ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases, and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC 840 build-to-suit guidance. In addition, as a result of applying the transition guidance, the Company also recorded an adjustment to the accumulated depreciation of related leasehold improvements to reflect a change in estimated useful life from the building life to the shorter of the building life and remaining lease term. Differences between the assets and liabilities derecognized were recorded to the opening balance of retained earnings. The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands): Balance Sheet Line Item Nature of Adjustment New Lease Guidance Adoption Adjustment Assets Property and equipment, net Derecognition - build-to-suit lease assets - building shell, cost $ (53,880 ) Derecognition - build-to-suit lease assets - building shell, accumulated depreciation 13,476 Change of useful life - leasehold improvements, accumulated depreciation (38,877 ) Finance lease right-of-use assets Recognition - finance lease ROU assets 49,597 Other assets Recognition - operating lease ROU assets 730 Liabilities Accrued and other current liabilities Derecognition - deferred rent, current (619 ) Derecognition - build-to-suit lease liabilities, current (545 ) Recognition - operating lease liabilities, current 404 Finance lease liabilities, current Recognition - finance lease liabilities, current 11,499 Long-term portion of lease obligations Derecognition - build-to-suit lease liabilities, non-current (95,613 ) Deferred rent Derecognition - deferred rent, non-current (3,038 ) Finance lease liabilities, non-current Recognition - finance lease liabilities, non-current 49,884 Other long-term liabilities Recognition - operating lease liabilities, non-current 250 Stockholders’ equity Accumulated deficit Cumulative decrease to accumulated deficit $ 8,688 The adoption of this guidance did not have a material impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the three months ended March 31, 2019. ASU 2018-02 In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2018 $ (2,281 ) $ (715,827 ) Impact of change in accounting principle upon adoption of ASU 2018-02 611 (611 ) Opening balance as of January 1, 2019 $ (1,670 ) $ (716,438 ) The adoption of this guidance had no impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the three months ended March 31, 2019. “Disclosure Update and Simplification,” ASU 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Recently Issued Accounting Guidance Not Yet Adopted Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 31, 2019 | |
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 for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. 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 (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. In the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. 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 (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), received marketing authorization from the NMPA for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca . 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 March 31, Agreement Performance Obligation 2019 2018 Japan License revenue $ — $ — Development revenue $ 246 $ 449 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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 74,089 $ — $ 74,089 Development revenue 14,154 207 14,361 Total license and development revenue $ 88,243 $ 207 $ 88,450 The revenue recognized under the Japan Agreement for the three months ended March 31, 2019 included an immaterial amount resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Japan Agreement includes $0.9 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 March 31, Agreement Performance Obligation 2019 2018 Europe License revenue $ — $ — Development revenue $ 4,613 $ 4,723 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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 370,481 $ — $ 370,481 Development revenue 207,450 2,334 209,784 Total license and development revenue $ 577,931 $ 2,334 $ 580,265 The revenue recognized under the Europe Agreement for the three months ended March 31, 2019 included an increase in revenue of $0.1 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Europe Agreement includes $12.7 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2019 2018 U.S. / RoW and China License revenue $ — $ — Development revenue 19,004 26,723 China performance obligation $ — $ — 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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 294,163 $ — $ 294,163 Co-development, information sharing & committee services 427,641 16,787 444,428 China performance obligation — 127,972 127,972 Total license and development revenue $ 721,804 $ 144,759 $ 866,563 The revenue recognized under the U.S./RoW Agreement for the three months ended March 31, 2019 included an increase in revenue of $0.9 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the U.S./RoW Agreement and China Agreement includes $172.3 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation, which are expected to be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. Deferred Revenue Deferred revenue represents amounts billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. The long term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying performance obligations. The long term portion of deferred revenue also includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China, which is not expected to occur within the next year. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
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): March 31, 2019 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 344,728 $ 150,368 $ — $ 495,096 Bond and mutual funds 10,591 — — 10,591 Equity investments 246 — — 246 Money market funds 9,395 — — 9,395 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,996 — 29,996 Total $ 364,960 $ 260,364 $ — $ 625,324 December 31, 2018 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 292,317 $ 224,953 $ — $ 517,270 Bond and mutual funds 10,484 — — 10,484 Equity investments 234 — — 234 Money market funds 541 — — 541 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,910 — 29,910 Total $ 303,576 $ 334,863 $ — $ 638,439 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): March 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,846 $ 1,846 December 31, 2018 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 98,105 $ 98,105 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. As of December 31, 2018, the Company had $96.2 million in lease obligations related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these liabilities previously recognized under ASC 840 build-to-suit designation. Refer to Note 1 for details. The remaining balance of $1.8 million as of March 31, 2019 under lease obligations is related to an expansion option in the Company’s long-term property lease with Shorenstein Properties LLC (“Alexandria” or “landlord”). This expansion option allowed the Company to occupy part of an adjacent building within 31 months of the lease commencement date in 2008. In 2012, the Company gave notice to its landlord that it would not exercise this expansion option, which resulted in a $5.0 million payment liability to the landlord that is financed over the remaining lease term to 2023. There were no transfers of assets or liabilities between levels for any of the periods presented. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | 4. Leases The Company currently has two building leases treated as finance leases. In 2006, The Company entered into a long-term property lease with Alexandria for its corporate headquarters in San Francisco, California, with an initial term of 15 years, scheduled to expire in 2023. The Company has an option to extend the lease for an additional 10 years through 2033. The lease contract provides for a fixed annual rent, with scheduled increases of two percent that occur on each anniversary of the rent commencement date. This lease requires the Company to pay all costs of ownership, operation, and maintenance of the premises, including without limitation all operating costs, insurance costs, and taxes. In 2013, the Company entered into a long-term property lease with Beijing Economic-Technological Development Area (“BDA”) Management Committee for a pilot plant located in Beijing Yizhuang Biomedical Park (“BYBP”) of BDA. The building is leased for an initial lease term of eight years, scheduled to expire in 2021. Renewal options are not specified within the lease contract. The lease contract provides for fixed quarterly rent payments, with scheduled increases that occur as detailed in the lease contract. This lease requires the Company to pay all operating and maintenance costs, and a fixed amount for property management fees. The Company currently has four additional real estate leases for space within a building, which are treated as operating leases. These leases have lease terms ranging from two to four years. These lease contracts provide for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs, and a fixed amount for property management fees. In addition, the Company has several office equipment leases for printers and copiers, with contracted lease terms ranging from three to five years. These lease contracts provide for fixed monthly rent payments, and are scheduled to automatically renew for an additional term upon lease expiration, unless purchased or returned. The Company does not anticipate exercising the additional lease terms and instead plans to return the equipment upon lease expiration. Additionally, the Company has one lease of an automobile in Cangzhou, China, with initial lease term of two years. The lease contract provides for fixed monthly rent payments, with no option to renew the lease. The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item March 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,598 Accumulated amortization (2,569 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 47,029 Operating: Right-of-use assets - cost 730 Accumulated amortization (122 ) Operating lease right-of-use assets, net Other assets 608 Total lease assets $ 47,637 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 11,766 Operating lease liabilities Accrued and other current liabilities 436 Non-current: Finance lease liabilities Finance lease liabilities, non-current 46,818 Operating lease liabilities Other long-term liabilities 129 Total lease liabilities $ 59,149 The components of lease expense were as follows (in thousands): Statement of Operations Line Item Three Months Ended March 31, 2019 Finance lease cost: Amortization of right-of-use assets Selling, general and administrative expenses $ 2,569 Interest on lease liabilities Interest expense 640 Operating lease cost Research and development, Selling, general and administrative expenses 126 Sublease income Selling, general and administrative expenses (588 ) Total lease cost $ 2,747 Supplemental cash flow information related to leases were as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 99 Operating cash flows from finance leases 435 Financing cash flows from finance leases 3,017 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 49,597 Operating leases $ 730 Lease term and discount rate were as follows: Three Months Ended March 31, 2019 Weighted-average remaining lease term (years): Finance leases 4.3 Operating leases 1.2 Weighted-average discount rate: Finance leases 4.43 % Operating leases 4.74 % Maturities of lease liabilities are as follows: Year Ending Finance Leases Operating Leases 2019 (Remaining nine month period) $ 10,326 $ 326 2020 14,106 217 2021 13,679 25 2022 13,879 16 2023 12,523 — Total future lease payments 64,513 584 Less: Interest (5,929 ) (19 ) Present value of lease liabilities $ 58,584 $ 565 The following information was previously disclosed under ASC 840 as of December 31, 2018: Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands): Year Ending Operating Leases 2019 $ 444 2020 232 2021 25 2022 16 2023 — Total minimum payments $ 717 Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands): Year Ending Lease financing obligations 2019 $ 14,379 2020 14,664 2021 14,179 2022 14,335 2023 12,872 Total minimum payments $ 70,429 |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): March 31, 2019 December 31, 2018 Cash $ 72,278 $ 38,783 US treasury notes and bills — 49,934 Money market funds 9,395 541 Total cash and cash equivalents $ 81,673 $ 89,258 At March 31, 2019 and December 31, 2018, a total of $31.5 million and $21.9 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations. Investments The Company’s investments consist of available-for-sale debt investments, marketable equity investments, a term deposit and a certificate of deposit. 