Document and Entity Information - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Mar. 15, 2019 |
Jun. 30, 2018 |
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| Document And Entity Information [Abstract] | |||
| Document Type | 10-K | ||
| Amendment Flag | false | ||
| Document Period End Date | Dec. 31, 2018 | ||
| Document Fiscal Year Focus | 2018 | ||
| Document Fiscal Period Focus | FY | ||
| Trading Symbol | AKBA | ||
| Entity Registrant Name | Akebia Therapeutics, Inc. | ||
| Entity Central Index Key | 0001517022 | ||
| Current Fiscal Year End Date | --12-31 | ||
| Entity Filer Category | Accelerated Filer | ||
| Entity Small Business | false | ||
| Entity Emerging Growth Company | true | ||
| Entity Ex Transition Period | true | ||
| Entity Shell Company | false | ||
| Entity Common Stock, Shares Outstanding | 117,122,262 | ||
| Entity Well-known Seasoned Issuer | Yes | ||
| Entity Voluntary Filers | No | ||
| Entity Current Reporting Status | Yes | ||
| Entity Public Float | $ 534,415,547 |
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- Definition Document and entity information. No definition available.
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- Definition If the value is true, then the document is an amendment to previously-filed/accepted document. No definition available.
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- Definition End date of current fiscal year in the format --MM-DD. No definition available.
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- Definition This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
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- 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.
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- 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.
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- 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.
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- 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
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- 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.
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- 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.
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| X | ||||||||||
- Definition Indicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate if registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, (4) Smaller Reporting Company (Non-accelerated), (5) Smaller Reporting Accelerated Filer or (6) Smaller Reporting Company and Large 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
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- Definition State aggregate market value of voting and non-voting common equity held by non-affiliates computed by reference to price at which the common equity was last sold, or average bid and asked price of such common equity, as of the last business day of registrant's most recently completed second fiscal quarter. The public float should be reported on the cover page of the registrants form 10K. No definition available.
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- 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
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- Definition Indicate if company meets the shell company criteria: a company with no or nominal operations, and with no or nominal assets or assets consisting solely of cash and cash equivalents. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicates that the company is a smaller reporting company with both a public float and revenues of less than $75 million. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
- Definition Indicate 'Yes' or 'No' if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. No definition available.
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- Definition Indicate 'Yes' or 'No' if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Is used on Form Type: 10-K, 10-Q, 8-K, 20-F, 6-K, 10-K/A, 10-Q/A, 20-F/A, 6-K/A, N-CSR, N-Q, N-1A. No definition available.
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| X | ||||||||||
- Definition Trading symbol of an instrument as listed on an exchange. No definition available.
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| 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
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| X | ||||||||||
- Definition Amount due from customers or clients, within one year of the balance sheet date (or the normal operating cycle, whichever is longer), for goods or services (including trade receivables) that have been delivered or sold in the normal course of business, reduced to the estimated net realizable fair value by an allowance established by the entity of the amount it deems uncertain of collection. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| 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
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| 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
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| X | ||||||||||
- Definition Value received from shareholders in common stock-related transactions that are in excess of par value or stated value and amounts received from other stock-related transactions. Includes only common stock transactions (excludes preferred stock transactions). May be called contributed capital, capital in excess of par, capital surplus, or paid-in capital. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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| 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
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| 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
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| 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
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| 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
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| 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://fasb.org/us-gaap/role/ref/legacyRef
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| 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://fasb.org/us-gaap/role/ref/legacyRef
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| 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 Amount, after deferred tax asset, of deferred tax liability attributable to taxable differences without jurisdictional netting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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- 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
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| 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
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- 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
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- References No definition available.
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| X | ||||||||||
- Definition The carrying value as of the balance sheet date of the current portion of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of noncurrent assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount after accumulated amortization of finite-lived and indefinite-lived intangible assets classified as other. No definition available.
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| 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
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| 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
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| 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
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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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| X | ||||||||||
- 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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| 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
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| X | ||||||||||
- References No definition available.
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Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Statement Of Financial Position [Abstract] | ||
| Preferred stock, par value | $ 0.00001 | $ 0.00001 |
| Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value | $ 0.00001 | $ 0.00001 |
| Common stock, shares authorized | 175,000,000 | 175,000,000 |
| Common stock, shares issued | 116,887,518 | 47,612,619 |
| Common stock, shares outstanding | 116,887,518 | 47,612,619 |
| X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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| 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
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| 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
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| 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
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| 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
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| 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
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| 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
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Amortization of intangible assets product. No definition available.
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| X | ||||||||||
- Definition License expense. No definition available.
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| X | ||||||||||
- 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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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The aggregate cost of goods produced and sold and services rendered during the reporting period. 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 The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or 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/2009/role/commonPracticeRef
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| 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
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| 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
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| X | ||||||||||
- Definition The net amount of nonoperating interest income (expense). No definition available.
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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 | ||||||||||
- References No definition available.
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| 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.
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
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| X | ||||||||||
- Definition Amount after tax, before reclassification adjustments, of unrealized holding gain (loss) on available-for-sale securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of income (expense) related to nonoperating activities, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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| 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://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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| 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
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| X | ||||||||||
- Definition Indicates type of cost of good or service sold. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- Definition Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Definition Amount of increase to additional paid-in capital (APIC) from recognition of equity-based compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of increase in additional paid in capital (APIC) resulting from the issuance of warrants. Includes allocation of proceeds of debt securities issued with detachable stock purchase warrants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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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 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://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares of stock issued during the period pursuant to acquisitions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares issued during the period as a result of the conversion of convertible securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares issued during the period as a result of an employee stock purchase plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares related to Restricted Stock Award forfeited during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares issued during the period related to Restricted Stock Awards, net of any shares forfeited. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Value of stock issued pursuant to acquisitions during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The gross value of stock issued during the period upon the conversion of convertible securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Aggregate change in value for stock issued during the period as a result of employee stock purchase plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Value of stock issued as a result of the exercise of stock options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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
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- Definition Amount of decrease of par value, additional paid in capital (APIC) and retained earnings of common and preferred stock retired from treasury when treasury stock is accounted for under the cost method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Consolidated Statements of Stockholders' Equity (Parenthetical) |
12 Months Ended |
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Dec. 31, 2016
shares
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| Statement Of Stockholders Equity [Abstract] | |
| Treasury shares retired | (8,643) |
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- References No definition available.
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| X | ||||||||||
- Definition Number of shares of common and preferred stock retired from treasury during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Deferred follow on offering issuance costs. No definition available.
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- Definition Fair value write-up of inventory sold. No definition available.
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- Definition Increase (decrease) in deferred rent. No definition available.
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| X | ||||||||||
- Definition Noncash interest expense. No definition available.
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| X | ||||||||||
- Definition Payments to acquire businesses net of acquired cash and restricted cash. No definition available.
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- Definition Proceeds from issuance of common stock net of issuance costs. No definition available.
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| X | ||||||||||
- 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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| X | ||||||||||
- Definition The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back 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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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for 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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| X | ||||||||||
- 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 aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of expense (income) related to adjustment to fair value of warrant liability. 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 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
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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 The increase (decrease) during the reporting period in the aggregate amount of expenses incurred but not yet paid. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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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| X | ||||||||||
- References No definition available.
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- Definition Amount of increase (decrease) in noncurrent assets classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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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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| X | ||||||||||
- 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 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 of expense (income) related to the increase (decrease) in reserve for business combination costs. Includes, but is not limited to, legal, accounting, and other costs incurred to consummate the merger. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash outflow to acquire investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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 Amount of cash inflow from maturity, prepayment and call of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash inflow from sale of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash inflow from exercise of stock options granted under share-based compensation arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow associated with the amount received from the stock plan during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash outflow for the obligation for a lease meeting the criteria for capitalization (with maturities exceeding one year or beyond the operating cycle of the entity, if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate amount of noncash, equity-based employee remuneration. This may include the value of stock or unit options, amortization of restricted stock or units, and adjustment for officers' compensation. As noncash, this element is an add back when calculating net cash generated by operating activities using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The fair value of stock issued in noncash financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Nature of Organization and Operations |
12 Months Ended |
|---|---|
Dec. 31, 2018 | |
| Accounting Policies [Abstract] | |
| Nature of Organization and Operations |
1. Nature of Organization and Operations Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. Akebia’s commercial product, Auryxia® (ferric citrate) is currently approved by the United States Food and Drug Administration, or FDA, and marketed for two indications in the United States, the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD. Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with DD-CKD and NDD-CKD under the trade name Riona® and approved, but not currently marketed, in the European Union as an oral treatment for the control of hyperphosphatemia in adult patients with DD-CKD and NDD-CKD under the trade name Fexeric®. The Company’s lead investigational product candidate, vadadustat, is an oral therapy in Phase 3 development. The Company believes vadadustat has the potential to set a new standard of care in the treatment of anemia due to CKD, acting via a novel hypoxia inducible factor, or HIF, pathway. HIF is the primary regulator of the production of red blood cells, or RBCs, in the body, as well as other important metabolic functions. On December 12, 2018, the Company completed a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger. Pursuant to the terms and conditions of the Agreement and Plan of Merger, or the Merger Agreement, each share of Keryx common stock, or Keryx Share, issued and outstanding immediately prior to the effective time of the Merger, or the Effective Time, was cancelled and converted into 0.37433, or the Exchange Multiplier, fully paid and non-assessable shares of Akebia common stock, or Akebia Shares, resulting in the issuance of an aggregate of 59,270,410 Akebia Shares. The Merger Agreement also provided that at the Effective Time, each Keryx restricted share award, to the extent outstanding, other than those Keryx restricted share awards that accelerated or lapsed as a result of the completion of the Merger, converted into an Akebia restricted stock unit, or RSU, award covering the number of Akebia Shares determined in accordance with the Exchange Multiplier, resulting in the issuance of Akebia RSUs covering an aggregate of 602,752 Akebia Shares. In addition, each outstanding and unexercised option to acquire Keryx Shares converted into an option to acquire Akebia Shares, with the number of shares and exercise price adjusted by the Exchange Multiplier, resulting in the assumption by Akebia of options to acquire an aggregate 3,967,290 Akebia Shares. Refer to Note 5 for additional details on the Merger. Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, raising capital, and providing general and administrative support for these operations. The Company began recording revenue from the U.S. sales of Auryxia on December 12, 2018 and revenue from sublicensing rights to Auryxia in Japan to the Company’s Japanese partners Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively JT and Torii. Ferric citrate is approved in Japan under the trade name Riona and in Europe under the trade name Fexeric. The Company has not generated a profit to date and may never generate profits from product sales. The Company’s product candidates are subject to long development cycles, and the Company may be unsuccessful in its efforts to develop, obtain marketing approval for or market its product candidates. The Company is subject to a number of risks including, but not limited to, risks relating to integration following the Merger, the need to obtain adequate additional funding, including the resources necessary to fund commercialization of Auryxia, the global Phase 3 program for vadadustat in NDD-CKD, called PRO2TECT, and DD-CKD, called INNO2VATE, and post-approval studies with respect to Auryxia, risks relating to market acceptance, coverage and reimbursement of Auryxia, risks related to maintaining the Company’s commercial organization and capabilities, risks relating to potential generic entrants, risks of clinical trial failures, the risk of relying on third parties, the risk that the Company never achieves profitability, protection of proprietary technology, compliance with governmental regulations, and dependence on key personnel, and the impact of legal, regulatory and administrative proceedings. Overall, the PRO2TECT and INNO2VATE Phase 3 programs are designed to enroll up to approximately 7,600 patients. In August 2016, the first patient was dosed in INNO2VATE. The Company completed enrollment in the larger of the two INNO2VATE studies, which enrolled 3,554 subjects, in February 2019, and it expects to complete enrollment in the smaller INNO2VATE study, enrolling approximately 350 subjects, by April 2019. The Company anticipates completing the larger of the two INNO2VATE studies in the first quarter of 2020, with completion of the smaller INNO2VATE study and availability of top-line data expected in the second quarter of 2020, subject to the accrual of major adverse cardiovascular events, or MACE. The first patient was dosed in PRO2TECT in December 2015. The Company expects full enrollment of PRO2TECT in 2019. The Company anticipates reporting top-line clinical data for the PRO2TECT studies in mid-2020, subject to the accrual of MACE. In December 2015, the Company entered into a collaboration agreement with Mitsubishi Tanabe Pharma Corporation, or MTPC, to develop and commercialize vadadustat in Japan and certain other countries in Asia, collectively, the MTPC Territory, for total payments of up to $245.0 million, comprised of a $20.0 million upfront payment, up to $50.0 million in specified development and regulatory milestones, and up to $175.0 million in specified commercial milestones, as well as tiered double-digit royalty payments up to 20% on sales of vadadustat in the MTPC Territory, subject to a reduction upon launch of a generic product on a country-by-country basis (Note 4). In December 2016, the Company entered into a collaboration and license agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka to develop and commercialize vadadustat in the United States. In December 2016, the Company received $125.0 million upfront payment, and in March 2017, Otsuka reimbursed the Company approximately $33.8 million for global expenses previously incurred by us for its ongoing global development program for vadadustat in DD-CKD and NDD-CKD patients. The agreement also provides for additional funding for the global development program for vadadustat, totaling $167.5 million or more, depending on the actual global development costs incurred. In addition, Akebia is eligible to receive from Otsuka up to $190.0 million in specified development and regulatory milestones and up to $575.0 million in specified commercial milestones. The Company will share with Otsuka the costs of developing and commercializing vadadustat in the United States and the profits from sales of vadadustat in the United after approval by the FDA and commercial launch (Note 4).
In April 2017, the Company entered into a collaboration and license agreement with Otsuka to develop and commercialize vadadustat in Europe, Russia, China, Canada, Australia, the Middle East and certain other territories. In April 2017, the Company received a $73.0 million upfront payment and $0.2 million for global expenses previously incurred by the Company in implementing the current global Phase 3 development plan for vadadustat in DD-CKD and NDD-CKD patients in excess of a specified threshold during the quarter-ended March 31, 2017. The agreement also provides for additional funding for the global development program for vadadustat, totaling $176.1 million or more, depending on the actual global development costs incurred. In addition, Akebia is eligible to receive from Otsuka up to $132.0 million in specified development and regulatory milestones and up to $525.0 million in specified commercial milestones (Note 4). From inception through December 31, 2018 the Company has raised approximately $468.4 million of net proceeds, including $377.4 million from several underwritten public offerings, $41.0 million from an at-the-market offering, or ATM, pursuant to sales agreements with Cantor Fitzgerald & Co. and $50.0 million from the sale of 3,571,429 shares of common stock to Vifor (International) Ltd., or Vifor Pharma. At inception of the Company’s collaboration agreements with Otsuka and MTPC, they committed to approximately $573.0 million or more in cost-share funding, which the Company generally continues to receive on a quarterly prepaid basis, and license payments. Of these commitments, the Company received approximately $272.0 million at the onset of the collaboration agreements.
Management of the Company completed its going concern assessment in accordance with ASC 205-40. The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan through at least the next twelve months from the filing of the Company’s 2018 Annual Report on Form 10-K, as required by ASC 205-40. There can be no assurance, however, that the current operating plan will be achieved in the time frame anticipated by the Company, or that its cash resources will fund the Company’s operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to the Company, or at all. The Company will require additional capital for the further commercialization of Auryxia and continued development and potential commercialization of the Company’s existing product candidates and would need to raise additional funds to pursue development activities related to any additional product candidates. If and until the Company can generate a sufficient amount of product revenue, the Company expects to finance future cash needs through public or private equity or debt offerings, payments from its collaborators, strategic transactions, or a combination of these approaches. |
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- References No definition available.
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- Definition The entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Summary of Significant Accounting Policies |
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| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). As discussed more fully below, as prescribed by the required adoption of ASC 606 on January 1, 2018, the Company revised its comparative financial statements for the year ended December 31, 2017 to give effect to ASC 606 as if it had been effective for that period. No changes for the adoption of ASC 606 were deemed necessary for the year ended December 31, 2016 and applicable interim periods within the year. New Accounting Pronouncements – Recently Adopted In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), a new revenue recognition standard which amends revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition. In 2015 and 2016, the FASB issued additional ASUs related to Topic 606, or ASC 606, that delayed the effective date of the guidance and clarified various aspects of the new revenue guidance, including principal versus agent considerations, identifying performance obligations, and licensing, and they include other improvements and practical expedients. The Company adopted this new standard on January 1, 2018 using the full retrospective transition method, and has elected to use the following practical expedients that are permitted under the rules of the adoption, which have been applied consistently to all contracts within all reporting periods presented:
As a result of adopting ASC 606 on January 1, 2018, the Company has revised its comparative financial statements for the year ended December 31, 2017 as if ASC 606 had been effective for that period, as set forth below. No changes for the adoption of ASC 606 were deemed necessary for the year ended December 31, 2016 and applicable interim periods within the year. With respect to the collaboration agreements with Otsuka, the Company concluded that there was no impact to revenue for the year ended December 31, 2017 after the adoption of ASC 606. The changes shown in the table below relate to the Company’s collaboration agreement with MTPC and the impact of when milestone payments can be recognized under the new standard as well as the period over which this revenue is recognized. Under ASC 605-28, Revenue Recognition-Milestone Method, the Company evaluated at contract inception whether each milestone was substantive. Substantive milestones are recognized as revenue in their entirety upon achievement, assuming all other revenue recognition criteria are met. Therefore, a $4.0 million MTPC development milestone, which was deemed to be substantive, would have been recognized in its entirety in the first quarter of 2018, when the milestone event occurred. Under ASC 606, these substantive milestone payments would be classified as variable consideration and included in the allocable transaction price over the remaining period of performance when it is probable that a significant reversal in the cumulative amount of revenue recognized would not occur. Under ASC 606, this resulted in the $4.0 million MTPC development milestone being included in the allocable consideration, of which $3.2 million was recognized as revenue in 2017 under the proportional performance method utilized for revenue recognition of the MTPC allocable consideration. As a result, the following financial statement line items for the year ended December 31, 2017 were affected. Consolidated Statement of Operations and Comprehensive Loss
Consolidated Balance Sheets
Consolidated Statement of Cash Flows
In October 2016, the FASB issued ASU 2016-18, Restricted Cash, which requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017 (fiscal year 2018 for the Company), and interim periods within those years, using a retrospective transition method to each period presented, with early adoption permitted. The Company elected to adopt this ASU effective January 1, 2018. The adoption of this guidance resulted in $1.3 million in restricted cash to be included with cash and cash equivalents at the beginning of the period in the consolidated statement of cash flows for each of the years ended December 31, 2018, 2017 and 2016. In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based award require an entity to apply modification accounting under ASC 718, Compensation – Stock Compensation. Specifically, awards will require modification accounting if the fair value, vesting condition or classification of the award is not the same immediately before and after a change to the terms and conditions of the award. This ASU is effective on a prospective basis beginning on January 1, 2018, with early adoption permitted. The Company adopted this ASU effective January 1, 2018, and since the Company did not have any modifications in fiscal 2018, the adoption of this ASU did not have an impact on the Company’s consolidated financial statements and disclosures. New Accounting Pronouncements – Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires entities to recognize right-of-use assets and lease liabilities for leases with lease terms of more than 12 months on their balance sheets and provide enhanced disclosures. In July 2018, the FASB issued additional ASUs related to Topic 842, or ASC 842, that clarified various aspects of the new lease guidance, including how to record certain transition adjustments, as well as other improvements and practical expedients. ASC 842 is effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years. Early application is permitted for all entities; however, the Company has elected not to early adopt. ASC 842 requires a modified retrospective approach for all leases existing at, or entered into after, the date of initial application, with an option to elect to use certain transition relief. The Company is currently evaluating the impact of this new standard on its consolidated financial statements and related disclosures; however, it expects the adoption of this new guidance will result in the Company recording additional assets and corresponding liabilities on its consolidated balance sheets, primarily relating to leases of office and lab space. The Company plans to adopt ASC 842 using the modified retrospective approach with the cumulative effect of adoption recognized to retained earnings on January 1, 2019. The Company also expects to elect the practical expedients upon transition that will retain the lease classification and initial direct costs for any leases that existed prior to the adoption of this new standard. The Company will not reassess whether any contracts entered into prior to the adoption are leases. The Company is also in the process of implementing appropriate changes to its controls to support lease accounting and related disclosures under the new standard. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. Currently, U.S. GAAP delays recognition of the full amount of credit losses until the loss is probable of occurring. Under this ASU, the income statement will reflect an entity’s current estimate of all expected credit losses. The measurement of expected credit losses will be based upon historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down of the security. This ASU is effective for annual periods beginning after December 15, 2019, and is applicable to the Company in fiscal year 2020. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial position and results of operations. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which simplifies how companies calculate goodwill impairments by eliminating Step 2 of the impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. ASU 2017-04 requires companies to compare the fair value of a reporting unit to its carrying amount and recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit's fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to the related reporting unit. This ASU is effective for annual periods beginning after December 15, 2019, and is applicable to the Company in fiscal year 2020. Early adoption is allowed, and the Company expects to early adopt ASU 2017-04 for annual and interim goodwill impairment tests conducted after January 1, 2019. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing novel therapeutics for patients with kidney disease. Derivative Financial Instruments The Company accounts for warrants and other derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives and Hedging, or ASC 815, based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s consolidated balance sheets and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s consolidated balance sheets at their fair value on the date of issuance and will be revalued on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. The warrant issued by the Company in connection with the Janssen Pharmaceutica NV Research and License Agreement, the Janssen Agreement, is classified as equity in the Company’s consolidated balance sheet. (See Note 12). Use of Estimates The preparation of 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 the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, inventories, income taxes, purchase price allocations related to business combinations, intangible assets and goodwill. Cash and Cash Equivalents Cash and cash equivalents consist of all cash on hand, deposits and funds invested in available for sale securities with original maturities of three months or less at the time of purchase. Cash equivalents are reported at fair value. At December 31, 2018, the Company’s cash equivalents are primarily in money market funds. The Company may maintain balances with its banks in excess of federally insured limits. Restricted cash is included in “other assets” in the consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheet that sum to the total of the amounts reported in the consolidated statement of cash flows subsequent to the adoption of ASU 2016-18 (in thousands):
Restricted cash represents amounts required for security deposits under the Company’s office and lab space lease agreements and cash balances held as collateral for the Company’s employee credit card program. Investments Management determines the appropriate classification of securities at the time of purchase and reevaluates such designation as of each balance sheet date. Currently, the Company classifies all securities as available for sale which are included in current assets as they are intended to fund current operations. The Company carries available for sale securities at fair value. The Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment and its application to certain investments. When assessing whether a decline in the fair value of a security is other-than-temporary, the Company considers the fair market value of the security, the duration of the security’s decline, and prospects for the underlying business. Based on these considerations, the Company did not identify any other-than-temporary unrealized losses at December 31, 2018. Unrealized losses on available for sale securities that are determined to be temporary, and not related to credit loss, are recorded in accumulated other comprehensive loss, a component of stockholders’ equity. The amortized cost of debt securities in this category reflects amortization of premiums and accretion of discounts to maturity computed under the effective interest method. The Company includes this amortization in the caption “Interest income” within the consolidated statements of operations and comprehensive loss. The Company also includes in net investment income, realized gains and losses and declines in value determined to be other than temporary. The Company bases the cost of securities sold upon the specific identification method and includes interest and dividends on securities in interest income. Accounts Receivable The Company’s accounts receivable represents amounts due to the Company from product sales (see Note 3) and from its collaboration agreements with MTPC and Otsuka (see Note 4). Reimbursable costs that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. Accounts receivable arising from product sales primarily represent amounts due from wholesale distributors as well as certain specialty pharmacy providers, or collectively, Customers. The Company deducts trade allowances for prompt payment, among other discounts, from its accounts receivable based on its experience that the Company’s Customers will earn these discounts and fees. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed as well as historical payment patterns and existing economic factors. The Company believes that credit risks associated with its Customers and collaboration partners are not significant. The Company did not have an allowance for doubtful accounts as of December 31, 2018 and 2017. Concentrations of Credit Risk and Off-Balance Sheet Risk Cash, cash equivalents, investments, and accounts receivable are the only financial instruments that potentially subject the Company to concentrations of credit risk. The Company maintains its cash, cash equivalents, and investments with high quality, accredited financial institutions and, accordingly, such funds are subject to minimal credit risk. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. Accounts receivable represent amounts due from the Company’s Customers and collaboration partners. As part of its credit management policy, the Company performs ongoing credit evaluations of its Customers and generally does not require collateral from any customer. The Company also monitors economic conditions of its collaboration partners to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection. Gross revenues and accounts receivable from each of the Company’s Customers or collaboration partners who individually accounted for 10% or more of total gross revenues and/or 10% or more of total gross accounts receivable consisted of the following:
Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Assets under capital lease are included in property and equipment. Property and equipment is depreciated using the straight-line method over the estimated useful lives of the assets, generally three to seven years. Such costs are periodically reviewed for recoverability when impairment indicators are present. Such indicators include, among other factors, operating losses, unused capacity, market value declines and technological obsolescence. Recorded values of asset groups of equipment that are not expected to be recovered through undiscounted future net cash flows are written down to current fair value, which generally is determined from estimated discounted future net cash flows (assets held for use) or net realizable value (assets held for sale). The following is the summary of property and equipment and related accumulated depreciation as of December 31, 2018 and 2017.
