X | ||||||||||
- Definition Boolean flag that is true when the XBRL content amends previously-filed or accepted submission. No definition available.
|
X | ||||||||||
- Definition Area code of city No definition available.
|
X | ||||||||||
- Definition End date of current fiscal year in the format --MM-DD. No definition available.
|
X | ||||||||||
- Definition Fiscal period values are FY, Q1, Q2, and Q3. 1st, 2nd and 3rd quarter 10-Q or 10-QT statements have value Q1, Q2, and Q3 respectively, with 10-K, 10-KT or other fiscal year statements having FY. No definition available.
|
X | ||||||||||
- Definition This is focus fiscal year of the document report in CCYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
|
X | ||||||||||
- Definition 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.
|
X | ||||||||||
- Definition Boolean flag that is true only for a form used as an quarterly report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Boolean flag that is true only for a form used as a transition report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'. No definition available.
|
X | ||||||||||
- Definition Address Line 1 such as Attn, Building Name, Street Name No definition available.
|
X | ||||||||||
- Definition Name of the City or Town No definition available.
|
X | ||||||||||
- Definition Code for the postal or zip code No definition available.
|
X | ||||||||||
- Definition Name of the state or province. No definition available.
|
X | ||||||||||
- Definition 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
|
X | ||||||||||
- Definition 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.
|
X | ||||||||||
- Definition Indicate 'Yes' or 'No' whether registrants (1) have filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
|
X | ||||||||||
- Definition Indicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen. No definition available.
|
X | ||||||||||
- Definition Indicate whether the registrant is one of the following: Large Accelerated Filer, Accelerated Filer, Non-accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition Two-character EDGAR code representing the state or country of incorporation. No definition available.
|
X | ||||||||||
- Definition Boolean flag that is true when the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition 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
|
X | ||||||||||
- Definition Boolean flag that is true when the registrant is a shell company as defined in Rule 12b-2 of the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition Indicates that the company is a Smaller Reporting Company (SRC). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition Local phone number for entity. No definition available.
|
X | ||||||||||
- Definition Title of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Name of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
X | ||||||||||
- Definition Trading symbol of an instrument as listed on an exchange. No definition available.
|
X | ||||||||||
- Definition Document and entity information. No definition available.
|
X | ||||||||||
- Definition Represents the long-term portion of the outstanding principal and accrued interest of advances in the form note agreements received by the entity to fund various product development efforts. No definition available.
|
X | ||||||||||
- Definition Lease obligations noncurrent. No definition available.
|
X | ||||||||||
- Definition Restricted time deposits noncurrent. No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, after allowance for credit loss, of right to consideration from customer for product sold and service rendered in normal course of business, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of expenses incurred but not yet paid nor invoiced, and liabilities classified as other. No definition available.
|
X | ||||||||||
- Definition Accumulated change in equity from transactions and other events and circumstances from non-owner sources, net of tax effect, at period end. Excludes Net Income (Loss), and accumulated changes in equity from transactions resulting from investments by owners and distributions to owners. Includes foreign currency translation items, certain pension adjustments, unrealized gains and losses on certain investments in debt and equity securities, other than temporary impairment (OTTI) losses related to factors other than credit losses on available-for-sale and held-to-maturity debt securities that an entity does not intend to sell and it is not more likely than not that the entity will be required to sell before recovery of the amortized cost basis, as well as changes in the fair value of derivatives related to the effective portion of a designated cash flow hedge. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Excess of issue price over par or stated value of the entity's capital stock and amounts received from other transactions involving the entity's stock or stockholders. Includes adjustments to additional paid in capital. Some examples of such adjustments include recording the issuance of debt with a beneficial conversion feature and certain tax consequences of equity instruments awarded to employees. Use this element for the aggregate amount of additional paid-in capital associated with common and preferred stock. For additional paid-in capital associated with only common stock, use the element additional paid in capital, common stock. For additional paid-in capital associated with only preferred stock, use the element additional paid in capital, preferred stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition For a classified balance sheet, the cumulative difference between the rental income or payments required by a lease agreement and the rental income or expense recognized on a straight-line basis, or other systematic and rational basis more representative of the time pattern in which use or benefit is granted or derived from the leased property, expected to be recognized in income or expense, by the lessor or lessee, respectively, more than one year after the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount after valuation and LIFO reserves of inventory expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all liabilities that are recognized. Liabilities are probable future sacrifices of economic benefits arising from present obligations of an entity to transfer assets or provide services to other entities in the future. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of liabilities and equity items, including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The total amount of investments that are intended to be held for an extended period of time (longer than one operating cycle). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which is directly or indirectly attributable to that ownership interest in subsidiary equity which is not attributable to the parent (that is, noncontrolling interest, previously referred to as minority interest). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of noncurrent assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of liabilities classified as other, due after one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of investments including trading securities, available-for-sale securities, held-to-maturity securities, and short-term investments classified as other and current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of stockholders' equity (deficit), net of receivables from officers, directors, owners, and affiliates of the entity, attributable to both the parent and noncontrolling interests. Amount excludes temporary equity. Alternate caption for the concept is permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Statement Of Financial Position [Abstract] | ||
Accounts receivable from related party | $ 4,311,000 | $ 47,210,000 |
Prepaid expenses and other current assets from related party | 127,981,000 | 0 |
Accrued and other current liabilities to related party | $ 781,000 | $ 444,000 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 125,000,000 | 125,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 86,847,000 | 85,432,000 |
Common stock, shares outstanding | 86,847,000 | 85,432,000 |
X | ||||||||||
- Definition Amount of receivables arising from transactions with related parties due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The aggregate amount of receivables to be collected from related parties where one party can exercise control or significant influence over another party; including affiliates, owners or officers and their immediate families, pension trusts, and so forth, at the financial statement date. which are usually due within one year (or one business cycle). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying amount as of the balance sheet date of obligations due all related parties. For classified balance sheets, represents the current portion of such liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) issued to shareholders (includes related preferred shares that were issued, repurchased, and remain in the treasury). May be all or portion of the number of preferred shares authorized. Excludes preferred shares that are classified as debt. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate share number for all nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer) held by stockholders. Does not include preferred shares that have been repurchased. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Revenue: | ||||
Total revenue | $ 191,566 | $ 43,952 | $ 215,429 | $ 75,876 |
Operating expenses: | ||||
Research and development | 52,008 | 52,138 | 102,505 | 109,112 |
Selling, general and administrative | 26,739 | 15,055 | 48,948 | 30,605 |
Total operating expenses | 78,747 | 67,193 | 151,453 | 139,717 |
Income (loss) from operations | 112,819 | (23,241) | 63,976 | (63,841) |
Interest and other, net | ||||
Interest expense | (736) | (2,750) | (1,507) | (5,519) |
Interest income and other, net | 4,125 | 2,645 | 8,303 | 4,717 |
Total interest and other, net | 3,389 | (105) | 6,796 | (802) |
Income (loss) before income taxes | 116,208 | (23,346) | 70,772 | (64,643) |
Provision for income taxes | 205 | 75 | 180 | 174 |
Net income (loss) | $ 116,003 | $ (23,421) | $ 70,592 | $ (64,817) |
Net income (loss) per share: | ||||
Basic | $ 1.34 | $ (0.28) | $ 0.82 | $ (0.78) |
Diluted | $ 1.26 | $ (0.28) | $ 0.77 | $ (0.78) |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 86,445 | 83,750 | 86,077 | 83,309 |
Diluted | 91,728 | 83,750 | 92,069 | 83,309 |
License Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 150,581 | $ 14,323 | $ 150,581 | $ 14,323 |
Development and Other Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 40,985 | $ 29,629 | $ 64,848 | $ 61,553 |
X | ||||||||||
- Definition Interest and other net. No definition available.
|
X | ||||||||||
- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The amount of interest income and other income recognized during the period. Included in this element is interest derived from investments in debt securities, cash and cash equivalents, and other investments which reflect the time value of money or transactions in which the payments are for the use or forbearance of money and other income from ancillary business-related activities (that is, excluding major activities considered part of the normal operations of the business). No definition available.
|
X | ||||||||||
- Definition Amount of the cost of borrowed funds accounted for as interest expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The net amount of nonoperating interest income (expense). No definition available.
|
X | ||||||||||
- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
|
X | ||||||||||
- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Astellas Agreement [Member] - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Collaboration services and other revenue from a related party | $ 17,223 | $ 6,145 | $ 22,082 | $ 11,317 |
License and milestone revenue from a related party | $ 117,470 | $ 14,323 | $ 117,470 | $ 14,323 |
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 | ||||||||||
- Details
|
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
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Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 116,003 | $ (23,421) | $ 70,592 | $ (64,817) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | (180) | 958 | 111 | 431 |
Available-for-sale investments: | ||||
Unrealized gain on investments, net of tax effect | 655 | 53 | 1,097 | 3 |
Other comprehensive income, net of taxes | 475 | 1,011 | 1,208 | 434 |
Comprehensive income (loss) | $ 116,478 | $ (22,410) | $ 71,800 | $ (64,383) |
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- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax and reclassification adjustments of other comprehensive income (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount after tax, before reclassification adjustments, of unrealized holding gain (loss) on available-for-sale securities. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Adjustments to additional paid in capital shares issued from stock plans net of payroll taxes paid. No definition available.
