Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Management’s Evaluation of our Disclosure Controls and Procedures
“Disclosure controls and procedures”, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act , are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission, or the SEC , rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in company reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of our disclosure controls and procedures as of December 31, 2025. Based upon their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2025, our disclosure controls and procedures were effective at a reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management, with the participation of our principal executive officer and principal financial officer, is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, our principal executive officer and principal financial officer and effected by our board of directors, management and other personnel to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.
Our management conducted the assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2025.
Remediation of Previously Identified Material Weakness
As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, management identified a material weakness in our internal control over financial reporting relating to our inventory process. Management is committed to maintaining a strong internal control environment. In response to the material weakness identified, management, with the oversight of the Audit Committee of the Board of Directors, took comprehensive actions to remediate the material weakness in internal control over financial reporting relating to our inventory process, including increasing the level of precision of our review controls that support the completeness, accuracy and reasonableness of the sales forecast used to support our inventory evaluations, including the identification and consideration of contrary evidence that could detect a potential error in the sales forecast. The remediation efforts addressed the material weakness and also enhanced our overall financial reporting control environment. As of December 31, 2025, we have determined that our previously reported material weakness has been remediated.
Akebia Therapeutics, Inc. | Form 10-K | Page 182
Table of Contents
Changes in Internal Control over Financial Reporting
Except for the remediation efforts as noted above, there have been no changes in our internal control over financial reporting during the quarter ended December 31, 2025, as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations of Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Akebia Therapeutics, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Akebia Therapeutics, Inc.’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Akebia Therapeutics, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 26, 2026, expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Akebia Therapeutics, Inc. | Form 10-K | Page 183
Table of Contents
Boston, Massachusetts
February 26, 2026
Item 9B. Other Information
Rule 10b5-1 - Director and Officer Trading Arrangements
From time to time, the Company's directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended, or the Exchange Act ), engage in open-market transactions with respect to Company securities, including to satisfy tax withholding obligations when equity awards vest or are exercised, and for diversification or other personal reasons.
Transactions in Company securities by directors and officers are required to be made in accordance with the Company’s insider trading policy, which requires that the transactions be in accordance with applicable U.S. federal securities laws that prohibit trading while in possession of material nonpublic information. Rule 10b5-1 under the Exchange Act provides an affirmative defense that enables directors and officers to prearrange transactions in the Company’s securities in a manner that avoids concerns about initiating transactions while in possession of material nonpublic information.
None of the Company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as each term is defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Director, Executive Officers and Corporate Governance
The information required by this Item 10 will be included in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission, or SEC, with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 11. Executive Compensation
The information required by this Item 11 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and, other than the information required by Item 402(v) of Regulation S-K, is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item 12 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item 13 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services
The information required by this Item 14 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.
Akebia Therapeutics, Inc. | Form 10-K | Page 184
Table of Contents
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) Documents filed as part of this Annual Report on Form 10-K.
(b) Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Stockholders’ Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2) Schedules
Schedules have been omitted as all required information has been disclosed in the consolidated financial statements and related footnotes.
(3) Exhibits
The Exhibits listed below are filed as part of this Annual Report on Form 10-K.
Akebia Therapeutics, Inc. | Form 10-K | Page 185
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
2.1** Agreement and Plan of Merger, dated as of June 28, 2018, by and among Akebia Therapeutics, Inc., Alpha Therapeutics Merger Sub, Inc., and Keryx Biopharmaceuticals, Inc.
8-K
001-36352
2.1 June 28, 2018
2.2 First Amendment to Agreement and Plan of Merger, dated as of October 1, 2018, by and among Akebia Therapeutics, Inc., Alpha Therapeutics Merger Sub, Inc. and Keryx Biopharmaceuticals, Inc.
