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Jun. 30, 2015
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Jul. 30, 2015
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Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | NKTR | |
Entity Registrant Name | NEKTAR THERAPEUTICS | |
Entity Central Index Key | 0000906709 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 132,371,000 |
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End date of current fiscal year in the format --MM-DD. No definition available.
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This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
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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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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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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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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
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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) or (5) Smaller Reporting 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. No definition available.
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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Accrued clinical trial expenses. No definition available.
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Liability Related To Sale Of Potential Future Royalties Non Current No definition available.
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Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) (USD $)
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Jun. 30, 2015
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Dec. 31, 2014
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Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares designated | 0 | 0 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 132,185,000 | 131,216,000 |
Common stock, shares outstanding | 132,185,000 | 131,216,000 |
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Condensed Consolidated Statements of Operations (Unaudited) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Revenue: | ||||
Product sales and royalty revenue | $ 11,713 | $ 5,891 | $ 19,812 | $ 11,808 |
Non-cash royalty revenue related to sale of future royalties | 4,740 | 4,837 | 8,702 | 10,610 |
License, collaboration and other revenue | 6,208 | 17,785 | 102,948 | 25,866 |
Total revenue | 22,661 | 28,513 | 131,462 | 48,284 |
Operating costs and expenses: | ||||
Cost of goods sold | 10,534 | 5,108 | 18,978 | 13,015 |
Research and development | 45,412 | 36,702 | 92,423 | 75,040 |
General and administrative | 10,184 | 9,619 | 20,487 | 19,547 |
Total operating costs and expenses | 66,130 | 51,429 | 131,888 | 107,602 |
Loss from operations | (43,469) | (22,916) | (426) | (59,318) |
Non-operating income (expense): | ||||
Interest expense | (4,118) | (4,488) | (8,289) | (9,021) |
Non-cash interest expense on liability related to sale of future royalties | (5,152) | (5,134) | (10,202) | (10,521) |
Interest income and other income (expense), net | 246 | 96 | 457 | 408 |
Total non-operating expense, net | (9,024) | (9,526) | (18,034) | (19,134) |
Loss before provision for income taxes | (52,493) | (32,442) | (18,460) | (78,452) |
Provision for income taxes | 164 | 195 | 377 | 386 |
Net loss | $ (52,657) | $ (32,637) | $ (18,837) | $ (78,838) |
Basic and diluted net loss per share | $ (0.40) | $ (0.26) | $ (0.14) | $ (0.63) |
Weighted average shares outstanding used in computing basic and diluted net loss per share | 131,643 | 127,040 | 131,502 | 125,301 |
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Revenue earned during the period relating to consideration received from another party for the right to use, but not own, certain of the entity's intangible assets. Revenue may contain one or more of the following elements: upfront fees, contract research, milestone payments, manufacturing and supply, royalties, and license fees. No definition available.
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Non-cash interest expense related to sale of royalties. No definition available.
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Non cash royalty revenue related to sale future royalties No definition available.
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Includes Product sales (aggregate revenue during the period from the sale of goods in the normal course of business, after deducting returns, allowances and discounts) and royalties (Revenue earned during the period from the leasing or otherwise lending to a third party the entity's rights or title to certain property. Royalty revenue is derived from a percentage or stated amount of sales proceeds or revenue generated Includes Product sales (aggregate revenue during the period from the sale of goods in the normal course of business, after deducting returns, allowances and discounts) and royalties (Revenue earned during the period from the leasing or otherwise lending to a third party the entity's rights or title to certain property. Royalty revenue is derived from a percentage or stated amount of sales proceeds or revenue generated by the third party using the entity's property). No definition available.
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Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Statement of Comprehensive Income [Abstract] | ||||
Comprehensive loss | $ (52,879) | $ (32,584) | $ (18,768) | $ (78,544) |
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Non-cash interest expense related to sale of royalties. No definition available.
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Proceeds From Issuance Of Common Stock Net Of Issuance Costs No definition available.
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Repayment Of And Proceeds From Sale Of Future Royalties Net Of Transaction Costs No definition available.
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Organization and Summary of Significant Accounting Policies
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6 Months Ended |
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Jun. 30, 2015
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | Note 1 — Organization and Summary of Significant Accounting Policies Organization We are a biopharmaceutical company headquartered in San Francisco, California and incorporated in Delaware. We are developing a pipeline of drug candidates that utilize our PEGylation and advanced polymer conjugate technology platforms with the objective to improve the benefits of drugs for patients. Our research and development activities have required significant ongoing investment to date and are expected to continue to require significant investment. As a result, we expect to continue to incur substantial losses and negative cash flows from operations in the future. We have financed our operations primarily through cash generated from licensing, collaboration and manufacturing agreements and financing transactions. At June 30, 2015, we had approximately $279.7 million in cash and investments in marketable securities. Also, as of June 30, 2015, we had $133.5 million in long-term debt, including $125.0 million of senior secured notes and $8.5 million of capital lease obligations, of which $5.6 million is current. Basis of Presentation and Principles of Consolidation Our consolidated financial statements include the financial position, results of operations and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics (India) Private Limited (Nektar India) and Nektar Therapeutics UK Limited. All intercompany accounts and transactions have been eliminated in consolidation. We prepared our Condensed Consolidated Financial Statements following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (GAAP) for annual periods can be condensed or omitted. In the opinion of management, these financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results. Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. Translation gains and losses are included in accumulated other comprehensive loss in the stockholders’ equity section of the Condensed Consolidated Balance Sheets. To date, such cumulative currency translation adjustments have not been significant to our consolidated financial position. Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized holding gains and losses on available-for-sale securities, neither of which were significant during the three and six months ended June 30, 2015 and 2014. In addition, there were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three and six months ended June 30, 2015 and 2014. The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2014 was derived from the audited consolidated financial statements which are included in our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 26, 2015. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and the accompanying notes to those financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014. Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The results and trends in these interim Condensed Consolidated Financial Statements are not necessarily indicative of the results to be expected for the full year or any other periods. Use of Estimates The preparation of consolidated financial statements in conformity with 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 consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Accounting estimates and assumptions are inherently uncertain. Actual results could differ materially from those estimates and assumptions. Our estimates include those related to estimated selling prices of deliverables in collaboration agreements, estimated periods of performance, the net realizable value of inventory, the impairment of investments, the impairment of goodwill and long-lived assets, contingencies, accrued clinical trial expenses, estimated interest expense from our liability related to our sale of future royalties, stock-based compensation, and ongoing litigation, among other estimates. We base our estimates on historical experience and on other assumptions that management believes are reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. As appropriate, estimates are assessed each period and updated to reflect current information and any changes in estimates will generally be reflected in the period first identified. Reclassifications Certain items previously reported in specific financial statement captions have been reclassified to conform to the current period presentation. Such reclassifications do not materially impact previously reported revenue, operating loss, net loss, total assets, liabilities or stockholders’ equity. Segment Information We operate in one business segment which focuses on applying our technology platforms to improve the performance of established and novel drug candidates. We operate in one segment because our business offerings have similar economics and other characteristics, including the nature of products and manufacturing processes, types of customers, distribution methods and regulatory environment. We are comprehensively managed as one business segment by our Chief Executive Officer and his management team. Significant Concentrations Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables from product sales and royalties, as well as milestones and time and materials based billings from collaborative research and development agreements. When appropriate, we provide for an allowance for doubtful accounts by reserving for specifically identified doubtful accounts. We generally do not require collateral from our customers. We perform a regular review of our customers’ payment histories and associated credit risk. We have not experienced significant credit losses from our accounts receivable and our allowance for doubtful accounts was not significant at either June 30, 2015 or December 31, 2014. We are dependent on our suppliers and contract manufacturers to provide raw materials, drugs and devices of appropriate quality and reliability and to meet applicable contract and regulatory requirements. In certain cases, we rely on single sources of supply of one or more critical materials. