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License and Collaboration Agreements | 12 Months Ended
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Dec. 31, 2017
Organization Consolidation And Presentation Of Financial Statements [Abstract] |
License and Collaboration Agreements | Note 10 — License and Collaboration Agreements We have entered into various collaboration agreements including license agreements and collaborative research, development and commercialization agreements with various pharmaceutical and biotechnology companies. Under these collaboration arrangements, we are entitled to receive license fees, upfront payments, milestone and other contingent payments, royalties, sales milestone payments, and payments for the manufacture and supply of our proprietary PEGylation materials and/or 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):
|  |  |  | Year Ended December 31, |
Partner |  | Agreement |  | 2017 |  |  | 2016 |  |  | 2015 |
Eli Lilly and Company |  | NKTR-358 |  | $ | 130,087 |  |  | $ | — |  |  | $ | — |
Ophthotech Corporation(1) |  | Fovista® |  |  | 19,123 |  |  |  | 1,408 |  |  |  | 1,398 |
Bayer Healthcare LLC(1) |  | BAY41-6551 (Amikacin Inhale) |  |  | 17,931 |  |  |  | 1,429 |  |  |  | 1,919 |
Baxalta Incorporated / Shire |  | ADYNOVATE® |  |  | 11,443 |  |  |  | 650 |  |  |  | 10,694 |
MAP Pharmaceuticals, Inc. / Allergan |  | SEMPRANA® |  |  | 11,000 |  |  |  | — |  |  |  | — |
Amgen, Inc. |  | Neulasta® |  |  | 5,000 |  |  |  | 5,000 |  |  |  | 5,000 |
AstraZeneca AB |  | MOVANTIK® and MOVANTIK® fixed-dose combination program |  |  | 4,600 |  |  |  | 33,000 |  |  |  | 130,000 |
Daiichi Sankyo Europe GmbH(1) |  | ONZEALDTM (NKTR-102) |  |  | 3,811 |  |  |  | 3,690 |  |  |  | — |
Roche(1) |  | PEGASYS® and MIRCERA® |  |  | — |  |  |  | 7,685 |  |  |  | 12,816 |
Other |  |  |  |  | 7,970 |  |  |  | 7,520 |  |  |  | 3,777 |
License, collaboration and other revenue |  |  |  | $ | 210,965 |  |  | $ | 60,382 |  |  | $ | 165,604 |
(1) | These collaboration agreements were completed as of December 31, 2017.
As of December 31, 2017, our collaboration agreements with partners included potential future payments for development milestones totaling approximately $305.5 million, including amounts from our agreements with Lilly and Baxalta described below. In addition, under our collaboration agreements we are entitled to receive other contingent payments, including contingent sales milestones and royalty payments, as described below. Eli Lilly and Company (Lilly): NKTR-358 Effective August 23, 2017, we entered into a worldwide license agreement with Eli Lilly and Company (Lilly) to co-develop NKTR-358, a novel immunological drug candidate that we invented. Under the terms of the agreement we (i) received an initial payment of $150.0 million in September 2017 and are eligible for up to $250.0 million in additional development milestones, (ii) will co-develop NKTR-358 with Lilly with Nektar responsible for completing Phase 1 clinical development and certain drug product development and supply activities, (iii) will share with Lilly Phase 2 development costs with 75% of those costs borne by Lilly and 25% of the costs borne by Nektar, (iv) will have the option to contribute funding to Phase 3 development on an indication-by-indication basis ranging from zero to 25% of development costs, and (v) will have the opportunity to receive up to double-digit sales royalty rates that escalate based upon our Phase 3 development cost contribution and the level of annual global product sales. Lilly will be responsible for all costs of global commercialization, and we will have an option to co-promote in the U.S. under certain conditions. A portion of the development milestones may be reduced by 50% under certain conditions, related to the final formulation of the approved product and the timing of prior approval (if any) of competitive products with a similar mechanism of action, which could reduce these milestone payments by 75% if both conditions occur. The agreement will continue until Lilly no longer has any royalty payment obligations to us or, if earlier, the termination of the agreement in accordance with its terms. The agreement may be terminated by Lilly for convenience, and may also be terminated under certain other circumstances, including material breach. We identified our license grant to Lilly, our ongoing Phase 1 clinical development obligation, our drug product development obligation and our obligation to supply clinical trial materials as the significant, non-contingent deliverables under the agreement and concluded that each of these deliverables represents a separate unit of accounting. The valuation of each unit of accounting involves significant estimates and assumptions, including but not limited to, expected market opportunity and pricing, assumed royalty rates, clinical trial costs, timelines and likelihood of success; in each case these estimates and assumptions covering long time periods. We determined the best estimate of the selling price for the license based on a discounted cash flow analysis of projected revenues from NKTR-358 and development and commercial costs using a discount rate based on a market participant’s weighted average cost of capital adjusted for forecasting risk. We determined the best estimate of selling prices for Phase 1 clinical development, drug product development and