8-K
001-36352
2.1 October 1, 2018
3.1 Ninth Amended and Restated Certificate of Incorporation
8-K
001-36352
3.1 March 28, 2014
3.2 Certificate of Amendment of Ninth Amended and Restated Certificate of Incorporation of Akebia Therapeutics, Inc.
8-K
001-36352
3.1 June 9, 2020
3.3 Second Amended and Restated Bylaws of Akebia Therapeutics, Inc.
8-K
001-36352
3.1 April 28, 2023
4.1 Form of Common Stock Certificate
S-1/A
333-193969
4.1 March 4, 2014
4.2 Fourth Amended and Restated Investors’ Rights Agreement, dated March 5, 2014
10-K
001-36352
4.4 March 4, 2015
4.3# Amendment No. 1 to Fourth Amended and Restated Investors’ Rights Agreement, dated June 28, 2017
10-K
001-36352
4.5 March 12, 2018
4.4# Investment Agreement between Akebia Therapeutics, Inc. and Vifor (International) Ltd., dated May 12, 2017
10-Q
001-36352
4.1 August 8, 2017
4.5! Investment Agreement between Akebia Therapeutics, Inc. and Vifor (International) Ltd., dated February 18, 2022
10-K
001-36352
4.5 March 1, 2022
4.6 Description of Registrant’s Securities
10-K
001-36352
4.6 February 25, 2021
4.7
Form of Warrant
10-K
001-36352
4.7 March 14, 2024
10.1† Form of Director and Officer Indemnification Agreement
10-K
001-36352
10.1 March 12, 2018
10.2 Office Lease Agreement Between MA-Riverview/245 First Street, L.L.C. and Akebia Therapeutics, Inc., dated December 3, 2013
S-1
333-193969
10.2 February 14, 2014
10.3 First Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated December 15, 2014
10-K
001-36352
10.3 March 4, 2015
10.4 Second Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated November 23, 2015
10-K
001-36352
10.4 March 14, 2016
Akebia Therapeutics, Inc. | Form 10-K | Page 186
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.5 Third Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated July 25, 2016
10-Q
001-36352
10.1 November 9, 2016
10.6 Fourth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc., dated May 1, 2017
10-K
001-36352
10.6 March 12, 2018
10.7 Fifth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc. dated April 9, 2018
10-Q
001-36352
10.1 August 8, 2018
10.8 Sixth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc. dated November 30, 2020
10-K
001-36352
10.8 February 25, 2021
10.9 Seventh Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc. dated May 6, 2024.
10-Q
001-36352
10.1 August 8, 2024
10.10*
1 80 CityPoint Waltham, Massachusetts Leas e Agre ement Between BP Third Avenue LLC and Akebia Therapeutics, In c . dated January 27, 2026
10.11†*
Akebia Therapeutics, Inc. F ifth Amended and Restated Non-Employee Director Compensation Program, effective January 26, 2026
10.12†
Executive Employment Agreement with John P. Butler, dated September 16, 2013
S-1
333-193969
10.7 February 14, 2014
10.13†
2014 Form of Executive Severance Agreement for Officers
S-1/A
333-193969
10.27 March 4, 2014
10.14†*
A mended a nd Restated Executive Severance Agreement, dated January 28, 2026, between Akebia Therapeutics, Inc. and John P. Butler
10.15†
A mended and Restated Executive Severance Agreement, dated January 28, 2026, between Akebia Therapeutics, Inc. and E rik J. Ostrowski
8-K
001-36352
99.2 January 30, 2026
10.16†*
2026 F o rm of Executive Severance Agreement for Non- CEO C-Level Executives
10.17†
2014 Incentive Plan
S-1
333-193969
10.29 March 4, 2014
10.18†
Amendment No. 1 to the Akebia Therapeutics, Inc. 2014 Incentive Plan
S-8
333-229366
4.4 January 25, 2019
10.19†
Amended and Restated 2014 Employee Stock Purchase Plan
DEF 14A 001-36352
Appendix A April 26, 2019
10.20†
Form of Non-Statutory Stock Option Agreement for Officers under 2014 Incentive Plan
S-1/A
333-193969
10.24 March 4, 2014
Akebia Therapeutics, Inc. | Form 10-K | Page 187
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.21†
Form of Non-Statutory Stock Option Agreement for Non-Employee Directors under 2014 Incentive Plan
S-1/A
333-193969
10.25 March 4, 2014
10.22†
Amended and Restated Cash Incentive Plan, effective January 19, 2022
10-K
001-36352
10.28 March 1, 2022
10.23†
Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan
10-K
001-36352
10.18 March 12, 2018
10.24†
Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan
10-K
001-36352
10.29 March 26, 2019
10.25†
Form of Officer Inducement Award Non-Statutory Stock Option Agreement