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): March 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 494,580 $ 516 $ — $ 495,096 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (4 ) 29,996 Bond and mutual funds 10,533 58 — 10,591 Equity investments 125 121 — 246 Total investments $ 615,238 $ 695 $ (4 ) $ 615,929 December 31, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 467,296 $ 109 $ (69 ) $ 467,336 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (90 ) 29,910 Bond and mutual funds 10,464 20 — 10,484 Equity investments 125 109 — 234 Total investments $ 587,885 $ 238 $ (159 ) $ 587,964 At March 31, 2019, all of the available-for-sale investments had contractual maturities within two years. The Company periodically reviews its available-for-sale investments and term deposit for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three months ended March 31, 2019 and 2018, the Company did not recognize any other-than-temporary impairment loss. Property and Equipment Property and equipment consisted of the following (in thousands): March 31, 2019 December 31, 2018 Leasehold improvements $ 101,229 $ 101,200 Building shell — 53,880 Laboratory equipment 16,480 16,405 Machinery 8,396 8,382 Computer equipment 6,650 6,473 Furniture and fixtures 5,643 5,690 Construction in progress 607 367 Total property and equipment $ 139,005 $ 192,397 Less: accumulated depreciation (93,177 ) (65,199 ) Property and equipment, net $ 45,828 $ 127,198 As of December 31, 2018, the Company had $53.9 million building shell cost and $13.5 million accumulated depreciation related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these assets previously recognized under ASC 840 build-to-suit designation. Up to December 31, 2018, the leasehold improvements related to these building leases were depreciated over the life of the building under ASC 840. Upon the adoption of ASC 842, these leasehold improvements should have a useful life based on the lease term. As a result, at the adoption date, the Company recorded a cumulative adjustment of $38.9 million to the accumulated depreciation for these leasehold improvements so that their net balance equals the undepreciated amount had the useful life of the leasehold improvements always been equal to the lease terms. Refer to Note 1 for details. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, 2019 December 31, 2018 Preclinical and clinical trial accruals $ 41,964 $ 35,413 Payroll and related accruals 12,368 21,430 Property taxes and other 2,969 1,095 Professional services 3,547 2,648 Other 5,430 5,537 Total accrued liabilities $ 66,278 $ 66,123 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 6. 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 March 31, 2019 2018 Research and development $ 9,578 $ 6,370 Selling, general and administrative 6,852 4,508 Total stock-based compensation expense $ 16,430 $ 10,878 The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended March 31, 2019 2018 Stock Options Expected term (in years) 5.3 5.4 Expected volatility 67.9 % 67.9 % Risk-free interest rate 2.6 % 2.7 % Expected dividend yield — — Weighted average estimated fair value $ 34.14 $ 32.18 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 Expected volatility 48.1 - 62.1 % 54.9 - 75.3 % Risk-free interest rate 1.3 - 2.9 % 0.8 - 1.6 % Expected dividend yield — — Weighted average estimated fair value $ 20.57 $ 10.93 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes The benefit for the three months ended March 31, 2019 was primarily due to the tax effect arising from other comprehensive income related to available-for-sale securities, partially offset by foreign taxes. The provision for income taxes for the three months ended March 31, 2018 was 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 | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 8. Related Party Transactions Astellas is an equity investor in the Company and considered a related party. The Company recorded revenue related to collaboration agreements with Astellas of $4.9 million and $5.2 million during the three months ended March 31, 2019 and 2018, respectively. The Company recorded expense related to collaboration agreements with Astellas of $0.5 million and $0.6 million during the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019 and December 31, 2018, accounts receivable from Astellas were $3.9 million and $47.2 million, respectively, and amounts due to Astellas were $0.5 million and $0.4 million, respectively. The accounts receivable from Astellas as of December 31, 2018 included $43.8 million related to the delivery of roxadustat API to Astellas during the fourth quarter of 2018, pursuant to an amendment to the Japan Agreement that will allow Astellas to manufacture roxadustat drug product for commercialization in Japan. This amount was received during the first quarter of 2019. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Description of Operations | Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company has applied its pioneering expertise in hypoxia-inducible factor (“HIF”) and connective tissue growth factor (“CTGF”) biology to develop innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat (FG-4592), the Company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity. Roxadustat has received approval of its New Drug Application (“NDA”) in anemia associated with chronic kidney disease (“CKD”) in dialysis-dependent patients from the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“China”). In conjunction with our collaboration partners, we have completed the Phase 3 trials of roxadustat intended to support B |
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, 2018 (“2018 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 2018 Form 10-K, except for the following: |
Leases | Leases The Company determines if an arrangement is a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company will reassess the incremental borrowing rate periodically for application to any new leases or lease modifications or if any company-specific or general business conditions warrant. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. |
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 ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases, and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC 840 build-to-suit guidance. In addition, as a result of applying the transition guidance, the Company also recorded an adjustment to the accumulated depreciation of related leasehold improvements to reflect a change in estimated useful life from the building life to the shorter of the building life and remaining lease term. Differences between the assets and liabilities derecognized were recorded to the opening balance of retained earnings. The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands): Balance Sheet Line Item Nature of Adjustment New Lease Guidance Adoption Adjustment Assets Property and equipment, net Derecognition - build-to-suit lease assets - building shell, cost $ (53,880 ) Derecognition - build-to-suit lease assets - building shell, accumulated depreciation 13,476 Change of useful life - leasehold improvements, accumulated depreciation (38,877 ) Finance lease right-of-use assets