Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Oct. 31, 2013 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'NKTR | ' |
Entity Registrant Name | 'NEKTAR THERAPEUTICS | ' |
Entity Central Index Key | '0000906709 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Large Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 116,115,377 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $65,411 | $25,437 |
Short-term investments | 118,139 | 251,757 |
Accounts receivable | 4,557 | 5,805 |
Inventory | 15,076 | 18,269 |
Other current assets | 4,759 | 13,363 |
Total current assets | 207,942 | 314,631 |
Restricted cash | 25,000 | 25,000 |
Property and equipment, net | 65,082 | 72,215 |
Goodwill | 76,501 | 76,501 |
Other assets | 8,510 | 9,443 |
Total assets | 383,035 | 497,790 |
Current liabilities: | ' | ' |
Accounts payable | 3,723 | 2,863 |
Accrued compensation | 13,910 | 8,773 |
Accrued expenses | 10,771 | 8,008 |
Accrued clinical trial expenses | 15,239 | 17,500 |
Deferred revenue, current portion | 21,300 | 21,896 |
Interest payable | 3,167 | 7,083 |
Other current liabilities | 12,803 | 12,414 |
Total current liabilities | 80,913 | 78,537 |
Senior secured notes | 125,000 | 125,000 |
Capital lease obligations, less current portion | 9,007 | 11,607 |
Liability related to sale of future royalties, less current portion | 125,167 | 128,266 |
Deferred revenue, less current portion | 82,233 | 96,551 |
Deferred gain | 1,748 | 2,404 |
Other long-term liabilities | 9,217 | 8,407 |
Total liabilities | 433,285 | 450,772 |
Commitments and contingencies | ' | ' |
Stockholders' equity (deficit): | ' | ' |
Preferred stock, 10,000 shares authorized, $0.0001 par value; no shares designated, issued or outstanding at September 30, 2013 or December 31, 2012 respectively | ' | ' |
Common stock, $0.0001 par value; 300,000 authorized; 115,990 shares and 115,259 shares issued and outstanding at September 30, 2013 and December 31, 2012, respectively | 11 | 11 |
Capital in excess of par value | 1,636,162 | 1,617,744 |
Accumulated other comprehensive loss | -1,689 | -357 |
Accumulated deficit | -1,684,734 | -1,570,380 |
Total stockholders' equity (deficit) | -50,250 | 47,018 |
Total liabilities and stockholders' equity (deficit) | $383,035 | $497,790 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, except Per Share data, unless otherwise specified | ||
Statement Of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000 | 10,000 |
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 | 300,000 |
Common stock, shares issued | 115,990 | 115,259 |
Common stock, shares outstanding | 115,990 | 115,259 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenue: | ' | ' | ' | ' |
Product sales | $14,672 | $8,355 | $36,806 | $24,994 |
Royalty revenue | 354 | 498 | 1,030 | 3,966 |
Non-cash royalty revenue related to sale of future royalties | 4,523 | 3,427 | 12,744 | 6,895 |
License, collaboration and other revenue | 41,360 | 6,132 | 67,195 | 24,190 |
Total revenue | 60,909 | 18,412 | 117,775 | 60,045 |
Operating costs and expenses: | ' | ' | ' | ' |
Cost of goods sold | 12,877 | 7,228 | 29,549 | 23,138 |
Research and development | 43,914 | 34,016 | 141,762 | 102,302 |
General and administrative | 10,643 | 10,068 | 30,700 | 30,750 |
Impairment of long-lived assets | ' | ' | ' | 1,675 |
Total operating costs and expenses | 67,434 | 51,312 | 202,011 | 157,865 |
Loss from operations | -6,525 | -32,900 | -84,236 | -97,820 |
Non-operating income (expense): | ' | ' | ' | ' |
Interest income | 116 | 603 | 639 | 1,865 |
Interest expense | -4,587 | -5,697 | -13,888 | -10,807 |
Non-cash interest expense on liability related to sale of future royalties | -5,616 | -5,487 | -16,644 | -12,641 |
Other income (expense), net | 262 | 156 | 385 | 913 |
Total non-operating expense, net | -9,825 | -10,425 | -29,508 | -20,670 |
Loss before provision for income taxes | -16,350 | -43,325 | -113,744 | -118,490 |
Provision for income taxes | 193 | 222 | 610 | 439 |
Net loss | ($16,543) | ($43,547) | ($114,354) | ($118,929) |
Basic and diluted net loss per share | ($0.14) | ($0.38) | ($0.99) | ($1.04) |
Weighted average shares outstanding used in computing basic and diluted net loss per share | 115,812 | 114,915 | 115,557 | 114,699 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Statement Of Income And Comprehensive Income [Abstract] | ' | ' | ' | ' |
Comprehensive loss | ($16,896) | ($42,772) | ($115,686) | ($117,671) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ' | ' |
Net loss | ($114,354) | ($118,929) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Non-cash interest expense on liability related to sale of future royalties | 16,644 | 12,641 |
Non-cash royalty revenue related to sale of future royalties | -12,744 | -6,895 |
Stock-based compensation | 13,165 | 12,015 |
Depreciation and amortization | 10,882 | 10,810 |
Impairment of long-lived assets | ' | 1,675 |
Other non-cash transactions | 332 | 641 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | 1,248 | 1,027 |
Inventory | 3,193 | -4,098 |
Other assets | 6,817 | 10,593 |
Accounts payable | 697 | -401 |
Accrued compensation | 5,137 | -120 |
Accrued expenses | 2,741 | -465 |
Accrued clinical trial expenses | -2,261 | 1,247 |
Deferred revenue | -14,914 | -3,430 |
Interest payable | -3,916 | 1,528 |
Other liabilities | -4,825 | -219 |
Net cash used in operating activities | -92,158 | -82,380 |
Cash flows from investing activities: | ' | ' |
Maturities of investments | 274,011 | 202,768 |
Purchases of investments | -140,569 | -126,609 |
Restricted cash | ' | -25,000 |
Sale of investments | ' | 5,378 |
Purchases of property and equipment | -1,382 | -5,744 |
Net cash provided by investing activities | 132,060 | 50,793 |
Cash flows from financing activities: | ' | ' |
Payments of capital lease obligations | -2,201 | -1,773 |
(Repayment of) proceeds from sale of future royalties, net of $4.4 million of transaction costs in 2012 | -3,000 | 119,588 |
Proceeds from issuance of senior secured notes, net of $4.4 million of transaction costs | ' | 78,006 |
Repayment of convertible subordinated notes | ' | -172,407 |
Proceeds from shares issued under equity compensation plans | 5,253 | 3,177 |
Net cash provided by financing activities | 52 | 26,591 |
Effect of exchange rates on cash and cash equivalents | 20 | 22 |
Net increase (decrease) in cash and cash equivalents | 39,974 | -4,974 |
Cash and cash equivalents at beginning of period | 25,437 | 15,312 |
Cash and cash equivalents at end of period | 65,411 | 10,338 |
Supplemental disclosure of cash flow information: | ' | ' |
Cash paid for interest | 17,097 | 9,010 |
Retirement of convertible subordinated notes in exchange for senior secured notes | ' | $42,548 |
