Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 23, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | NKTR | |
Entity Registrant Name | NEKTAR THERAPEUTICS | |
Entity Central Index Key | 906709 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 131,526,201 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $129,452 | $12,365 |
Restricted cash | 25,000 | 25,000 |
Short-term investments | 171,353 | 225,459 |
Accounts receivable, net | 2,885 | 3,607 |
Inventory | 12,511 | 12,952 |
Other current assets | 6,092 | 8,817 |
Total current assets | 347,293 | 288,200 |
Property, plant and equipment, net | 69,267 | 70,368 |
Goodwill | 76,501 | 76,501 |
Other assets | 6,151 | 6,552 |
Total assets | 499,212 | 441,621 |
Current liabilities: | ||
Accounts payable | 5,024 | 2,703 |
Accrued compensation | 9,356 | 5,749 |
Accrued expenses | 8,245 | 6,418 |
Accrued clinical trial expenses | 8,747 | 7,708 |
Interest payable | 3,167 | 6,917 |
Capital lease obligations, current portion | 5,412 | 4,512 |
Deferred revenue, current portion | 24,959 | 24,473 |
Other current liabilities | 10,534 | 5,567 |
Total current liabilities | 75,444 | 64,047 |
Senior secured notes | 125,000 | 125,000 |
Capital lease obligations, less current portion | 4,386 | 4,139 |
Liability related to sale of future royalties | 121,558 | 120,471 |
Deferred revenue, less current portion | 78,418 | 76,911 |
Other long-term liabilities | 17,101 | 14,721 |
Total liabilities | 421,907 | 405,289 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value, 10,000 shares authorized, no shares designated, issued or outstanding at March 31, 2015 or December 31, 2014, respectively | 0 | 0 |
Common stock, $0.0001 par value, 300,000 authorized, 131,451 shares and 131,216 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively | 13 | 13 |
Capital in excess of par value | 1,831,057 | 1,824,195 |
Accumulated other comprehensive loss | -1,276 | -1,567 |
Accumulated deficit | -1,752,489 | -1,786,309 |
Total stockholders' equity | 77,305 | 36,332 |
Total liabilities and stockholders' equity | $499,212 | $441,621 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $0.00 | $0.00 |
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 | $0.00 | $0.00 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 131,451,000 | 131,216,000 |
Common stock, shares outstanding | 131,451,000 | 131,216,000 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenue: | ||
Product sales and royalty revenue | $8,099 | $5,917 |
Non-cash royalty revenue related to sale of future royalties | 3,962 | 5,773 |
License, collaboration and other revenue | 96,740 | 8,081 |
Total revenue | 108,801 | 19,771 |
Operating costs and expenses: | ||
Cost of goods sold | 8,444 | 7,907 |
Research and development | 47,011 | 38,338 |
General and administrative | 10,303 | 9,928 |
Total operating costs and expenses | 65,758 | 56,173 |
Income (loss) from operations | 43,043 | -36,402 |
Non-operating income (expense): | ||
Interest expense | -4,171 | -4,533 |
Non-cash interest expense on liability related to sale of future royalties | -5,050 | -5,387 |
Interest income and other income (expense), net | 211 | 312 |
Total non-operating expense, net | -9,010 | -9,608 |
Income (loss) before provision for income taxes | 34,033 | -46,010 |
Provision for income taxes | 213 | 191 |
Net income (loss) | $33,820 | ($46,201) |
Net income (loss) per share: | ||
Basic | $0.26 | ($0.37) |
Diluted | $0.25 | ($0.37) |
Weighted average shares outstanding used in computing net income (loss) per share | ||
Basic | 131,359 | 123,543 |
Diluted | 135,667 | 123,543 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Statement of Comprehensive Income [Abstract] | ||
Comprehensive income (loss) | $34,111 | ($45,960) |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash flows from operating activities: | ||
Net income (loss) | $33,820 | ($46,201) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Non-cash royalty revenue related to sale of future royalties | -3,962 | -5,773 |
Non-cash interest expense on liability related to sale of future royalties | 5,050 | 5,387 |
Stock-based compensation | 5,177 | 4,361 |
Depreciation and amortization | 2,973 | 3,264 |
Other non-cash transactions | -938 | 777 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 722 | 374 |
Inventory | 441 | 580 |
Other assets | 2,809 | -718 |
Accounts payable | 2,241 | -6,126 |
Accrued compensation | 3,607 | -4,827 |
Accrued expenses | 1,811 | 693 |
Accrued clinical trial expenses | 1,039 | -3,179 |
Interest payable | -3,750 | -3,750 |
Deferred revenue | 1,993 | -5,957 |
Other liabilities | 10,279 | -1,195 |
Net cash provided by (used in) operating activities | 63,312 | -62,290 |
Cash flows from investing activities: | ||
Maturities of investments | 73,434 | 56,972 |