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop and produce our drug candidates or our ability to meet our supply obligations could be significantly impaired, which could have a material adverse effect on our business, financial condition and results of operations. Revenue Recognition Our revenue is derived from our arrangements with pharmaceutical and biotechnology collaboration partners and may result from one or more of the following: upfront and license fees, payments for contract research and development, milestone payments, manufacturing and supply payments, and royalties. Our performance obligations under our collaborations may include licensing our intellectual property, manufacturing and supply obligations, and research and development obligations. In order to account for the multiple-element arrangements, we identify the deliverables included within the arrangement and evaluate which deliverables represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. Revenue is recognized separately for each identified unit of accounting when the basic revenue recognition criteria are met: there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. At the inception of each new multiple-element arrangement or the material modification of an existing multiple-element arrangement, we allocate all consideration received under multiple-element arrangements to all units of accounting based on the relative selling price method, generally based on our best estimate of selling price (ESP). The objective of ESP is to determine the price at which we would transact a sale if the product or service was sold on a stand-alone basis. We determine ESP for the elements in our collaboration arrangements by considering multiple factors including, but not limited to, technical complexity of the performance obligation and similarity of elements to those performed under previous arrangements. Since we apply significant judgment in arriving at the ESPs, any material change in our estimates would significantly affect the allocation of the total consideration to the different elements of a multiple element arrangement. Product sales Product sales are primarily derived from fixed price and cost-plus manufacturing and supply agreements with our collaboration partners. We have not experienced any significant returns from our customers. Royalty revenue Generally, we are entitled to royalties from our collaboration partners based on the net sales of their approved drugs that are marketed and sold in one or more countries where we hold royalty rights. We recognize royalty revenue when the cash is received or when the royalty amount to be received is estimable and collection is reasonably assured. With respect to the non-cash royalties related to sale of future royalties described at Note 4, revenue is recognized when estimable, otherwise, revenue is recognized during the period in which the related royalty report is received, which generally occurs in the quarter after the applicable product sales are made. License, collaboration and other revenue The amount of upfront fees and other payments received by us in license and collaboration arrangements that are allocated to continuing performance obligations, such as manufacturing and supply obligations, are deferred and generally recognized ratably over our expected performance period under each respective arrangement. We make our best estimate of the period over which we expect to fulfill our performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these collaboration arrangements, significant judgment is required to determine the duration of the performance period and this estimate is periodically re-evaluated. Contingent consideration received from the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved, which we believe is consistent with the substance of our performance under our various license and collaboration agreements. A milestone is defined as an event (i) that can only be achieved based in whole or in part either on the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the entity. A milestone is substantive if the consideration earned from the achievement of the milestone is consistent with our performance required to achieve the milestone or the increase in value to the collaboration resulting from our performance, relates solely to our past performance, and is reasonable relative to all of the other deliverables and payments within the arrangement. Our license and collaboration agreements with our partners provide for payments to us upon the achievement of development milestones, such as the completion of clinical trials or regulatory submissions, approvals by regulatory authorities, and commercial launches of drugs. Given the challenges inherent in developing and obtaining regulatory approval for drug products and in achieving commercial launches, there was substantial uncertainty whether any such milestones would be achieved at the time of execution of these licensing and collaboration agreements. In addition, we evaluated whether the development milestones meet the remaining criteria to be considered substantive. As a result of our analysis, we consider our remaining development milestones under all of our license and collaboration agreements to be substantive and, accordingly, we expect to recognize as revenue future payments received from such milestones only if and as each milestone is achieved. Our license and collaboration agreements with certain partners also provide for contingent payments to us based solely upon the performance of the respective partner. For such contingent amounts we expect to recognize the payments as revenue when earned under the applicable contract, which is generally upon completion of performance by the respective partner, provided that collection is reasonably assured. Our license and collaboration agreements with our partners also provide for payments to us upon the achievement of specified sales volumes of approved drugs. We consider these payments to be similar to royalty payments and we will recognize such sales-based payments upon achievement of such sales volumes, provided that collection is reasonably assured. Research and Development Expense Research and development costs are expensed as incurred and include salaries, benefits and other operating costs such as outside services, supplies and allocated overhead costs. We perform research and development for our proprietary drug candidates and technology development and for certain third parties under collaboration agreements. For our proprietary drug candidates and our internal technology development programs, we invest our own funds without reimbursement from a third party. We record accruals for the estimated costs of our clinical trial activities performed by third parties. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of certain clinical trial activities. We generally accrue costs associated with the start-up and reporting phases of the clinical trials ratably over the estimated duration of the start-up and reporting phases. We generally accrue costs associated with the treatment phase of clinical trials based on the total estimated cost of the treatment phase on a per patient basis and we expense the per patient cost ratably over the estimated patient treatment period based on patient enrollment in the trials. In specific circumstances, such as for certain time-based costs, we recognize clinical trial expenses using a methodology that we consider to be more reflective of the timing of costs incurred. Advance payments for goods or services that will be used or rendered for future research and development activities are capitalized as prepaid expenses and recognized as expense as the related goods are delivered or the related services are performed. We base our estimates on the best information available at the time. However, additional information may become available to us which may allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. Such increases or decreases in cost are generally considered to be changes in estimates and will be reflected in research and development expenses in the period identified.
Long-Lived Assets We assess the impairment of long-lived assets, primarily property, plant and equipment and goodwill included in other non-current assets, whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. When such events occur, we determine whether there has been an impairment in value by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. In the case of goodwill impairment, market capitalization is generally used as the measure of fair value. If an impairment in value exists, the asset is written down to its estimated fair value. In March 2015, we announced that the primary endpoint for our BEACON Phase 3 clinical study for NKTR-102 as a single-agent therapy for women with advanced metastatic breast cancer did not achieve statistical significance. As a result, we performed an impairment analysis for our long-lived assets, including goodwill, as well as our primary long-lived asset group which is dedicated to NKTR-102. Based on this analysis, we concluded that there is no impairment at March 31, 2015 or June 30, 2015. Income Taxes For the three and six months ended June 30, 2015 and 2014, we recorded an income tax provision for our Nektar India operations at an effective tax rate of approximately 34%. The U.S. federal deferred tax assets generated from our net operating losses have been fully reserved, as we believe it is not more likely than not that the benefit will be realized. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued guidance codified in Accounting Standards Codification (ASC) 606, Revenue Recognition — Revenue from Contracts with Customers, which amends the guidance in former ASC 605, Revenue Recognition, and is effective for public companies for fiscal years beginning after December 15, 2017. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. We are currently evaluating the impact of the provisions of ASC 606. In April 2015, the FASB issued guidance to simplify the presentation of debt issuance costs by requiring debt issuance costs to be presented as a deduction from the corresponding debt liability. This guidance is effective for our interim and annual periods beginning January 1, 2016. Upon adoption, the new guidance must be applied retrospectively to all periods presented. We do not believe the adoption of this guidance will have a material impact on our consolidated financial statements. |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash and Investments in Marketable Securities | Note 2 — Cash and Investments in Marketable Securities Cash and investments in marketable securities, including cash equivalents and restricted cash, are as follows (in thousands).
