Document and Entity Information
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6 Months Ended | |
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Jun. 30, 2015
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Jul. 31, 2015
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Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | FGEN | |
Entity Registrant Name | FIBROGEN INC | |
Entity Central Index Key | 0000921299 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 60,564,900 |
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End date of current fiscal year in the format --MM-DD. No definition available.
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This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
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The end date of the period reflected on the cover page if a periodic report. For all other reports and registration statements containing historical data, it is the date up through which that historical data is presented. If there is no historical data in the report, use the filing date. The format of the date is CCYY-MM-DD. No definition available.
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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Condensed Consolidated Balance Sheets (Parenthetical) (USD $)
In Thousands, except Share data, unless otherwise specified |
Jun. 30, 2015
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Dec. 31, 2014
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Statement of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 10,331 | $ 5,033 |
Accrued liabilities to related parties | $ 5,817 | $ 4,594 |
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 | 60,370,000 | 59,046,000 |
Common stock, shares outstanding | 60,370,000 | 59,046,000 |
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Condensed Consolidated Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Revenue: | ||||
License and milestone revenue (includes $4,860, $3,718, $9,552 and $6,460 from a related party) | $ 106,879 | $ 82,463 | $ 118,385 | $ 97,148 |
Collaboration services and other revenue (includes $719, $866, $1,353 and $1,617 from a related party) | 13,671 | 7,495 | 18,463 | 10,686 |
Total revenue | 120,550 | 89,958 | 136,848 | 107,834 |
Operating expenses: | ||||
Research and development | 51,555 | 33,269 | 102,094 | 58,919 |
General and administrative | 9,680 | 7,516 | 20,162 | 13,948 |
Total operating expenses | 61,235 | 40,785 | 122,256 | 72,867 |
Income from operations | 59,315 | 49,173 | 14,592 | 34,967 |
Interest expense | (2,762) | (2,725) | (5,520) | (5,451) |
Interest and other income, net | 707 | 383 | 1,550 | 1,075 |
Income before income taxes | 57,260 | 46,831 | 10,622 | 30,591 |
Provision (benefit) from income taxes | 205 | 0 | (66) | 0 |
Net income | $ 57,055 | $ 46,831 | $ 10,688 | $ 30,591 |
Net income per share: | ||||
Basic | $ 0.95 | $ 1.36 | $ 0.18 | $ 0.74 |
Diluted | $ 0.83 | $ 0.58 | $ 0.15 | $ 0.46 |
Weighted average number of common shares used to calculate net income per share: | ||||
Basic | 59,798 | 13,347 | 59,499 | 13,279 |
Diluted | 68,752 | 37,106 | 69,354 | 21,639 |
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Revenue from multiple-deliverable arrangements that include licensing fees and services revenue and the amount of consideration recognized during the period for milestones. Licensing revenue is consideration received from another party for the right to use, but not own, certain of the entity's intangible assets. Licensing arrangements include, but are not limited to, rights to use a patent, copyright, technology, manufacturing process, software or trademark. Licensing fees are generally, but not always, fixed as to amount and not dependent upon the revenue generated by the licensing party. An entity may receive licensing fees for licenses that also generate royalty payments to the entity. Services revenue may be derived by providing other, non-specified, services during the reporting period. No definition available.
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Condensed Consolidated Statements of Operations (Parenthetical) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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License and milestone revenue from a related party | $ 106,879 | $ 82,463 | $ 118,385 | $ 97,148 |
Collaboration services and other revenue from a related party | 13,671 | 7,495 | 18,463 | 10,686 |
Astellas Agreement [Member]
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License and milestone revenue from a related party | 4,860 | 3,718 | 9,552 | 6,460 |
Collaboration services and other revenue from a related party | $ 719 | $ 866 | $ 1,353 | $ 1,617 |
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Revenue recognized from co-development services, manufacturing of clinical supplies, committee services and information services and other revenue. No definition available.
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Revenue from multiple-deliverable arrangements that include licensing fees and services revenue and the amount of consideration recognized during the period for milestones. Licensing revenue is consideration received from another party for the right to use, but not own, certain of the entity's intangible assets. Licensing arrangements include, but are not limited to, rights to use a patent, copyright, technology, manufacturing process, software or trademark. Licensing fees are generally, but not always, fixed as to amount and not dependent upon the revenue generated by the licensing party. An entity may receive licensing fees for licenses that also generate royalty payments to the entity. Services revenue may be derived by providing other, non-specified, services during the reporting period. No definition available.
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Condensed Consolidated Statements of Comprehensive Income (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2015
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Jun. 30, 2014
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Statement of Comprehensive Income [Abstract] | ||||
Net income | $ 57,055 | $ 46,831 | $ 10,688 | $ 30,591 |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 508 | 185 | 2,213 | 195 |
Available-for-sale investments: | ||||
Unrealized gain (loss) on investments, net of tax effect | (368) | (280) | 343 | (820) |
Reclassification from accumulated other comprehensive loss | (25) | 0 | (30) | 0 |
Net change in unrealized gain (loss) on available-for-sale investments | (393) | (280) | 313 | (820) |
Other comprehensive income (loss), net of taxes | 115 | (95) | 2,526 | (625) |
Comprehensive income | $ 57,170 | $ 46,736 | $ 13,214 | $ 29,966 |
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Description of Operations and Summary of Significant Accounting Policies
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Description of Operations and Summary of Significant Accounting Policies |
Description of Operations FibroGen, Inc. (“FibroGen,” the “Company,” or “we” and other similar pronouns) was incorporated in 1993 in Delaware and is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. Our focus in the areas of fibrosis and hypoxia-inducible factor (“HIF”) biology has generated multiple programs targeting various therapeutic areas. Our most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (“HIF-PHs”) in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (“CKD”). FG-3019 is our monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), pancreatic cancer and liver fibrosis. We have taken a global approach with respect to the development and future commercialization of our product candidates, and this includes development and commercialization in the People’s Republic of China (“China”). On November 10, 2014, we effected a 1-for-2.5 reverse split of our common stock. Upon the effectiveness of the reverse stock split, (i) every 2.5 shares of outstanding common stock were combined into one share of common stock, (ii) the number of shares of common stock for which each outstanding option or warrant to purchase common stock is exercisable was proportionally decreased on a 1-for-2.5 basis, (iii) the exercise price of each outstanding option or warrant to purchase common stock was proportionately increased on a 1-for- 2.5 basis, (iv) the exchange ratio for each share of outstanding FibroGen Europe Oy (“FibroGen Europe”) share of stock which is exchangeable into our common stock was proportionately reduced on a 1-for-2.5 basis, and (v) the conversion ratio for each share of outstanding preferred stock which is convertible into our common stock was proportionately reduced on a 1-for-2.5 basis. All of the outstanding common stock share numbers (including shares of common stock which our outstanding preferred stock shares were convertible into), common stock warrants, share prices, exercise prices and per share amounts have been adjusted in these condensed consolidated financial statements, on a retroactive basis, to reflect this 1-for-2.5 reverse stock split for all periods presented. The par value per share and the authorized number of shares of common stock and preferred stock were not adjusted as a result of the reverse stock split. On November 19, 2014, we closed the initial public offering (“IPO”) of our common stock. In our IPO, we sold 9,315,000 shares of our common stock at a public offering price of $18.00 per share. Net proceeds from our IPO and concurrent private placement were $171.8 million, after deducting underwriting discounts and commissions of $11.7 million and offering expenses of $4.1 million. AstraZeneca AB (“AstraZeneca”), one of our collaboration partners, agreed to purchase from us concurrently with the closing of our IPO in a private placement shares of our common stock with an aggregate purchase price of $20.0 million at a price per share equal to the IPO price. Upon the closing of our IPO, all outstanding shares of our convertible preferred stock automatically converted into 33,919,954 shares of common stock and 958,996 shares of FibroGen Europe convertible preferred stock were converted into shares of our common stock. Our proceeds from the sale of the common stock sold in the concurrent private placement were $20.0 million. Basis of Presentation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. All inter-company transactions and balances have been eliminated in consolidation. We operate in one segment—the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The December 31, 2014 condensed consolidated balance sheet data contained within this Form 10-Q was derived from audited consolidated financial statements included in our Form 10-K for the year ended December 31, 2014, but does not include all disclosures required by accounting principles generally accepted in the United States. The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. In our opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair presentation of our financial position, results of operations and cash flows for the interim periods presented.