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- Definition Shares issued from stock plans net of payroll taxes paid shares. No definition available.
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- Definition Amount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of the effect of a change in accounting principle on net income. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax and reclassification adjustments, of appreciation (loss) in value of unsold available-for-sale securities. Excludes amounts related to other than temporary impairment (OTTI) loss. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of shares issued which are neither cancelled nor held in the treasury. No definition available.
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- Definition Amount of stockholders' equity (deficit), net of receivables from officers, directors, owners, and affiliates of the entity, attributable to both the parent and noncontrolling interests. Amount excludes temporary equity. Alternate caption for the concept is permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Details
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- Definition Increase (decrease) in accrued interest for finance lease liabilities. No definition available.
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- Definition Increase decrease in lease obligations. No definition available.
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- Definition Payments to acquire available for sale securities and term deposit. No definition available.
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- Definition Unrealized gain loss on cash equivalents and short term equity investments. No definition available.
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- Definition The sum of the periodic adjustments of the differences between securities' face values and purchase prices that are charged against earnings. This is called accretion if the security was purchased at a discount and amortization if it was purchased at premium. As a noncash item, this element is an adjustment to net income when calculating cash provided by or used in operations using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition This item represents the difference between the gross realized gains and losses realized on the sale of debt or equity securities categorized neither as held-to-maturity nor trading securities. No definition available.
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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; including, but not limited to, disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in cash, cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; including effect from exchange rate change. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) from effect of exchange rate changes on cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; held in foreign currencies; including, but not limited to, disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of cash outflow for principal payment on finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of amortization expense attributable to right-of-use asset from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount before tax of foreign currency transaction realized gain (loss) recognized in the income statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of gain (loss) on sale or disposal of property, plant and equipment assets, excluding oil and gas property and timber property. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The increase (decrease) during the reporting period in the aggregate amount of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in amount due within one year (or one business cycle) from customers for the credit sale of goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in accrued expenses, and obligations classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of increase (decrease) in obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The increase (decrease) during the reporting period in the aggregate value of all inventory held by the reporting entity, associated with underlying transactions that are classified as operating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of increase (decrease) in noncurrent operating liabilities classified as other. No definition available.
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- Definition Amount of increase (decrease) in operating assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in prepaid expenses, and assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of cash outflow to satisfy grantee's tax withholding obligation for award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow associated with the sale, maturity and collection of all investments such as debt, security and so forth during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow associated with the sale of debt and equity securities classified as available-for-sale securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow from the sale of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash outflow for short-term and long-term debt and lease obligation. No definition available.
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- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Significant Accounting Policies |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Significant Accounting Policies |
Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”), incorporated in 1993 in Delaware and headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”), is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (“HIF”), connective tissue growth factor (“CTGF”) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the Company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity, completing Phase 3 clinical development worldwide for the treatment of anemia in chronic kidney disease (“CKD”), with a New Drug Application (“NDA”) now approved by the National Medical Products Administration (“NMPA”) in China. The Company and its collaboration partners AstraZeneca AB (“AstraZeneca”) and Astellas Pharma Inc. (“Astellas”) are in the process of preparing an NDA for submission to the United States (“U.S.”) Food and Drug Administration (“FDA”) and a Marketing Authorization Application (“MAA”) for submission to the European Medicines Agency (“EMA”) this year. Astellas submitted an NDA for the treatment of anemia in CKD patients on dialysis in Japan in September 2018, which is currently under review by the Pharmaceuticals and Medical Devices Agency (“PMDA”). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (“MDS”). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), and advancing towards Phase 3 for the treatment of pancreatic cancer. Pamrevlumab is also currently in a Phase 2 trial for Duchenne muscular dystrophy (“DMD”). FibroGen is also developing a biosynthetic cornea in China. Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. (“FibroGen China”). All inter-company transactions and balances have been eliminated in consolidation. The Company operates in one segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the 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 financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2018 (“2018 Form 10-K”). The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2018 Form 10-K, except for the following: Leases The Company determines if an arrangement is a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases (“ASC 842”) are accounted for as finance leases under the requirements of ASC 842. Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company will reassess the incremental borrowing rate periodically for application to any new leases or lease modifications or if any company-specific or general business conditions warrant. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. Inventories Inventories are stated at the lower of cost and net realizable value. The cost of inventories are determined using full absorption and standard costing, which approximates cost based on a first-in, first-out method. The Company reviews the standard costs of raw materials, work-in-process and finished goods periodically, and at least annually, to ensure that its inventories approximate current actual costs. The cost of inventories includes direct material costs, direct labor and manufacturing overhead. The Company regularly reviews the need to adjust the carrying value of excess and obsolete inventories to their estimated net realizable value, if less than cost, based primarily on its estimated forecast of product demand and product expiration period. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue and deferred revenue, estimates of accruals related to clinical trial costs, valuation allowances for deferred tax assets, and valuation and recognition of stock-based compensation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. Net Income (Loss) per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data):
Diluted shares did not include 4.4 million and 3.4 million securities for the three and six months ended June 30, 2019, and 8.8 million and 8.7 million securities for the three and six months ended June 30, 2018, respectively, as they were anti-dilutive. Recently Issued and Adopted Accounting Guidance ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) (“ASU 2016-02”). Under this guidance, an entity is required to recognize ROU assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which provides entities the option to initially apply ASU 2016-02 at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company adopted the above guidance under ASC 842 as of January 1, 2019, using the modified retrospective transition method, through a cumulative-effect adjustment at the beginning of the first quarter of 2019. The Company elected the optional transition method under the guidance, which allowed it to continue applying previous lease guidance (ASC 840) for the comparative prior year periods presentation in the year of adoption. Accordingly, the Company recognized a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases, and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC 840 build-to-suit guidance. In addition, as a result of applying the transition guidance, the Company also recorded an adjustment to the accumulated depreciation of related leasehold improvements to reflect a change in estimated useful life from the building life to the shorter of the building life and remaining lease term. Differences between the assets and liabilities derecognized were recorded to the opening balance of retained earnings. The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands):
The adoption of this guidance did not have a material impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the six months ended June 30, 2019. ASU 2018-02 In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This guidance allows for the reclassification from accumulated other comprehensive income to retained earnings for the stranded tax effects arising from the reduction of the U.S. federal statutory income tax rate from 35% to 21%. This guidance was effective for annual reporting period beginning after December 15, 2018, including interim periods. The Company adopted this guidance on January 1, 2019 using the modified retrospective approach. The impacts, based on the aggregate portfolio approach, to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands):
The adoption of this guidance had no impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the six months ended June 30, 2019. SEC Disclosure Requirement In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, “Disclosure Update and Simplification,” amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, the changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. This analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is presented. This final rule was effective as of November 5, 2018. Accordingly, the Company included the condensed consolidated statements of changes in stockholders’ equity in Form 10-Q starting the first quarter of 2019. ASU 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This guidance expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance also specifies that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. This guidance was effective for annual reporting period beginning after December 15, 2018, including interim periods. The Company adopted this guidance on January 1, 2019, and the adoption of this guidance had no impact to the Company’s consolidated financial statements. Recently Issued Accounting Guidance Not Yet Adopted In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This guidance requires capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This guidance should be applied either retrospectively or prospectively, and is effective for annual reporting period beginning after December 15, 2019 including interim periods, with early adoption permitted. The Company is currently evaluating the impact on its consolidated financial statements upon the adoption of this guidance. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. This guidance amends existing fair value measurement disclosure requirements by adding, changing, or removing certain disclosures. This guidance is effective for annual reporting period beginning after December 15, 2019 including interim periods, with early adoption permitted. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The Company does not anticipate a material impact to its consolidated financial statements upon adoption of this guidance. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Subsequently in April 2019, the FASB issued amendments to the guidance, ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, and in May 2019, ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief. This guidance requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. The measurement of expected credit losses is based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability. ASU 2019-04 clarifies that equity instruments without readily determinable fair values for which an entity has elected the measurement alternative should be remeasured to fair value as of the date that an observable transaction occurred. ASU 2019-05 provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. The amendments should be applied on either a prospective transition or modified-retrospective approach depending on the subtopic. This guidance is effective for the annual reporting period beginning after December 15, 2019, including interim periods within that reporting period. The Company does not anticipate a material impact to its consolidated financial statements upon adoption of this guidance. |
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- References No definition available.