We invest in liquid, high quality debt securities. Our investments in debt securities are subject to interest rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in securities with maturities of two years or less and maintain a weighted average maturity of one year or less. As of June 30, 2015 and December 31, 2014, all of our investments had maturities of one year or less. Gross unrealized gains and losses were not significant at either June 30, 2015 or December 31, 2014. During the three months ended June 30, 2015 and the three and six months ended June 30, 2014, we did not sell any of our available-for-sale securities. During the six months ended June 30, 2015, we sold available-for-sale securities totaling $5.2 million, and gross realized gains and losses on those sales were not significant. The cost of securities sold is based on the specific identification method. Restricted cash of $25.0 million was required to be maintained in a separate account until July 1, 2015 under the terms of our 12% senior secured notes due July 2017. This restriction expired on July 1, 2015 and the restricted funds were returned to us. We are currently required by a covenant under the senior secured notes to maintain the aggregate balance of our unrestricted cash and cash equivalents of not less than $25.0 million at the end of any two consecutive fiscal quarters, subject to certain conditions.
Our portfolio of cash and investments in marketable securities includes (in thousands):
All of our investments are categorized as Level 1 or Level 2, as explained in the table above. We use a market approach to value our Level 2 investments. The disclosed fair value related to our investments is based primarily on the reported fair values in our period-end brokerage statements, which are based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data. We independently validate these fair values using available market quotes and other information. During the three and six months ended June 30, 2015 and 2014, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. Additionally, as of June 30, 2015, based on a discounted cash flow analysis using Level 3 inputs including financial discount rates, we believe the $125.0 million carrying amount of our 12% Senior Secured Notes due July 2017 is consistent with its fair value. |
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Inventory | Note 3 — Inventory Inventory consists of the following (in thousands):
Inventory is generally manufactured upon receipt of firm purchase orders from our collaboration partners. Inventory includes direct materials, direct labor, and manufacturing overhead and cost is determined on a first-in, first-out basis. Inventory is valued at the lower of cost or market and defective or excess inventory is written down to net realizable value based on historical experience or projected usage. |
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Liability Related to Sale of Future Royalties | Note 4 — Liability Related to Sale of Future Royalties On February 24, 2012, we entered into a Purchase and Sale Agreement (the Purchase and Sale Agreement) with RPI Finance Trust (RPI), an affiliate of Royalty Pharma, pursuant to which we sold, and RPI purchased, our right to receive royalty payments (the Royalty Entitlement) arising from the worldwide net sales, from and after January 1, 2012, of (a) CIMZIA®, under our license, manufacturing and supply agreement with UCB Pharma (UCB), and (b) MIRCERA®, under our license, manufacturing and supply agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (together referred to as Roche). We received aggregate cash proceeds of $124.0 million for the Royalty Entitlement. Although we sold all of our rights to receive royalties from the CIMZIA® and MIRCERA® products, as a result of our ongoing manufacturing and supply obligations related to the generation of these royalties, we will continue to account for these royalties as revenue. We recorded the $124.0 million in proceeds from this transaction as a liability (Royalty Obligation) that will be amortized using the interest method over the estimated life of the Purchase and Sale Agreement as royalties from the CIMZIA® and MIRCERA® products are remitted directly to RPI. During the six months ended June 30, 2015 and 2014, we recognized $8.7 million and $10.6 million, respectively, in aggregate royalties from net sales of CIMZIA® and MIRCERA®.
Since its inception, our estimate of the total interest expense on the Royalty Obligation resulted in an effective annual interest rate of approximately 17%. We periodically assess the estimated royalty payments to RPI from UCB and Roche and to the extent such payments are greater or less than our initial estimates, or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the Royalty Obligation. Pursuant to the Purchase and Sale Agreement, in March 2014 and March 2013, we were required to pay RPI $7.0 million and $3.0 million, respectively, as a result of worldwide net sales of MIRCERA® for the 12 month periods ended December 31, 2013 and 2012 not reaching certain minimum thresholds. The Purchase and Sale Agreement does not include any other potential payments related to minimum net sales thresholds and, therefore, we do not expect to make any further payments to RPI related to this agreement. In addition, the Purchase and Sale Agreement grants RPI the right to receive certain reports and other information relating to the Royalty Entitlement and contains other representations and warranties, covenants and indemnification obligations that are customary for a transaction of this nature. To our knowledge, we are currently in compliance with these provisions of the Purchase and Sale Agreement, however, if we were to breach our obligations, we could be required to pay damages to RPI that are not limited to the purchase price we received in the sale transaction. |
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Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 5 — Commitments and Contingencies Legal Matters From time to time, we are involved in lawsuits, arbitrations, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are reviewed at least quarterly and adjusted to reflect the impact of settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of our operations of that period and on our cash flows and liquidity. Indemnifications in Connection with Commercial Agreements As part of our collaboration agreements with our partners related to the license, development, manufacture and supply of drugs based on our proprietary technologies and drug candidates, we generally agree to defend, indemnify and hold harmless our partners from and against third party liabilities arising out of the agreement, including product liability (with respect to our activities) and infringement of intellectual property to the extent the intellectual property is developed by us and licensed to our partners. The term of these indemnification obligations is generally perpetual any time after execution of the agreement. There is generally no limitation on the potential amount of future payments we could be required to make under these indemnification obligations. From time to time we enter into other strategic agreements such as divestitures and financing transactions pursuant to which we are required to make representations and warranties and undertake to perform or comply with certain covenants. In the event it is determined that we breached certain of the representations and warranties or covenants made by us in any such agreements, we could incur substantial indemnification liabilities depending on the timing, nature, and amount of any such claims. To date, we have not incurred costs to defend lawsuits or settle claims related to these indemnification obligations. Because the aggregate amount of any potential indemnification obligation is not a stated amount, the overall maximum amount of any such obligations cannot be reasonably estimated. No liabilities have been recorded for these obligations in our Condensed Consolidated Balance Sheets at either June 30, 2015 or December 31, 2014. |
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License and Collaboration Agreements
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License and Collaboration Agreements | Note 6 — License and Collaboration Agreements We have entered into various collaboration agreements including license agreements and collaborative research, manufacturing, development and commercialization agreements with various pharmaceutical and biotechnology companies. Under these collaboration agreements, we are entitled to receive license fees, upfront payments, milestone payments, royalties, sales milestones, and payments for the manufacture and supply of our proprietary PEGylation materials and/or reimbursement for research and development activities. All of our collaboration agreements are generally cancelable by our partners without significant financial penalty. Our costs of performing these services are generally included in research and development expense, except that costs for product sales to our collaboration partners are included in cost of goods sold. In accordance with our collaboration agreements, we recognized license, collaboration and other revenue as follows (in thousands):