Fair Value of Financial Instruments We define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Our valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. We classify these inputs into the following hierarchy: Level 1—Quoted prices for identical instruments in active markets. Level 2—Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3—Unobservable inputs and little, if any, market activity for the assets. The assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Carrying amounts of certain of our financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value due to their short maturities. Revenue Recognition Substantially all of our revenues to date have been generated from our collaboration agreements. Our collaboration agreements include multiple deliverables, and we, therefore, follow the guidance in Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition–Multiple-Element Arrangements” (“ASC 605-25”). ASC 605-25:
We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. Significant judgment may be required in determining whether a deliverable provides stand-alone value, determining the amount of arrangement consideration that is fixed or determinable, and estimating the stand-alone selling price of each unit of accounting. To date, we have determined that the selling price for the deliverables within our collaboration agreements should be determined using BESP, as neither VSOE nor TPE is available. The process for determining BESP involves significant judgment on our part and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services.
For each unit of accounting identified within an arrangement, we determine the period over which the deliverables are provided and the performance obligation is satisfied. Service revenue is recognized using a proportional performance method. Direct labor hours or full time equivalents are typically used as the measurement of performance. Revenue may be recognized using a straight line method when performance is expected to occur roughly consistently over a period of time. Payments or reimbursements resulting from our research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis. To the extent payments are required to be made to the collaboration partners pursuant to research and development efforts, those costs are charged to research and development using the guidance pursuant to ASC Topic 605-250, “Customer Payments and Incentives”, which states that cash consideration given by a vendor to a customer is presumed to be a reduction of the selling prices unless the vendor receives an identifiable benefit in exchange for the consideration that is sufficiently separable from the recipient’s purchase of the vendor’s products, and the vendor can reasonably estimate the fair value of the benefit. Each of our collaboration agreements includes milestones for which we follow ASC Topic 605-28, “Revenue Recognition—Milestone Method” (“ASC 605-28”). ASC 605-28 establishes the milestone method as an acceptable method of revenue recognition for certain contingent event-based payments under research and development arrangements. Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event (i) that can only be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. Determining whether a milestone is substantive is a matter of judgment and that assessment must be made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either our performance to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement. Payments for achieving milestones which are not considered substantive are treated as additional arrangement consideration and are allocated following the relative selling price method previously described. Net Income per Share Immediately prior to the IPO, the Company had authorized 125,000,000 shares of Preferred Stock with a par value of $0.01 per share. The Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Royalty Acquisition Preferred Stock and Series G-1 Preferred Stock are collectively referred to as the “Junior Preferred Stock”. The Series E Redeemable Convertible Preferred Stock and Series F Redeemable Convertible Preferred Stock are collectively referred to as the “Senior Preferred Stock”. As of December 31, 2014, there was no outstanding convertible preferred stock as all issued and outstanding preferred stock were converted to common stock at the closing of the Company’s IPO in November 2014. Prior to the IPO, we applied the two-class method to calculate basic and diluted net income per share of common stock. The two-class method is an earnings allocation method under which earnings per share is calculated for common stock considering a participating security’s rights to undistributed earnings as if all such earnings had been distributed during the period. The Junior Preferred Stock were participating securities due to their dividend rights and the Senior Preferred Stock had stated dividend rates. During periods of net income, the calculation of basic net income per share was reclassified to exclude the income attributable to all participating securities from the numerator and exclude the dilutive impact of those shares from the denominator. During periods of net loss, all participating securities were not included in the calculation of net loss per share because the preferred stockholders had no contractual obligation to participate in losses.
The following is a reconciliation of the basic and diluted net income per share calculation for the periods presented (in thousands, except per share data):
Diluted net income per share does not include the effect of 3.8 million and 18.6 million securities for the quarters ended June 30, 2015 and 2014 and 1.8 million and 33.9 million securities for the six months ended June 30, 2015 and 2014. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. ASU 2014-09 is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The effective date for ASU 2014-09was initially for fiscal years beginning after December 15, 2016. In July 2015, the FASB approved a one year deferral of this standard with a new effective date for fiscal years beginning after December 15, 2017. The new guidelines can be implemented using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption. We are currently evaluating the impact of this guidance on our consolidated financial statements. |
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Collaboration Agreements |
Astellas Agreements Japan Agreement In June 2005, we entered into a collaboration agreement with Astellas Pharma Inc. (“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). The Japan Agreement also provides for additional development and regulatory approval milestone payments up to $117.5 million, a commercial sales related milestone of $15.0 million and additional consideration based on net sales (as defined) in the low 20% range after commercial launch. A clinical milestone payment of $12.5 million was received in 2013. We evaluated the criteria under ASC 605-28 (as disclosed in Note 1) and concluded that the aforementioned milestone was substantive.