Condensed_Consolidated_Stateme3
Condensed Consolidated Statements of Cash Flows (Parenthetical) (USD $) | 9 Months Ended |
In Millions, unless otherwise specified | Sep. 30, 2012 |
Statement Of Cash Flows [Abstract] | ' |
Net of transaction costs | $4.40 |
Issuance of senior secured notes, transaction costs | $4.40 |
Organization_and_Summary_of_Si
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2013 | |
Accounting Policies [Abstract] | ' |
Organization and Summary of Significant Accounting Policies | ' |
Note 1 — Organization and Summary of Significant Accounting Policies | |
Organization | |
We are a clinical-stage 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 resources to date and are expected to continue to require significant resources. 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 from licensing, collaboration and manufacturing agreements and financing transactions. At September 30, 2013, we had approximately $208.6 million in cash and investments in marketable securities, of which $25.0 million was restricted in relation to our 12% senior secured notes, and $147.6 million in indebtedness. The indebtedness includes $125.0 million in aggregate principal amount of 12.0% senior secured notes due July 15, 2017, but excludes our long-term liability relating to the sale of future royalties. As is further described in Note 4, this royalty obligation liability will generally not be settled in cash, but we expect to be required to make a cash payment of $7.0 million in 2014 as a certain specified worldwide net sales threshold is not expected to be met. | |
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 material to our consolidated financial position. | |
Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized holding gains and losses on available-for-sale securities, neither of which were significant during the three and nine month periods ended September 30, 2013 and 2012. In addition, there were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three and nine month periods ended September 30, 2013 and 2012. | |
The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2012 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, 2012 filed with the SEC on March 1, 2013. 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, 2012. | |
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 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates and assumptions. On an ongoing basis, we evaluate our estimates, including those related to deferred revenue recognition periods, inventories, 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. | |
Reclassifications | |
Certain items previously reported in specific financial statement captions have been reclassified to conform to the current period presentation. Such reclassifications do not materially impact previously reported revenue, operating loss, net loss, total assets, liabilities or stockholders’ equity. | |
Segment Information | |
We operate in one business segment which focuses on applying our technology platforms to improve the performance of established and novel drug candidates. We operate in one segment because our business offerings have similar economics and other characteristics, including the nature of products and manufacturing processes, types of customers, distribution methods and regulatory environment. We are comprehensively managed as one business segment by our Chief Executive Officer and his management team. | |
Significant Concentrations | |
Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables from product sales and royalties, as well as time and materials based billings from collaborative research and development agreements. 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 September 30, 2013 or December 31, 2012. | |
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 | |
We enter into arrangements with pharmaceutical and biotechnology collaboration partners that may involve multiple deliverables. Our arrangements may contain one or more of the following elements: upfront fees, contract research and development, milestone payments, manufacturing and supply payments, royalties, and license fees. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. Revenue is recognized separately for each element. | |
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 cost-plus and fixed price manufacturing and supply agreements with our collaboration partners and revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. We have not experienced any significant returns from our customers. | |
Royalty revenue | |
Generally, we are entitled to royalties from our 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 in Note 4, 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 | |
Upfront fees received by us in license and collaboration arrangements that include future obligations, such as manufacturing and supply obligations, are 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. | |
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, obtaining regulatory approvals for and achieving commercial launches of drug products, 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 evaluate 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. | |
Income Taxes | |
For the three and nine month periods ended September 30, 2013 and 2012, we recorded an income tax provision for our Nektar India operations at effective tax rates of approximately 34% in 2013 and 32% in 2012. 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. |
Cash_and_Investments_in_Market
Cash and Investments in Marketable Securities | 9 Months Ended | ||||||||||
Sep. 30, 2013 | |||||||||||
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): | |||||||||||
Estimated Fair Value at | |||||||||||
September 30, | December 31, | ||||||||||
2013 | 2012 | ||||||||||
Cash and cash equivalents | $ | 65,411 | $ | 25,437 | |||||||
Short-term investments | 118,139 | 251,757 | |||||||||
Restricted cash | 25,000 | 25,000 | |||||||||
Total cash and investments in marketable securities | $ | 208,550 | $ | 302,194 | |||||||
Restricted cash of $25.0 million is required to be maintained until July 1, 2017 under the terms of our 12% Senior Secured Notes due July 2017. | |||||||||||
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. Investments in securities with remaining maturities of less than one year, or where our intent is to use the investments to fund current operations or to make them available for current operations, are classified as short-term investments. As of September 30, 2013 and December 31, 2012, all of our investments had contractual maturities of one year or less and were classified as short-term. | |||||||||||