Depreciation expense, including expense associated with assets under capital leases, was approximately $0.9 million, $0.6 million and $0.3 million for the years ended December 31, 2018, 2017 and 2016, respectively. Inventories The Company values its inventories at the lower-of-cost or net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company classifies its inventory costs as long-term, in other assets in its consolidated balance sheets, when it expects to utilize the inventory beyond their normal operating cycle. Prior to the regulatory approval of its product candidates, the Company incurs expenses for the manufacture of material that could potentially be available to support the commercial launch of its products. Until the first reporting period when regulatory approval has been received or is otherwise considered probable and the future economic benefit is expected to be realized, the Company records all such costs as research and development expense. Inventory used in clinical trials is also expensed as research and development expense, when selected for such use. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical manufacturing campaign. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of product sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. Additionally, the Company’s product is subject to strict quality control and monitoring that it performs throughout the manufacturing process. In the event that certain batches or units of product no longer meet quality specifications, the Company will record a charge to cost of product sales to write-down any unmarketable inventory to its estimated net realizable value. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Revenue Recognition The Company generates revenues primarily from sales of Auryxia, see Note 3, and from its collaborations with MTPC and Otsuka, see Note 4. The Company recognizes revenue in accordance with ASC 606, which applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps:
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net The Company sells Auryxia in the United States, or U.S., primarily to wholesale distributors as well as certain specialty pharmacy providers. These Customers resell the Company’s product to health care providers and patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s product. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that it would have recognized is one year or less. Reserves for Variable Consideration Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between the Company and its Customers, health care providers, payors and other indirect customers relating to the Company’s sales of its products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount will be credited to the Customer) or as a current liability (if the amount is payable to a Customer or a party other than a Customer). When appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts and Allowances: The Company generally provides Customers with discounts that include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss through December 31, 2018. The Company records a corresponding reduction of accounts receivable (if the trade discount and/or allowance will be credited to the Customer) or an increase in accrued expense (if the trade discount and/or allowance is payable to a Customer) on the consolidated balance sheets. Product Returns: Consistent with industry practice, the Company generally offers Customers a limited right of return which allows for the product to be returned when the product expiry is within an allowable window. This right of return lapses once the product is provided to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return reserve using available industry data and its own historical sales information, including its visibility into the inventory remaining in the distribution channel. Provider Chargebacks and Discounts: Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s resale of the product. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed but for which the Company has not yet issued a credit. Commercial and Medicare Part D Rebates: The Company contracts with various commercial payor organizations, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates the rebates for commercial and Medicare Part D payors based upon (i) its contracts with the payors and (ii) information obtained from its Customers and other third parties regarding the payor mix for Auryxia. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Other Government Rebates: The Company is subject to discount obligations under state Medicaid programs and other government programs. The Company estimates its Medicaid and other government programs rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period. Other Incentives: Other incentives that the Company offers include voluntary patient assistance programs such as the Company’s co-pay assistance program, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on actual claims processed during a given period, as well as historical utilization data to estimate the amount the Company expects to receive associated with product that has been recognized as revenue, but remains in in the distribution channel at the end of each reporting period. Collaboration Revenues The Company enters into out-license and collaboration agreements which are within the scope of ASC 606, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments may result in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company implements the five-step model noted above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine whether the individual deliverables should be accounted for as separate performance obligations or as a combined performance obligation, and to determine the stand-alone selling price for each performance obligation identified in the contract. A deliverable represents a separate performance obligation if both of the following criteria are met: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer, and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. With regard to the MTPC and Otsuka collaboration agreements, the Company recognizes revenue related to amounts allocated to the identified performance obligation on a proportional performance basis as the underlying services are performed. Licenses of Intellectual Property If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to assess the milestone as probable of being achieved. There is considerable judgment involved in determining whether a milestone is probable of being reached at each specific reporting period. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenues as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. Manufacturing Supply Services Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license, collaboration and other revenues when the licensee obtains control of the goods, which is upon delivery. Royalties The Company will recognize sales-based royalties, including milestone payments based on the level of sales, at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company receives royalty payments from JT and Torii, based on net sales of Riona in Japan. Collaborative Arrangements The Company records the elements of its collaboration agreements that represent joint operating activities in accordance with ASC Topic 808, Collaborative Arrangements (ASC 808). Accordingly, the elements of the collaboration agreements that represent activities in which both parties are active participants and to which both parties are exposed to the significant risks and rewards that are dependent on the commercial success of the activities are recorded as collaborative arrangements. The Company considers the guidance in ASC 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions, in determining the appropriate treatment for the transactions between the Company and its collaborative partner and the transactions between the Company and third parties. Generally, the classification of transactions under the collaborative arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Therefore, the Company recognizes its allocation of the shared costs incurred with respect to the jointly conducted medical affairs and commercialization and non-promotional activities under the U.S. collaboration with Otsuka as a component of the related expense in the period incurred. During the year ended December 31, 2018, the Company incurred approximately $1.2 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, as defined below in Note 4, of which approximately $0.5 million are reimbursable by Otsuka and recorded as a reduction to research and development expense. During the year ended December 31, 2018, Otsuka incurred approximately $1.1 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, of which approximately $0.5 million are reimbursable by the Company and recorded as an increase to research and development expense. To the extent product revenue is generated from the collaboration, the Company will recognize its share of the net sales on a gross basis if it is deemed to be the principal in the transactions with customers, or on a net basis if it is instead deemed to be the agent in the transactions with customers, consistent with the guidance in ASC 606. Business Combinations The Company accounts for the acquisition of a business in accordance with ASC Topic 805, Business Combinations, or ASC 805. Amounts paid for each acquisition are allocated to the assets acquired and liabilities assumed based on their fair values at the date of acquisition. The Company determines the fair value of acquired intangible assets based on detailed valuations that use certain information and assumptions provided by management, which is considered management’s best estimate of inputs and assumptions that a market participant would use. The Company allocates any excess purchase price over the fair value of the net tangible and intangible assets acquired to goodwill. Under ASC 805, transaction costs are not included as a component of consideration transferred and are expensed as incurred. Additionally, in accordance with ASC 805, a transaction entered into by or on behalf of the acquirer or primarily for the benefit of the acquirer or the combined entity, rather than primarily for the benefit of the acquiree (before the combination), is treated as separate transaction. Intangible Assets The Company maintains definite-lived intangible assets related to developed product rights for Auryxia and a favorable contract, which were acquired on December 12, 2018 as part of the Merger. Intangible assets are initially recorded at fair value and stated net of accumulated amortization and impairments. The Company amortizes its intangible assets that have finite lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized. Amortization for the Company’s intangible assets are recorded over their estimated useful live of 4 - 9 years. The Company reviews intangible assets subject to amortization to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life. If an impairment indicator exists, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of the intangible asset to its carrying value on the consolidated balance sheet. If the carrying value of the intangible asset exceeds the undiscounted cash flows used in the recoverability test, the Company will write the carrying value down to the fair value in the period identified. The Company calculates the fair value of intangible assets as the present value of estimated future cash flows expected to be generated from the intangible asset using a risk-adjusted discount rate. In determining estimated future cash flows associated with its intangible assets, the Company uses market participant assumptions pursuant to ASC 820. Goodwill The Company allocates any excess purchase price over the fair value of the net tangible and intangible assets acquired in a business combination to goodwill. Goodwill is evaluated for impairment on an annual basis as of October 1, and more frequently if indicators are present or changes in circumstances suggest that impairment may exist. The Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of its reporting unit, the Company would record an impairment loss equal to the difference. As described above, the Company operates in one operating segment which the Company considers to be the only reporting unit. Fair Value of Financial Instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures, or ASC 820, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments, and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Items measured at fair value on a recurring basis include available for sale securities (see Note 7). The carrying amounts of prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to their short-term maturities. The rate implicit within the Company’s capital lease obligation approximates market interest rates. Items measured at fair value on a nonrecurring basis include property and equipment, intangible assets and goodwill. The Company remeasures the fair value of these assets upon the occurrence of certain events. There were no such remeasurements to property and equipment for the year ended December 31, 2018. There were no impairments to assets measured using level 3 inputs in fiscal year 2018 or 2017. The Company’s other financial instruments mainly consists of debt (see Note 11). The carrying amounts for the amount drawn on the Company’s line of credit facility with Silicon Valley Bank approximates fair value because the interest rate is variable and reflects current market rates. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in providing research and development activities, including salaries and benefits, facilities costs, overhead costs, contract research and development services, and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. External research and development expenses associated with the Company’s programs include clinical trial site costs, research compounds and clinical manufacturing costs, costs incurred for consultants and other outside services, such as data management and statistical analysis support, and materials and supplies used in support of the clinical and preclinical programs. Internal costs of the Company’s clinical program include salaries, benefits, stock-based compensation, and an allocation of the Company’s facility costs. When third-party service providers’ billing terms do not coincide with the Company’s period-end, the Company is required to make estimates of its obligations to those third parties, including clinical trial and pharmaceutical development costs, contractual services costs and costs for supply of its drug candidates, incurred in a given accounting period and record accruals at the end of the period. The Company bases its estimates on its knowledge of the research and development programs, services performed for the period, past history for related activities and the expected duration of the third-party service contract, where applicable. Advertising Expenses The costs of advertising are expensed as incurred and included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. For the year ended December 31, 2018, advertising expenses totaled $0.5 million. The Company did not incur any advertising expenses for the years ended December 31, 2017 and 2016. Income Taxes Income taxes are recorded in accordance with FASB Topic 740, Income Taxes, or ASC 740, which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. All deferred taxes as of December 31, 2018 and 2017 are classified as noncurrent within the income tax provision (see Note 14). The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation—Stock Compensation, or ASC 718. ASC 718 requires all stock-based payments to employees, including grants of employee stock options, restricted stock, restricted stock units, or RSUs, and modifications to existing stock awards, to be recognized in the statements of operations and comprehensive loss based on their fair values. The Company accounts for stock-based awards to non-employees in accordance with ASC Topic 505-50, Equity-Based Payments to Non-Employees, or ASC 505-50, which requires the fair value of the award to be re-measured at fair value until a performance commitment is reached or counterparty performance is complete. The Company’s stock-based awards are comprised of stock options, shares of restricted stock, shares of common stock and warrants. The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Company uses a blend of its stock price and the quoted market price of comparable public companies to determine the fair value of restricted stock awards and common stock awards. The Black-Scholes option pricing model requires the input of certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to the lack of company-specific historical and implied volatility data for trading the Company’s stock in the public market, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. During 2017, the Company began to estimate its volatility by using a blend of its stock price history for the length of time it has market data for its stock and the historical volatility of similar public companies for the expected term of each grant. The Company is a commercial-stage biopharmaceutical company and the representative group of companies has certain similar characteristics to the Company. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. For options granted to non-employees, the Company utilizes the contractual term of the arrangement as the basis for the expected term assumption. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock, which is similar to the Company’s peer group. The Company’s stock-based awards are subject to either service- or performance-based vesting conditions. Compensation expense related to awards to employees with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term, and is adjusted for pre-vesting forfeitures in the period in which the forfeitures occur. Consistent with the guidance in ASC 505- 50, compensation expense related to awards to non-employees with service-based vesting conditions is recognized on a straight-line basis based on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance-based vesting conditions is recognized based on the grant date fair value over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. Consistent with the guidance in ASC 505-50, compensation expense related to awards to non-employees with performance-based vesting conditions is recognized based on the then-current fair value at each financial reporting date prior to the measurement date over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. For awards with performance conditions in which the award does not vest unless the performance condition is met, the Company recognizes expense if, and to the extent that, the Company estimates that achievement of the performance condition is probable. If the Company concludes that vesting is probable, it recognizes expense from the date it reaches this conclusion through the estimated vesting date. Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, preferred stock, stock options, warrants, restricted stock and RSUs are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. Diluted net income per share is calculated by dividing the net income by the weighted-average common shares outstanding for the period, including any dilutive effect from outstanding options, warrants, restricted stock and RSUs using the treasury stock method. |
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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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3. Product Revenue, Net The Company began recording product revenue from the U.S. sales of Auryxia on December 12, 2018 following the consummation of the Merger. Total net product revenue was $6.8 million for the period from December 12, 2018 to December 31, 2018. The following table summarizes activity in each of the product revenue allowance and reserve categories for the period from December 12, 2018 to December 31, 2018 (in thousands):
Chargebacks, discounts and returns are recorded as a direct reduction of revenue on the consolidated statement of operations with a corresponding reduction to accounts receivable on the consolidated balance sheets. Rebates, distribution-related fees, and other sales-related deductions are recorded as a reduction in revenue on the consolidated statement of operations with a corresponding increase to accrued liabilities or accounts payable on the consolidated balance sheets. |
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- Definition The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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License, Collaboration and Other Significant Agreements |
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| Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| License, Collaboration and Other Significant Agreements |
4. License, Collaboration and Other Significant Agreements The Company recognized $200.9 million, $181.2 million and $1.5 million in license, collaboration and other revenue for the years ended December 31, 2018, 2017 and 2016, respectively. The $200.9 million in license, collaboration and other revenue for the year ended December 31, 2018 included $200.5 million of the transaction price for the Company’s collaboration agreements with MTPC and Otsuka (discussed below), all of which are recognized based on a proportional performance method, approximately $0.3 million for other services related to clinical and regulatory related activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement, and $0.1 million for license revenue related to royalties received from JT and Torii based on their sales of Riona in Japan. The $181.2 million in license, collaboration and other revenue for the year ended December 31, 2017 included $181.2 million of the transaction price for the MTPC Agreement and the Company’s collaboration agreements with Otsuka and approximately $31,000 for other services related to clinical and regulatory related activities performed by the Company on behalf of MTPC that are not included in the performance obligations identified under the MTPC Agreement. The $1.5 million in license and collaboration revenue for the year ended December 31, 2016 related to the transaction price for the Company’s collaboration agreement with Otsuka in the U.S. During the years ended December 31, 2018, 2017 and 2016, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of December 31, 2018:
The following table presents changes in the Company’s contract assets and liabilities during the years ended December 31, 2018 and 2017 (in thousands):
During the years ended December 31, 2018 and 2017, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands):
The Company did not recognize revenues as a result of changes in contract assets or contract liabilities during the year ended December 31, 2016. Mitsubishi Tanabe Pharma Corporation Collaboration Agreement Summary of Agreement On December 11, 2015, the Company and MTPC entered into a collaboration agreement, or the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries, collectively, the MTPC Territory. In addition, the Company will supply vadadustat for both clinical and commercial use in the MTPC Territory, subject to MTPC’s option to manufacture commercial drug product in the MTPC Territory. The Company and MTPC agreed that, instead of including Japanese patients in the Company’s global Phase 3 program for vadadustat, MTPC would be the sponsor of a Phase 3 program for vadadustat in Japan. Following consultation with the Japanese Pharmaceuticals and Medical Devices Agency, or the PMDA, MTPC initiated its Phase 3 development program for vadadustat in Japanese patients in Japan in the fourth quarter of 2017, and reported top-line data for the two Phase 3 pivotal trials and data from the two supportive Phase 3 studies in March 2019. MTPC is responsible for the costs of the Phase 3 program in Japan and other studies required there, and will make no funding payments for the global Phase 3 program. In consideration for the exclusive license and other rights contained in the MTPC Agreement, MTPC is obligated to make payments totaling up to $265.0 million, comprised of a $20.0 million upfront payment, up to $50.0 million in specified development and regulatory milestones, up to $175.0 million in specified commercial milestones, and a $20.0 million advance payment for Phase 2 studies in Japanese patients completed by the Company and reimbursable by MTPC, as well as tiered double-digit royalty payments of up to 20% on sales of vadadustat in the MTPC Territory, subject to reduction upon launch of a generic product on a country-by-country basis. The Company completed its Phase 2 study of vadadustat in non-dialysis dependent, or NDD, Japanese patients in Japan and reported top-line data in the third quarter of 2017. The Company also announced top-line data of its Phase 2 study of vadadustat in dialysis-dependent, or DD, Japanese patients in Japan in the first quarter of 2018. The costs of these Phase 2 studies are reimbursable by MTPC. MTPC was obligated to reimburse the Company for costs to complete the Phase 2 studies in excess of the $20.0 million advance payment. The Company incurred approximately $20.5 million in Phase 2 costs through June 30, 2018 and did not incur any additional costs subsequent to June 30, 2018 as the studies have been completed. As a result, MTPC reimbursed the Company an additional approximately $0.5 million related to the two Phase 2 studies which was collected in the fourth quarter of 2018. MTPC has sole responsibility for the commercialization of vadadustat in the MTPC Territory as well as for Medical Affairs (as defined in the MTPC Agreement) in the MTPC Territory. Akebia is responsible for manufacturing and supplying vadadustat for clinical use in the MTPC Territory. Akebia will enter into a supply agreement with MTPC for the commercial supply of vadadustat prior to commercial launch. The Company and MTPC have established a joint steering committee pursuant to the MTPC Agreement to oversee development and commercialization of vadadustat in the MTPC Territory, including approval of any development or commercialization plans. Unless earlier terminated, the MTPC Agreement will continue in effect on a country-by-country basis until the later of the following: expiration of the last-to-expire patent covering vadadustat in such country in the MTPC Territory; expiration of marketing or regulatory exclusivity in such country in the MTPC Territory; or ten years after the first commercial sale of vadadustat in such country in the MTPC Territory. MTPC may terminate the MTPC Agreement upon twelve months’ notice at any time after the second anniversary of the effective date of the MTPC Agreement. Either party may terminate the MTPC Agreement upon the material breach of the other party that is not cured within a specified time period or upon the insolvency of the other party. MTPC is required to make certain milestone payments to the Company aggregating up to approximately $225.0 million upon the achievement of specified development, regulatory and commercial events. More specifically, the Company received $10.0 million in development milestone payments and is eligible to receive up to $40.0 million in regulatory milestone payments and up to $175.0 million in commercial milestone payments associated with aggregate sales of all products. Additionally, if vadadustat is commercialized, the Company would be entitled to receive tiered royalty payments in the low double digits based on a percentage of net sales. Royalty payments are subject to certain reductions, including upon the introduction of competitive products in certain instances. Royalties are due on a country-by-country basis from the date of first commercial sale of a licensed product in a country until the last to occur of: (i) the expiration of the last to expire valid claim within the intellectual property covering the licensed product, (ii) the expiration of marketing or regulatory exclusivity in such country, or (iii) the tenth anniversary of the first commercial sale of such licensed product in such country. Due to the uncertainty of pharmaceutical development and the high historical failure rates associated with drug development, although the Company has received $10.0 million in development milestones, no additional milestone or royalty payments may ever be received from MTPC. In September 2017, the Company provided MTPC with an option to access data from the Company’s global Phase 3 vadadustat program for payments to the Company of up to $25.0 million, which is in addition to the milestone payments described above. Revenue Recognition The Company evaluated the elements of the MTPC Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, MTPC, is a customer. The Company’s arrangement with MTPC contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop and commercialize vadadustat (the License Deliverable) in the MTPC Territory, (ii) clinical supply of vadadustat (the Clinical Supply Deliverable), (iii) knowledge transfer, (iv) Phase 2 dosing study research services (the Research Deliverable), and (v) rights to future know-how. The Company has identified two performance obligations in connection with its material promises under the MTPC Agreement. Factors considered in making the assessment of which material promises will be accounted for as separate performance obligations included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the MTPC Agreement does not include a general right of return. The two performance obligations identified in connection with the Company’s obligations under the MTPC Agreement are as follows:
The License Deliverable is not distinct from the Clinical Supply Deliverable. More specifically, the license delivered to MTPC does not provide the right to manufacture vadadustat. MTPC therefore, is prohibited from manufacturing any licensed product during clinical trials. Accordingly, MTPC must obtain the clinical trial products from the Company, which significantly limits the ability for MTPC to use the license for their intended use in a way that generates economic benefits. The License Deliverable is not distinct from the knowledge transfer because MTPC cannot fully utilize the license for its intended purpose without the corresponding information regarding know-how, development data and regulatory materials possessed by the Company. The License Deliverable is not distinct from the Research Deliverable because MTPC cannot fully utilize the license for its intended purpose without the performance of the Phase 2 dosing studies. The Phase 2 dosing studies needed to be performed prior to the PMDA approving any Phase 3 study to be performed in the MTPC Territory. Furthermore, MTPC cannot benefit from the Phase 2 dosing studies without the license and the undelivered Phase 3 clinical supply. The License Deliverable is not distinct from the clinical supply, knowledge transfer or Phase 2 studies. As a result, the License Deliverable, clinical supply, knowledge transfer and Phase 2 studies do not qualify for separation and have been combined as a single performance obligation (the License, Research and Clinical Supply Performance Obligation).
The License, Research and Clinical Supply Deliverables combined are distinct from the rights to future know-how because MTPC can obtain the value of the License, Research and Clinical Supply Deliverables without receipt of any rights to future know-how that may be discovered or developed in the future. As a result, the rights to future know-how qualify for separation from the License, Research and Clinical Supply Performance Obligation. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a best estimate of standalone selling price for the License, Research and Clinical Supply Performance Obligation because the estimate of standalone selling price associated with the Rights to Future Know-How Performance Obligation was determined to be immaterial. The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the estimated cost for the Phase 2 studies, (iii) a non-substantive milestone associated with the first patient enrolled in the NDD-CKD Phase 3 study, and (iv) the cost of all clinical supply provided to MTPC for the Phase 3 studies. No other development and no regulatory milestones have been included in the transaction price at inception, as all other milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. The total aggregate amount of development milestones is $10.0 million and the total aggregate amount of the regulatory milestones is up to $40.0 million. The total aggregate amount of sales milestones is up to $175.0 million. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to MTPC and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. No amounts were allocated to the Rights to Future Know-How Performance Obligation because the associated best estimate of standalone selling price was determined to be immaterial; therefore the arrangement consideration will be allocated to the License, Research and Clinical Supply Performance Obligation. As of December 31, 2018, the transaction price is comprised of: (i) the up-front payment of $20.0 million, (ii) the cost for the Phase 2 studies of $20.5 million, (iii) the cost of all clinical supply provided to MTPC for the Phase 3 studies, and (iv) $10.0 million in development milestones received, comprised of a $6.0 million and a $4.0 million development milestone. All development milestones have been reached as of December 31, 2018. No regulatory milestones have been assessed as probable of being reached as of December 31, 2018 and thus have been fully constrained. Revenue for the License, Research and Clinical Supply Performance Obligation for the MTPC Agreement is being recognized using a proportional performance method using the Company’s delivery of clinical supply of vadadustat to MTPC for the Phase 3 study as the basis for recognition. The Company recognized $9.3 million in revenue during the year ended December 31, 2018, with respect to the MTPC Agreement, and approximately $42.9 million during the year ended December 31, 2017. The revenue is classified as collaboration revenue in the accompanying consolidated statements of operations. No revenue was recognized in 2016 with respect to the MTPC Agreement as the applicable revenue recognition criteria was not satisfied until 2017. As of December 31, 2018, there is no deferred revenue and no accounts receivable. U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. Summary of Agreement On December 18, 2016, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka U.S. Agreement. The collaboration is focused on the development and commercialization of vadadustat in the United States. Under the terms of the Otsuka U.S. Agreement, the Company is responsible for leading the development of vadadustat, including the ongoing Phase 3 development program. The Company and Otsuka will co-commercialize vadadustat in the United States, subject to the approval of vadadustat by the FDA. Under the terms of the Otsuka U.S. Agreement, the Company granted to Otsuka a co-exclusive, non-sublicensable license under certain intellectual property controlled by the Company solely to perform medical affairs activities and to conduct non-promotional and commercialization activities related to vadadustat in accordance with the associated plans. The co-exclusive license relates to activities that will be jointly conducted by the Company and Otsuka pursuant to the terms of the Otsuka U.S. Agreement. Additionally, the parties agreed not to promote, market or sell any competing product in the territory covered by the agreement. Pursuant to the terms of the Otsuka U.S. Agreement, the Company is responsible for performing all activities related to the development of vadadustat as outlined in the current global development plan. The current global development plan encompasses all activities with respect to the ongoing PRO2TECT and INNO2VATE clinical programs through the filing for marketing approval, as well as certain other studies. Under the Otsuka U.S. Agreement, subject to the terms of the Otsuka Funding Option, as described below, the Company controls and retains final decision‑making authority with respect to, among other things, the development of vadadustat. The Company’s obligations related to the conduct of the current global development plan include the associated manufacturing and supply services for vadadustat. Under the Otsuka U.S. Agreement, the parties jointly conduct, and have equal responsibility for, all medical affairs, commercialization and non-promotional activities pursuant to underlying plans as agreed to by the parties. If approved by the FDA, the Company will provide vadadustat to Otsuka for commercialization pursuant to a separate supply agreement to be negotiated. The activities under the Otsuka U.S. Agreement are governed by a joint steering committee, or JSC, formed by an equal number of representatives from the Company and Otsuka. The JSC coordinates and monitors the parties’ activities under the collaboration. Among other responsibilities, the JSC manages the overall strategic alignment between the parties, oversees the current global development plan and reviews other detailed plans setting forth the parties’ activities under the arrangement, including the medical affairs plan and commercialization and non-promotional activities plan. Additionally, the parties established a joint development committee, or JDC, which is comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JDC shares information related to, and reviews and discusses activities and progress under, the current global development plan and any other development that may be conducted pursuant to the collaboration. The Company and Otsuka also established a joint manufacturing committee, or JMC, which is comprised of an equal number of representatives from each of the parties. Among other responsibilities, the JMC oversees the manufacturing plan and related manufacturing activities. In support of the potential commercialization of vadadustat, the parties established a joint commercialization committee, or JCC, which is comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JCC oversees the activities and progress under the commercialization and non-promotional activities plan and all other sales and marketing activities. Subject to the terms of the Otsuka Funding Option, as described below, the Company has retained final decision‑making authority with respect to all development matters, U.S. pricing strategy and certain other key commercialization matters. Under the terms of the Otsuka U.S. Agreement, the Company received a $125.0 million up-front, non-refundable, non-creditable cash payment in December 2016. In March 2017, the Company received a payment of approximately $33.8 million, which represents reimbursement for Otsuka’s share of costs previously incurred by the Company in implementing the current global development plan through December 31, 2016. Commencing in the third quarter of 2017, whereupon the Company had incurred a specified amount of incremental costs, Otsuka began to contribute, as required by the Otsuka U.S. Agreement, a percentage of the remaining costs incurred under the current global development plan. The Company estimates that Otsuka’s funding of the current global development plan costs subsequent to December 31, 2016 will total $167.5 million or more, depending on the actual costs incurred toward the current global development plan. The costs associated with the performance of any development activities in addition to those outlined in the current global development plan will be subject to a cost sharing or reimbursement mechanism to be determined by the parties. Costs incurred with respect to medical affairs and commercialization and non-promotional activities will generally be shared equally by the parties. In addition, if the costs incurred in completing the activities under the current global development plan exceed a certain threshold, or the Cost Threshold, then the Company may elect to require Otsuka to increase the aggregate percentage of current global development costs it funds under the Otsuka U.S. Agreement and the Otsuka International Agreement, as defined below, from 52.5% to 80%, or the Otsuka Funding Option. In such event, the excess of the payments made under such election and Otsuka’s allocated share of the current global development costs is fully creditable against future payments due to the Company under the arrangement, provided that future payments due to the Company may not be reduced by more than 50% in any calendar year and any remaining creditable amount above 50% in any calendar year will be applied to subsequent future payments until fully credited. In addition, decisions regarding certain development matters will be made jointly by the Company and Otsuka in accordance with the procedures set forth in the Otsuka U.S. Agreement. In September 2018, the Company exercised the Otsuka Funding Option, which will be effective when the Cost Threshold is exceeded. The Company estimates that the Cost Threshold will be exceeded in the second quarter of 2019. In addition, Otsuka would be required to make certain milestone payments to the Company upon the achievement of specified development, regulatory and commercial events. More specifically, the Company is eligible to receive up to $125.0 million in development milestone payments and up to $65.0 million in regulatory milestone payments for the first product to achieve the associated event. Moreover, the Company is eligible for up to $575.0 million in commercial milestone payments associated with aggregate sales of licensed products, subject to reduction as set forth above. Due to the uncertainty of pharmaceutical development and the high historical failure rates associated therewith, no milestone payments may ever be received from Otsuka. Under the Otsuka U.S. Agreement, the Company and Otsuka share the costs of developing and commercializing vadadustat in the United States and the profits from the sales of vadadustat after approval by the FDA. In connection with the profit share calculation, net sales include gross sales to third-party customers net of discounts, rebates, chargebacks, taxes, freight and insurance charges and other applicable deductions. Shared costs generally include costs attributable or reasonably allocable to the manufacture of vadadustat for commercialization purposes and the performance of medical affairs activities, non-promotional activities and commercialization activities. Unless earlier terminated, the Otsuka U.S. Agreement will expire in the U.S. on a product-by-product basis on the date that one or more generic versions of vadadustat first achieves 90% market penetration. Either party may terminate the Otsuka U.S. Agreement in its entirety upon an uncured breach or insolvency on the part of the other party. Otsuka may terminate the Otsuka U.S. Agreement in its entirety upon 12 months’ prior written notice at any time after the release of the first topline data from the global Phase 3 development program for vadadustat. In the event of termination of the Otsuka U.S. Agreement, all rights and licensees granted to Otsuka under the Otsuka U.S. Agreement will automatically terminate and the licenses granted to the Company will become freely sublicensable. In addition, the upfront payment, all development costs and milestone payments received by the Company prior to such termination will not be refunded to Otsuka. Revenue Recognition The Company evaluated the elements of the Otsuka U.S. Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer. The Company’s arrangement with Otsuka contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop, perform medical affairs activities with respect to and conduct non-promotional and commercialization activities related to vadadustat and products containing or comprising vadadustat (the License Deliverable), (ii) development services to be performed pursuant to the current global development plan (the Development Services Deliverable), (iii) rights to future intellectual property (the Future IP Deliverable), and (iv) joint committee services (the Committee Deliverable). The Company has identified three performance obligations in connection with its obligations under the Otsuka U.S. Agreement. Factors considered in making the assessment of which material promises will be accounted for as separate performance obligations included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the Otsuka U.S. Agreement does not include a general right of return. The three performance obligations identified in connection with the Company’s obligations under the Otsuka U.S. Agreement are as follows:
The License Deliverable is not distinct from the Development Services Deliverable, due to the limitations inherent in the license conveyed. More specifically, the license conveyed to Otsuka does not provide Otsuka with the right to manufacture vadadustat and products containing or comprising vadadustat. However, the manufacturing and supply services that are conducted as part of the services to be performed pursuant to the current global development plan are necessary for Otsuka to fully exploit the associated license for its intended purpose. The value of the rights provided through the license conveyed will be realized when the underlying products covered by the intellectual property progress through the development cycle, receive regulatory approval and are commercialized. Products containing or comprising vadadustat cannot be commercialized until the development services under the current global development plan are completed. Accordingly, Otsuka must obtain the manufacturing and supply of the associated products that are included within the development services to be performed pursuant to the current global development plan from the Company in order to derive benefit from the license, which significantly limits the ability for Otsuka to utilize the License Deliverable for its intended purpose in a way that generates economic benefits.
The License and Development Services deliverables combined are distinct from the Future IP Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development services without the receipt of any other intellectual property that may be discovered or developed in the future. The Future IP Deliverable is distinct from the Committee Deliverable because the joint committee services have no bearing on the value to be derived from the rights to potential future intellectual property. As a result, the Future IP Deliverable qualifies as a separate performance obligation.
The License and Development Services deliverables combined are distinct from the Committee Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development services without the joint committee services. The Committee Deliverable also is distinct from the rights to Future IP Deliverable because the joint committee services have no bearing on the value to be derived from the rights to potential future intellectual property. As a result, the Committee Deliverable qualifies as a separate performance obligation. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of standalone selling price for the Committee Performance Obligation after considering the nature of the services to be performed and estimates of the associated effort and rates applicable to such services that would be expected to be realized under similar contracts. The Company developed a best estimate of standalone selling price for the Future IP Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a best estimate of standalone selling price for the License Performance Obligation due to the following: (i) the best estimates of standalone selling price associated with the Future IP Performance Obligation was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Performance Obligation and the Committee Performance Obligation was determined to be similar. The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to December 31, 2016. No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. No amounts were allocated to the Future IP Performance Obligation because the associated best estimate of standalone selling price was determined to be immaterial. Due to the similar performance period and recognition pattern between the License Performance Obligation and the Committee Performance Obligation, the transaction price has been allocated to the License Performance Obligation and the Committee Performance Obligation on a combined basis. Accordingly, the Company will recognize revenue related to the allocable arrangement consideration on a proportional performance basis as the underlying development services are performed pursuant to the current global development plan which is commensurate with the period and consistent with the pattern over which the Company’s obligations are satisfied for both the License Performance Obligation and the Committee Performance Obligation. Effectively, the Company has treated the arrangement as if the License Performance Obligation and the Committee Performance Obligation are a single performance obligation. As of December 31, 2018, the transaction price totaling $326.3 million is comprised of: (i) the up-front payment of $125.0 million, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016 of $33.8 million, and (iii) the estimate of the cost share payments to be received of approximately $167.5 million with respect to amounts incurred by the Company subsequent to December 31, 2016. As of December 31, 2018, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. During the years ended December 31, 2018, 2017 and 2016, the Company recognized revenue totaling approximately $103.9 million, $86.0 million and $1.5 million, respectively, with respect to the Otsuka U.S. Agreement. The revenue is classified as collaboration revenue in the accompanying consolidated statements of operations. As of December 31, 2018, there is approximately $63.4 million of deferred revenue related to the Otsuka U.S. Agreement of which $33.5 million is classified as current and $29.9 million is classified as long-term in the accompanying consolidated balance sheet based on the performance period of the underlying obligations. Additionally, as of December 31, 2018, there is approximately $7.2 million in contract liabilities (included in accounts payable) in the accompanying consolidated balance sheet. The Company determined that the medical affairs, commercialization and non-promotional activities elements of the Otsuka U.S. Agreement represent joint operating activities in which both parties are active participants and of which both parties are exposed to significant risks and rewards that are dependent on the success of the activities. Accordingly, the Company is accounting for the joint medical affairs, commercialization and non-promotional activities in accordance with ASC No. 808, Collaborative Arrangements (ASC 808). Additionally, the Company has determined that in the context of the medical affairs, commercialization and non-promotional activities, Otsuka does not represent a customer as contemplated by ASC 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions. As a result, the activities conducted pursuant to the medical affairs, commercialization and non-promotional activities plans will be accounted for as a component of the related expense in the period incurred. During the year ended December 31, 2018, the Company incurred approximately $1.2 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement of which approximately $0.5 million are reimbursable by Otsuka and recorded as a reduction to research and development expense during the year ended December 31, 2018. During the year ended December 31, 2018, Otsuka incurred approximately $1.1 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, of which approximately $0.5 million are reimbursable by the Company and recorded as an increase to research and development expense during the year ended December 31, 2018. International Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. Summary of Agreement On April 25, 2017, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka International Agreement. The collaboration is focused on the development and commercialization of vadadustat in Europe, Russia, China, Canada, Australia, the Middle East and certain other territories, collectively, the Otsuka International Territory. Under the terms of the Otsuka International Agreement, the Company is responsible for leading the development of vadadustat, including the ongoing global Phase 3 development program. Otsuka has the sole responsibility, at its own cost, for the commercialization of vadadustat in the Otsuka International Territory, subject to the approval by the relevant regulatory authorities. Under the terms of the Otsuka International Agreement, the Company granted to Otsuka an exclusive, sublicensable license under certain intellectual property controlled by the Company to develop and commercialize vadadustat and products containing or comprising vadadustat in the Otsuka International Territory. Pursuant to the terms of the Otsuka International Agreement, the Company is responsible for performing all activities related to the development of vadadustat as outlined in the current global development plan; however, the parties may agree to allocate certain responsibilities to Otsuka. Under the Otsuka International Agreement, and subject to the terms of the Otsuka Funding Option described above, the Company controls and retains final decision-making authority with respect to, among other things, the development of vadadustat other than with respect to certain development matters specific to the Otsuka International Territory. Per the terms of the Otsuka International Agreement, Otsuka is generally responsible for the conduct of any development activities that may be required for marketing approvals in the Otsuka International Territory or otherwise performed with respect to the Otsuka International Territory that are incremental to those included in the current global development plan. The Company’s obligations related to the conduct of the current global development plan include the associated manufacturing and supply services for vadadustat. Under the Otsuka International Agreement, Otsuka is to be solely responsible for the conduct of all medical affairs and commercialization activities in the Otsuka International Territory pursuant to underlying plans as reviewed and discussed by the parties. If approved by the relevant jurisdictional regulatory health authorities in the Otsuka International Territory, the Company will provide vadadustat to Otsuka for commercialization pursuant to a separate supply agreement to be negotiated. Additionally, the parties agreed not to promote, market or sell any competing product in the territory covered by the agreement. The activities under the Otsuka International Agreement are governed by a JSC formed by an equal number of representatives from the Company and Otsuka. The JSC coordinates and monitors the parties’ activities under the collaboration. Among other responsibilities, the JSC manages the overall strategic alignment between the parties, oversees the current global development plan and reviews other detailed plans setting forth any other development activities that may be conducted under the arrangement. Additionally, the parties established a JDC, which is comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JDC shares information related to, and reviews and discusses activities and progress under, the current global development plan and any other development that may be conducted pursuant to the collaboration. The Company and Otsuka also established a JMC, which is comprised of an equal number of representatives from each of the parties. Among other responsibilities, the JMC oversees the manufacturing plan and related manufacturing activities. In support of the potential commercialization of vadadustat, the parties established a JCC, which is comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JCC manages the activities and progress under the commercialization and non-promotional activities plan and all other sales and marketing activities. Subject to the terms of the Otsuka Funding Option described above, the Company has retained final decision‑making authority with respect to all development matters, other than decisions related to certain development matters specific to the Otsuka International Territory. Otsuka has retained final decision‑making authority with respect to all commercialization matters, other than decisions related to certain marketing matters. Under the terms of the Otsuka International Agreement, the Company received a $73.0 million up-front, non-refundable, non-creditable cash payment. The Company also received a payment of approximately $0.2 million which represents reimbursement for Otsuka’s share of costs previously incurred by the Company in implementing the current global development plan in excess of a specified threshold during the quarter ended March 31, 2017. Commencing in the second quarter of 2017, Otsuka began to contribute, as required by the Otsuka International Agreement, a percentage of the remaining costs incurred under the current global development plan. The Company estimates that Otsuka’s funding of the current global development plan costs subsequent to March 31, 2017 will total roughly $176.1 million or more, depending on the actual current global development plan costs incurred. The costs associated with the performance of any mutually agreed upon development activities in addition to those outlined in the current global development plan will be subject to a cost sharing or reimbursement mechanism to be determined by the parties. Otsuka may elect to conduct additional studies of vadadustat in the EU, subject to the Company’s right to delay such studies based on its objectives outside the Otsuka International Territory. Otsuka will pay a percentage of the costs of any such studies, and the Company will pay its portion of the costs in the form of a credit against future amounts due to the Company under the Otsuka International Agreement. The costs incurred related to any other development activities, which are pursued solely for obtaining or maintaining marketing approval in the Otsuka International Territory or otherwise performed solely with respect to the Otsuka International Territory that are incremental to the development activities included in the current global development plan, will be borne in their entirety by Otsuka. Otsuka will pay costs incurred with respect to medical affairs and commercialization activities in the Otsuka International Territory. In addition, Otsuka would be required to make certain milestone payments to the Company upon the achievement of specified development, regulatory and commercial events. More specifically, the Company is eligible to receive up to $80.0 million in development milestone payments and up to $52.0 million in regulatory milestone payments for the first licensed product to achieve the associated event. Moreover, the Company is eligible for up to $525.0 million in commercial milestone payments associated with aggregate sales of all licensed products. Additionally, to the extent vadadustat is commercialized, the Company would be entitled to receive tiered royalty payments ranging from the low double digits to the low thirties based on a percentage of net sales. Royalties are due on a country-by-country basis from the date of the first commercial sale of a licensed product in a country until the latest to occur of: (i) the expiration date in such country of the last to expire valid claim within the intellectual property covering the licensed product, (ii) the date of expiration of data or regulatory exclusivity in such country or (iii) the tenth anniversary of the first commercial sale of such licensed product in such country. Due to the uncertainty of pharmaceutical development and the high historical failure rates associated therewith, no milestone or royalty payments may ever be received from Otsuka. There are no cancellation, termination or refund provisions in the Otsuka International Agreement that contain material financial consequences to the Company. Unless earlier terminated, the Otsuka International Agreement will expire upon the expiration of the royalty term in the last country in the Otsuka International Territory. Either party may terminate the Otsuka International Agreement in its entirety upon an uncured material breach or insolvency on the part of the other party. Otsuka may terminate the Otsuka International Agreement in its entirety or for a specific region in the Otsuka International Territory upon 12 months’ prior written notice at any time after the release of the first topline data from either the PRO2TECT Phase 3 development program or the INNO2VATE Phase 3 development program, whichever comes first. In the event of termination of the Otsuka International Agreement, all rights and licensees granted to Otsuka under the Otsuka International Agreement will automatically terminate, and the licenses granted to the Company will become freely sublicensable, but potentially subject to a future royalty. In addition, the upfront payment, all development costs and milestone payments received by the Company prior to such termination will not be eligible for refund to Otsuka. Revenue Recognition The Company has accounted for the Otsuka International Agreement separately from the collaboration arrangement with Otsuka with respect to the U.S. due to the lack of interrelationship and interdependence of the elements and payment terms within each of the contracts as they relate to the respective territories. Accordingly, the Company has applied the guidance in ASC 606 solely in reference to the terms and conditions of the Otsuka International Agreement, while the Otsuka U.S. Agreement has continued to be accounted for as a discrete agreement in its own right. The Company evaluated the Otsuka International Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, Otsuka, is a customer. The Company’s arrangement with Otsuka related to the Otsuka International Territory contains the following material promises under the contract at inception: (i) license under certain of the Company’s intellectual property to develop and commercialize (including the associated packaging) vadadustat and products containing or comprising vadadustat and development services to be performed pursuant to the current global development plan (the License and Development Services Deliverable), (ii) rights to future intellectual property (the Future IP Deliverable) and (iii) joint committee services (the Committee Deliverable). The Company has identified three performance obligations in connection with its obligations under the Otsuka International Agreement. Factors considered in making this assessment of which material promises will be accounted for as a separate performance obligation included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the good or service is highly interdependent or highly interrelated to the other elements in the arrangement, and whether there are other vendors that can provide the items. Additionally, the Otsuka International Agreement does not include a general right of return. The three performance obligations identified in connection with the Company’s obligations under the Otsuka International Agreement are as follows:
The Company has determined that the license granted to Otsuka pursuant to the Otsuka International Agreement will be accounted for as component of the development services as opposed to a separately identified promise. Although the rights granted under the license are effective throughout the entire term of the arrangement, the Company will not be providing significant additional contributions of study data, regulatory submissions and regulatory approvals beyond the point that services under the current global development plan are conducted. Therefore, the period and pattern of recognition would be the same for both the license and the development services. Consequently, the Company has concluded that the license will effectively be treated as an inherent part of the associated development services promise instead of as a separate promise. As a result, the License and Development Services Deliverable will be treated as a single performance obligation (the License Performance Obligation).
The License and Development Services Deliverable is distinct from the Future IP Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development services without the receipt of any other intellectual property that may be discovered or developed in the future. The Future IP Deliverable is distinct from the Committee Deliverable because the Committee Deliverable has no bearing on the value to be derived from the rights to potential future intellectual property. As a result, the Future IP Deliverable qualifies as a separate performance obligation.