Europe Agreement In April 2006, we entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million. Clinical milestone payments of $40.0 million and $50.0 million were received in 2010 and 2012. We evaluated the criteria under ASC 605-28 (as disclosed in Note 1) and concluded that each of those milestones was substantive. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. AstraZeneca Agreements U.S./Rest of World Agreement Effective July 30, 2013, we entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the United States 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 has agreed to pay upfront, non-contingent and time-based payments totaling $374.0 million, which we expect to receive in various amounts through June 2016, of which $312.0 million was received as of June 30, 2015. In addition, the U.S./RoW Agreement also provides for development and regulatory approval based milestone payments of up to $550.0 million, which include potential future indications which the companies choose to pursue, and commercial related milestone payments of up to $325.0 million. During the second quarter of 2015, we received a $15.0 million development milestone payment as a result of the finalization of our two audited pre-clinical carcinogenicity study reports. We evaluated the criteria under ASC 605-28 (as disclosed in Note 1) and concluded that each of those milestones was substantive. Under the U.S./RoW Agreement, we and AstraZeneca will share equally in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million. Any additional development costs incurred by us during the development period in excess of the $233.0 million (aggregated spend) will be fully reimbursed by AstraZeneca. AstraZeneca will pay us tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition we will receive a transfer price for delivery of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range. China Agreement Effective July 30, 2013, we (through our subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received as of March 31, 2014). In addition, the China Agreement provides for AstraZeneca to pay regulatory approval and other approval related milestones of up to $161.0 million. The China Agreement also provides for sales related milestone payments of up to $167.5 million and contingent payments of $20.0 million related to possible future compounds. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. Accounting for the Astellas Agreements For each of the Astellas agreements, we evaluated the deliverables within the respective arrangements and separated them into various units of accounting. Deliverables that did not provide standalone value have been combined with other deliverables to form a unit of accounting that collectively has standalone value, with revenue being recognized on the combined unit of accounting, rather than the individual deliverables. There are no right-of-return provisions for the delivered items in the Astellas agreements. For the Astellas agreements, we allocated arrangement consideration to various units of accounting based on BESP of each deliverable within each unit of accounting using the relative selling price method as we did not have VSOE or TPE of selling price for such deliverables. Arrangement consideration includes non-contingent upfront payments of $360.1 million and cumulative co-development billings of $114.5 million (for the Europe Agreement) as of June 30, 2015. For the technology license under the Japan Agreement and Europe Agreement, BESP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. Our cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. BESP also considered certain future royalty payments associated with commercial performance of our compounds, transfer prices and expected gross margins. The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
Any consideration received for each Astellas agreement after the initial proceeds on the agreement signing date were also (and will be also) allocated to the various units of accounting above per agreement using the relative selling price method under ASC 605-25-30-2 and 30-5. Under the Japan Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $95.0 million in substantive 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. Under the Europe Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $335.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, including up to $25.0 million in milestone payments in connection with receipt of marketing approval in Russia. Accounting for the AstraZeneca Agreements We evaluated whether or not the U.S./RoW and China Agreements should be accounted for as a single arrangement and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time are a single arrangement. Accordingly, upfront and other non-contingent arrangement consideration received and to be received has been and will be pooled together and allocated to each of the units of accounting in both the U.S./RoW and China Agreements based on their relative fair values. We evaluated the deliverables within the arrangement and separated them into various units of accounting. Deliverables that did not provide stand-alone value have been combined with other deliverables to form a unit of accounting that collectively has stand-alone value, with revenue being recognized on the combined unit of accounting, rather than the individual deliverables. There are no right-of-return provisions for the delivered items in the agreements. For the technology license under the AstraZeneca U.S./RoW Agreement, BESP was determined based on a two-step process. The first step involved determining an implied royalty rate that would result in the net present value of future cash flows to equal to zero (i.e. where the IRR on the transaction would equal the target return for the investment). This results in an upper bound estimation of the magnitude of royalties that a hypothetical acquirer would reasonably pay for the forecasted cash flow stream. Our cash flow forecasts were derived from probability-adjusted revenue and expense projections. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. The second step involved applying the implied royalty rate, which was determined to be 40%, against the probability-adjusted projected net revenues by territory and determining the value of the license as the net present value of future cash flows after adjusting for taxes. The discount rate utilized was 17.5%. U.S./RoW Agreement: The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
Under the terms of the U.S./RoW Agreement, AstraZeneca has agreed to pay upfront, non-contingent and time-based payments totaling $374.0 million, which we expect to receive in various amounts through June 2016, of which $82.0 million was received as of December 31, 2013 and was determined to be fixed and determinable upon the execution of the collaboration agreement. Out of the remaining payments of $292.0 million, which are contractually due, $230.0 million have extended payment terms and, accordingly, were not considered to be fixed or determinable upon the execution of the agreement. As such, for these remaining payments, the amount of revenue recognized is limited to the amount of cash consideration received; additionally, for each of the amounts received, the amount of revenue recognized is determined on the basis of applying the relative selling price method to each of the units of accounting underlying the agreement. Further, $62.0 million of the remaining payment is contingent upon the occurrence of a specified event and accordingly is also not considered fixed or determinable. Under the U.S./RoW Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $325.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in a non-substantive deferred approval milestone, which would be paid if certain competitors do not launch a HIF compound in the U.S. on or before January 1, 2023, and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. China Agreement: The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
For the China Agreement, we retained manufacturing rights as an essential part of a strategy to pursue domestic regulatory pathway for product approval which requires the regulatory licensure of the manufacturing facility in order to commence commercial shipment. The prospects for the collaboration as a whole would have been substantially different had manufacturing rights been provided to AstraZeneca. Because the retention of manufacturing rights by us was a significant factor in the collaboration strategy, rather than simply a mechanism to properly compensate us, we concluded that the license and development services do not have stand-alone value apart from the manufacturing rights. Accordingly, all the deliverables identified, including co-development services, under the China Agreement have been treated as a single unit of account and all revenue allocable to this unit of account is deferred until delivery of commercial drug product has begun. Upon commencement of delivery of commercial drug product, revenue would be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million, of which $16.2 million was received as of December 31, 2013 and was determined to be fixed and determinable upon the execution of the collaboration agreement. The remainder of the upfront payments of $12.0 million had extended payment terms and, accordingly, is not considered to be fixed or determinable upon the execution of the agreement. This payment of $12.0 million was received as of March 31, 2014. Under the China Agreement, we are also eligible to receive from AstraZeneca an aggregate of approximately $328.5 million in potential milestone payments, comprised of (i) up to $15.0 million in substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $167.5 million in milestone payments upon the achievement of specified commercial sales events. As we are accounting for both the U.S./RoW and China Agreements as one arrangement, any consideration received after the initial proceeds on the agreement signing date were also (and will be also) allocated to the various units of accounting above using the relative selling price method under ASC 605-25-30-2 and 30-5.