Gross unrealized gains and losses were not significant at either September 30, 2013 or December 31, 2012. During the three and nine month periods ended September 30, 2013, we did not sell any of our available-for-sale securities. During the three and nine month periods ended September 30, 2012, we sold available-for-sale securities totaling $5.4 million and realized gains and losses were not significant in the three and nine month periods ended September 30, 2012. | |||||||||||
Our portfolio of cash and investments in marketable securities includes (in thousands): | |||||||||||
Estimated Fair Value at | |||||||||||
Fair Value | September 30, | December 31, | |||||||||
Hierarchy | 2013 | 2012 | |||||||||
Level | |||||||||||
Corporate notes and bonds | 2 | $ | 93,902 | $ | 241,158 | ||||||
U.S. corporate commercial paper | 2 | 28,036 | 3,990 | ||||||||
Obligations of U.S. government agencies | 2 | — | 6,108 | ||||||||
Obligations of U.S. states and municipalities | 2 | — | 1,504 | ||||||||
Available-for-sale investments | 121,938 | 252,760 | |||||||||
Money market funds | 1 | 58,751 | 22,487 | ||||||||
Cash, including restricted cash | N/A | 27,861 | 26,947 | ||||||||
Total cash and investments in marketable securities | $ | 208,550 | $ | 302,194 | |||||||
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 and nine month periods ended September 30, 2013 and 2012, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. | |||||||||||
Additionally, as of September 30, 2013, 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 | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
Inventory | ' | ||||||||
Note 3 — Inventory | |||||||||
Inventory consists of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Raw materials | $ | 4,913 | $ | 7,489 | |||||
Work-in-process | 8,638 | 6,661 | |||||||
Finished goods | 1,525 | 4,119 | |||||||
Total inventory | $ | 15,076 | $ | 18,269 | |||||
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 stated at the lower of cost or market and is net of reserves determined using specific identification plus an estimated reserve for defective or excess inventory based on historical experience or projected usage. |
Liability_Related_to_Sale_of_F
Liability Related to Sale of Future Royalties | 9 Months Ended |
Sep. 30, 2013 | |
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 Nektar’s license, manufacturing and supply agreement with UCB Pharma (UCB), and (b) MIRCERA®, under Nektar’s 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 for the Royalty Entitlement of $124.0 million. As part of this sale, we incurred approximately $4.4 million in transaction costs, which will be amortized to interest expense over the estimated life of the Purchase and Sale Agreement. 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 nine months ended September 30, 2013 and 2012, we recognized $12.7 million and $9.6 million, respectively, in aggregate royalties from net sales of CIMZIA® and MIRCERA®, of which the $2.7 million recognized in the three months ended March 31, 2012 was retained by us as this amount resulted from royalties on product sales in the fourth quarter of 2011. | |
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 2013, we were required to pay RPI $3.0 million because worldwide net sales of MIRCERA® for the 12 month period ended on December 31, 2012 did not reach a required threshold. Furthermore, we are required to make an additional payment of up to $7.0 million if the specified worldwide net sales threshold of MIRCERA® for the 12 month period ending on December 31, 2013 is not achieved. As of September 30, 2013, we have concluded that it is probable that the minimum 2013 MIRCERA® net sales threshold will not be met and, therefore, we expect to make the $7.0 million payment to RPI described above in early 2014. The liability for this expected $7.0 million payment is included in other current liabilities on our Condensed Consolidated Balance Sheet at September 30, 2013. | |
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. In particular, if we breach our obligations under the Purchase and Sale Agreement, 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 | 9 Months Ended |
Sep. 30, 2013 | |
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, it could have a material adverse impact on the results of our operations of that period and on our cash flows and liquidity. | |
On November 18, 2009, the Research Foundation of the State University of New York (SUNY) filed an action against Nektar in the United States District Court for the Northern District of New York. SUNY seeks to recover amounts it alleges it is owed pursuant to a technology licensing contract between Nektar and SUNY. On May 15, 2013, the court granted Nektar’s motion for summary judgment regarding SUNY’s claim for specific performance, granted SUNY summary judgment regarding one of the milestone payments at issue, and otherwise denied Nektar’s motion for summary judgment and SUNY’s motion for partial summary judgment. As a result of the granting of SUNY’s summary judgment regarding one of the milestone payments at issue, in the three months ended June 30, 2013, we accrued a contingent liability of $3.0 million (inclusive of interest). The court’s decision is not a final judgment and we continue to dispute SUNY’s claims, which we believe are without merit. The trial is currently scheduled to start in the first quarter of 2014. Other than the approximately $3.0 million liability noted above, no reasonable estimate of the possible loss or range of loss can be made at this time and no other liabilities have been recorded for this matter in our Condensed Consolidated Balance Sheets at either September 30, 2013 or December 31, 2012. | |
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, 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. | |
As part of the sale of our royalty interest in the CIMZIA® and MIRCERA® products, we and RPI made representations and warranties and entered into certain covenants and ancillary agreements which are supported by indemnity obligations. Additionally, as part of our pulmonary asset sale to Novartis in 2008, we and Novartis made representations and warranties and entered into certain covenants and ancillary agreements which are supported by an indemnity obligation. In the event it is determined that we breached certain of the representations and warranties or covenants and agreements 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. If any of our indemnification obligations is triggered, we may incur substantial liabilities. 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 September 30, 2013 or December 31, 2012. |
License_and_Collaboration_Agre