Purchases of investments | -24,432 | -110,661 |
Sale of investments | 5,215 | |
Purchases of property, plant and equipment | -1,059 | -4,524 |
Net cash provided by (used in) investing activities | 53,158 | -58,213 |
Cash flows from financing activities: | ||
Payment of capital lease obligations | -1,098 | -825 |
Repayment of proceeds from sale of future royalties | -7,000 | |
Issuance of common stock, net of issuance costs | 116,619 | |
Proceeds from shares issued under equity compensation plans | 1,685 | 5,074 |
Net cash provided by financing activities | 587 | 113,868 |
Effect of exchange rates on cash and cash equivalents | 30 | 11 |
Net increase (decrease) in cash and cash equivalents | 117,087 | -6,624 |
Cash and cash equivalents at beginning of period | 12,365 | 39,067 |
Cash and cash equivalents at end of period | 129,452 | 32,443 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $7,855 | $7,961 |
Organization_and_Summary_of_Si
Organization and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [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 March 31, 2015, we had approximately $325.8 million in cash and investments in marketable securities, of which $25.0 million was restricted in relation to our 12% senior secured notes due July 15, 2017. Also, as of March 31, 2015, we had $134.8 million in long-term debt, including $125.0 million of senior secured notes and $9.8 million of capital lease obligations, of which $5.4 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 income (loss) consists of our net income (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 months ended March 31, 2015 and 2014. In addition, there were no significant reclassifications out of accumulated other comprehensive income (loss) to the statements of operations during the three months ended March 31, 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. On an ongoing basis, we evaluate our estimates, including 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. 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 income (loss), net income (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 March 31, 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 health 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. | |
Income Taxes | |
For the three month periods ended March 31, 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, 2016. We are currently evaluating the impact of the provisions of ASC 606. |
Cash_and_Investments_in_Market
Cash and Investments in Marketable Securities | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
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). Cash and cash equivalents at March 31, 2015 includes a $100.0 million U.S. commercial launch milestone payment received on March 31, 2015 from our collaboration agreement with AstraZeneca AB. | |||||||||||
Estimated Fair Value at | |||||||||||
March 31, | December 31, | ||||||||||
2015 | 2014 | ||||||||||
Cash and cash equivalents | $ | 129,452 | $ | 12,365 | |||||||
Short-term investments | 171,353 | 225,459 | |||||||||
Restricted cash | 25,000 | 25,000 | |||||||||
Total cash and investments in marketable securities | $ | 325,805 | $ | 262,824 | |||||||
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 March 31, 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 March 31, 2015 or December 31, 2014. During the three month period ended March 31, 2015, we sold available-for-sale securities totaling $5.2 million and gross realized gains and losses on those sales were not significant. During the three month period ended March 31, 2014, we did not sell any of our available-for-sale securities. The cost of securities sold is based on the specific identification method. | |||||||||||
Restricted cash of $25.0 million is required to be maintained in a separate account until July 1, 2015 under the terms of our 12% senior secured notes due July 2017. Upon release of this restriction on July 1, 2015, a covenant of the senior secured notes requires that the aggregate balance of our unrestricted cash and cash equivalents at the end of any two consecutive fiscal quarters may not be less than $25.0 million, subject to certain conditions. | |||||||||||
Our portfolio of cash and investments in marketable securities includes (in thousands): | |||||||||||
Estimated Fair Value at | |||||||||||
Fair Value | March 31, | December 31, | |||||||||
Hierarchy | 2015 | 2014 | |||||||||
Level | |||||||||||
Corporate notes and bonds | 2 | $ | 135,400 | $ | 182,544 | ||||||
Corporate commercial paper | 2 | 35,953 | 42,915 | ||||||||
Available-for-sale investments | 171,353 | 225,459 | |||||||||
Money market funds | 1 | 123,558 | 11,229 | ||||||||
Cash, including restricted cash | N/A | 30,894 | 26,136 | ||||||||