Summary of revenue recognized under the collaboration agreements The table below summarizes the accounting treatment for the various deliverables pursuant to each of the Astellas and AstraZeneca agreements. License amounts identified below are included in the “License and milestone revenue” line item in the condensed consolidated statements of operations. All other elements identified below are included in the “Collaboration services 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):
As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the Japan Agreement, along with any associated deferred revenue as follows (in thousands):
Amounts recognized as revenue under the Europe Agreement were as follows (in thousands):
As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the Europe Agreement, along with any associated deferred revenue as follows (in thousands):
Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands):
As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the U.S./RoW Agreement, along with any associated deferred revenue as follows (in thousands):
Other Revenues Other revenues consist of royalty payments received, which are recorded on a monthly basis as they are reported to us, and collagen feasibility sales. Other revenues were immaterial for all periods presented. Deferred Revenue Deferred revenue represents amounts billed to our 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 deliverables. 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 deliverables. 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. |
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Fair Value Measurements
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Jun. 30, 2015
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements |
The fair values of our financial assets that are measured on a recurring basis are as follows (in thousands):
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 our financial liabilities that are carried at historical cost are as follows (in thousands):
The fair values of our financial liabilities were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows. There were no transfers of assets or liabilities between levels for any of the periods presented. |
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Balance Sheet Components
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Jun. 30, 2015
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components |
Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands):
Investments All investments are classified as available-for-sale. The amortized cost, gross unrealized holding gains or losses, and fair value of our available-for-sale investments by major investments type are summarized in the tables below (in thousands):
At June 30, 2015 all of the available-for-sale investments had contractual maturities within four years. We periodically review our available-for-sale investments for other-than-temporary impairment. We consider factors such as the duration, severity and the reason for the decline in value, the potential recovery period and our intent to sell. For debt securities, we also consider whether (i) it is more likely than not that we 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 quarters and six months ended June 30, 2015 and 2014, we did not recognize any other-than-temporary impairment loss. At June 30, 2015, a total of $30.9 million of our cash and cash equivalents were held outside of the U.S. in our foreign subsidiaries to be used primarily for our China operations. Accrued Liabilities Accrued liabilities consisted of the following (in thousands):
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Stock-Based Compensation
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Jun. 30, 2015
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
Stock-based compensation expense was allocated to research and development and general and administrative expense for the periods presented as follows (in thousands):
The weighted-average assumptions used to estimate the fair value of stock options using the Black-Scholes option valuation model and the resulting weighted average fair value of stock options granted during the periods presented were as follows:
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Income Taxes
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Income Tax Disclosure [Abstract] | |||
Income Taxes |
We recorded a provision for income taxes for the quarter ended June 30, 2015 due to the discrete tax effect arising from a change in the valuation of our available-for-sale securities portfolio. We recorded a benefit for income taxes for the six months ended June 30, 2015 due to the discrete tax effect arising from other comprehensive income related to available-for-sale securities. We did not record a provision for income taxes for the quarter and six months ended June 30, 2014 as we generated a net operating loss for the year ended December 31, 2014. Based upon the weight of available evidence, which includes our historical operating performance, reported cumulative net losses since inception and expected continuing net loss, we have established and continue to maintain a full valuation allowance against our deferred tax assets as we do not currently believe that realization of those assets is more likely than not. |
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Related Party Transactions
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Related Party Transactions [Abstract] | |||
Related Party Transactions |
Astellas is an equity investor of ours and, therefore, considered a related party. We recorded revenue related to collaboration agreements with Astellas of $5.6 million and $4.6 million during the quarter ended June 30, 2015 and 2014 and $10.9 million and $8.1 million during the six months ended June 30, 2015 and 2014. We recorded expense related to collaboration agreements with Astellas of $1.3 million and $2.4 million during the quarter ended June 30, 2015 and 2014 and $4.4 million and $4.5 million during the six months ended June 30, 2015 and 2014. As of June 30, 2015 and December 31, 2014, accounts receivable from Astellas were $10.3 million and $5.0 million and amounts due to Astellas were $5.8 million and $4.3 million. Julian N. Stern, a director of ours since November 1996, is of counsel to the law firm of Goodwin Procter LLP, which he joined in 2008. He has received, and continues to receive, no compensation from Goodwin Procter LLP since joining it as of counsel. We retain Goodwin Procter LLP as legal counsel for various matters, primarily consisting of intellectual property. During the quarter and six months ended June 30, 2015 and 2014, the payments made by us to Goodwin Procter LLP were not material. As of June 30, 2015 and December 31, 2014, amounts due to Goodwin Proctor LLP were not material. |
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Description of Operations and Summary of Significant Accounting Policies (Policies)
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe and FibroGen China Anemia Holdings, Ltd. All inter-company transactions and balances have been eliminated in consolidation. We operate in one segment—the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The December 31, 2014 condensed consolidated balance sheet data contained within this Form 10-Q was derived from audited consolidated financial statements included in our Form 10-K for the year ended December 31, 2014, but does not include all disclosures required by accounting principles generally accepted in the United States. The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. In our opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair presentation of our financial position, results of operations and cash flows for the interim periods presented. |
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Fair Value of Financial Instruments | Fair Value of Financial Instruments We define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Our valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. We classify these inputs into the following hierarchy: Level 1—Quoted prices for identical instruments in active markets. Level 2—Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3—Unobservable inputs and little, if any, market activity for the assets. The assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Carrying amounts of certain of our financial instruments including cash equivalents, investments, receivables, accounts payable and accrued liabilities approximate fair value due to their short maturities. |
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Revenue Recognition | Revenue Recognition Substantially all of our revenues to date have been generated from our collaboration agreements. Our collaboration agreements include multiple deliverables, and we, therefore, follow the guidance in Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition–Multiple-Element Arrangements” (“ASC 605-25”). ASC 605-25:
We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. Significant judgment may be required in determining whether a deliverable provides stand-alone value, determining the amount of arrangement consideration that is fixed or determinable, and estimating the stand-alone selling price of each unit of accounting. To date, we have determined that the selling price for the deliverables within our collaboration agreements should be determined using BESP, as neither VSOE nor TPE is available. The process for determining BESP involves significant judgment on our part and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services.
For each unit of accounting identified within an arrangement, we determine the period over which the deliverables are provided and the performance obligation is satisfied. Service revenue is recognized using a proportional performance method. Direct labor hours or full time equivalents are typically used as the measurement of performance. Revenue may be recognized using a straight line method when performance is expected to occur roughly consistently over a period of time. Payments or reimbursements resulting from our research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis. To the extent payments are required to be made to the collaboration partners pursuant to research and development efforts, those costs are charged to research and development using the guidance pursuant to ASC Topic 605-250, “Customer Payments and Incentives”, which states that cash consideration given by a vendor to a customer is presumed to be a reduction of the selling prices unless the vendor receives an identifiable benefit in exchange for the consideration that is sufficiently separable from the recipient’s purchase of the vendor’s products, and the vendor can reasonably estimate the fair value of the benefit. Each of our collaboration agreements includes milestones for which we follow ASC Topic 605-28, “Revenue Recognition—Milestone Method” (“ASC 605-28”). ASC 605-28 establishes the milestone method as an acceptable method of revenue recognition for certain contingent event-based payments under research and development arrangements. Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event (i) that can only be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. Determining whether a milestone is substantive is a matter of judgment and that assessment must be made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either our performance to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement. Payments for achieving milestones which are not considered substantive are treated as additional arrangement consideration and are allocated following the relative selling price method previously described. |
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Net Income per Share | Net Income per Share Immediately prior to the IPO, the Company had authorized 125,000,000 shares of Preferred Stock with a par value of $0.01 per share. The Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Royalty Acquisition Preferred Stock and Series G-1 Preferred Stock are collectively referred to as the “Junior Preferred Stock”. The Series E Redeemable Convertible Preferred Stock and Series F Redeemable Convertible Preferred Stock are collectively referred to as the “Senior Preferred Stock”. As of December 31, 2014, there was no outstanding convertible preferred stock as all issued and outstanding preferred stock were converted to common stock at the closing of the Company’s IPO in November 2014. Prior to the IPO, we applied the two-class method to calculate basic and diluted net income per share of common stock. The two-class method is an earnings allocation method under which earnings per share is calculated for common stock considering a participating security’s rights to undistributed earnings as if all such earnings had been distributed during the period. The Junior Preferred Stock were participating securities due to their dividend rights and the Senior Preferred Stock had stated dividend rates. During periods of net income, the calculation of basic net income per share was reclassified to exclude the income attributable to all participating securities from the numerator and exclude the dilutive impact of those shares from the denominator. During periods of net loss, all participating securities were not included in the calculation of net loss per share because the preferred stockholders had no contractual obligation to participate in losses.