The License and Development Services Deliverable is distinct from the Committee Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development service without the joint committee services. The Committee Deliverable is distinct from the Future IP Deliverable because the Committee Deliverable has no bearing on the value to be derived from the rights to potential future intellectual property. As a result, the Committee Deliverable qualifies as a separate performance obligation. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of standalone selling price for the Committee Performance Obligation after considering the nature of the services to be performed and estimates of the associated effort and rates applicable to such services that would be expected to be realized under similar contracts. The Company developed a best estimate of standalone selling price for the Future IP Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a best estimate of standalone selling price for the License Performance Obligation due to the following: (i) the best estimates of standalone selling price associated with the Future IP Performance Obligation was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Performance Obligation and the Committee Performance Obligation was determined to be similar. The Company has concluded that a change in the key assumptions used to determine the best estimate of standalone selling price for each performance obligation would not have a significant impact on the allocation of arrangement consideration. The transaction price at inception was comprised of: (i) the up-front payment, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to March 31, 2017. No development or regulatory milestones were included in the transaction price at inception, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including whether the receipt of the milestone payment is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Otsuka and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. No amounts were allocated to the Future IP Performance Obligation because the associated best estimate of standalone selling price was determined to be immaterial. Due to the similar performance period and recognition pattern between the License Performance Obligation and the Committee Performance Obligation, the transaction price has been allocated to the License Performance Obligation and the Committee Performance Obligation on a combined basis. Accordingly, the Company will recognize revenue related to the allocable arrangement consideration on a proportional performance basis as the underlying development services are performed pursuant to the current global development plan which is commensurate with the period and consistent with the pattern over which the Company’s obligations are satisfied for both the License Performance Obligation and the Committee Performance Obligation. Effectively, the Company has treated the arrangement as if the License Performance Obligation and the Committee Performance Obligation are a single performance obligation. As of December 31, 2018, the transaction price totaling $249.3 million is comprised of: (i) the up-front payment of $73.0 million, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017 of $0.2 million, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to March 31, 2017 of $176.1 million. As of December 31, 2018, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. During the years ended December 31, 2018 and 2017, the Company recognized revenue totaling approximately $87.3 million and $52.3 million, respectively, with respect to the Otsuka International Agreement. The revenue is classified as collaboration revenue in the accompanying consolidated statements of operations. As of December 31, 2018, there is approximately $44.6 million of deferred revenue related to the Otsuka International Agreement of which $23.5 million is classified as current and $21.1 million is classified as long-term in the accompanying consolidated balance sheet based on the performance period of the underlying obligations. Additionally, as of December 31, 2018, there is approximately $6.3 million in contract liabilities (included in accounts payable) in the accompanying consolidated balance sheet. Janssen Pharmaceutica NV Research and License Agreement Summary of Agreement On February 9, 2017, the Company entered into a Research and License Agreement, the Janssen Agreement, with Janssen Pharmaceutica NV, or Janssen, a subsidiary of Johnson & Johnson, pursuant to which Janssen granted the Company an exclusive license under certain intellectual property rights to develop and commercialize worldwide certain HIF prolyl hydroxylase targeted compounds. Under the terms of the Janssen Agreement, Janssen granted to the Company a license for a three-year research term to conduct research on the HIF compound portfolio, unless the Company elects to extend such research term for up to two additional one-year periods upon payment of an extension fee. During the research term, the Company may designate one or more compounds as candidates for development and commercialization. Once a compound is designated for development and commercialization, the Company will be solely responsible for the development and commercialization of the compound worldwide at its own cost and expense. Under the terms of the Janssen Agreement, the Company made an upfront payment of $1.0 million in cash to Janssen and issued a warrant to purchase 509,611 shares of the Company’s common stock. In addition, Janssen could be eligible to receive up to an aggregate of $16.5 million from the Company in specified development milestone payments on a product-by-product basis. Janssen will also be eligible to receive up to $215.0 million from the Company in specified commercial milestones as well as tiered, escalating royalties ranging from a low to mid-single digit percentage of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory. Unless earlier terminated, the Janssen Agreement will expire on a product-by-product and country-by-country basis upon the expiration of the last royalty term, which ends upon the longer of the expiration of the patents licensed under the Janssen Agreement, the expiration of regulatory exclusivity for such product, or 10 years from first commercial sale of such product. The Company may terminate the Janssen Agreement in its entirety or only with respect to a particular licensed compound or product upon 180 days’ prior written notice to Janssen. The parties also have customary termination rights, subject to a cure period, in the event of the other party’s material breach of the Janssen Agreement or in the event of certain additional circumstances. As discussed above, the Company issued a Common Stock Purchase Warrant, or the Warrant, to Johnson & Johnson Innovation – JJDC, Inc., or JJDC, an affiliate of Janssen, for 509,611 shares of the Company’s common stock at an exercise price of $9.81 per share. The Warrant is exercisable by JJDC, in whole or in part, at any time prior to February 9, 2022. The Warrant and the shares issuable upon exercise of the Warrant will be sold and issued without registration under the Securities Act of 1933, as amended, or the Securities Act. The Company recorded the fair value of the Warrant in the amount of $3.4 million to additional paid-in capital and research and development expense in March 2017. Vifor Pharma License Agreement Summary of Agreement On May 12, 2017, the Company entered into a License Agreement, or the Vifor Agreement, with Vifor (International) Ltd., or Vifor Pharma, pursuant to which the Company granted Vifor Pharma an exclusive license to sell vadadustat solely to Fresenius Kidney Care Group LLC, or FKC, an affiliate of Fresenius Medical Care North America, in the United States. The license grant under the Vifor Agreement is conditioned upon the approval of vadadustat for DD-CKD patients by the FDA, inclusion of vadadustat in a bundled reimbursement model, and payment by Vifor Pharma of a $20.0 million milestone upon the occurrence of these two events. The Vifor Agreement is structured as a profit share arrangement between the Company and Vifor Pharma in which the Company will receive a majority of the profit from Vifor Pharma’s sales of vadadustat to FKC in the United States. The Company will share the milestone payment and the revenue from the profit share with Otsuka pursuant to the Otsuka U.S. Agreement. The Company retains all rights to commercialize vadadustat for use in the NDD-CKD market and in other dialysis organizations in the United States, which will be done in collaboration with Otsuka following FDA approval. Prior to FDA approval of vadadustat, the Company and Vifor Pharma will enter into a commercial supply agreement for vadadustat pursuant to which the Company will supply all of Vifor Pharma’s requirements for vadadustat in the United States. In addition, pursuant to the Vifor Agreement, Vifor Pharma entered into supply agreements that govern the terms pursuant to which Vifor Pharma would supply vadadustat to FKC for use in patients at its dialysis centers, subject to FDA approval; however, FKC is not obligated to utilize vadadustat in its clinics. During the term of the Vifor Agreement, Vifor Pharma will not sell to FKC or its affiliates any HIF product that competes with vadadustat in the United States. Unless earlier terminated, the Vifor Agreement will expire upon the later of the expiration of all patents that claim or cover vadadustat, or expiration of data or regulatory exclusivity for vadadustat in the United States. Vifor Pharma may terminate the Vifor Agreement in its entirety upon 12 months’ prior written notice after the release of the first topline data in the vadadustat global Phase 3 program for dialysis-dependent CKD patients. Either party may terminate the Vifor Agreement in the event of the other party’s uncured material breach. The Company may also terminate the Vifor Agreement upon the occurrence of other events, such as for specific violations of the Vifor Agreement or if there are changes in Vifor Pharma’s relationship with FKC. Investment Agreement In connection with the Vifor Agreement, in May 2017, the Company and Vifor Pharma entered into an investment agreement, or the Investment Agreement, pursuant to which the Company sold an aggregate of 3,571,429 shares of the Company’s common stock, or the Shares, to Vifor Pharma at a price per share of $14.00 for a total of $50.0 million. The amount representing the premium over the closing stock price of $12.69 on the date of the transaction, totaling $4.7 million, was determined by the Company to represent consideration related to the Vifor Agreement. As the parties’ rights under the Vifor Agreement are conditioned upon (a) the approval of vadadustat for DD-CKD patients by the FDA; (b) inclusion of vadadustat in a bundled reimbursement model; and (c) payment by Vifor Pharma of a $20.0 million milestone upon the occurrence of these two events, in accordance with ASC 606, the Company has determined that the full transaction price is fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including clinical and regulatory risks that must be overcome in order for the parties’ rights to become effective and the probability of the $20.0 million milestone being achieved. Accordingly, the $4.7 million continues to be recorded as deferred revenue in the accompanying unaudited condensed consolidated balance sheets. Upon the satisfaction of the aforementioned conditions, revenue will be recognized as the Company supplies vadadustat to Vifor Pharma using a proportional performance method. Vifor Pharma has agreed to a lock-up restriction such that it agrees not to sell the Shares for a period of time following the effective date of the Investment Agreement as well as a customary standstill agreement. In addition, the Investment Agreement contains voting agreements made by Vifor Pharma with respect to the Shares. The Shares have not been registered pursuant to the Securities Act, and were issued and sold in reliance upon the exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder. License Agreement with Panion & BF Biotech, Inc In connection with the Merger, the Company now has a license agreement with Panion & BF Biotech, Inc., or Panion, under which Keryx, our wholly owned subsidiary, remains the contracting party. Under the license agreement with Panion and the subsequent Amended and Restated License Agreement, collectively the Panion License Agreement, the Company in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, for the development and commercialization of ferric citrate. In addition, Panion is eligible to receive royalty payments based on a mid-single digit percentage of net sales of ferric citrate in the licensed territory. The Panion License Agreement terminates upon the expiration of the Company’s obligations to pay royalties thereunder. In addition, the Company may terminate the Panion License Agreement (i) in its entirety or (ii) with respect to one or more countries in the territory covered by the agreement, in either, case upon 90 days’ notice. The Company and Panion also have the right to terminate the Panion License Agreement upon the occurrence of an uncured breach of a material provision of the Panion License Agreement and certain insolvency events. On October 24, 2018, prior to the consummation of the Merger, Akebia and Keryx entered into a letter agreement with Panion, the Panion Letter Agreement, pursuant to which Panion agreed to rescind any and all prior termination threats or notices relating to the license agreement and waived its rights to terminate the license agreement based on any breach by Keryx of its obligation to use commercially reasonable efforts to commercialize Auryxia outside the United States until the parties execute an amendment to the license agreement in accordance with the terms of the Panion Letter Agreement following consummation of the Merger. These terms include establishing a joint steering committee consisting of Panion and Akebia representatives to oversee the development and commercialization of Fexeric in Europe and providing Panion with an exclusive license under Keryx-owned patents covering the rights to make, use, sell, offer for sale and import ferric citrate in certain countries in the Asia-Pacific region. The parties intend to work together to agree on a regulatory plan for Fexeric in Europe within four months after execution of the Panion Letter Agreement. The parties also intent to work together to agree on a commercialization plan for Fexeric in Europe following execution of the amendment. The amendment is expected to include alternatives in the event a commercialization plan is not agreed upon, such as payment of an annual license maintenance fee to Panion or the return of European intellectual property rights to Panion. Under the terms of the Panion Letter Agreement, Panion also agreed that Keryx will have the right, but not the obligation, to conduct any litigation against any infringer of patent rights under the license agreement on the terms agreed upon in the Panion Letter Agreement. In addition, Keryx made a $500,000 payment to Panion promptly after execution of the Panion Letter Agreement. During the period from December 12, 2018 to December 31, 2018, the Company has incurred approximately $0.4 million in royalty payments due to Panion relating to Akebia sales of Auryxia in the United States and JT and Torii net sales of Riona in Japan, as the company is required to pay a low double-digit percent of sublicense income to Panion under the terms of the license agreement. Sublicense Agreement with Japan Tobacco, Inc. and its subsidiary, Torii Pharmaceutical Co., Ltd. Summary of Agreement In connection with the Merger, the Company now has a Sublicense Agreement with JT and Torii, and the Amended and Restated Sublicense Agreement with JT and Torii, collectively the JT and Torii Sublicense Agreement, under which Keryx, our wholly owned subsidiary, remains the contracting party. Under the JT and Torii Sublicense Agreement, JT and Torii obtained the exclusive sublicense rights for the development and commercialization of ferric citrate in Japan. JT and Torii are responsible for the future development and commercialization costs in Japan. Ferric citrate is currently approved by the Japanese Ministry of Health, Labour and Welfare for manufacturing and marketing in Japan for the treatment of hyperphosphatemia in patients with CKD. Ferric citrate is being marketed in Japan by Torii, under the brand name Riona. The Company is eligible to receive royalty payments based on a tiered double-digit percentage of net sales of Riona in Japan escalating up to the mid-teens, subject to certain reductions upon expiration or termination of the Amended and Restated License Agreement between Keryx and Panion & BF Biotech, Inc., or Panion, by which Keryx in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, for the development and commercialization of ferric citrate. The company is and is entitled to receive up to an additional $55.0 million upon the achievement of certain annual net sales milestones. The sublicense terminates upon the expiration of all underlying patent rights. Also, JT and Torii may terminate the sublicense agreement with or without cause upon at least six months prior written notice to us. Additionally, either party may terminate the sublicense agreement for cause upon 60 days’ prior written notice after the breach of any uncured material provision of the sublicense agreement, or after certain insolvency events. Revenue Recognition The Company evaluated the elements of the JT and Torii Sublicense Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, JT and Torii, is a customer. The Company’s arrangement with JT and Torii contains the following material promises under the contract at inception: (i) exclusive license to develop and commercialize ferric citrate in Japan (the License Deliverable), (ii) supply of ferric citrate until JT and Torii could secure their own source (the Supply Deliverable), (iii) knowledge transfer, and (iv) rights to future know-how. The Company has identified two performance obligations in connection with its obligations under the JT and Torii Sublicense Agreement.
The License Deliverable does is not distinct from the Supply Deliverable. More specifically, JT and Torii was unable to manufacture ferric citrate at the onset of the agreement as it had not secured a source for this manufacturing. This significantly limits the ability for JT and Torii to use the license for their intended use in a way that generates economic benefits. The License Deliverable does is not distinct from the knowledge transfer because JT and Torii cannot fully utilize the license for its intended purpose without the corresponding information regarding know-how, development data and regulatory materials possessed by the Company. The License Deliverable does is not distinct from the supply or knowledge transfer. As a result, the License Deliverable, supply, and knowledge transfer do not qualify for separation and have been combined as a single performance obligation (the License Supply Performance Obligation).
The License and Supply Deliverables combined are distinct from the rights to future know-how because JT and Torii can obtain the value of the License and Supply Deliverables without receipt of any rights to future know-how that may be discovered or developed in the future. As a result, the rights to future know-how qualify for separation from the License and Supply Performance Obligation. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License and Supply Performance Obligation and allocated the entire transaction price to this performance obligation. Additionally, as of the consummation of the Merger, the services associated with the License and Supply Performance Obligation were completed and JT and Torii had secured their own source to manufacture ferric citrate. As such, any initial license fees as well as any development-based milestones and manufacturing fee revenue were received and recognized prior to the Merger. The Company determined that the remaining consideration that may be payable to the Company under the terms of the sublicense agreement are either quarterly royalties on net sales or payments due upon the achievement of sales-based milestones. In accordance with ASC 606, the Company recognizes sales-based royalties, including milestone payments based on the level of sales, when the related sales occur as these amounts have been determined to relate predominantly to the license granted to JT and Torii and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. During the period from December 12, 2018 to December 31, 2018, the Company recognized $0.1 million in license revenue related to royalties earned on net sales of ferric citrate in Japan. The Company records the associated mid-single digit percentage of net sales royalty expense due to Panion, the licensor of ferric citrate, in the same period as the royalty revenue from JT and Torii is recorded. |
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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://fasb.org/us-gaap/role/ref/legacyRef
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Business Combination |
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| Business Combination |
5. Business Combination On December 12, 2018, the Company completed the Merger with Keryx. Keryx, headquartered in Boston, Massachusetts, is focused on the development and commercialization of medicines for people with kidney disease. Keryx’s proprietary product, Auryxia® (ferric citrate) tablets, is approved by the U.S. Food and Drug Administration, or FDA, for two indications: (1) the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and (2) the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. Akebia has been determined to be the accounting acquirer and has accounted for the transaction as a business combination using the acquisition method of accounting under ASC 805. Accordingly, the results of Keryx’s operations are included in our consolidated financial statements from December 12, 2018, the date the Merger was completed. Keryx’s revenues and net loss from December 12, 2018 to December 31, 2018 were $6.9 million and $3.8 million, respectively. Pursuant to the terms and conditions of the Merger Agreement, each outstanding share of Keryx common stock, excluding the Baupost Additional Shares discussed below, and each outstanding Keryx equity award were converted into Akebia common stock and substantially similar Akebia awards, respectively, at an exchange ratio of 0.37433 for a total fair value consideration of $527.8 million consisting of the following (in thousands):
The fair value of the Akebia common stock and Akebia awards issued was calculated using $8.94 per share, the closing price of Akebia common stock on December 12, 2018. The portion of the fair value relating to the Akebia RSUs and stock options represents the fair value attributable to precombination employee services. The fair value relating to future employee service will be expensed as stock-based compensation on a straight-line basis over the remaining service periods of those awards. Additionally, immediately prior to the Merger, Baupost agreed to convert its $164.7 million of Keryx’s Convertible Notes into 35,582,335 Keryx Shares, in accordance with the terms of the governing indenture agreement, in exchange for an additional 4,000,000 Keryx Shares (the “Baupost Additional Shares”). The aggregate 39.6 million Keryx Shares were then converted into Akebia shares at the 0.37433 exchange ratio. The fair value of the Baupost Additional Shares, on an as-converted bases, of $13.4 million has been excluded from the purchase price and recorded within general and administrative expenses in our consolidated financial statements, as the issuance of those shares by Keryx is considered to be a separate transaction under ASC 805 since it was entered into by or on behalf of the acquirer or primarily for the benefit of the acquirer or the combined entity. The Company has allocated the $527.8 million purchase price to the identifiable assets acquired and liabilities assumed in the business combination at their fair values as of December 12, 2018 as follows (in thousands):
In performing the purchase price allocation, the Company considered, among other factors, the intended future use of acquired assets, analysis of historical financial performance and estimates of future performance of Keryx’s business. As part of the purchase price allocation, the Company identified developed product rights for Auryxia as the primary intangible asset. The fair value of the developed product rights for Auryxia is determined using the multi-period excess earnings method which is a variation of the income approach, and is a valuation technique that provides an estimate of the fair value of an asset based on the principle that the value of an intangible asset is equal to the present value of the incremental after-tax cash flows attributable to the asset, after taking charges for the use of other assets employed by the business. Key estimates and assumptions used in this model are projected revenues and expenses related to the asset, estimated contributory asset charges, and a risk-adjusted discount rate of 20.0% used to calculate the present value of the future expected cash inflows from the asset. The intangible asset will be amortized over its estimated useful life, which for Auryxia is 9 years. The Company also identified an executory contract in the supply agreement between Keryx and BioVectra Inc., or BioVectra, which includes future firm purchase commitments. This executory contract was deemed to have an off-market element related to the amount of purchase commitments that exceed the current forecast and as such, the Company recorded a liability in purchase accounting. As of the acquisition date, the preliminary fair value of the off-market element was $29.5 million. The preliminary goodwill represents the excess of the purchase price over the estimated fair value of net assets acquired. The factors contributing to the recognition of goodwill were based on several strategic and synergistic benefits that were expected to be realized from the Merger. These benefits included the expectation that the combined company would establish itself as a leading renal company with enhanced position and large market opportunity, synergistic utilization of Keryx’s commercial organization, and strengthening the combined company’s financial profile. Such goodwill is not deductible for tax purposes. In connection with the Merger, the Company identified a preliminary deferred tax liability of $35.1 million as a result of the difference in the book basis and tax basis related to the identifiable inventory, other intangible assets, net and other liability. In determining the deferred tax liability to be recorded the Company elected to first consider the recoverability of the deferred tax assets acquired in the acquisition before considering the recoverability of the acquirer’s existing deferred tax assets. The deferred tax liability recorded as part of purchase accounting creates a source of future income against which the Company can benefit it’s tax attributes. The use of the Company’s tax attributes resulted in a release of the corresponding valuation allowance which was recorded as a benefit in the statement of operations. The fair values of deferred taxes may be subject to change as additional information becomes known and certain tax returns are finalized. Accordingly, the purchase price allocation is preliminary and remains subject to potential adjustments for the finalization of income taxes relating to purchase accounting. There can be no assurance that such finalizations will not result in material changes from the preliminary purchase price allocation. The Company’s estimates and assumptions are subject to change during the measurement period, which is up to one year from the acquisition date, as the Company finalizes the valuations of assets acquired and liabilities assumed. In connection with the Merger, the Company incurred $23.1 million of direct transaction costs, which along with the expense associated with the Baupost Additional Shares, is recorded within general and administrative expenses in our consolidated financial statements for the year ended December 31, 2018. The unaudited estimated pro forma results presented below include the effects of the Merger as if it had been consummated as of January 1, 2017. The non-recurring charges attributed to the Merger and incurred in 2018 include $13.4 million of expense associated with the Baupost Additional Shares, $39.5 million of acquisition-related costs, $10.4 million of stock-based compensation expenses as a result of the change in control, $4.5 million of bonus and severance payments, and $35.1 million of tax benefits. These expenses are included in the Company’s historical income statement for the year ended December 31, 2018 and are reflected in pro forma earnings for the year ended December 31, 2017. The pro forma results include the amortization expense related to the fair value of the acquired intangible asset associated with the Auryxia developed product rights, a favorable office lease intangible asset, the impact of a step-up in inventory, incremental stock-based compensation and rent expense. The pro forma results exclude the amortization of debt discount associated with Keryx’s Convertible Notes. In addition, the pro forma results do not include any anticipated synergies or other expected benefits of the Merger. Accordingly, the unaudited estimated pro forma financial information below is not necessarily indicative of what the actual results of operations of the combined companies would have been had the acquisition occurred as of January 1, 2017, nor are they indicative of future results of operations:
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- Definition The entire disclosure for a business combination (or series of individually immaterial business combinations) completed during the period, including background, timing, and recognized assets and liabilities. The disclosure may include leverage buyout transactions (as applicable). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Available for Sale Securities |
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| Investments Debt And Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Available for Sale Securities |
6. Available for Sale Securities Available for sale securities at December 31, 2018 and 2017 consist of the following:
The estimated fair value of the Company’s available for sale securities balance at December 31, 2018, by contractual maturity, is as follows (in thousands):
There were no realized gains or losses on available for sale securities for the years ended December 31, 2018 or 2017. The following table summarizes the Company’s available for sale securities that were in a continuous unrealized loss position, but were not deemed to be other-than-temporarily impaired, as of December 31, 2018 and 2017:
There were 51 securities and 60 securities as of December 31, 2018 and 2017, respectively, that were in an unrealized loss position. The Company considered the decline in the market value of these securities to be primarily attributable to current economic conditions. The contractual terms of these securities do not permit the issuer to settle the securities at a price less than the amortized cost basis of the investment. As of December 31, 2018, the Company does not intend to sell these securities and it was not more likely than not that the Company would be required to sell these securities before the recovery of their amortized cost basis, which may be at maturity. As a result, the Company did not consider these investments to be other-than-temporarily impaired as of December 31, 2018. |
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition The entire disclosure for investments in certain debt and equity securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value of Financial Instruments |
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| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments |
7. Fair Value of Financial Instruments The Company utilizes a portfolio management company for the valuation of the majority of its investments. This company is an independent, third-party vendor recognized to be an industry leader with access to market information that obtains or computes fair market values from quoted market prices, pricing for similar securities, recently executed transactions, cash flow models with yield curves and other pricing models. For valuations obtained from the pricing service, the Company performs due diligence to understand how the valuation was calculated or derived, focusing on the valuation technique used and the nature of the inputs. Based on the fair value hierarchy, the Company classifies its cash equivalents and available for sale securities within Level 1 or Level 2. This is because the Company values its cash equivalents and available for sale securities using quoted market prices or alternative pricing sources and models utilizing market observable inputs. Assets measured or disclosed at fair value on a recurring basis as of December 31, 2018 and December 31, 2017 are summarized below:
The Company’s corporate debt securities are all investment grade.
The Company had no assets or liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) at December 31, 2018 and December 31, 2017. Investment securities are exposed to various risks such as interest rate, market and credit. Due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, it is at least reasonably possible that changes in risks in the near term would result in material changes in the fair value of investments. |
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- References No definition available.
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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://fasb.org/us-gaap/role/ref/legacyRef
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Inventory |
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| Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventory |
8. Inventory The components of inventory are summarized as follows:
Long-term inventory, which primarily consists of raw materials and work in process, is included in other assets in the Company’s consolidated balance sheets. There were no inventory amounts written down as a result of excess, obsolescence, scrap or other reasons that would be charged to cost of sales during the period from December 12, 2018 through December 31, 2018. If future sales of Auryxia are lower than expected, the Company may be required to write-down the value of such inventories. Inventory write-downs and losses on purchase commitments are recorded as a component of cost of sales in the consolidated statement of operations. |
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- References No definition available.
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| X | ||||||||||
- Definition The entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Intangible Assets and Goodwill |
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| Goodwill And Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intangible Assets and Goodwill |
9. Intangible Assets and Goodwill Intangible Assets The following table presents the Company’s intangible assets:
On December 12, 2018, the Company completed the Merger, whereby it acquired certain definite-lived intangible assets, including the developed product rights for Auryxia. The Company recorded $1.5 million in amortization expense related to intangible assets using the straight-line method, which is considered the best estimate of economic benefit, during the year ended December 31, 2018. Estimated future amortization expense for intangible assets as of December 31, 2018 is as follows:
Goodwill As of December 31, 2018, the Company had goodwill of $55.1 million, generated from the Merger, in its consolidated balance sheet. Goodwill will be evaluated for impairment on an annual basis as of October 1, and more frequently if indicators are present or changes in circumstances suggest that an impairment may exist. |
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- References No definition available.
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- Definition The entire disclosure for goodwill and intangible assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Accrued Expenses |
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| Accrued Expenses |
10. Accrued Expenses Accrued expenses are as follows:
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- Definition The entire disclosure for accounts payable and accrued liabilities at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Debt |
12 Months Ended |
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Dec. 31, 2018 | |
| Debt Disclosure [Abstract] | |
| Debt |
11. Debt Revolving Line of Credit Keryx, our wholly owned subsidiary following the Merger, has a $40.0 million revolving line of credit, or the Line of Credit, under its Loan and Security Agreement with Silicon Valley Bank, or SVB. Availability under the Line of Credit is subject to a borrowing base comprised of eligible receivables and eligible inventory as set forth in the Loan and Security Agreement. As of December 31, 2018, the Company had approximately $16.0 million in available borrowing base under the Revolving Loan Facility, of which $15.0 million is outstanding. Proceeds from the Line of Credit may be used for working capital and general business purposes. The Line of Credit is secured by substantially all of Keryx’s assets other than its intellectual property. The Line of Credit restricts Keryx’s ability to grant any interest in its intellectual property other than certain permitted licenses and permitted encumbrances set forth in the Loan and Security Agreement. The principal amount outstanding under the Loan and Security Agreement bears interest at a floating rate per annum equal to the greater of (i) 2.0% above the “prime rate,” as reported in The Wall Street Journal and (ii) 6.75%, which interest is payable monthly. Principal amounts borrowed under the Line of Credit may be repaid and, prior to the maturity date, re-borrowed, subject to the terms and conditions set forth in the Loan and Security Agreement. The Line of Credit matures on the date that is the earlier of (i) two years after the effective date of the Loan and Security Agreement and (ii) ninety days prior to the maturity of any portion of any Permitted Convertible Debt, as defined under the Loan and Security Agreement. Upon entry into the Loan and Security Agreement (payable in installments and subject to certain conditions), and at the one year anniversary of the effective date of the Loan and Security Agreement (or, if earlier, upon termination of or an event of default under the Loan and Security Agreement), Keryx must pay to SVB a fee equal to 1.00% of the Line of Credit. Keryx is also required to pay on a quarterly basis a fee equal to 0.25% per annum of the average unused portion of the Line of Credit. Keryx must pay a termination fee of 2.00% of the Line of Credit, if the Loan and Security Agreement is terminated prior to the maturity date, subject to certain exceptions. The Loan and Security Agreement contains customary covenants applicable to Keryx and its subsidiaries, including maintaining insurance on its business, achievement of minimum revenue amounts, the incurrence of additional indebtedness, and future encumbrances on Keryx’s assets. In addition, the Keryx must maintain a liquidity ratio, defined as (i) the sum of unrestricted and unencumbered cash and cash equivalents maintained at SVB or its affiliates plus net billed accounts receivable divided by (ii) all outstanding obligations and liabilities of Keryx to SVB, including the aggregate amount of Keryx’s obligations to SVB under any business credit cards, of at least 1.5 to 1.0, measured monthly. Upon an event of default under the Loan and Security Agreement, SVB is entitled to accelerate and demand payment of all amounts outstanding under the Loan and Security Agreement, stop advancing money or extending credit to Keryx, demand that Keryx deposit at least 105% of the face amount of any letters of credit remaining undrawn to secure all obligations thereunder, and exercise other remedies available to SVB under the Loan and Security Agreement and at law or in equity. As of December 31, 2018, the Company has determined that events of default have already occurred, and has not obtained a formal waiver from SVB with respect to these events of default. As a result, the Company has classified the outstanding principal of $15.0 million as a current liability in its consolidated balance sheet as of December 31, 2018. So long as these events of default are not waived or otherwise resolved, SVB has the right to take any of the foregoing remedies. If SVB were to accelerate all of the obligations outstanding under the Loan and Security Agreement, the Company would be required to pay the outstanding principal and other fees to SVB, and the Company would no longer have access to the Line of Credit. These events of default have no impact on the Company’s liquidity, as the Company’s operating plan and cash forecast assumes the payment of all amounts due to SVB and no future borrowings under the Line of Credit. During the period from December 12, 2018 through December 31, 2018, the Company recognized approximately $65,000 of interest expense related to the Line of Credit. The Company did not incur any amortization expense related to the origination fee and other additional fees noted above as such fees were included in the fair value of the Line of Credit as of December 12, 2018, the date of which the Merger was consummated, in accordance with ASC 805. |
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- References No definition available.
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| X | ||||||||||
- Definition The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Warrant |
12 Months Ended |
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Dec. 31, 2018 | |
| Warrant Disclosure [Abstract] | |
| Warrant |
12. Warrant
In connection with the Janssen Agreement, in February 2017, the Company issued a warrant to purchase 509,611 shares of the Company’s common stock at an exercise price of $9.81 per share. The warrant was fully vested upon issuance and exercisable in whole or in part, at any time prior to February 9, 2022. The warrant satisfied the equity classification criteria of ASC 815, and is therefore classified as an equity instrument. The fair value at issuance of $3.4 million was calculated using the Black-Scholes option pricing model and was charged to research and development expense as it represented consideration for a license for which the underlying intellectual property was deemed to have no alternative future use. As of December 31, 2018, the warrant remains outstanding and expires on February 9, 2022. |
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- Definition Warrant disclosure. No definition available.
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- Definition Warrant disclosure. No definition available.
