Strategic Collaborations and Other Significant Agreements | 3. Strategic Collaborations and Other Significant Agreements Mitsubishi Tanabe Pharma Corporation Collaboration Agreement Summary of Agreement On December 11, 2015, the Company and MTPC entered into a collaboration agreement, the MTPC Agreement, providing MTPC with exclusive development and commercialization rights to vadadustat, the Company’s product candidate for the treatment of anemia related to chronic kidney disease, in Japan and certain other Asian countries, collectively, the Territory. Pursuant to the MTPC Agreement, MTPC has an exclusive license to develop and commercialize vadadustat in the Territory. In addition, the Company will supply vadadustat for both clinical and commercial use in the Territory. The Company and MTPC agreed to pursue a local development plan and, following consultation with the Japanese Pharmaceuticals and Medical Devices Agency, or the PMDA, MTPC initiated a local Phase 3 development for vadadustat in Japan, the Local Scenario. In consideration for the exclusive license and other rights contained in the MTPC Agreement, under the Local Scenario Japanese patients would not be included in the Phase 3 program and MTPC would make payments totaling up to $245.0 million based on the achievement of certain development, regulatory and sales milestones, as well as tiered double-digit royalty payments up to 20% on sales of vadadustat in the Territory. Under the Local Scenario, MTPC is responsible for the costs of local development in Japan and will make no additional funding payments for the global Phase 3 program. The Company recently completed its Phase 2 study of vadadustat in non-dialysis-dependent, NDD, Japanese patients and is currently conducting its Phase 2 study of vadadustat in dialysis-dependent Japanese patients in Japan and expects findings by the end of 2017. Under the Local Scenario, these Phase 2 studies are considered local development costs and reimbursable by MTPC. Therefore, of the $40.0 million received by the Company in 2016, $20.0 million is being applied towards costs already incurred by the Company for the Phase 2 studies and MTPC will reimburse the Company for costs in excess of $20.0 million to complete the studies. The Company has incurred approximately $17.4 million in Phase 2 costs through September 2017 and anticipates incurring an additional approximately $8.0 million in Phase 2 costs through the end of the studies. As a result, MTPC would be required to reimburse the Company an additional approximately $5.0 million related to the two Phase 2 studies. Pursuant to the terms of the MTPC Agreement for the Local Scenario, MTPC is responsible for performing all Phase 3 activities related to the development of vadadustat in the Territory and has sole responsibility for the commercialization of vadadustat in the Territory as well as for Medical Affairs (as defined in the MTPC Agreement) in the Territory. Akebia is responsible for the completion of Phase 2 dosing studies as reimbursed by MTPC, manufacturing and supplying vadadustat for clinical use in the Territory and, if approved by the FDA, will enter into a supply agreement with MTPC for the commercial supply of vadadustat prior to commercial launch. The Company and MTPC have established a joint steering committee pursuant to the agreement to oversee development and commercialization of vadadustat in the Territory, including approval of any development or commercialization plans. Unless earlier terminated, the MTPC Agreement will continue in effect on a country-by-country basis until the later of: expiration of the last-to-expire patent covering vadadustat in such country in the Territory; expiration of marketing or regulatory exclusivity in such country in the Territory; or ten years after the first commercial sale of vadadustat in such country in the Territory. MTPC may terminate the MTPC Agreement upon twelve months’ notice at any time after the second anniversary of the effective date of the MTPC Agreement. Either party may terminate the MTPC Agreement upon the material breach of the other party that is not cured within a specified time period or upon the insolvency of the other party. Under the Local Scenario, MTPC is required to make certain milestone payments to the Company aggregating to approximately $225.0 million upon the achievement of specified development, regulatory and commercial events. More specifically, the Company is eligible to receive up to $10.0 million in development milestone payments, up to $40.0 million in regulatory milestone payments for the first product to achieve the associated event and up to $175.0 million in commercial milestone payments associated with aggregate sales of all products. Additionally, if vadadustat is commercialized, the Company would be entitled to receive tiered royalty payments in the low double digits based on a percentage of net sales. Royalty payments are subject to certain reductions, including upon the introduction of competitive products in certain instances. Royalties are due on a country-by-country basis from the date of first commercial sale of a licensed product in a country until the last to occur of: (i) the expiration of the last to expire valid claim within the intellectual property covering the licensed product, (ii) the expiration of marketing or regulatory exclusivity in