The following is a reconciliation of the basic and diluted net income per share calculation for the periods presented (in thousands, except per share data):
Diluted net income per share does not include the effect of 3.8 million and 18.6 million securities for the quarters ended June 30, 2015 and 2014 and 1.8 million and 33.9 million securities for the six months ended June 30, 2015 and 2014. |
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Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. ASU 2014-09 is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The effective date for ASU 2014-09was initially for fiscal years beginning after December 15, 2016. In July 2015, the FASB approved a one year deferral of this standard with a new effective date for fiscal years beginning after December 15, 2017. The new guidelines can be implemented using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption. We are currently evaluating the impact of this guidance on our consolidated financial statements. |
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Collaboration Agreements | Accounting for the Astellas Agreements For each of the Astellas agreements, we evaluated the deliverables within the respective arrangements and separated them into various units of accounting. Deliverables that did not provide standalone value have been combined with other deliverables to form a unit of accounting that collectively has standalone value, with revenue being recognized on the combined unit of accounting, rather than the individual deliverables. There are no right-of-return provisions for the delivered items in the Astellas agreements. For the Astellas agreements, we allocated arrangement consideration to various units of accounting based on BESP of each deliverable within each unit of accounting using the relative selling price method as we did not have VSOE or TPE of selling price for such deliverables. Arrangement consideration includes non-contingent upfront payments of $360.1 million and cumulative co-development billings of $114.5 million (for the Europe Agreement) as of June 30, 2015. For the technology license under the Japan Agreement and Europe Agreement, BESP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5% to 20.0%. Our cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. BESP also considered certain future royalty payments associated with commercial performance of our compounds, transfer prices and expected gross margins. The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
Any consideration received for each Astellas agreement after the initial proceeds on the agreement signing date were also (and will be also) allocated to the various units of accounting above per agreement using the relative selling price method under ASC 605-25-30-2 and 30-5. Under the Japan Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $95.0 million in substantive 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. Under the Europe Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $335.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, including up to $25.0 million in milestone payments in connection with receipt of marketing approval in Russia. Accounting for the AstraZeneca Agreements We evaluated whether or not the U.S./RoW and China Agreements should be accounted for as a single arrangement and concluded that the agreements should be accounted for as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time are a single arrangement. Accordingly, upfront and other non-contingent arrangement consideration received and to be received has been and will be pooled together and allocated to each of the units of accounting in both the U.S./RoW and China Agreements based on their relative fair values. We evaluated the deliverables within the arrangement and separated them into various units of accounting. Deliverables that did not provide stand-alone value have been combined with other deliverables to form a unit of accounting that collectively has stand-alone value, with revenue being recognized on the combined unit of accounting, rather than the individual deliverables. There are no right-of-return provisions for the delivered items in the agreements. For the technology license under the AstraZeneca U.S./RoW Agreement, BESP was determined based on a two-step process. The first step involved determining an implied royalty rate that would result in the net present value of future cash flows to equal to zero (i.e. where the IRR on the transaction would equal the target return for the investment). This results in an upper bound estimation of the magnitude of royalties that a hypothetical acquirer would reasonably pay for the forecasted cash flow stream. Our cash flow forecasts were derived from probability-adjusted revenue and expense projections. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. The second step involved applying the implied royalty rate, which was determined to be 40%, against the probability-adjusted projected net revenues by territory and determining the value of the license as the net present value of future cash flows after adjusting for taxes. The discount rate utilized was 17.5%. U.S./RoW Agreement: The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
Under the terms of the U.S./RoW Agreement, AstraZeneca has agreed to pay upfront, non-contingent and time-based payments totaling $374.0 million, which we expect to receive in various amounts through June 2016, of which $82.0 million was received as of December 31, 2013 and was determined to be fixed and determinable upon the execution of the collaboration agreement. Out of the remaining payments of $292.0 million, which are contractually due, $230.0 million have extended payment terms and, accordingly, were not considered to be fixed or determinable upon the execution of the agreement. As such, for these remaining payments, the amount of revenue recognized is limited to the amount of cash consideration received; additionally, for each of the amounts received, the amount of revenue recognized is determined on the basis of applying the relative selling price method to each of the units of accounting underlying the agreement. Further, $62.0 million of the remaining payment is contingent upon the occurrence of a specified event and accordingly is also not considered fixed or determinable. Under the U.S./RoW Agreement, we are 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 substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $325.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in a non-substantive deferred approval milestone, which would be paid if certain competitors do not launch a HIF compound in the U.S. on or before January 1, 2023, and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. China Agreement: The units of accounting that were analyzed, along with their general timing of delivery or performance of service and general timing of revenue recognition, are as follows:
For the China Agreement, we retained manufacturing rights as an essential part of a strategy to pursue domestic regulatory pathway for product approval which requires the regulatory licensure of the manufacturing facility in order to commence commercial shipment. The prospects for the collaboration as a whole would have been substantially different had manufacturing rights been provided to AstraZeneca. Because the retention of manufacturing rights by us was a significant factor in the collaboration strategy, rather than simply a mechanism to properly compensate us, we concluded that the license and development services do not have stand-alone value apart from the manufacturing rights. Accordingly, all the deliverables identified, including co-development services, under the China Agreement have been treated as a single unit of account and all revenue allocable to this unit of account is deferred until delivery of commercial drug product has begun. Upon commencement of delivery of commercial drug product, revenue would be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million, of which $16.2 million was received as of December 31, 2013 and was determined to be fixed and determinable upon the execution of the collaboration agreement. The remainder of the upfront payments of $12.0 million had extended payment terms and, accordingly, is not considered to be fixed or determinable upon the execution of the agreement. This payment of $12.0 million was received as of March 31, 2014. Under the China Agreement, we are also eligible to receive from AstraZeneca an aggregate of approximately $328.5 million in potential milestone payments, comprised of (i) up to $15.0 million in substantive milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in substantive milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $167.5 million in milestone payments upon the achievement of specified commercial sales events. As we are accounting for both the U.S./RoW and China Agreements as one arrangement, any consideration received after the initial proceeds on the agreement signing date were also (and will be also) allocated to the various units of accounting above using the relative selling price method under ASC 605-25-30-2 and 30-5. |