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Stockholders' Equity |
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| Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stockholders' Equity |
13. Stockholders’ Equity Authorized and Outstanding Capital Stock As of December 31, 2018, the authorized capital stock of the Company included 175,000,000 shares of common stock, par value $0.00001 per share, of which 116,887,518 and 47,612,619 shares were issued and outstanding at December 31, 2018 and 2017, respectively; and 25,000,000 shares of undesignated preferred stock, par value $0.00001 per share, of which 0 shares were issued and outstanding at December 31, 2018 and December 31, 2017. At-the-Market Facility In May 2016, the Company established an at-the-market, or ATM, equity offering program pursuant to which it was able to offer and sell up to $75.0 million its common stock at the then current market prices from time to time. In September 2016, the Company commenced sales under this program. Through December 31, 2017, the Company sold 1,080,908 shares of common stock under this program with net proceeds (after deducting commissions and other offering expenses) of $12.1 million. Additionally, the Company sold 694,306 shares in the three months ended March 31, 2018 for net proceeds (after deducting commissions and other offering expenses) of approximately $10.5 million. The Company has not sold any additional shares under this program subsequent to March 31, 2018. Equity Offering In March 2018, the Company completed a follow-on public equity offering, whereby the Company sold 8,500,000 shares of common stock at a public offering price of $10.50 per share. The aggregate net proceeds received by the Company from the offering were approximately $84.8 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company. Shares Issued and Awards Assumed in Connection with Business Combination On December 12, 2018, the Company completed the Merger. Pursuant to the terms and conditions of the Merger Agreement, each Keryx Share issued and outstanding as of the Effective Time was cancelled and converted into 0.37433 fully paid and non-assessable Akebia Shares. As a result, in December 2018, the Company issued 57,773,090 shares of common stock to Keryx shareholders, and 1,497,320 shares issued as part of the Baupost Additional Shares which has been excluded from the business combination purchase price (see Note 5). Additionally, in connection with the Merger, the Company converted outstanding and unexercised options to purchase Keryx Shares into 3,967,290 options to purchase Akebia Shares, as adjusted to the reflect the Exchange Multiplier, of which 3,733,336 are service-based stock options and 233,954 are performance-based stock options. The Company also converted outstanding Keryx Restricted Shares into 602,752 Akebia RSUs, of which 486,709 are service-based RSUs and 116,043 are performance-based RSUs. Acceleration of Equity Awards In connection with the closing of the Merger, certain executives of Keryx were terminated and as a result, the Company accelerated in full the vesting of all of the outstanding equity awards for each such executive, consistent with his or her existing employment agreements. Additionally, subject to limited exceptions, all outstanding equity awards held by certain officers of Akebia also had the vesting of their outstanding equity awards accelerated in full upon consummation of the Merger as a result of the change in control provision included in each such officer’s award agreements and their Executive Severance Agreements. As a result, the Company recognized $9.7 million of stock-based compensation expense related to the acceleration of awards. Equity Plans On February 28, 2014, the Company’s Board of Directors adopted its 2014 Incentive Plan and its 2014 Employee Stock Purchase Plan, or the ESPP, which were subsequently approved by its shareholders and became effective upon the closing of the Company’s initial public offering on March 25, 2014. The Company’s 2014 Incentive Plan was subsequently amended on December 11, 2018, which amendment did not require shareholder approval. The Company’s 2014 Incentive Plan, as amended, is referred to as the 2014 Plan. The 2014 Plan replaced the Company’s Amended and Restated 2008 Equity Incentive Plan, the 2008 Plan; however, options or other awards granted under the 2008 Plan prior to the adoption of the 2014 Plan that have not been settled or forfeited remain outstanding and effective. In May 2016 the Company’s Board of Directors approved an inducement award program that was separate from the Company’s equity plans and which, consistent with Nasdaq Listing Rule 5635(c)(4), did not require shareholder approval, or the Inducement Award Program. For 2018, the Company authorized the issuance of up to 750,000 shares for the purpose of granting options to purchase shares of the Company’s common stock to new hires under the Inducement Award Program, of which 375,750 options to purchase shares of the Company’s common stock were granted during the year. At December 31, 2018, 349,374 options granted in 2018 under the Inducement Award Program remain outstanding. The 2014 Plan allows for the granting of stock options, stock appreciation rights, or SARs, restricted stock, unrestricted stock, RSUs, performance awards and other awards convertible into or otherwise based on shares of the Company’s common stock. Dividend equivalents may also be provided in connection with an award under the 2014 Plan. The Company’s employees, officers, directors and consultants and advisors are eligible to receive awards under the 2014 Plan. The Company initially reserved 1,785,000 shares of its common stock for the issuance of awards under the 2014 Plan. The 2014 Plan provides that the number of shares reserved and available for issuance under the 2014 Plan will automatically increase annually on January 1st of each calendar year, by an amount equal to three percent (3%) of the number of shares of the Company’s common stock outstanding on a fully diluted basis as of the close of business on the immediately preceding December 31st, or the 2014 Plan Evergreen Provision. The Company’s Board of Directors may act prior to January 1st of any year to provide that there will be no automatic increase in the number of shares available for grant under the 2014 Plan for that year (or that the increase will be less than the amount that would otherwise have automatically been made). On December 12, 2018, in connection with the consummation of the Merger, the Company assumed outstanding and unexercised options to purchase Keryx Shares, as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, under the following Keryx equity plans, or the Keryx Equity Plans: the Keryx 1999 Share Option Plan, the Keryx 2004 Long-Term Incentive Plan, the Keryx 2007 Incentive Plan, the Keryx Amended and Restated 2013 Incentive Plan, and the Keryx 2018 Equity Incentive Plan, or the Keryx 2018 Plan. In addition, the number of Keryx Shares available for issuance under the Keryx 2018 Plan, as adjusted by the Exchange Multiplier pursuant to the terms of the Merger Agreement, may be used for awards by the Company under its 2014 Plan, or the Assumed Shares, provided that the Company uses the Assumed Shares for individuals who were not employees or directors of the Company prior to the consummation of the Merger. During the year ended December 31, 2018, the Company granted 862,148 options to purchase Akebia Shares to employees under the 2014 Plan, 375,750 options to purchase Akebia Shares to employees under the Inducement Award Program, 644,340 Akebia RSUs to employees under the 2014 Plan, and 262,500 options to purchase Akebia Shares to directors under the 2014 Plan. Additionally, as noted above, the Company assumed 3,967,290 options and issued 602,752 Akebia RSUs in connection with the Merger. The ESPP provides for the issuance of options to purchase shares of the Company’s common stock to participating employees at a discount to their fair market value. The maximum aggregate number of shares of the Company’s common stock available for purchase pursuant to the exercise of options granted under the ESPP will be the lesser of (a) 262,500 shares, increased on each anniversary of the adoption of the ESPP by one percent (1%) of the total shares of common stock then outstanding, the ESPP Evergreen Provision, and (b) 739,611 shares, which is equal to five percent (5%) of the total shares of common stock outstanding on the date of the adoption of the ESPP on a fully diluted, as converted basis. Under the ESPP, each offering period is six months, at the end of which employees may purchase shares of the Company’s common stock through payroll deductions made over the term of the offering. The per-share purchase price at the end of each offering period is equal to the lesser of eighty-five percent (85%) of the closing price of the Company’s common stock at the beginning or end of the offering period. Shares Reserved for Future Issuance The Company has reserved for future issuance the following number of shares of common stock:
Stock-Based Compensation Stock Options Service-Based Stock Options On February 28, 2018, as part of the Company’s annual grant of equity, the Company issued 522,200 stock options to employees. In addition, the Company issues stock options to directors, new hires and occasionally to other employees not in connection with the annual grant process. Options granted by the Company vest over periods of between 12 and 48 months, subject, in each case, to the individual’s continued service through the applicable vesting date. Options vest either 100% on the first anniversary of the grant date or in installments of (i) 25% at the one year anniversary and (ii) 12 equal quarterly installments beginning after the one year anniversary of the grant date, subject to the individual’s continuous service with the Company. Options generally expire ten years after the date of grant. The Company recorded approximately $11.9 million, $6.5 million and $4.7 million of stock-based compensation expense related to stock options granted during fiscal years 2018, 2017 and 2016, respectively. On December 12, 2018, pursuant to the Merger Agreement, each outstanding and unexercised option to acquire Keryx Shares granted under a Keryx equity plan converted into an option to acquire Akebia Shares, with the number of shares and exercise price adjusted by the Exchange Multiplier. As a result, the Company assumed 3,733,336 service-based options related to the Merger. The vesting schedule for these options is consistent with the vesting schedule noted above. The Company recorded approximately $0.2 million of stock-based compensation expense related to stock options assumed in 2018. The assumptions used in the Black-Scholes pricing model to estimate the grant date fair value of options granted under the 2014 Plan are as follows:
The following table summarizes the Company’s stock option activity, excluding performance-based options, for the year ended December 31, 2018:
The weighted-average grant date fair values of options granted in the years ended December 31, 2018, 2017, and 2016 were $7.12, $8.47, and $5.22 per share, respectively. The total intrinsic value of options exercised during the years ended December 31, 2018, 2017, and 2016 were $1.2 million, $2.7 million, and $0.6 million, respectively. The fair value of options that vested during the years ended December 31, 2018, 2017, and 2016 were $13.6 million, $5.6 million, and $4.6 million, respectively. As of December 31, 2018, there was approximately $8.7 million of unrecognized compensation cost related to stock options under the Company’s 2014 Plan or made pursuant to the Inducement Award Program, which is expected to be recognized over a weighted average period of 2.86 years. Performance-Based Stock Options On December 12, 2018, pursuant to the Merger Agreement, each outstanding and unexercised performance-based option to acquire Keryx Shares granted under a Keryx equity plan converted into a service-based option or performance-based option to acquire Akebia Shares, with the number of shares and exercise price adjusted by the Exchange Multiplier. As a result, the Company issued 233,954 performance-based options related to the Merger. The Company did not have any performance based-options outstanding in fiscal year 2018 prior to the Merger. The potential range of shares issuable pursuant to the Company’s performance-based options range from 0% to 100% of the target shares based on financial measures. Performance-based options vest up to 50% upon achievement of performance condition and up to 50% one year following achievement of the performance condition. The following table summarizes the Company’s performance-based option activity for the year ended December 31, 2018:
The Company did not record any stock-based compensation expense related to performance-based options during 2018, 2017 and 2016. There were no performance-based options that vested during fiscal years 2018, 2017 or 2016. As of December 31, 2018, there was up to approximately $0.5 million of unrecognized compensation costs related to performance-based stock options under the Company’s 2014 Plan, which if the performance conditions are achieved, is expected to be recognized in a 1.0 year period. Restricted Stock On December 23, 2013, the Company issued 450,224 shares of restricted stock to employees and 79,067 shares of restricted stock to non-employees at a grant date fair value of $7.42 per share. The aggregate grant date fair value for the shares of restricted stock issued on December 23, 2013 totaled approximately $3.9 million. The Company records stock-based compensation expense for restricted stock awards based on the grant date fair value for employees and the reporting date and upon vesting fair value for non-employees. The fair value of the award is considered the intrinsic value as of each measurement date. Compensation expense related to the restricted stock awards was being recognized over the associated requisite service period. The Company recorded approximately $0.2 million of stock-based compensation expense related to restricted stock during 2017. Restricted shares were fully vested as of December 31, 2017 and there were no additional grants of restricted stock during the year ended December 31, 2018, as such, there was no stock-based compensation expense related to restricted stock during the year ended December 31, 2018. Restricted Stock Units On February 28, 2018, as part of the Company’s annual grant of equity, the Company issued 367,250 RSUs to employees. In addition, the Company occasionally issues RSUs not in connection with the annual grant process to employees. 100% of each RSU grant vests on either the first or the third anniversary of the grant date, subject, in each case, to the individual’s continued service through the applicable vesting date. The expense recognized for these awards is based on the grant date fair value of the Company’s common stock multiplied by the number of units granted and recognized on a straight-line basis over the vesting period. The Company recorded approximately $5.8 million, $2.0 million and $0.8 million of stock-based compensation expense related to the Akebia employee RSUs in 2018, 2017 and 2016, respectively. On December 12, 2018, pursuant to the Merger Agreement, each Keryx Share that was subject to a Keryx restricted share award, other than those Keryx restricted shares that accelerated or lapsed as a result of the completion of the Merger, was converted into an RSU award of Akebia, covering the number of Akebia Shares determined in accordance with the Exchange Multiplier. As a result, the Company issued 486,709 service-based RSUs in substitution for Keryx restricted share awards in connection with the Merger. These RSUs vest either (i) in 3 equal annual installments beginning after the one-year anniversary of the grant date or (ii) one third on the one year anniversary of the grant date with the remaining RSUs vesting on the first day of each calendar quarter over the next two years thereafter. The Company recorded approximately $0.9 million of stock-based compensation expense related to RSUs issued in 2018 in substitution for the Keryx restricted share awards. A following table summarizes the Company’s RSU activity for the year ended December 31, 2018:
As of December 31, 2018, there was approximately $5.4 million of unrecognized compensation cost related to RSUs, which is expected to be recognized over a weighted average period of 2.2 years. Employee Stock Purchase Plan
The first offering period under the ESPP opened on January 2, 2015. The Company issued 48,768 shares during the year ended December 31, 2018. The Company recorded approximately $0.2 million, $0.2 million and $0.1 million of stock-based compensation expense related to the ESPP during 2018, 2017 and 2016, respectively. Compensation Expense Summary
The Company has recognized the following compensation cost related to share-based awards:
Compensation expense by type of award:
Included in the compensation expense of stock options and RSUs for the year ended December 31, 2018, is approximately $1.1 million related to awards assumed under the Merger and acceleration of the vesting for awards of certain officers of Keryx.
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- Definition The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Taxes |
14. Income Taxes Effective January 1, 2018, (as noted in Note 2) the Company adopted ASC 606, using the full retrospective transition method. Under this method, the Company has revised its consolidated financial statements for the year ended December 31, 2017, and applicable interim periods within those years, as if ASC 606 had been effective for those periods. The adoption of this guidance did not have a significant impact on the Company’s related tax disclosures. The Company’s income tax provision was computed based on the federal statutory rate and the state statutory rates, net of the related federal benefit. There was no current or deferred income tax expense or benefit for the years ended December 31, 2017 and 2016 due to the Company’s net losses and increases in its valuation allowance against its deferred tax assets. At December 31, 2018 the Company recorded a tax benefit of $28.3 million as a result of the Merger with Keryx. As part of purchase accounting, the Company recorded a deferred tax liability that is a source of income for which the Company can benefit from its tax attributes. The use of the Company’s tax attributes resulted in a release of the corresponding valuation allowance associated with this benefit. The provision for income taxes for each of the years ended December 31, 2018, 2017 and 2016 consisted of the following:
Our effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2018, 2017 and 2016:
On December 22, 2017, "H.R.1," known as the Tax Cuts and Jobs Act, was signed into law. The Tax Cuts and Jobs Act, among other items, reduces the corporate income tax rate from 35% to 21%, effective January 1, 2018. As such, Akebia completed a revaluation of its net deferred tax assets. Akebia's deferred tax assets, net of deferred tax liabilities, represent expected corporate tax benefits anticipated to be realized in the future. The reduction in the federal corporate tax rate reduces these benefits. For the year ended December 31, 2017, the Company evaluated the impact of the "Tax Cuts and Jobs Act," and determined that a reduction in its deferred tax asset of $43.0 million be recorded in the fourth quarter of 2017. However, the Company’s lack of earnings history and the uncertainty surrounding the Company’s ability to generate taxable income prior to the utilization of the deferred tax assets is completely offset by a valuation allowance. In 2018 the Company completed its review of the Tax Cuts and Jobs Act and has finalized adjustments related to its deferred tax assets and liabilities that resulted from the changes in the tax law. For the year ended December 31, 2017, the Company had taxable income primarily due to timing differences. The income was fully offset with available net operating losses, or NOLs, for regular federal and state tax purposes. The Company did have a tax liability that was based on the Alternative Minimum Tax and resulted in approximately $0.8 million of Federal Tax, however due to tax reform, the amount is fully refundable through 2021 and thus the net result is that the Company recorded an income tax receivable of approximately $0.8 million rather than a tax expense for the year ended December 31, 2017. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. When realization of the deferred tax asset is more likely than not to occur, the benefit related to the deductible temporary differences attributable to operations is recognized as a reduction of income tax expense. Valuation allowances are provided against deferred tax assets when, based on all available evidence, it is considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. The Company cannot be certain that future taxable income will be sufficient to realize its deferred tax assets, and accordingly a valuation allowance has been provided on its deferred tax assets. The Company continues to maintain the underlying tax benefits to offset future taxable income and to monitor the need for a valuation allowance based on the profitability of its future operations. The valuation allowance increased by approximately $23.3 million and decreased by approximately $4.9 million, during the years ended December 31, 2018 and 2017, respectively. Significant components of the Company’s deferred tax assets and liabilities are as follows:
At December 31, 2018 and 2017, the Company has approximately $0.6 million (after amortization of $1.3 million) and $0.8 million (after amortization of $1.1 million), respectively, of start-up expenses capitalized for income tax purposes with amortization available to offset future federal, state and local income tax. As of December 31, 2018 and 2017, the Company has approximately $790.0 million and $179.7 million, respectively, of federal NOL carry-forwards which expire through 2037. Included in the $790.0 million of federal NOLs are losses of $208.0 million that will carry forward indefinitely as a result of the Tax Cuts and Jobs Act. Additionally, at December 31, 2018 and 2017, the Company has approximately $442.4 million and $74.6 million, respectively, of state NOL carry-forwards which expired through 2038. The Company also has approximately $3.7 million of state research and development tax credit carryforwards which expire through 2038. Under the provisions of the Internal Revenue Code, the net operating losses and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating losses and tax credit carryforwards may become subject to an annual limitation under Internal Revenue Code 382 and 383 if there is more than a 50% change in ownership of the stockholders that own 5% or more of the company’s outstanding stock over a three-year period. The Company has completed an evaluation of its ownership changes and concluded that an ownership change did occur on December 12, 2018 for both Akebia and Keryx in connection with the Merger. As a consequence of this ownership change, the Company’s NOL’s and tax credit carryforwards allocable to the tax periods preceding the ownership change became subject to limitation under Section 382. The Company has reduced its associated deferred tax assets by $44.9 million as a result of the limitation. The Company generated research credits but has not conducted a formal study to document its qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carry-forwards and the valuation allowance. The Company files income tax returns in the U.S. federal and various state and local jurisdictions. For federal and state income tax purposes, the 2017, 2016 and 2015 tax years remain open for examination under the normal three-year statute of limitations. The statute of limitations for income tax audits in the United States will commence upon utilization of net operating losses and will expire three years from the filing of the tax return the loss was utilized on. There was no accrual for uncertain tax positions or for interest and penalties related to uncertain tax positions for 2018, 2017 and 2016. The Company does not believe that there will be a material change in its unrecognized tax positions over the next twelve months. All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. |
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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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Employee Retirement Plan |
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Dec. 31, 2018 | |
| Compensation And Retirement Disclosure [Abstract] | |
| Employee Retirement Plan |
15. Employee Retirement Plan During 2008, the Company established a retirement plan, or the Plan, authorized by Section 401(k) of the Internal Revenue Code. In accordance with the Plan, all employees who have attained the age of 21 are eligible to participate in the Plan as of the first Entry Date, as defined, following their date of employment. Each employee can contribute a percentage of compensation up to a maximum of the statutory limits per year. Company contributions are discretionary and contributions in the amount of approximately $0.3 million, $0.2 million and $0.2 million were made during the years ended December 31, 2018, 2017 and 2016, respectively. |
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- References No definition available.
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- Definition The entire disclosure for pension and other postretirement benefits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Commitments and Contingencies |
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| Commitments And Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies |
16. Commitments and Contingencies Leases The Company leases approximately 65,167 square feet of office and lab space in Cambridge, Massachusetts under a lease which was most recently amended in April 2018, collectively the Cambridge Lease. Under the Third Amendment to the Cambridge Lease, or the Third Amendment, executed in July 2016, total monthly lease payments under the initial base rent were approximately $242,000 and are subject to annual rent escalations. In addition to such annual rent escalations, base rent payments for a portion of said premises commenced on January 1, 2017 in the monthly amount of approximately $22,000. The Fourth Amendment to the Cambridge Lease, executed in May 2017, provided additional storage space to the Company and did not impact rent payments. In April 2018, the Company entered into a Fifth Amendment to the Cambridge Lease, or the Fifth Amendment, for an additional 19,805 square feet of office space on the 12th floor. Monthly lease payments for the existing 45,362 square feet of office and lab space, under the Third Amendment, remain unchanged. The new space leased by the Company was delivered in September 2018 and additional monthly lease payments of approximately $135,000 will commence in February 2019 and are subject to annual rent escalations, commencing in September 2019. Additionally, as a result of the Merger, the Company now has a lease for 27,300 square feet of office space in Boston, Massachusetts, or the Boston Lease, which expires in February 2023. The total monthly lease payments under the base rent are approximately $136,000 and are subject to annual rent escalations. Committed landlord contributions included in the Cambridge Lease totaled $3,289,170, including $1,083,453 in leasehold improvements not yet utilized. The landlord contributions are being accounted for as a deferred lease incentive and reduction in monthly rent expense over the term of the lease. The term of the Cambridge Lease with respect to the office space expires on September 11, 2026, with one five year extension option available. The term of the Cambridge Lease with respect to the lab space expires on November 30, 2021, with an extension option for one additional period of two years. The term of the Boston Lease office space expires on February 28, 2023, with an extension option for one additional five year extension option available. Under the Fifth Amendment, the total security deposit in connection with the Cambridge Lease increased by $0.5 million from $1.3 million to $1.8 million. In May 2018, the security deposit was reduced by $0.2 million to $1.6 million, which remains in effect as of December 31, 2018. Additionally, the Company recorded $0.8 million for the security deposit under the Boston Lease. Both the Cambridge Lease and the Boston Lease have their security deposits is in the form of a letter of credit, all of which are included in other assets in the Company’s consolidated balance sheets as of December 31, 2018. The Company recognizes rent expense for the space it currently occupies under the Cambridge Lease and records a deferred lease obligation representing the cumulative difference between actual facility lease payments and lease expense recognized ratably over the lease period, which is included in the Company’s consolidated balance sheets as of December 31, 2018 and December 31, 2017. At December 31, 2018, the Company’s future minimum payments required under these leases are as follows:
The Company recorded approximately $3.7 million, $3.2 million and $2.5 million in rent expense for the years ended December 31, 2018, 2017 and 2016, respectively. Manufacturing Agreements As part of the Merger, the Company retained Keryx’s commercial supply agreements with BioVectra Inc., or BioVectra, and Siegfried Evionnaz SA, or Siegfried, to supply commercial drug substance for Auryxia. Pursuant to the BioVectra Manufacture and Supply Agreement and the Product Manufacture and Supply and Facility Construction Agreement, collectively the BioVectra Agreement, the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at predetermined prices. The price per metric kilogram will decrease with an increase in quantity above the minimum purchase quantity. In addition, the BioVectra Agreement contained contingent milestone payments for capital developments in connection with construction of an expansion of the site of the BioVectra production facility for the manufacture of drug substance for Auryxia. These milestone payments were achieved by BioVectra and fully recorded prior to the Merger. These milestone payments are recorded in other assets and amortized into drug substance as inventory is released to the Company. The term of the BioVectra Agreement expires in late 2026, after which, it automatically renews for specified terms until terminated. The Company may terminate the BioVectra Agreement prior to the expiration of the contract term, which could result in early termination fee. As of December 31, 2018, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $154.0 million through the end of the contract term. As part of purchase accounting, the Company identified an executory contract in the supply agreement between Keryx and BioVectra, which includes future firm purchase commitments. This executory contract was deemed to have an off-market element related to the amount of purchase commitments that exceed the current forecast and as such, the Company recorded a liability in purchase accounting. As of the acquisition date, the preliminary fair value of the off-market element was $29.5 million Pursuant to the Siegfried Master Manufacturing Services and Supply Agreement, or the Siegfried Agreement, the Company has agreed to purchase a minimum quantity of drug substance of Auryxia at predetermined prices. The price per metric kilogram will decrease with an increase in quantity above the minimum purchase quantity. The term of the Siegfried Agreement expires on December 31, 2021, after which, it automatically renews for one-year terms until terminated. The Siegfried Agreement provides for certain termination rights prior to December 31, 2021 for the Company. As of December 31, 2018, the Company is required to purchase a minimum quantity of drug substance for Auryxia annually at a total cost of approximately $85.1 million through the year ended December 31, 2021. Other Third Party Contracts Under the Company’s agreement with IQVIA, formerly known as Quintiles IMS, to provide contract research organization services for the PRO2TECT and INNO2VATE programs, the total remaining contract costs as of December 31, 2018 were approximately $106.3 million. The estimated period of substantive performance for the committed work with IQVIA is through the end of 2020. The Company also contracts with various other organizations to conduct research and development activities with remaining contract costs to the Company of approximately $102.8 million at December 31, 2018. The scope of the services under these research and development contracts can be modified and the contracts cancelled by the Company upon written notice. In some instances, the contracts may be cancelled by the third party upon written notice. |
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- Definition The entire disclosure for commitments and contingencies. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Net Loss per Share |
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| Net Loss per Share |
17. Net Loss per Share The shares in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect:
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Quarterly Results (unaudited) |
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| Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Quarterly Results (unaudited) |
18. Quarterly Results (unaudited)
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- Definition The entire disclosure for quarterly financial data. Includes, but is not limited to, tabular presentation of financial information for fiscal quarters, effect of year-end adjustments, and an explanation of matters or transactions that affect comparability of the information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summary of Significant Accounting Policies (Policies) |
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| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation |
Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). As discussed more fully below, as prescribed by the required adoption of ASC 606 on January 1, 2018, the Company revised its comparative financial statements for the year ended December 31, 2017 to give effect to ASC 606 as if it had been effective for that period. No changes for the adoption of ASC 606 were deemed necessary for the year ended December 31, 2016 and applicable interim periods within the year. |
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| New Accounting Pronouncements |
New Accounting Pronouncements – Recently Adopted In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), a new revenue recognition standard which amends revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition. In 2015 and 2016, the FASB issued additional ASUs related to Topic 606, or ASC 606, that delayed the effective date of the guidance and clarified various aspects of the new revenue guidance, including principal versus agent considerations, identifying performance obligations, and licensing, and they include other improvements and practical expedients. The Company adopted this new standard on January 1, 2018 using the full retrospective transition method, and has elected to use the following practical expedients that are permitted under the rules of the adoption, which have been applied consistently to all contracts within all reporting periods presented:
As a result of adopting ASC 606 on January 1, 2018, the Company has revised its comparative financial statements for the year ended December 31, 2017 as if ASC 606 had been effective for that period, as set forth below. No changes for the adoption of ASC 606 were deemed necessary for the year ended December 31, 2016 and applicable interim periods within the year. With respect to the collaboration agreements with Otsuka, the Company concluded that there was no impact to revenue for the year ended December 31, 2017 after the adoption of ASC 606. The changes shown in the table below relate to the Company’s collaboration agreement with MTPC and the impact of when milestone payments can be recognized under the new standard as well as the period over which this revenue is recognized. Under ASC 605-28, Revenue Recognition-Milestone Method, the Company evaluated at contract inception whether each milestone was substantive. Substantive milestones are recognized as revenue in their entirety upon achievement, assuming all other revenue recognition criteria are met. Therefore, a $4.0 million MTPC development milestone, which was deemed to be substantive, would have been recognized in its entirety in the first quarter of 2018, when the milestone event occurred. Under ASC 606, these substantive milestone payments would be classified as variable consideration and included in the allocable transaction price over the remaining period of performance when it is probable that a significant reversal in the cumulative amount of revenue recognized would not occur. Under ASC 606, this resulted in the $4.0 million MTPC development milestone being included in the allocable consideration, of which $3.2 million was recognized as revenue in 2017 under the proportional performance method utilized for revenue recognition of the MTPC allocable consideration. As a result, the following financial statement line items for the year ended December 31, 2017 were affected. Consolidated Statement of Operations and Comprehensive Loss
Consolidated Balance Sheets
Consolidated Statement of Cash Flows
In October 2016, the FASB issued ASU 2016-18, Restricted Cash, which requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017 (fiscal year 2018 for the Company), and interim periods within those years, using a retrospective transition method to each period presented, with early adoption permitted. The Company elected to adopt this ASU effective January 1, 2018. The adoption of this guidance resulted in $1.3 million in restricted cash to be included with cash and cash equivalents at the beginning of the period in the consolidated statement of cash flows for each of the years ended December 31, 2018, 2017 and 2016. In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based award require an entity to apply modification accounting under ASC 718, Compensation – Stock Compensation. Specifically, awards will require modification accounting if the fair value, vesting condition or classification of the award is not the same immediately before and after a change to the terms and conditions of the award. This ASU is effective on a prospective basis beginning on January 1, 2018, with early adoption permitted. The Company adopted this ASU effective January 1, 2018, and since the Company did not have any modifications in fiscal 2018, the adoption of this ASU did not have an impact on the Company’s consolidated financial statements and disclosures. New Accounting Pronouncements – Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires entities to recognize right-of-use assets and lease liabilities for leases with lease terms of more than 12 months on their balance sheets and provide enhanced disclosures. In July 2018, the FASB issued additional ASUs related to Topic 842, or ASC 842, that clarified various aspects of the new lease guidance, including how to record certain transition adjustments, as well as other improvements and practical expedients. ASC 842 is effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years. Early application is permitted for all entities; however, the Company has elected not to early adopt. ASC 842 requires a modified retrospective approach for all leases existing at, or entered into after, the date of initial application, with an option to elect to use certain transition relief. The Company is currently evaluating the impact of this new standard on its consolidated financial statements and related disclosures; however, it expects the adoption of this new guidance will result in the Company recording additional assets and corresponding liabilities on its consolidated balance sheets, primarily relating to leases of office and lab space. The Company plans to adopt ASC 842 using the modified retrospective approach with the cumulative effect of adoption recognized to retained earnings on January 1, 2019. The Company also expects to elect the practical expedients upon transition that will retain the lease classification and initial direct costs for any leases that existed prior to the adoption of this new standard. The Company will not reassess whether any contracts entered into prior to the adoption are leases. The Company is also in the process of implementing appropriate changes to its controls to support lease accounting and related disclosures under the new standard. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. Currently, U.S. GAAP delays recognition of the full amount of credit losses until the loss is probable of occurring. Under this ASU, the income statement will reflect an entity’s current estimate of all expected credit losses. The measurement of expected credit losses will be based upon historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down of the security. This ASU is effective for annual periods beginning after December 15, 2019, and is applicable to the Company in fiscal year 2020. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial position and results of operations. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which simplifies how companies calculate goodwill impairments by eliminating Step 2 of the impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. ASU 2017-04 requires companies to compare the fair value of a reporting unit to its carrying amount and recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit's fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to the related reporting unit. This ASU is effective for annual periods beginning after December 15, 2019, and is applicable to the Company in fiscal year 2020. Early adoption is allowed, and the Company expects to early adopt ASU 2017-04 for annual and interim goodwill impairment tests conducted after January 1, 2019. |
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| Segment Information |
Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing novel therapeutics for patients with kidney disease. |
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| Derivative Financial Instruments |
Derivative Financial Instruments The Company accounts for warrants and other derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives and Hedging, or ASC 815, based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s consolidated balance sheets and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s consolidated balance sheets at their fair value on the date of issuance and will be revalued on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. The warrant issued by the Company in connection with the Janssen Pharmaceutica NV Research and License Agreement, the Janssen Agreement, is classified as equity in the Company’s consolidated balance sheet. (See Note 12). |
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| Use of Estimates |
Use of Estimates The preparation of 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 the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, inventories, income taxes, purchase price allocations related to business combinations, intangible assets and goodwill. |
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| Cash and Cash Equivalents |
Cash and Cash Equivalents Cash and cash equivalents consist of all cash on hand, deposits and funds invested in available for sale securities with original maturities of three months or less at the time of purchase. Cash equivalents are reported at fair value. At December 31, 2018, the Company’s cash equivalents are primarily in money market funds. The Company may maintain balances with its banks in excess of federally insured limits. Restricted cash is included in “other assets” in the consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheet that sum to the total of the amounts reported in the consolidated statement of cash flows subsequent to the adoption of ASU 2016-18 (in thousands):
Restricted cash represents amounts required for security deposits under the Company’s office and lab space lease agreements and cash balances held as collateral for the Company’s employee credit card program. |
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| Investments |
Investments Management determines the appropriate classification of securities at the time of purchase and reevaluates such designation as of each balance sheet date. Currently, the Company classifies all securities as available for sale which are included in current assets as they are intended to fund current operations. The Company carries available for sale securities at fair value. The Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment and its application to certain investments. When assessing whether a decline in the fair value of a security is other-than-temporary, the Company considers the fair market value of the security, the duration of the security’s decline, and prospects for the underlying business. Based on these considerations, the Company did not identify any other-than-temporary unrealized losses at December 31, 2018. Unrealized losses on available for sale securities that are determined to be temporary, and not related to credit loss, are recorded in accumulated other comprehensive loss, a component of stockholders’ equity. The amortized cost of debt securities in this category reflects amortization of premiums and accretion of discounts to maturity computed under the effective interest method. The Company includes this amortization in the caption “Interest income” within the consolidated statements of operations and comprehensive loss. The Company also includes in net investment income, realized gains and losses and declines in value determined to be other than temporary. The Company bases the cost of securities sold upon the specific identification method and includes interest and dividends on securities in interest income. |
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| Accounts Receivable |
Accounts Receivable The Company’s accounts receivable represents amounts due to the Company from product sales (see Note 3) and from its collaboration agreements with MTPC and Otsuka (see Note 4). Reimbursable costs that have not been invoiced as of the balance sheet date are recorded as unbilled accounts receivable. Accounts receivable arising from product sales primarily represent amounts due from wholesale distributors as well as certain specialty pharmacy providers, or collectively, Customers. The Company deducts trade allowances for prompt payment, among other discounts, from its accounts receivable based on its experience that the Company’s Customers will earn these discounts and fees. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed as well as historical payment patterns and existing economic factors. The Company believes that credit risks associated with its Customers and collaboration partners are not significant. The Company did not have an allowance for doubtful accounts as of December 31, 2018 and 2017. |
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| Concentrations of Credit Risk and Off-Balance Sheet Risk |
Concentrations of Credit Risk and Off-Balance Sheet Risk Cash, cash equivalents, investments, and accounts receivable are the only financial instruments that potentially subject the Company to concentrations of credit risk. The Company maintains its cash, cash equivalents, and investments with high quality, accredited financial institutions and, accordingly, such funds are subject to minimal credit risk. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. Accounts receivable represent amounts due from the Company’s Customers and collaboration partners. As part of its credit management policy, the Company performs ongoing credit evaluations of its Customers and generally does not require collateral from any customer. The Company also monitors economic conditions of its collaboration partners to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection. Gross revenues and accounts receivable from each of the Company’s Customers or collaboration partners who individually accounted for 10% or more of total gross revenues and/or 10% or more of total gross accounts receivable consisted of the following:
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| Property and Equipment |
Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Assets under capital lease are included in property and equipment. Property and equipment is depreciated using the straight-line method over the estimated useful lives of the assets, generally three to seven years. Such costs are periodically reviewed for recoverability when impairment indicators are present. Such indicators include, among other factors, operating losses, unused capacity, market value declines and technological obsolescence. Recorded values of asset groups of equipment that are not expected to be recovered through undiscounted future net cash flows are written down to current fair value, which generally is determined from estimated discounted future net cash flows (assets held for use) or net realizable value (assets held for sale). The following is the summary of property and equipment and related accumulated depreciation as of December 31, 2018 and 2017.