Recognition - finance lease ROU assets 49,597 Other assets Recognition - operating lease ROU assets 730 Liabilities Accrued and other current liabilities Derecognition - deferred rent, current (619 ) Derecognition - build-to-suit lease liabilities, current (545 ) Recognition - operating lease liabilities, current 404 Finance lease liabilities, current Recognition - finance lease liabilities, current 11,499 Long-term portion of lease obligations Derecognition - build-to-suit lease liabilities, non-current (95,613 ) Deferred rent Derecognition - deferred rent, non-current (3,038 ) Finance lease liabilities, non-current Recognition - finance lease liabilities, non-current 49,884 Other long-term liabilities Recognition - operating lease liabilities, non-current 250 Stockholders’ equity Accumulated deficit Cumulative decrease to accumulated deficit $ 8,688 The adoption of this guidance did not have a material impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the three months ended March 31, 2019. ASU 2018-02 In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2018 $ (2,281 ) $ (715,827 ) Impact of change in accounting principle upon adoption of ASU 2018-02 611 (611 ) Opening balance as of January 1, 2019 $ (1,670 ) $ (716,438 ) The adoption of this guidance had no impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the three months ended March 31, 2019. “Disclosure Update and Simplification,” ASU 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. |
Recently Issued Accounting Guidance Not Yet Adopted | Recently Issued Accounting Guidance Not Yet Adopted Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Collaboration Arrangements | Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. 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 (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. In the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. 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 (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), received marketing authorization from the NMPA for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca . |
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) | 3 Months Ended |
Mar. 31, 2019 | |
ASU 2016-02 [Member] | |
Schedule of Impacts Upon Adoption of New Guidance | The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands): Balance Sheet Line Item Nature of Adjustment New Lease Guidance Adoption Adjustment Assets Property and equipment, net Derecognition - build-to-suit lease assets - building shell, cost $ (53,880 ) Derecognition - build-to-suit lease assets - building shell, accumulated depreciation 13,476 Change of useful life - leasehold improvements, accumulated depreciation (38,877 ) Finance lease right-of-use assets Recognition - finance lease ROU assets 49,597 Other assets Recognition - operating lease ROU assets 730 Liabilities Accrued and other current liabilities Derecognition - deferred rent, current (619 ) Derecognition - build-to-suit lease liabilities, current (545 ) Recognition - operating lease liabilities, current 404 Finance lease liabilities, current Recognition - finance lease liabilities, current 11,499 Long-term portion of lease obligations Derecognition - build-to-suit lease liabilities, non-current (95,613 ) Deferred rent Derecognition - deferred rent, non-current (3,038 ) Finance lease liabilities, non-current Recognition - finance lease liabilities, non-current 49,884 Other long-term liabilities Recognition - operating lease liabilities, non-current 250 Stockholders’ equity Accumulated deficit Cumulative decrease to accumulated deficit $ 8,688 |
ASU 2018-02 [Member] | |
Schedule of Impacts Upon Adoption of New Guidance | The impacts, based on the aggregate portfolio approach, to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands): Accumulated Other Comprehensive Loss Accumulated Deficit Balance at December 31, 2018 $ (2,281 ) $ (715,827 ) Impact of change in accounting principle upon adoption of ASU 2018-02 611 (611 ) Opening balance as of January 1, 2019 $ (1,670 ) $ (716,438 ) |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Japan [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2019 2018 Japan License revenue $ — $ — Development revenue $ 246 $ 449 |
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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 74,089 $ — $ 74,089 Development revenue 14,154 207 14,361 Total license and development revenue $ 88,243 $ 207 $ 88,450 |
Europe [Member] | |
Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement were as follows (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2019 2018 Europe License revenue $ — $ — Development revenue $ 4,613 $ 4,723 |
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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 370,481 $ — $ 370,481 Development revenue 207,450 2,334 209,784 Total license and development revenue $ 577,931 $ 2,334 $ 580,265 |
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 March 31, Agreement Performance Obligation 2019 2018 U.S. / RoW and China License revenue $ — $ — Development revenue 19,004 26,723 China performance obligation $ — $ — |
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 March 31, 2019 Deferred Revenue at March 31, 2019 Total Consideration Through March 31, 2019 License $ 294,163 $ — $ 294,163 Co-development, information sharing & committee services 427,641 16,787 444,428 China performance obligation — 127,972 127,972 Total license and development revenue $ 721,804 $ 144,759 $ 866,563 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): March 31, 2019 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 344,728 $ 150,368 $ — $ 495,096 Bond and mutual funds 10,591 — — 10,591 Equity investments 246 — — 246 Money market funds 9,395 — — 9,395 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,996 — 29,996 Total $ 364,960 $ 260,364 $ — $ 625,324 December 31, 2018 Level 1 Level 2 Level 3 Total US treasury notes and bills $ 292,317 $ 224,953 $ — $ 517,270 Bond and mutual funds 10,484 — — 10,484 Equity investments 234 — — 234 Money market funds 541 — — 541 Term deposit — 80,000 — 80,000 Certificate of deposit — 29,910 — 29,910 Total $ 303,576 $ 334,863 $ — $ 638,439 |
