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Item 9A. Controls and Procedures

2024-03-14 compared with 2023-03-10 · 379 added, 148 removed, 148 unchanged (78% of the section changed)

1 unchanged sentence

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

As of December 31, 2022, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.

Our 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.

Our Chief Executive Officer and Chief Financial Officer have concluded based upon the evaluation described below that, as of December 31, 2022, our disclosure controls and procedures were effective at the reasonable assurance level.

“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, 2023.

Based upon their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2023, our disclosure controls and procedures were not effective because of a material weakness in the design of our internal control over financial reporting related to our accounting for inventories and inventory related transactions which is described in more detail below.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management, with the participation of our Chief Executive Officer and Chief 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 Securities Exchange Act of 1934 as a process designed by, or under the supervision of, the Company’s Chief Executive Officer and Chief Financial Officer and effected by the Company’s 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 and 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;

(2) Provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors;

(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 Company’s consolidated financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

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 policies or procedures may deteriorate.

Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the criteria set forth in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO.

Based on the assessment, management has concluded that our internal control over financial reporting was effective as of December 31, 2022.

Remediation of Previously Identified Material Weakness

As disclosed in our 2021 Annual Report on Form 10-K, management identified a material weakness in our internal control over financial reporting relating to our inventory process.

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, 2023, based on criteria established in Internal Control— Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013.

As a result of this assessment, our management has concluded that, as of December 31, 2023, our internal control over financial reporting was ineffective due to the material weakness described below.

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Material Weakness - Inventories

As of December 31, 2023, our management concluded that we did not design and maintain effective controls over the completeness and accuracy of accounting for inventory and inventory related transactions, including inventory reconciliations, calculation of overheads, presentation of inventories in our balance sheet between short-term and long-term and our liabilities related to the calculation of firm purchase commitment liability.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be prevented or detected on a timely basis.

Specifically, we did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing, (iii) the classification of inventory within the balance sheet and cost of product and other revenue related costs in the statement of operations, (iv) the calculation of estimated excess firm purchase commitment liability and (v) the verification that the existence of all inventories subject to physical inventory counts were accurately counted.

Remediation Efforts of the Material Weakness - Inventories

The control deficiencies described above resulted in certain accounting errors, including in our internal preliminary consolidated financial statements for the year ended December 31, 2023, that were corrected prior to the issuance of such annual consolidated financial statements.

Our management has taken, plans to continue to take, actions to remediate the deficiency in our internal control over financial reporting and has implemented new processes, procedures and controls designed to address the underlying causes associated with the material weakness.

For example, we are in the process of:

(i) implementing and documenting new processes and controls to help ensure the completeness and accuracy of our inventory reconciliations,

(ii) engaging additional third-party subject matter experts and accounting personnel with U.S.

GAAP experience specific to inventory accounting,

(iii) enhancing the accuracy of key reports used to calculate the firm purchase commitment liability;

(iv) establishing effective monitoring and oversight controls to help to ensure the completeness and accuracy of inventory included in our financial statements and related disclosures.

These control deficiencies did not have any material impact on our current or prior period consolidated annual or interim financial statements, but could have resulted in material misstatements of our annual or interim financial statements that would not have been prevented or detected on a timely basis.

Accordingly, our management has concluded that the control deficiencies were a material weakness in the Company’s internal control over financial reporting.

As management continues to evaluate and work to improve our internal control over financial reporting, management may determine it is necessary to take additional measures to address the material weakness.

Until the controls have been operating for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively, the material weakness described above will continue to exist.

Remediation of Previously Identified Material Weakness - Product Return Reserves

As disclosed in our 2022 Annual Report on Form 10-K/A, our management identified a material weakness in our internal control over financial reporting relating to product return reserves.

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;

(i) designing and implementing more robust controls throughout 2022, including through increased training of individuals within the supply chain, manufacturing, quality and inventory processes, including review documentation requirements, (ii) designing controls to address the completeness and accuracy of key reports utilized in the execution of internal controls, (iii) implementing an inventory count policy and standard operating procedures to ensure consistency and accuracy of the inventory count process and adherence to these policies at facilities managed by third party logistics and contract manufacturing organizations, and (iv) continuing to engage an outside firm in 2022 to assist management with performing sufficient testing throughout the year to validate the operating effectiveness of certain controls over financial reporting.

