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LICENSE, COLLABORATION AND OTHER REVENUE | 12 Months Ended
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Dec. 31, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
LICENSE, COLLABORATION AND OTHER REVENUE | LICENSE, COLLABORATION AND OTHER REVENUE The Company recognized the following revenues from its license, collaboration and other revenue agreements (in thousands):
|  |  |  | Years Ended December 31,
Entity |  | Description |  | 2025 |  | 2024 |  | 2023
Medice |  | License and Product Supply of Vafseo in EU |  | $ | 411 |  |  | $ | 22 |  |  | $ | 10,968 |
TPC, formerly known as Mitsubishi Tanabe Pharma |  | License and Product Supply of Vafseo in Japan |  | 2,794 |  |  | 2,612 |  |  | 5,735 |
JT and Torii |  | License and royalties related to the sale of Riona in Japan |  | 5,659 |  |  | 5,366 |  |  | 5,394 |
Otsuka |  | Terminated U.S. and International Agreements |  | — |  |  | — |  |  | 2,225 |
Total License, Collaboration and Other Revenue |  | $ | 8,864 |  |  | $ | 8,000 |  |  | $ | 24,322 |
The following table presents changes in the Company’s contract assets and liabilities related to license, collaboration and other revenue agreements (in thousands):
| Year Ended December 31, 2025
| Balance at Beginning of Period |  | Additions |  | Deductions |  | Balance at End of Period
Contract assets: |  |  |  |  |  |  |
Accounts receivable(1) | $ | 2,010 |  |  | $ | 8,894 |  |  | $ | (8,513) |  |  | $ | 2,391 |
Contract liability: |  |  |  |  |  |  |
Deferred revenue | $ | — |  |  | $ | — |  |  | $ | — |  |  | $ | — |
| Year Ended December 31, 2024
| Balance at Beginning of Period |  | Additions |  | Deductions |  | Balance at End of Period
Contract assets: |  |  |  |  |  |  |
Accounts receivable(1) | $ | 3,333 |  |  | $ | 8,562 |  |  | $ | (9,885) |  |  | $ | 2,010 |
Contract liabilities: |  |  |  |  |  |  |
Deferred revenue (long-term)(2) | $ | 43,296 |  |  | $ | — |  |  | $ | (43,296) |  |  | $ | — |
(1)Excludes accounts receivable from product sales of Auryxia and Vafseo which are included in the accompanying consolidated balance sheets as of December 31, 2025 and 2024. (2)See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, for further information. During the years ended December 31, 2025, 2024 and 2023, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods (in thousands):
|  | Years Ended December 31,
Revenue Recognized in the Period from: |  | 2025 |  | 2024 |  | 2023
Deferred revenue - beginning of the period |  | $ | — |  |  | $ | — |  |  | $ | 3,738 |
During each of the years ended December 31, 2025, 2024 and 2023, the Company recognized no revenue from performance obligations satisfied in previous periods. Medice License Agreement On May 24, 2023, or the Medice Effective Date, the Company and MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, entered into a License Agreement, or the Medice License Agreement, pursuant to which the Company granted to Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in adult patients with CKD in the EEA, the UK, Switzerland and Australia, or collectively, the Medice Territory. Under the Medice License Agreement, the Company received an up-front payment of $10.0 million and is eligible to receive the following payments: (i) commercial milestone payments up to an aggregate of $100.0 million, and (ii) tiered royalties ranging from 10% to 30% of Medice's annual net sales of Vafseo in the Medice Territory, subject to reduction in certain circumstances. The royalties will expire on a country-by-country basis upon the latest to occur of (a) the date of expiration of the last-to-expire valid claim of any Company, Medice or joint patent that covers Vafseo in such country in the Medice Territory, (b) the date of expiration of data or regulatory exclusivity for Vafseo in such country in the Medice Territory and (c) the date that is twelve years from first commercial sale of Vafseo in such country in the Medice Territory. Under the Medice License Agreement, the Company retains the right to develop Vafseo for non-dialysis patients with anemia due to CKD in the Medice Territory. If the Company develops Vafseo for non-dialysis patients and Vafseo receives marketing approval in the Medice Territory, Medice will commercialize Vafseo for both indications in the Medice Territory. In this instance, the Company would receive 70% of the net product margin of any sales of Vafseo in the non-dialysis patient population, unless Medice requests to share the cost of the development necessary to gain approval to market Vafseo for non-dialysis patients in the Medice Territory and the parties agree on alternative financial terms. If the Company develops Vafseo for non-dialysis patients, the Company has determined that the activities under the Medice License 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, if the Company develops Vafseo for non-dialysis patients the Company will account for the joint activities in accordance with ASC No. 808, Collaborative Arrangements, or ASC 808. Additionally, the Company has determined that in the context of the development of Vafseo for non-dialysis patients, Medice does not represent a customer as contemplated by ASC 606. As a result, the activities conducted pursuant to development activities for Vafseo for non-dialysis patients will be accounted for as a component of the related expense in the period incurred. The Medice License Agreement expires on the date of expiration of all payment obligations due thereunder with respect to Vafseo in the last country in the Medice Territory, unless earlier terminated