clinical supply deliverables based on the nature of the services to be performed and estimates of the associated efforts and third-party rates for similar services. Based on these estimates at agreement inception, the $150.0 million upfront payment was allocated $125.9 million to the license, $17.6 million to the Phase 1 clinical development and $6.5 million to the drug product development based on our estimate of their relative selling prices. We did not allocate any of the upfront arrangement consideration to the clinical trial material supply obligations as we will receive incremental consideration when we deliver such materials. We recognized license revenue upon the effective date of the arrangement in August 2017. We will recognize revenue related to Phase 1 clinical development and drug product development activities using the proportionate performance method as services are provided over the estimated service period, which we estimate will continue until the end of 2019. As a result, during the year ended December 31, 2017, we recognized $125.9 million of revenue related to the license and $4.2 million of revenue related to Phase 1 clinical development and drug product development activities. We recorded the remaining $19.9 million related to Phase 1 clinical development and drug product development activities as deferred revenue as of December 31, 2017. Ophthotech Corporation: Fovista® On October 27, 2017, we terminated our license and supply agreement with Ophthotech Corporation (Ophthotech) dated September 2006, pursuant to 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 were the exclusive supplier of all of Ophthotech’s clinical and commercial requirements for our proprietary PEGylation reagent used in Fovista®. The termination of our agreement with Ophthotech followed Opthotech’s previous announcements, in December 2016 and August 2017, that their three pivotal Phase 3 studies investigating the superiority of Fovista® therapy in combination with Lucentis® therapy compared to Lucentis® monotherapy and evaluating Fovista® in combination with Eylea® or Avastin® compared to Eylea® or Avastin® monotherapy for the treatment of wet age-related macular degeneration (AMD) did not achieve the pre-specified primary endpoints. Under our agreement with Ophthotech, in June 2014, we received a $19.8 million payment from Ophthotech in connection with its licensing agreement with Novartis. In addition, in January 2017, we received a $12.7 million advance payment from Ophthotech, which included $10.4 million for reagent shipments recognized in the second quarter of 2017 as well as approximately $2.3 million for 2017 minimum purchase requirements. As a result of the termination of this agreement, we recognized the remaining $18.0 million of deferred revenue from this arrangement in the three months ended December 31, 2017. Bayer Healthcare LLC: BAY41-6551 (Amikacin Inhale) In December 2017, Bayer Healthcare LLC (Bayer) terminated our co-development, license and co-promotion agreement entered into in August 2007 to develop a specially-formulated inhaled Amikacin. Under this agreement, we were responsible for development, manufacturing and supply of our proprietary nebulizer device included in the Amikacin product. Bayer was responsible for most clinical development and commercialization activities and costs, all activities and costs to support worldwide regulatory filings, approvals and related activities, further development of Amikacin Inhale and final product packaging and distribution. The termination of this agreement followed Bayer’s announcement in November 2017 that the Phase 3 Amikacin Inhale clinical program for the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia did not meet its primary endpoint or key secondary endpoints. Under this collaboration, we received an upfront payment of $40.0 million (which was paid to us in 2007) and milestone payments totaling $30.0 million (the last of which was paid to us in 2013). As a result of the termination of the agreement, we recognized the remaining $16.8 million of deferred revenue related to this arrangement in the three months ended December 31, 2017. Baxalta Incorporated: Hemophilia We are a party to an exclusive research, development, license and manufacturing and supply agreement with Baxalta Incorporated (Baxalta), a subsidiary of Shire plc, entered into in September 2005 to develop products designed to improve therapies for Hemophilia A patients using our PEGylation technology. Under the terms of the agreement, we are entitled to research and development funding for our active programs, which are now complete for Factor VIII, and are responsible for supplying Baxalta with its requirements of our proprietary materials. Baxalta is responsible for all clinical development, regulatory, and commercialization expenses. The agreement is terminable by the parties under customary conditions. This Hemophilia A program includes ADYNOVATE®, which was approved by the FDA in November 2015 for use in adults and adolescents, aged 12 years and older, who have Hemophilia A, and is now marketed in the U.S. As a result of the FDA’s approval, we earned a $10.0 million development milestone in November 2015. Under the terms of this agreement, we are also entitled to a $10.0 million development milestone due upon marketing authorization in the EU, which was achieved in January 2018. In addition, we