The remediation efforts addressed the material weakness and also enhanced our overall financial reporting control environment.

As of December 31, 2022, we have determined that our previously reported material weakness has been remediated.

In response to the material weakness previously 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 product return reserves, including;

(i) designed controls to address the completeness and accuracy of key reports utilized in the execution of internal controls related product return reserve calculations, (ii) engaged additional third party subject matter experts with U.S.

GAAP experience specific to product returns accounting and (iii) established effective monitoring and oversight controls to help to ensure the completeness and accuracy of our accrued product returns included in our financial statements and related disclosures as well as continued to engage an outside firm to assist management with performing sufficient testing throughout the year to validate the operating effectiveness of certain controls over financial reporting.

These remediation efforts also enhanced our overall financial reporting control environment related to product return reserves.

As of December 31, 2023, we determined that our previously reported material weakness related to product return reserves has been remediated.

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Changes in Internal Control over Financial Reporting

Except for the remediation efforts as noted in the preceding paragraphs, there have been no changes in the Company’s internal control over financial reporting during the fourth quarter of 2022, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Ernst & Young, LLP, the Company’s independent registered public accounting firm, has issued an auditor’s report on management’s assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2022.

This report is included below.

Except for the remediation efforts as noted “—Remediation Efforts of the Material Weakness – Inventory” and “—Remediation of Previously Identified Material Weakness – Returns” above, there have been no changes in our internal control over financial reporting during the year ended December 31, 2023, as defined in Rules 13a-15(f) and 15(d)-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

2 unchanged sentences

We have audited Akebia Therapeutics, Inc.’s internal control over financial reporting as of December 31, 2023, 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, 2022, 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 consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes and our report dated March 10, 2023 expressed an unqualified opinion thereon.

In our opinion, because of the effect of the material weakness described below on the achievement of the objectives of the control criteria, Akebia Therapeutics, Inc.

(the “Company”) has not maintained effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

The following material weakness has been identified and included in management’s assessment.

Management has identified a material weakness in controls related to the Company’s inventory process.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders’ (deficit) equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes.

This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the 2023 consolidated financial statements, and this report does not affect our report dated March 14, 2024, which 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.

7 unchanged sentences

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;

A company’s internal control over financial reporting includes those policies and procedures

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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;

6 unchanged sentences

Other Information

We confirm that we do not hold any deposits or securities or maintain any accounts at Silicon Valley Bank.

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.

The following table describes, for the fourth quarter of 2023, each trading arrangement for the sale or purchase of Company securities adopted or terminated by our directors and officers that is either (1) a contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (a “Rule 10b5-1 trading arrangement”) or (2) a “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K):

Name (Title) Action Taken (Date of Action) Type of Trading Arrangement Nature of Trading Arrangement Duration of Trading Arrangement Aggregate Number of Securities

Butler ( President and Chief Executive Officer )

December 1, 2023 Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted

Sale Until final settlement of any RSUs

Indeterminable (1)

Ellen Snow ( Senior Vice President, Chief Financial Officer and Treasurer )

November 20, 2023 Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted Sale

Until final settlement of any RSUs

Indeterminable (1)

( Senior Vice President, Research & Development and Chief Medical Officer )

November 17, 2023 Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted

Until final settlement of any RSUs

Indeterminable (1)

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Michel Dahan ( Senior Vice President, Chief Operating Officer )

December 3, 2023 Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted

Until final settlement of any RSUs

Indeterminable (1)

Hadas ( Senior Vice President, Chief Legal Officer and Corporate Secretary )

November 14, 2023 Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted Sale

Until final settlement of any RSUs

Indeterminable (1)

(1) The number of shares subject to RSUs that will be sold to satisfy applicable tax withholding obligations upon vesting is unknown as the number will vary based on the extent to which vesting conditions are satisfied, the market price of the Company’s common stock at the time of settlement and the potential future grant of additional RSUs subject to this arrangement.

This trading arrangement, which applies to RSUs whether vesting is based on the passage of time and/or the achievement of performance goals, provides for the automatic sale of shares that would otherwise be issuable on each settlement date of a RSU in an amount sufficient to satisfy the applicable tax withholding obligation, with the proceeds of the sale delivered to the Company in satisfaction of the applicable tax withholding obligation.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

10 unchanged sentences

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 2024 Annual Meeting of Stockholders and is incorporated herein by reference.