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- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Collaboration Agreements |
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Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaboration Agreements |
Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The aggregate amount of such consideration received through June 30, 2019 totals $77.6 million. Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). Under the Europe Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $425.0 million in potential milestone payments, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of such consideration received through June 30, 2019 totals $410.0 million. In the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE+ data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for an MAA submission to the EMA during their fiscal year 2019, which ends on March 31, 2020, following the Company’s NDA submission to the FDA. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $129.5 million was recognized as revenue during the period from performance obligations satisfied or partially satisfied as of June 30, 2019. According to the Europe Agreement, these milestone payments are not billable to Astellas until the submission of an MAA, therefore this $130.0 million was recorded as an unbilled contract asset as of June 30, 2019. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. The aggregate amount of such consideration received through June 30, 2019 totals $389.0 million. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $41.6 million was recognized as revenue during the period from performance obligations satisfied or partially satisfied as of June 30, 2019. According to the U.S/RoW Agreement, this milestone payment is not billable to AstraZeneca until the Company has submitted the NDA, therefore this $50.0 million was recorded as an unbilled contract asset as of June 30, 2019. China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca paid upfront, non-contingent and non-refundable payments totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. The aggregate amount of such consideration received through June 30, 2019 totals $55.2 million. As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), received marketing authorization from the NMPA for roxadustat, a first-in-class HIF-PH inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca. On December 29, 2018, FibroGen Beijing received First Manufacturing Approval for a Product in the Field in the Territory, which allows production for Phase IV clinical studies, patients’ early experience programs, donation programs, as well as to supply products for testing and assessments required prior to launch. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca. These milestones payments were received in the first quarter of 2019. Summary of Revenue Recognized Under the Collaboration Agreements The table below summarizes the accounting treatment for the various performance obligations pursuant to each of the Astellas and AstraZeneca agreements. License amounts identified below are included in the “License revenue” line item in the condensed consolidated statements of operations. All other elements identified below are included in the “Development and other revenue” line item in the condensed consolidated statements of operations. Amounts recognized as revenue under the Japan Agreement were as follows (in thousands):
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands):
The revenue recognized under the Japan Agreement for the three months ended June 30, 2019 included an immaterial amount resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Japan Agreement includes $0.5 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the Europe Agreement were as follows (in thousands):
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement, along with any associated deferred revenue as follows (in thousands):
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The revenue recognized under the Europe Agreement for the three months ended June 30, 2019 included an increase in revenue of $129.2 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the Europe Agreement includes $9.4 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period. Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands):
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands):
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The revenue recognized under the U.S./RoW Agreement for the three months ended June 30, 2019 included an increase in revenue of $41.9 million resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods. The remainder of the transaction price related to the U.S./RoW Agreement and China Agreement includes $149.4 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation, which are expected to be recognized in a pattern consistent with estimated deliveries of the commercial drug product. Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. The long term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying performance obligations. Deferred revenue includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China. As of December 31, 2018, such deferred revenue was included in long-term deferred revenue. As of June 30, 2019, following receipt of the Chinese Good Manufacturing Practices license by FibroGen Beijing in the second quarter of 2019, approximately $0.5 million of the related deferred revenue was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized as a result of the transfer of control of commercial drug product in China. |
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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Fair Value Measurements |
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Fair Value Measurements |
The fair values of the Company’s 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 the Company’s financial liabilities that are carried at historical cost are as follows (in thousands):
The fair values of the Company’s financial liabilities were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows. As of December 31, 2018, the Company had $96.2 million in lease obligations related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these liabilities previously recognized under ASC 840 build-to-suit designation. Refer to Note 1 for details. The remaining balance of $1.7 million as of June 30, 2019 under lease obligations is related to an expansion option in the Company’s long-term property lease with Shorenstein Properties LLC (“Alexandria” or “landlord”). This expansion option allowed the Company to occupy part of an adjacent building within 31 months of the lease commencement date in 2008. In 2012, the Company gave notice to its landlord that it would not exercise this expansion option, which resulted in a $5.0 million payment liability to the landlord that is financed over the remaining lease term to 2023. There were no transfers of assets or liabilities between levels for any of the periods presented. |
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- Definition The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Leases |
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Leases |
The Company currently has two building leases treated as finance leases. In 2006, the Company entered into a long-term property lease with Alexandria for its corporate headquarters in San Francisco, California, with an initial term of 15 years, scheduled to expire in 2023. The Company has an option to extend the lease for an additional 10 years through 2033. The lease contract provides for a fixed annual rent, with scheduled increases of two percent that occur on each anniversary of the rent commencement date. This lease requires the Company to pay all costs of ownership, operation, and maintenance of the premises, including without limitation all operating costs, insurance costs, and taxes. In 2013, the Company entered into a long-term property lease with Beijing Economic-Technological Development Area (“BDA”) Management Committee for a pilot plant located in Beijing Yizhuang Biomedical Park (“BYBP”) of BDA. The building is leased for an initial lease term of eight years, scheduled to expire in 2021. Renewal options are not specified within the lease contract. The lease contract provides for fixed quarterly rent payments, with scheduled increases that occur as detailed in the lease contract. This lease requires the Company to pay all operating and maintenance costs, and a fixed amount for property management fees. The Company currently has five additional real estate leases for space within a building, which are treated as operating leases. These leases have lease terms ranging from two to four years. These lease contracts provide for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs, and a fixed amount for property management fees. In addition, the Company has several immaterial lease arrangements for office equipment, scientific devices and automobile leases, with contracted lease terms ranging from two to five years, treated as finance leases or operating leases, respectively. The Company’s lease assets and related lease liabilities were as follows (in thousands):
The components of lease expense were as follows (in thousands):
Supplemental cash flow information related to leases were as follows (in thousands):
Lease term and discount rate were as follows at June 30, 2019:
Maturities of lease liabilities are as follows:
The following information was previously disclosed under ASC 840 as of December 31, 2018: Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands):
Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands):
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- References No definition available.
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- Definition The entire disclosure for lessee entity's leasing arrangements including, but not limited to, all of the following: (a.) The basis on which contingent rental payments are determined, (b.) The existence and terms of renewal or purchase options and escalation clauses, (c.) Restrictions imposed by lease agreements, such as those concerning dividends, additional debt, and further leasing. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
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Balance Sheet Components |
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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):
At June 30, 2019 and December 31, 2018, a total of $26.0 million and $21.9 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations. Investments The Company’s investments consist of available-for-sale debt investments, marketable equity investments, a term deposit and a certificate of deposit. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale investments by major investments type are summarized in the tables below (in thousands):
At June 30, 2019, all of the available-for-sale investments had contractual maturities within one year. The Company periodically reviews its available-for-sale investments and term deposit for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three and six months ended June 30, 2019 and 2018, the Company did not recognize any other-than-temporary impairment loss. Inventories Inventories consisted of the following (in thousands):
The Company started capitalizing inventory costs in June 2019 when FibroGen China began productions of roxadustat for commercial sales purposes. There was no provision to write-down excess and obsolete inventory for the three months ended June 30, 2019. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following (in thousands):
The unbilled contract assets as of June 30, 2019 were related to two regulatory milestones totaling $130.0 million under the Europe Agreement with Astellas associated with the planned MAA submission in Europe, and a $50.0 million regulatory milestone under the U.S./RoW Agreement with AstraZeneca associated with the planned NDA submission in the U.S. See Note 2 for details. Property and Equipment Property and equipment consisted of the following (in thousands):
As of December 31, 2018, the Company had $53.9 million building shell cost and $13.5 million accumulated depreciation related to its building leases under build-to-suit arrangements. Upon the adoption of ASC 842 as of January 1, 2019, using the modified retrospective transition method, the Company derecognized these assets previously recognized under ASC 840 build-to-suit designation. Up to December 31, 2018, the leasehold improvements related to these building leases were depreciated over the life of the building under ASC 840. Upon the adoption of ASC 842, these leasehold improvements should have a useful life based on the lease term. As a result, at the adoption date, the Company recorded a cumulative adjustment of $38.9 million to the accumulated depreciation for these leasehold improvements so that their net balance equals the undepreciated amount had the useful life of the leasehold improvements always been equal to the lease terms. Refer to Note 1 for details. Accrued Liabilities Accrued liabilities consisted of the following (in thousands):
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- References No definition available.