License and Collaboration Agreements | 9 Months Ended | ||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' | ||||||||||||||||||
License and Collaboration Agreements | ' | ||||||||||||||||||
Note 6 — License and Collaboration Agreements | |||||||||||||||||||
We have entered into various license agreements and collaborative research, manufacturing, development and commercialization agreements with pharmaceutical and biotechnology companies. We refer to these types of agreements as collaboration agreements. Under these collaboration agreements, we are entitled to receive license fees, upfront payments, milestone payments, royalties, sales milestones, payment 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 | Nine months ended | ||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||
Partner | Drug or Drug Candidate | 2013 | 2012 | 2013 | 2012 | ||||||||||||||
AstraZeneca AB | Naloxegol (NKTR-118) and naloxegol fixed-dose combination program (NKTR-119) | $ | 25,000 | $ | 7 | $ | 25,016 | $ | 48 | ||||||||||
Bayer Healthcare LLC | BAY41-6551 (Amikacin Inhale) | 779 | 714 | 14,604 | 2,257 | ||||||||||||||
Roche | PEGASYS® and MIRCERA® | 2,625 | 2,011 | 7,875 | 5,134 | ||||||||||||||
Affymax, Inc. | Omontys® | 6,779 | 198 | 7,149 | 2,610 | ||||||||||||||
Amgen, Inc. | Neulasta® | 1,250 | 1,250 | 3,750 | 3,750 | ||||||||||||||
Baxter Healthcare | BAX 855 (Hemophilia) | 201 | 741 | 1,499 | 5,794 | ||||||||||||||
Other | 4,726 | 1,211 | 7,302 | 4,597 | |||||||||||||||
License, collaboration, and other revenue | $ | 41,360 | $ | 6,132 | $ | 67,195 | $ | 24,190 | |||||||||||
As of September 30, 2013, our collaboration agreements included potential future payments for development milestones totaling approximately $144.3 million, including the milestone amounts from our agreements with Bayer and Baxter described below. In addition, we are entitled to receive up to $245.0 million and $75.0 million of contingent payments related to the naloxegol (formerly known as NKTR-118) and naloxegol fixed-dose combination (formerly known as NKTR-119) 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 or nine months ended September 30, 2013, except as described below. | |||||||||||||||||||
AstraZeneca AB: naloxegol (NKTR-118) and naloxegol fixed-dose combination program (NKTR-119) | |||||||||||||||||||
In September 2009, we entered into a license agreement with AstraZeneca AB (AstraZeneca), as amended by AstraZeneca and us in August 2013, under which we granted AstraZeneca a worldwide, exclusive, perpetual, royalty-bearing, and sublicensable license under our patents and other intellectual property to develop, market, and sell naloxegol (formerly known as NKTR-118) and naloxegol fixed-dose combination program (formerly known as NKTR-119). AstraZeneca is responsible for all costs associated with research, development and commercialization and is responsible for all drug development and commercialization decisions for naloxegol and the naloxegol fixed-dose combination program. As of September 30, 2013, we are entitled to receive up to an additional $245.0 million and $75.0 million of contingent payments related to naloxegol and the naloxegol fixed-dose combination program, respectively, based on development events to be pursued and completed solely by AstraZeneca, as described below. | |||||||||||||||||||
On September 25, 2013, the European Medicines Agency (EMA) notified AstraZeneca that it had accepted for review the naloxegol regulatory approval application filed by AstraZeneca in August 2013. As a result, Nektar was entitled to a $25.0 million payment from AstraZeneca, which was received on September 30, 2013 and was fully recognized as revenue in the three months ended September 30, 2013. | |||||||||||||||||||
On September 16, 2013, AstraZeneca filed a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for naloxegol. The FDA typically makes its acceptance determinations regarding NDAs within 60 days after filing, although the outcome and exact timing of such acceptance determination remains subject to the discretion of the FDA. If the NDA submitted by AstraZeneca is accepted for review by the FDA, we will be entitled to a $70.0 million payment. If the FDA does not require a future clinical trial or other significant studies to assess the cardiovascular safety (CV Safety Study) of naloxegol prior to an approval decision, AstraZeneca is obligated to pay us an additional $35.0 million. If the FDA does require a CV Safety Study, AstraZeneca may terminate the license agreement with us in its entirety or only with respect to its rights in the United States. If AstraZeneca elects to terminate the license agreement in its entirety due to a CV Safety Study, we would be required to repay them the $70.0 million payment plus accrued interest at 4.5% compounded annually in four installments in accordance with the following payment schedule: $10.0 million plus accrued interest on January 15, 2015, $10.0 million plus accrued interest on January 15, 2016, $20.0 million plus accrued interest on January 15, 2017 and $30.0 million plus accrued interest on January 15, 2018. If AstraZeneca elects to terminate the license agreement only with respect to its rights in the U.S., then such repayment amount would be funded through a 50% reduction of non-U.S. royalty amounts otherwise payable to us until the aggregate amount of such royalty reduction equals the total principal amount of $70.0 million plus accumulated interest at 4.5% compounded annually. If the FDA requires a post-approval cardiovascular safety study as a condition to approval of the naloxegol NDA, then the royalty rate payable to us from net sales of naloxegol in the U.S. by AstraZeneca would be reduced by two percentage points until the aggregate accumulated amount of such royalty payment reduction is equal to a maximum of $35.0 million. | |||||||||||||||||||
We will be entitled to the remaining $140.0 million of contingent payments if naloxegol is approved by the FDA and EMA and commercial launch is achieved in the U.S. and one major country in the European Union. In addition, we are also entitled to sales milestone payments and royalties based on annual worldwide net sales of naloxegol and naloxegol fixed-dose combination products. | |||||||||||||||||||
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 the years prior to 2013, we received an upfront payment of $40.0 million in 2007 and milestone payments of $20.0 million, of which $10.0 million was recorded as a liability to Bayer for the reimbursement of its costs of the Phase 3 clinical trial. | |||||||||||||||||||