are entitled to sales milestones upon achievement of annual sales targets and royalties based on annual worldwide net sales of products resulting from this agreement. In October 2017, we entered into a right to sublicense agreement with Baxalta under which we granted to Baxalta the right to grant a nonexclusive sublicense to certain patents that were previously exclusively licensed to Baxalta under our 2005 agreement. Under the right to sublicense agreement, Baxalta paid us $12.0 million in November 2017 and agreed to pay us single digit royalty payments based upon net sales of the products covered under the sublicense throughout the term of the agreement. We determined that this right to sublicense agreement should be considered a material modification of the existing arrangement described above. We have identified our grant of the right to sublicense and our ongoing obligation to supply PEGylation materials specified in the 2005 agreement as the undelivered units of accounting in the arrangement. We made our best estimates of the selling price of these deliverable and recognized the $11.0 million allocated to the right to sublicense and allocated $1.0 million to our ongoing supply obligation unit of accounting. As of December 31, 2017, we have deferred revenue of approximately $1.0 million related to this agreement, which we expect to recognize through January 2028, the estimated end of our supply obligations under the arrangement. MAP Pharmaceuticals, Inc.: SEMPRANA® In August 2006, we entered into a restated and amended license agreement with MAP Pharmaceuticals, Inc. (MAP) under which we granted a license to technology used by MAP in the development of its drug candidate SEMPRANA®, a potential treatment for chronic migraine headache. Under our agreement, we are entitled to development milestone payments, royalties and a share of sublicensing payments received by MAP. In January 2011, MAP announced a collaboration with Allergan, Inc. (Allergan) to co-promote SEMPRANA®, under which MAP has received upfront and sublicensing payments totaling $80.0 million from Allergan. In 2013, Allergan acquired MAP and MAP became a wholly-owned subsidiary of Allergan. In January 2015, we filed a breach of contract action against Allergan and MAP. In December 2017, we, Allergan and MAP entered into a Settlement Agreement and Release. Pursuant to this agreement, Allergan paid Nektar $15.0 million in December 2017 in exchange for relief of any claims related to our share of payments received by MAP from Allergan as well as a specified development milestone payment due to Nektar. We have no continuing performance obligations under the MAP agreement. As a result, in the year ended December 31, 2017, we recognized $11.0 million as license revenue related to our share of payments due to us under the MAP agreement and recorded the remaining $4.0 million, which primarily represents the reimbursement of legal expenses, as a gain on settlement recorded in general and administrative expenses. As of December 31, 2017, we have no deferred revenue related to this agreement. 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 guarantee the manufacture and supply of our proprietary PEGylation materials (Polymer Materials) to Amgen in an existing manufacturing suite to be used exclusively for the manufacture of Polymer Materials for Amgen (the Manufacturing Suite) in our manufacturing facility in Huntsville, Alabama (the Facility). This supply arrangement is on a non-exclusive basis (other than the use of the Manufacturing Suite and certain equipment) whereby we are free to manufacture and supply the Polymer Materials to any other third party and Amgen is free to procure the Polymer Materials from any other third party. 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 Polymer Materials to Amgen including without limitation the Additional Rights described below and manufacturing fees that are calculated based on fixed and variable components applicable to the Polymer Materials ordered by Amgen and delivered by us. Amgen has no minimum purchase commitments. If quantities of the Polymer Materials ordered by Amgen exceed specified quantities, significant additional payments become payable to us in return for our guaranteeing the supply of additional quantities of the Polymer Materials. The term of the amended and restated agreement ends on October 29, 2020. In the event we become subject to a bankruptcy or insolvency proceeding, we cease to own or control the Facility, we fail to manufacture and supply or certain other events, Amgen or its designated third party will have the right to elect, among certain other options, to take title to the dedicated equipment and access the Facility to operate the Manufacturing Suite solely for the purpose of manufacturing the Polymer Materials. Amgen may terminate the amended and restated agreement for convenience or due to an uncured material default by us. As of December 31, 2017, we have deferred revenue of approximately $14.2 million related to this agreement, which we expect to recognize through October 2020, the estimated end of our obligations under this agreement. AstraZeneca AB: MOVANTIK® (naloxegol oxalate), previously referred to as naloxegol and NKTR-118, and MOVANTIK® fixed-dose combination program, previously referred to as NKTR-119 In September 2009, we entered into 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 