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- Definition The entire disclosure for supplemental balance sheet disclosures, including descriptions and amounts for assets, liabilities, and equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stock-Based Compensation |
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
Stock-based compensation expense was allocated to research and development and selling, general and administrative expense as follows (in thousands):
The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows:
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- Definition The entire disclosure for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Income Taxes |
6 Months Ended | ||
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Jun. 30, 2019 | |||
Income Tax Disclosure [Abstract] | |||
Income Taxes |
The provisions for income taxes for the three and six months ended June 30, 2019 and 2018 were due to foreign taxes. Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its deferred tax assets as it does not currently believe that realization of those assets is more likely than not. |
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- References No definition available.
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- Definition The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Related Party Transactions |
6 Months Ended | ||
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Related Party Transactions [Abstract] | |||
Related Party Transactions |
Astellas is an equity investor in the Company and considered a related party. The Company recorded revenue related to collaboration agreements with Astellas of $134.7 million and $139.6 million for the three and six months ended June 30, 2019, respectively, and $20.5 million and $25.6 million for the three and six months ended June 30, 2018, respectively. The Company recorded expense related to collaboration agreements with Astellas of $0.8 million and $0.2 million during the three months ended June 30, 2019 and 2018, respectively, and $1.3 million and $0.7 million during the six months ended June 30, 2019 and 2018. As of June 30, 2019 and December 31, 2018, accounts receivable from Astellas were $4.3 million and $47.2 million, respectively, and amounts due to Astellas were $0.8 million and $0.4 million, respectively. The accounts receivable from Astellas as of December 31, 2018 included $43.8 million related to the delivery of roxadustat API to Astellas during the fourth quarter of 2018, pursuant to an amendment to the Japan Agreement that will allow Astellas to manufacture roxadustat drug product for commercialization in Japan. This amount was received during the first quarter of 2019. Prepaid expenses and other current assets as of June 30, 2019 included $128.0 million of net unbilled contract asset, representing a $130.0 million unbilled contract asset related to two regulatory milestones under the Europe Agreement with Astellas associated with the planned MAA submission to the EMA, net of $2.0 million of associated deferred revenue. See Note 2 for details. According to the Europe Agreement, this $130.0 million is not billable to Astellas until the submission of an MAA, therefore the net contract asset was included in the prepaid expenses and other current assets line on the Company’s condensed consolidated balance sheet as of June 30, 2019. There was no such contract asset balance as of December 31, 2018. |
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- References No definition available.
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- Definition The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Description of Operations |
Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”), incorporated in 1993 in Delaware and headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”), is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (“HIF”), connective tissue growth factor (“CTGF”) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the Company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (“HIF-PH”) activity, completing Phase 3 clinical development worldwide for the treatment of anemia in chronic kidney disease (“CKD”), with a New Drug Application (“NDA”) now approved by the National Medical Products Administration (“NMPA”) in China. The Company and its collaboration partners AstraZeneca AB (“AstraZeneca”) and Astellas Pharma Inc. (“Astellas”) are in the process of preparing an NDA for submission to the United States (“U.S.”) Food and Drug Administration (“FDA”) and a Marketing Authorization Application (“MAA”) for submission to the European Medicines Agency (“EMA”) this year. Astellas submitted an NDA for the treatment of anemia in CKD patients on dialysis in Japan in September 2018, which is currently under review by the Pharmaceuticals and Medical Devices Agency (“PMDA”). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (“MDS”). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), and advancing towards Phase 3 for the treatment of pancreatic cancer. Pamrevlumab is also currently in a Phase 2 trial for Duchenne muscular dystrophy (“DMD”). FibroGen is also developing a biosynthetic cornea in China. |
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Basis of Presentation and Principles of Consolidation |
Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. (“FibroGen China”). All inter-company transactions and balances have been eliminated in consolidation. The Company operates in one segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the 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 financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2018 (“2018 Form 10-K”). The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2018 Form 10-K, except for the following: |
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Leases |
Leases The Company determines if an arrangement is a lease at inception date when it is given control of the underlying assets. The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company’s building leases previously accounted for as build-to-suit arrangements prior to the adoption of Accounting Standards Codification (“ASC”) 842 - Leases (“ASC 842”) are accounted for as finance leases under the requirements of ASC 842. Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company will reassess the incremental borrowing rate periodically for application to any new leases or lease modifications or if any company-specific or general business conditions warrant. Lease ROU assets include any lease payments made and initial direct costs incurred. The Company has lease agreements with lease and non-lease components. The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms. Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition; the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period; the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period. Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets. Operating leases are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets. |
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Inventories |
Inventories Inventories are stated at the lower of cost and net realizable value. The cost of inventories are determined using full absorption and standard costing, which approximates cost based on a first-in, first-out method. The Company reviews the standard costs of raw materials, work-in-process and finished goods periodically, and at least annually, to ensure that its inventories approximate current actual costs. The cost of inventories includes direct material costs, direct labor and manufacturing overhead. The Company regularly reviews the need to adjust the carrying value of excess and obsolete inventories to their estimated net realizable value, if less than cost, based primarily on its estimated forecast of product demand and product expiration period. |
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Use of Estimates |
Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue and deferred revenue, estimates of accruals related to clinical trial costs, valuation allowances for deferred tax assets, and valuation and recognition of stock-based compensation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. |
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Net Income (Loss) per Share |
Net Income (Loss) per Share The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data):
Diluted shares did not include 4.4 million and 3.4 million securities for the three and six months ended June 30, 2019, and 8.8 million and 8.7 million securities for the three and six months ended June 30, 2018, respectively, as they were anti-dilutive. |
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Recently Issued and Adopted Accounting Guidance |
Recently Issued and Adopted Accounting Guidance ASC 842 In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) (“ASU 2016-02”). Under this guidance, an entity is required to recognize ROU assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which provides entities the option to initially apply ASU 2016-02 at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company adopted the above guidance under ASC 842 as of January 1, 2019, using the modified retrospective transition method, through a cumulative-effect adjustment at the beginning of the first quarter of 2019. The Company elected the optional transition method under the guidance, which allowed it to continue applying previous lease guidance (ASC 840) for the comparative prior year periods presentation in the year of adoption. Accordingly, the Company recognized a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. In addition, the Company elected the package of transitional practical expedients permitted under the transition guidance under ASC 842, which among other things allows the Company to carry forward its historical lease classification, and not to reassess initial direct costs for any existing leases. Meanwhile, the Company did not elect the hindsight practical expedient because it has limited number of leases, lease terms are straightforward, and most of its lease renewals are undefined until negotiated. In addition, the Company has elected the short term accounting policy practical expedient and does not apply the balance sheet recognition requirements for short-term leases (excluding expenses relating to leases with a lease term of one month or less), by class of underlying asset to which the right of use relates. The Company has not elected the non-lease components practical expedient, and therefore accounts for each lease component separately from the non-lease components. Upon adoption of ASC 842, the Company classified its existing building leases that were previously accounted for as build-to-suit arrangements as finance leases, and applied the transition guidance. Accordingly, the Company derecognized the assets and liabilities previously recognized under ASC 840 build-to-suit guidance. In addition, as a result of applying the transition guidance, the Company also recorded an adjustment to the accumulated depreciation of related leasehold improvements to reflect a change in estimated useful life from the building life to the shorter of the building life and remaining lease term. Differences between the assets and liabilities derecognized were recorded to the opening balance of retained earnings. The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands):
The adoption of this guidance did not have a material impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the six months ended June 30, 2019. ASU 2018-02 In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This guidance allows for the reclassification from accumulated other comprehensive income to retained earnings for the stranded tax effects arising from the reduction of the U.S. federal statutory income tax rate from 35% to 21%. This guidance was effective for annual reporting period beginning after December 15, 2018, including interim periods. The Company adopted this guidance on January 1, 2019 using the modified retrospective approach. The impacts, based on the aggregate portfolio approach, to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands):
The adoption of this guidance had no impact to the Company’s condensed consolidated statement of operations or condensed consolidated statement of cash flows for the six months ended June 30, 2019. SEC Disclosure Requirement In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, “Disclosure Update and Simplification,” amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, the changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. This analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is presented. This final rule was effective as of November 5, 2018. Accordingly, the Company included the condensed consolidated statements of changes in stockholders’ equity in Form 10-Q starting the first quarter of 2019. ASU 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This guidance expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance also specifies that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. This guidance was effective for annual reporting period beginning after December 15, 2018, including interim periods. The Company adopted this guidance on January 1, 2019, and the adoption of this guidance had no impact to the Company’s consolidated financial statements. |
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Recently Issued Accounting Guidance Not Yet Adopted |
Recently Issued Accounting Guidance Not Yet Adopted In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This guidance requires capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This guidance should be applied either retrospectively or prospectively, and is effective for annual reporting period beginning after December 15, 2019 including interim periods, with early adoption permitted. The Company is currently evaluating the impact on its consolidated financial statements upon the adoption of this guidance. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. This guidance amends existing fair value measurement disclosure requirements by adding, changing, or removing certain disclosures. This guidance is effective for annual reporting period beginning after December 15, 2019 including interim periods, with early adoption permitted. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The Company does not anticipate a material impact to its consolidated financial statements upon adoption of this guidance. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Subsequently in April 2019, the FASB issued amendments to the guidance, ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, and in May 2019, ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief. This guidance requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. The measurement of expected credit losses is based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability. ASU 2019-04 clarifies that equity instruments without readily determinable fair values for which an entity has elected the measurement alternative should be remeasured to fair value as of the date that an observable transaction occurred. ASU 2019-05 provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. The amendments should be applied on either a prospective transition or modified-retrospective approach depending on the subtopic. This guidance is effective for the annual reporting period beginning after December 15, 2019, including interim periods within that reporting period. The Company does not anticipate a material impact to its consolidated financial statements upon adoption of this guidance. |