in accordance with the terms of the Medice License Agreement. Either party may, subject to a cure period, terminate the Medice License Agreement in the event of the other party's uncured material breach. Medice has the right to terminate the Medice License Agreement in its entirety for convenience upon twelve months' prior written notice delivered on or after the date that is twelve months after the Medice Effective Date. The Company evaluated the elements of the Medice License Agreement in accordance with the provisions of ASC 606 and concluded Medice is a customer. The Company identified one performance obligation in connection with its obligations under the Medice License Agreement, which is the license, or License Performance Obligation. The transaction price at inception was comprised of the up-front payment of $10.0 million, of which the Company received $8.6 million during the quarter ended June 30, 2023. The remaining $1.4 million was withheld by the German Federal Tax Office and was included in prepaid expenses and other current assets as of December 31, 2024 in the consolidated balance sheet. The $1.4 million was received during the year ended December 31, 2025. Pursuant to the terms of the Medice License Agreement, the up-front payment of $10.0 million is non-refundable and non-creditable against any other amount due to the Company and was allocated to the License Performance Obligation, which was satisfied as of the Medice Effective Date. As such, the Company recognized the $10.0 million up-front payment as license, collaboration and other revenue in the consolidated statement of operations and comprehensive loss during the year ended December 31, 2023. In accordance with ASC 606, the Company will recognize sales-based royalties and milestone payments at the later of when the performance obligation is satisfied or the related sales occur. During the years ended December 31, 2025, 2024 and 2023, the Company recognized $0.1 million in revenue from Medice royalties, immaterial revenue from Medice royalties and no revenue from Medice royalties, respectively. As of December 31, 2025, there were $0.1 million contract assets, and no accounts receivable, payables or deferred revenue in connection with the Medice License Agreement. Medice Letter Agreement On December 6, 2023, the Company and Medice entered into a letter agreement, or the Medice Letter Agreement, pursuant to which the Company agreed to sell to Medice a partial batch of Vafseo in order to achieve packaging validation for the Medice Territory. The Company previously recognized revenue under this arrangement when risk of loss passed to Medice and delivery occurred. During the year ended December 31, 2023, the Company recognized $1.0 million in collaboration, license and other revenue under the Medice Letter Agreement. Supply of Drug Product to Medice On September 13, 2024, the Company and Medice entered into a supply agreement, or the Medice Supply Agreement, under which the Company supplies Vafseo drug product to Medice for commercial and developmental use in the Medice Territory. The Company recognizes revenue under this arrangement when risk of loss passes to Medice, delivery has occurred, and Medice has accepted the product. The Company recognized $0.3 million of revenue under the Medice Supply Agreement during the year ended December 31, 2025. The Company did not recognize any revenue under the Medice Supply Agreement during the years ended December 31, 2024 or 2023. As of December 31, 2025, there were $0.3 million accounts receivable and no contract assets, payables or deferred revenue in connection with the Medice Supply Agreement. Supply of Drug Substance to Medice On November 12, 2025, the Company and Medice entered into Amendment #1 to the License Agreement, or the Medice Amendment. Pursuant to the Medice Amendment, the Company agreed to supply vadadustat drug substance to Medice pursuant to the terms of a supply agreement dated concurrently with the Medice Amendment and granted Medice the right to manufacture Vafseo tablets using the vadadustat drug substance to be supplied by the Company. In addition, the Medice Amendment provides that any know-how or patent rights arising out of Medice’s manufacture of Vafseo tablets will be owned by the Company. The Company did not recognize any revenue related to the supply of vadadustat drug substance to Medice during the years ended December 31, 2025, 2024 or 2023. TPC Collaboration Agreement On December 11, 2015, the Company and TPC entered into the TPC Agreement, providing TPC with exclusive development and commercialization rights to Vafseo in the TPC Territory, which was amended effective as of December 2, 2022. In addition, the Company supplies Vafseo to TPC for both clinical and commercial use in the TPC Territory. In February 2021, the Company entered into the Royalty Agreement with HCR, whereby the Company sold its right to receive royalties and sales milestones under the TPC Agreement, subject to certain caps and other terms and conditions. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, for more information. Unless earlier terminated, the TPC Agreement will continue in effect on a country-by-country basis until the later of the following: expiration of the last-to-expire patent covering Vafseo in such country in the TPC Territory; expiration of marketing or regulatory exclusivity in such country in the TPC Territory; or ten years after the first commercial sale of Vafseo in such country in the TPC Territory. TPC may terminate the TPC Agreement upon twelve months’ notice at any time after the second anniversary of the effective date of the TPC Agreement. Either party may terminate the TPC 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 TPC Agreement, TPC is required to make certain milestone payments to the Company aggregating up to approximately $225.0 million upon the achievement of specified development, regulatory and commercial events. The Company has received $10.0 million in development milestone payments. Of the $40.0 million in regulatory milestone payments the Company is eligible for, the Company received $10.0 million in relation to the Japanese NDA filing in the third quarter of 2019 and $15.0 million following regulatory approval of Vafseo in Japan in the third quarter of 2020. The Company is also entitled to receive up to $175.0 million in commercial milestone payments associated with aggregate sales of all products. In consideration for the exclusive license and other rights contained in the TPC Agreement, TPC made a $20.0 million upfront payment as well as a $20.5 million payment for Phase 2 studies in Japanese patients completed by the Company and reimbursed by TPC. Additionally, the Company is entitled to receive tiered royalty payments ranging from 13% to 20% of annual net sales of Vafseo in the TPC Territory, subject to reduction in certain circumstances. The Company evaluated the elements of the TPC Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, TPC, is a customer. The Company identified two performance obligations in connection with its material promises under the TPC Agreement as follows: (i) License, Research and Clinical Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation. The transaction price was comprised of: (i) the up-front payment of $20.0 million, (ii) the cost for the Phase 2 studies of $20.5 million, (iii) the cost of all clinical supply provided to TPC for the Phase 3 studies, (iv) $10.0 million in development milestones received, (v) $25.0 million in regulatory milestones received and (vi) $8.7 million in royalties from net sales of Vafseo. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. As of December 31, 2025, all development milestones and $25.0 million in regulatory milestones have been achieved. No other regulatory milestones or commercial milestones have been assessed as probable and have been fully constrained until the period in which they are achieved. The Company allocates the transaction price to each performance obligation based on the Company’s best estimate of the relative standalone selling price. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it is immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License, Research and Clinical Supply Performance Obligation and allocated the entire transaction price to this performance obligation. Revenue for the License, Research and Clinical Supply Performance Obligation for the TPC Agreement is being recognized using a proportional performance method, for which all deliverables have been completed. The Company recognizes any revenue from TPC royalties in the period in which the sales occur. The Company recognized revenue from TPC royalties of $1.8 million, $1.9 million and $2.0 million during the years ended December 31, 2025, 2024 and 2023, respectively. As noted above, in February 2021, the Company entered into the Royalty Agreement, whereby the Company sold its right to receive these royalties and sales milestones under the TPC Agreement, subject to certain caps and other conditions. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, for more information. The revenue is classified as collaboration, license and other revenue in the accompanying consolidated statements of operations and comprehensive loss. As of December 31, 2025, there were no accounts receivable, payables or deferred revenue and $0.5 million in contract assets recorded in connection with the TPC Agreement. Supply of Drug Product to TPC On July 15, 2020, the Company and TPC entered into a supply agreement, or the TPC Supply Agreement, under which the Company supplies Vafseo drug product to TPC for commercial use in Japan and certain other Asian countries, as contemplated by the TPC Agreement. The term of the TPC Supply Agreement extends throughout the term of the TPC Agreement, and the termination provisions of the TPC Agreement govern termination of the TPC Supply Agreement. On December 16, 2022, the Company, TPC and Esteve executed an Assignment of Supply Agreement, or the Esteve Assignment Agreement, pursuant to which the rights and obligations of the Company under the Esteve Agreement were transferred to TPC. The Company has no further obligation to take delivery of, or pay for, product delivered by Esteve except as disclosed in Note 10, Commitments and Contingencies. The Company does not recognize revenue under this arrangement until risk of loss on the drug product passes to TPC and delivery has occurred and TPC has accepted the product. During the years ended December 31, 2025, 2024 and 2023, the Company recognized $1.0 million, $0.7 million and $3.7 million of revenue, respectively, under the TPC Supply Agreement. As of December 31, 2025, there were no accounts receivable, deferred revenue or other current liabilities relating to the TPC Supply Agreement. JT and Torii Sublicense Agreement The Company has an Amended and Restated Sublicense Agreement, which was amended in June 2013, with JT and Torii, or the JT and Torii Sublicense Agreement, under which JT and Torii obtained the exclusive sublicense rights for the development and commercialization of ferric citrate hydrate in Japan. JT and Torii are responsible for the future development