such country, or (iii) the tenth anniversary of the first commercial sale of such licensed product in such country. Due to the uncertainty of pharmaceutical development and the high historical failure rates associated with drug development, no milestone or royalty payments may ever be received from MTPC. In September 2017, the Company and MTPC entered into a new agreement that provided MTPC with an option to access data from the Company’s global Phase 3 vadadustat program for payments to the Company of up to $25.0 million. Revenue Recognition The Company evaluated the elements of the MTPC Agreement in accordance with the provisions of ASC 605-25. The Company’s arrangement with MTPC contains the following deliverables: (i) license under certain of the Company’s intellectual property to develop and commercialize vadadustat (the License Deliverable), (ii) clinical supply of vadadustat, (iii) knowledge transfer, (iv) Phase 2 dosing study research services, and (v) rights to future know-how. The Company has identified two units of accounting in connection with its obligations under the MTPC Agreement. Factors considered in making the assessment of standalone value included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the value of the deliverable is dependent on the other elements in the arrangement, whether there are other vendors that can provide the items and if the customer could use the item for its intended purpose without the other deliverables in the arrangement. Additionally, the License Agreement does not include a general right of return. The two units of accounting identified in connection with the Company’s obligations under the MTPC Agreement are as follows: (i) License, Research Services and Clinical Supply Unit of Accounting The License Deliverable does not have standalone value and qualify for separation from the clinical supply of vadadustat. More specifically, the license delivered to MTPC does not provide the contractual right to manufacture vadadustat. MTPC is contractually prohibited from manufacturing any Licensed Product covered by the licenses during clinical trials. Accordingly, MTPC must obtain the clinical trial products from the Company which significantly limits the ability for MTPC to use the license for their intended use on a standalone basis. The License Deliverable does not have standalone value and qualify for separation from the knowledge transfer because MTPC cannot fully utilize the license for its intended purpose without the corresponding information regarding know-how, development data and regulatory materials possessed by the Company. The License Deliverable does not have standalone value and qualify for separation from the Phase 2 dosing study research services because MTPC cannot fully utilize the license for its intended purpose without the performance of the Phase 2 dosing studies. The Phase 2 dosing studies need to be performed prior to the PMDA approving any Phase 3 study to be performed in the Territory. Furthermore, MTPC cannot benefit from the Phase 2 dosing studies without the license and the undelivered Phase 3 clinical supply. The License Deliverable does not have standalone value from the clinical supply, knowledge transfer or Phase 2 studies. As a result, the License Deliverable, clinical supply, knowledge transfer and Phase 2 studies have been combined as a single unit of accounting (the License, Research and Clinical Supply Unit of Accounting) (ii) Rights to Future Know-How The License, Research and Clinical Supply Unit of Accounting has standalone value and qualifies for separation from the rights to future know how because MTPC can obtain the value of the License, Research and Clinical Supply Unit of Accounting without receipt of any rights to future know how that may be discovered or developed in the future. The Company has determined that neither VSOE of selling price nor TPE of selling price is available for either of the units of accounting identified at inception of the arrangement with MTPC. Accordingly, the selling price of each unit of accounting was determined based on the Company’s BESP. The Company developed the BESP with the objective of determining the price at which it would sell such an item if it were to be sold regularly on a standalone basis. The Company developed the BESP for the Rights to Future Know How Unit of Accounting primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a BESP for the License, Research and Clinical Supply Unit of Accounting because the BESP associated with the Rights to Future Know How Unit of Accounting was determined to be immaterial. The Company has concluded that a change in the key assumptions used to determine the BESP for each unit of accounting would not have a significant impact on the allocation of arrangement consideration. Allocable arrangement consideration is comprised of: (i) the up-front payment of $20.0 million, (ii) the estimate of the cost for the Phase 2 studies of at least $20.0 million, and (iii) the cost of all clinical supply provided to MTPC for the Phase 3 studies. No amounts were allocated to the Rights to Know How Unit of Accounting because the associated BESP was determined to be immaterial therefore the arrangement consideration will be allocated to the License, Research Services and Clinical Supply Unit of Accounting. The has evaluated all the development, regulatory