Fair Values of Financial Liabilities Carried at Historical Cost | The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands): March 31, 2019 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 1,846 $ 1,846 December 31, 2018 Level 1 Level 2 Level 3 Total Lease obligations $ — $ — $ 98,105 $ 98,105 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of Lease Assets and Related Lease Liabilities | The Company’s lease assets and related lease liabilities were as follows (in thousands): Balance Sheet Line Item March 31, 2019 Assets Finance: Right-of-use assets - cost $ 49,598 Accumulated amortization (2,569 ) Finance lease right-of-use assets, net Finance lease right-of-use assets 47,029 Operating: Right-of-use assets - cost 730 Accumulated amortization (122 ) Operating lease right-of-use assets, net Other assets 608 Total lease assets $ 47,637 Liabilities Current: Finance lease liabilities Finance lease liabilities, current $ 11,766 Operating lease liabilities Accrued and other current liabilities 436 Non-current: Finance lease liabilities Finance lease liabilities, non-current 46,818 Operating lease liabilities Other long-term liabilities 129 Total lease liabilities $ 59,149 |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Statement of Operations Line Item Three Months Ended March 31, 2019 Finance lease cost: Amortization of right-of-use assets Selling, general and administrative expenses $ 2,569 Interest on lease liabilities Interest expense 640 Operating lease cost Research and development, Selling, general and administrative expenses 126 Sublease income Selling, general and administrative expenses (588 ) Total lease cost $ 2,747 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases were as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 99 Operating cash flows from finance leases 435 Financing cash flows from finance leases 3,017 Right-of-use assets obtained in exchange for new lease liabilities: Finance leases 49,597 Operating leases $ 730 |
Schedule of Lease Term and Discount Rate | Lease term and discount rate were as follows: Three Months Ended March 31, 2019 Weighted-average remaining lease term (years): Finance leases 4.3 Operating leases 1.2 Weighted-average discount rate: Finance leases 4.43 % Operating leases 4.74 % |
Schedule of Maturities of Finance and Operating Leases Liabilities | Maturities of lease liabilities are as follows: Year Ending Finance Leases Operating Leases 2019 (Remaining nine month period) $ 10,326 $ 326 2020 14,106 217 2021 13,679 25 2022 13,879 16 2023 12,523 — Total future lease payments 64,513 584 Less: Interest (5,929 ) (19 ) Present value of lease liabilities $ 58,584 $ 565 |
Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations | Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands): Year Ending Operating Leases 2019 $ 444 2020 232 2021 25 2022 16 2023 — Total minimum payments $ 717 |
Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations | Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands): Year Ending Lease financing obligations 2019 $ 14,379 2020 14,664 2021 14,179 2022 14,335 2023 12,872 Total minimum payments $ 70,429 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands): March 31, 2019 December 31, 2018 Cash $ 72,278 $ 38,783 US treasury notes and bills — 49,934 Money market funds 9,395 541 Total cash and cash equivalents $ 81,673 $ 89,258 |
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, marketable equity investments, a term deposit and a certificate of deposit. 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): March 31, 2019 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 494,580 $ 516 $ — $ 495,096 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (4 ) 29,996 Bond and mutual funds 10,533 58 — 10,591 Equity investments 125 121 — 246 Total investments $ 615,238 $ 695 $ (4 ) $ 615,929 December 31, 2018 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value US treasury notes and bills $ 467,296 $ 109 $ (69 ) $ 467,336 Term deposit 80,000 — — 80,000 Certificates of deposit 30,000 — (90 ) 29,910 Bond and mutual funds 10,464 20 — 10,484 Equity investments 125 109 — 234 Total investments $ 587,885 $ 238 $ (159 ) $ 587,964 |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): March 31, 2019 December 31, 2018 Leasehold improvements $ 101,229 $ 101,200 Building shell — 53,880 Laboratory equipment 16,480 16,405 Machinery 8,396 8,382 Computer equipment 6,650 6,473 Furniture and fixtures 5,643 5,690 Construction in progress 607 367 Total property and equipment $ 139,005 $ 192,397 Less: accumulated depreciation (93,177 ) (65,199 ) Property and equipment, net $ 45,828 $ 127,198 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, 2019 December 31, 2018 Preclinical and clinical trial accruals $ 41,964 $ 35,413 Payroll and related accruals 12,368 21,430 Property taxes and other 2,969 1,095 Professional services 3,547 2,648 Other 5,430 5,537 Total accrued liabilities $ 66,278 $ 66,123 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 2018 Research and development $ 9,578 $ 6,370 Selling, general and administrative 6,852 4,508 Total stock-based compensation expense $ 16,430 $ 10,878 |
Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan | The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows: Three Months Ended March 31, 2019 2018 Stock Options Expected term (in years) 5.3 5.4 Expected volatility 67.9 % 67.9 % Risk-free interest rate 2.6 % 2.7 % Expected dividend yield — — Weighted average estimated fair value $ 34.14 $ 32.18 ESPPs Expected term (in years) 0.5 - 2.0 0.5 - 2.0 Expected volatility 48.1 - 62.1 % 54.9 - 75.3 % Risk-free interest rate 1.3 - 2.9 % 0.8 - 1.6 % Expected dividend yield — — Weighted average estimated fair value $ 20.57 $ 10.93 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) - Segment | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | ||
Number of operating segment | 1 | |
Short term investments maturity | 12 months | |
U.S. federal statutory income tax rate | 21.00% | 35.00% |
Summary of Significant Accounti
Summary of Significant Accounting Policies - Schedule of Impacts to Condensed Consolidated Balance Sheet Upon Adoption of 842 Guidance (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Assets | ||
Property and equipment, net | $ 45,828 | $ 127,198 |
Finance lease right-of-use assets | 47,029 | 0 |
Liabilities, stockholders’ equity and non-controlling interests | ||
Finance lease liabilities, current | 11,766 | 0 |
Deferred rent | 0 | 3,038 |
Finance lease liabilities, non-current | 46,818 | 0 |
Accumulated deficit | (753,161) | $ (715,827) |
Derecognition Build to Suit Lease Assets [Member] | Building Shell [Member] | ||
Assets | ||
Property and equipment, net | (53,880) | |
Derecognition Build to Suit Lease Assets Accumulated Depreciation [Member] | Building Shell [Member] | ||
Assets | ||
Property and equipment, net | 13,476 | |
Leasehold Improvements Accumulated Depreciation [Member] | ||
Assets | ||
Property and equipment, net | (38,877) | |
Recognition Finance Lease Assets [Member] | ||
Assets | ||
Finance lease right-of-use assets | 49,597 | |
Recognition Operating Lease Assets [Member] | ||
Assets | ||
Other assets | 730 | |