As a result of the start of the Phase 3 clinical trial by Bayer in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia in April 2013, we achieved the $10.0 million development milestone, which was received and recognized as revenue in the three months ended June 30, 2013. The receipt of this milestone also triggered the payment of our $10.0 million obligation to Bayer, which was paid in June 2013. | |||||||||||||||||||
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 September 30, 2013, we have deferred revenue of approximately $22.9 million related to this agreement, which we expect to recognize through December 2026, the estimated end of our obligations under this agreement. | |||||||||||||||||||
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 September 30, 2013, we have deferred revenue of approximately $11.5 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 September 30, 2013, we have deferred revenue of approximately $17.4 million related to this agreement, 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 we expect to deliver in the last quarter of 2013, for total consideration of approximately $18.0 million. | |||||||||||||||||||
Affymax, Inc.: OMONTYS® | |||||||||||||||||||
In April 2004, we entered into a license, manufacturing and supply agreement with Affymax, Inc. (Affymax) under which we provided Affymax with a worldwide, non-exclusive license under certain of our proprietary PEGylation technology to develop, manufacture and commercialize OMONTYS® (peginesatide). | |||||||||||||||||||
On March 27, 2012, the FDA approved OMONTYS® to treat anemia in patients with chronic kidney disease on dialysis and OMONTYS® sales were initiated in the second quarter of 2012. On February 23, 2013, Affymax and Takeda Pharmaceutical Company Limited (Takeda) announced a voluntary recall of all lots of OMONTYS® drug product as a result of new post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. Effective as of April 1, 2013, Affymax announced that it had amended its collaboration agreement with Takeda to transfer regulatory, manufacturing, and development responsibilities for OMONTYS® to Takeda. In July 2013, Affymax terminated the license, manufacturing and supply agreement with Nektar. | |||||||||||||||||||
We have received milestone and related payments under our agreement with Affymax and, as a result of the termination of our agreement with Affymax and our related performance obligations, we recognized the remaining $6.7 million of deferred revenue from this agreement in the three months ended September 30, 2013. | |||||||||||||||||||
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. As of September 30, 2013, we have deferred revenue of approximately $35.4 million related to this agreement, which we expect to recognize through October 2020, 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. Under the terms of this agreement, we are entitled to up to $28.0 million of development milestones related to Hemophilia A 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 products resulting from this agreement. This Hemophilia A program includes BAX 855, which is currently in a Phase 3 clinical study initiated in February 2013. As of September 30, 2013, we do not have significant deferred revenue related to this agreement. | |||||||||||||||||||
Other | |||||||||||||||||||
In addition, we have a number of collaboration agreements with other partners under which we are entitled to up to a total of $66.3 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 | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased 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 | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Cost of goods sold | $ | 327 | $ | 353 | $ | 974 | $ | 1,121 | |||||||||
Research and development expense | 2,071 | 1,670 | 5,923 | 5,296 | |||||||||||||
General and administrative expense | 2,166 | 1,957 | 6,268 | 5,598 | |||||||||||||
Total stock-based compensation | $ | 4,564 | $ | 3,980 | $ | 13,165 | $ | 12,015 | |||||||||
During the three months ended September 30, 2013 and 2012, we granted 449,010 and 434,060 stock options, respectively. The weighted average grant-date fair value of options granted during the three months ended September 30, 2013 and 2012 was $7.11 per share and $4.78 per share, respectively. | |||||||||||||||||
During the nine months ended September 30, 2013 and 2012, we granted 3,438,320 and 3,416,780 stock options, respectively. The weighted average grant-date fair value of options granted during the nine months ended September 30, 2013 and 2012 was $4.95 per share and $3.91 per share, respectively. | |||||||||||||||||
As a result of stock issuances under our equity compensation plans, during the three months ended September 30, 2013 and 2012, we issued 306,859 and 292,485 common shares, respectively, and during the nine months ended September 30, 2013 and 2012, we issued 731,073 and 587,421 common shares, respectively. |
Net_Loss_Per_Share
Net Loss Per Share | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||||||
Net Loss Per Share | ' | ||||||||||||||||
Note 8 — Net Loss Per Share | |||||||||||||||||
Basic net loss per share is calculated based on the weighted-average number of common shares outstanding during the periods presented. For all periods presented in the accompanying Condensed Consolidated Statements of Operations, the net loss available to common stockholders is equal to the reported net loss. Basic and diluted net loss per share are the same due to our historical net losses and the requirement to exclude potentially dilutive securities which would have an anti-dilutive effect on net loss per share. The weighted average of these potentially dilutive securities has been excluded from the diluted net loss per share calculation and is as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Stock options | 9,739 | 14,301 | 12,999 | 13,836 | |||||||||||||
Organization_and_Summary_of_Si1
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Accounting Policies [Abstract] | ' |
Organization | ' |
Organization | |
We are a clinical-stage 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 resources to date and are expected to continue to require significant resources. 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 from licensing, collaboration and manufacturing agreements and financing transactions. At September 30, 2013, we had approximately $208.6 million in cash and investments in marketable securities, of which $25.0 million was restricted in relation to our 12% senior secured notes, and $147.6 million in indebtedness. The indebtedness includes $125.0 million in aggregate principal amount of 12.0% senior secured notes due July 15, 2017, but excludes our long-term liability relating to the sale of future royalties. As is further described in Note 4, this royalty obligation liability will generally not be settled in cash, but we expect to be required to make a cash payment of $7.0 million in 2014 as a certain specified worldwide net sales threshold is not expected to be met. | |