sales milestones may received in connection with the MTPC Agreement. In evaluating if milestone is substantive, assesses whether: (i) consideration is commensurate with either Company’s to achieve the milestone the of value of delivered item(s) result of specific resulting performance to achieve milestone, (ii) the relates to performance, and (iii) the consideration is reasonable relative to all the deliverables and payment terms within the arrangement. All regulatory milestones, with the exception of one development milestone associated with the near term progress of the Phase 3 study, substantive contingent nature the milestone, specifically reviewing factors scientific, clinical, regulatory, commercial other risks must overcome to achieve the milestone well as level of effort investment Accordingly, amounts will recognized revenue in full in in which the associated milestone is all other revenue recognition criteria are met. The non-substantive development milestone will be included in the arrangement consideration, if and when received, and allocated to the License, Research Services and Clinical Unit of Accounting within the arrangement and recognized as revenue when those underlying obligations are satisfied. The total aggregate amount of development milestones is million and total aggregate of milestones is up to million. All milestones, up to $175.0 million, will accounted for in same manner royalties recorded revenue upon achievement the milestone, assuming all . The will recognize royalty revenue in sale of related product(s), the terms, that the sales measurable and no performance obligations, other revenue recognition criteria met. Revenue for the fixed and determinable consideration of $40.0 million that was received in January 2016, will be recognized, using a proportional performance method, as the Company delivers clinical supply of vadadustat to MTPC for the Phase 3 study. The Company expects to begin to deliver the clinical supply of vadadustat to MTPC in the fourth quarter of 2017. Therefore, at September 30, 2017 the $40.0 million is recorded as deferred revenue in the accompanying consolidated balance sheets. Otsuka Pharmaceutical Co. Ltd. U.S. Collaboration and License Agreement Summary of Agreement On December 18, 2016, the Company entered into a collaboration and license agreement with Otsuka, or the Otsuka U.S. Agreement. The collaboration is focused on the development and commercialization of vadadustat in the United States. Under the terms of the Otsuka U.S. Agreement, the Company will continue to lead the development of vadadustat, including the ongoing Phase 3 development program. The Company and Otsuka will co-commercialize vadadustat in the United States, subject to the approval of vadadustat by the FDA. Under the terms of the Otsuka U.S. Agreement, the Company granted to Otsuka a co-exclusive, non-sublicensable license under certain intellectual property controlled by the Company solely to perform medical affairs activities and to conduct non-promotional and commercialization activities related to vadadustat in accordance with the associated plans. The co-exclusive license relates to activities that will be jointly conducted by the Company and Otsuka pursuant to the terms of the Otsuka U.S. Agreement. Pursuant to the terms of the Otsuka U.S. Agreement, the Company is responsible for performing all activities related to the development of vadadustat as outlined in the current global development plan. The current global development plan encompasses all activities with respect to the ongoing PRO 2 2 Under the Otsuka U.S. Agreement, the parties jointly conduct, and have equal responsibility for, all medical affairs, commercialization and non-promotional activities pursuant to underlying plans as agreed to by the parties. If approved by the FDA, the Company will provide vadadustat to Otsuka for commercialization pursuant to a separate supply agreement to be negotiated. The activities under the Otsuka U.S. Agreement are governed by a joint steering committee, or JSC, formed by an equal number of representatives from the Company and Otsuka. The JSC coordinates and monitors the parties’ activities under the collaboration. Among other responsibilities, the JSC manages the overall strategic alignment between the parties, oversees the current global development plan and reviews the other detailed plans setting forth the parties’ activities under the arrangement, including the medical affairs plan and commercialization and non-promotional activities plan. Additionally, the parties established a joint development committee, or JDC, which is comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JDC will share information related to, and review and discuss activities and progress under, the current global development plan and any other development that may be conducted pursuant to the collaboration. In support of the potential commercialization of vadadustat, the parties will establish a joint commercialization committee, or JCC, which will be comprised of an equal number of representatives from the Company and Otsuka. Among other responsibilities, the JCC will manage the activities and progress under the commercialization and non-promotional activities plan and all other sales and marketing activities. The Company has retained the final decision‑making authority with respect to