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Collaboration Arrangements |
Astellas Agreements Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). Under the Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $132.5 million in potential milestone payments, comprised of (i) up to $22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $15.0 million in milestone payments upon the achievement of specified commercial sales milestone. The aggregate amount of such consideration received through June 30, 2019 totals $77.6 million. Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). Under the Europe Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $425.0 million in potential milestone payments, comprised of (i) up to $90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), (ii) up to $335.0 million in milestone payments upon achievement of specified regulatory milestone events. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range. The aggregate amount of such consideration received through June 30, 2019 totals $410.0 million. In the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of chemotherapy induced anemia (“CIA”). AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. For revenue recognition purposes, the Company concluded that this new indication represents a modification to the Europe agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA under the Europe Agreement is estimated to continue through the end of 2023 to allow for development of this indication. During the second quarter of 2019, the Company received positive topline results from analyses of pooled major adverse cardiac event (“MACE”) and MACE+ data from its Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients, enabling Astellas to prepare for an MAA submission to the EMA during their fiscal year 2019, which ends on March 31, 2020, following the Company’s NDA submission to the FDA. The Company evaluated the two regulatory milestone payments associated with the planned MAA submission and concluded that these milestones became probable of being achieved in the second quarter of 2019. Accordingly, the total consideration of $130.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Europe Agreement in the second quarter of 2019, of which $129.5 million was recognized as revenue during the period from performance obligations satisfied or partially satisfied as of June 30, 2019. According to the Europe Agreement, these milestone payments are not billable to Astellas until the submission of an MAA, therefore this $130.0 million was recorded as an unbilled contract asset as of June 30, 2019. AstraZeneca Agreements U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $374.0 million (such amounts were fully received as of June 2016). Under the U.S./RoW Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $875.0 million in potential milestone payments, comprised of (i) up to $65.0 million in milestone payments upon achievement of specified clinical and development milestone events, $15.0 million of which was received in 2015 as a result of the finalization of its two audited pre-clinical carcinogenicity study reports, (ii) up to $325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $325.0 million in milestone payments upon the achievement of specified commercial sales events. The aggregate amount of such consideration received through June 30, 2019 totals $389.0 million. As mentioned above, during the second quarter of 2019, the Company received positive topline results from analyses of pooled MACE and MACE+ data from its Phase 3 trials for roxadustat, enabling the Company’s NDA submission to the FDA. The Company evaluated the regulatory milestone payment associated with this planned NDA submission and concluded that this milestone became probable of being achieved in the second quarter of 2019. Accordingly, the consideration of $50.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the U.S./ RoW Agreement in the second quarter of 2019, of which $41.6 million was recognized as revenue during the period from performance obligations satisfied or partially satisfied as of June 30, 2019. According to the U.S/RoW Agreement, this milestone payment is not billable to AstraZeneca until the Company has submitted the NDA, therefore this $50.0 million was recorded as an unbilled contract asset as of June 30, 2019. China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca paid upfront, non-contingent and non-refundable payments totaling $28.2 million (such amounts were fully received in 2014). Under the China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $348.5 million in potential milestone payments, comprised of (i) up to $15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $187.5 million in milestone payments upon the achievement of specified commercial sales and other events. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development. The aggregate amount of such consideration received through June 30, 2019 totals $55.2 million. As mentioned above, in the fourth quarter of 2018, the Company was engaged in the final stages of review with its partners over the proposed development of roxadustat for the treatment of CIA. AstraZeneca and Astellas approved the program in December 2018 and January 2019, respectively. Costs associated with the development of this indication are expected to be shared 50/50 between AstraZeneca and Astellas. In addition to CIA, in December 2018, anemia of chronic inflammation (“ACI”) and multiple myeloma (“MM”) have been approved for development by AstraZeneca and is expected to be fully funded by them. For revenue recognition purposes, the Company concluded that the addition of these new indications represents a modification to the collaboration agreements and will be accounted for separately, meaning the development costs associated with the new indications are distinct from the original development costs. The development service period for roxadustat for the treatment of CIA, ACI and MM under the AstraZeneca agreements is estimated to continue through the end of 2024, to allow for development of these additional indications. On December 17, 2018, FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), received marketing authorization from the NMPA for roxadustat, a first-in-class HIF-PH inhibitor, for the treatment of anemia caused by CKD in patients on dialysis. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca. On December 29, 2018, FibroGen Beijing received First Manufacturing Approval for a Product in the Field in the Territory, which allows production for Phase IV clinical studies, patients’ early experience programs, donation programs, as well as to supply products for testing and assessments required prior to launch. This approval triggered a $6.0 million milestone payable to the Company by AstraZeneca. These milestones payments were received in the first quarter of 2019. |
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Other Revenues |
Other Revenues Other revenues consist primarily of collagen material sold for research purposes. Other revenues were immaterial for all periods presented. |
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Deferred Revenue |
Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. The long term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying performance obligations. Deferred revenue includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China. As of December 31, 2018, such deferred revenue was included in long-term deferred revenue. As of June 30, 2019, following receipt of the Chinese Good Manufacturing Practices license by FibroGen Beijing in the second quarter of 2019, approximately $0.5 million of the related deferred revenue was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized as a result of the transfer of control of commercial drug product in China. |
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- Definition Disclosure of accounting policy for collaborative arrangements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for computing basic and diluted earnings or loss per share for each class of common stock and participating security. Addresses all significant policy factors, including any antidilutive items that have been excluded from the computation and takes into account stock dividends, splits and reverse splits that occur after the balance sheet date of the latest reporting period but before the issuance of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for leasing arrangement entered into by lessee. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Significant Accounting Policies (Tables) |
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Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation |
The following is a reconciliation of the basic and diluted net income (loss) per share calculation for the periods presented (in thousands, except per share data):
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Schedule of Impacts Upon Adoption of New Guidance |
The impacts to the select line items from the Company’s condensed consolidated balance sheet upon adoption of the ASC 842 guidance are as follows (in thousands):
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Schedule of Impacts Upon Adoption of New Guidance | The impacts, based on the aggregate portfolio approach, to the Company’s accumulated other comprehensive loss and accumulated deficit upon adoption of this guidance are as follows (in thousands):
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- Definition Tabular disclosure of an entity's basic and diluted earnings per share calculations, including a reconciliation of numerators and denominators of the basic and diluted per-share computations for income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of prior period adjustments to previously issued financial statements including (1) the effect of the correction on each financial statement line item and any per-share amounts affected for each prior period presented (2) the cumulative effect of the change on retained earnings or other appropriate components of equity or net assets in the statement of financial position, as of the beginning of the earliest period presented, and (3) the effect of the prior period adjustments (both gross and net of applicable income tax) on the net income of each prior period presented in the entity's annual report for the year in which the adjustments are made. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Collaboration Agreements (Tables) |
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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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Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue |
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement, along with any associated deferred revenue as follows (in thousands):
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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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Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue |
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement, along with any associated deferred revenue as follows (in thousands):
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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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Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue |
The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands):
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Fair Value Measurements (Tables) |
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Values of Financial Assets Measured on Recurring Basis |
The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
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Fair Values of Financial Liabilities Carried at Historical Cost |
The fair values of the Company’s financial liabilities that are carried at historical cost are as follows (in thousands):
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X | ||||||||||
- Definition Tabular disclosure of assets, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, by class that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of liabilities measured at fair value measured on a recurring or nonrecurring basis. Includes, but is not limited to, fair value measurements recorded and the reasons for the measurements, level within the fair value hierarchy in which the fair value measurements are categorized and transfers between levels 1 and 2. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Leases (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Lease Assets and Related Lease Liabilities |
The Company’s lease assets and related lease liabilities were as follows (in thousands):
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Components of Lease Expense |
The components of lease expense were as follows (in thousands):
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Schedule of Supplemental Cash Flow Information Related to Leases |
Supplemental cash flow information related to leases were as follows (in thousands):
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Schedule of Lease Term and Discount Rate |
Lease term and discount rate were as follows at June 30, 2019:
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Schedule of Maturities of Finance and Operating Leases Liabilities |
Maturities of lease liabilities are as follows:
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Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations |
Future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2018 were as follows (in thousands):
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Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations |
Future minimum lease payments, on a consolidated basis, under the Company’s facility lease financing obligations as of December 31, 2018 were as follows (in thousands):
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X | ||||||||||
- Definition Schedule of lease assets and related lease liabilities. No definition available.