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 material to our consolidated financial position. | |
Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized holding gains and losses on available-for-sale securities, neither of which were significant during the three and nine month periods ended September 30, 2013 and 2012. In addition, there were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three and nine month periods ended September 30, 2013 and 2012. | |
The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2012 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, 2012 filed with the SEC on March 1, 2013. 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, 2012. | |
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 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates and assumptions. On an ongoing basis, we evaluate our estimates, including those related to deferred revenue recognition periods, inventories, 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. | |
Reclassifications | ' |
Reclassifications | |
Certain items previously reported in specific financial statement captions have been reclassified to conform to the current period presentation. Such reclassifications do not materially impact previously reported revenue, operating loss, net loss, total assets, liabilities or stockholders’ equity. | |
Segment Information | ' |
Segment Information | |
We operate in one business segment which focuses on applying our technology platforms to improve the performance of established and novel drug candidates. We operate in one segment because our business offerings have similar economics and other characteristics, including the nature of products and manufacturing processes, types of customers, distribution methods and regulatory environment. We are comprehensively managed as one business segment by our Chief Executive Officer and his management team. | |
Significant Concentrations | ' |
Significant Concentrations | |
Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables from product sales and royalties, as well as time and materials based billings from collaborative research and development agreements. 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 September 30, 2013 or December 31, 2012. | |
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 | |
We enter into arrangements with pharmaceutical and biotechnology collaboration partners that may involve multiple deliverables. Our arrangements may contain one or more of the following elements: upfront fees, contract research and development, milestone payments, manufacturing and supply payments, royalties, and license fees. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. Revenue is recognized separately for each element. | |
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 cost-plus and fixed price manufacturing and supply agreements with our collaboration partners and revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured. We have not experienced any significant returns from our customers. | |
Royalty revenue | |
Generally, we are entitled to royalties from our 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 in Note 4, 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 | |
Upfront fees received by us in license and collaboration arrangements that include future obligations, such as manufacturing and supply obligations, are 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. | |
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, obtaining regulatory approvals for and achieving commercial launches of drug products, 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 evaluate 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. | |
Income Taxes | ' |
Income Taxes | |
For the three and nine month periods ended September 30, 2013 and 2012, we recorded an income tax provision for our Nektar India operations at effective tax rates of approximately 34% in 2013 and 32% in 2012. 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. |
Cash_and_Investments_in_Market1
Cash and Investments in Marketable Securities (Tables) | 9 Months Ended | ||||||||||
Sep. 30, 2013 | |||||||||||
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 | |||||||||||
September 30, | December 31, | ||||||||||
2013 | 2012 | ||||||||||
Cash and cash equivalents | $ | 65,411 | $ | 25,437 | |||||||
Short-term investments | 118,139 | 251,757 | |||||||||
Restricted cash | 25,000 | 25,000 | |||||||||
Total cash and investments in marketable securities | $ | 208,550 | $ | 302,194 | |||||||
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 | September 30, | December 31, | |||||||||
Hierarchy | 2013 | 2012 | |||||||||
Level | |||||||||||
Corporate notes and bonds | 2 | $ | 93,902 | $ | 241,158 | ||||||
U.S. corporate commercial paper | 2 | 28,036 | 3,990 | ||||||||
Obligations of U.S. government agencies | 2 | — | 6,108 | ||||||||
Obligations of U.S. states and municipalities | 2 | — | 1,504 | ||||||||
Available-for-sale investments | 121,938 | 252,760 | |||||||||
Money market funds | 1 | 58,751 | 22,487 | ||||||||
Cash, including restricted cash | N/A | 27,861 | 26,947 | ||||||||
Total cash and investments in marketable securities | $ | 208,550 | $ | 302,194 | |||||||
Inventory_Tables
Inventory (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
Inventory | ' | ||||||||
Inventory consists of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Raw materials | $ | 4,913 | $ | 7,489 | |||||
Work-in-process | 8,638 | 6,661 | |||||||
Finished goods | 1,525 | 4,119 | |||||||
Total inventory | $ | 15,076 | $ | 18,269 | |||||
License_and_Collaboration_Agre1
License and Collaboration Agreements (Tables) | 9 Months Ended | ||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||
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 | Nine months ended | ||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||
Partner | Drug or Drug Candidate | 2013 | 2012 | 2013 | 2012 | ||||||||||||||
AstraZeneca AB | Naloxegol (NKTR-118) and naloxegol | $ | 25,000 | $ | 7 | $ | 25,016 | $ | 48 | ||||||||||
fixed-dose combination program | |||||||||||||||||||
(NKTR-119) | |||||||||||||||||||
Bayer Healthcare LLC | BAY41-6551 (Amikacin Inhale) | 779 | 714 | 14,604 | 2,257 | ||||||||||||||
Roche | PEGASYS® and MIRCERA® | 2,625 | 2,011 | 7,875 | 5,134 | ||||||||||||||
Affymax, Inc. | Omontys® | 6,779 | 198 | 7,149 | 2,610 | ||||||||||||||