Depreciation expense, including expense associated with assets under capital leases, was approximately $0.9 million, $0.6 million and $0.3 million for the years ended December 31, 2018, 2017 and 2016, respectively. |
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| Inventories |
Inventories The Company values its inventories at the lower-of-cost or net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company classifies its inventory costs as long-term, in other assets in its consolidated balance sheets, when it expects to utilize the inventory beyond their normal operating cycle. Prior to the regulatory approval of its product candidates, the Company incurs expenses for the manufacture of material that could potentially be available to support the commercial launch of its products. Until the first reporting period when regulatory approval has been received or is otherwise considered probable and the future economic benefit is expected to be realized, the Company records all such costs as research and development expense. Inventory used in clinical trials is also expensed as research and development expense, when selected for such use. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical manufacturing campaign. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of product sales in the consolidated statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. Additionally, the Company’s product is subject to strict quality control and monitoring that it performs throughout the manufacturing process. In the event that certain batches or units of product no longer meet quality specifications, the Company will record a charge to cost of product sales to write-down any unmarketable inventory to its estimated net realizable value. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. |
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| Revenue Recognition |
Revenue Recognition The Company generates revenues primarily from sales of Auryxia, see Note 3, and from its collaborations with MTPC and Otsuka, see Note 4. The Company recognizes revenue in accordance with ASC 606, which applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps:
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net The Company sells Auryxia in the United States, or U.S., primarily to wholesale distributors as well as certain specialty pharmacy providers. These Customers resell the Company’s product to health care providers and patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s product. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that it would have recognized is one year or less. Reserves for Variable Consideration Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between the Company and its Customers, health care providers, payors and other indirect customers relating to the Company’s sales of its products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount will be credited to the Customer) or as a current liability (if the amount is payable to a Customer or a party other than a Customer). When appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts and Allowances: The Company generally provides Customers with discounts that include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss through December 31, 2018. The Company records a corresponding reduction of accounts receivable (if the trade discount and/or allowance will be credited to the Customer) or an increase in accrued expense (if the trade discount and/or allowance is payable to a Customer) on the consolidated balance sheets. Product Returns: Consistent with industry practice, the Company generally offers Customers a limited right of return which allows for the product to be returned when the product expiry is within an allowable window. This right of return lapses once the product is provided to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return reserve using available industry data and its own historical sales information, including its visibility into the inventory remaining in the distribution channel. Provider Chargebacks and Discounts: Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s resale of the product. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed but for which the Company has not yet issued a credit. Commercial and Medicare Part D Rebates: The Company contracts with various commercial payor organizations, primarily health insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates the rebates for commercial and Medicare Part D payors based upon (i) its contracts with the payors and (ii) information obtained from its Customers and other third parties regarding the payor mix for Auryxia. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Other Government Rebates: The Company is subject to discount obligations under state Medicaid programs and other government programs. The Company estimates its Medicaid and other government programs rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period. Other Incentives: Other incentives that the Company offers include voluntary patient assistance programs such as the Company’s co-pay assistance program, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on actual claims processed during a given period, as well as historical utilization data to estimate the amount the Company expects to receive associated with product that has been recognized as revenue, but remains in in the distribution channel at the end of each reporting period. Collaboration Revenues The Company enters into out-license and collaboration agreements which are within the scope of ASC 606, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments may result in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company implements the five-step model noted above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine whether the individual deliverables should be accounted for as separate performance obligations or as a combined performance obligation, and to determine the stand-alone selling price for each performance obligation identified in the contract. A deliverable represents a separate performance obligation if both of the following criteria are met: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer, and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. With regard to the MTPC and Otsuka collaboration agreements, the Company recognizes revenue related to amounts allocated to the identified performance obligation on a proportional performance basis as the underlying services are performed. Licenses of Intellectual Property If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to assess the milestone as probable of being achieved. There is considerable judgment involved in determining whether a milestone is probable of being reached at each specific reporting period. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenues as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. Manufacturing Supply Services Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license, collaboration and other revenues when the licensee obtains control of the goods, which is upon delivery. Royalties The Company will recognize sales-based royalties, including milestone payments based on the level of sales, at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company receives royalty payments from JT and Torii, based on net sales of Riona in Japan. Collaborative Arrangements The Company records the elements of its collaboration agreements that represent joint operating activities in accordance with ASC Topic 808, Collaborative Arrangements (ASC 808). Accordingly, the elements of the collaboration agreements that represent activities in which both parties are active participants and to which both parties are exposed to the significant risks and rewards that are dependent on the commercial success of the activities are recorded as collaborative arrangements. The Company considers the guidance in ASC 606-10-15, Revenue from Contracts with Customers – Scope and Scope Exceptions, in determining the appropriate treatment for the transactions between the Company and its collaborative partner and the transactions between the Company and third parties. Generally, the classification of transactions under the collaborative arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Therefore, the Company recognizes its allocation of the shared costs incurred with respect to the jointly conducted medical affairs and commercialization and non-promotional activities under the U.S. collaboration with Otsuka as a component of the related expense in the period incurred. During the year ended December 31, 2018, the Company incurred approximately $1.2 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, as defined below in Note 4, of which approximately $0.5 million are reimbursable by Otsuka and recorded as a reduction to research and development expense. During the year ended December 31, 2018, Otsuka incurred approximately $1.1 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement, of which approximately $0.5 million are reimbursable by the Company and recorded as an increase to research and development expense. To the extent product revenue is generated from the collaboration, the Company will recognize its share of the net sales on a gross basis if it is deemed to be the principal in the transactions with customers, or on a net basis if it is instead deemed to be the agent in the transactions with customers, consistent with the guidance in ASC 606. |
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| Business Combinations |
Business Combinations The Company accounts for the acquisition of a business in accordance with ASC Topic 805, Business Combinations, or ASC 805. Amounts paid for each acquisition are allocated to the assets acquired and liabilities assumed based on their fair values at the date of acquisition. The Company determines the fair value of acquired intangible assets based on detailed valuations that use certain information and assumptions provided by management, which is considered management’s best estimate of inputs and assumptions that a market participant would use. The Company allocates any excess purchase price over the fair value of the net tangible and intangible assets acquired to goodwill. Under ASC 805, transaction costs are not included as a component of consideration transferred and are expensed as incurred. Additionally, in accordance with ASC 805, a transaction entered into by or on behalf of the acquirer or primarily for the benefit of the acquirer or the combined entity, rather than primarily for the benefit of the acquiree (before the combination), is treated as separate transaction. |
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| Intangible Assets |
Intangible Assets The Company maintains definite-lived intangible assets related to developed product rights for Auryxia and a favorable contract, which were acquired on December 12, 2018 as part of the Merger. Intangible assets are initially recorded at fair value and stated net of accumulated amortization and impairments. The Company amortizes its intangible assets that have finite lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized. Amortization for the Company’s intangible assets are recorded over their estimated useful live of 4 - 9 years. The Company reviews intangible assets subject to amortization to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life. If an impairment indicator exists, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of the intangible asset to its carrying value on the consolidated balance sheet. If the carrying value of the intangible asset exceeds the undiscounted cash flows used in the recoverability test, the Company will write the carrying value down to the fair value in the period identified. The Company calculates the fair value of intangible assets as the present value of estimated future cash flows expected to be generated from the intangible asset using a risk-adjusted discount rate. In determining estimated future cash flows associated with its intangible assets, the Company uses market participant assumptions pursuant to ASC 820. |
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| Goodwill |
Goodwill The Company allocates any excess purchase price over the fair value of the net tangible and intangible assets acquired in a business combination to goodwill. Goodwill is evaluated for impairment on an annual basis as of October 1, and more frequently if indicators are present or changes in circumstances suggest that impairment may exist. The Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of its reporting unit, the Company would record an impairment loss equal to the difference. As described above, the Company operates in one operating segment which the Company considers to be the only reporting unit. |
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| Fair Value of Financial Instruments |
Fair Value of Financial Instruments The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures, or ASC 820, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments, and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Items measured at fair value on a recurring basis include available for sale securities (see Note 7). The carrying amounts of prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to their short-term maturities. The rate implicit within the Company’s capital lease obligation approximates market interest rates. Items measured at fair value on a nonrecurring basis include property and equipment, intangible assets and goodwill. The Company remeasures the fair value of these assets upon the occurrence of certain events. There were no such remeasurements to property and equipment for the year ended December 31, 2018. There were no impairments to assets measured using level 3 inputs in fiscal year 2018 or 2017. The Company’s other financial instruments mainly consists of debt (see Note 11). The carrying amounts for the amount drawn on the Company’s line of credit facility with Silicon Valley Bank approximates fair value because the interest rate is variable and reflects current market rates. |
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| Research and Development Costs |
Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in providing research and development activities, including salaries and benefits, facilities costs, overhead costs, contract research and development services, and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. External research and development expenses associated with the Company’s programs include clinical trial site costs, research compounds and clinical manufacturing costs, costs incurred for consultants and other outside services, such as data management and statistical analysis support, and materials and supplies used in support of the clinical and preclinical programs. Internal costs of the Company’s clinical program include salaries, benefits, stock-based compensation, and an allocation of the Company’s facility costs. When third-party service providers’ billing terms do not coincide with the Company’s period-end, the Company is required to make estimates of its obligations to those third parties, including clinical trial and pharmaceutical development costs, contractual services costs and costs for supply of its drug candidates, incurred in a given accounting period and record accruals at the end of the period. The Company bases its estimates on its knowledge of the research and development programs, services performed for the period, past history for related activities and the expected duration of the third-party service contract, where applicable. |
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| Advertising Expenses |
Advertising Expenses The costs of advertising are expensed as incurred and included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. For the year ended December 31, 2018, advertising expenses totaled $0.5 million. The Company did not incur any advertising expenses for the years ended December 31, 2017 and 2016. |
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| Income Taxes |
Income Taxes Income taxes are recorded in accordance with FASB Topic 740, Income Taxes, or ASC 740, which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. All deferred taxes as of December 31, 2018 and 2017 are classified as noncurrent within the income tax provision (see Note 14). The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. |
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| Stock-Based Compensation |
Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation—Stock Compensation, or ASC 718. ASC 718 requires all stock-based payments to employees, including grants of employee stock options, restricted stock, restricted stock units, or RSUs, and modifications to existing stock awards, to be recognized in the statements of operations and comprehensive loss based on their fair values. The Company accounts for stock-based awards to non-employees in accordance with ASC Topic 505-50, Equity-Based Payments to Non-Employees, or ASC 505-50, which requires the fair value of the award to be re-measured at fair value until a performance commitment is reached or counterparty performance is complete. The Company’s stock-based awards are comprised of stock options, shares of restricted stock, shares of common stock and warrants. The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Company uses a blend of its stock price and the quoted market price of comparable public companies to determine the fair value of restricted stock awards and common stock awards. The Black-Scholes option pricing model requires the input of certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to the lack of company-specific historical and implied volatility data for trading the Company’s stock in the public market, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. During 2017, the Company began to estimate its volatility by using a blend of its stock price history for the length of time it has market data for its stock and the historical volatility of similar public companies for the expected term of each grant. The Company is a commercial-stage biopharmaceutical company and the representative group of companies has certain similar characteristics to the Company. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. For options granted to non-employees, the Company utilizes the contractual term of the arrangement as the basis for the expected term assumption. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock, which is similar to the Company’s peer group. The Company’s stock-based awards are subject to either service- or performance-based vesting conditions. Compensation expense related to awards to employees with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term, and is adjusted for pre-vesting forfeitures in the period in which the forfeitures occur. Consistent with the guidance in ASC 505- 50, compensation expense related to awards to non-employees with service-based vesting conditions is recognized on a straight-line basis based on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance-based vesting conditions is recognized based on the grant date fair value over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. Consistent with the guidance in ASC 505-50, compensation expense related to awards to non-employees with performance-based vesting conditions is recognized based on the then-current fair value at each financial reporting date prior to the measurement date over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. For awards with performance conditions in which the award does not vest unless the performance condition is met, the Company recognizes expense if, and to the extent that, the Company estimates that achievement of the performance condition is probable. If the Company concludes that vesting is probable, it recognizes expense from the date it reaches this conclusion through the estimated vesting date. |
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| Net Loss per Share |
Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, preferred stock, stock options, warrants, restricted stock and RSUs are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. Diluted net income per share is calculated by dividing the net income by the weighted-average common shares outstanding for the period, including any dilutive effect from outstanding options, warrants, restricted stock and RSUs using the treasury stock method. |
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- References No definition available.
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- Definition Disclosure of accounting policy for advertising costs. For those costs that cannot be capitalized, discloses whether such costs are expensed as incurred or the first period in which the advertising takes place. For direct response advertising costs that are capitalized, describes those assets and the accounting policy used, including a description of the qualifying activity, the types of costs capitalized and the related amortization period. An entity also may disclose its accounting policy for cooperative advertising arrangements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). No definition available.
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- Definition Disclosure of accounting policy for completed business combinations (purchase method, acquisition method or combination of entities under common control). This accounting policy may include a general discussion of the purchase method or acquisition method of accounting (including for example, the treatment accorded contingent consideration, the identification of assets and liabilities, the purchase price allocation process, how the fair values of acquired assets and liabilities are determined) and the entity's specific application thereof. An entity that acquires another entity in a leveraged buyout transaction generally discloses the accounting policy followed by the acquiring entity in determining the basis used to value its interest in the acquired entity, and the rationale for that accounting policy. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for credit risk. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for its derivative instruments and hedging activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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 accounting policy for determining the fair value of financial instruments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for goodwill. This accounting policy also may address how an entity assesses and measures impairment of goodwill, how reporting units are determined, how goodwill is allocated to such units, and how the fair values of the reporting units are determined. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for finite-lived intangible assets. This accounting policy also might address: (1) the amortization method used; (2) the useful lives of such assets; and (3) how the entity assesses and measures impairment of such assets. 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 investments in financial assets, including marketable securities (debt and equity securities with readily determinable fair values), investments accounted for under the equity method and cost method, securities borrowed and loaned, and repurchase and resale agreements. For marketable securities, the disclosure may include the entity's accounting treatment for transfers between investment categories and how the fair values for such securities are determined. Also, for all investments, an entity may describe its policy for assessing, recognizing and measuring impairment of the investment. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact. No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for long-lived, physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, basis of assets, depreciation and depletion methods used, including composite deprecation, estimated useful lives, capitalization policy, accounting treatment for costs incurred for repairs and maintenance, capitalized interest and the method it is calculated, disposals and impairments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for trade and other accounts receivable, and finance, loan and lease receivables, including those classified as held for investment and held for sale. This disclosure may include (1) the basis at which such receivables are carried in the entity's statements of financial position (2) how the level of the valuation allowance for receivables is determined (3) when impairments, charge-offs or recoveries are recognized for such receivables (4) the treatment of origination fees and costs, including the amortization method for net deferred fees or costs (5) the treatment of any premiums or discounts or unearned income (6) the entity's income recognition policies for such receivables, including those that are impaired, past due or placed on nonaccrual status and (7) the treatment of foreclosures or repossessions (8) the nature and amount of any guarantees to repurchase receivables. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for costs it has 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. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for revenue recognition. If the entity has different policies for different types of revenue transactions, the policy for each material type of transaction is generally disclosed. If a sales transaction has multiple element arrangements (for example, delivery of multiple products, services or the rights to use assets) the disclosure may indicate the accounting policy for each unit of accounting as well as how units of accounting are determined and valued. The disclosure may encompass important judgment as to appropriateness of principles related to recognition of revenue. The disclosure also may indicate the entity's treatment of any unearned or deferred revenue that arises from the transaction. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
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- Definition Disclosure of accounting policy for segment reporting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for stock option and stock incentive plans. This disclosure may include (1) the types of stock option or incentive plans sponsored by the entity (2) the groups that participate in (or are covered by) each plan (3) significant plan provisions and (4) how stock compensation is measured, and the methodologies and significant assumptions used to determine that measurement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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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Summary of Significant Accounting Policies (Tables) |
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| Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheet that sum to the total of the amounts reported in the consolidated statement of cash flows subsequent to the adoption of ASU 2016-18 (in thousands):
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| Revenue and Gross Accounts Receivable By Major Customer |
Gross revenues and accounts receivable from each of the Company’s Customers or collaboration partners who individually accounted for 10% or more of total gross revenues and/or 10% or more of total gross accounts receivable consisted of the following:
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| Summary of Property and Equipment and Related Accumulated Depreciation |
The following is the summary of property and equipment and related accumulated depreciation as of December 31, 2018 and 2017.
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| ASC 606 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Impact on Consolidated Financial Statements as Result of Adopting ASC 606 | As a result of adopting ASC 606 on January 1, 2018, the Company has revised its comparative financial statements for the year ended December 31, 2017 as if ASC 606 had been effective for that period, as set forth below.
Consolidated Statement of Operations and Comprehensive Loss
Consolidated Balance Sheets
Consolidated Statement of Cash Flows
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- Definition Reconciliation of cash, cash equivalents, and restricted cash. 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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- Definition Tabular disclosure of changes in accounting principles, including adoption of new accounting pronouncements, that describes the new methods, amount and effects on financial statement line items. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the nature of a concentration, a benchmark to which it is compared, and the percentage that the risk is to the benchmark. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Details
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Product Revenue, Net (Tables) |
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| Revenue From Contract With Customer [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Product Revenue Allowance and Reserve Categories | The following table summarizes activity in each of the product revenue allowance and reserve categories for the period from December 12, 2018 to December 31, 2018 (in thousands):
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- Definition Schedule Of Product Revenue Allowance And Reserve Categories. No definition available.
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- References No definition available.
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License, Collaboration and Other Significant Agreements (Tables) |
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| Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Revenues Recognized From License, Collaboration and Other Significant Agreements |
During the years ended December 31, 2018, 2017 and 2016, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of December 31, 2018:
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| Deferred Revenues Balance |
During the years ended December 31, 2018, 2017 and 2016, the Company recognized the following revenues from its license, collaboration and other significant agreements and had the following deferred revenue balances as of December 31, 2018:
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| Schedule of Changes In Contract Assets and Liabilities |
The following table presents changes in the Company’s contract assets and liabilities during the years ended December 31, 2018 and 2017 (in thousands):
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| Schedule of Revenue Recognized Resulting from Changes in Contract Asset and Contract Liability |
During the years ended December 31, 2018 and 2017, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands):
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- Definition Collaborative arrangement revenue recognition. No definition available.
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| X | ||||||||||
- Definition Deferred revenue recognition. No definition available.
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| X | ||||||||||
- Definition Schedule of revenue recognized resulting from changes in contract asset and contract liability. No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of contract balances and changes in contract balances. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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Business Combination (Tables) |
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| Business Combinations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Total Fair Value Consideration |
Pursuant to the terms and conditions of the Merger Agreement, each outstanding share of Keryx common stock, excluding the Baupost Additional Shares discussed below, and each outstanding Keryx equity award were converted into Akebia common stock and substantially similar Akebia awards, respectively, at an exchange ratio of 0.37433 for a total fair value consideration of $527.8 million consisting of the following (in thousands):
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| Summary of Purchase Price of Identifiable Assets Acquired and Liabilities Assumed | The Company has allocated the $527.8 million purchase price to the identifiable assets acquired and liabilities assumed in the business combination at their fair values as of December 12, 2018 as follows (in thousands):
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| Summary of Unaudited Estimated Pro Forma Financial Information | Accordingly, the unaudited estimated pro forma financial information below is not necessarily indicative of what the actual results of operations of the combined companies would have been had the acquisition occurred as of January 1, 2017, nor are they indicative of future results of operations:
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| X | ||||||||||
- Definition Schedule of business acquisitions transaction price. No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of pro forma results of operations for a material business acquisition or series of individually immaterial business acquisitions that are material in the aggregate. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of the amounts recognized as of the acquisition date for each major class of assets acquired and liabilities assumed. May include but not limited to the following: (a) acquired receivables; (b) contingencies recognized at the acquisition date; and (c) the fair value of noncontrolling interests in the acquiree. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Available for Sale Securities (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments Debt And Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Available for Sale Securities at Fair Value |
Available for sale securities at December 31, 2018 and 2017 consist of the following:
|
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| Estimated Fair Value of Available for Sale Securities by Contractual Maturity |
The estimated fair value of the Company’s available for sale securities balance at December 31, 2018, by contractual maturity, is as follows (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Available for Sale Securities that were in Continuous Unrealized Loss Position | The following table summarizes the Company’s available for sale securities that were in a continuous unrealized loss position, but were not deemed to be other-than-temporarily impaired, as of December 31, 2018 and 2017:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- Definition Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
- Definition Tabular disclosure of fair value amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in unrealized loss position. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Tabular disclosure of maturities of an entity's investments as well as any other information pertinent to the investments. No definition available.
|
| X | ||||||||||
- References No definition available.
|
Fair Value of Financial Instruments (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assets Measured or Disclosed at Fair Value on Recurring Basis |
Assets measured or disclosed at fair value on a recurring basis as of December 31, 2018 and December 31, 2017 are summarized below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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
|
| X | ||||||||||
- References No definition available.
|
Inventory (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Components of Inventory |
The components of inventory are summarized as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- References No definition available.
|
| 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
|
Intangible Assets and Goodwill (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Goodwill And Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Intangible Assets |
The following table presents the Company’s intangible assets:
|
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| Schedule of Estimated Future Amortization Expense for Intangible Assets | Estimated future amortization expense for intangible assets as of December 31, 2018 is as follows
|
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| X | ||||||||||
- Definition Tabular disclosure of amortization expense of assets, excluding financial assets, that lack physical substance, having a limited useful life. No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of assets, excluding financial assets and goodwill, lacking physical substance with a finite life, by either major class or business segment. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Accrued Expenses (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Payables And Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Components of Accrued Expenses |
Accrued expenses are as follows:
|
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| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of the components of accrued liabilities. No definition available.
|
Stockholders' Equity (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Reserved Shares of Common Stock for Future Issuance |
The Company has reserved for future issuance the following number of shares of common stock:
|
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| Schedule of Assumptions Used in Black-Scholes Option Pricing Model |
The assumptions used in the Black-Scholes pricing model to estimate the grant date fair value of options granted under the 2014 Plan are as follows:
|
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| Schedule of Stock Option Activity |
The following table summarizes the Company’s stock option activity, excluding performance-based options, for the year ended December 31, 2018:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Performance-based Option Activity |
The following table summarizes the Company’s performance-based option activity for the year ended December 31, 2018:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Compensation Cost Related to Share-Based Awards |
The Company has recognized the following compensation cost related to share-based awards:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Compensation Expense by Type of Award |
Compensation expense by type of award:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Restricted Stock Units | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Restricted Stock Activity |
A following table summarizes the Company’s RSU activity for the year ended December 31, 2018:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- Definition Schedule of common stock reserved for future issuance. No definition available.
|
| X | ||||||||||
- Definition Schedule of compensation cost for share based payment arrangements allocation of share based compensation costs by award. No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of the allocation of equity-based compensation costs to a given line item on the balance sheet and income statement for the period. This may include the reporting line for the costs and the amount capitalized and expensed. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure of the changes in outstanding nonvested performance-based units. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure of the changes in outstanding nonvested restricted stock units. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Income Taxes (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Provision for Income Taxes | The provision for income taxes for each of the years ended December 31, 2018, 2017 and 2016 consisted of the following:
|
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| Schedule of Effective Income Tax Rate Differs From Statutory Federal Income Tax Rate |
Our effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2018, 2017 and 2016:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Significant Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows:
|
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| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of the components of income tax expense attributable to continuing operations for each year presented including, but not limited to: current tax expense (benefit), deferred tax expense (benefit), investment tax credits, government grants, the benefits of operating loss carryforwards, tax expense that results from allocating certain tax benefits either directly to contributed capital or to reduce goodwill or other noncurrent intangible assets of an acquired entity, adjustments of a deferred tax liability or asset for enacted changes in tax laws or rates or a change in the tax status of the entity, and adjustments of the beginning-of-the-year balances of a valuation allowance because of a change in circumstances that causes a change in judgment about the realizability of the related deferred tax asset in future years. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure of the components of net deferred tax asset or liability recognized in an entity's statement of financial position, including the following: the total of all deferred tax liabilities, the total of all deferred tax assets, the total valuation allowance recognized for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Tabular disclosure of the reconciliation using percentage or dollar amounts of the reported amount of income tax expense attributable to continuing operations for the year to the amount of income tax expense that would result from applying domestic federal statutory tax rates to pretax income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Commitments and Contingencies (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments And Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Future Minimum Payments Required Under Leases |
At December 31, 2018, the Company’s future minimum payments required under these leases are as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- References No definition available.
|
| 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/legacyRef
|
Net Loss per Share (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share |
The shares in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Quarterly Results (unaudited) (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Quarterly Results |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of quarterly financial data. Includes, but is not limited to, financial information for fiscal quarters, cumulative effect of a change in accounting principle and earnings per share data. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Nature of Organization and Operations - Additional Information (Details) |
1 Months Ended | 12 Months Ended | 144 Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dec. 12, 2018
shares
|
Apr. 30, 2019
Subject
|
Feb. 28, 2019
Subject
|
Mar. 31, 2018
shares
|
Apr. 30, 2017
USD ($)
|
Mar. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
Dec. 31, 2018
USD ($)
Patient
shares
|
Dec. 31, 2017
USD ($)
shares
|
Dec. 31, 2016
USD ($)
shares
|
Dec. 31, 2018
USD ($)
shares
|
|
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Proceeds from sale of stock | $ 468,400,000 | |||||||||||
| Proceeds from issuance of public offering | $ 95,452,000 | $ 114,580,000 | $ 66,623,000 | |||||||||
| Number of months for operating plan sufficiently funded by cash resources | 12 months | |||||||||||
| Common Stock | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Issuance of common stock, net of issuance costs, shares | shares | 9,194,306 | 8,672,270 | 7,865,293 | |||||||||
| Follow-on public offering | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Proceeds from issuance of public offering | 377,400,000 | |||||||||||
| Follow-on public offering | Cantor Fitzgerald & Co | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Proceeds from issuance of public offering | $ 41,000,000 | |||||||||||
| Follow-on public offering | Common Stock | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Issuance of common stock, net of issuance costs, shares | shares | 8,500,000 | |||||||||||
| Vifor Pharma | Common Stock | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Issuance of common stock, net of issuance costs, shares | shares | 3,571,429 | |||||||||||
| Otsuka Pharmaceutical Co. Ltd. and Mitsubishi Tanabe Pharma Corporation | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Minimum committed amount in cost share funding and license payments under collaboration agreements | $ 573,000,000 | |||||||||||
| Amount received from cost-share funding and license payments | $ 272,000,000 | |||||||||||
| Merger Agreement | Keryx | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Issued and outstanding cancelled, converted common stock | 0.37433 | |||||||||||
| Number of shares cancelled and converted in merger, shares issued | shares | 59,270,410 | |||||||||||
| Protect and Innovate | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Number of patients | Patient | 7,600 | |||||||||||
| Larger Innovate Study | Subsequent Event | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Number of enrolled subjects | Subject | 3,554 | |||||||||||
| Smaller Innovate Study | Scenario Forecast | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Number of enrolled subjects | Subject | 350 | |||||||||||
| Development and Commercialize Collaboration Agreement | Mitsubishi Tanabe Pharma Corporation | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Collaborative arrangement right description | In December 2015, the Company entered into a collaboration agreement with Mitsubishi Tanabe Pharma Corporation, or MTPC, to develop and commercialize vadadustat in Japan and certain other countries in Asia, collectively, the MTPC Territory, for total payments of up to $245.0 million, comprised of a $20.0 million upfront payment, up to $50.0 million in specified development and regulatory milestones, and up to $175.0 million in specified commercial milestones, as well as tiered double-digit royalty payments up to 20% on sales of vadadustat in the MTPC Territory, subject to a reduction upon launch of a generic product on a country-by-country basis (Note 4). | |||||||||||
| Upfront cash payment received | $ 20,000,000 | $ 20,000,000 | ||||||||||
| Development and Commercialize Collaboration Agreement | Mitsubishi Tanabe Pharma Corporation | Maximum | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Milestone revenue | 245,000,000 | |||||||||||
| Additional milestone payments development costs fund | $ 50,000,000 | |||||||||||
| Royalty payment percentage | 20.00% | |||||||||||
| Development and Commercialize Collaboration Agreement | Mitsubishi Tanabe Pharma Corporation | Commercial Milestone Payments | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Milestone revenue | $ 175,000,000 | |||||||||||
| Development and Commercialize Collaboration Agreement | Mitsubishi Tanabe Pharma Corporation | Commercial Milestone Payments | Maximum | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Milestone revenue | $ 175,000,000 | |||||||||||
| Development and Commercialize Collaboration and License Agreement | Otsuka Pharmaceutical Company. Ltd. | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Upfront cash payment received | $ 73,000,000 | $ 125,000,000 | ||||||||||
| Development and Commercialize Collaboration and License Agreement | Otsuka Pharmaceutical Company. Ltd. | Global Development Plan | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Reimbursement for Otsuka's share of costs previously incurred | 200,000 | $ 33,800,000 | ||||||||||
| Development and Commercialize Collaboration and License Agreement | Otsuka Pharmaceutical Company. Ltd. | Minimum | Global Development Plan | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Collaborative arrangements cost sharing payments | 176,100,000 | 167,500,000 | ||||||||||
| Development and Commercialize Collaboration and License Agreement | Otsuka Pharmaceutical Company. Ltd. | Potential Development and Commercialization Milestones | Maximum | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Milestone revenue | 132,000,000 | 190,000,000 | ||||||||||
| Development and Commercialize Collaboration and License Agreement | Otsuka Pharmaceutical Company. Ltd. | Potential Commercial Milestone Payments | Maximum | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Milestone revenue | $ 525,000,000 | $ 575,000,000 | ||||||||||
| License Agreement | Vifor Pharma | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Proceeds from sale of stock | $ 50,000,000 | |||||||||||
| Restricted Stock Units | Merger Agreement | Keryx | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Number of shares cancelled and converted in merger, shares issued | shares | 602,752 | |||||||||||
| Stock Options | Merger Agreement | Keryx | ||||||||||||
| Nature Of Organization And Operations [Line Items] | ||||||||||||
| Number of shares cancelled and converted in merger, shares issued | shares | 3,967,290 | |||||||||||
| X | ||||||||||
- Definition Business combination equity cancelled and converted number of shares issued. No definition available.
|
| X | ||||||||||
- Definition Collaborative arrangements cost sharing payments. No definition available.
|
| X | ||||||||||
- Definition Milestone payment received. No definition available.
|
| X | ||||||||||
- Definition Minimum committed amount in cost-share funding and license payments under collaboration agreements. No definition available.
|
| X | ||||||||||
- Definition Nature of organization and operations. No definition available.
|
| X | ||||||||||
- Definition Number of enrolled subjects. No definition available.
|
| X | ||||||||||
- Definition Number of patients. No definition available.
|
| X | ||||||||||
- Definition Operating plan sufficiently funded by cash resources, period. No definition available.
|
| X | ||||||||||
- Definition Payment received for license agreement reimbursement of previously costs incurred. No definition available.
|
| X | ||||||||||
- Definition Potential payment for achievement of specified commercial milestones. No definition available.
|
| X | ||||||||||
- Definition Potential payment for achievement of specified development and regulatory milestones. No definition available.
|
| X | ||||||||||
- Definition Royalty payment percentage. No definition available.
|
| X | ||||||||||
- Definition Upfront cash payment received. No definition available.
|
| X | ||||||||||
- Definition Description of rights and obligations under the collaborative arrangements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Cash received from licensees for license fees during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Ratio applied to the conversion of stock split, for example but not limited to, one share converted to two or two shares converted to one. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Summary of Significant Accounting Policies - Additional Information (Details) |
1 Months Ended | 3 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|---|
|
Dec. 31, 2015
USD ($)
|
Mar. 31, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
Segment
|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
|
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Recognized revenue under license agreement | $ 137,726,000 | $ 125,454,000 | |||
| Number of operating segments | Segment | 1 | ||||
| Allowance for doubtful accounts | $ 0 | 0 | |||
| Depreciation expense | 900,000 | 600,000 | $ 300,000 | ||
| Remeasurements to property and equipment | 0 | ||||
| Significant uncertain tax positions | $ 0 | 0 | |||
| Expected dividend yield | 0.00% | ||||
| Selling, General, and Administrative Expenses | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Advertising expenses | $ 500,000 | 0 | 0 | ||
| Fair Value, Inputs, Level 3 | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Assets impairments charges | $ 0 | 0 | |||
| Maximum | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Property, plant and equipment, Useful life | 7 years | ||||
| Intangible assets, estimated useful life | 9 years | ||||
| Minimum | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Property, plant and equipment, Useful life | 3 years | ||||
| Intangible assets, estimated useful life | 4 years | ||||
| Gross Revenues | Customer Concentration Risk | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Concentration risk percentage | 10.00% | ||||
| Accounts Receivable | Customer Concentration Risk | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Concentration risk percentage | 10.00% | ||||
| Accounting Standards Update 2016-18 | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Restricted cash included with cash and cash equivalents at beginning of period | $ 1,300,000 | 1,300,000 | $ 1,300,000 | ||
| Otsuka U.S. Agreement | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Cost share costs for license agreement | 1,200,000 | ||||
| Reimbursable by Otsuka | 500,000 | ||||
| Cost share costs by partner for license agreement | 1,100,000 | ||||
| Reimbursable to Otsuka | 500,000 | ||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Maximum | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Milestone revenue | $ 245,000,000 | ||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | ASC 606 | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Recognized revenue under license agreement | $ 3,200,000 | ||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development Milestones | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Milestone revenue | $ 4,000,000 | 10,000,000 | |||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development Milestones | ASC 606 | |||||
| Summary Of Significant Accounting Policies [Line Items] | |||||
| Allocated arrangement consideration | $ 4,000,000 | ||||
| X | ||||||||||
- Definition Allocated arrangement consideration under license agreement. No definition available.
|
| X | ||||||||||
- Definition Cost share costs incurred by partner for license agreement. No definition available.
|
| X | ||||||||||
- Definition Cost share costs incurred for license agreement. No definition available.
|
| X | ||||||||||
- Definition Fair value remeasurements to property and equipment. No definition available.
|
| X | ||||||||||
- Definition Milestone payment received. No definition available.
|
| X | ||||||||||
- Definition Payment for license agreement reimbursement of costs incurred. No definition available.
|
| X | ||||||||||
- Definition Payment received for license agreement reimbursement of costs incurred. No definition available.
|
| X | ||||||||||
- Definition Summary of significant accounting policies. No definition available.
|
| X | ||||||||||
- Definition Amount charged to advertising expense for the period, which are expenses incurred with the objective of increasing revenue for a specified brand, product or product line. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition For an unclassified balance sheet, a valuation allowance for receivables due a company that are expected to be uncollectible. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of write-down of assets recognized in the income statement. Includes, but is not limited to, losses from tangible assets, intangible assets and goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition For an entity that discloses a concentration risk in relation to quantitative amount, which serves as the "benchmark" (or denominator) in the equation, this concept represents the concentration percentage derived from the division. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of revenue recognized that was previously included in balance of obligation to transfer good or service to customer for which consideration from customer has been received or is due. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- 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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| X | ||||||||||
- Definition Useful life of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
- Definition Amount recognized for uncertainty in income taxes classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Represents the quantification of the effect of adopting the new accounting standard or change in accounting principle expected by the entity to have a significant effect on the entity's financial statements. No definition available.
|
| 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.
|
| X | ||||||||||
- Definition Useful life of long lived, physical assets used in the normal conduct of business and not intended for resale, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Examples include, but not limited to, land, buildings, machinery and equipment, office equipment, furniture and fixtures, and computer equipment. No definition available.
|
| X | ||||||||||
- 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 | ||||||||||
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| X | ||||||||||
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Summary of Significant Accounting Policies - Impact on Consolidated Statement of Operations and Comprehensive Loss as Result of Adopting ASC 606 (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017 |
[1] | Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
| Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||||
| Collaboration revenue | $ 207,742 | $ 181,227 | $ 1,535 | |||||||||||
| Type of revenue [extensible list] | akba:CollaborationMember | |||||||||||||
| Operating loss | $ (90,158) | $ (27,843) | $ (35,662) | $ (24,498) | $ 14,610 | $ (24,176) | $ (22,136) | $ (44,972) | (178,161) | $ (76,674) | (136,460) | |||
| Net loss | $ (60,054) | $ (26,047) | $ (34,069) | $ (23,418) | $ 15,524 | $ (23,134) | $ (21,518) | $ (44,543) | $ (143,588) | $ (73,671) | $ (135,747) | |||
| Net loss per share - basic and diluted | $ (0.87) | $ (0.46) | $ (0.60) | $ (0.48) | $ (2.47) | $ (1.69) | $ (3.60) | |||||||
| As originally reported under ASC 605 | ASC 606 | ||||||||||||||
| Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||||
| Collaboration revenue | $ 177,984 | |||||||||||||
| Type of revenue [extensible list] | akba:CollaborationMember | |||||||||||||
| Operating loss | $ (79,917) | |||||||||||||
| Net loss | $ (76,914) | |||||||||||||
| Net loss per share - basic and diluted | $ (1.77) | |||||||||||||
| Effect of change | ASC 606 | ||||||||||||||
| Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||||
| Collaboration revenue | $ 3,243 | |||||||||||||
| Type of revenue [extensible list] | akba:CollaborationMember | |||||||||||||
| Operating loss | $ 3,243 | |||||||||||||
| Net loss | $ 3,243 | |||||||||||||
| Net loss per share - basic and diluted | $ 0.08 | |||||||||||||
| ||||||||||||||
| X | ||||||||||
- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or 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/2009/role/commonPracticeRef
|
| 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 The net result for the period of deducting operating expenses from operating revenues. 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://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 Indicates type of revenue from product and service. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Summary of Significant Accounting Policies - Impact on Consolidated Balance Sheets as Result of Adopting ASC 606 (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Summary Of Significant Accounting Policies [Line Items] | ||
| Short-term deferred revenue | $ 56,980 | $ 81,667 |
| Accumulated deficit | $ (514,395) | (370,807) |
| As originally reported under ASC 605 | ASC 606 | ||
| Summary Of Significant Accounting Policies [Line Items] | ||
| Short-term deferred revenue | 84,910 | |
| Accumulated deficit | (374,050) | |
| Effect of change | ASC 606 | ||
| Summary Of Significant Accounting Policies [Line Items] | ||
| Short-term deferred revenue | (3,243) | |
| Accumulated deficit | $ 3,243 |
| X | ||||||||||
- Definition Summary of significant accounting policies. No definition available.