S-8
333-222728
4.4 January 26, 2018
10.26†
Form of Inducement Award Non-Statutory Stock Option Agreement for Non-Officers
S-8
333-222728
4.5 January 26, 2018
10.27†
Form of Officer Performance-Based Stock Option Award, under the Company's 2014 Incentive Plan, as amended
10-Q
001-36352
10.1 November 4, 2021
10.28†
Form of Officer Performance-Based Restricted Stock Unit Award, under the Company's 2014 Incentive Plan, as amended
10-Q
001-36352
10.2 November 4, 2021
10.29†
Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (Retention Awards)
10-Q
001-36352
10.6 August 4, 2022
10.30†
Form of Officer Non-Statutory Stock Option Agreement under 2014 Incentive Plan (Retention Awards)
10-Q
001-36352
10.7 August 4, 2022
10.31†
Form of Officer Stock Appreciation Rights Award Agreement under 2014 Incentive Plan
10-Q
001-36352
10.3 May 8, 2023
10.32†
Akebia Therapeutics, Inc. 2023 Stock Incentive Plan , as amended
8-K
001-36352
99.1 June 13, 2025
10.33†
Form of Non-Employee Director Stock Option Agreement under 2023 Stock Incentive Plan
10-Q
001-36352
10.10
August 28, 2023
10.34†
Form of Non-Employee Director Restricted Stock Unit Agreement under 2023 Stock Incentive Plan
10-Q
001-36352
10.12 August 28, 2023
10.35†
Form of Officer Stock Option Agreement under 2023 Stock Incentive Plan
10-Q
001-36352
10.11 August 28, 2023
10.36†
Form of Officer Restricted Stock Unit Agreement under 2023 Stock Incentive Plan
10-Q
001-36352
10.13 August 28, 2023
10.37†
Form of Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan
10-Q
001-36352
10.14 August 28, 2023
Akebia Therapeutics, Inc. | Form 10-K | Page 188
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.38†
Form of Officer Executive Severance Agreement (Reflecting Clawback Policy)
10-K
001-36352
10.43 March 14, 2024
10.39†
Form of Officer Cash Bonus Agreement (Reflecting Clawback Policy)
10-K
001-36352
10.44 March 14, 2024
10.40†
Form of Officer Stock Option Agreement under 2023 Stock Incentive Plan (Reflecting Clawback Policy)
10-K
001-36352
10.45 March 14, 2024
10.41†
Form of Officer Restricted Stock Unit Agreement under 2023 Stock Incentive Plan (Reflecting Clawback Policy)
10-K
001-36352
10.46 March 14, 2024
10.42†*
F orm of Officer Restricted S tock Unit Agreement under 2023 Stock Incentive Plan (Reflecting C-Level ESA Terms and Clawback Policy )
10.43†*
F orm of Officer Stock Option Agreement under 202 3 Stock Incentive Plan (Reflecting C-Level ESA Terms and Clawback Policy )
10.44†*
Form of Officer Restricted Stock Agreement under 2023 Stock Incentive Plan (Reflecting C-Le vel ESA Terms)
10.45†*
F orm of Officer Stock Option Agreement under 2023 Stock Incentive Plan (Reflecting C-Level ESA Terms)
10.46†
Form of Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan (Reflecting Clawback Policy)
10-K
001-36352
10.47 March 14, 2024
10.47†
Form of Non-Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan
S-8
333-284590
99.2 January 30, 2025
10.48†
Keryx Biopharmaceuticals, Inc. Amended and Restated 2013 Incentive Plan
8-K
000-30929
10.1 May 27, 2016
10.49†
Keryx Biopharmaceuticals, Inc. 2018 Equity Incentive Plan
S-8
333-226005
99.1 June 29, 2018
10.50†
Form of Indemnification Agreement between Keryx Biopharmaceuticals, Inc. and its Directors and Officers
10-Q
000-30929
10.1 November 9, 2016
10.51†
Form of Employee Agreement (Confidentiality, Non-Competition, Non-Solicitation and Development Agreement) applicable to Officers
10-K
001-36352
10.56 March 26, 2019
10.52†
Keryx Biopharmaceuticals, Inc. Fourth Amended and Restated Directors Equity Compensation Plan
8-K
000-30929
10.2 May 27, 2016
10.53†
Keryx Biopharmaceuticals, Inc. Third Amended and Restated Directors Equity Compensation Plan
10-Q
000-30929
10.1 August 7, 2014
10.54†
Keryx Biopharmaceuticals, Inc. Director Non-Statutory Stock Option Award Terms and Conditions under the Third Amended and Restated Directors Equity Compensation Plan
10-K
001-36352
10.59 March 26, 2019
Akebia Therapeutics, Inc. | Form 10-K | Page 189
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.55†
Form of Officer Retention Letter Agreement
10-Q
001-36352
10.6 May 9, 2022
10.56†
Separation Agreement with Ellen Snow, dated March 15, 2024
10-Q
001-36352
10.11 May 9, 2024
10.57!