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X | ||||||||||
- Definition Schedule of lease term and discount rate. No definition available.
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X | ||||||||||
- Definition Schedule of maturities of finance and operating leases liabilities. No definition available.
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X | ||||||||||
- Definition Schedule of supplemental cash flow information related to leases. No definition available.
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X | ||||||||||
- Definition Tabular disclosure of lessee's lease cost. Includes, but is not limited to, interest expense for finance lease, amortization of right-of-use asset for finance lease, operating lease cost, short-term lease cost, variable lease cost and sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of future minimum lease payments as of the date of the latest balance sheet presented, in aggregate and for each of the five years succeeding fiscal years, with separate deductions from the total for the amount representing executor costs, including any profit thereon, included in the minimum lease payments and for the amount of the imputed interest necessary to reduce the net minimum lease payments to present value. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
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X | ||||||||||
- Definition Tabular disclosure of future minimum payments required in the aggregate and for each of the five succeeding fiscal years for operating leases having initial or remaining noncancelable lease terms in excess of one year and the total minimum rentals to be received in the future under noncancelable subleases as of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
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Balance Sheet Components (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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):
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Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Available-for-Sale Investments |
The Company’s investments consist of available-for-sale debt investments, marketable equity investments, a term deposit and a certificate of deposit. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale investments by major investments type are summarized in the tables below (in thousands):
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Schedule of Inventory |
Inventories consisted of the following (in thousands):
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Schedule of Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands):
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Schedule of Property and Equipment |
Property and equipment consisted of the following (in thousands):
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Schedule of Accrued Liabilities |
Accrued liabilities consisted of the following (in thousands):
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X | ||||||||||
- Definition Tabular disclosure of the amounts paid in advance for capitalized costs that will be expensed with the passage of time or the occurrence of a triggering event, and will be charged against earnings within one year or the normal operating cycle, if longer; the aggregate carrying amount of current assets, not separately presented elsewhere in the balance sheet; and other deferred costs. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Tabular disclosure of the components of accrued liabilities. No definition available.
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X | ||||||||||
- Definition Tabular disclosure of the reconciliation of available-for-sale securities from cost basis to fair value. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of the components of cash and cash equivalents. No definition available.
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X | ||||||||||
- Definition Tabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stock-Based Compensation (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Allocated Stock-Based Compensation Expense |
Stock-based compensation expense was allocated to research and development and selling, general and administrative expense as follows (in thousands):
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Schedule of Assumptions used to Estimate Fair Value of Stock Options Granted and Purchases under 2014 Employee Share Purchase Plan |
The assumptions used to estimate the fair value of stock options granted and purchases under the Company’s 2014 Employee Share Purchase Plan (“ESPP”) using the Black-Scholes option valuation model were as follows:
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X | ||||||||||
- Definition Schedule of share based payment award stock options and employee stock purchase plan valuation assumptions. No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Significant Accounting Policies - Additional Information (Detail) shares in Millions |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2019
shares
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Jun. 30, 2018
shares
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Jun. 30, 2019
Segment
shares
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Jun. 30, 2018
shares
|
Dec. 31, 2017 |
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Accounting Policies [Abstract] | |||||
Number of operating segment | Segment | 1 | ||||
Short term investments maturity | 12 months | ||||
Anti-dilutive shares | shares | 4.4 | 8.8 | 3.4 | 8.7 | |
U.S. federal statutory income tax rate | 21.00% | 35.00% |
X | ||||||||||
- Definition Short term investments maximum maturity period. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Number of operating segments. An operating segment is a component of an enterprise: (a) that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the same enterprise), (b) whose operating results are regularly reviewed by the enterprise's chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance, and (c) for which discrete financial information is available. An operating segment may engage in business activities for which it has yet to earn revenues, for example, start-up operations may be operating segments before earning revenues. No definition available.
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Significant Accounting Policies - Summary of Reconciliation of Basic and Diluted Net Income (Loss) Per Share Calculation (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
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Earnings Per Share [Abstract] | ||||
Net income (loss) | $ 116,003 | $ (23,421) | $ 70,592 | $ (64,817) |
Weighted average number of common shares used to calculate net income (loss) per share: | ||||
Basic | 86,445 | 83,750 | 86,077 | 83,309 |
Dilutive effect of potential common shares | 5,283 | 0 | 5,992 | 0 |
Diluted | 91,728 | 83,750 | 92,069 | 83,309 |
Net income (loss) per share: | ||||
Basic | $ 1.34 | $ (0.28) | $ 0.82 | $ (0.78) |
Diluted | $ 1.26 | $ (0.28) | $ 0.77 | $ (0.78) |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition The sum of dilutive potential common shares or units used in the calculation of the diluted per-share or per-unit computation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Accrued and other liabilities current. No definition available.
|
X | ||||||||||
- Definition Long term portion of capital lease obligations. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition For a classified balance sheet, the cumulative difference between the rental income or payments required by a lease agreement and the rental income or expense recognized on a straight-line basis, or other systematic and rational basis more representative of the time pattern in which use or benefit is granted or derived from the leased property, expected to be recognized in income or expense, by the lessor or lessee, respectively, more than one year after the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Aggregated carrying amounts of obligations as of the balance sheet date, excluding long-term debt, incurred as part of the normal operations that are expected to be paid after one year or beyond the normal operating cycle, if longer. Alternate captions include Total Deferred Credits and Other Liabilities. No definition available.
|
X | ||||||||||
- Definition Amount of assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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Summary of Significant Accounting Policies - Schedule of Impacts to Accumulated Other Comprehensive Loss and Accumulated Deficit Upon Adoption of Guidance (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Jan. 01, 2019 |
Dec. 31, 2018 |
---|---|---|---|
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | $ (462) | $ (2,281) | |
Accumulated deficit | $ (637,158) | $ (715,827) | |
ASU 2018-02 [Member] | |||
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | $ (1,670) | ||
Accumulated deficit | (716,438) | ||
Impact of change in accounting principle upon adoption of ASU 2018-02 [Member] | ASU 2018-02 [Member] | |||
Accounting Policy [Line Items] | |||
Accumulated other comprehensive loss | 611 | ||
Accumulated deficit | $ (611) |
X | ||||||||||
- Definition Accounting policy. No definition available.