Total cash and investments in marketable securities | $ | 325,805 | $ | 262,824 | |||||||
Level 1 — | Quoted prices in active markets for identical assets or liabilities. | ||||||||||
Level 2 — | Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | ||||||||||
Level 3 — | Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. | ||||||||||
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 month periods ended March 31, 2015 and 2014, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. | |||||||||||
Additionally, as of March 31, 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. |
Inventory
Inventory | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Inventory Disclosure [Abstract] | |||||||||
Inventory | Note 3 — Inventory | ||||||||
Inventory consists of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Raw materials | $ | 2,401 | $ | 2,200 | |||||
Work-in-process | 7,665 | 5,187 | |||||||
Finished goods | 2,445 | 5,565 | |||||||
Total inventory | $ | 12,511 | $ | 12,952 | |||||
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. |
Liability_Related_to_Sale_of_F
Liability Related to Sale of Future Royalties | 3 Months Ended |
Mar. 31, 2015 | |
Text Block [Abstract] | |
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 three months ended March 31, 2015 and 2014, we recognized $4.0 million and $5.8 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. As of March 31, 2015, we do not expect to make any further payments related to the Purchase and Sale 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. |
Commitments_and_Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2015 | |
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 divestures 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 March 31, 2015 or December 31, 2014. |
License_and_Collaboration_Agre
License and Collaboration Agreements | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||
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): | |||||||||||
Three months ended | |||||||||||
March 31, | |||||||||||
Partner | Drug or Drug Candidate | 2015 | 2014 | ||||||||
AstraZeneca AB | MOVANTIKTM (NKTR-118) and MOVANTIKTM fixed-dose combination program (NKTR-119) | $ | 90,000 | $ | — | ||||||
Roche | PEGASYS® and MIRCERA® | 3,212 | 3,197 | ||||||||
Amgen, Inc. | Neulasta® | 1,250 | 1,250 | ||||||||
Bayer Healthcare LLC | BAY41-6551 (Amikacin Inhale) | 810 | 752 | ||||||||
Baxter Healthcare | BAX 855 (Hemophilia) | 109 | 337 | ||||||||
Other | 1,359 | 2,545 | |||||||||
License, collaboration, and other revenue | $ | 96,740 | $ | 8,081 | |||||||
As of March 31, 2015, our collaboration agreements with partners included potential future payments for development milestones totaling approximately $128.3 million, including amounts from our agreements with Baxter, 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 three months ended March 31, 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, of which $5.0 million will be paid in July 2015 and $5.0 million will be paid in July 2016. This $10.0 million obligation has been recorded 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 March 31, 2015. 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. | |||||||||||
In general, other than as described above and in this paragraph, AstraZeneca has full responsibility for all research, development and commercialization costs under our naloxegol 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 March 31, 2015, we have deferred revenue of approximately $3.8 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 March 31, 2015, we have deferred revenue of approximately $9.4 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 March 31, 2015, we have deferred revenue of approximately $4.0 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 March 31, 2015, we have deferred revenue of approximately $27.9 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 March 31, 2015, we have received an upfront payment of $40.0 million 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 March 31, 2015, we have deferred revenue of approximately $20.4 million related to this agreement, which we expect to recognize through February 2028, the estimated end of our obligations under this agreement. | |||||||||||
Baxter Healthcare: Hemophilia | |||||||||||