As of June 30, 2015, our collaboration agreements with partners included potential future payments for development milestones totaling approximately $128.3 million, including amounts from our agreements with Baxalta, Bayer, and Ophthotech described below. In addition, we are entitled to receive the contingent payments described below related to the MOVANTIKTM and MOVANTIKTM fixed-dose combination drug development programs, respectively, based on development and regulatory events to be pursued and completed solely by AstraZeneca. There have been no material changes to our collaboration agreements in the six months ended June 30, 2015, except as described below. AstraZeneca AB: MOVANTIKTM (naloxegol oxalate), previously referred to as naloxegol and NKTR-118, and MOVANTIKTM fixed-dose combination program, previously referred to as NKTR-119 We are a party to an agreement with AstraZeneca AB (AstraZeneca) under which we granted AstraZeneca a worldwide, exclusive license under our patents and other intellectual property to develop, market, and sell MOVANTIKTM and MOVANTIKTM fixed-dose combination program. AstraZeneca is responsible for all research, development and commercialization and is responsible for all drug development and commercialization decisions for MOVANTIKTM and the MOVANTIKTM fixed-dose combination program. AstraZeneca paid us an upfront payment of $125.0 million, which we received in the fourth quarter of 2009 and which was fully recognized as of December 31, 2010. We will be entitled to up to an additional $40.0 million of contingent payments upon the first commercial sale of MOVENTIG® (the naloxegol brand name in the European Union or EU) in one major European Union country. We are also entitled to receive up to $75.0 million of commercial launch contingent payments related to the MOVANTIKTM fixed-dose combination program, based on development events to be pursued and completed solely by AstraZeneca. In addition, we are entitled to significant and escalating double-digit royalty payments and sales milestone payments based on annual worldwide net sales of MOVANTIKTM and MOVANTIKTM fixed-dose combination products. On September 16, 2014, the United States Food and Drug Administration (FDA) approved MOVANTIKTM for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. On December 9, 2014, AstraZeneca announced that MOVENTIG® has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). As a result of the FDA’s approval, on September 16, 2014, we were entitled to a $35.0 million non-refundable payment from AstraZeneca, which was fully recognized as revenue in September 2014 and was received in October 2014. In addition, the FDA’s approval of MOVANTIKTM extinguished our contingent obligation to repay the $70.0 million payment made to us by AstraZeneca in November 2013 after the MOVANTIKTM New Drug Application was accepted for review by the FDA. As a result, in September 2014, we fully recognized as revenue this $70.0 million payment. On March 31, 2015, AstraZeneca announced that MOVANTIK™ launched in the United States which resulted in our receipt of a $100.0 million non-refundable commercial launch milestone payment on March 31, 2015, which was recognized as revenue in March 2015. In addition, in March 2015, we agreed to pay AstraZeneca a total of $10.0 million to fund U.S. television advertising in consideration for certain additional commercial information rights. We recorded this $10.0 million obligation as a liability, with $5.0 million included in other current liabilities and $5.0 million included in other long-term liabilities in our Condensed Consolidated Balance Sheet at June 30, 2015. We made the initial $5.0 million payment to AstraZeneca in July 2015 and will pay the remaining $5.0 million in July 2016. We determined that this $10.0 million obligation should be recorded as a reduction of revenue, which we recorded in the three months ended March 31, 2015. As of June 30, 2015, we do not have deferred revenue related to this agreement. In general, other than as described above and in this paragraph, AstraZeneca has full responsibility for all research, development and commercialization costs under our license agreement. As part of its approval of MOVANTIKTM, the FDA required AstraZeneca to perform a post-marketing, observational epidemiological study comparing MOVANTIKTM to other treatments of OIC in patients with chronic, non-cancer pain. As a result, the royalty rate payable to us from net sales of MOVANTIKTM in the U.S. by AstraZeneca will be reduced by up to two percentage points to fund 33% of the external costs incurred by AstraZeneca to fund such post approval study subject to a $35.0 million aggregate cap. Any costs incurred by AstraZeneca can only be recovered by the reduction of the royalty paid to us. In no case can amounts be recovered by the reduction of a contingent payment due from AstraZeneca to us or through a payment from us to AstraZeneca. Roche: PEGASYS® and MIRCERA® In February 1997, we entered into a license, manufacturing and supply agreement with Roche, under which we granted Roche a worldwide, exclusive license to certain intellectual property related to our proprietary PEGylation materials used in the manufacture and commercialization of PEGASYS®. As of June 30, 2015, we have deferred revenue of approximately $2.6 million related to this agreement, which we expect to recognize through December 2015, the period through which we are required to provide back-up manufacturing and supply services related to PEGASYS®. In February 2012, we entered into a toll-manufacturing agreement with Roche under which we will manufacture the proprietary PEGylation material used by Roche to produce MIRCERA®. Roche entered into the toll-manufacturing agreement with the objective of establishing us as a secondary back-up supply source on a non-exclusive basis. Under the terms of our toll-manufacturing agreement, Roche paid us an upfront payment of $5.0 million and an additional $22.0 million in performance-based milestone payments upon our achievement of certain manufacturing readiness, validation and production milestones, including the delivery of specified quantities of PEGylation materials, all of which were completed as of January 2013. Roche will also pay us additional consideration for any future orders of the PEGylation materials for MIRCERA® beyond the initial quantities manufactured through January 2013. Roche has the right to terminate the toll-manufacturing agreement due to an uncured material default by us. As of June 30, 2015, we have deferred revenue of approximately $8.1 million, which we expect to recognize through December 2016, the estimated end of our obligations under this agreement. In August 2013, we agreed to deliver additional quantities of PEGylation materials used by Roche to produce PEGASYS® and MIRCERA®, all of which were delivered in the last quarter of 2013, for total consideration of $18.6 million. We determined that these incremental activities should be considered a material modification of the existing PEGASYS® and MIRCERA® -related arrangements described above. As a result, we allocated the $18.6 million consideration to each of these arrangements and determined the amounts to be recognized or deferred based on the estimated selling prices of the undelivered obligations. As of June 30, 2015, we have deferred revenue of approximately $3.4 million related to these activities, which we expect to recognize through December 2016, the estimated end of our obligations under the modified arrangements. Amgen, Inc.: Neulasta® In October 2010, we amended and restated an existing supply and license agreement by entering into a supply, dedicated suite and manufacturing guarantee agreement (the amended and restated agreement) and a license agreement with Amgen Inc. and Amgen Manufacturing, Limited (together referred to as Amgen). Under the terms of the amended and restated agreement, we received a $50.0 million payment in the fourth quarter of 2010 in return for our guaranteeing the supply of certain quantities of our proprietary PEGylation materials to Amgen. As of June 30, 2015, we have deferred revenue of approximately $26.7 million related to this agreement, which we expect to recognize through October 2020, the estimated end of our obligations under this agreement. Bayer Healthcare LLC: BAY41-6551 (Amikacin Inhale) In August 2007, we entered into a co-development, license and co-promotion agreement with Bayer Healthcare LLC (Bayer) to develop a specially-formulated inhaled Amikacin. We are responsible for development and manufacturing and supply of the nebulizer device included in the Amikacin product. In April 2013, Bayer initiated a Phase 3 clinical trial in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia. As of June 30, 2015, we have received an upfront payment of $40.0 million (which was paid to us in 2007) and milestone payments totaling $30.0 million. In addition, in June 2013, we made a $10.0 million payment to Bayer for the reimbursement of some of its costs of the Phase 3 clinical trial. In addition, we are entitled to receive a total of up to $50.0 million for development milestones upon achievement of certain development objectives, as well as sales milestones upon achievement of annual sales targets and royalties based on annual worldwide net sales of Amikacin Inhale. As of June 30, 2015, we have deferred revenue of approximately $20.0 million related to this agreement, which we expect to recognize through February 2028, the estimated end of our obligations under this agreement. Baxalta: Hemophilia We are a party to an exclusive research, development, license and manufacturing and supply agreement with Baxalta Incorporated (Baxalta) executed in September 2005 to develop products designed to improve therapies for Hemophilia A patients using our PEGylation technology. This Hemophilia A program includes BAX 855, which will be marketed in the U.S. under the brand name ADYNOVATE upon approval. Under the terms of this agreement, as of June 30, 2015, we are entitled to up to $20.0 million of development milestones upon achievement of certain development objectives, including $10.0 million due upon marketing authorization in the U.S., as well as sales milestones upon achievement of annual sales targets and royalties based on annual worldwide net sales of products resulting from this agreement. In August 2014, Baxalta announced positive top-line results from its Phase 3 pivotal clinical trial of BAX 855 which met the primary endpoint for the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. As a result of this Phase 3 clinical trial meeting its primary endpoint, we earned development milestones totaling $8.0 million in September 2014. In December 2014, Baxalta announced that it filed a biologic license application with the FDA for BAX 855. As of June 30, 2015, we do not have significant deferred revenue related to this agreement. Ophthotech Corporation: Fovista® We are a party to an agreement with Ophthotech Corporation (Ophthotech), dated September 30, 2006, under which Ophthotech received a worldwide, exclusive license to certain of our proprietary PEGylation technology to develop, manufacture and sell Fovista®. Under the terms of our agreement, we are the exclusive supplier of all of Ophthotech’s clinical and commercial requirements for our proprietary PEGylation reagent used in Fovista®, which is currently in a Phase 3 clinical program. On May 19, 2014, Ophthotech entered into a Licensing and Commercialization Agreement with Novartis Pharma AG for Fovista®. Under our agreement with Ophthotech, we received a $19.75 million payment in connection with this licensing agreement in June 2014. As of June 30, 2015, we have deferred revenue of approximately $18.2 million related to this agreement, which we expect to recognize through March 2029, the estimated end of our obligations under our agreement with Ophthotech. In addition, we are entitled to up to $9.5 million in additional payments based upon Ophthotech’s potential achievement of certain regulatory and sales milestones. We are also entitled to royalties on net sales of Fovista® that vary based on sales levels. Other In addition, as of June 30, 2015, we have a number of collaboration agreements, including with our collaboration partner UCB, under which we are entitled to up to a total of $51.8 million of development milestones upon achievement of certain development objectives, as well as sales milestones upon achievement of annual sales targets and royalties based on net sales of commercialized products, if any. However, given the current phase of development of the potential products under these collaboration agreements, we cannot estimate the probability or timing of achieving these milestones. As of June 30, 2015, we have deferred revenue of approximately $18.0 million related to these other collaboration agreements, which we expect to recognize through 2020, the estimated end of our obligations under those agreements. |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | Note 7 — Stock-Based Compensation Total stock-based compensation expense was recognized in our Condensed Consolidated Statements of Operations as follows (in thousands):