|
| 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://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
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| X | ||||||||||
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Summary of Significant Accounting Policies - Impact on Consolidated Statement of Cash Flows as Result of Adopting ASC 606 (Details) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017 |
Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||||
| Summary Of Significant Accounting Policies [Line Items] | ||||||||||||||
| Net loss | $ (60,054) | $ (26,047) | $ (34,069) | $ (23,418) | $ 15,524 | [1] | $ (23,134) | $ (21,518) | $ (44,543) | $ (143,588) | $ (73,671) | $ (135,747) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
| Deferred revenue | (66,935) | (17,665) | 197,289 | |||||||||||
| Cash, cash equivalents, and restricted cash at beginning of the period | 71,437 | 188,616 | 71,437 | 188,616 | 51,059 | |||||||||
| Cash, cash equivalents, and restricted cash at end of the period | $ 107,099 | 71,437 | 107,099 | 71,437 | 188,616 | |||||||||
| As originally reported under ASC 605 | ASC 606 | ||||||||||||||
| Summary Of Significant Accounting Policies [Line Items] | ||||||||||||||
| Net loss | (76,914) | |||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
| Deferred revenue | (14,422) | |||||||||||||
| Cash, cash equivalents, and restricted cash at beginning of the period | $ 71,437 | $ 188,616 | $ 71,437 | 188,616 | ||||||||||
| Cash, cash equivalents, and restricted cash at end of the period | $ 71,437 | 71,437 | $ 188,616 | |||||||||||
| Effect of change | ASC 606 | ||||||||||||||
| Summary Of Significant Accounting Policies [Line Items] | ||||||||||||||
| Net loss | 3,243 | |||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
| Deferred revenue | $ (3,243) | |||||||||||||
| ||||||||||||||
| X | ||||||||||
- Definition Summary of significant accounting policies. No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for 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
|
| X | ||||||||||
- 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
|
| 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 | ||||||||||
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| X | ||||||||||
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Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|---|---|---|---|---|
| Summary Of Significant Accounting Policies [Line Items] | ||||
| Cash and cash equivalents | $ 104,644 | $ 70,156 | $ 187,335 | $ 49,778 |
| Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | 107,099 | 71,437 | 188,616 | 51,059 |
| Other Assets | ||||
| Summary Of Significant Accounting Policies [Line Items] | ||||
| Restricted cash, noncurrent | $ 2,455 | $ 1,281 | $ 1,281 | $ 1,281 |
| X | ||||||||||
- Definition Summary of significant accounting policies. 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 Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for 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
|
| X | ||||||||||
- Definition Amount of cash restricted as to withdrawal or usage, classified as noncurrent. 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. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
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Summary of Significant Accounting Policies - Revenue and Gross Accounts Receivable By Major Customer (Details) - Customer Concentration Risk |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Percent of Total Gross Revenues | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 10.00% | ||
| Percent of Total Gross Revenues | Otsuka Pharmaceutical Company. Ltd. | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 90.00% | 76.00% | 100.00% |
| Percent of Gross Accounts Receivable | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 10.00% | ||
| Percent of Gross Accounts Receivable | Otsuka Pharmaceutical Company. Ltd. | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 96.00% | ||
| Percent of Gross Accounts Receivable | Fresenius Medical Care Rx | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 42.00% | ||
| Percent of Gross Accounts Receivable | McKesson Corporation | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 22.00% | ||
| Percent of Gross Accounts Receivable | Cardinal Health, Inc. | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 13.00% | ||
| Percent of Gross Accounts Receivable | AmerisourceBergen Drug Corporation | |||
| Concentration Risk [Line Items] | |||
| Concentration risk percentage | 11.00% | ||
| 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 For an entity that discloses a concentration risk in relation to quantitative amount, which serves as the "benchmark" (or denominator) in the equation, this concept represents the concentration percentage derived from the division. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summary of Significant Accounting Policies - Summary of Property and Equipment and Related Accumulated Depreciation (Details) - USD ($) $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
| Property, Plant and Equipment [Line Items] | ||
| Gross property, plant and equipment | $ 9,981 | $ 4,676 |
| Less accumulated depreciation | (1,958) | (1,059) |
| Net property and equipment | $ 8,023 | 3,617 |
| Minimum | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 3 years | |
| Maximum | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 7 years | |
| Computer equipment and software | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 3 years | |
| Gross property, plant and equipment | $ 1,593 | 630 |
| Furniture and fixtures | ||
| Property, Plant and Equipment [Line Items] | ||
| Gross property, plant and equipment | $ 1,170 | 800 |
| Furniture and fixtures | Minimum | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 5 years | |
| Furniture and fixtures | Maximum | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 7 years | |
| Equipment | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 7 years | |
| Gross property, plant and equipment | $ 1,780 | 628 |
| Leasehold improvements | ||
| Property, Plant and Equipment [Line Items] | ||
| Leasehold improvements, Useful Life | Shorter of the useful life or remaining lease term (10 years) | |
| Gross property, plant and equipment | $ 5,324 | 2,582 |
| Leasehold improvements | Maximum | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 10 years | |
| Office equipment under capital lease | ||
| Property, Plant and Equipment [Line Items] | ||
| Property, plant and equipment, Useful life | 3 years | |
| Gross property, plant and equipment | $ 114 | $ 36 |
| 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 Describes the periods of time over which an entity anticipates to receive utility from its property, plant and equipment (that is, the periods of time over which an entity allocates the initial cost of its property, plant and equipment). 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
|
| X | ||||||||||
- Definition Useful life of long lived, physical assets used in the normal conduct of business and not intended for resale, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Examples include, but not limited to, land, buildings, machinery and equipment, office equipment, furniture and fixtures, and computer equipment. No definition available.
|
| X | ||||||||||
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Product Revenue, Net - Additional Information (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Disaggregation Of Revenue [Line Items] | |||||
| Total revenues | $ 207,742 | $ 181,227 | $ 1,535 | ||
| Product Revenue, Net | |||||
| Disaggregation Of Revenue [Line Items] | |||||
| Total revenues | $ 6,800 | $ 6,824 | $ 6,824 | ||
| 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, 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://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
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|
Product Revenue, Net - Summary of Product Revenue Allowance and Reserve Categories (Details) $ in Thousands |
1 Months Ended |
|---|---|
|
Dec. 31, 2018
USD ($)
| |
| Valuation And Qualifying Accounts Disclosure [Line Items] | |
| Balance at December 12, 2018 | $ 22,131 |
| Provisions related to sales | 4,226 |
| Credits/payments made relating to sales | (2,620) |
| Balance at December 31, 2018 | 23,737 |
| Chargebacks and Discounts | |
| Valuation And Qualifying Accounts Disclosure [Line Items] | |
| Balance at December 12, 2018 | 466 |
| Provisions related to sales | 415 |
| Credits/payments made relating to sales | (365) |
| Balance at December 31, 2018 | 516 |
| Rebates, Fees and other Deductions | |
| Valuation And Qualifying Accounts Disclosure [Line Items] | |
| Balance at December 12, 2018 | 21,247 |
| Provisions related to sales | 3,869 |
| Credits/payments made relating to sales | (2,255) |
| Balance at December 31, 2018 | 22,861 |
| Returns | |
| Valuation And Qualifying Accounts Disclosure [Line Items] | |
| Balance at December 12, 2018 | 418 |
| Provisions related to sales | (58) |
| Balance at December 31, 2018 | $ 360 |
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of valuation and qualifying accounts and reserves. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of increase in valuation and qualifying accounts and reserves from charge to cost and expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of decrease in valuation and qualifying accounts and reserves. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
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|
License, Collaboration and Other Significant Agreements - Additional Information (Details) |
1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | 144 Months Ended | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oct. 24, 2018
USD ($)
|
May 12, 2017
USD ($)
|
Apr. 25, 2017
USD ($)
|
Feb. 09, 2017
USD ($)
$ / shares
shares
|
Dec. 31, 2018
USD ($)
shares
|
May 31, 2017
USD ($)
$ / shares
shares
|
Mar. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
Dec. 31, 2018
USD ($)
shares
|
Sep. 30, 2018
USD ($)
|
Jun. 30, 2018
USD ($)
|
Mar. 31, 2018
USD ($)
|
Mar. 31, 2017
USD ($)
|
Dec. 31, 2018
USD ($)
shares
|
Jun. 30, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
Obligation
shares
|
Dec. 31, 2017
USD ($)
shares
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2018
USD ($)
shares
|
Sep. 30, 2017
USD ($)
|
|
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | $ 207,742,000 | $ 181,227,000 | $ 1,535,000 | ||||||||||||||||||
| Deferred revenue | $ 112,689,000 | $ 112,689,000 | $ 112,689,000 | 112,689,000 | $ 112,689,000 | ||||||||||||||||
| Deferred revenue, current | 56,980,000 | 56,980,000 | 56,980,000 | 56,980,000 | 81,667,000 | 56,980,000 | |||||||||||||||
| Deferred revenue, noncurrent | $ 55,709,000 | $ 55,709,000 | $ 55,709,000 | $ 55,709,000 | $ 97,957,000 | $ 55,709,000 | |||||||||||||||
| Common stock shares sold | shares | 116,887,518 | 116,887,518 | 116,887,518 | 116,887,518 | 47,612,619 | 116,887,518 | |||||||||||||||
| Proceeds from common stock sold | $ 468,400,000 | ||||||||||||||||||||
| Panion & BF Biotech, Incorporation | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| License agreement payment | $ 500,000 | ||||||||||||||||||||
| Accounts Payable | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Deferred revenue | $ 13,492,000 | $ 13,492,000 | $ 13,492,000 | $ 13,492,000 | 13,492,000 | ||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 0 | ||||||||||||||||||||
| Number of performance obligations | Obligation | 3 | ||||||||||||||||||||
| Deferred revenue | 63,360,000 | 63,360,000 | 63,360,000 | $ 63,360,000 | 63,360,000 | ||||||||||||||||
| Collaborative arrangements cost sharing payments | $ 167,500,000 | ||||||||||||||||||||
| Percentage of market penetration for license agreement | 90.00% | ||||||||||||||||||||
| License agreement, notice period for termination | 12 months | ||||||||||||||||||||
| Transaction price | $ 326,300,000 | ||||||||||||||||||||
| Reimbursement for Otsuka's share of costs previously incurred | $ 33,800,000 | ||||||||||||||||||||
| Transaction price, description | As of December 31, 2018, the transaction price totaling $326.3 million is comprised of: (i) the up-front payment of $125.0 million, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016 of $33.8 million, and (iii) the estimate of the cost share payments to be received of approximately $167.5 million with respect to amounts incurred by the Company subsequent to December 31, 2016. As of December 31, 2018, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. | ||||||||||||||||||||
| Deferred revenue, current | 33,451,000 | 33,451,000 | 33,451,000 | $ 33,451,000 | 33,451,000 | ||||||||||||||||
| Deferred revenue, noncurrent | 29,909,000 | 29,909,000 | 29,909,000 | 29,909,000 | 29,909,000 | ||||||||||||||||
| Cost share costs incurred | 1,200,000 | ||||||||||||||||||||
| Reimbursable by Otsuka | 500,000 | ||||||||||||||||||||
| Cost share costs by partner for license agreement | 1,100,000 | ||||||||||||||||||||
| Reimbursable to Otsuka | 500,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Accounts Payable | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Deferred revenue, current | 7,200,000 | 7,200,000 | 7,200,000 | $ 7,200,000 | 7,200,000 | ||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Percentage of increase in funding to fund current global development costs | 80.00% | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Minimum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Percentage of increase in funding to fund current global development costs | 52.50% | ||||||||||||||||||||
| Reduction in percentage of future payments due upon current global development costs creditable | 50.00% | ||||||||||||||||||||
| Percentage of remaining creditable amount applied to future payments | 50.00% | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Development and Regulatory Milestones | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 0 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Commercial Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 575,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Development Milestones | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 125,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Regulatory Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 65,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | Up-front, Non-refundable and Non-creditable | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | $ 125,000,000 | $ 125,000,000 | |||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Number of performance obligations | Obligation | 3 | ||||||||||||||||||||
| Deferred revenue | 44,650,000 | 44,650,000 | 44,650,000 | $ 44,650,000 | 44,650,000 | ||||||||||||||||
| Transaction price | 249,300,000 | ||||||||||||||||||||
| Reimbursement for Otsuka's share of costs previously incurred | $ 200,000 | ||||||||||||||||||||
| Transaction price, description | As of December 31, 2018, the transaction price totaling $249.3 million is comprised of: (i) the up-front payment of $73.0 million, (ii) the cost share payment with respect to amounts incurred by the Company during the quarter ended March 31, 2017 of $0.2 million, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to March 31, 2017 of $176.1 million. As of December 31, 2018, no development or regulatory milestones have been assessed as probable of being reached and thus have been fully constrained. | ||||||||||||||||||||
| Deferred revenue, current | 23,529,000 | 23,529,000 | 23,529,000 | $ 23,529,000 | 23,529,000 | ||||||||||||||||
| Deferred revenue, noncurrent | 21,121,000 | 21,121,000 | 21,121,000 | 21,121,000 | 21,121,000 | ||||||||||||||||
| Estimate Subsequent Cost Share Payment Receivable | 176,100,000 | ||||||||||||||||||||
| Milestone or royalty payments received | $ 0 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Accounts Payable | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Deferred revenue, current | 6,300,000 | 6,300,000 | 6,300,000 | 6,300,000 | 6,300,000 | ||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Development and Regulatory Milestones | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 0 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Commercial Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 525,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Development Milestones | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 80,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Regulatory Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 52,000,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | Up-front, Non-refundable and Non-creditable | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 73,000,000 | 73,000,000 | |||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Global Development Plan | Development and Commercialize United States Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Reimbursement for Otsuka's share of costs previously incurred | $ 33,800,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Global Development Plan | Development and Commercialize United States Collaboration and License Agreement | Minimum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Collaborative arrangements cost sharing payments | 167,500,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Global Development Plan | Development and Commercialize International Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Reimbursement for Otsuka's share of costs previously incurred | $ 200,000 | ||||||||||||||||||||
| Otsuka Pharmaceutical Company. Ltd. | Global Development Plan | Development and Commercialize International Collaboration and License Agreement | Minimum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Estimate Subsequent Cost Share Payment Receivable | $ 176,100,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | $ 20,000,000 | 20,000,000 | |||||||||||||||||||
| Development costs incurred | 0 | $ 20,500,000 | |||||||||||||||||||
| Reimbursement of development costs incurred | $ 500,000 | ||||||||||||||||||||
| Collaboration Agreement, expiration period | 10 years | ||||||||||||||||||||
| Collaboration Agreement, notice period for termination | 12 months | ||||||||||||||||||||
| Additional milestone or royalty payments received | $ 0 | ||||||||||||||||||||
| Number of performance obligations | Obligation | 2 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 265,000,000 | ||||||||||||||||||||
| Milestone revenue | 50,000,000 | ||||||||||||||||||||
| Milestone revenue | 245,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Upfront | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Incurred clinical and commercial development cost | 20,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development and Regulatory Milestones | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 50,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Commercial Milestone Payments | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 175,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Commercial Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 175,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development, Regulatory and Sales Milestones | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Percentage of royalty payments on sales | 20.00% | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development, Regulatory and Commercial Events | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 225,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development Milestones | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 4,000,000 | 10,000,000 | |||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Development Milestones | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 40,000,000 | ||||||||||||||||||||
| Milestone revenue | 175,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development and Commercialize Collaboration Agreement | Regulatory Milestone Payments | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 40,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | New Agreement | Maximum | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Data access fee receivable | $ 25,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Upfront cash payment received | 20,000,000 | ||||||||||||||||||||
| Cost of research services | 20,500,000 | ||||||||||||||||||||
| Deferred revenue | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||
| Accounts receivable | 0 | 0 | $ 0 | 0 | $ 0 | ||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | Regulatory Milestone Payments | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 0 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | Development Milestones One | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | 6,000,000 | ||||||||||||||||||||
| Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | Development Milestones Two | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 4,000,000 | ||||||||||||||||||||
| Janssen Pharmaceutica NV | Development And Commercialize Research And License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 215,000,000 | ||||||||||||||||||||
| Collaboration Agreement, expiration period | 10 years | ||||||||||||||||||||
| Collaboration Agreement, notice period for termination | 180 days | ||||||||||||||||||||
| Upfront cash payment received | $ 16,500,000 | ||||||||||||||||||||
| Upfront payment made in cash | $ 1,000,000 | ||||||||||||||||||||
| Warrant to purchase common stock, shares | shares | 509,611 | ||||||||||||||||||||
| Johnson & Johnson Innovation | Development And Commercialize Research And License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Warrant to purchase common stock, shares | shares | 509,611 | ||||||||||||||||||||
| Fair value of warrant | $ 3,400,000 | $ 3,400,000 | |||||||||||||||||||
| Exercise price | $ / shares | $ 9.81 | ||||||||||||||||||||
| Vifor (International) Ltd. | License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Milestone revenue | $ 20,000,000 | $ 20,000,000 | |||||||||||||||||||
| License agreement, notice period for termination | 12 months | ||||||||||||||||||||
| Deferred revenue, noncurrent | $ 4,700,000 | ||||||||||||||||||||
| Common stock shares sold | shares | 3,571,429 | ||||||||||||||||||||
| Sale of stock, price per share | $ / shares | $ 14.00 | ||||||||||||||||||||
| Proceeds from common stock sold | $ 50,000,000 | ||||||||||||||||||||
| Premium over the closing stock price of common stock | $ / shares | $ 12.69 | ||||||||||||||||||||
| Premium amount over the closing stock price of common stock | $ 4,700,000 | ||||||||||||||||||||
| Japan Tobacco Incorporation And Torii Pharmaceutical Company Limited | License Agreement | Panion & BF Biotech, Incorporation | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Royalty payments | 400,000 | ||||||||||||||||||||
| Japan Tobacco Incorporation And Torii Pharmaceutical Company Limited | Sublicense Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | $ 100,000 | ||||||||||||||||||||
| Number of performance obligations | Obligation | 2 | ||||||||||||||||||||
| License agreement, notice period for termination | 6 months | ||||||||||||||||||||
| Potential payment for achievement of annual net sales milestones | $ 55,000,000 | ||||||||||||||||||||
| Prior written notice for termination on the breach of agreement period | 60 days | ||||||||||||||||||||
| License, Collaboration and Other Revenue | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | $ 53,026,000 | $ 53,169,000 | $ 48,793,000 | $ 45,930,000 | $ 200,918,000 | $ 181,227,000 | 1,535,000 | ||||||||||||||
| License, Collaboration and Other Revenue | Clinical and Regulatory Activities | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 335,000 | 31,000 | |||||||||||||||||||
| License, Collaboration and Other Revenue | Mitsubishi Tanabe Pharma Corporation and Otsuka Pharmaceutical Company Limited | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 200,471,000 | 181,196,000 | 1,535,000 | ||||||||||||||||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 1,500,000 | ||||||||||||||||||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 103,870,000 | 85,971,000 | 1,535,000 | ||||||||||||||||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 87,320,000 | 52,307,000 | |||||||||||||||||||
| License, Collaboration and Other Revenue | Mitsubishi Tanabe Pharma Corporation | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 9,281,000 | 42,918,000 | |||||||||||||||||||
| License, Collaboration and Other Revenue | Mitsubishi Tanabe Pharma Corporation | Development And Commercialize Research And License Agreement | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | 9,300,000 | $ 42,900,000 | $ 0 | ||||||||||||||||||
| License, Collaboration and Other Revenue | Japan Tobacco Incorporation And Torii Pharmaceutical Company Limited | |||||||||||||||||||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||
| Recognized revenue under license agreement | $ 112,000 | ||||||||||||||||||||
| X | ||||||||||
- Definition Additional milestone or royalty payments received. No definition available.
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| X | ||||||||||
- Definition Closing stock price of common stock. No definition available.
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| X | ||||||||||
- Definition Collaboration agreement, expiration period. No definition available.
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| X | ||||||||||
- Definition Collaboration agreement, termination, notice period. No definition available.
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| X | ||||||||||
- Definition Collaborative and license arrangement, transaction price. No definition available.
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| X | ||||||||||
- Definition Collaborative arrangement of premium amount over closing stock price of common stock. No definition available.
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| X | ||||||||||
- Definition Collaborative arrangements cost sharing payments. No definition available.
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| X | ||||||||||
- Definition Cost of research services. No definition available.
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| X | ||||||||||
- Definition Cost share costs incurred by partner for license agreement. No definition available.
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| X | ||||||||||
- Definition Cost share costs incurred for license agreement. No definition available.
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| X | ||||||||||
- Definition Data access fee receivable. No definition available.
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| X | ||||||||||
- Definition Development costs incurred. No definition available.
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| X | ||||||||||
- Definition Estimate subsequent cost funding under plan. No definition available.
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| X | ||||||||||
- Definition Incurred clinical and commercial development cost. No definition available.
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| X | ||||||||||
- Definition License agreement payment. No definition available.
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| X | ||||||||||
- Definition License agreement, termination, notice period. No definition available.
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| X | ||||||||||
- Definition Milestone or royalty payment received. No definition available.
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| X | ||||||||||
- Definition Milestone payment received. No definition available.
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| X | ||||||||||
- Definition Number of performance obligations. No definition available.
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| X | ||||||||||
- Definition Payment for license agreement reimbursement of costs incurred. No definition available.
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| X | ||||||||||
- Definition Payment receivable for license agreement reimbursement of previously costs incurred. No definition available.
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| X | ||||||||||
- Definition Payment received for license agreement reimbursement of costs incurred. No definition available.
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| X | ||||||||||
- Definition Payment received for license agreement reimbursement of previously costs incurred. No definition available.
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| X | ||||||||||
- Definition Percentage of increase in funding to fund current global development costs. No definition available.
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| X | ||||||||||
- Definition Percentage of remaining creditable amount applied to future payments. No definition available.
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| X | ||||||||||
- Definition Percentage of royalty payments on sales. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of annual net sales milestones. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of specified commercial milestones. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of specified development and regulatory milestones. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of specified development milestones. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of specified milestones. No definition available.
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| X | ||||||||||
- Definition Potential payment for achievement of specified regulatory milestones. No definition available.
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| X | ||||||||||
- Definition Prior written notice for termination on the breach of agreement period. No definition available.
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| X | ||||||||||
- Definition Proceeds from reimbursement of development costs incurred. No definition available.
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| X | ||||||||||
- Definition Reduction in percentage of future payments due upon current global development costs creditable. No definition available.
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| X | ||||||||||
- Definition Royalty payments due to related party. No definition available.
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| X | ||||||||||
- Definition Threshold for percentage of market penetration for license agreement expiration. No definition available.
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| X | ||||||||||
- Definition Upfront cash payment received. No definition available.
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| X | ||||||||||
- Definition Upfront payment paid in cash. No definition available.
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| X | ||||||||||
- Definition For unclassified balance sheet, amounts due from customers or clients for goods or services that have been delivered or sold in the normal course of business. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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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| 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
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| X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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://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 noncurrent. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- 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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| 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://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Description of method, input, and assumption used to determine transaction price. Includes, but is not limited to, estimating variable consideration, adjusting consideration for effect of time value of money, and measuring noncash consideration. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Per share amount received by subsidiary or equity investee for each share of common stock issued or sold in the stock transaction. No definition available.
|
| X | ||||||||||
- Definition Fair value portion of warrants not settleable in cash classified as equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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License, Collaboration and Other Significant Agreements - Revenues Recognized From License, Collaboration and Other Significant Agreements (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |||||
|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | $ 207,742,000 | $ 181,227,000 | $ 1,535,000 | ||||
| License, Collaboration and Other Revenue | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | $ 53,026,000 | $ 53,169,000 | $ 48,793,000 | $ 45,930,000 | 200,918,000 | 181,227,000 | 1,535,000 |
| License, Collaboration and Other Revenue | Mitsubishi Tanabe Pharma Corporation | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 9,281,000 | 42,918,000 | |||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 1,500,000 | ||||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize United States Collaboration and License Agreement | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 103,870,000 | 85,971,000 | 1,535,000 | ||||
| License, Collaboration and Other Revenue | Otsuka Pharmaceutical Company. Ltd. | Development and Commercialize International Collaboration and License Agreement | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 87,320,000 | 52,307,000 | |||||
| License, Collaboration and Other Revenue | Mitsubishi Tanabe Pharma Corporation and Otsuka Pharmaceutical Company Limited | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 200,471,000 | 181,196,000 | $ 1,535,000 | ||||
| License, Collaboration and Other Revenue | Japan Tobacco Incorporation and Torii Pharmaceutical Company Limited | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | 112,000 | ||||||
| License, Collaboration and Other Revenue | Clinical and Regulatory Activities | |||||||
| License, Collaboration and Other Revenue: | |||||||
| License, Collaboration and Other Revenue | $ 335,000 | $ 31,000 | |||||
| X | ||||||||||
- Definition License, collaboration and other revenue. 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://fasb.org/us-gaap/role/ref/legacyRef
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License, Collaboration and Other Significant Agreements - Deferred Revenues Balance (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Deferred Revenue: | ||
| Short-Term | $ 56,980 | $ 81,667 |
| Long-Term | 55,709 | $ 97,957 |
| Total | 112,689 | |
| Otsuka Pharmaceutical Company. Ltd. | U.S. | ||
| Deferred Revenue: | ||
| Short-Term | 33,451 | |
| Long-Term | 29,909 | |
| Total | 63,360 | |
| Otsuka Pharmaceutical Company. Ltd. | International | ||
| Deferred Revenue: | ||
| Short-Term | 23,529 | |
| Long-Term | 21,121 | |
| Total | 44,650 | |
| Vifor Pharma | ||
| Deferred Revenue: | ||
| Long-Term | 4,679 | |
| Total | $ 4,679 |
| X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable. 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://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 noncurrent. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
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License, Collaboration and Other Significant Agreements - Schedule of Changes In Contract Assets and Liabilities (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract liabilities, Balance at End of Period | $ 112,689 | ||||
| Other Current Assets | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract assets, Additions | 531 | ||||
| Contract assets, Deductions | (531) | ||||
| Accounts Receivable | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract assets, Balance at Beginning of Period | [1] | 34,186 | $ 33,823 | ||
| Contract assets, Additions | [1] | 146,267 | 43,324 | ||
| Contract assets, Deductions | [1] | (178,866) | (42,961) | ||
| Contract assets, Balance at End of Period | [1] | 1,587 | 34,186 | ||
| Deferred Revenue | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract liabilities, Balance at Beginning of Period | 179,624 | 197,289 | |||
| Contract liabilities, Additions | 133,537 | 163,562 | |||
| Contract liabilities, Deductions | (200,472) | (181,227) | |||
| Contract liabilities, Balance at End of Period | 112,689 | $ 179,624 | |||
| Accounts Payable | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract liabilities, Additions | 17,919 | ||||
| Contract liabilities, Deductions | (4,427) | ||||
| Contract liabilities, Balance at End of Period | $ 13,492 | ||||
| |||||
| X | ||||||||||
- Definition Contract with customer asset additions. No definition available.
|
| X | ||||||||||
- Definition Contract with customer asset deductions. No definition available.
|
| X | ||||||||||
- Definition Contract with customer liability additions. No definition available.
|
| X | ||||||||||
- Definition Contract with customer liability deductions. 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, after allowance for credit loss, of right to consideration in exchange for good or service transferred to customer when right is conditioned on something other than passage of time, classified as current. 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://fasb.org/us-gaap/role/ref/legacyRef
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License, Collaboration and Other Significant Agreements - Schedule of Changes In Contract Assets and Liabilities (Parenthetical) (Details) - Accounts Receivable - USD ($) |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||
|---|---|---|---|---|---|
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract assets - Accounts receivable | [1] | $ 1,587,000 | $ 34,186,000 | $ 33,823,000 | |
| Product Sales | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract assets - Accounts receivable | 15,100,000 | ||||
| Other Services Related to Clinical and Regulatory Activities | |||||
| Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
| Contract assets - Accounts receivable | $ 5,000 | $ 30,000 | |||
| |||||
| 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 allowance for credit loss, of right to consideration in exchange for good or service transferred to customer when right is conditioned on something other than passage of time, classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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License, Collaboration and Other Significant Agreements - Schedule of Revenue Recognized Resulting from Changes in Contract Asset and Contract Liability (Details) - USD ($) $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
| Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
| Amounts included in deferred revenue at the beginning of the period | $ 137,726 | $ 125,454 |
| Performance obligations satisfied in previous periods | $ 6,659 | $ 275 |
| X | ||||||||||
- Definition Amount of revenue recognized that was previously included in balance of obligation to transfer good or service to customer for which consideration from customer has been received or is due. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of revenue recognized from performance obligation satisfied or partially satisfied in previous reporting periods. Includes, but is not limited to, change in transaction price. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- References No definition available.
|
Business Combination - Additional Information (Details) |
1 Months Ended | 12 Months Ended | |
|---|---|---|---|
|
Dec. 12, 2018
USD ($)
$ / shares
|
Dec. 31, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
shares
|
|
| Business Acquisition [Line Items] | |||
| Deferred tax liabilities | $ 6,631,000 | $ 6,631,000 | |
| Keryx Biopharmaceuticals, Inc. | |||
| Business Acquisition [Line Items] | |||
| Revenue | 6,900,000 | ||
| Net loss | 3,800,000 | ||
| Total fair value consideration | $ 527,754,000 | ||
| Business combination, Purchase price | $ 527,754,000 | ||
| Risk-adjusted discount rate used to calculate present value of future expected cash inflows of intangible assets | 20.00% | ||
| Preliminary fair value of the off-market element | $ 29,510,000 | ||
| Goodwill deductible for tax purposes | 0 | ||
| Deferred tax liabilities | $ 35,100,000 | 35,100,000 | |
| Keryx Biopharmaceuticals, Inc. | Non-recurring Charges | |||
| Business Acquisition [Line Items] | |||
| Fair value of additional shares issued | 13,400,000 | ||
| Direct transaction costs | 39,500,000 | ||
| Stock-based compensation expenses | 10,400,000 | ||
| Bonus and severance payments | 4,500,000 | ||
| Business combination tax benefits | 35,100,000 | ||
| Keryx Biopharmaceuticals, Inc. | General and Administrative Expenses | |||
| Business Acquisition [Line Items] | |||
| Direct transaction costs | $ 23,100,000 | ||
| Keryx Biopharmaceuticals, Inc. | Auryxia | |||
| Business Acquisition [Line Items] | |||
| Intangible asset, estimated useful life | 9 years | ||
| Keryx Biopharmaceuticals, Inc. | Common Stock | |||
| Business Acquisition [Line Items] | |||
| Total fair value consideration | $ 516,492,000 | ||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | |||
| Business Acquisition [Line Items] | |||
| Issued and outstanding cancelled, converted common stock | 0.37433 | 0.37433 | |
| Total fair value consideration | $ 527,800,000 | ||
| Share price of additional shares and awards issued | $ / shares | $ 8.94 | ||
| Additional shares expected to be issued | shares | 4,000,000 | ||
| Aggregate shares available for conversion | shares | 39,600,000 | ||
| Fair value of additional shares issued | $ 13,400,000 | ||
| Keryx Biopharmaceuticals, Inc. | Notes Conversion Agreement | |||
| Business Acquisition [Line Items] | |||
| Convertible notes amount | $ 164,700,000 | ||
| Keryx Biopharmaceuticals, Inc. | Notes Conversion Agreement | Common Stock | |||
| Business Acquisition [Line Items] | |||
| Convertible notes converted into shares | shares | 35,582,335 |
| X | ||||||||||
- Definition Aggregate number of shares available for conversion. No definition available.
|
| X | ||||||||||
- Definition Business combination bonus and severance payments. No definition available.
|
| X | ||||||||||
- Definition Business combination recognized identifiable assets acquired and liabilities assumed noncurrent liabilities fair value of off-market element. No definition available.
|
| X | ||||||||||
- Definition Business combination risk adjusted discount rates used to calculate present value of future expected cash inflows of intangible assets. No definition available.
|
| X | ||||||||||
- Definition Business combination stock based compensation expenses. No definition available.
|
| X | ||||||||||
- Definition Business combination tax benefits. No definition available.
|
| X | ||||||||||
- Definition Fair value of subsidiary or equity method investee cumulative number of additional shares issued for all transactions. No definition available.
|
| X | ||||||||||
- Definition Subsidiary or equity method investee cumulative number of additional shares expected to be issued for all transactions. 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 amount of goodwill arising from a business combination that is expected to be deductible for tax purposes. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Price of a single share of a number of saleable stocks paid or offered to be paid in a business combination. No definition available.
|
| X | ||||||||||
- Definition This element represents acquisition-related costs incurred to effect a business combination which costs have been expensed during the period. Such costs include finder's fees; advisory, legal, accounting, valuation, and other professional or consulting fees; general administrative costs, including the costs of maintaining an internal acquisitions department; and may include costs of registering and issuing debt and equity securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of consideration transferred, consisting of acquisition-date fair value of assets transferred by the acquirer, liabilities incurred by the acquirer, and equity interest issued by the acquirer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition This element represents the amount of earnings or loss of the acquiree since the acquisition date included in the consolidated income statement for the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition This element represents the amount of revenue of the acquiree since the acquisition date included in the consolidated income statement for the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount recognized for assets, including goodwill, in excess of (less than) the aggregate liabilities assumed. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The value of the financial instrument(s) that the original debt is being converted into in a noncash (or part noncash) transaction. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of shares issued in exchange for the original debt being converted in a noncash (or part noncash) transaction. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or payments in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount, after deferred tax asset, of deferred tax liability attributable to taxable differences without jurisdictional netting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Useful life of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
- Definition Ratio applied to the conversion of stock split, for example but not limited to, one share converted to two or two shares converted to one. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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| X | ||||||||||
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Business Combination - Summary of Total Fair Value Consideration (Details) - Keryx Biopharmaceuticals, Inc. $ in Thousands |
Dec. 12, 2018
USD ($)
|
|---|---|
| Business Acquisition [Line Items] | |
| Total fair value consideration | $ 527,754 |
| Akebia Common Stock | |
| Business Acquisition [Line Items] | |
| Total fair value consideration | 516,492 |
| Akebia RSUs | Precombination Employee Services | |
| Business Acquisition [Line Items] | |
| Total fair value consideration | 304 |
| Akebia Stock Options | Precombination Employee Services | |
| Business Acquisition [Line Items] | |
| Total fair value consideration | $ 10,958 |
| 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 transferred, consisting of acquisition-date fair value of assets transferred by the acquirer, liabilities incurred by the acquirer, and equity interest issued by the acquirer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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Business Combination - Summary of Total Fair Value Consideration (Parenthetical) (Details) - shares |
12 Months Ended | |
|---|---|---|
Dec. 12, 2018 |
Dec. 31, 2018 |
|
| Akebia Common Stock | ||
| Business Acquisition [Line Items] | ||
| Shares issued | 57,773,090 | |
| Keryx Biopharmaceuticals, Inc. | Akebia RSUs | ||
| Business Acquisition [Line Items] | ||
| RSU / Options issued | 602,752 | |
| Keryx Biopharmaceuticals, Inc. | Akebia Stock Options | ||
| Business Acquisition [Line Items] | ||
| RSU / Options issued | 3,967,290 | |
| Keryx Biopharmaceuticals, Inc. | Akebia Common Stock | ||
| Business Acquisition [Line Items] | ||
| Shares issued | 57,773,090 |
| X | ||||||||||
- Definition Number of shares of equity interests issued or issuable to acquire entity. 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 Number of shares of stock issued during the period pursuant to acquisitions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
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| X | ||||||||||
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| X | ||||||||||
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|
Business Combination - Summary of Purchase Price of Identifiable Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 12, 2018 |
|---|---|---|
| Business Acquisition [Line Items] | ||
| Goodwill | $ 55,053 | |
| Keryx Biopharmaceuticals, Inc. | ||
| Business Acquisition [Line Items] | ||
| Cash and cash equivalents | $ 5,257 | |
| Inventory | 235,597 | |
| Trade accounts receivable, net | 15,834 | |
| Prepaid expenses and other current assets | 8,399 | |
| Goodwill | $ 55,100 | 55,053 |
| Intangible assets: | ||
| Developed product rights for Auryxia | 329,130 | |
| Other intangible assets | 545 | |
| Property and equipment, net | 3,646 | |
| Other assets | 14,441 | |
| Accounts payable | (17,570) | |
| Accrued expenses | (42,972) | |
| Deferred tax liability | (35,096) | |
| Debt | (15,000) | |
| Fair value of unfavorable executory contract | (29,510) | |
| Total purchase price | $ 527,754 |
| X | ||||||||||
- Definition Business combination recognized identifiable assets acquired and liabilities assumed current liabilities accrued expenses. No definition available.