Amgen, Inc. | Neulasta® | 1,250 | 1,250 | 3,750 | 3,750 | ||||||||||||||
Baxter Healthcare | BAX 855 (Hemophilia) | 201 | 741 | 1,499 | 5,794 | ||||||||||||||
Other | 4,726 | 1,211 | 7,302 | 4,597 | |||||||||||||||
License, collaboration, and other revenue | $ | 41,360 | $ | 6,132 | $ | 67,195 | $ | 24,190 | |||||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ' | ||||||||||||||||
Total 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 | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Cost of goods sold | $ | 327 | $ | 353 | $ | 974 | $ | 1,121 | |||||||||
Research and development expense | 2,071 | 1,670 | 5,923 | 5,296 | |||||||||||||
General and administrative expense | 2,166 | 1,957 | 6,268 | 5,598 | |||||||||||||
Total stock-based compensation | $ | 4,564 | $ | 3,980 | $ | 13,165 | $ | 12,015 | |||||||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||||||
Weighted Average Securities Excluded from Diluted Net Loss Per Share | ' | ||||||||||||||||
The weighted average of these potentially dilutive securities has been excluded from the diluted net loss per share calculation and is as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Stock options | 9,739 | 14,301 | 12,999 | 13,836 | |||||||||||||
Organization_and_Summary_of_Si2
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | |
Segment | |||||
Organization And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Cash and investments in marketable securities | $208,550,000 | ' | $208,550,000 | ' | $302,194,000 |
Restricted cash | 25,000,000 | ' | 25,000,000 | ' | 25,000,000 |
Indebtedness | 147,600,000 | ' | 147,600,000 | ' | ' |
Senior secured notes, issued | 125,000,000 | ' | 125,000,000 | ' | 125,000,000 |
Senior secured notes, interest rate | 12.00% | ' | 12.00% | ' | ' |
Number of business segments | ' | ' | 1 | ' | ' |
Effective income tax rate | 34.00% | 32.00% | 34.00% | 32.00% | ' |
Maximum [Member] | ' | ' | ' | ' | ' |
Organization And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Contingent payment related to royalty obligation | 7,000,000 | ' | 7,000,000 | ' | ' |
12% Senior Secured Notes due July 2017 [Member] | ' | ' | ' | ' | ' |
Organization And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Restricted cash | $25,000,000 | ' | $25,000,000 | ' | ' |
Senior secured notes, interest rate | 12.00% | ' | 12.00% | ' | ' |
Maturity date of senior secured notes | ' | ' | 15-Jul-17 | ' | ' |
Cash_and_Investments_in_Market2
Cash and Investments in Marketable Securities - Cash and Investments in Marketable Securities, Including Cash Equivalents and Restricted Cash (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Cash Cash Equivalents And Available For Sale Investments [Abstract] | ' | ' | ' | ' |
Cash and cash equivalents | $65,411 | $25,437 | $10,338 | $15,312 |
Short-term investments | 118,139 | 251,757 | ' | ' |
Restricted cash | 25,000 | 25,000 | ' | ' |
Total cash and investments in marketable securities | $208,550 | $302,194 | ' | ' |
Cash_and_Investments_in_Market3
Cash and Investments in Marketable Securities - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | |
Cash and Investments in Marketable Securities [Line Items] | ' | ' | ' | ' |
Restricted cash | ' | $25,000,000 | ' | $25,000,000 |
Senior secured notes, interest rate | ' | 12.00% | ' | ' |
Senior Secured Notes maturity date | ' | '2017-07 | ' | ' |
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 | 5,400,000 | ' | 5,400,000 | ' |
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 |
12% Senior Secured Notes due July 2017 [Member] | ' | ' | ' | ' |
Cash and Investments in Marketable Securities [Line Items] | ' | ' | ' | ' |
Restricted cash | ' | $25,000,000 | ' | ' |
Senior secured notes, interest rate | ' | 12.00% | ' | ' |
Cash_and_Investments_in_Market4
Cash and Investments in Marketable Securities - Portfolio of Cash and Investments in Marketable Securities (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Available-for-sale investments | $121,938 | $252,760 |
Cash, including restricted cash | 27,861 | 26,947 |
Total cash and investments in marketable securities | 208,550 | 302,194 |
Corporate notes and bonds [Member] | Fair Value Level 2 [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Available-for-sale investments | 93,902 | 241,158 |
U.S. corporate commercial paper [Member] | Fair Value Level 2 [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Available-for-sale investments | 28,036 | 3,990 |
Obligations of U.S. government agencies [Member] | Fair Value Level 2 [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Available-for-sale investments | ' | 6,108 |
Obligations of U.S. states and municipalities [Member] | Fair Value Level 2 [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Available-for-sale investments | ' | 1,504 |
Money market funds [Member] | Fair Value Level 1 [Member] | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Investment fair value disclosure | $58,751 | $22,487 |
Inventory_Inventory_Detail
Inventory - Inventory (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $4,913 | $7,489 |
Work-in-process | 8,638 | 6,661 |
Finished goods | 1,525 | 4,119 |
Total inventory | $15,076 | $18,269 |
Liability_Related_to_Sale_of_F1
Liability Related to Sale of Future Royalties - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Mar. 31, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Feb. 24, 2012 | Mar. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Maximum [Member] | Milestone Scenario One [Member] | Milestone Scenario One [Member] | Milestone Scenario Two [Member] | Purchase and Sale Agreement with RPI [Member] | CIMZIA and MIRCERA [Member] | CIMZIA and MIRCERA [Member] | CIMZIA and MIRCERA [Member] | |||||
Liability Related to Sale of Future Royalties [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from sale of royalty rights | ' | ' | ' | ' | ' | ' | ' | ' | $124,000,000 | ' | ' | ' |
Transaction costs related to sale of potential future royalties | ' | ' | ' | 4,400,000 | ' | ' | ' | ' | 4,400,000 | ' | ' | ' |
Royalty revenue and non-cash royalty revenue from Cimzia and Mircera | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12,700,000 | 9,600,000 |
Royalty revenues | 354,000 | 498,000 | 1,030,000 | 3,966,000 | ' | ' | ' | ' | ' | 2,700,000 | ' | ' |
Annual interest rate | ' | ' | 17.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payment made for milestone not achieved year one | ' | ' | ' | ' | ' | 3,000,000 | ' | ' | ' | ' | ' | ' |
Contingent payment related to royalty obligation | ' | ' | ' | ' | $7,000,000 | ' | ' | ' | ' | ' | ' | ' |