During the three months ended June 30, 2015 and 2014, we granted 68,200 and 642,860 stock options, respectively, at a weighted average grant-date fair value of $4.81 per share and $5.24 per share, respectively. During the six months ended June 30, 2015 and 2014, we granted 479,010 and 3,776,040 stock options, respectively, at a weighted average grant-date fair value of $6.31 per share and $5.84 per share, respectively. The number of stock options granted during the six months ended June 30, 2014 was significantly higher than the stock options granted during the six months ended June 30, 2015 because we made our annual employee stock option grant for the 2013 performance period in February 2014 and our annual employee stock option grant for the 2014 performance period in December 2014. As a result of stock issuances under our equity compensation plans, during the three months ended June 30, 2015 and 2014, we issued 733,952 and 350,513 common shares, respectively, and during the six months ended June 30, 2015 and 2014, we issued 969,250 and 1,017,887 common shares, respectively. |
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Net Loss Per Share
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6 Months Ended |
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Jun. 30, 2015
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Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 8 — Net Loss Per Share Basic net loss per share is calculated based on the weighted-average number of common shares outstanding during the periods presented. For all periods presented in the accompanying Condensed Consolidated Statements of Operations, the net loss available to common stockholders is equal to the reported net loss. Basic and diluted net loss per share are the same due to our historical net losses and the requirement to exclude potentially dilutive securities which would have an anti-dilutive effect on net loss per share. During the three and six month periods ended June 30, 2015 and 2014, potentially dilutive securities consisted of common shares underlying outstanding stock options. During the three months ended June 30, 2015 and 2014, there were weighted average outstanding stock options of 21.6 million and 22.5 million, respectively, and during the six months ended June 30, 2015 and 2014, there were weighted average outstanding stock options of 21.7 million and 21.9 million, respectively. |
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Organization and Summary of Significant Accounting Policies (Policies)
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6 Months Ended |
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Jun. 30, 2015
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization We are a biopharmaceutical company headquartered in San Francisco, California and incorporated in Delaware. We are developing a pipeline of drug candidates that utilize our PEGylation and advanced polymer conjugate technology platforms with the objective to improve the benefits of drugs for patients. Our research and development activities have required significant ongoing investment to date and are expected to continue to require significant investment. As a result, we expect to continue to incur substantial losses and negative cash flows from operations in the future. We have financed our operations primarily through cash generated from licensing, collaboration and manufacturing agreements and financing transactions. At June 30, 2015, we had approximately $279.7 million in cash and investments in marketable securities. Also, as of June 30, 2015, we had $133.5 million in long-term debt, including $125.0 million of senior secured notes and $8.5 million of capital lease obligations, of which $5.6 million is current. |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation Our consolidated financial statements include the financial position, results of operations and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics (India) Private Limited (Nektar India) and Nektar Therapeutics UK Limited. All intercompany accounts and transactions have been eliminated in consolidation. We prepared our Condensed Consolidated Financial Statements following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (GAAP) for annual periods can be condensed or omitted. In the opinion of management, these financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results. Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. Translation gains and losses are included in accumulated other comprehensive loss in the stockholders’ equity section of the Condensed Consolidated Balance Sheets. To date, such cumulative currency translation adjustments have not been significant to our consolidated financial position. Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized holding gains and losses on available-for-sale securities, neither of which were significant during the three and six months ended June 30, 2015 and 2014. In addition, there were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three and six months ended June 30, 2015 and 2014. The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2014 was derived from the audited consolidated financial statements which are included in our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 26, 2015. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and the accompanying notes to those financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014. Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The results and trends in these interim Condensed Consolidated Financial Statements are not necessarily indicative of the results to be expected for the full year or any other periods. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with 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 consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Accounting estimates and assumptions are inherently uncertain. Actual results could differ materially from those estimates and assumptions. Our estimates include those related to estimated selling prices of deliverables in collaboration agreements, estimated periods of performance, the net realizable value of inventory, the impairment of investments, the impairment of goodwill and long-lived assets, contingencies, accrued clinical trial expenses, estimated interest expense from our liability related to our sale of future royalties, stock-based compensation, and ongoing litigation, among other estimates. We base our estimates on historical experience and on other assumptions that management believes are reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. As appropriate, estimates are assessed each period and updated to reflect current information and any changes in estimates will generally be reflected in the period first identified. |
Reclassifications | Reclassifications Certain items previously reported in specific financial statement captions have been reclassified to conform to the current period presentation. Such reclassifications do not materially impact previously reported revenue, operating loss, net loss, total assets, liabilities or stockholders’ equity. |
Segment Information | Segment Information We operate in one business segment which focuses on applying our technology platforms to improve the performance of established and novel drug candidates. We operate in one segment because our business offerings have similar economics and other characteristics, including the nature of products and manufacturing processes, types of customers, distribution methods and regulatory environment. We are comprehensively managed as one business segment by our Chief Executive Officer and his management team. |
Significant Concentrations | Significant Concentrations Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables from product sales and royalties, as well as milestones and time and materials based billings from collaborative research and development agreements. When appropriate, we provide for an allowance for doubtful accounts by reserving for specifically identified doubtful accounts. We generally do not require collateral from our customers. We perform a regular review of our customers’ payment histories and associated credit risk. We have not experienced significant credit losses from our accounts receivable and our allowance for doubtful accounts was not significant at either June 30, 2015 or December 31, 2014. We are dependent on our suppliers and contract manufacturers to provide raw materials, drugs and devices of appropriate quality and reliability and to meet applicable contract and regulatory requirements. In certain cases, we rely on single sources of supply of one or more critical materials. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop and produce our drug candidates or our ability to meet our supply obligations could be significantly impaired, which could have a material adverse effect on our business, financial condition and results of operations. |