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Description of Operations and Summary of Significant Accounting Policies (Tables)
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Jun. 30, 2015
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Reconciliation of Basic and Diluted Net Income per Share Calculation | The following is a reconciliation of the basic and diluted net income per share calculation for the periods presented (in thousands, except per share data):
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Collaboration Agreements (Tables)
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Jun. 30, 2015
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Japan [Member]
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Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Japan Agreement were as follows (in thousands):
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Total Arrangement Consideration Allocated to Deliverables along with Associated Deferred Revenue | As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the Japan Agreement, along with any associated deferred revenue as follows (in thousands):
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Europe [Member]
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Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the Europe Agreement were as follows (in thousands):
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Total Arrangement Consideration Allocated to Deliverables along with Associated Deferred Revenue | As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the Europe Agreement, along with any associated deferred revenue as follows (in thousands):
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U.S./RoW [Member]
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Summary of Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands):
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Total Arrangement Consideration Allocated to Deliverables along with Associated Deferred Revenue | As of June 30, 2015, the total arrangement consideration has been allocated to each of the following deliverables under the U.S./RoW Agreement, along with any associated deferred revenue as follows (in thousands):
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Fair Value Measurements (Tables)
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Jun. 30, 2015
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Values of Financial Assets Measured on Recurring Basis | The fair values of our financial assets that are measured on a recurring basis are as follows (in thousands):
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Fair Values of Financial Liabilities Carried at Historical Cost | The fair values of our financial liabilities that are carried at historical cost are as follows (in thousands):
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Balance Sheet Components (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
|
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consisted of the following (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments | The amortized cost, gross unrealized holding gains or losses, and fair value of our available-for-sale investments by major investments type are summarized in the tables below (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands):
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Stock-Based Compensation (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
|
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Allocated Stock-Based Compensation Expense | Stock-based compensation expense was allocated to research and development and general and administrative expense for the periods presented as follows (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Weighted-average Assumptions used to Estimate Fair Value of Stock Awards | The weighted-average assumptions used to estimate the fair value of stock options using the Black-Scholes option valuation model and the resulting weighted average fair value of stock options granted during the periods presented were as follows:
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Description of Operations and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $)
In Millions, except Share data, unless otherwise specified |
0 Months Ended | 3 Months Ended | 6 Months Ended | 0 Months Ended | 6 Months Ended | |||||
---|---|---|---|---|---|---|---|---|---|---|
Nov. 19, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
Segment
|
Jun. 30, 2014
|
Dec. 31, 2014
|
Nov. 19, 2014
|
Nov. 19, 2014
FibroGen Europe [Member]
|
Nov. 10, 2014
Common stock [Member]
|
Jun. 30, 2015
Common stock [Member]
|
|
Accounting Policy [Line Items] | ||||||||||
Description reverse stock split | On November 10, 2014, we effected a 1-for-2.5 reverse split of our common stock. Upon the effectiveness of the reverse stock split, (i) every 2.5 shares of outstanding common stock were combined into one share of common stock, (ii) the number of shares of common stock for which each outstanding option or warrant to purchase common stock is exercisable was proportionally decreased on a 1-for-2.5 basis, (iii) the exercise price of each outstanding option or warrant to purchase common stock was proportionately increased on a 1-for- 2.5 basis, (iv) the exchange ratio for each share of outstanding FibroGen Europe Oy (“FibroGen Europe”) share of stock which is exchangeable into our common stock was proportionately reduced on a 1-for-2.5 basis, and (v) the conversion ratio for each share of outstanding preferred stock which is convertible into our common stock was proportionately reduced on a 1-for-2.5 basis. All of the outstanding common stock share numbers (including shares of common stock which our outstanding preferred stock shares were convertible into), common stock warrants, share prices, exercise prices and per share amounts have been adjusted in these condensed consolidated financial statements, on a retroactive basis, to reflect this 1-for-2.5 reverse stock split for all periods presented. The par value per share and the authorized number of shares of common stock and preferred stock were not adjusted as a result of the reverse stock split. | |||||||||
Reverse stock split ratio | 0.4 | |||||||||
Common stock shares sold | 9,315,000 | |||||||||
Public offering price | $ 18.00 | |||||||||
Net proceeds from initial public offering and concurrent private placement | $ 171.8 | |||||||||
Underwriting discounts and commissions | 11.7 | |||||||||
Offering expenses | 4.1 | |||||||||
Common stock, aggregate purchase price | $ 20.0 | |||||||||
Convertible preferred stock converted into shares of common stock | 33,919,954 | 958,996 | ||||||||
Number of operating segment | 1 | |||||||||
Preferred stock, authorized shares | 125,000,000 | 125,000,000 | 125,000,000 | |||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Convertible preferred stock outstanding | 0 | 0 | 0 | |||||||
Anti-dilutive securities excluded from computation of diluted net income per share | 3,800,000 | 18,600,000 | 1,800,000 | 33,900,000 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Offering expenses related to the entity's first offering of stock to the public. No definition available.
|
X | ||||||||||
- Definition
The net cash inflow associated with the amount received from entity's first offering of stock to the public and concurrent private placement. No definition available.
|
X | ||||||||||
- Definition
Underwriting discounts and commissions related to the entity's first offering of stock to the public. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Description of Operations and Summary of Significant Accounting Policies - Schedule of Reconciliation of Basic and Diluted Net Income per Share Calculation (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Schedule Of Earnings Per Share Basic And Diluted [Line Items] | ||||
Net income | $ 57,055 | $ 46,831 | $ 10,688 | $ 30,591 |
Net income attributable to Senior Preferred and common stockholders | 57,055 | 21,597 | 10,688 | 16,801 |
Net income attributable to common stockholders | 57,055 | 18,123 | 10,688 | 9,853 |
Weighted average shares used to compute net income per share: | ||||
Basic | 59,798 | 13,347 | 59,499 | 13,279 |
Dilutive effect of Senior Preferred stock | 0 | 15,336 | 0 | 0 |
Dilutive effect of potential common shares | 8,954 | 8,423 | 9,855 | 8,360 |
Diluted | 68,752 | 37,106 | 69,354 | 21,639 |
Net income per share: | ||||
Basic | $ 0.95 | $ 1.36 | $ 0.18 | $ 0.74 |
Diluted | $ 0.83 | $ 0.58 | $ 0.15 | $ 0.46 |
Junior Preferred Stock [Member]
|
||||
Schedule Of Earnings Per Share Basic And Diluted [Line Items] | ||||
Less: Undistributed earnings allocated to Preferred stockholders | 0 | (25,234) | 0 | (13,790) |
Senior Preferred Stock [Member]
|
||||
Schedule Of Earnings Per Share Basic And Diluted [Line Items] | ||||
Less: Undistributed earnings allocated to Preferred stockholders | $ 0 | $ (3,474) | $ 0 | $ (6,948) |
X | ||||||||||
- Definition
Dilutive effect of potential common shares. No definition available.