In September 2005, we entered into an exclusive research, development, license and manufacturing and supply agreement with Baxter Healthcare SA and Baxter Healthcare Corporation (together referred to as Baxter) to develop products designed to improve therapies for Hemophilia A patients using our PEGylation technology. This Hemophilia A program includes BAX 855. Under the terms of this agreement, as of March 31, 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, Baxter 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 achieved development milestones totaling $8.0 million in September 2014. In December 2014, Baxter announced that it filed a biologic license application with the FDA for BAX 855. As of March 31, 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 March 31, 2015, we have deferred revenue of approximately $18.6 million related to this agreement, which we expect to recognize through March 2028, 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 March 31, 2015, we have a number of collaboration agreements, including 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. |
StockBased_Compensation
Stock-Based Compensation | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
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): | |||||||||
Three months ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Cost of goods sold | $ | 324 | $ | 319 | |||||
Research and development expense | 2,422 | 1,973 | |||||||
General and administrative expense | 2,431 | 2,069 | |||||||
Total stock-based compensation | $ | 5,177 | $ | 4,361 | |||||
During the three months ended March 31, 2015 and 2014, we granted 410,810 and 3,133,180 stock options, respectively, at a weighted-average grant-date fair value of $6.56 per share and $5.97 per share, respectively. As a result of stock issuances under our equity compensation plans, during the three months ended March 31, 2015 and 2014, we issued 235,298 and 667,374 common shares, respectively. |
Net_Income_Loss_Per_Share
Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2015 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | Note 8 — Net Income (Loss) Per Share |
Basic net income (loss) per share is calculated based on the weighted-average number of common shares outstanding during the periods presented. Diluted net income (loss) per share is calculated based on the weighted-average number of common shares outstanding, including potential dilutive securities. For all periods presented in the accompanying Condensed Consolidated Statements of Operations, the net income (loss) available to common stockholders is equal to the reported net income (loss). | |
The calculation of diluted net income per share for the three months ended March 31, 2015 includes the weighted-average of potentially dilutive securities, which consists of stock options to purchase approximately 4.3 million shares. Stock options to purchase approximately 8.5 million weighted-average shares of our common stock outstanding during the three months ended March 31, 2015 were excluded from the computation of diluted net income per share for that period because their effect was antidilutive. | |
For periods in which we have generated a net loss, basic and diluted net loss per share are the same due to the requirement to exclude potentially dilutive securities which would have an anti-dilutive effect on net loss per share. Potentially dilutive securities for the three months ended March 31, 2014 consisted of weighted-average outstanding stock options to purchase 21.7 million shares. |
Organization_and_Summary_of_Si1
Organization and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [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 March 31, 2015, we had approximately $325.8 million in cash and investments in marketable securities, of which $25.0 million was restricted in relation to our 12% senior secured notes due July 15, 2017. Also, as of March 31, 2015, we had $134.8 million in long-term debt, including $125.0 million of senior secured notes and $9.8 million of capital lease obligations, of which $5.4 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 income (loss) consists of our net income (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 months ended March 31, 2015 and 2014. In addition, there were no significant reclassifications out of accumulated other comprehensive income (loss) to the statements of operations during the three months ended March 31, 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. On an ongoing basis, we evaluate our estimates, including 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. 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 income (loss), net income (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 March 31, 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 health 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. | |
Income Taxes | Income Taxes |
For the three month periods ended March 31, 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, 2016. We are currently evaluating the impact of the provisions of ASC 606. |
Cash_and_Investments_in_Market1
Cash and Investments in Marketable Securities (Tables) | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
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). | ||||||||||