Royalty agreement contingent payment description | ' | ' | ' | ' | ' | ' | 'Because worldwide net sales of MIRCERA for the 12 month period ending on December 31, 2012 did not reach a required threshold. | 'If the specified worldwide net sales threshold of MIRCERA for the 12 month period ending on December 31, 2013 is not achieved. | ' | ' | ' | ' |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | Sep. 30, 2013 |
In Millions, unless otherwise specified | |
Commitments And Contingencies Disclosure [Abstract] | ' |
Accrued contingent liability with interest | $3 |
License_and_Collaboration_Agre2
License and Collaboration Agreements - License, Collaboration and Other Revenue (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | $41,360 | $6,132 | $67,195 | $24,190 |
AstraZeneca AB [Member] | Naloxegol (NKTR-118) and naloxegol fixed-dose combination program (NKTR-119) [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 25,000 | 7 | 25,016 | 48 |
Bayer Healthcare LLC [Member] | BAY41-6551 (Amikacin Inhale) [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 779 | 714 | 14,604 | 2,257 |
Roche [Member] | PEGASYS and MIRCERA [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 2,625 | 2,011 | 7,875 | 5,134 |
Affymax, Inc. [Member] | Omontys [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 6,779 | 198 | 7,149 | 2,610 |
Amgen, Inc. [Member] | Neulasta [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 1,250 | 1,250 | 3,750 | 3,750 |
Baxter Healthcare [Member] | BAX 855 (Hemophilia) [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | 201 | 741 | 1,499 | 5,794 |
Other [Member] | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' |
License, collaboration, and other revenue | $4,726 | $1,211 | $7,302 | $4,597 |
License_and_Collaboration_Agre3
License and Collaboration Agreements - Additional Information (Detail) (USD $) | Sep. 30, 2013 | Sep. 25, 2013 | Sep. 30, 2013 | Dec. 31, 2013 | Sep. 30, 2013 | Feb. 29, 2012 | Feb. 29, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 16, 2013 | Sep. 16, 2013 | Sep. 16, 2013 | Sep. 16, 2013 | Sep. 16, 2013 | Sep. 30, 2013 | Sep. 16, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2007 | Jun. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2007 | Dec. 31, 2007 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 |
In Millions, unless otherwise specified | Naloxegol [Member] | Naloxegol [Member] | Roche [Member] | Roche [Member] | Roche [Member] | Roche [Member] | Roche [Member] | Baxter Healthcare [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | AstraZeneca AB [Member] | Bayer Healthcare LLC [Member] | Bayer Healthcare LLC [Member] | Bayer Healthcare LLC [Member] | Bayer Healthcare LLC [Member] | Bayer Healthcare LLC [Member] | Amgen, Inc. [Member] | Affymax, Inc. [Member] | Other Member [Member] | |
US and EU Commercial Launch [Member] | Subsequent Event [Member] | MIRCERA [Member] | MIRCERA [Member] | MIRCERA [Member] | PEGASYS [Member] | BAX 855 (Hemophilia) [Member] | January 15, 2015 [Member] | January 15, 2016 [Member] | January 15, 2017 [Member] | January 15, 2018 [Member] | FDA Acceptance [Member] | Naloxegol [Member] | Naloxegol [Member] | Naloxegol [Member] | Naloxegol fixed-dose combination programs [Member] | Performance-based milestone payments [Member] | Upfront payment arrangement [Member] | Omontys [Member] | |||||||||
Performance-based milestone payments [Member] | Upfront payment arrangement [Member] | Pre-approval Cardiovascular Safety Study Not Required [Member] | |||||||||||||||||||||||||
Deferred Revenue Arrangement [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential future additional payments for development milestones | $144.30 | ' | ' | ' | ' | ' | ' | ' | $28 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $50 | ' | ' | ' | ' | $66.30 |
Contingent payments receivable based on development events regulatory to be pursued and completed solely by others | ' | ' | 140 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 70 | ' | 245 | 35 | 75 | ' | ' | ' | ' | ' | ' | ' | ' |
Development milestones achieved | ' | 25 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10 | ' | ' | ' | ' | ' | ' |
Contingent repayment of payments not yet received | ' | ' | ' | ' | ' | ' | ' | ' | ' | 70 | 10 | 10 | 20 | 30 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Accrued interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4.50% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reduction on non-U.S. royalty for repayment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential reduction on non-U.S. royalty for repayment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Accumulated reduction in royalty payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 35 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Received upfront and milestone payments | ' | ' | ' | ' | ' | 22 | 5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20 | 40 | ' | ' | ' |
Performance milestone payments recorded as a liability to Bayer | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10 | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | 17.4 | ' | ' | 11.5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 22.9 | ' | ' | 35.4 | 0 | ' |
Expected total consideration related to future product sales | ' | ' | ' | 18 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue recognized | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $6.70 | ' |
StockBased_Compensation_Total_
Stock-Based Compensation - Total Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation | $4,564 | $3,980 | $13,165 | $12,015 |
Cost of goods sold [Member] | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation | 327 | 353 | 974 | 1,121 |
Research and development expense [Member] | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation | 2,071 | 1,670 | 5,923 | 5,296 |
General and administrative expense [Member] | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation | $2,166 | $1,957 | $6,268 | $5,598 |
StockBased_Compensation_Additi
Stock-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Stock options [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Granted stock options | 449,010 | 434,060 | 3,438,320 | 3,416,780 |
Weighted average grant-date fair value | $7.11 | $4.78 | $4.95 | $3.91 |
Common Stock [Member] | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Stock issuances under equity compensation plans | 306,859 | 292,485 | 731,073 | 587,421 |
Net_Loss_Per_Share_Weighted_Av
Net Loss Per Share - Weighted Average Securities Excluded from Diluted Net Loss Per Share (Detail) (Stock options [Member]) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Stock options [Member] | ' | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' |
Weighted average diluted securities excluded from diluted net loss per share | 9,739 | 14,301 | 12,999 | 13,836 |