Revenue Recognition | Revenue Recognition Our revenue is derived from our arrangements with pharmaceutical and biotechnology collaboration partners and may result from one or more of the following: upfront and license fees, payments for contract research and development, milestone payments, manufacturing and supply payments, and royalties. Our performance obligations under our collaborations may include licensing our intellectual property, manufacturing and supply obligations, and research and development obligations. In order to account for the multiple-element arrangements, we identify the deliverables included within the arrangement and evaluate which deliverables represent separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. Revenue is recognized separately for each identified unit of accounting when the basic revenue recognition criteria are met: there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. At the inception of each new multiple-element arrangement or the material modification of an existing multiple-element arrangement, we allocate all consideration received under multiple-element arrangements to all units of accounting based on the relative selling price method, generally based on our best estimate of selling price (ESP). The objective of ESP is to determine the price at which we would transact a sale if the product or service was sold on a stand-alone basis. We determine ESP for the elements in our collaboration arrangements by considering multiple factors including, but not limited to, technical complexity of the performance obligation and similarity of elements to those performed under previous arrangements. Since we apply significant judgment in arriving at the ESPs, any material change in our estimates would significantly affect the allocation of the total consideration to the different elements of a multiple element arrangement. Product sales Product sales are primarily derived from fixed price and cost-plus manufacturing and supply agreements with our collaboration partners. We have not experienced any significant returns from our customers. Royalty revenue Generally, we are entitled to royalties from our collaboration partners based on the net sales of their approved drugs that are marketed and sold in one or more countries where we hold royalty rights. We recognize royalty revenue when the cash is received or when the royalty amount to be received is estimable and collection is reasonably assured. With respect to the non-cash royalties related to sale of future royalties described at Note 4, revenue is recognized when estimable, otherwise, revenue is recognized during the period in which the related royalty report is received, which generally occurs in the quarter after the applicable product sales are made. License, collaboration and other revenue The amount of upfront fees and other payments received by us in license and collaboration arrangements that are allocated to continuing performance obligations, such as manufacturing and supply obligations, are deferred and generally recognized ratably over our expected performance period under each respective arrangement. We make our best estimate of the period over which we expect to fulfill our performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these collaboration arrangements, significant judgment is required to determine the duration of the performance period and this estimate is periodically re-evaluated. Contingent consideration received from the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved, which we believe is consistent with the substance of our performance under our various license and collaboration agreements. A milestone is defined as an event (i) that can only be achieved based in whole or in part either on the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the entity. A milestone is substantive if the consideration earned from the achievement of the milestone is consistent with our performance required to achieve the milestone or the increase in value to the collaboration resulting from our performance, relates solely to our past performance, and is reasonable relative to all of the other deliverables and payments within the arrangement. Our license and collaboration agreements with our partners provide for payments to us upon the achievement of development milestones, such as the completion of clinical trials or regulatory submissions, approvals by regulatory authorities, and commercial launches of drugs. Given the challenges inherent in developing and obtaining regulatory approval for drug products and in achieving commercial launches, there was substantial uncertainty whether any such milestones would be achieved at the time of execution of these licensing and collaboration agreements. In addition, we evaluated whether the development milestones meet the remaining criteria to be considered substantive. As a result of our analysis, we consider our remaining development milestones under all of our license and collaboration agreements to be substantive and, accordingly, we expect to recognize as revenue future payments received from such milestones only if and as each milestone is achieved. Our license and collaboration agreements with certain partners also provide for contingent payments to us based solely upon the performance of the respective partner. For such contingent amounts we expect to recognize the payments as revenue when earned under the applicable contract, which is generally upon completion of performance by the respective partner, provided that collection is reasonably assured. Our license and collaboration agreements with our partners also provide for payments to us upon the achievement of specified sales volumes of approved drugs. We consider these payments to be similar to royalty payments and we will recognize such sales-based payments upon achievement of such sales volumes, provided that collection is reasonably assured. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred and include salaries, benefits and other operating costs such as outside services, supplies and allocated overhead costs. We perform research and development for our proprietary drug candidates and technology development and for certain third parties under collaboration agreements. For our proprietary drug candidates and our internal technology development programs, we invest our own funds without reimbursement from a third party. We record accruals for the estimated costs of our clinical trial activities performed by third parties. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of certain clinical trial activities. We generally accrue costs associated with the start-up and reporting phases of the clinical trials ratably over the estimated duration of the start-up and reporting phases. We generally accrue costs associated with the treatment phase of clinical trials based on the total estimated cost of the treatment phase on a per patient basis and we expense the per patient cost ratably over the estimated patient treatment period based on patient enrollment in the trials. In specific circumstances, such as for certain time-based costs, we recognize clinical trial expenses using a methodology that we consider to be more reflective of the timing of costs incurred. Advance payments for goods or services that will be used or rendered for future research and development activities are capitalized as prepaid expenses and recognized as expense as the related goods are delivered or the related services are performed. We base our estimates on the best information available at the time. However, additional information may become available to us which may allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. Such increases or decreases in cost are generally considered to be changes in estimates and will be reflected in research and development expenses in the period identified. |
Long-Lived Assets | Long-Lived Assets We assess the impairment of long-lived assets, primarily property, plant and equipment and goodwill included in other non-current assets, whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. When such events occur, we determine whether there has been an impairment in value by comparing the asset’s carrying value with its fair value, as measured by the anticipated undiscounted net cash flows of the asset. In the case of goodwill impairment, market capitalization is generally used as the measure of fair value. If an impairment in value exists, the asset is written down to its estimated fair value. In March 2015, we announced that the primary endpoint for our BEACON Phase 3 clinical study for NKTR-102 as a single-agent therapy for women with advanced metastatic breast cancer did not achieve statistical significance. As a result, we performed an impairment analysis for our long-lived assets, including goodwill, as well as our primary long-lived asset group which is dedicated to NKTR-102. Based on this analysis, we concluded that there is no impairment at March 31, 2015 or June 30, 2015. |
Income Taxes | Income Taxes For the three and six months ended June 30, 2015 and 2014, we recorded an income tax provision for our Nektar India operations at an effective tax rate of approximately 34%. The U.S. federal deferred tax assets generated from our net operating losses have been fully reserved, as we believe it is not more likely than not that the benefit will be realized. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued guidance codified in Accounting Standards Codification (ASC) 606, Revenue Recognition — Revenue from Contracts with Customers, which amends the guidance in former ASC 605, Revenue Recognition, and is effective for public companies for fiscal years beginning after December 15, 2017. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. We are currently evaluating the impact of the provisions of ASC 606. In April 2015, the FASB issued guidance to simplify the presentation of debt issuance costs by requiring debt issuance costs to be presented as a deduction from the corresponding debt liability. This guidance is effective for our interim and annual periods beginning January 1, 2016. Upon adoption, the new guidance must be applied retrospectively to all periods presented. We do not believe the adoption of this guidance will have a material impact on our consolidated financial statement |
Liability Related to Sale of Future Royalties | We periodically assess the estimated royalty payments to RPI from UCB and Roche and to the extent such payments are greater or less than our initial estimates, or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the Royalty Obligation. |
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Cash and Investments in Marketable Securities (Tables)
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Jun. 30, 2015
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash and Investments in Marketable Securities, Including Cash Equivalents and Restricted Cash | Cash and investments in marketable securities, including cash equivalents and restricted cash, are as follows (in thousands).