|
| X | ||||||||||
- Definition Business combination recognized identifiable assets acquired and liabilities assumed noncurrent liabilities fair value of off-market element. No definition available.
|
| X | ||||||||||
- Definition Business combination, recognized identifiable assets acquired and liabilities assumed, other intangible assets. 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 currency on hand as well as demand deposits with banks or financial institutions, acquired at the acquisition date. 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. 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, acquired at the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount due from customers or clients for goods or services, including trade receivables, that have been delivered or sold in the normal course of business, and amounts due from others, including related parties expected to be converted to cash, sold or exchanged within one year or the normal operating cycle, if longer, acquired at the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of liabilities incurred for goods and services received that are used in an entity's business and related party payables, assumed at the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred tax liability attributable to taxable temporary difference assumed at the acquisition date that are classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition The amount of identifiable intangible assets recognized as of the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The amount of inventory recognized as of the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of long-term debt due after one year or the normal operating cycle, if longer, assumed at the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of other assets expected to be realized or consumed after one year or the normal operating cycle, if longer, acquired at the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The amount of property, plant, and equipment recognized as of the acquisition date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount recognized for assets, including goodwill, in excess of (less than) the aggregate liabilities assumed. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Business Combination - Summary of Unaudited Estimated Pro Forma Financial Information (Details) - Keryx Biopharmaceuticals, Inc. - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
| Business Acquisition [Line Items] | ||
| Total revenue | $ 305,822 | $ 240,125 |
| Net loss | $ (322,664) | $ (331,118) |
| Net loss per share, basic and diluted | $ (2.75) | $ (3.22) |
| X | ||||||||||
- Definition Business acquisition pro forma earnings per share basic and diluted. 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 pro forma net Income or Loss for the period as if the business combination or combinations had been completed at the beginning of a period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition The pro forma revenue for a period as if the business combination or combinations had been completed at the beginning of the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Details
|
Available for Sale Securities - Summary of Available for Sale Securities at Fair Value (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|---|---|---|---|---|
| Schedule Of Available For Sale Securities [Line Items] | ||||
| Amortized Cost | $ 217,257 | $ 248,078 | ||
| Gross Unrealized Gains | 1 | |||
| Gross Unrealized Losses | (262) | (442) | ||
| Fair Value | 216,996 | 247,636 | ||
| Cash and cash equivalents | 104,644 | 70,156 | $ 187,335 | $ 49,778 |
| Cash and cash equivalents, Fair Value | 104,644 | 70,156 | ||
| Total cash, cash equivalents, and available for sale securities - Amortized Cost | 321,901 | 318,234 | ||
| Total cash, cash equivalents, and available for sale securities - Fair Value | 321,640 | 317,792 | ||
| U.S. government debt securities | ||||
| Schedule Of Available For Sale Securities [Line Items] | ||||
| Amortized Cost | 158,518 | 175,155 | ||
| Gross Unrealized Gains | 1 | |||
| Gross Unrealized Losses | (198) | (352) | ||
| Fair Value | 158,321 | 174,803 | ||
| Certificates of deposit | ||||
| Schedule Of Available For Sale Securities [Line Items] | ||||
| Amortized Cost | 245 | 14,117 | ||
| Fair Value | 245 | 14,117 | ||
| Corporate debt securities | ||||
| Schedule Of Available For Sale Securities [Line Items] | ||||
| Amortized Cost | 58,494 | 58,806 | ||
| Gross Unrealized Losses | (64) | (90) | ||
| Fair Value | $ 58,430 | $ 58,716 |
| X | ||||||||||
- Definition Cash cash equivalents and short term investments amortized cost. No definition available.
|
| X | ||||||||||
- Definition Amount, before tax, of unrealized gain in accumulated other comprehensive income (AOCI) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (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 investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| 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 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 Cash includes currency on hand as well as demand deposits with banks or financial institutions. It also includes other kinds of accounts that have the general characteristics of demand deposits in that the customer may deposit additional funds at any time and effectively may withdraw funds at any time without prior notice or penalty. Cash equivalents, excluding items classified as marketable securities, include short-term, highly liquid Investments that are both readily convertible to known amounts of cash, and so near their maturity that they present minimal 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. Short-term investments, exclusive of cash equivalents, generally consist of marketable securities intended to be sold within one year (or the normal operating cycle if longer) and may include trading securities, available-for-sale securities, or held-to-maturity securities (if maturing within one year), as applicable. 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 | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Available for Sale Securities - Estimated Fair Value of Available for Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Investments Debt And Equity Securities [Abstract] | ||
| Due in one year or less | $ 216,751 | |
| Due after one year | 245 | |
| Total available for sale securities | $ 216,996 | $ 247,636 |
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in net income (available-for-sale), classified as noncurrent. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
Available for Sale Securities - Additional Information (Details) |
12 Months Ended | |
|---|---|---|
|
Dec. 31, 2018
USD ($)
Security
|
Dec. 31, 2017
USD ($)
Security
|
|
| Investments Debt And Equity Securities [Abstract] | ||
| Gains (losses) on available for sale securities | $ | $ 0 | $ 0 |
| Available-for-sale, securities in unrealized loss position, number of securities | Security | 51 | 60 |
| X | ||||||||||
- Definition Amount of realized gain (loss) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/recommendedDisclosureRef
|
| X | ||||||||||
- Definition Number of investments in debt securities measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in unrealized loss position. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- References No definition available.
|
Available for Sale Securities - Summary of Available for Sale Securities that were in Continuous Unrealized Loss Position (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Schedule Of Available For Sale Securities [Line Items] | ||
| Unrealized Loss for Less Than 12 Months, Grosss Unrealized Losses | $ (223) | $ (433) |
| Unrealized Loss for Less Than 12 Months, Estimated Fair Value | 174,456 | 229,528 |
| Unrealized Loss for 12 Months or More, Gross Unrealized Losses | (39) | (9) |
| Unrealized Loss for 12 Months or More, Estimated Fair Value | 29,934 | 3,991 |
| Total, Gross Unrealized Losses | (262) | (442) |
| Total, Estimated Fair Value | 204,390 | 233,519 |
| U.S. government debt securities | ||
| Schedule Of Available For Sale Securities [Line Items] | ||
| Unrealized Loss for Less Than 12 Months, Grosss Unrealized Losses | (159) | (343) |
| Unrealized Loss for Less Than 12 Months, Estimated Fair Value | 116,026 | 170,812 |
| Unrealized Loss for 12 Months or More, Gross Unrealized Losses | (39) | (9) |
| Unrealized Loss for 12 Months or More, Estimated Fair Value | 29,934 | 3,991 |
| Total, Gross Unrealized Losses | (198) | (352) |
| Total, Estimated Fair Value | 145,960 | 174,803 |
| Corporate debt securities | ||
| Schedule Of Available For Sale Securities [Line Items] | ||
| Unrealized Loss for Less Than 12 Months, Grosss Unrealized Losses | (64) | (90) |
| Unrealized Loss for Less Than 12 Months, Estimated Fair Value | 58,430 | 58,716 |
| Total, Gross Unrealized Losses | (64) | (90) |
| Total, Estimated Fair Value | $ 58,430 | $ 58,716 |
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in continuous unrealized loss position for more than 12 months. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of accumulated unrealized loss on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in continuous unrealized loss position for 12 months or longer. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in continuous unrealized loss position for less than 12 months. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of accumulated unrealized loss on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in continuous unrealized loss position for less than 12 months. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in unrealized loss position. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of accumulated unrealized loss on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), in unrealized loss position. 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 | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Fair Value of Financial Instruments - Assets Measured or Disclosed at Fair Value on Recurring Basis (Details) - USD ($) |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Cash and cash equivalents, Fair Value | $ 104,644,000 | $ 70,156,000 |
| Assets Measured at fair value on recurring basis | 216,751,000 | |
| Level 3 | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 0 | 0 |
| Fair value measurements recurring | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Cash and cash equivalents, Fair Value | 104,644,000 | 70,156,000 |
| Assets Measured at fair value on recurring basis | 321,640,000 | 317,792,000 |
| Fair value measurements recurring | Certificates of deposit | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 245,000 | 14,117,000 |
| Fair value measurements recurring | U.S. government debt securities | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 158,321,000 | 174,803,000 |
| Fair value measurements recurring | Corporate debt securities | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 58,430,000 | 58,716,000 |
| Fair value measurements recurring | Level 1 | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Cash and cash equivalents, Fair Value | 104,644,000 | 70,156,000 |
| Assets Measured at fair value on recurring basis | 104,644,000 | 70,156,000 |
| Fair value measurements recurring | Level 2 | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 216,996,000 | 247,636,000 |
| Fair value measurements recurring | Level 2 | Certificates of deposit | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 245,000 | 14,117,000 |
| Fair value measurements recurring | Level 2 | U.S. government debt securities | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | 158,321,000 | 174,803,000 |
| Fair value measurements recurring | Level 2 | Corporate debt securities | ||
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | $ 58,430,000 | $ 58,716,000 |
| X | ||||||||||
- Definition Available for sale securities debt securities current including cash and cash equivalents. No definition available.
|
| X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| 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.
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Fair Value of Financial Instruments - Additional Information (Details) - Level 3 - USD ($) |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
| Assets Measured at fair value on recurring basis | $ 0 | $ 0 |
| Liabilities measured at fair value on recurring basis | $ 0 | $ 0 |
| X | ||||||||||
- Definition Available for sale securities debt securities current including cash and cash equivalents. 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 Fair value of financial and nonfinancial obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Inventory - Components of Inventory (Details) $ in Thousands |
Dec. 31, 2018
USD ($)
|
|---|---|
| Inventory Disclosure [Abstract] | |
| Raw materials | $ 1,880 |
| Work in process | 215,122 |
| Finished goods | 18,182 |
| Total inventory | 235,184 |
| Inventory | 114,245 |
| Other assets | $ 120,939 |
| X | ||||||||||
- Definition Inventory gross before other inventory. No definition available.
|
| 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 Gross 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
|
| 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
|
| X | ||||||||||
- Definition Amount before valuation and LIFO reserves of other 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
|
Inventory - Additional Information (Details) |
1 Months Ended |
|---|---|
|
Dec. 31, 2018
USD ($)
| |
| Inventory Disclosure [Abstract] | |
| Inventory amounts written down | $ 0 |
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of loss from reductions in inventory due to subsequent measurement adjustments, including, but not limited to, physical deterioration, obsolescence, or changes in price levels. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Intangible Assets and Goodwill - Summary of Intangible Assets (Details) $ in Thousands |
12 Months Ended |
|---|---|
|
Dec. 31, 2018
USD ($)
| |
| Finite Lived Intangible Assets [Line Items] | |
| Intangible Assets | $ 329,675 |
| Less accumulated amortization | (1,522) |
| Total intangible assets, net | 328,153 |
| Developed Product Rights for Auryxia | |
| Finite Lived Intangible Assets [Line Items] | |
| Intangible Assets | $ 329,130 |
| Intangible asset, estimated useful life | 9 years |
| Other Intangible Assets | |
| Finite Lived Intangible Assets [Line Items] | |
| Intangible Assets | $ 545 |
| Intangible asset, estimated useful life | 4 years |
| X | ||||||||||
- Definition Useful life of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
- Definition Accumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. 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 after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Intangible Assets and Goodwill - Additional Information (Details) - USD ($) $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2018 |
Dec. 12, 2018 |
|
| Finite Lived Intangible Assets [Line Items] | ||
| Amortization expense | $ 1,522 | |
| Goodwill | 55,053 | |
| Keryx Biopharmaceuticals, Inc. | ||
| Finite Lived Intangible Assets [Line Items] | ||
| Goodwill | $ 55,100 | $ 55,053 |
| X | ||||||||||
- Definition The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back 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
|
| 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 impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Intangible Assets and Goodwill - Schedule of Estimated Future Amortization Expense for Intangible Assets (Details) $ in Thousands |
Dec. 31, 2018
USD ($)
|
|---|---|
| Goodwill And Intangible Assets Disclosure [Abstract] | |
| 2019 | $ 36,531 |
| 2020 | 36,531 |
| 2021 | 36,531 |
| 2022 | 36,531 |
| 2023 | 36,423 |
| Thereafter | 145,606 |
| Total intangible assets, net | $ 328,153 |
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized after 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. No definition available.
|
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during 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/legacyRef
|
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during 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/legacyRef
|
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during 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/legacyRef
|
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during 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/legacyRef
|
| X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during 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/legacyRef
|
| X | ||||||||||
- Definition Amount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
Accrued Expenses - Components of Accrued Expenses (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Payables And Accruals [Abstract] | ||
| Accrued clinical | $ 71,881 | $ 43,297 |
| Product revenue allowances | 22,861 | |
| Merger costs | 16,071 | |
| Accrued bonus | 9,537 | 3,388 |
| Accrued commercial manufacturing | 6,383 | |
| Accrued severance | 3,962 | |
| Royalties | 2,430 | |
| Professional fees | 2,367 | 808 |
| Accrued payroll | 2,255 | 795 |
| Accrued vacation | 1,088 | 797 |
| Income tax payable | 987 | |
| Accrued other | 12,082 | 2,369 |
| Total accrued expenses | $ 150,917 | $ 52,441 |
| X | ||||||||||
- Definition Accrued clinical expenses current. No definition available.
|
| X | ||||||||||
- Definition Accrued Commercial Manufacturing Current No definition available.
|
| X | ||||||||||
- Definition Accrued merger costs current. No definition available.
|
| X | ||||||||||
- Definition Accrued product revenue allowances current. No definition available.
|
| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable for incentive compensation awarded to employees and directors or earned by them based on the terms of one or more relevant arrangements. 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 Carrying amount as of the balance sheet date of the unpaid sum of the known and estimated amounts payable to satisfy all currently due domestic and foreign income tax obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| 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 | ||||||||||
- 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 Carrying value as of the balance sheet date of obligations incurred through that date and payable for royalties. 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 Carrying value as of the balance sheet date of the obligations incurred through that date and payable for employees' services provided. 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 Carrying value as of the balance sheet date of obligations incurred and payable for unused vacation time owed to employees based on the entity's vacation benefit given to its employees. 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
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition For a classified balance sheet, the carrying amount as of the balance sheet date of the portion of the obligations recognized for the various benefits provided to former or inactive employees, their beneficiaries, and covered dependents after employment but before retirement that is payable within one year of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Debt - Additional Information (Details) - USD ($) |
1 Months Ended | |
|---|---|---|
Dec. 12, 2018 |
Dec. 31, 2018 |
|
| Line Of Credit Facility [Line Items] | ||
| Line of credit, outstanding principal balance | $ 15,000,000 | |
| Loan and Security Agreement | Silicon Valley Bank | Revolving Credit Facility | ||
| Line Of Credit Facility [Line Items] | ||
| Line of credit, maximum borrowing capacity | $ 40,000,000 | |
| Line of credit, available borrowing base | 16,000,000 | |
| Line of credit, outstanding principal balance | 15,000,000 | |
| Line of credit, stated interest rate | 6.75% | |
| Line of credit, frequency of periodic interest payment | monthly | |
| Line of credit, term | 2 years | |
| Line of credit, commitment fee description | Upon entry into the Loan and Security Agreement (payable in installments and subject to certain conditions), and at the one year anniversary of the effective date of the Loan and Security Agreement (or, if earlier, upon termination of or an event of default under the Loan and Security Agreement), Keryx must pay to SVB a fee equal to 1.00% of the Line of Credit. Keryx is also required to pay on a quarterly basis a fee equal to 0.25% per annum of the average unused portion of the Line of Credit. Keryx must pay a termination fee of 2.00% of the Line of Credit, if the Loan and Security Agreement is terminated prior to the maturity date, subject to certain exceptions. | |
| Line of credit, commitment fee percentage | 1.00% | |
| Line of credit, frequency of commitment fee on unused portion | quarterly basis | |
| Percentage of commitment fees percent on unused portion of credit facility | 0.25% | |
| Line of credit, termination fee percentage | 2.00% | |
| Covenant terms, description | The Loan and Security Agreement contains customary covenants applicable to Keryx and its subsidiaries, including maintaining insurance on its business, achievement of minimum revenue amounts, the incurrence of additional indebtedness, and future encumbrances on Keryx’s assets. In addition, the Keryx must maintain a liquidity ratio, defined as (i) the sum of unrestricted and unencumbered cash and cash equivalents maintained at SVB or its affiliates plus net billed accounts receivable divided by (ii) all outstanding obligations and liabilities of Keryx to SVB, including the aggregate amount of Keryx’s obligations to SVB under any business credit cards, of at least 1.5 to 1.0, measured monthly. | |
| Minimum liquidity ratio | 150.00% | |
| Line of credit, debt default, description | Upon an event of default under the Loan and Security Agreement, SVB is entitled to accelerate and demand payment of all amounts outstanding under the Loan and Security Agreement, stop advancing money or extending credit to Keryx, demand that Keryx deposit at least 105% of the face amount of any letters of credit remaining undrawn to secure all obligations thereunder, and exercise other remedies available to SVB under the Loan and Security Agreement and at law or in equity. | |
| Interest expense | $ 65,000 | |
| Amortization expense of origination and other fees | $ 0 | |
| Loan and Security Agreement | Silicon Valley Bank | Revolving Credit Facility | Minimum | ||
| Line Of Credit Facility [Line Items] | ||
| Line of credit, debt default, percentage | 105.00% | |
| Loan and Security Agreement | Silicon Valley Bank | Revolving Credit Facility | Prime Rate | Minimum | ||
| Line Of Credit Facility [Line Items] | ||
| Line of credit, variable interest rate | 2.00% |
| X | ||||||||||
- Definition Debt default line of credit percentage. No definition available.
|
| X | ||||||||||
- Definition Line of credit termination fee percentage. No definition available.
|
| X | ||||||||||
- Definition Minimum liquidity ratio. No definition available.
|
| X | ||||||||||
- Definition Amount of amortization expense attributable to debt issuance costs. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
- Definition Percentage points added to the reference rate to compute the variable rate on the debt instrument. No definition available.
|
| X | ||||||||||
- Definition Contractual interest rate for funds borrowed, under the debt agreement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Period of time between issuance and maturity of debt instrument, in PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
- Definition Discussion of the facts and amounts pertaining to each failure to comply with an affirmative or negative covenant of a long-term debt instrument, including violating payment terms or an inability to meet certain minimum financial requirements or achieve or maintain certain financial ratios. The discussion would generally be expected to also include whether or not the failure can and will be overcome and a description of the terms of any waivers, including the amount of the waiver and the period of time covered by the waiver, and if reclassification of long-term debt to current has been made in the current balance sheet. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of the cost of borrowed funds accounted for as interest expense for debt. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Description of the fees for amounts available, but unused under the credit facility. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The fee, expressed as a percentage of the line of credit facility, for the line of credit facility regardless of whether the facility has been used. No definition available.
|
| X | ||||||||||
- Definition Description of the conditions for borrowing under the credit facility including the nature of any restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Description of when the fee for available but unused credit capacity is required to be paid (for example, annually, quarterly, or monthly). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Description of the frequency of periodic payments, which may be presented in a variety of ways (for example, monthly, quarterly, annually). 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 Maximum borrowing capacity under the credit facility without consideration of any current restrictions on the amount that could be borrowed or the amounts currently outstanding under the facility. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of borrowing capacity currently available under the credit facility (current borrowing capacity less the amount of borrowings outstanding). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The fee, expressed as a percentage of the line of credit facility, for available but unused credit capacity under the credit facility. No definition available.
|
| X | ||||||||||
- Definition The carrying value as of the balance sheet date of the current portion of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
|
Warrant - Additional Information (Details) - Janssen Agreement - USD ($) $ / shares in Units, $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2018 |
Feb. 28, 2017 |
|
| Class Of Warrant Or Right [Line Items] | ||
| Warrant to purchase common stock, shares | 509,611 | |
| Exercise price | $ 9.81 | |
| Fair value of warrant at issuance | $ 3.4 | |
| Warrant expiration date | Feb. 09, 2022 |
| X | ||||||||||
- Definition Class of warrant or right, expiration date. No definition available.
|
| X | ||||||||||
- Definition Exercise price per share or per unit of warrants or rights outstanding. 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 Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Fair value portion of warrants not settleable in cash classified as equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Stockholders' Equity - Additional Information (Details) |
1 Months Ended | 3 Months Ended | 12 Months Ended | 16 Months Ended | 24 Months Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dec. 12, 2018
USD ($)
Installment
shares
|
Feb. 28, 2018
shares
|
Dec. 31, 2018
USD ($)
$ / shares
shares
|
Mar. 31, 2018
USD ($)
$ / shares
shares
|
May 31, 2016
USD ($)
|
Mar. 31, 2018
USD ($)
$ / shares
shares
|
Dec. 31, 2018
USD ($)
Installment
$ / shares
shares
|
Dec. 31, 2017
USD ($)
$ / shares
shares
|
Dec. 31, 2016
USD ($)
$ / shares
shares
|
Dec. 31, 2017
USD ($)
$ / shares
shares
|
Dec. 23, 2013
USD ($)
$ / shares
shares
|
Dec. 31, 2015
shares
|
Feb. 28, 2014
shares
|
|
| Class of Stock [Line Items] | |||||||||||||
| Common stock, shares authorized | 175,000,000 | 175,000,000 | 175,000,000 | 175,000,000 | |||||||||
| Common stock, par value | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||||||
| Common stock, shares issued | 116,887,518 | 116,887,518 | 47,612,619 | 47,612,619 | |||||||||
| Common stock, shares outstanding | 116,887,518 | 116,887,518 | 47,612,619 | 47,612,619 | |||||||||
| Preferred stock, shares authorized | 25,000,000 | 25,000,000 | 25,000,000 | 25,000,000 | |||||||||
| Preferred stock, par value | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||||||
| Preferred stock, shares issued | 0 | 0 | 0 | 0 | |||||||||
| Preferred stock, shares outstanding | 0 | 0 | 0 | 0 | |||||||||
| Proceeds from the issuance of common stock, net of issuance costs | $ | $ 95,452,000 | $ 114,580,000 | $ 66,736,000 | ||||||||||
| Stock-based compensation expense | $ | $ 19,040,000 | $ 12,280,000 | $ 5,825,000 | ||||||||||
| Common stock, shares reserved for future issuance | 14,948,900 | 14,948,900 | 7,341,253 | 7,341,253 | |||||||||
| Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 7.12 | $ 8.47 | $ 5.22 | ||||||||||
| Intrinsic value of options exercised | $ | $ 1,200,000 | $ 2,700,000 | $ 600,000 | ||||||||||
| Fair value of options vested | $ | 13,600,000 | 5,600,000 | 4,600,000 | ||||||||||
| Performance-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 0 | 0 | 0 | ||||||||||
| Granted, Shares | 233,954 | ||||||||||||
| Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 18.96 | ||||||||||||
| Fair value of options vested | $ | $ 0 | 0 | 0 | ||||||||||
| Oustanding, Shares | 0 | 202,136 | 202,136 | ||||||||||
| Vesting percentage, Following achievement of performance condition | 50.00% | ||||||||||||
| Inducement Award Program | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Maximum shares of common stock authorized to be issued | 750,000 | 750,000 | |||||||||||
| Granted, Shares | 375,750 | ||||||||||||
| Outstanding, Shares | 349,374 | 349,374 | |||||||||||
| Inducement Award Program | Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 375,750 | ||||||||||||
| Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 12,114,000 | $ 6,512,000 | 4,674,000 | ||||||||||
| Granted, Shares | 1,500,398 | ||||||||||||
| Outstanding, Shares | 8,144,752 | 8,144,752 | 3,660,014 | 3,660,014 | |||||||||
| Shares issued | 522,200 | ||||||||||||
| Stock-based compensation description | Options vest either 100% on the first anniversary of the grant date or in installments of (i) 25% at the one year anniversary and (ii) 12 equal quarterly installments beginning after the one year anniversary of the grant date, subject to the individual’s continuous service with the Company. | ||||||||||||
| Options expiration after the date of grant | 10 years | ||||||||||||
| Stock-based compensation expense | $ | $ 11,900,000 | $ 6,500,000 | 4,700,000 | ||||||||||
| Intrinsic value of options exercised | $ | $ 1,222,914 | ||||||||||||
| Stock Options | Share-based Compensation Award, Tranche, First Anniversary of Grant Date | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting percentage | 100.00% | ||||||||||||
| Stock Options | Share Based Compensation Award Tranche One | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting periods | 1 year | ||||||||||||
| Vesting percentage | 25.00% | ||||||||||||
| Stock Options | Share Based Compensation Award Tranche Two | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Number of equal quarterly installments | Installment | 12 | ||||||||||||
| Restricted Stock Units | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 6,731,000 | $ 2,021,000 | 780,000 | ||||||||||
| Granted, Shares | 367,250 | 644,340 | |||||||||||
| Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 11.22 | ||||||||||||
| Weighted average period of recognition for unrecognized compensation costs | 2 years 2 months 12 days | ||||||||||||
| Oustanding, Shares | 846,273 | 846,273 | 728,738 | 728,738 | |||||||||
| RSUs Issued related to merger | 486,709 | ||||||||||||
| Unrecognized compensation cost | $ | $ 5,400,000 | $ 5,400,000 | |||||||||||
| Restricted Stock Units | Share Based Compensation Award Tranche One | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting percentage | 100.00% | ||||||||||||
| Restricted Stock Units | Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 5,800,000 | $ 2,000,000 | 800,000 | ||||||||||
| Restricted Stock | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 0 | $ 158,000 | $ 266,000 | ||||||||||
| Granted, Shares | 0 | ||||||||||||
| Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 7.42 | ||||||||||||
| Grant-date fair value of restricted stock issued | $ | $ 3,900,000 | ||||||||||||
| Restricted Stock | Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 450,224 | ||||||||||||
| Restricted Stock | Non Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 79,067 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Common stock issuance | 3,967,290 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Restricted Stock Units | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Common stock issuance | 602,752 | ||||||||||||
| Stock-based compensation expense | $ | $ 900,000 | ||||||||||||
| RSUs Issued related to merger | 486,709 | ||||||||||||
| RSUs Issued related to merger, description | These RSUs vest either (i) in 3 equal annual installments beginning after the one-year anniversary of the grant date or (ii) one third on the one year anniversary of the grant date with the remaining RSUs vesting on the first day of each calendar quarter over the next two years thereafter. | ||||||||||||
| RSUs, Number of vesting installements | Installment | 3 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Issued and outstanding cancelled, converted common stock | 0.37433 | 0.37433 | |||||||||||
| Common stock issuance | 57,773,090 | ||||||||||||
| Issuance of Baupost additional shares | 1,497,320 | ||||||||||||
| Stock-based compensation expense | $ | $ 9,700,000 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Service-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Converted outstanding and unexercised options to purchase shares | 3,733,336 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Performance-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Converted outstanding and unexercised options to purchase shares | 233,954 | ||||||||||||
| Converted outstanding RSUs | 116,043 | ||||||||||||
| Granted, Shares | 233,954 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Service-Based RSUs | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Converted outstanding RSUs | 486,709 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Converted outstanding and unexercised options to purchase shares | 3,967,290 | ||||||||||||
| Stock-based compensation expense | $ | $ 200,000 | ||||||||||||
| Company assumed in the merger | 3,967,290 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Restricted Stock Units | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Converted outstanding RSUs | 602,752 | ||||||||||||
| Company assumed in the merger | 602,752 | ||||||||||||
| Keryx Biopharmaceuticals, Inc. | Merger Agreement | Stock options and RSUs | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 1,100,000 | ||||||||||||
| Common Stock | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Common stock, shares outstanding | 116,887,518 | 116,887,518 | 47,612,619 | 38,615,709 | 47,612,619 | 30,662,218 | |||||||
| Issuance of common stock, net of issuance costs, shares | 9,194,306 | 8,672,270 | 7,865,293 | ||||||||||
| Issuance of Baupost additional shares | 1,497,320 | ||||||||||||
| Common Stock | Follow-on public offering | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Issuance of common stock, net of issuance costs, shares | 8,500,000 | ||||||||||||
| Proceeds from the issuance of common stock, net of issuance costs | $ | $ 84,800,000 | ||||||||||||
| Sale of stock, price per share | $ / shares | $ 10.50 | $ 10.50 | |||||||||||
| Maximum | Performance-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Potential share issuable percentage | 100.00% | ||||||||||||
| Vesting percentage, upon achievement of performance condition | 50.00% | ||||||||||||
| Maximum | Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting periods | 48 months | ||||||||||||
| Maximum | Restricted Stock Units | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting periods | 3 years | ||||||||||||
| Minimum | Performance-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Potential share issuable percentage | 0.00% | ||||||||||||
| Minimum | Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting periods | 12 months | ||||||||||||
| Minimum | Restricted Stock Units | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Vesting periods | 1 year | ||||||||||||
| At The Market Equity Offering Program | Common Stock | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Issuance of common stock, net of issuance costs, shares | 694,306 | 0 | 1,080,908 | ||||||||||
| Proceeds from the issuance of common stock, net of issuance costs | $ | $ 10,500,000 | $ 12,100,000 | |||||||||||
| At The Market Equity Offering Program | Maximum | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Common stock sales agreement amount | $ | $ 75,000,000 | ||||||||||||
| 2014 Plans | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Common stock, shares reserved for future issuance | 4,526,563 | 4,526,563 | 1,790,600 | 1,790,600 | 1,785,000 | ||||||||
| Incremental rate at which the shares reserved for issuance increase | 3.00% | ||||||||||||
| 2014 Plans | Performance-Based Stock Options | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Compensation not yet recognized, stock options | $ | $ 500,000 | $ 500,000 | |||||||||||
| Weighted average period of recognition for unrecognized compensation costs | 1 year | ||||||||||||
| 2014 Plans | Inducement Award Program | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Compensation not yet recognized, stock options | $ | $ 8,700,000 | $ 8,700,000 | |||||||||||
| Weighted average period of recognition for unrecognized compensation costs | 2 years 10 months 9 days | ||||||||||||
| 2014 Plans | Stock Options | Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 862,148 | ||||||||||||
| 2014 Plans | Stock Options | Director | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 262,500 | ||||||||||||
| 2014 Plans | Restricted Stock Units | Employees | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Granted, Shares | 644,340 | ||||||||||||
| 2014 Employee Stock Purchase Plan | |||||||||||||
| Class of Stock [Line Items] | |||||||||||||
| Stock-based compensation expense | $ | $ 200,000 | $ 200,000 | $ 100,000 | ||||||||||
| Maximum shares of common stock authorized to be issued | 262,500 | 262,500 | |||||||||||
| Percentage of increase on common stock authorized on each anniversary | 1.00% | ||||||||||||
| Number of common stock outstanding | 739,611 | ||||||||||||
| Common stock shares authorized percentage under the plan | 5.00% | ||||||||||||
| Purchase price at the end of offering period | 85.00% | ||||||||||||
| Offering period | 6 months | ||||||||||||
| Shares issued | 48,768 | ||||||||||||
| X | ||||||||||
- Definition Allocated share based compensation granted expense. No definition available.
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| X | ||||||||||
- Definition Annual increase in aggregate number of shares reserved for future issuance as percentage shares outstanding. No definition available.
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| X | ||||||||||
- Definition Common stock sales agreement amount. No definition available.
|
| X | ||||||||||
- Definition Proceeds from issuance of common stock net of issuance costs. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award additional shares authorized percentage of common stock issued. No definition available.
|
| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, award vesting rights following achievement of performance condition, percentage. No definition available.
|
| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, award vesting rights upon achievement of performance condition, percentage. No definition available.
|
| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, converted outstanding and unexercised options to purchase. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options assumed in merger. No definition available.
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| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options converted outstanding options. No definition available.
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| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options grants in period aggregate weighted average grant date fair value. No definition available.
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| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options issued in merger. No definition available.
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| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options number of vesting installments. No definition available.
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| X | ||||||||||
- Definition Maximum number of shares that may be issued in accordance with the plan as a proportion of outstanding capital stock. No definition available.
|
| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, offering period. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options assumed in acquired shares. No definition available.
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| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, periodic vesting, number of installments. No definition available.
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| X | ||||||||||
- Definition Share-based compensation arrangement by share-based payment award, potential share issuable, percentage. No definition available.