all development matters, pricing strategy and certain other key commercialization matters. Under the terms of the Otsuka U.S. Agreement, the Company received a $125.0 million up-front, non-refundable, non-creditable cash payment in December 2016. In March 2017, the Company received a payment of approximately $33.8 million, which represents reimbursement for Otsuka’s share of costs previously incurred by the Company in implementing the current global development plan through December 31, 2016. Going forward, Otsuka will contribute a percentage of the remaining costs to be incurred under the current global development plan subsequent to December 31, 2016, commencing upon the date on which the Company has incurred a specified amount of incremental costs. The Company estimates that Otsuka’s funding of the current global development plan costs subsequent to December 31, 2016 will total $153.6 million or more. The costs associated with the performance of any development activities in addition to those outlined in the current global development plan will be subject to a cost sharing or reimbursement mechanism to be determined by the parties. Costs incurred with respect to medical affairs and commercialization and non-promotional activities will generally be shared equally by the parties. Either party’s share of the medical affairs and/or commercialization activities may be increased at such party’s request upon mutual agreement of the parties. In addition, if the costs incurred in completing the activities under the current global development plan exceed a certain threshold, then the Company may elect to require Otsuka to fund a higher percentage of the current global development costs. In such event, the excess of the payments made under such election and Otsuka’s allocated share of the current global development costs is fully creditable against future payments due to the Company under the arrangement. In addition, Otsuka would be required to make certain milestone payments to the Company upon the achievement of specified development, regulatory and commercial events. More specifically, the Company is eligible to receive up to $125.0 million in development milestone payments and up to $65.0 million in regulatory milestone payments for the first product to achieve the associated event. Moreover, the Company is eligible for up to $575.0 million in commercial milestone payments associated with aggregate sales of all products. Due to the uncertainty of pharmaceutical development and the high historical failure rates associated therewith, no milestone payments may ever be received from Otsuka. Under the Otsuka U.S. Agreement, the Company and Otsuka share the costs of developing and commercializing vadadustat in the United States and the profits from the sales of vadadustat after approval by the FDA. In connection with the profit share calculation, net sales include gross sales to third-party customers net of discounts, rebates, chargebacks, taxes, freight and insurance charges and other applicable deductions. Shared costs generally include costs attributable or reasonably allocable to the manufacture of vadadustat for commercialization purposes and the performance of medical affairs activities, non-promotional activities and commercialization activities. Under the Otsuka U.S. Agreement, Otsuka originally had a limited period of time in which it can exercise an option to convert the arrangement from a profit share to a right to receive a mid-single digit royalty on future net sales of commercialized products (the Royalty Conversion Option). On August 4, 2017, Otsuka agreed to waive its right to exercise the Royalty Conversion Option in advance of its expiration, consequently, Otsuka has no further right to elect to exercise this option. Unless earlier terminated, the Agreement will expire on a country-by-country and product-by-product basis on the date that one or more generic versions of vadadustat first achieves 90% market penetration. Either party may terminate the Otsuka U.S. Agreement in its entirety upon an uncured breach or insolvency on the part of the other party. Otsuka may terminate the Otsuka U.S. Agreement in its entirety upon 12 months’ prior written notice at any time after the release of the first topline data from the global Phase 3 development program. In the event of termination of the Otsuka U.S. Agreement, all rights and licensees granted to Otsuka under the Otsuka U.S. Agreement will automatically terminate and the licenses granted to the Company will become freely sublicensable. In addition, the upfront payment, all development costs and milestone payments received by the Company prior to such termination will not be refunded to Otsuka. Revenue Recognition The Company evaluated the elements of the Otsuka US Agreement in accordance with the provisions of ASC 605-25. The Company’s arrangement with Otsuka contains the following deliverables: (i) license under certain of the Company’s intellectual property to develop, perform medical affairs activities with respect to and conduct non-promotional and commercialization activities related to vadadustat and products containing or comprising vadadustat (the License Deliverable), (ii) development services to be performed pursuant to the current global development plan (the Development Services Deliverable), (iii) rights to future intellectual property (the Future IP Deliverable), and (iv) joint committee services (the Committee Deliverable). The Company has identified three units of accounting in connection with its obligations under the Otsuka U.S. Agreement. Factors considered in making the assessment of standalone value included, among other things, the capabilities of the collaboration partner, whether any other vendor sells the item separately, whether the value of the deliverable is dependent on the other elements in the arrangement, whether there are other vendors that can provide the items and if the customer could use the item for its intended purpose without the other deliverables in the arrangement. Additionally, the Otsuka U.S. Agreement does not include a general right of return. The three units of accounting identified in connection with the Company’s obligations under the Otsuka U.S. Agreement are as follows: (i) License and Development Services Combined (License Unit of Accounting) The License Deliverable does not qualify for separation from the Development Services Deliverable, due to the contractual limitations inherent in the license conveyed. More specifically, Otsuka does not have the contractual right to manufacture vadadustat and products containing or comprising vadadustat. However, the manufacturing and supply services that are conducted as part of the services to be performed pursuant to the current global development plan are necessary for Otsuka to fully exploit the associated license for its intended purpose. The value of the rights provided through the license conveyed will be realized when the underlying products covered by the intellectual property progress through the development cycle, receive regulatory approval and are commercialized. Products containing or comprising vadadustat cannot be commercialized until the development services under the current global development plan are completed. Accordingly, Otsuka must obtain the manufacturing and supply of the associated products that is included within the development services to be performed pursuant to the current global development plan from the Company in order to derive benefit from the license which significantly limits the ability for Otsuka to utilize the License Deliverable for its intended purpose on a standalone basis. (ii) Rights to Future Intellectual Property The License Deliverable and the Development Services Deliverable qualify for separation from the Future IP Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development services without the receipt of any other intellectual property that may be discovered or developed in the future. The Future IP Deliverable qualifies for separation from the Committee Deliverable because the joint committee services have no bearing on the value to be derived from the rights to potential future intellectual property. (iii) Joint Committee Services The License Deliverable and Development Services Deliverable qualify for separation from the Committee Deliverable because Otsuka can obtain the value of the license using the clinical trial materials implicit in the development services without the joint committee services. The Committee Deliverable has standalone value from the rights to Future IP Deliverable because the joint committee services have no bearing on the value to be derived from the rights to potential future intellectual property. The Company has determined that neither VSOE of selling price nor TPE of selling price is available for any of the units of accounting identified at inception of the arrangement with Otsuka. Accordingly, the selling price of each unit of accounting was determined based on the Company’s BESP. The Company developed the BESP with the objective of determining the price at which it would sell such an item if it were to be sold regularly on a standalone basis. In developing the BESP for the Joint Committee Services Unit of Accounting, the Company considered the nature of the services to be performed and estimates of the associated effort and rates applicable to such services that would be expected to be realized under similar contracts. The Company developed the BESP for the Rights to Future Intellectual Property Unit of Accounting primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement. The Company did not develop a BESP for the License Unit of Accounting due to the following: (i) the BESP associated with the Rights to Future Intellectual Property Unit of Accounting was determined to be immaterial and (ii) the period of performance and pattern of recognition for the License Unit of Accounting and the Joint Committee Services Unit of Accounting was determined to be similar. The Company has concluded that a change in the key assumptions used to determine the BESP for each unit of accounting would not have a significant impact on the allocation of arrangement consideration. Allocable arrangement consideration at inception is comprised of: (i) the up-front payment of $125.0 million, (ii) the cost share payment with respect to amounts incurred by the Company through December 31, 2016 of $33.8 million, and (iii) an estimate of the cost share payments to be received with respect to amounts incurred by the Company subsequent to December 31, 2016 of $153.6 million. No amounts were allocated to the Rights to Future Intellectual Property Unit of Accounting because the associated BESP