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Portfolio of Cash and Investments in Marketable Securities | Our portfolio of cash and investments in marketable securities includes (in thousands):
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Inventory (Tables)
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Jun. 30, 2015
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Inventory | Inventory consists of the following (in thousands):
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License and Collaboration Agreements (Tables)
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Jun. 30, 2015
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
License, Collaboration and Other Revenue | In accordance with our collaboration agreements, we recognized license, collaboration and other revenue as follows (in thousands):
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Jun. 30, 2015
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation Expense | Total stock-based compensation expense was recognized in our Condensed Consolidated Statements of Operations as follows (in thousands):
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Organization and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $)
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Jun. 30, 2015
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Mar. 31, 2015
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Jun. 30, 2014
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Jun. 30, 2014
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Dec. 31, 2014
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Cash and investments in marketable securities | $ 279,660,000 | $ 279,660,000 | $ 262,824,000 | |||
Senior secured notes | 125,000,000 | 125,000,000 | 125,000,000 | |||
Long-term debt | 133,500,000 | 133,500,000 | ||||
Capital lease obligations | 8,500,000 | 8,500,000 | ||||
Capital lease obligations, current portion | 5,643,000 | 5,643,000 | 4,512,000 | |||
Number of business segments | 1 | |||||
Asset impairment charges | $ 0 | $ 0 | ||||
Effective income tax rate | 34.00% | 34.00% | 34.00% | 34.00% |
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Cash and Investments in Marketable Securities - Cash and Investments in Marketable Securities, Including Cash Equivalents and Restricted Cash (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
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Dec. 31, 2014
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Jun. 30, 2014
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Dec. 31, 2013
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Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||||
Cash and cash equivalents | $ 20,875 | $ 12,365 | $ 30,699 | $ 39,067 |
Restricted cash | 25,000 | 25,000 | ||
Short-term investments | 233,785 | 225,459 | ||
Total cash and investments in marketable securities | $ 279,660 | $ 262,824 |
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Cash And Restricted Cash No definition available.
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Cash, Restricted Cash, Cash Equivalents, And Available For Sale Investments No definition available.
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Inventory - Inventory (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
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Dec. 31, 2014
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---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,392 | $ 2,200 |
Work-in-process | 6,117 | 5,187 |
Finished goods | 1,615 | 5,565 |
Total inventory | $ 10,124 | $ 12,952 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Liability Related to Sale of Future Royalties - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | 1 Months Ended | 0 Months Ended | |||
---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Mar. 31, 2013
Milestone Scenario One [Member]
|
Mar. 31, 2014
Milestone Scenario Two [Member]
|
Feb. 24, 2012
Purchase and Sale Agreement with RPI [Member]
|
|
Liability Related to Sale of Future Royalties [Line Items] | |||||||
Proceeds from sale of royalty rights | $ 124,000,000 | ||||||
Non-cash royalty revenue related to sale of future royalties | 4,740,000 | 4,837,000 | 8,702,000 | 10,610,000 | |||
Annual interest rate | 17.00% | ||||||
Payment made for milestone not achieved year one | 3,000,000 | ||||||
Payment made for milestone not achieved year two | $ 7,000,000 | ||||||
Royalty agreement contingent payment description | As a result of worldwide net sales of MIRCERA® for the 12 month periods ended December 31, 2013 and 2012 not reaching certain minimum thresholds. |
X | ||||||||||
- Definition
Estimated Annual Interest Rate On Royalty Liability No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Non cash royalty revenue related to sale future royalties No definition available.
|
X | ||||||||||
- Definition
Payment Made For Milestone Not Achieved Year One No definition available.
|
X | ||||||||||
- Definition
Payment Made For Milestone Not Achieved Year Two No definition available.
|
X | ||||||||||
- Definition
Proceeds from sale of potential future royalties gross. No definition available.
|
X | ||||||||||
- Definition
Royalty agreement contingent payment description. No definition available.
|
Commitments and Contingencies - Additional Information (Detail) (Indemnification Obligation [Member], USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Indemnification Obligation [Member]
|
||
Loss Contingencies [Line Items] | ||
Indemnification obligations, liabilities | $ 0 | $ 0 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
License and Collaboration Agreements - License, Collaboration and Other Revenue (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | $ 6,208 | $ 17,785 | $ 102,948 | $ 25,866 |
AstraZeneca AB [Member] | MOVANTIKTM (NKTR-118) and MOVANTIKTM fixed-dose combination program (NKTR-119) [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | 0 | 0 | 90,000 | 0 |
Roche [Member] | PEGASYS and MIRCERA [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | 3,197 | 3,219 | 6,408 | 6,415 |
Amgen, Inc. [Member] | Neulasta [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | 1,250 | 1,250 | 2,500 | 2,500 |
Bayer Healthcare LLC [Member] | BAY41-6551 (Amikacin Inhale) [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | 395 | 2,393 | 1,205 | 3,146 |
Baxalta [Member] | BAX 855 (Hemophilia) [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | 88 | 669 | 197 | 1,006 |
Other [Member]
|
||||
License And Collaboration Agreements [Line Items] | ||||
License, collaboration and other revenue | $ 1,278 | $ 10,254 | $ 2,638 | $ 12,799 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Revenue earned during the period relating to consideration received from another party for the right to use, but not own, certain of the entity's intangible assets. Revenue may contain one or more of the following elements: upfront fees, contract research, milestone payments, manufacturing and supply, royalties, and license fees. No definition available.