Estimated Fair Value at | |||||||||||
March 31, | December 31, | ||||||||||
2015 | 2014 | ||||||||||
Cash and cash equivalents | $ | 129,452 | $ | 12,365 | |||||||
Short-term investments | 171,353 | 225,459 | |||||||||
Restricted cash | 25,000 | 25,000 | |||||||||
Total cash and investments in marketable securities | $ | 325,805 | $ | 262,824 | |||||||
Portfolio of Cash and Investments in Marketable Securities | Our portfolio of cash and investments in marketable securities includes (in thousands): | ||||||||||
Estimated Fair Value at | |||||||||||
Fair Value | March 31, | December 31, | |||||||||
Hierarchy | 2015 | 2014 | |||||||||
Level | |||||||||||
Corporate notes and bonds | 2 | $ | 135,400 | $ | 182,544 | ||||||
Corporate commercial paper | 2 | 35,953 | 42,915 | ||||||||
Available-for-sale investments | 171,353 | 225,459 | |||||||||
Money market funds | 1 | 123,558 | 11,229 | ||||||||
Cash, including restricted cash | N/A | 30,894 | 26,136 | ||||||||
Total cash and investments in marketable securities | $ | 325,805 | $ | 262,824 | |||||||
Inventory_Tables
Inventory (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Inventory Disclosure [Abstract] | |||||||||
Inventory | Inventory consists of the following (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Raw materials | $ | 2,401 | $ | 2,200 | |||||
Work-in-process | 7,665 | 5,187 | |||||||
Finished goods | 2,445 | 5,565 | |||||||
Total inventory | $ | 12,511 | $ | 12,952 | |||||
License_and_Collaboration_Agre1
License and Collaboration Agreements (Tables) | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
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): | ||||||||||
Three months ended | |||||||||||
March 31, | |||||||||||
Partner | Drug or Drug Candidate | 2015 | 2014 | ||||||||
AstraZeneca AB | MOVANTIKTM (NKTR-118) and MOVANTIKTM fixed-dose combination program (NKTR-119) | $ | 90,000 | $ | — | ||||||
Roche | PEGASYS® and MIRCERA® | 3,212 | 3,197 | ||||||||
Amgen, Inc. | Neulasta® | 1,250 | 1,250 | ||||||||
Bayer Healthcare LLC | BAY41-6551 (Amikacin Inhale) | 810 | 752 | ||||||||
Baxter Healthcare | BAX 855 (Hemophilia) | 109 | 337 | ||||||||
Other | 1,359 | 2,545 | |||||||||
License, collaboration, and other revenue | $ | 96,740 | $ | 8,081 | |||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
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): | ||||||||
Three months ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Cost of goods sold | $ | 324 | $ | 319 | |||||
Research and development expense | 2,422 | 1,973 | |||||||
General and administrative expense | 2,431 | 2,069 | |||||||
Total stock-based compensation | $ | 5,177 | $ | 4,361 | |||||
Organization_and_Summary_of_Si2
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Segment | |||
Organization And Summary Of Significant Accounting Policies [Line Items] | |||
Cash and investments in marketable securities | $325,805,000 | $262,824,000 | |
Senior secured notes, issued | 125,000,000 | 125,000,000 | |
Restricted cash | 25,000,000 | 25,000,000 | |
Long-term debt | 134,800,000 | ||
Capital lease obligations | 9,800,000 | ||
Capital lease obligations, current | 5,412,000 | 4,512,000 | |
Number of business segments | 1 | ||
Asset impairment charges | 0 | ||
Effective income tax rate | 34.00% | 34.00% | |
12% Senior Secured Notes Due July 2017 [Member] | |||
Organization And Summary Of Significant Accounting Policies [Line Items] | |||
Senior secured notes, interest rate | 12.00% | ||
Senior secured notes, maturity date | 15-Jul-17 | ||
Restricted cash | $25,000,000 |
Cash_and_Investments_in_Market2
Cash and Investments in Marketable Securities - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | |
Cash and Investments in Marketable Securities [Line Items] | ||||
Maximum maturity term for debt securities investment | Two years or less | |||
Weighted average maturity term for debt securities investment | One year or less | |||
Available-for-sale securities, sold | $5,200,000 | $0 | ||
Restricted cash | 25,000,000 | 25,000,000 | 25,000,000 | |
Level 1 to level 2 transfers | 0 | 0 | 0 | |
Level 2 to level 1 transfers | 0 | 0 | 0 | |
Senior secured notes, carrying amount | 125,000,000 | 125,000,000 | 125,000,000 | |
AstraZeneca AB [Member] | United States [Member] | ||||
Cash and Investments in Marketable Securities [Line Items] | ||||
Received upfront and milestone payments | 100,000,000 | |||
12% Senior Secured Notes Due July 2017 [Member] | ||||
Cash and Investments in Marketable Securities [Line Items] | ||||
Restricted cash | 25,000,000 | 25,000,000 | ||
Senior secured notes, interest rate | 12.00% | 12.00% | ||
Senior secured notes, maturity date | 15-Jul-17 | |||
12% Senior Secured Notes Due July 2017 [Member] | Level 3 [Member] | ||||