|
X | ||||||||||
- Definition Accumulated change in equity from transactions and other events and circumstances from non-owner sources, net of tax effect, at period end. Excludes Net Income (Loss), and accumulated changes in equity from transactions resulting from investments by owners and distributions to owners. Includes foreign currency translation items, certain pension adjustments, unrealized gains and losses on certain investments in debt and equity securities, other than temporary impairment (OTTI) losses related to factors other than credit losses on available-for-sale and held-to-maturity debt securities that an entity does not intend to sell and it is not more likely than not that the entity will be required to sell before recovery of the amortized cost basis, as well as changes in the fair value of derivatives related to the effective portion of a designated cash flow hedge. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition The amount of additional consideration based on net sales of product as defined under a collaboration agreement. No definition available.
|
X | ||||||||||
- Definition Amount of aggregate consideration receivable under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the amount of milestone payments related to commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition Estimated joint development extended service period. 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 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 Transaction price allocated to performance obligations. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of transaction price allocated to performance obligation that has not been recognized as revenue. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
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- Details
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- Details
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- Details
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X | ||||||||||
- Definition Amount of aggregate consideration receivable under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Commercial sales and other events milestone. No definition available.
|
X | ||||||||||
- Definition Represents the amount of milestone payments related to commercial sales under the collaborative agreement. No definition available.
|
X | ||||||||||
- Definition Contract with customer liability, milestone method revenue recognized. No definition available.
|
X | ||||||||||
- Definition Development milestone payment received. No definition available.
|
X | ||||||||||
- Definition Estimated joint development extended service period. 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 total amount of non-contingent, non-refundable, upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition Represents the total amount of non-contingent, non-refundable, upfront payments included under the collaborative agreement as arrangement consideration. No definition available.
|
X | ||||||||||
- Definition Transaction price allocated to performance obligations. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of transaction price allocated to performance obligation that has not been recognized as revenue. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
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- Details
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- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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- Details
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X | ||||||||||
- Details
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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 development services under the collaboration agreement as of a given date. No definition available.
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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- Details
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- Details
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- Details
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X | ||||||||||
- Definition Variable consideration payment received from estimated future co-development billing. No definition available.
|
X | ||||||||||
- Definition Amount of revenue recognized arising from contract liability from change in timeframe for performance obligation to be satisfied. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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- Details
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- Details
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- Details
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- Definition Supplies, net. No definition available.
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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Collaboration Agreements - Deferred Revenue - Additional Information (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 52,019 | $ 0 |
AstraZeneca Agreements [Member] | China [Member] | ||
Contract with Customer, Liability [Abstract] | ||
Deferred revenue | $ 500 |
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Fair value portion of probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of investment in debt and equity securities categorized neither as held-to-maturity nor trading. No definition available.
|
X | ||||||||||
- Definition Fair value portion of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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Fair Value Measurements - Fair Values of Financial Liabilities Carried at Historical Cost (Detail) - Lease obligations [Member] - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,745 | $ 98,105 |
Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | 0 | 0 |
Level 3 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value disclosure | $ 1,745 | $ 98,105 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Fair value of financial and nonfinancial obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
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- Details
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- Details
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- Details
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- Definition Lessee, finance lease commencement date. No definition available.
|
X | ||||||||||
- Definition Lessee, finance lease, remaining lease maximum expansion period. No definition available.
|
X | ||||||||||
- Definition Lessee, finance lease remaining term. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of transfers of assets measured on a recurring basis out of Level 1 of the fair value hierarchy into Level 2. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of transfers of assets measured on a recurring basis out of Level 2 of the fair value hierarchy into Level 1. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of transfers of liabilities measured on a recurring basis out of Level 1 of the fair value hierarchy into Level 2. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of transfers of liabilities measured on a recurring basis out of Level 2 of the fair value hierarchy into Level 1. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of transfers of financial instrument classified as a liability into level 3 of the fair value hierarchy. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of transfers of financial instrument classified as a liability out of level 3 of the fair value hierarchy. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of transfer of financial instrument classified as an asset into level 3 of the fair value hierarchy. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of transfers of financial instrument classified as an asset out of level 3 of the fair value hierarchy. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Fair value of financial and nonfinancial obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
|
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- Details
|
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- Details
|
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- Details
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X | ||||||||||
- Definition Lessee, finance lease, additional lease expiration period. No definition available.
|
X | ||||||||||
- Definition Lessee, finance lease, expiration period. No definition available.
|
X | ||||||||||
- Definition Lessee, finance lease, option to extend the additional lease term. No definition available.
|
X | ||||||||||
- Definition Number of finance leases. No definition available.
|
X | ||||||||||
- Definition Number of operating leases. No definition available.
|
X | ||||||||||
- Definition Percentage increases on each anniversary of rent commencement date. No definition available.
|
X | ||||||||||
- Definition Indicates (true false) whether lessee has option to extend finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Description of terms and conditions of option to extend lessee's finance lease. Includes, but is not limited to, information about option recognized as part of right-of-use asset and lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Term of lessee's finance lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Term of lessee's operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
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- Details
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- Details
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- Details
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- Details
|
Leases - Schedule of Lease Assets and Related Lease Liabilities (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Leases [Abstract] | ||
Right-of-use assets - cost | $ 49,676 | |
Accumulated amortization | (5,140) | |
Finance lease right-of-use assets, net | 44,536 | $ 0 |
Right-of-use assets - cost | 1,212 | |
Accumulated amortization | (273) | |
Operating lease right-of-use assets, net | 939 | |
Total lease assets | 45,475 | |
Finance lease liabilities | 12,071 | 0 |
Operating lease liabilities | 591 | |
Finance lease liabilities | 43,780 | $ 0 |
Operating lease liabilities | 346 | |
Total lease liabilities | $ 56,788 |
X | ||||||||||
- Definition Finance lease accumulated amortization. No definition available.
|
X | ||||||||||
- Definition Finance lease and operating lease assets. No definition available.
|
X | ||||||||||
- Definition Finance lease and operating lease liability. No definition available.
|
X | ||||||||||
- Definition Finance lease, right-of-use assets - cost. No definition available.
|
X | ||||||||||
- Definition Operating lease, accumulated amortization. No definition available.
|
X | ||||||||||
- Definition Operating lease, right-of-use assets - cost. No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Leases - Components of Lease Expense (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | |
---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Finance lease cost: | |||
Amortization of right-of-use assets | $ 2,571 | $ 5,140 | $ 0 |
Interest on lease liabilities | 609 | 1,249 | |
Operating lease cost | 163 | 289 | |
Sublease income | (237) | (824) | |
Total lease cost | $ 3,106 | $ 5,854 |
X | ||||||||||
- Definition Amount of interest expense on finance lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of amortization expense attributable to right-of-use asset from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lease cost recognized by lessee for lease contract. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of single lease cost, calculated by allocation of remaining cost of lease over remaining lease term. Includes, but is not limited to, single lease cost, after impairment of right-of-use asset, calculated by amortization of remaining right-of-use asset and accretion of lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Amount of sublease income excluding finance and operating lease expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 191 | |
Operating cash flows from finance leases | 1,053 | |
Financing cash flows from finance leases | 5,850 | $ 0 |
Right-of-use assets obtained in exchange for new lease liabilities: | ||
Finance leases | 49,676 | |
Operating leases | $ 1,212 |
X | ||||||||||
- Definition Cash paid for amounts included in the measurement of lease liabilities. No definition available.
|
X | ||||||||||
- Definition Right-of-use assets obtained in exchange for new lease liabilities. No definition available.
|
X | ||||||||||
- Definition Amount of interest paid on finance lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash outflow for principal payment on finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash outflow from operating lease, excluding payments to bring another asset to condition and location necessary for its intended use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of increase in right-of-use asset obtained in exchange for finance lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Amount of increase in right-of-use asset obtained in exchange for operating lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
Leases - Schedule of Lease Term and Discount Rate (Detail) |
Jun. 30, 2019 |
---|---|
Weighted-average remaining lease term (years): | |
Finance leases | 4 years 1 month 6 days |
Operating leases | 1 year 4 months 24 days |
Weighted-average discount rate: | |
Finance leases | 4.43% |
Operating leases | 4.74% |
X | ||||||||||
- Definition Weighted-average discount rate. No definition available.
|
X | ||||||||||
- Definition Weighted-average remaining lease term. No definition available.