MOVANTIK® and MOVANTIK® fixed-dose combination program. AstraZeneca is responsible for all research, development and commercialization and is responsible for all drug development and commercialization decisions for MOVANTIK® and the MOVANTIK® 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. In addition, we have received the payments described further below based on development events related to MOVANTIK® completed solely by AstraZeneca. We are entitled to receive up to $75.0 million of commercial launch contingent payments related to the MOVANTIK® 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 MOVANTIK® and MOVANTIK® fixed-dose combination products. On September 16, 2014, the United States Food and Drug Administration (FDA) approved MOVANTIK® for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. On December 9, 2014, AstraZeneca announced that MOVENTIG® (the naloxegol brand name in the European Union or EU) had 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). In March 2015, we received and recognized a $100.0 million non-refundable payment resulting from the U.S. commercial launch of MOVANTIK®. In March 2015, we agreed to pay AstraZeneca a total of $10.0 million to fund U.S. television advertising in consideration for certain additional commercial information rights. We recorded this $10.0 million obligation as a liability and made the initial $5.0 million payment to AstraZeneca in July 2015 and the remaining $5.0 million payment in July 2016. We determined that this $10.0 million obligation should be recorded as a reduction of revenue, which we recorded in 2015. In August 2015, we received and recognized as revenue an additional $40.0 million non-refundable payment triggered by the first commercial sale of MOVENTIG® in Germany. On March 1, 2016, AstraZeneca announced that it had entered into an agreement with ProStrakan Group plc, a subsidiary of Kyowa Hakko Kirin Co. Ltd. (Kirin), granting Kirin exclusive marketing rights to MOVENTIG® in the EU, Iceland, Liechtenstein, Norway and Switzerland. Under the terms of AstraZeneca’s agreement with Kirin, Kirin made a $70.0 million upfront payment to AstraZeneca and will make additional payments based on achieving market access milestones, tiered net sales royalties, as well as sales milestones. Under our license agreement with AstraZeneca, we will share the upfront payment, market access milestones, royalties and sales milestones from Kirin with AstraZeneca receiving 60% and Nektar receiving 40%. This payment sharing arrangement is in lieu of other royalties payable by AstraZeneca to us and a portion of the sales milestones as described below. Our 40% share of royalty payments made by Kirin to AstraZeneca will be financially equivalent to us receiving high single-digit to low double-digit royalties dependent on the level of Kirin’s net sales. Kirin’s MOVENTIG® net sales will be included for purposes of achieving the annual global sales milestones payable to us by AstraZeneca and will also be included for purposes of determining the applicable ex-U.S. royalty rate, from the tier schedule in our AstraZeneca license agreement, that will be applied to ex-U.S. sales outside of the Kirin territory. The global sales milestones under our license agreement with AstraZeneca will be reduced in relation to the amount of Kirin MOVENTIG® net sales that contribute to any given annual sales milestone target. As a result, in April 2016, we received 40% (or $28.0 million) of the $70.0 million payment received by AstraZeneca from Kirin. In the years ended December 31, 2017 and 2016, we recognized a total of $4.6 million and $33.0 million, respectively, related to our share of such license-related payments made to AstraZeneca. As of December 31, 2017, we do not have deferred revenue related to our agreement with AstraZeneca. Daiichi Sankyo Europe GmbH: ONZEALD TM (etirinotecan pegol), also referred to as NKTR-102 In December 2017, Daiichi Sankyo Europe GmbH (Daiichi) terminated our collaboration and license agreement made effective in May 2016, under which we granted Daiichi exclusive commercialization rights in the European Economic Area, Switzerland, and Turkey (collectively, the European Territory) to ONZEALDTM (etirinotecan pegol). Daiichi was responsible for all commercialization activities in the European Territory and we were responsible for supplying Daiichi with ONZEALDTM and for funding and conducting a Phase 3 confirmatory trial in patients with advanced breast cancer who have brain metastases, which was initiated in the fourth quarter of 2016. Daiichi terminated the agreement after the European Medicines Agency’s Committee for Medicinal Products for Human Use confirmed in November 2017 that it declined the conditional marketing authorization application for ONZEALDTM in the EU. Under the terms of the agreement, Daiichi paid us a $20.0 million up-front payment in August 2016, of which $12.5 million was refundable to Daiichi if conditional approval was not achieved and the agreement was terminated. This $12.5 million contingent termination payment from us to Daiichi was recorded in our liability related to refundable upfront payment balance in our Consolidated Balance Sheet at December 31, 2016 and was paid to Daiichi in December 2017. In 2016, we allocated the $7.5 million non-refundable portion of the $20.0 million upfront payment from Daiichi to the license grant and our development