Cash and Investments in Marketable Securities [Line Items] | ||||
Senior secured notes, interest rate | 12.00% | 12.00% | ||
Senior secured notes, maturity date | 15-Jul-17 | |||
Senior secured notes, carrying amount | $125,000,000 | $125,000,000 |
Cash_and_Investments_in_Market3
Cash and Investments in Marketable Securities - Cash and Investments in Marketable Securities, Including Cash Equivalents and Restricted Cash (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||||
Cash and cash equivalents | $129,452 | $12,365 | $32,443 | $39,067 |
Short-term investments | 171,353 | 225,459 | ||
Restricted cash | 25,000 | 25,000 | ||
Total cash and investments in marketable securities | $325,805 | $262,824 |
Cash_and_Investments_in_Market4
Cash and Investments in Marketable Securities - Portfolio of Cash and Investments in Marketable Securities (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | $171,353 | $225,459 |
Cash, including restricted cash | 30,894 | 26,136 |
Total cash and investments in marketable securities | 325,805 | 262,824 |
Corporate Notes and Bonds [Member] | Fair Value Hierarchy Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 135,400 | 182,544 |
Corporate Commercial Paper [Member] | Fair Value Hierarchy Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 35,953 | 42,915 |
Money Market Funds [Member] | Fair Value Hierarchy Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | $123,558 | $11,229 |
Inventory_Inventory_Detail
Inventory - Inventory (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ||
Raw materials | $2,401 | $2,200 |
Work-in-process | 7,665 | 5,187 |
Finished goods | 2,445 | 5,565 |
Total inventory | $12,511 | $12,952 |
Liability_Related_to_Sale_of_F1
Liability Related to Sale of Future Royalties - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | 0 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Feb. 24, 2012 | |
Liability Related to Sale of Future Royalties [Line Items] | |||||
Non-cash royalty revenue | $3,962,000 | $5,773,000 | |||
Annual interest rate | 17.00% | ||||
Royalty agreement contingent payment description | As a result of worldwide net sales of MIRCERAfor the 12 month periods ended December 31, 2013 and 2012 not reaching certain minimum thresholds. | ||||
Milestone Scenario One [Member] | |||||
Liability Related to Sale of Future Royalties [Line Items] | |||||
Payment made for milestone not achieved year one | 3,000,000 | ||||
Milestone Scenario Two [Member] | |||||
Liability Related to Sale of Future Royalties [Line Items] | |||||
Payment made for milestone not achieved year two | 7,000,000 | ||||
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 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (Indemnification Obligation [Member], USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Indemnification Obligation [Member] | ||
Loss Contingencies [Line Items] | ||
Indemnification Obligations, liabilities | $0 | $0 |
License_and_Collaboration_Agre2
License and Collaboration Agreements - License, Collaboration and Other Revenue (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | $96,740 | $8,081 |
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 | 90,000 | 0 |
Roche [Member] | PEGASYS and MIRCERA [Member] | ||
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | 3,212 | 3,197 |
Amgen, Inc. [Member] | Neulasta [Member] | ||
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | 1,250 | 1,250 |
Bayer Healthcare LLC [Member] | BAY41-6551 (Amikacin Inhale) [Member] | ||
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | 810 | 752 |
Baxter Healthcare [Member] | BAX 855 (Hemophilia) [Member] | ||
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | 109 | 337 |
Other [Member] | ||
License And Collaboration Agreements [Line Items] | ||
License, collaboration and other revenue | $1,359 | $2,545 |
License_and_Collaboration_Agre3
License and Collaboration Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | 3 Months Ended | 1 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | ||||
Mar. 31, 2015 | Dec. 31, 2013 | Feb. 29, 2012 | Dec. 31, 2010 | Jun. 30, 2014 | Mar. 31, 2015 | Sep. 16, 2014 | Oct. 31, 2014 | Dec. 31, 2009 | Jun. 30, 2013 | Dec. 31, 2007 | Sep. 30, 2014 | Jul. 31, 2016 | Jul. 31, 2015 | |
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | $128,300,000 | |||||||||||||
Roche [Member] | MIRCERA [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Deferred revenue | 9,400,000 | 9,400,000 | ||||||||||||
Consideration received for product delivered in 2013 | 18,600,000 | |||||||||||||
Roche [Member] | MIRCERA [Member] | Performance-based Milestone Payments [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 22,000,000 | |||||||||||||
Roche [Member] | MIRCERA [Member] | Upfront Payment Arrangement in 2007 [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 5,000,000 | |||||||||||||