Derecognition Deferred Rent Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Accrued and other current liabilities | (619) | |
Derecognition Build to Suit Lease Liabilities Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Accrued and other current liabilities | (545) | |
Recognition Operating Lease Liabilities Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Accrued and other current liabilities | 404 | |
Recognition Finance Lease Liabilities Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Finance lease liabilities, current | 11,499 | |
Derecognition Build to Suit Lease Liabilities Non Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Long-term portion of lease obligations | (95,613) | |
Derecognition Deferred Rent Non Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Deferred rent | (3,038) | |
Recognition Finance Lease Liabilities Non Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Finance lease liabilities, non-current | 49,884 | |
Recognition Operating Lease Liabilities Non Current [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Other long-term liabilities | 250 | |
Cumulative Decrease to Accumulated Deficit [Member] | ||
Liabilities, stockholders’ equity and non-controlling interests | ||
Accumulated deficit | $ 8,688 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - Schedule of Impacts to Accumulated Other Comprehensive Loss and Accumulated Deficit Upon Adoption of Guidance (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | $ (937) | $ (2,281) | |
Accumulated deficit | $ (753,161) | $ (715,827) | |
ASU 2018-02 [Member] | |||
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | $ (1,670) | ||
Accumulated deficit | (716,438) | ||
Impact of change in accounting principle upon adoption of ASU 2018-02 [Member] | ASU 2018-02 [Member] | |||
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | 611 | ||
Accumulated deficit | $ (611) |
Collaboration Agreements - Aste
Collaboration Agreements - Astellas Agreements - Additional Information (Detail) - Astellas Agreement [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | 35 Months Ended | 45 Months Ended | |
Apr. 30, 2006 | Jun. 30, 2005 | Mar. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2009 | Feb. 28, 2009 | |
Japan [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront, non-contingent and time-based payments received | $ 40.1 | |||||
Potential milestone payments | $ 132.5 | |||||
Commercial sales milestone | 15 | |||||
Japan [Member] | Clinical and Development Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | 22.5 | |||||
Japan [Member] | Regulatory Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 95 | |||||
Europe [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront, non-contingent and time-based payments received | $ 320 | |||||
Potential milestone payments | $ 425 | |||||
Percentage of joint development costs committed to fund | 50.00% | |||||
Additional consideration based on net sales description | Low 20% range | |||||
Estimated joint development extended service period | 2023 | |||||
Europe [Member] | Clinical and Development Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 90 | |||||
Europe [Member] | Regulatory Milestone [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential milestone payments | $ 335 |
Collaboration Agreements - Astr
Collaboration Agreements - AstraZeneca Agreements - Additional Information 1 (Detail) - AstraZeneca Agreements [Member] - USD ($) $ in Millions | Dec. 29, 2018 | Dec. 17, 2018 | Jul. 30, 2013 | Mar. 31, 2019 | 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 | ||||
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 | ||||
Estimated joint development extended service period | 2024 | ||||
Milestone payment, revenue recognition | $ 6 | $ 6 | |||
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 - Summ
Collaboration Agreements - Summary of Revenue Recognized under Agreement (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | $ 23,863 | $ 31,925 |
License Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Development Revenue [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 23,863 | 31,925 |
Astellas Agreement [Member] | License Revenue [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Astellas Agreement [Member] | License Revenue [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
Astellas Agreement [Member] | Development Revenue [Member] | Japan [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 246 | 449 |
Astellas Agreement [Member] | Development Revenue [Member] | Europe [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 4,613 | 4,723 |
AstraZeneca Agreements [Member] | China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
AstraZeneca Agreements [Member] | License Revenue [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | 0 | 0 |
AstraZeneca Agreements [Member] | Development Revenue [Member] | U.S./RoW and China [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Total revenue | $ 19,004 | $ 26,723 |
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 | Mar. 31, 2019USD ($) |
Astellas Agreement [Member] | Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | $ 88,243 |
Deferred Revenue | 207 |
Total Consideration | 88,450 |
Astellas Agreement [Member] | Japan [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 14,154 |
Deferred Revenue | 207 |
Total Consideration | 14,361 |
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 | 577,931 |
Deferred Revenue | 2,334 |
Total Consideration | 580,265 |
Astellas Agreement [Member] | Europe [Member] | Development Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 207,450 |
Deferred Revenue | 2,334 |
Total Consideration | 209,784 |
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 | 721,804 |
Deferred Revenue | 144,759 |
Total Consideration | 866,563 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | License Revenue [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 294,163 |
Deferred Revenue | 0 |
Total Consideration | 294,163 |
AstraZeneca Agreements [Member] | U.S./RoW and China [Member] | Co-development, information sharing & committee services [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Cumulative Revenue | 427,641 |
Deferred Revenue | 16,787 |
Total Consideration | 444,428 |
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 | 127,972 |
Total Consideration | $ 127,972 |
Collaboration Agreements - Su_2
Collaboration Agreements - Summary of Revenue Recognized Under the Collaboration Agreements - Additional Information 4 (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Japan [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | $ 0.9 |
Europe [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Remainder of transaction price, variable consideration from estimated future co-development billing | 12.7 |