service deliverables based on their relative estimated selling prices. As a result, we recognized $3.7 million of revenue in 2016 from this arrangement, primarily related to the delivery of the license. As a result of the termination of the arrangement, we recognized the remaining $3.2 million of deferred revenue in the three months ended December 31, 2017. Roche: PEGASYS® and MIRCERA® In February 2012, we entered into a toll-manufacturing agreement with Roche under which we agreed to 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 a total of $27.0 million, including amounts for the delivery of specified quantities of PEGylation materials, all of which were completed as of January 2013. In addition, in 2013, we delivered additional quantities of PEGylation materials used by Roche to produce PEGASYS® and MIRCERA® for total consideration of $18.6 million. As of December 31, 2016, we no longer had any continuing manufacturing or supply obligations under this MIRCERA® agreement and, therefore, we have no deferred revenue related to this agreement. 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®. Our performance obligations under this PEGASYS® agreement ended on December 31, 2015. Bristol-Myers Squibb: NKTR-214 On September 21, 2016, we entered into a Clinical Trial Collaboration Agreement (Clinical Trial Agreement) with Bristol-Myers Squibb Company (BMS), pursuant to which we and BMS collaborated to conduct Phase 1/2 clinical trials evaluating our IL-2-based CD122-biased agonist, known as NKTR-214, and BMS’ human monoclonal antibody that binds PD-1, known as Opdivo® (nivolumab), as a potential combination treatment regimen in five tumor types and eight indications, and such other clinical trials evaluating the combined therapy as may be mutually agreed upon by the parties (each, a Combination Therapy Trial). We acted as the sponsor of each Combination Therapy Trial. Under the Clinical Trial Agreement, BMS was responsible for 50% of all out-of-pocket costs reasonably incurred in connection with third party contract research organizations, laboratories, clinical sites and institutional review boards. We recorded cost reimbursement payments to us from BMS as a reduction to research and development expense and we have recorded a total of $7.8 million of such reimbursements in the year ended December 31, 2017 and since the inception of our collaboration. Each party was otherwise responsible for its own internal costs, including internal personnel costs, incurred in connection with each Combination Therapy Trial. Nektar and BMS used commercially reasonable efforts to manufacture and supply NKTR-214 and Opdivo® (nivolumab), respectively, for each Combination Therapy Trial with each party bearing its own costs related thereto. Ownership of, and global commercial rights to, NKTR-214 remain solely with us under the Clinical Trial Agreement. If we wish to license the right to commercialize NKTR-214 in one of certain major market territories prior to September 30, 2018 (Exclusivity Expiration Date), we must first negotiate with BMS, for a period of three months (Negotiation Period), to grant an exclusive license to develop and commercialize NKTR-214 in any of these major market territories. If we do not reach an agreement with BMS for an exclusive license within the Negotiation Period, we will be free to license any right to NKTR-214 to other parties in any territory worldwide except that in the event that we receive a license offer from a third party during a period of 90 calendar days after the end of the Negotiation Period, we will provide BMS ten business days to match the terms of such third-party offer. After the Exclusivity Expiration Date, we are free to license NKTR-214 without any further obligation to BMS. Each party grants to the other party a non-exclusive, worldwide (subject to certain exceptions in the case of the license granted by BMS), non-transferable and royalty-free research and development license to such licensing party’s patent rights, technology and regulatory documentation to use its compound solely to the extent necessary to discharge its obligations under the Clinical Trial Agreement with respect to the conduct of the Combination Therapy Trials. The Clinical Trial Agreement will be superseded and replaced by the Strategic Collaboration Agreement entered into between us and BMS on February 13, 2018 (BMS Collaboration Agreement), which is summarized in Note 14, if and when the BMS Collaboration Agreement becomes effective. Other In addition, as of December 31, 2017, we have a number of other collaboration agreements, including with our collaboration partners UCB and Halozyme, under which we are entitled to up to a total of $45.5 million of development milestones upon achievement of certain development objectives, as well as sales milestones upon achievement of annual sales targets and royalties based on net sales of commercialized products, if any. However, given the current phase of development of the potential products under these collaboration agreements, we cannot estimate the probability or timing of achieving these milestones. As of December 31, 2017, we have deferred revenue of approximately $2.9 million related to these other collaboration agreements, which we expect to recognize through 2020, the estimated end of our obligations under those agreements.

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