Roche [Member] | PEGASYS [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Deferred revenue | 3,800,000 | 3,800,000 | ||||||||||||
Roche [Member] | PEGASYS and MIRCERA [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Deferred revenue | 4,000,000 | 4,000,000 | ||||||||||||
Amgen, Inc. [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 50,000,000 | |||||||||||||
Deferred revenue | 27,900,000 | 27,900,000 | ||||||||||||
Ophthotech Corporation [Member] | Fovista [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | 9,500,000 | |||||||||||||
Received upfront and milestone payments | 19,750,000 | |||||||||||||
Deferred revenue | 18,600,000 | 18,600,000 | ||||||||||||
AstraZeneca AB [Member] | United States [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 100,000,000 | |||||||||||||
Liability to AZ for DTC advertising payments | 10,000,000 | 10,000,000 | ||||||||||||
Reduction of revenue | -10,000,000 | |||||||||||||
AstraZeneca AB [Member] | United States [Member] | Other Current Liabilities [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Liability to AZ for DTC advertising payments | 5,000,000 | 5,000,000 | ||||||||||||
AstraZeneca AB [Member] | United States [Member] | Other Long-Term Liabilities [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Liability to AZ for DTC advertising payments | 5,000,000 | 5,000,000 | ||||||||||||
AstraZeneca AB [Member] | Scenario, Forecast [Member] | United States [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Liability to AZ for DTC advertising payments | 5,000,000 | 5,000,000 | ||||||||||||
AstraZeneca AB [Member] | MOVANTIK [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 100,000,000 | 70,000,000 | 35,000,000 | |||||||||||
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 | |||||||||||||
AstraZeneca AB [Member] | MOVANTIK [Member] | European Union [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Contingent payments receivable based on development events regulatory to be pursued and completed solely by others | 40,000,000 | 40,000,000 | ||||||||||||
AstraZeneca AB [Member] | MOVANTIKTM (NKTR-118) and MOVANTIKTM fixed-dose combination program (NKTR-119) [Member] | Upfront Payment Arrangement in 2007 [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 125,000,000 | |||||||||||||
AstraZeneca AB [Member] | Movantik Fixed-dose Combination Program [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Contingent payments receivable based on development events regulatory to be pursued and completed solely by others | 75,000,000 | 75,000,000 | ||||||||||||
Bayer Healthcare LLC [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | 50,000,000 | |||||||||||||
Deferred revenue | 20,400,000 | 20,400,000 | ||||||||||||
Payment made to Bayer for cost of Phase 3 clinical trial | 10,000,000 | |||||||||||||
Bayer Healthcare LLC [Member] | Performance-based Milestone Payments [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 30,000,000 | |||||||||||||
Bayer Healthcare LLC [Member] | Upfront Payment Arrangement in 2007 [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Received upfront and milestone payments | 40,000,000 | |||||||||||||
Baxter Healthcare [Member] | BAX 855 (Hemophilia) [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | 20,000,000 | |||||||||||||
Deferred revenue | 0 | 0 | ||||||||||||
Development milestones achieved | 8,000,000 | |||||||||||||
Baxter Healthcare [Member] | BAX 855 (Hemophilia) [Member] | United States [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | 10,000,000 | |||||||||||||
Other [Member] | ||||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||||
Potential future additional payments for development milestones | $51,800,000 |
StockBased_Compensation_StockB
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | $5,177 | $4,361 |
Cost of Goods Sold [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | 324 | 319 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | 2,422 | 1,973 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | $2,431 | $2,069 |
StockBased_Compensation_Additi
Stock-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock issuances under equity compensation plans | 235,298 | 667,374 |
Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted stock options | 410,810 | 3,133,180 |
Weighted-average grant-date fair value | 6.56 | 5.97 |
Net_Income_Loss_Per_Share_Addi
Net Income (Loss) Per Share - Additional Information (Detail) (Stock Options [Member]) | 3 Months Ended | |
In Millions, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average diluted securities included in calculation of diluted net income per share | 4.3 | |
Weighted average diluted securities excluded from diluted net loss per share | 8.5 | 21.7 |