was determined to be immaterial. Due to the similar performance period and recognition pattern between the License Unit of Accounting and the Joint Committee Services Unit of Accounting, the arrangement consideration totaling $312.4 million has been allocated to the License Unit of Accounting and the Joint Committee Services Unit of Accounting on a combined basis. Accordingly, the Company will recognize revenue related to the allocable arrangement consideration on a proportional performance basis as the underlying development services are performed pursuant to the current global development plan which is commensurate with the period and consistent with the pattern over which the Company’s obligations are satisfied for both the License Unit of Accounting and the Joint Committee Services Unit of Accounting. Effectively, the Company has treated the arrangement as if the License Unit of Accounting and the Joint Committee Services Unit of Accounting are a single unit of accounting. The has evaluated all the development, regulatory commercial milestones may received in connection with the Otsuka U.S. Agreement. In evaluating if milestone is substantive, assesses whether: (i) consideration is commensurate with either Company’s to achieve the milestone the of value of delivered item(s) result of specific resulting performance to achieve milestone, (ii) the relates to performance, and (iii) the consideration is reasonable relative to all the deliverables and payment terms within the arrangement. All regulatory milestones substantive contingent nature the milestone, specifically reviewing factors scientific, clinical, regulatory, commercial other risks must overcome to achieve the milestone well as level of effort investment Accordingly, amounts will recognized revenue in full in in which the associated milestone is all other revenue recognition met. All milestones will be recorded revenue upon achievement of the milestone, assuming all revenue recognition met. During the three and nine months ended September 30, 2017, the Company recognized revenue totaling approximately $22.5 million and $60.0 million, respectively, with respect to the Otsuka U.S. Agreement. The revenue is classified as collaboration revenue in the accompanying consolidated statement of operations. As of September 30, 2017, there is approximately $97.3 million of deferred revenue related to the Otsuka U.S. Agreement of which $48.5 million is classified as current and $48.8 million is classified as long-term in the accompanying consolidated balance sheet based on the performance period of the underlying obligations. The Company determined that the medical affairs, commercialization and non-promotional activities elements of the Otsuka U.S. Agreement represent joint operating activities in which both parties are active participants and of which both parties are exposed to significant risks and rewards that are dependent on the success of the activities. Accordingly, the Company is accounting for the joint medical affairs, commercialization and non-promotional activities in accordance with ASC No. 808, Collaborative Arrangements Revenue Recognition–Multiple-Element Arrangements During the three months ended September 30, 2017, the Company incurred approximately $0.3 million of costs related to the cost-sharing provisions of the Otsuka U.S. Agreement of which approximately $0.1 million are reimbursable by Otsuka and recorded as a reduction to research and development expense during the three months ended September 30, 2017. Otsuka Pharmaceutical Co. Ltd. EU Collaboration and License Agreement Summary of Agreement On April 25, 2017, the Company entered into a collaboration and license agreement with Otsuka, the Otsuka EU Agreement. The collaboration is focused on the development and commercialization of vadadustat in Europe, Russia, China, Canada, Australia, the Middle East and certain other territories, collectively, the Territory. Under the terms of the Otsuka EU Agreement, the Company will continue to lead the development of vadadustat, including the ongoing global Phase 3 development program. Otsuka has the sole responsibility, at its own cost, for the commercialization of vadadustat in the Territory, subject to the approval by the relevant regulatory authorities. Under the terms of the Otsuka EU Agreement, the Company granted to Otsuka an exclusive, sublicensable license under certain intellectual property controlled by the Company to develop and commercialize vadadustat and products containing or comprising vadadustat in the Territory. Pursuant to the terms of the Otsuka EU Agreement, the Company is responsible for performing all activities related to the development of vadadustat as outlined in the current global development plan; however, the parties may agree to allocate certain responsibilities to Otsuka. The current global development plan encompasses all activities with respect to the ongoing PRO 2 2 Under the Otsuka EU Agreement, Otsuka is to be solely responsible for the conduct of all medical affairs and commercialization activities in the Territory pursuant to underlying plans as reviewed and discussed by the parties. If approved by the relevant jurisdictional regulatory health authorities in the Territory, the Company will provide vadadustat to Otsuka for commercialization pursuant to a separate supply agreement to be negotiated |