|
X | ||||||||||
- Definition Weighted average discount rate for finance lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Weighted average remaining lease term for finance lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Weighted average discount rate for operating lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Weighted average remaining lease term for operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands |
Jun. 30, 2019
USD ($)
|
---|---|
Finance Leases | |
2019 (Remaining six month period) | $ 7,002 |
2020 | 14,089 |
2021 | 13,678 |
2022 | 13,878 |
2023 | 12,523 |
Total future lease payments | 61,170 |
Less: Interest | (5,319) |
Present value of lease liabilities | 55,851 |
Operating Leases | |
2019 (Remaining six month period) | 313 |
2020 | 507 |
2021 | 134 |
2022 | 19 |
2023 | 0 |
Total future lease payments | 973 |
Less: Interest | (36) |
Present value of lease liabilities | $ 937 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease, due in fifth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease, due in fourth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease, due in third fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease, due in second fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease, due in remainder of fiscal year following latest fiscal year ended. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments in excess of discounted obligation for lease payments for finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in fifth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in fourth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in third fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in second fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease having an initial or remaining lease term in excess of one year due in remainder of fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments in excess of discounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Leases - Schedule of Future Minimum Lease Payments Under all Non-Cancelable Operating Lease Obligations (Detail) $ in Thousands |
Dec. 31, 2018
USD ($)
|
---|---|
Leases [Abstract] | |
2019 | $ 444 |
2020 | 232 |
2021 | 25 |
2022 | 16 |
2023 | 0 |
Total minimum payments | $ 717 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of required minimum rental payments for leases having an initial or remaining non-cancelable letter-terms in excess of one year. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for operating leases having an initial or remaining non-cancelable lease term in excess of one year due in the next fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for operating leases having an initial or remaining non-cancelable lease term in excess of one year due in the fifth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for operating leases having an initial or remaining non-cancelable lease term in excess of one year due in the fourth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for operating leases having an initial or remaining non-cancelable lease term in excess of one year due in the third fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for operating leases having an initial or remaining non-cancelable lease term in excess of one year due in the second fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
Leases - Schedule of Future Minimum Lease Payments on Consolidated Basis Under Company's Facility Financing Lease Obligations (Detail) $ in Thousands |
Dec. 31, 2018
USD ($)
|
---|---|
Leases [Abstract] | |
2019 | $ 14,379 |
2020 | 14,664 |
2021 | 14,179 |
2022 | 14,335 |
2023 | 12,872 |
Total minimum payments | $ 70,429 |
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the next fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the fifth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the fourth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the third fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the second fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- References No definition available.
|
Balance Sheet Components - Schedule of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 40,783 | $ 38,783 |
US treasury notes and bills | 0 | 49,934 |
Money market funds | 33,804 | 541 |
Total cash and cash equivalents | $ 74,587 | $ 89,258 |
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Investment in short-term money-market instruments (such as commercial paper, banker's acceptances, repurchase agreements, government securities, certificates of deposit, and so forth) which are highly liquid (that is, readily convertible to known amounts of cash) and so near their maturity that they present an insignificant risk of changes in value because of changes in interest rates. Generally, only investments with original maturities of three months or less qualify as cash equivalents by definition. Original maturity means an original maturity to the entity holding the investment. For example, both a three-month US Treasury bill and a three-year Treasury note purchased three months from maturity qualify as cash equivalents. However, a Treasury note purchased three-years ago does not become a cash equivalent when its remaining maturity is three months. No definition available.
|
X | ||||||||||
- Definition Debt (bills, notes or bonds) that are issued by the government of the United States which are short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments with original maturities of three months or less qualify under that definition. Original maturity means original maturity to the entity holding the investment. For example, both a three-month US Treasury bill and a three-year Treasury note purchased three months from maturity qualify as cash equivalents. However, a Treasury note purchased three-years ago does not become a cash equivalent when its remaining maturity is three months. No definition available.
|
X | ||||||||||
- Definition Represents the maximum contractual maturity period for available-for-sale securities. No definition available.
|
X | ||||||||||
- Definition Number of regulatory milestones. No definition available.
|
X | ||||||||||
- Definition Amount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of valuation reserve for inventory. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The amount by which the fair value of an investment in debt and equity securities categorized as Available-for-sale is less than the amortized cost basis or carrying amount of that investment at the balance sheet date and the decline in fair value is deemed to be other than temporary, before considering whether or not such amount is recognized in earnings or other comprehensive income. No definition available.
|
X | ||||||||||
- Definition Amount before accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition Amount of investment in debt and equity securities categorized neither as held-to-maturity nor trading. No definition available.
|
X | ||||||||||
- Definition Amount before tax of unrealized gain in accumulated other comprehensive income (AOCI) on investments in debt and equity securities classified as available-for-sale. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before tax of unrealized loss in accumulated other comprehensive income (AOCI) on investments in debt and equity securities classified as available-for-sale. No definition available.
|
X | ||||||||||
- Definition This item represents the cost of debt and equity securities, which are categorized neither as held-to-maturity nor trading, net of adjustments including accretion, amortization, collection of cash, previous other-than-temporary impairments recognized in earnings (less any cumulative-effect adjustments recognized, as defined), and fair value hedge accounting adjustments, if any. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Investments Schedule [Abstract] | ||
Raw materials | $ 797 | |
Work-in-progress | 1,035 | |
Finished goods | 149 | |
Total inventories | $ 1,981 | $ 0 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount before valuation and LIFO reserves of completed merchandise or goods expected to be sold within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount after valuation and LIFO reserves of inventory expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before valuation and LIFO reserves of raw materials expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before valuation and LIFO reserves of merchandise or goods in the production process expected to be completed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Prepaid Expense And Other Assets Current [Abstract] | ||
Unbilled contract assets | $ 180,000 | $ 0 |
Deferred revenues from associated contracts | (52,019) | 0 |
Net unbilled contract assets | 127,981 | 0 |
Prepaid assets | 4,716 | 2,705 |
Other current assets | 3,899 | 2,224 |
Total prepaid expenses and other current assets | $ 136,596 | $ 4,929 |
X | ||||||||||
- Definition Supplies, net. No definition available.
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of current assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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Balance Sheet Components - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Accrued Liabilities Current [Abstract] | ||
Preclinical and clinical trial accruals | $ 41,104 | $ 35,413 |
Payroll and related accruals | 14,001 | 21,430 |
Property taxes and other | 1,778 | 1,095 |
Professional services | 3,588 | 2,648 |
Other | 6,074 | 5,537 |
Total accrued liabilities | $ 66,545 | $ 66,123 |
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 Property taxes and other current. No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for professional fees, such as for legal and accounting services received. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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 services received from employees, such as accrued salaries and bonuses, payroll taxes and fringe benefits. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of expenses incurred but not yet paid classified as other, due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Stock-Based Compensation - Schedule of Allocated Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 17,642 | $ 13,231 | $ 34,072 | $ 24,109 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 10,450 | 7,894 | 20,028 | 14,264 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 7,192 | $ 5,337 | $ 14,044 | $ 9,845 |
X | ||||||||||
- Definition Amount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
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- Details
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- Definition The estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the maximum percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. No definition available.
|
X | ||||||||||
- Definition The estimated measure of the minimum percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. No definition available.
|
X | ||||||||||
- Definition The risk-free interest rate assumption that is used in valuing an option on its own shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum risk-free interest rate assumption that is used in valuing an option on its own shares. No definition available.
|
X | ||||||||||
- Definition The minimum risk-free interest rate assumption that is used in valuing an option on its own shares. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition The weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Expected term of award under share-based payment arrangement, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Supplies, net. No definition available.
|
X | ||||||||||
- Definition Amount of receivables arising from transactions with related parties due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The aggregate amount of receivables to be collected from related parties where one party can exercise control or significant influence over another party; including affiliates, owners or officers and their immediate families, pension trusts, and so forth, at the financial statement date. which are usually due within one year (or one business cycle). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying amount as of the balance sheet date of obligations due all related parties. For classified balance sheets, represents the current portion of such liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Definition Expenses recognized resulting from transactions (excluding transactions that are eliminated in consolidated or combined financial statements) with related party. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of revenue, fees and commissions earned from transactions between (a) a parent company and its subsidiaries; (b) subsidiaries of a common parent; (c) an entity and trusts for the benefit of employees, for example, but not limited to, pension and profit-sharing trusts that are managed by or under the trusteeship of the entity's management; (d) an entity and its principal, owners, management, or members of their immediate families; and (e) affiliates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Definition Amount of consideration paid in advance for supplies that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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