Europe [Member] | Astellas Agreement [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | 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 | 172.3 |
U.S./RoW and China [Member] | AstraZeneca Agreements [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Changes in revenue due to prior period adjustment of performance obligations | $ 0.9 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Values of Financial Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 615,929 | $ 587,964 |
US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 495,096 | 467,336 |
Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,591 | 10,484 |
Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 246 | 234 |
Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | 80,000 |
Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 29,996 | 29,910 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 625,324 | 638,439 |
Fair Value, Measurements, Recurring [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 495,096 | 517,270 |
Fair Value, Measurements, Recurring [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,591 | 10,484 |
Fair Value, Measurements, Recurring [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 246 | 234 |
Fair Value, Measurements, Recurring [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 9,395 | 541 |
Fair Value, Measurements, Recurring [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | 80,000 |
Fair Value, Measurements, Recurring [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 29,996 | 29,910 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 364,960 | 303,576 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 344,728 | 292,317 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 10,591 | 10,484 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 246 | 234 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 9,395 | 541 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 260,364 | 334,863 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 150,368 | 224,953 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 80,000 | 80,000 |
Fair Value, Measurements, Recurring [Member] | Level 2 [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 29,996 | 29,910 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total fair value of financial assets | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | US treasury notes and bills [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Bond and mutual funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Equity investments [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Money market funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Term deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Certificate of deposit [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Investments | $ 0 | $ 0 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Values of Financial Liabilities Carried at Historical Cost (Detail) - Lease obligations [Member] - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,846 | $ 98,105 |
Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,846 | $ 98,105 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Lease payment liability | $ 58,584,000 | |
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 |
Shorenstein Properties LLC [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Lease commencement date | 2008 | |
Lease payment liability | $ 5,000,000 | |
Remaining lease term | 2023 | |
Building [Member] | Shorenstein Properties LLC [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Lease maximum expansion period | 31 months | |
Lease obligations [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,846,000 | 98,105,000 |
Lease obligations [Member] | Long-term property lease [Member] | Shorenstein Properties LLC [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,800,000 | |
Lease obligations [Member] | Building [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 96,200,000 |
Leases - Additional Information
Leases - Additional Information (Detail) - Lease | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2013 | Dec. 31, 2006 | |
Minimum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 2 years | ||
Maximum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 4 years | ||
Shorenstein Properties LLC [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, finance lease, initial lease term | 15 years | ||
Lessee, finance lease, expiration period | 2023 | ||
Lessee, finance lease, option to extend the additional lease term | 10 years | ||
Lessee, finance lease, additional lease expiration period | 2033 | ||
Percentage increases on each anniversary of rent commencement date | 2.00% | ||
Lessee, finance lease, existence of option to extend | true | ||
Lessee, finance lease, option to extend | The Company has an option to extend the lease for an additional 10 years through 2033. | ||
Beijing Economic-Technological Development Area [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, finance lease, initial lease term | 8 years | ||
Lessee, finance lease, expiration period | 2021 | ||
Lessee, finance lease, existence of option to extend | false | ||
Building [Member] | |||
Lessee Lease Description [Line Items] | |||
Number of finance leases | 2 | ||
Number of operating leases | 4 | ||
Office Equipment [Member] | Minimum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 3 years | ||
Office Equipment [Member] | Maximum [Member] | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, lease term | 5 years | ||
Automobile [Member] | |||
Lessee Lease Description [Line Items] | |||
Number of operating leases | 1 | ||
Lessee, operating lease, lease term | 2 years | ||
Lessee, operating lease, existence of option to extend | false |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
Right-of-use assets - cost | $ 49,598 | |
Accumulated amortization | (2,569) | |
Finance lease right-of-use assets, net | 47,029 | $ 0 |
Right-of-use assets - cost | 730 | |
Accumulated amortization | (122) | |
Operating lease right-of-use assets, net | 608 | |
Total lease assets | 47,637 | |
Finance lease liabilities | 11,766 | 0 |
Operating lease liabilities | 436 | |
Finance lease liabilities | 46,818 | $ 0 |
Operating lease liabilities | 129 | |
Total lease liabilities | $ 59,149 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Finance lease cost: | ||
Amortization of right-of-use assets | $ 2,569 | $ 0 |
Interest on lease liabilities | 640 | |
Operating lease cost | 126 | |
Sublease income | (588) | |
Total lease cost | $ 2,747 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 99 | |
Operating cash flows from finance leases | 435 | |