Collaboration Agreement between Akebia Therapeutics, Inc. and Tanabe Pharma Corporation, formerly Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015
10-K
001-36352
10.49 March 1, 2022
10.58#
Letter Agreement between Akebia Therapeutics, Inc. and Tanab e Pharma Corporation, formerly Mitsubishi Tanabe Pharma Corporation, dated September 26, 2017
10-Q
001-36352
10.1 November 8, 2017
10.59!
Amendment No. 1 to Collaboration Agreement, dated December 2, 2022, by and between Akebia Therapeutics, Inc. and Tanabe Pharma Corporation, formerly Mitsubishi Tanabe Pharma Corporation
10-K
001-36352
10.53 March 10, 2022
10.60!
Second Amended and Restated License Agreement, dated February 18, 2022, by and between Akebia Therapeutics, Inc. and Vifor (International) Ltd.
10-K
001-36352
10.54 March 1, 2022
10.61!
Amendment #1 to Second Amended and Restated License Agreement, dated May 3, 2024, by and between Akebia Therapeutics, Inc. and Vifor (International) Ltd.
10-Q
001-36352
10.3 August 8, 2024
10.62!
Termination and Settlement Agreement, dated July 10, 2024, by and between Akebia Therapeutics, Inc. and Vifor (International) Ltd.
10-Q
001-36352
10.4 August 8, 2024
10.63
Amended and Restated Open Market Sale Agreement, dated September 3, 2024, by and between Akebia Therapeutics, Inc. and Jefferies LLC
S-3
333-281903
1.2 September 3, 2025
10.64!
Second Amended and Restated License Agreement dated April 17, 2019, by and between Akebia Therapeutics, Inc. and Panion & BF Biotech, Inc.
10-Q
001-36352
10.1 August 8, 2019
10.65#
Amended and Restated Sub-License Agreement, dated June 8, 2009, as amended by the First Amendment thereto, dated June 12, 2013, by and between Keryx Biopharmaceuticals, Inc., Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd
10-Q
000-30929
10.1 November 7, 2017
10.66!
Master Manufacturing Services Agreement by and between Keryx Biopharmaceuticals, Inc. and Patheon Manufacturing Services LLC and certain of its affiliates, dated September 27, 2016, and related Product Agreement dated September 27, 2016, and related Product Agreement dated October 12, 2016
10-K
001-36352
10.58 March 1, 2022
Akebia Therapeutics, Inc. | Form 10-K | Page 190
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.67!
Product Agreement, dated August 29, 2017, by and between Keryx Biopharmaceuticals, Inc. and Patheon Inc. (an affiliate of Patheon Manufacturing Services LLC) related to the Master Manufacturing Services Agreement by and between Keryx Biopharmaceuticals, Inc. and Patheon Manufacturing Services LLC and certain of its affiliates dated November 12, 2016
10-K
001-36352
10.78 March 13, 2025
10.68#
Master Manufacturing Services and Supply Agreement, dated December 20, 2017, by and between Keryx Biopharmaceuticals, Inc. and Siegfried Evionnaz SA
10-K
000-30929
10.13 February 21, 2018
10.69
Amendment No. 1 to Master Manufacturing Services and Supply Agreement, dated as of December 21, 2020, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.
10-K
001-36352
10.57 February 25, 2021
10.70
Amendment No. 2 to Master Manufacturing Services and Supply Agreement, dated as of January 29, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.
10-K
001-36352
10.58 February 25, 2021
10.71!
Amendment No. 3 to Master Manufacturing Services and Supply Agreement, dated as of February 11, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.
10-K
001-36352
10.59 February 25, 2021
10.72
Amendment No. 4 to Master Manufacturing Services and Supply Agreement, dated as of December 17, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.
10-K
001-36352
10.64 March 1, 2022
10.73!