|
X | ||||||||||
- Definition
Net income after adjustments for dividends on junior preferred stock (declared in the period) and/or cumulative junior preferred stock (accumulated for the period). No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Collaboration Agreements - Astellas Agreements - Additional Information (Detail) (Astellas Agreement [Member], USD $)
In Millions, unless otherwise specified |
1 Months Ended | 6 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|---|---|---|---|
Feb. 28, 2009
|
Feb. 28, 2009
Japan [Member]
|
Jun. 30, 2005
Japan [Member]
|
Jun. 30, 2015
Japan [Member]
|
Dec. 31, 2013
Japan [Member]
|
Feb. 28, 2009
Europe [Member]
|
Apr. 30, 2006
Europe [Member]
|
Jun. 30, 2015
Europe [Member]
|
Dec. 31, 2012
Europe [Member]
|
Dec. 31, 2010
Europe [Member]
|
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront, non-contingent and time-based payments | $ 360.1 | $ 40.1 | $ 320.0 | |||||||
Development and regulatory approval milestones | 117.5 | 425.0 | ||||||||
Commercial sales milestone | 15.0 | |||||||||
Additional consideration based on net sales description | Low 20% range | Low 20% range | ||||||||
Clinical development milestones | $ 12.5 | $ 50.0 | $ 40.0 | |||||||
Percentage of joint development costs committed to fund | 50.00% |
X | ||||||||||
- Definition
The amount of additional consideration based on net sales of product as defined under a collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of milestone payments related to clinical development under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of milestone payments related to commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the potential amount of milestone payments related to development and regulatory approval under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the percentage of costs that will be funded by the other party under a collaborative agreement for development costs. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of fixed and determinable non-contingent upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Details
|
Collaboration Agreements - AstraZeneca Agreements - Additional Information 1 (Detail) (AstraZeneca Agreements [Member], USD $)
In Millions, unless otherwise specified |
0 Months Ended | 6 Months Ended | 3 Months Ended | 0 Months Ended | |||
---|---|---|---|---|---|---|---|
Jul. 30, 2013
U.S./RoW [Member]
|
Jun. 30, 2015
U.S./RoW [Member]
|
Jul. 30, 2013
U.S./RoW [Member]
|
Jun. 30, 2015
U.S./RoW [Member]
Development Milestones [Member]
|
Mar. 31, 2014
China [Member]
|
Jul. 30, 2013
China [Member]
|
Jul. 30, 2013
China [Member]
|
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Expected upfront, non-contingent and time-based payments | $ 374.0 | ||||||
Upfront, non-contingent and time-based payments | 312.0 | 12.0 | |||||
Development and regulatory approval milestones | 550.0 | 161.0 | |||||
Commercial sales milestone | 325.0 | 167.5 | |||||
Receipt of development milestone payment | 15.0 | ||||||
Shared development costs | 233.0 | ||||||
Additional consideration based on net sales description | Low 20% range | ||||||
Proceeds from upfront payments | 28.2 | ||||||
Contingent payment | $ 62.0 | $ 20.0 |
X | ||||||||||
- Definition
The amount of additional consideration based on net sales of product as defined under a collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of milestone payments related to commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of contingent payments provided for under the collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the potential amount of milestone payments related to development and regulatory approval under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Development Milestone Payment Received No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of expected non-contingent upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of upfront payments received under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of development costs that will be shared under collaborative agreement. No definition available.
|
X | ||||||||||
- Details
|
Collaboration Agreements - Accounting for the Astellas Agreements - Additional Information 2 (Detail) (Astellas Agreement [Member], USD $)
In Millions, unless otherwise specified |
1 Months Ended | 6 Months Ended | 1 Months Ended | 111 Months Ended | 1 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Feb. 28, 2009
|
Jun. 30, 2015
Minimum [Member]
|
Jun. 30, 2015
Maximum [Member]
|
Feb. 28, 2009
Europe [Member]
|
Apr. 30, 2006
Europe [Member]
|
Jun. 30, 2015
Europe [Member]
|
Apr. 30, 2006
Europe [Member]
Clinical and Development Milestone [Member]
|
Apr. 30, 2006
Europe [Member]
Regulatory Milestone [Member]
|
Apr. 30, 2006
Europe [Member]
Marketing approval milestone [Member]
|
Feb. 28, 2009
Japan [Member]
|
Jun. 30, 2005
Japan [Member]
|
Jun. 30, 2005
Japan [Member]
Clinical and Development Milestone [Member]
|
Jun. 30, 2005
Japan [Member]
Regulatory Milestone [Member]
|
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||
Upfront, non-contingent and time-based payments | $ 360.1 | $ 320.0 | $ 40.1 | ||||||||||
Development costs | 114.5 | ||||||||||||
Discount rate applied | 17.50% | 20.00% | |||||||||||
Non-contingent performance period | 36 months | ||||||||||||
Total potential milestones | 425.0 | 132.5 | |||||||||||
Substantive milestones | $ 90.0 | $ 335.0 | $ 25.0 | $ 22.5 | $ 95.0 |
X | ||||||||||
- Definition
Represents the amount of fixed and determinable co-development payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
The non-contingent performance period related to a deliverable under a collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the total potential amount of milestone payments related to development, regulatory approval and commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of fixed and determinable non-contingent upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of substantive milestones that could be earned upon the achievement of certain pre-determined events from the total potential amount of milestone payments under the collaborative agreement. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Collaboration Agreements - Accounting for the AstraZeneca Agreements - Additional Information 3 (Detail) (AstraZeneca Agreements [Member], USD $)
In Millions, unless otherwise specified |
6 Months Ended | 0 Months Ended | 1 Months Ended | 6 Months Ended | 0 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Mar. 31, 2014
China [Member]
|
Dec. 31, 2013
China [Member]
|
Jul. 30, 2013
China [Member]
|
Jul. 30, 2013
China [Member]
Clinical and Development Milestone [Member]
|
Jul. 30, 2013
China [Member]
Regulatory Milestone [Member]
|
Dec. 31, 2013
U.S./RoW [Member]
|
Jul. 30, 2013
U.S./RoW [Member]
|
Jul. 30, 2013
U.S./RoW [Member]
|
Jun. 30, 2015
U.S./RoW [Member]
|
Jul. 30, 2013
U.S./RoW [Member]
Clinical and Development Milestone [Member]
|
Jul. 30, 2013
U.S./RoW [Member]
Regulatory Milestone [Member]
|
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Royalty rate against projected net revenues | 40.00% | |||||||||||
Discount rate applied | 17.50% | |||||||||||
Non-contingent performance period | 65 months | |||||||||||
Expected upfront, non-contingent and time-based payments | $ 374.0 | |||||||||||
Upfront, non-contingent and time-based payments | 16.2 | 82.0 | ||||||||||
Remaining up-front, non-contingent and time-based payments | 292.0 | |||||||||||
Upfront, non-contingent and time-based payments with extended payment terms | 12.0 | 230.0 | ||||||||||
Contingent payment | 20.0 | 62.0 | ||||||||||
Total potential milestones | 328.5 | 875.0 | ||||||||||
Substantive milestones | 15.0 | 146.0 | 65.0 | 325.0 | ||||||||
Commercial sales milestone | 167.5 | 325.0 | ||||||||||
Non-substantive milestones | 160.0 | |||||||||||
Proceeds from upfront payments | 28.2 | |||||||||||
Upfront payments received | $ 12.0 | $ 312.0 |
X | ||||||||||
- Definition
Represents the amount of milestone payments related to commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of contingent payments provided for under the collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of expected non-contingent upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
The non-contingent performance period related to a deliverable under a collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of non-substantive milestones that could be earned upon the achievement of certain pre-determined events from the total potential amount of milestone payments under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the total potential amount of milestone payments related to development, regulatory approval and commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of fixed and determinable non-contingent upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of upfront payments included under the collaborative agreement as arrangement consideration with extended terms. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of upfront payments received under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of remaining upfront and non-contingent and time based payments under the collaboration agreement. No definition available.
|
X | ||||||||||
- Definition
Implied royalty rate used to find the net present value of future cash flows. No definition available.