Financing cash flows from finance leases | 3,017 | $ 0 |
Right-of-use assets obtained in exchange for new lease liabilities: | ||
Finance leases | 49,597 | |
Operating leases | $ 730 |
Leases - Schedule of Lease Term
Leases - Schedule of Lease Term and Discount Rate (Detail) | Mar. 31, 2019 |
Weighted-average remaining lease term (years): | |
Finance leases | 4 years 3 months 18 days |
Operating leases | 1 year 2 months 12 days |
Weighted-average discount rate: | |
Finance leases | 4.43% |
Operating leases | 4.74% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Finance Leases | |
2019 (Remaining nine month period) | $ 10,326 |
2020 | 14,106 |
2021 | 13,679 |
2022 | 13,879 |
2023 | 12,523 |
Total future lease payments | 64,513 |
Less: Interest | (5,929) |
Present value of lease liabilities | 58,584 |
Operating Leases | |
2019 (Remaining nine month period) | 326 |
2020 | 217 |
2021 | 25 |
2022 | 16 |
2023 | 0 |
Total future lease payments | 584 |
Less: Interest | (19) |
Present value of lease liabilities | $ 565 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 444 |
2020 | 232 |
2021 | 25 |
2022 | 16 |
2023 | 0 |
Total minimum payments | $ 717 |
Leases - Schedule of Future M_2
Leases - Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 14,379 |
2020 | 14,664 |
2021 | 14,179 |
2022 | 14,335 |
2023 | 12,872 |
Total minimum payments | $ 70,429 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 72,278 | $ 38,783 |
US treasury notes and bills | 0 | 49,934 |
Money market funds | 9,395 | 541 |
Total cash and cash equivalents | $ 81,673 | $ 89,258 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) | Mar. 31, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 81,673,000 | $ 81,673,000 | $ 89,258,000 | |
Contractual maturities of available-for-sale investments | 2 years | |||
Other-than-temporary impairment loss | 0 | $ 0 | ||
Building shell cost | $ 139,005,000 | 139,005,000 | 192,397,000 | |
Accumulated depreciation | 93,177,000 | 93,177,000 | 65,199,000 | |
Building shell [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Building shell cost | 0 | 0 | 53,880,000 | |
Building [Member] | Build to suit arrangements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Accumulated depreciation | 13,500,000 | |||
Leasehold improvements [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Building shell cost | 101,229,000 | 101,229,000 | 101,200,000 | |
Leasehold improvements [Member] | Accounting standards update 2016-02 [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Accumulated depreciation | 38,900,000 | 38,900,000 | ||
Foreign subsidiaries [Member] | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Cash and cash equivalents | $ 31,500,000 | $ 31,500,000 | $ 21,900,000 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 615,238 | $ 587,885 |
Gross Unrealized Holding Gains | 695 | 238 |
Gross Unrealized Holding Losses | (4) | (159) |
Fair Value | 615,929 | 587,964 |
US treasury notes and bills [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 494,580 | 467,296 |
Gross Unrealized Holding Gains | 516 | 109 |
Gross Unrealized Holding Losses | 0 | (69) |
Fair Value | 495,096 | 467,336 |
Term deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 80,000 | 80,000 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 80,000 | 80,000 |
Certificate of deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,000 | 30,000 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | (4) | (90) |
Fair Value | 29,996 | 29,910 |
Bond and mutual funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,533 | 10,464 |
Gross Unrealized Holding Gains | 58 | 20 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | 10,591 | 10,484 |
Equity investments [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125 | 125 |
Gross Unrealized Holding Gains | 121 | 109 |
Gross Unrealized Holding Losses | 0 | 0 |
Fair Value | $ 246 | $ 234 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 139,005 | $ 192,397 |
Less: accumulated depreciation | (93,177) | (65,199) |
Property and equipment, net | 45,828 | 127,198 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 101,229 | 101,200 |
Building shell [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 0 | 53,880 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 16,480 | 16,405 |
Machinery [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,396 | 8,382 |
Computer Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,650 | 6,473 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 5,643 | 5,690 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 607 | $ 367 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 41,964 | $ 35,413 |
Payroll and related accruals | 12,368 | 21,430 |
Property taxes and other | 2,969 | 1,095 |
Professional services | 3,547 | 2,648 |
Other | 5,430 | 5,537 |
Total accrued liabilities | $ 66,278 | $ 66,123 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Allocated Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 16,430 | $ 10,878 |
Research and development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 9,578 | 6,370 |
Selling, general and administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 6,852 | $ 4,508 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
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 4 months 24 days |
Expected volatility | 67.90% | 67.90% |
Risk-free interest rate | 2.60% | 2.70% |
Expected dividend yield | 0.00% | 0.00% |
Weighted average estimated fair value | $ 34.14 | $ 32.18 |
2014 Employee Share Purchase Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 48.10% | 54.90% |
Expected volatility, maximum | 62.10% | 75.30% |
Risk-free interest rate, minimum | 1.30% | 0.80% |
Risk-free interest rate, maximum | 2.90% | 1.60% |
Expected dividend yield | 0.00% | 0.00% |
Weighted average estimated fair value | $ 20.57 | $ 10.93 |
2014 Employee Share Purchase Plan [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 6 months | 6 months |
2014 Employee Share Purchase Plan [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 2 years | 2 years |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | |||
Accounts receivable from related party | $ 3,898 | $ 47,210 | |
Accrued liabilities to related party | 519 | 444 | |
Astellas [Member] | Collaborative Arrangement [Member] | |||
Related Party Transaction [Line Items] | |||
Revenue related to collaboration agreements | 4,900 | $ 5,200 | |
Expense related to collaboration agreements | 500 | $ 600 | |
Accounts receivable from related party | 3,900 | 47,200 | |
Accrued liabilities to related party | $ 500 | 400 | |
Astellas [Member] | Astellas Agreement [Member] | API Shipment [Member] | |||
Related Party Transaction [Line Items] | |||
Accrued liabilities to related party | $ 43,800 |