Amendment No. 5 to Master Manufacturing Services and Supply Agreement, dated February 28, 2023, by and between Keryx Biopharmaceuticals, Inc. and Siegfried Evionnaz SA
10-Q
001-36352
10.2 May 8, 2023
10.74#
Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc. and Cardinal Health 105, Inc., dated October 16, 2014 and First Amendment to Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc. and Cardinal Health 105, Inc., dated April 14, 2015
10-K
001-36352
10.60 March 26, 2019
10.75!
Termination and Settlement Agreement, dated December 22, 2022, by and between Keryx Biopharmaceuticals, Inc. and BioVectra Inc.
10-K
001-36352
10.70 March 10, 2023
10.76!
Loan Agreement, dated November 11, 2019, by and among Akebia Therapeutics, Inc., Keryx Biopharmaceuticals, Inc., Biopharma Credit plc and Biopharma Credit Investments V (Master) LP
10-K
001-36352
10.62 March 12, 2020
10.77!
First Amendment and Waiver, dated February 18, 2022, by and among Akebia Therapeutics, Inc., Biopharma Credit plc, BPCR Limited Partnership and Biopharma Credit Investments V (Master) LP
10-K
001-36352
10.69 March 1, 2022
Akebia Therapeutics, Inc. | Form 10-K | Page 191
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.78!
Second Amendment and Waiver, dated July 15, 2022, by and among Akebia Therapeutics, Inc., Biopharma Credit plc, BPCR Limited Partnership and Biopharma Credit Investments V (Master) LP
10-Q
001-36352
10.9 August 4, 2022
10.79!
Third Amendment to Loan Agreement, dated as of June 30, 2023, by and among Akebia Therapeutics, Inc., Biopharma Credit plc, BPCR Limited Partnership and Biopharma Credit Investments V (Master) LP
10-Q
001-36352
10.2 August 28, 2023
10.80!
Fourth Amendment to Loan Agreement dated as of October 31, 2023, by and among Akebia Therapeutics, Inc., BioPharma Credit PLC, BPCR Limited Partnership, and BioPharma Credit Investments V (Master) LP
10-K
001-36352
10.93 March 14, 2024
10.81!
Guaranty and Security Agreement, dated November 25, 2019, by and between Akebia Therapeutics, Inc., Keryx Biopharmaceuticals, Inc. and Biopharma Credit plc
10-K
001-36352
10.63 March 12, 2022
10.82!
Supply Agreement, dated as of March 11, 2020, by and between Akebia Therapeutics, Inc. and Patheon, Inc.
10-Q
001-36352
10.1 May 5, 2020
10.83!
Supply Agreement, dated as of April 2, 2020, by and between Akebia Therapeutics, Inc. and STA Pharmaceutical Hong Kong Limited
10-Q
001-36352
10.2 August 10, 2020
10.84!
Amendment #1 to Supply Agreement, dated as of April 15, 2021, by and between Akebia Therapeutics, Inc, and STA Pharmaceutical Hong Kong Limited
10-Q
001-36352
10.1 August 5, 2021
10.85!
Amendment #2 to the Supply Agreement, dated as of April 15, 2024, by and between Akebia Therapeutics, Inc. and STA Pharmaceutical Hong Kong Limited
10-Q
001-36352
10.2 August 8, 2024
10.86!
A mendment # 3 to the Suppl y Agreement , dated as of August 15, 2025, by and between Akebia Thera pe utics, Inc. and STA P harmaceutical Hong K ong Limited
10-Q
001-36352
10.1 November 10, 2025
10.87!
Supply Agreement, dated February 10, 2021, by and between Akebia Therapeutics, Inc. and STA Pharmaceutical Hong Kong Limited
10-Q
001-36352
10.4 May 10, 2021
10.88!
Amendment #1 to Supply Agreement, dated October 15, 2024, by and between Akebia Therapeutics, Inc. and STA Pharmaceutical Hong Kong Limited
10-Q
001-36352
10.5 November 7, 2024
10.89!
Royalty Interest Acquisition Agreement, dated February 25, 2021, by and between Akebia Therape utics, Inc. and HealthCare Royalty Partners IV, L.P.
10-Q
001-36352
10.5 May 10, 2021
10.90!
License Agreement, dated May 24, 2023, by and between Akebia Therapeutics, Inc. and MEDICE Arzneimittel Pütter GmbH & Co. KG
10-Q
001-36352
10.1 August 28, 2023
Akebia Therapeutics, Inc. | Form 10-K | Page 192
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
10.91!*
A mendment #1 to License Agreement, dated November 12, 2025, by and between Akebia Therapeutics, Inc. and MEDICE Ar zneimittel Pütter G mbH & Co. KG
10.92!