|
License and Collaboration Agreements - Additional Information (Detail) (USD $)
|
6 Months Ended | 3 Months Ended | 1 Months Ended | 3 Months Ended | 1 Months Ended | 6 Months Ended | 3 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | 0 Months Ended | 3 Months Ended | 1 Months Ended | 6 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Dec. 31, 2013
Roche [Member]
MIRCERA [Member]
|
Jun. 30, 2015
Roche [Member]
MIRCERA [Member]
|
Feb. 29, 2012
Roche [Member]
MIRCERA [Member]
Performance-based Milestone Payments [Member]
|
Feb. 29, 2012
Roche [Member]
MIRCERA [Member]
Upfront Payment Arrangement in 2007 [Member]
|
Jun. 30, 2015
Roche [Member]
PEGASYS [Member]
|
Jun. 30, 2015
Roche [Member]
PEGASYS and MIRCERA [Member]
|
Dec. 31, 2010
Amgen, Inc. [Member]
|
Jun. 30, 2015
Amgen, Inc. [Member]
|
Jun. 30, 2014
Ophthotech Corporation [Member]
Fovista [Member]
|
Jun. 30, 2015
Ophthotech Corporation [Member]
Fovista [Member]
|
Mar. 31, 2015
AstraZeneca AB [Member]
United States [Member]
|
Jun. 30, 2015
AstraZeneca AB [Member]
United States [Member]
Other Current Liabilities [Member]
|
Jun. 30, 2015
AstraZeneca AB [Member]
United States [Member]
Other Long-Term Liabilities [Member]
|
Jul. 31, 2016
AstraZeneca AB [Member]
Scenario, Forecast [Member]
United States [Member]
|
Jul. 31, 2015
AstraZeneca AB [Member]
Scenario, Forecast [Member]
United States [Member]
|
Sep. 16, 2014
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Oct. 31, 2014
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Nov. 30, 2013
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Mar. 31, 2015
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Jun. 30, 2015
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Sep. 16, 2014
AstraZeneca AB [Member]
MOVANTIK [Member]
|
Jun. 30, 2015
AstraZeneca AB [Member]
MOVANTIK [Member]
European Union [Member]
|
Sep. 16, 2014
AstraZeneca AB [Member]
MOVANTIK [Member]
United States [Member]
|
Dec. 31, 2009
AstraZeneca AB [Member]
MOVANTIKTM (NKTR-118) and MOVANTIKTM fixed-dose combination program (NKTR-119) [Member]
Upfront Payment Arrangement in 2007 [Member]
|
Jun. 30, 2015
AstraZeneca AB [Member]
Movantik Fixed-dose Combination Program [Member]
|
Jun. 30, 2013
Bayer Healthcare LLC [Member]
|
Jun. 30, 2015
Bayer Healthcare LLC [Member]
|
Jun. 30, 2015
Bayer Healthcare LLC [Member]
Performance-based Milestone Payments [Member]
|
Dec. 31, 2007
Bayer Healthcare LLC [Member]
Upfront Payment Arrangement in 2007 [Member]
|
Sep. 30, 2014
Baxalta [Member]
BAX 855 (Hemophilia) [Member]
|
Jun. 30, 2015
Baxalta [Member]
BAX 855 (Hemophilia) [Member]
|
Jun. 30, 2015
Baxalta [Member]
BAX 855 (Hemophilia) [Member]
United States [Member]
|
Jun. 30, 2015
Other [Member]
|
|
Deferred Revenue Arrangement [Line Items] | ||||||||||||||||||||||||||||||||||
Potential future additional payments for development milestones | $ 128,300,000 | $ 9,500,000 | $ 50,000,000 | $ 20,000,000 | $ 10,000,000 | $ 51,800,000 | ||||||||||||||||||||||||||||
Received upfront and milestone payments | 22,000,000 | 5,000,000 | 50,000,000 | 19,750,000 | 35,000,000 | 70,000,000 | 100,000,000 | 125,000,000 | 30,000,000 | 40,000,000 | ||||||||||||||||||||||||
Contingent payments receivable based on development events regulatory to be pursued and completed solely by others | 40,000,000 | 75,000,000 | ||||||||||||||||||||||||||||||||
Liability to AZ for DTC advertising payments | 10,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||||||||||||||||||||
Reduction of revenue | (10,000,000) | |||||||||||||||||||||||||||||||||
Deferred revenue | 8,100,000 | 2,600,000 | 3,400,000 | 26,700,000 | 18,200,000 | 0 | 20,000,000 | 0 | 18,000,000 | |||||||||||||||||||||||||
Potential reduction in U.S. royalty rate for repayment | 2.00% | |||||||||||||||||||||||||||||||||
Percentage of post approval study costs to repay | 33.00% | |||||||||||||||||||||||||||||||||
Maximum potential reduction in royalties | 35,000,000 | |||||||||||||||||||||||||||||||||
Consideration received for product delivered in 2013 | 18,600,000 | |||||||||||||||||||||||||||||||||
Payment made to Bayer for cost of Phase 3 clinical trial | 10,000,000 | |||||||||||||||||||||||||||||||||
Development milestones achieved | $ 8,000,000 |
X | ||||||||||
- Definition
Consideration received for product delivered. No definition available.
|
X | ||||||||||
- Definition
Contingent payments receivable based on development events. No definition available.
|
X | ||||||||||
- Definition
Increase Decrease In Revenue No definition available.
|
X | ||||||||||
- Definition
Liability to AZ for DTC advertising payments. No definition available.
|
X | ||||||||||
- Definition
Payment made to Bayer for cost of Phase 3 clinical trial. No definition available.
|
X | ||||||||||
- Definition
Percentage of post approval study costs to repay. No definition available.
|
X | ||||||||||
- Definition
Potential development milestones. No definition available.
|
X | ||||||||||
- Definition
Potential Reduction In Future Royalty Payments To Repay Post Approval Studies No definition available.
|
X | ||||||||||
- Definition
Potential royalty reduction on sales to repay post-approval study if required. No definition available.
|
X | ||||||||||
- Definition
Upfront and Milestone Payments Received Under License Agreement No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 4,560 | $ 4,164 | $ 9,737 | $ 8,525 |
Cost of Goods Sold [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 239 | 280 | 563 | 599 |
Research and Development Expense [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 2,125 | 1,832 | 4,547 | 3,805 |
General and Administrative Expense [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 2,196 | $ 2,052 | $ 4,627 | $ 4,121 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Stock-Based Compensation - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock issuances under equity compensation plans | 733,952 | 350,513 | 969,250 | 1,017,887 |
Stock Options [Member]
|
||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted stock options | 68,200 | 642,860 | 479,010 | 3,776,040 |
Weighted average grant-date fair value | $ 4.81 | $ 5.24 | $ 6.31 | $ 5.84 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Net Loss Per Share - Additional Information (Detail) (Stock Options [Member])
In Millions, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Stock Options [Member]
|
||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average diluted securities excluded from diluted net loss per share | 21.6 | 22.5 | 21.7 | 21.9 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|