|
X | ||||||||||
- Definition
Represents the total amount of substantive milestones that could be earned upon the achievement of certain pre-determined events from the total potential amount of milestone payments under the collaborative agreement. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Collaboration Agreements - Summary of Revenue Recognized under Agreement (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total license and milestone revenue | $ 106,879 | $ 82,463 | $ 118,385 | $ 97,148 |
Collaboration services revenue | 13,671 | 7,495 | 18,463 | 10,686 |
Revenue recognized | 120,550 | 89,958 | 136,848 | 107,834 |
Astellas Agreement [Member]
|
||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Total license and milestone revenue | 4,860 | 3,718 | 9,552 | 6,460 |
Collaboration services revenue | 719 | 866 | 1,353 | 1,617 |
Astellas Agreement [Member] | Japan [Member]
|
||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
License revenue | 91 | 155 | 528 | 230 |
Milestones revenue | 0 | 0 | 0 | 0 |
Total license and milestone revenue | 91 | 155 | 528 | 230 |
Collaboration services revenue | 42 | 89 | 100 | 176 |
Astellas Agreement [Member] | Europe [Member]
|
||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
License revenue | 4,769 | 3,563 | 9,024 | 6,230 |
Milestones revenue | 0 | 0 | 0 | 0 |
Total license and milestone revenue | 4,769 | 3,563 | 9,024 | 6,230 |
Collaboration services revenue | 677 | 777 | 1,253 | 1,441 |
AstraZeneca Agreements [Member] | China-single unit of accounting [Member]
|
||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Revenue recognized | 0 | 0 | 0 | 0 |
AstraZeneca Agreements [Member] | U.S./RoW [Member]
|
||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
License revenue | 87,019 | 78,745 | 93,833 | 90,688 |
Milestones revenue | 15,000 | 0 | 15,000 | 0 |
Total license and milestone revenue | 102,019 | 78,745 | 108,833 | 90,688 |
Collaboration services revenue | $ 12,942 | $ 6,590 | $ 17,080 | $ 9,025 |
X | ||||||||||
- Definition
Revenue recognized from co-development services, manufacturing of clinical supplies, committee services and information services and other revenue. No definition available.
|
X | ||||||||||
- Definition
Revenue from multiple-deliverable arrangements that include licensing fees and services revenue and the amount of consideration recognized during the period for milestones. Licensing revenue is consideration received from another party for the right to use, but not own, certain of the entity's intangible assets. Licensing arrangements include, but are not limited to, rights to use a patent, copyright, technology, manufacturing process, software or trademark. Licensing fees are generally, but not always, fixed as to amount and not dependent upon the revenue generated by the licensing party. An entity may receive licensing fees for licenses that also generate royalty payments to the entity. Services revenue may be derived by providing other, non-specified, services during the reporting period. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
The total cash consideration received under a collaboration agreement that has been allocated to the different significant units of accounting and includes the portion that has been deferred for revenue recognition. No definition available.
|
X | ||||||||||
- Definition
Total amount of revenue recognized for license and collaboration services under the collaboration agreement as of a given date. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Fair Value Measurements - Additional Information (Detail) (USD $)
|
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2015
|
Dec. 31, 2014
|
|
Fair Value Disclosures [Abstract] | ||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 |
Transfers of assets from level 2 to 1 | 0 | 0 |
Transfers of liabilities from level 1 to 2 | 0 | 0 |
Transfers of liabilities from level 2 to 1 | 0 | 0 |
Transfers of assets into level 3 | 0 | 0 |
Transfers of assets out of level 3 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
Jun. 30, 2014
|
Dec. 31, 2013
|
---|---|---|---|---|
Cash and Cash Equivalents [Abstract] | ||||
Cash | $ 108,893 | $ 151,653 | ||
Money market funds | 127,643 | 13,802 | ||
Total cash and cash equivalents | $ 236,536 | $ 165,455 | $ 182,662 | $ 76,332 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
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, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 150,243 | $ 158,816 |
Gross Unrealized Holding Gains | 362 | 331 |
Gross Unrealized Holding Losses | (166) | (514) |
Estimated Fair Value | 150,439 | 158,633 |
Corporate bonds [Member]
|
||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 150,119 | 158,692 |
Gross Unrealized Holding Gains | 287 | 254 |
Gross Unrealized Holding Losses | (166) | (514) |
Estimated Fair Value | 150,240 | 158,432 |
Equity investments [Member]
|
||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 124 | 124 |
Gross Unrealized Holding Gains | 75 | 77 |
Estimated Fair Value | $ 199 | $ 201 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
Balance Sheet Components - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
Dec. 31, 2013
|
|
Schedule of Available-for-sale Securities [Line Items] | ||||||
Contractual maturities of available-for-sale investments | 4 years | |||||
Other-than-temporary impairment loss | $ 0 | $ 0 | $ 0 | $ 0 | ||
Cash and cash equivalents | 236,536,000 | 182,662,000 | 236,536,000 | 182,662,000 | 165,455,000 | 76,332,000 |
Foreign subsidiaries [Member]
|
||||||
Schedule of Available-for-sale Securities [Line Items] | ||||||
Cash and cash equivalents | $ 30,900,000 | $ 30,900,000 |
X | ||||||||||
- Definition
Represents the maximum contractual maturity period for available-for-sale securities. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
Balance Sheet Components - Schedule of Accrued Liabilities (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Payables and Accruals [Abstract] | ||
Preclinical and clinical trial accruals | $ 32,251 | $ 25,418 |
Payroll and related accruals | 9,625 | 15,608 |
Professional services | 1,121 | 2,401 |
Other | 3,243 | 5,558 |
Total accrued liabilities | $ 46,240 | $ 48,985 |
X | ||||||||||
- Definition
Total of the carrying values as of the balance sheet date of obligations incurred through that date and payable for obligations related to pre-clinical and clinical trial activities, including those performed by third parties. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
Stock-Based Compensation - Schedule of Allocated Stock-Based Compensation Expense (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 6,942 | $ 670 | $ 13,388 | $ 1,465 |
Research and development [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 4,434 | 408 | 8,656 | 883 |
General and administrative [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 2,508 | $ 262 | $ 4,732 | $ 582 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
Stock-Based Compensation - Schedule of Weighted-average Assumptions used to Estimate Fair Value of Stock Awards (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Employee stock options [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 2 months 12 days | 0 years | 5 years 2 months 12 days | 0 years |
Expected volatility | 70.00% | 0.00% | 70.00% | 0.00% |
Risk-free interest rate | 1.70% | 0.00% | 1.70% | 0.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 12.27 | $ 0.00 | $ 16.68 | $ 0.00 |
Employee stock purchase plans [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 1 year 3 months 18 days | 0 years | 1 year 3 months 18 days | 0 years |
Expected volatility | 65.00% | 0.00% | 65.00% | 0.00% |
Risk-free interest rate | 0.30% | 0.00% | 0.30% | 0.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted average estimated fair value | $ 9.75 | $ 0.00 | $ 9.75 | $ 0.00 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Income Taxes - Additional information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Income Tax Disclosure [Abstract] | ||||
Provision (benefit) for income taxes | $ 205 | $ 0 | $ (66) | $ 0 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Related Party Transactions - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
|
Related Party Transaction [Line Items] | |||||
Accounts receivable from related party | $ 10,331,000 | $ 10,331,000 | $ 5,033,000 | ||
Accrued liabilities to related parties | 5,817,000 | 5,817,000 | 4,594,000 | ||
Astellas Agreement [Member]
|
|||||
Related Party Transaction [Line Items] | |||||
Revenue related to collaboration agreements | 5,600,000 | 4,600,000 | 10,900,000 | 8,100,000 | |
Expense related to collaboration agreements | 1,300,000 | 2,400,000 | 4,400,000 | 4,500,000 | |
Accounts receivable from related party | 10,300,000 | 10,300,000 | 5,000,000 | ||
Accrued liabilities to related parties | $ 5,800,000 | $ 5,800,000 | $ 4,300,000 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|