Agreement for the Provision of a Loan Facility dated January 29, 2024 between Akebia Therap eutics, Inc. and Kreos Capital VII (UK) Limited
10-K
001-36352
10.102 March 14, 2024
10.93!
Amendment #1 to Agreement for the Provision of a Loan Facility, dated July 10, 2024, by and between Akebia Therapeutics, Inc. and Kreos Capital VII (UK) Limited
10-Q
001-36352
10.5 August 8, 2024
10.94!
Second Amendment to Agreement for the Provision of a Loan Facility, dated February 3, 2025, by and between Akebia Therapeutics, Inc. and Kreos Capital VII (UK) Limited
10-K
001-36352
10.105 March 13, 2025
10.95
Warrant Agreement dated January 29, 2024 by and between the Company and Kreos Capital VII Aggregator SCSp
10-K
001-36352
10.103 March 14, 2024
10.96!*
A sset Purchase Agreement by and between Akebia Therapeutics, Inc., Q32 Bio Inc. and Q32 Bio Operations Inc. dated No vember 28, 2025
10.97!*
License Agreement by and between Cyclerion Therapeutics, Inc. and Akebia Therapeutics, Inc. dated June 3, 2021
10.98!*
A mendment #1 to License Agreement by and between Cyclerion Therapeutics, Inc. and Akebia Therapeutics, Inc. dated December 13, 2024
19.1
Akebia Therapeutics, Inc. Insider Trading Compliance Policy
10-K
001-36352
19.1 March 13, 2025
21.1 List of Subsidiaries
10-K
001-36352
21.1 February 25, 2021
23.1* Consent of Ernst & Young LLP
31.1* Certification of Principal Executive Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended
31.2* Certification of Principal Financial Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended
32.1* Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350
97.1†
Akebia Therapeutics, Inc. Dodd-Frank Compensation Recovery Policy
10-K
001-36352
97.1 March 14, 2024
Akebia Therapeutics, Inc. | Form 10-K | Page 193
Table of Contents
Incorporated by Reference
Exhibit
Number Description of Exhibit Schedule/ Form
File No.
Exhibit
Filed Date/ Period End Date
101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document)
101.SCH* Inline XBRL Taxonomy Extension Schema Document
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB* Inline XBRL Taxonomy Extension Labels Linkbase Document
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Filed, or submitted electronically, herewith
† Indicates management contract or compensatory plan
# Indicates portions of the exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment
! Indicates portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K
** The schedules to the Agreement and Plan of Merger have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company will furnish copies of such schedules to the Securities and Exchange Commission upon request by the Commission
Item 16. Form 10-K Summary
None.
Akebia Therapeutics, Inc. | Form 10-K | Page 194
Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
AKEBIA THERAPEUTICS, INC.
Date: February 26, 2026
By: /s/ John P. Butler
John P. Butler
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report was signed by the following persons on behalf of the registrant and in the capacities and on the date indicated.
Akebia Therapeutics, Inc. | Form 10-K | Page 195
Table of Contents
Date: February 26, 2026
By: /s/ John P. Butler
John P. Butler
Director, President and Chief Executive Officer (Principal Executive Officer)
Date: February 26, 2026
By: /s/ Erik J. Ostrowski
Erik J. Ostrowski
Senior Vice President, Chief Financial Officer and Chief Business Officer (Principal Financial Officer)
Date: February 26, 2026
/s/ Richard C. Malabre
Richard C. Malabre
Senior Vice President, Chief Accounting Officer (Principal Accounting Officer)
Date: February 26, 2026
By: /s/ Adrian Adams
Adrian Adams
Chairperson and Director
Date: February 26, 2026
By: /s/ Ron Frieson
Ron Frieson
Director
Date: February 26, 2026
By: /s/ Steven C. Gilman
Steven C. Gilman
Director
Date: February 26, 2026
By: /s/ Michael Rogers
Michael Rogers
Director
Date: February 26, 2026
By: /s/ Cynthia Smith
Cynthia Smith
Director
Date: February 26, 2026
By: /s/ Myles Wolf
Myles Wolf
Director
Date: February 26, 2026
By: /s/ LeAnne M. Zumwalt
LeAnne M. Zumwalt
Director
Akebia Therapeutics, Inc. | Form 10-K | Page 196