and commercialization costs in Japan. The Company is eligible to receive royalty payments based on a tiered low double-digit percentage of net sales of Riona in Japan inclusive of amounts that the Company must pay to Panion on JT and Torii's net sales of Riona under the Panion License Agreement subject to certain reductions upon expiration or termination of the Amended and Restated License Agreement between the Company and Panion, pursuant to which Company in-licensed the exclusive worldwide rights, excluding certain Asian-Pacific countries, for the development and commercialization of ferric citrate. The Company is entitled to receive up to an additional $55.0 million upon the achievement of certain annual net sales milestones. The sublicense under the JT and Torii Sublicense Agreement terminates upon the expiration of all underlying patent rights. Also, JT and Torii may terminate the JT and Torii Sublicense Agreement with or without cause upon at least six months' prior written notice to the Company. Additionally, either party may terminate the JT and Torii Sublicense Agreement for cause upon 60 days’ prior written notice after the breach of any uncured material provision of the JT and Torii Sublicense Agreement, or after certain insolvency events. The Company evaluated the elements of the JT and Torii Sublicense Agreement in accordance with the provisions of ASC 606 and concluded that the contract counterparty, JT and Torii, is a customer. The Company identified two performance obligations in connection with its obligations under the JT and Torii Sublicense Agreement: (i) License and Supply Performance Obligation and (ii) Rights to Future Know-How Performance Obligation. The Company developed a best estimate of the standalone selling price for the Rights to Future Know-How Performance Obligation primarily based on the likelihood that additional intellectual property covered by the license conveyed will be developed during the term of the arrangement and determined it immaterial. As such, the Company did not develop a best estimate of standalone selling price for the License and Supply Performance Obligation and allocated the entire transaction price to this performance obligation. Additionally, as of the consummation of the Merger, the services associated with the License and Supply Performance Obligation were completed and JT and Torii had secured their own source to manufacture ferric citrate hydrate. As such, any initial license fees as well as any development-based milestones and manufacturing fee revenue were received and recognized prior to the Merger. The Company determined that the remaining consideration that may be payable to the Company under the terms of the sublicense agreement are either quarterly royalties on net sales or payments due upon the achievement of sales-based milestones. In accordance with ASC 606, the Company recognizes sales-based royalties and milestone payments based on the level of sales, when the related sales occur as these amounts have been determined to relate predominantly to the license granted to JT and Torii and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. During the years ended December 31, 2025, 2024 and 2023, the Company recognized license revenue of $5.7 million, $5.4 million and $5.4 million related to royalties earned on net sales of Riona in Japan, respectively. The Company records the associated mid-single digit percentage of net sales royalty expense due to Panion, the licensor of Riona, in the same period as the royalty revenue from JT and Torii is recorded. As of December 31, 2025, there was $1.5 million in accounts receivables relating to the JT and Torii Sublicense Agreement. Prior Collaboration and License Agreements U.S. Collaboration and License Agreement with Otsuka Pharmaceutical Co. Ltd. On December 18, 2016, the Company entered into a collaboration and license agreement, or Otsuka U.S. Agreement, with Otsuka Pharmaceutical Co. Ltd, or Otsuka. The collaboration was focused on the development and commercialization of Vafseo in the U.S. On May 12, 2022, the Company received notice from Otsuka that Otsuka had elected to terminate the Otsuka U.S. Agreement and the April 25, 2017 collaboration and license agreement with Otsuka, or Otsuka International Agreement. On June 30, 2022, the Company and Otsuka entered into the Termination and Settlement Agreement, or Otsuka Termination Agreement, pursuant to which, among other things, the Company and Otsuka agreed to terminate the Otsuka U.S. Agreement and the Otsuka International Agreement as of June 30, 2022. During the year ended December 31, 2023, the Company recognized $2.2 million in collaboration, license and other revenue in connection with the Packaging Validation Transfer Agreement entered into with Otsuka on April 20, 2023. Under the Packaging Validation Transfer Agreement, the parties agreed that responsibility for all remaining packaging validation activities would be transferred from Otsuka to the Company in consideration of payments made by Otsuka to the Company. The Company evaluated the agreement under ASC 606 and concluded it was closely tied to the prior collaboration, license and other revenue agreements and under ASC 606 recognized collaboration, license and other revenue during the year ended December 31, 2023.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (a) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (b) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Topic 808 -Publisher FASB -URI https://asc.fasb.org/808/tableOfContent + Details
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