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| X | ||||||||||
- Definition Represents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of shares of equity interests issued or issuable to acquire entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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 Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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| X | ||||||||||
- Definition Unrecognized cost of unvested share-based compensation awards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Weighted average period over which unrecognized compensation is expected to be recognized for equity-based compensation plans, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the 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 Unrecognized cost of unvested options awarded to employees as compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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| 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 | ||||||||||
- Definition Per share amount received by subsidiary or equity investee for each share of common stock issued or sold in the stock transaction. No definition available.
|
| X | ||||||||||
- Definition Period which an employee's right to exercise an award is no longer contingent on satisfaction of either a service condition, market condition or a performance condition, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Description of award terms as to how many shares or portion of an award are no longer contingent on satisfaction of either a service condition, market condition or a performance condition, thereby giving the employee the legal right to convert the award to shares, to sell the shares, and be entitled to the cash proceeds of such sale. For example, vesting may be expressed as being 25 percent of the shares under option on each anniversary of the grant date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition General descriptive information regarding an arrangement under which employees and directors receive: (a) awards of equity shares, equity share options, or other equity instruments; or (b) the entity incurs liabilities to them: (1) in amounts based, at least in part, on the price of the entity's shares or other equity instruments; or (2) that require or may require settlement by issuance of the entity's shares. Such an arrangement is usually provided to employees and directors to compensate them, provide performance incentives to them, and to attract or retain their services. May also include pertinent information particular to a plan that is not elsewhere specified in the taxonomy. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of grants made during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The weighted average fair value at grant date for nonvested equity-based awards issued during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of non-vested equity-based payment instruments, excluding stock (or unit) options, that validly exist and are outstanding as of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The maximum number of shares (or other type of equity) originally approved (usually by shareholders and board of directors), net of any subsequent amendments and adjustments, for awards under the equity-based compensation plan. As stock or unit options and equity instruments other than options are awarded to participants, the shares or units remain authorized and become reserved for issuance under outstanding awards (not necessarily vested). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of accumulated difference between fair value of underlying shares on dates of exercise and exercise price on options exercised (or share units converted) into shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
| X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Maximum number of shares that may be issued in accordance with the plan as a proportion of outstanding capital stock. No definition available.
|
| X | ||||||||||
- Definition Number of share instruments newly issued under a share-based compensation plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Percentage of vesting of share-based compensation awards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Period from grant date that an equity-based award expires, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Fair value of options vested. Excludes equity instruments other than options, for example, but not limited to, share units, stock appreciation rights, restricted stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Purchase price of common stock expressed as a percentage of its fair value. No definition available.
|
| X | ||||||||||
- Definition Number of shares issued during the period as a result of the conversion of convertible securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Ratio applied to the conversion of stock split, for example but not limited to, one share converted to two or two shares converted to one. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
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| X | ||||||||||
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Stockholders' Equity - Summary of Reserved Shares of Common Stock for Future Issuance (Details) - shares |
Dec. 31, 2018 |
Dec. 31, 2017 |
Feb. 28, 2014 |
|---|---|---|---|
| Class of Stock [Line Items] | |||
| Common stock, shares reserved for future issuance | 14,948,900 | 7,341,253 | |
| Warrant To Purchase Common Stock | |||
| Class of Stock [Line Items] | |||
| Common stock, shares reserved for future issuance | 509,611 | 509,611 | |
| Stock Options and Restricted Stock Units | |||
| Class of Stock [Line Items] | |||
| Common stock, shares reserved for future issuance | 9,309,204 | 4,388,752 | |
| 2014 Plans | |||
| Class of Stock [Line Items] | |||
| Common stock, shares reserved for future issuance | 4,526,563 | 1,790,600 | 1,785,000 |
| Employee Stock Purchase Plan | |||
| Class of Stock [Line Items] | |||
| Common stock, shares reserved for future issuance | 603,522 | 652,290 |
| 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 Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
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| X | ||||||||||
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| X | ||||||||||
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| X | ||||||||||
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Stockholders' Equity - Summary of Reserved Shares of Common Stock for Future Issuance (Parenthetical) (Details) - shares |
Jan. 01, 2019 |
Dec. 12, 2018 |
Jan. 01, 2018 |
Jan. 01, 2017 |
Feb. 28, 2016 |
Jan. 30, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 19, 2017 |
Feb. 28, 2014 |
|---|---|---|---|---|---|---|---|---|---|---|
| Class of Stock [Line Items] | ||||||||||
| Common stock, shares reserved for future issuance | 14,948,900 | 7,341,253 | ||||||||
| Employee Stock Purchase Plan | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Increase in common stock, shares reserved for future issuance | 0 | |||||||||
| Common stock, shares reserved for future issuance | 603,522 | 652,290 | ||||||||
| Maximum aggregate number of shares available for purchase | 739,611 | |||||||||
| 2014 Plans | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Increase in common stock, shares reserved for future issuance | 2,323,213 | 1,575,329 | 1,265,863 | |||||||
| Common stock, shares reserved for future issuance | 4,526,563 | 1,790,600 | 1,785,000 | |||||||
| 2014 Plans | Subsequent Event | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Increase in common stock, shares reserved for future issuance | 3,801,198 | |||||||||
| Inducement Award Program | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Common stock, shares reserved for future issuance | 750,000 | |||||||||
| Inducement Award Program | Subsequent Event | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Common stock, shares reserved for future issuance | 3,150,000 |
| X | ||||||||||
- Definition Increase decrease in common stock capital shares reserved for future issuance. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award maximum number of shares available for purchase. 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 Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stockholders' Equity - Schedule of Assumptions Used in Black-Scholes Option Pricing Model (Details) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
| Dividend yield | 0.00% | ||
| 2014 Plan | |||
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
| Risk-free interest rate, minimum | 2.54% | 1.81% | 1.16% |
| Risk-free interest rate, maximum | 3.01% | 2.27% | 2.03% |
| Dividend yield | 0.00% | 0.00% | 0.00% |
| Volatility, minimum | 61.65% | 78.57% | 64.78% |
| Volatility, maximum | 77.04% | 85.81% | 82.40% |
| 2014 Plan | Minimum | |||
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
| Expected term (years) | 5 years 6 months 3 days | 5 years 6 months 3 days | 5 years 6 months 3 days |
| 2014 Plan | Maximum | |||
| Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
| Expected term (years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
| X | ||||||||||
- 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 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 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 Expected term of share-based compensation awards, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
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| X | ||||||||||
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Stockholders' Equity - Schedule of Stock Option Activity (Details) - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Aggregate Intrinsic Value | |||
| Exercised, Aggregate Intrinsic Value | $ 1,200,000 | $ 2,700,000 | $ 600,000 |
| Stock Options | |||
| Share under option | |||
| Outstanding beginning balance, Shares | 3,660,014 | ||
| Granted, Shares | 1,500,398 | ||
| Assumed in connection with the Merger | 3,733,336 | ||
| Exercised, Shares | (178,382) | ||
| Forfeited, Shares | (570,614) | ||
| Outstanding ending balance, Shares | 8,144,752 | 3,660,014 | |
| Options exercisable at end of period, Shares | 6,423,555 | ||
| Vested and Expected to vest at end of period, Shares | 8,144,752 | ||
| Weighted Average-Exercise Price | |||
| Outstanding beginning balance, Weighted-Average Exercise Price | $ 9.47 | ||
| Granted, Weighted-Average Exercise Price | 10.72 | ||
| Assumed in connection with the Merger,Weighted-Average Exercise Price | 17.83 | ||
| Exercised, Weighted-Average Exercise Price | 3.63 | ||
| Forfeited, Weighted-Average Exercise Price | 10.78 | ||
| Outstanding ending balance, Weighted-Average Exercise Price | 13.57 | $ 9.47 | |
| Options exercisable at end of period, Weighted-Average Exercise Price | 14.32 | ||
| Vested and Expected to vest at end of period, Weighted-Average Exercise Price | $ 13.57 | ||
| Weighted-Average Remaining Contractual Term | |||
| Outstanding ending balance, Weighted-Average Contractual Life(in years) | 7 years 5 months 8 days | ||
| Options exercisable at end of period, Weighted-Average Contractual Life(in years) | 6 years 11 months 26 days | ||
| Aggregate Intrinsic Value | |||
| Outstanding, Aggregate Intrinsic Value | $ 2,351,316 | $ 21,932,858 | |
| Exercised, Aggregate Intrinsic Value | 1,222,914 | ||
| Forfeited, Aggregate Intrinsic Value | 1,171,979 | ||
| Options exercisable at end of period, Aggregate Intrinsic Value | $ 2,351,316 | ||
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options assumed in connection with acquired shares. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options forfeited in period intrinsic value. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by shares based payment award options outstanding aggregate intrinsic value rollforward No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangements by share based payment award options assumed in connection with merger weighted average exercise price. No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition The number of shares into which fully or partially vested stock options outstanding as of the balance sheet date can be currently converted under the option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The weighted-average price as of the balance sheet date at which grantees can acquire the shares reserved for issuance on vested portions of options outstanding and currently exercisable under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of accumulated difference between fair value of underlying shares on dates of exercise and exercise price on options exercised (or share units converted) into shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of shares under options that were cancelled during the reporting period as a result of occurrence of a terminating event specified in contractual agreements pertaining to the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
| X | ||||||||||
- Definition Amount by which the current fair value of the underlying stock exceeds the exercise price of options outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
| X | ||||||||||
- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Number of fully vested and expected to vest options outstanding that can be converted into shares under option plan. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted-average exercise price, at which grantee can acquire shares reserved for issuance, for fully vested and expected to vest options outstanding. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted average price at which option holders acquired shares when converting their stock options into shares. No definition available.
|
| X | ||||||||||
- Definition Weighted average price at which grantees could have acquired the underlying shares with respect to stock options that were terminated. No definition available.
|
| X | ||||||||||
- Definition Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
|
| X | ||||||||||
- Definition Amount of difference between fair value of the underlying shares reserved for issuance and exercise price of vested portions of options outstanding and currently exercisable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted average remaining contractual term for vested portions of options outstanding and currently exercisable or convertible, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted average remaining contractual term for option awards outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Stockholders' Equity - Schedule of Performance-based Option Activity (Details) - $ / shares |
12 Months Ended | |||
|---|---|---|---|---|
Dec. 12, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Weighted Average-Exercise Price | ||||
| Granted, Weighted-Average Exercise Price | $ 7.12 | $ 8.47 | $ 5.22 | |
| Performance-Based Stock Options | ||||
| Share | ||||
| Granted, Shares | 233,954 | |||
| Forfeited/cancelled, Shares | (31,818) | |||
| Outstanding ending balance, Shares | 0 | 202,136 | ||
| Weighted Average-Exercise Price | ||||
| Granted, Weighted-Average Exercise Price | $ 18.96 | |||
| Forfeited/cancelled, Weighted-Average Exercise Price | 13.52 | |||
| Outstanding ending balance, Weighted-Average Exercise Price | $ 19.82 | |||
| Weighted-Average Remaining Contractual Term | ||||
| Outstanding ending balance, Weighted-Average Contractual Life(in years) | 7 years 5 months 1 day | |||
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options weighted average remaining contractual term. No definition available.
|
| X | ||||||||||
- Definition The number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted average fair value as of the grant date of equity-based award plans other than stock (unit) option plans that were not exercised or put into effect as a result of the occurrence of a terminating event. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of grants made during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The weighted average fair value at grant date for nonvested equity-based awards issued during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of non-vested equity-based payment instruments, excluding stock (or unit) options, that validly exist and are outstanding as of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
| X | ||||||||||
- Definition The weighted average fair value of nonvested awards on equity-based plans excluding option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, revenue or profit achievement stock award plan) for which the employer is contingently obligated to issue equity instruments or transfer assets to an employee who has not yet satisfied service or performance criteria necessary to gain title to proceeds from the sale of the award or underlying shares or units. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
| X | ||||||||||
- Definition Weighted average remaining contractual term for equity-based awards excluding options, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Stockholders' Equity - Summary of Company Restricted Stock Activity (Details) - $ / shares |
12 Months Ended | |||
|---|---|---|---|---|
Feb. 28, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Restricted stock activity, Shares | ||||
| Granted, Weighted-Average Grant Date Fair Value | $ 7.12 | $ 8.47 | $ 5.22 | |
| Restricted Stock Units | ||||
| Restricted stock activity, Shares | ||||
| Outstanding beginning balance, Shares | 728,738 | |||
| Granted, Shares | 367,250 | 644,340 | ||
| Issued in connection with the Merger | 486,709 | |||
| Vested, Shares | (818,395) | |||
| Forfeited, Shares | (195,119) | |||
| Outstanding ending balance, Shares | 846,273 | 728,738 | ||
| Outstanding beginning balance, Weighted-Average Exercise Price | $ 9.26 | |||
| Granted, Weighted-Average Grant Date Fair Value | 11.22 | |||
| Issued in connection with the Merger,Weighted-Average Grant Date Fair Value | 8.94 | |||
| Vested, Weighted-Average Grant Date Fair Value | 10.40 | |||
| Forfeited, Weighted-Average Grant Date Fair Value | 10.58 | |||
| Outstanding ending balance, Weighted-Average Exercise Price | $ 9.16 | $ 9.26 | ||
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options issued in merger. No definition available.
|
| X | ||||||||||
- Definition Share based compensation arrangement by share based payment award equity instruments other than options issued in merger weighted average grant date fair value. No definition available.
|
| X | ||||||||||
- Definition The number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted average fair value as of the grant date of equity-based award plans other than stock (unit) option plans that were not exercised or put into effect as a result of the occurrence of a terminating event. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of grants made during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The weighted average fair value at grant date for nonvested equity-based awards issued during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of non-vested equity-based payment instruments, excluding stock (or unit) options, that validly exist and are outstanding as of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
| X | ||||||||||
- Definition The weighted average fair value of nonvested awards on equity-based plans excluding option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, revenue or profit achievement stock award plan) for which the employer is contingently obligated to issue equity instruments or transfer assets to an employee who has not yet satisfied service or performance criteria necessary to gain title to proceeds from the sale of the award or underlying shares or units. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The number of equity-based payment instruments, excluding stock (or unit) options, that vested during the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The weighted average fair value as of grant date pertaining to an equity-based award plan other than a stock (or unit) option plan for which the grantee gained the right during the reporting period, by satisfying service and performance requirements, to receive or retain shares or units, other instruments, or cash in accordance with the terms of the arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
Stockholders Equity - Compensation Cost Related to Share-Based Awards (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | $ 19,040 | $ 12,280 | $ 5,825 |
| Research and Development | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | 5,755 | 6,496 | 2,136 |
| Selling, General and Administrative | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | $ 13,285 | $ 5,784 | $ 3,689 |
| X | ||||||||||
- Definition Represents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees. 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 | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Stockholders Equity - Schedule of Compensation Expense by Type of Award (Details) - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | $ 19,040,000 | $ 12,280,000 | $ 5,825,000 |
| Warrants | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | 3,413,000 | ||
| Stock Options | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | 12,114,000 | 6,512,000 | 4,674,000 |
| Restricted Stock | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | 0 | 158,000 | 266,000 |
| Restricted Stock Units | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | 6,731,000 | 2,021,000 | 780,000 |
| Employee Stock Purchase Plan | |||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
| Stock-based compensation expense | $ 195,000 | $ 176,000 | $ 105,000 |
| X | ||||||||||
- Definition Represents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees. 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 | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Income Taxes - Additional Information (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |||
|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Income Tax Disclosure [Line Items] | |||||
| Current income tax expense or benefit | $ 127,000 | $ 0 | $ 0 | ||
| Deferred income tax expense or benefit | (28,465,000) | $ 0 | $ 0 | ||
| Income tax benefit | $ 28,338,000 | $ 28,338,000 | |||
| Corporate income tax rate | 21.00% | 34.00% | 34.00% | ||
| Tax Cuts and Jobs Act of 2017 change in tax rate reduction in deferred tax asset | $ 43,000,000 | ||||
| Alternative minimum tax payable | 800,000 | $ 800,000 | |||
| Alternative minimum tax receivable | 800,000 | 800,000 | |||
| Increase (decrease) in valuation allowance, deferred tax assets | $ 23,300,000 | (4,900,000) | |||
| Deferred capitalized start up expense net of amortization | 600,000 | 800,000 | 600,000 | 800,000 | |
| Deferred income tax amortization | 1,300,000 | 1,100,000 | |||
| Research and development credits | 2,899,000 | 25,322,000 | $ 2,899,000 | 25,322,000 | |
| Term of change in ownership of stockholders | 3 years | ||||
| Increase (decrease) in deferred tax assets | $ 44,900,000 | ||||
| Accrual for uncertain tax positions | 0 | 0 | 0 | 0 | $ 0 |
| Accrual for interest and penalties related to uncertain tax positions | 0 | 0 | 0 | 0 | $ 0 |
| Federal | |||||
| Income Tax Disclosure [Line Items] | |||||
| Net operating loss carryforwards | 790,000,000 | 179,700,000 | $ 790,000,000 | 179,700,000 | |
| Operating Loss Carryforwards Expiration Year | 2037 | ||||
| Net operating loss carryforwards indefinitely due to tax cut and jobs act | 208,000,000 | $ 208,000,000 | |||
| State | |||||
| Income Tax Disclosure [Line Items] | |||||
| Net operating loss carryforwards | 442,400,000 | $ 74,600,000 | $ 442,400,000 | $ 74,600,000 | |
| Operating Loss Carryforwards Expiration Year | 2038 | ||||
| Research and development credits | $ 3,700,000 | $ 3,700,000 | |||
| Federal and State | Tax Year 2017 | |||||
| Income Tax Disclosure [Line Items] | |||||
| Tax years remain open for examination | 2017 | ||||
| Federal and State | Tax Year 2016 | |||||
| Income Tax Disclosure [Line Items] | |||||
| Tax years remain open for examination | 2016 | ||||
| Federal and State | Tax Year 2015 | |||||
| Income Tax Disclosure [Line Items] | |||||
| Tax years remain open for examination | 2015 | ||||
| Maximum | |||||
| Income Tax Disclosure [Line Items] | |||||
| Corporate income tax rate | 35.00% | ||||
| Minimum | |||||
| Income Tax Disclosure [Line Items] | |||||
| Percentage of change in ownership of stockholders | 50.00% | ||||
| Percentage of change in ownership of stockholders holding outstanding stock | 5.00% | ||||
| Keryx Biopharmaceuticals, Inc. | |||||
| Income Tax Disclosure [Line Items] | |||||
| Income tax benefit | $ 28,300,000 | ||||
| X | ||||||||||
- Definition Alternative minimum tax payable. No definition available.
|
| X | ||||||||||
- Definition Alternative minimum tax receivable. No definition available.
|
| X | ||||||||||
- Definition Deferred income tax amortization. No definition available.
|
| X | ||||||||||
- Definition Income tax disclosure. No definition available.
|
| X | ||||||||||
- Definition Increase (decrease) in deferred tax assets. No definition available.
|
| X | ||||||||||
- Definition Liability for uncertain tax positions. No definition available.
|
| X | ||||||||||
- Definition Operating loss carryforwards expiration year. No definition available.
|
| X | ||||||||||
- Definition Percentage of change in ownership of stockholders. No definition available.
|
| X | ||||||||||
- Definition Percentage of change in ownership of stockholders holding outstanding stock. No definition available.
|
| X | ||||||||||
- Definition Tax cuts and jobs act of 2017 change in tax rate reduction in deferred tax asset. No definition available.
|
| X | ||||||||||
- Definition Tax cuts and jobs act of 2017 operating loss carry forwards indefinitely. No definition available.
|
| X | ||||||||||
- Definition Term of change in ownership of stockholders. No definition available.
|
| X | ||||||||||
- Definition Amount, after accumulated amortization and accumulated impairment loss, of asset recognized from cost incurred to obtain or fulfill contract with customer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of current income tax expense (benefit) pertaining to taxable income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred income tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible research tax credit carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The amount of estimated penalties and interest accrued as of the balance sheet date arising from income tax examinations. 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 Tax year that remains open to examination under enacted tax laws, in CCYY format. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of increase (decrease) in the valuation allowance for a specified deferred tax asset. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
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| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Income Taxes - Schedule of Provision for Income Taxes (Details) - USD ($) |
3 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Current: | ||||
| Federal | $ 23,000 | |||
| State | 104,000 | |||
| Total Current: | 127,000 | $ 0 | $ 0 | |
| Deferred: | ||||
| Federal | (16,383,000) | |||
| State | (12,082,000) | |||
| Total Deferred: | (28,465,000) | $ 0 | $ 0 | |
| Total Income Taxes | $ (28,338,000) | $ (28,338,000) | ||
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of current federal tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of current income tax expense (benefit) pertaining to taxable income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of current state and local tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred federal income tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of deferred income tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred state and local tax expense (benefit) pertaining to income (loss) from continuing operations. 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
|
Income Taxes - Schedule of Effective Income Tax Rate Differs From Statutory Federal Income Tax Rate (Details) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Income Tax Disclosure [Abstract] | |||
| Federal tax at statutory rate | 21.00% | 34.00% | 34.00% |
| State and local tax at statutory rate | 4.10% | 3.80% | 1.40% |
| Research and development tax credits | 5.00% | 11.90% | 6.40% |
| Equity compensation | (0.60%) | (0.20%) | |
| Alternative minimum tax | (1.30%) | ||
| Change in valuation allowance | 16.30% | 6.90% | (41.60%) |
| Impact of US tax reform | (54.70%) | ||
| Non-Deductible Transaction Costs | (3.10%) | ||
| Other Permanent Differences | (0.70%) | ||
| Reduction in DTA for change in ownership | (26.10%) | ||
| Effective tax rate | 16.50% | 0.00% | 0.00% |
| X | ||||||||||
- Definition Effective income tax rate reconciliation, increase (decrease) in deferred tax assets due to change in ownership. No definition available.
|
| X | ||||||||||
- Definition Effective income tax reconciliation alternative minimum tax. No definition available.
|
| X | ||||||||||
- Definition Percentage of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to changes in the valuation allowance for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to changes in the income tax rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to nondeductible expenses. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to equity-based compensation costs. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference, between reported income tax expense (benefit) and the expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations, that is attributable to tax exempt income, equity in earnings (loss) of an unconsolidated subsidiary, minority interest income (expense), tax holiday, disposition of a business, disposition of an asset, repatriation of foreign earnings, repatriation of foreign earnings jobs creation act of 2004, change in enacted tax rate, prior year income taxes, change in deferred tax asset valuation allowance, and other adjustments. No definition available.
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations applicable to state and local income tax expense (benefit), net of federal tax expense (benefit). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to research tax credit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
Income Taxes -Schedule of Significant Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
|---|---|---|
| Deferred tax assets: | ||
| Accrued expenses | $ 4,993 | $ 4,305 |
| Deferred revenue | 28,533 | 32,093 |
| Intangible assets | 509 | |
| Stock based compensation | 9,514 | 3,129 |
| Research and development credits | 2,899 | 25,322 |
| Other non-current liabilities | 7,567 | |
| Net operating loss carryforward | 189,842 | 42,335 |
| Other | 853 | 600 |
| Total deferred tax assets | 244,201 | 108,293 |
| Less valuation allowance | (131,424) | (108,112) |
| Total deferred tax assets, net of valuation allowance | 112,777 | 181 |
| Deferred tax liabilities: | ||
| Fixed assets | (121) | (181) |
| Intangible Assets | (81,847) | |
| Inventory | (37,440) | |
| Total deferred tax liabilities | (119,408) | (181) |
| Net deferred tax liability | $ (6,631) | |
| Net deferred tax liability | $ 0 |
| X | ||||||||||
- Definition Deferred tax assets other non-current liabilities. No definition available.
|
| X | ||||||||||
- Definition Amount of deferred tax liability attributable to taxable temporary differences. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from deferred income. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from intangible assets including goodwill. No definition available.
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences and carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount, after allocation of valuation allowances and deferred tax liability, of deferred tax asset attributable to deductible differences and carryforwards, without jurisdictional netting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount after allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences and carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible operating loss carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount, before allocation of valuation allowance, of deferred tax asset attributable to deductible temporary differences, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible research tax credit carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from share-based compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from accrued liabilities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of valuation allowance of deferred tax asset attributable to deductible temporary differences and carryforwards, classified as noncurrent. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount, after deferred tax asset, of deferred tax liability attributable to taxable differences without jurisdictional netting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of deferred tax consequences attributable to taxable temporary differences derived from inventory. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred tax liability attributable to taxable temporary differences from intangible assets other than goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of deferred tax liability attributable to taxable temporary differences from property, plant, and equipment. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Employee Retirement Plan - Additional Information (Details) $ in Millions |
12 Months Ended | ||
|---|---|---|---|
|
Dec. 31, 2018
USD ($)
Age
|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
|
| Compensation And Retirement Disclosure [Abstract] | |||
| Employers contributions to defined contribution plan | $ | $ 0.3 | $ 0.2 | $ 0.2 |
| Employees eligibility age to participate in retirement plan | Age | 21 | ||
| X | ||||||||||
- Definition Defined contribution plan employees age to be eligible under plan. No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of discretionary contributions made by an employer to a defined contribution plan. No definition available.
|
Commitments and Contingencies - Additional Information (Details) |
1 Months Ended | 12 Months Ended | ||||||
|---|---|---|---|---|---|---|---|---|
|
May 31, 2018
USD ($)
|
Apr. 30, 2018
USD ($)
ft²
|
Jul. 31, 2016
USD ($)
ft²
|
Dec. 31, 2018
USD ($)
ft²
Extension_Option
|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
Dec. 12, 2018
USD ($)
|
Mar. 31, 2018
USD ($)
|
|
| Commitments And Contingencies [Line Items] | ||||||||
| Landlord contributions accounted for deferred lease incentive | $ 3,289,170 | |||||||
| Landlord contribution for leasehold improvements | 1,083,453 | |||||||
| Rent expense associated with lease | $ 3,700,000 | $ 3,200,000 | $ 2,500,000 | |||||
| Total remaining contract costs | 106,300,000 | |||||||
| Contract cost incurred in research and development activities | $ 102,800,000 | |||||||
| Keryx Biopharmaceuticals, Inc. | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Preliminary fair value of the off-market element | $ 29,510,000 | |||||||
| BioVectra Inc | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Agreement expiration year | 2026 | |||||||
| Description of termination of agreement prior to contract term | The Company may terminate the BioVectra Agreement prior to the expiration of the contract term, which could result in early termination fee. | |||||||
| Cost of purchased minimum quantity product | $ 154,000,000 | |||||||
| Siegfried Evionnaz SA | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Cost of purchased minimum quantity product | $ 85,100,000 | |||||||
| Agreement expiration date | Dec. 31, 2021 | |||||||
| Agreement renewal term termination | 1 year | |||||||
| Agreement early termination | Dec. 31, 2021 | |||||||
| Letter of Credit | Other Current Assets | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Increase (decrease) in security deposit in connection with lease | $ (200,000) | 500,000 | ||||||
| Total security deposit in connection with lease | $ 1,800,000 | $ 1,600,000 | $ 1,300,000 | |||||
| Office Space | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Lease expiration date | Sep. 11, 2026 | |||||||
| Lease period, number of extension options | Extension_Option | 1 | |||||||
| Lease extension period | 5 years | |||||||
| Lab Space | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Lease expiration date | Nov. 30, 2021 | |||||||
| Lease period, number of extension options | Extension_Option | 1 | |||||||
| Lease extension period | 2 years | |||||||
| Cambridge Lease Amendment | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Area of property leased | ft² | 65,167 | |||||||
| Third Amendment to the Cambridge Lease | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Area of property leased | ft² | 45,362 | |||||||
| Monthly lease payments | $ 242,000 | |||||||
| Operating lease payments commencement date | Jan. 01, 2017 | |||||||
| Lease Monthly Payments On Or About January 1 2017 | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Monthly lease payments | $ 22,000 | |||||||
| Fifth Amendment to the Cambridge Lease | Office Space | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Area of property leased | ft² | 19,805 | |||||||
| Monthly lease payments | $ 135,000 | |||||||
| Operating lease payments commencement date | Feb. 28, 2019 | |||||||
| Leased property delivered, date | 2018-09 | |||||||
| Leased property subject to annual rent escalations, commencement date | 2019-09 | |||||||
| Boston Lease | Office Space | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Area of property leased | ft² | 27,300 | |||||||
| Monthly lease payments | $ 136,000 | |||||||
| Lease expiration month year | 2023-02 | |||||||
| Keryx Biopharmaceuticals, Inc. | Letter of Credit | Other Current Assets | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Total security deposit in connection with lease | $ 800,000 | |||||||
| Keryx Biopharmaceuticals, Inc. | Office Space | ||||||||
| Commitments And Contingencies [Line Items] | ||||||||
| Lease expiration date | Feb. 28, 2023 | |||||||
| Lease period, number of extension options | Extension_Option | 1 | |||||||
| Lease extension period | 5 years | |||||||
| X | ||||||||||
- Definition Agreement early termination. No definition available.
|
| X | ||||||||||
- Definition Agreement expiration date. No definition available.
|
| X | ||||||||||
- Definition Agreement expiration year. No definition available.
|
| X | ||||||||||
- Definition Agreement renewal term termination. No definition available.
|
| X | ||||||||||
- Definition Business combination recognized identifiable assets acquired and liabilities assumed noncurrent liabilities fair value of off-market element. No definition available.
|
| X | ||||||||||
- Definition Commitments and contingencies. No definition available.
|
| X | ||||||||||
- Definition Cost of purchased minimum quantity product. No definition available.
|
| X | ||||||||||
- Definition Description of termination of agreement prior to contract term. No definition available.
|
| X | ||||||||||
- Definition Lease expiration month year. No definition available.
|
| X | ||||||||||
- Definition Leased property delivered, date. No definition available.
|
| X | ||||||||||
- Definition Leased property subject to annual rent escalations, commencement date. No definition available.
|
| X | ||||||||||
- Definition Leasehold improvement allowance not yet used. No definition available.
|
| X | ||||||||||
- Definition Lessee leasing arrangements, operating leases, number of lease period extension options. No definition available.
|
| X | ||||||||||
- Definition Operating lease payments commencement date. No definition available.
|
| X | ||||||||||
- Definition Purchase committed program remaining contract costs. No definition available.
|
| X | ||||||||||
- Definition Area of a real estate property. No definition available.
|
| X | ||||||||||
- Definition This item represents the deferred credit for an incentive or inducement received by a lessee from a lessor, in order to motivate the lessee to enter the lease agreement, which incentive or inducement is to be recognized as a reduction of rental expense over the lease term. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The increase (decrease) during the reporting period in security deposits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of rent expense incurred for leased assets, including but not limited to, furniture and equipment, that is not directly or indirectly associated with the manufacture, sale or creation of a product or product line. No definition available.
|
| X | ||||||||||
- Definition Date which lease or group of leases is set to expire, in CCYY-MM-DD format. No definition available.
|
| X | ||||||||||
- Definition Term of lessor's operating lease renewal, 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 This element represents the payments that the lessee is obligated to make or can be required to make in connection with a property under the terms of an agreement classified as an operating lease, excluding contingent rentals and a guarantee by the lessee of the lessor's debt and the lessee's obligation to pay (apart from the rental payments) executory costs such as insurance, maintenance, and taxes. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The amount of costs incurred under a research and development arrangement accounted for as a contract to perform research and development for others. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The amount of an asset, typically cash, provided to a counterparty to provide certain assurance of performance by the entity pursuant to the terms of a written or oral agreement, such as a lease. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Commitments and Contingencies - Schedule of Future Minimum Payments Required Under Leases (Details) $ in Thousands |
Dec. 31, 2018
USD ($)
|
|---|---|
| Commitments And Contingencies Disclosure [Abstract] | |
| Operating Lease, 2019 | $ 6,777 |
| Operating Lease, 2020 | 7,008 |
| Operating Lease, 2021 | 7,064 |
| Operating Lease, 2022 | 6,735 |
| Operating Lease, 2023 | 5,347 |
| Operating Lease, Thereafter | 13,934 |
| Operating Lease, Total | $ 46,865 |
| 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/legacyRef
|
| 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/legacyRef
|
| 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/legacyRef
|
| 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/legacyRef
|
| 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/legacyRef
|
| 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/legacyRef
|
| 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 after 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/legacyRef
|
Net Loss per Share - Anti-Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share (Details) - shares |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
| Anti-dilutive securities excluded from calculation of diluted net loss per share | 9,818,815 | 4,898,363 | 3,672,666 |
| Warrants | |||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
| Anti-dilutive securities excluded from calculation of diluted net loss per share | 509,611 | 509,611 | |
| Stock Options | |||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
| Anti-dilutive securities excluded from calculation of diluted net loss per share | 8,346,888 | 3,660,014 | 3,148,006 |
| Unvested Restricted Stock | |||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
| Anti-dilutive securities excluded from calculation of diluted net loss per share | 92,972 | ||
| Restricted Stock Units | |||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
| Anti-dilutive securities excluded from calculation of diluted net loss per share | 962,316 | 728,738 | 431,688 |
| 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
|
| 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 | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Quarterly Results (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017 |
[1] | Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
| Quarterly Financial Information [Line Items] | |||||||||||||||
| Total revenues | $ 207,742 | $ 181,227 | $ 1,535 | ||||||||||||
| Cost of goods sold | $ 7,768 | 7,768 | |||||||||||||
| Total operating expenses | 142,240 | $ 81,012 | $ 84,455 | $ 70,428 | $ 75,949 | $ 65,459 | $ 50,656 | $ 65,837 | 378,135 | 257,901 | 137,995 | ||||
| Loss from operations | (90,158) | (27,843) | (35,662) | (24,498) | 14,610 | (24,176) | (22,136) | (44,972) | (178,161) | (76,674) | (136,460) | ||||
| Other income (expense), net | 1,766 | 1,796 | 1,593 | 1,080 | 914 | 1,042 | 618 | 429 | |||||||
| Benefit for income taxes | (28,338) | (28,338) | |||||||||||||
| Net income (loss) | $ (60,054) | $ (26,047) | $ (34,069) | $ (23,418) | $ 15,524 | $ (23,134) | $ (21,518) | $ (44,543) | $ (143,588) | $ (73,671) | $ (135,747) | ||||
| Net income (loss) per share: | |||||||||||||||
| basic and diluted | $ (0.87) | $ (0.46) | $ (0.60) | $ (0.48) | $ (2.47) | $ (1.69) | $ (3.60) | ||||||||
| basic | $ 0.33 | $ (0.49) | $ (0.53) | $ (1.15) | |||||||||||
| diluted | $ 0.31 | $ (0.49) | $ (0.53) | $ (1.15) | |||||||||||
| Weighted-average number of common shares: | |||||||||||||||
| basic and diluted | 69,404,187 | 57,027,598 | 56,890,295 | 48,613,565 | 58,038,252 | 43,500,795 | 37,716,949 | ||||||||
| basic | 47,353,166 | 46,938,618 | 40,819,957 | 38,759,221 | |||||||||||
| diluted | 49,719,548 | 46,938,618 | 40,819,957 | 38,759,221 | |||||||||||
| Product Revenue, Net | |||||||||||||||
| Quarterly Financial Information [Line Items] | |||||||||||||||
| Total revenues | $ 6,800 | $ 6,824 | $ 6,824 | ||||||||||||
| License, Collaboration and Other Revenue | |||||||||||||||
| Quarterly Financial Information [Line Items] | |||||||||||||||
| Total revenues | $ 53,026 | $ 53,169 | $ 48,793 | $ 45,930 | $ 200,918 | $ 181,227 | $ 1,535 | ||||||||
| Collaboration Revenue | |||||||||||||||
| Quarterly Financial Information [Line Items] | |||||||||||||||
| Total revenues | $ 90,559 | $ 41,283 | $ 28,520 | $ 20,865 | |||||||||||
| |||||||||||||||
| X | ||||||||||
- Definition quarterly financial information line items No definition available.
|
| X | ||||||||||
- Definition The aggregate cost of goods produced and sold and services rendered during the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| 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 | ||||||||||
- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or 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/2009/role/commonPracticeRef
|
| 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 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 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 The aggregate amount of income or expense from ancillary business-related activities (that is to say, excluding major activities considered part of the normal operations of the business). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| 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 | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. 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://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 Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
|
| 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
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| X | ||||||||||
- Details
|