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Exhibits and Financial Statement Schedules

4 unchanged sentences

Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Stockholders’ Equity

Consolidated Statements of Stockholders’ (Deficit) Equity

Consolidated Statements of Cash Flows

1 unchanged sentence

(2) Schedules

Schedules have been omitted as all required information has been disclosed in the financial statements and related footnotes.

Schedules have been omitted as all required information has been disclosed in the consolidated financial statements and related footnotes.

The Exhibits listed below are filed as part of this Annual Report on Form 10-K.

Number Description of Exhibit

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Incorporated by Reference

Number Description of Exhibit Schedule/ Form

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.

(incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K (001-36352), filed on June 28, 2018)

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.

(incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K (001-36352) , filed on October 1, 2018)

3.1 Ninth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (001-36352) , filed on March 28, 2014)

2.1 October 1, 2018

3.1 Ninth Amended and Restated Certificate of Incorporation

3.1 March 28, 2014

3.2 Certificate of Amendment of Ninth Amended and Restated Certificate of Incorporation of Akebia Therapeutics, Inc.

(incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K (001-36352) , filed on June 9, 2020)

3.3 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K (001-36352) , filed on March 28, 2014)

4.1 Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

4.2 Fourth Amended and Restated Investors’ Rights Agreement, dated March 5, 2014 (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 4, 2015)

3.1 June 9, 2020

3.3 Second Amended and Restated Bylaws of Akebia Therape utics, Inc.

3.1 April 28, 2023

4.1 Form of Common Stock Certificate

4.1 March 4, 2014

4.2 Fourth Amended and Restated Investors’ Rights Agreement, dated March 5, 2014

4.4 March 4, 2015

4.3# Amendment No.

1 to Fourth Amended and Restated Investors’ Rights Agreement, dated June 28, 2017 (incorporated by reference to Exhibit 4.5 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

1 to Fourth Amended and Restated Investors’ Rights Agreement, dated June 28, 2017

4.5 March 12, 2018

4.4# Investment Agreement between Akebia Therapeutics, Inc.

and Vifor (International) Ltd., dated May 12, 2017 (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2017)

and Vifor (International) Ltd., dated May 12, 2017

4.1 August 8, 2017

Investment Agreement between Akebia Therapeutics, Inc.

and Vifor (International) Ltd., dated February 18, 2022 (incorporated by reference to Exhibit 4.5 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

4.6 Description of Registrant’s Securities (incorporated by reference to Exhibit 4.6 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

Form of Director and Officer Indemnification Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

and Vifor (International) Ltd., dated February 18, 2022

4.5 March 1, 2022

4.6 Description of Registrant’s Securities

4.6 February 25, 2021

Form of Warrant

10.1† Form of Director and Officer Indemnification Agreement

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 (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1 (333-193969), filed on 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 (incorporated by reference to Exhibit 10.3 to the Company’s Annual Report on Form 10-K (001-36352) , filed on 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 (incorporated by reference to Exhibit 10.4 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 14, 2016)

10.5 Third Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated July 25, 2016 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on November 9, 2016)

Number Description of Exhibit

10.6 Fourth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc., dated May 1, 2017 (incorporated by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

and Akebia Therapeutics, Inc., dated December 3, 2013

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

10.3 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

10.4 March 14, 2016

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Incorporated by Reference

Number Description of Exhibit Schedule/ Form

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

10.1 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

10.6 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 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2018)

dated April 9, 2018

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 (incorporated by reference to Exhibit 10.8 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

dated November 30, 2020

10.8 February 25, 2021

10.9 One Marina Park Drive Office Lease dated April 29, 2015, by and between Keryx Biopharmaceuticals, Inc.

and Fallon Cornerstone One MPD LLC (incorporated by reference to Exhibit 10.29 to Keryx Biopharmaceuticals, Inc.’s Annual Report on Form 10-K (000-30929) , filed on March 1, 2017)

and Fallon Cornerstone One MPD LLC

10.29 March 1, 2017

10.10 First Amendment to One Marina Park Drive Office Lease, dated February 24, 2022, by and between Keryx Biopharmaceuticals, Inc.

and CLPF One Marina Park Drive LLC (successor-in-interest to Fallon Cornerstone One MPD LLC) (incorporated by reference to Exhibit 10.10 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

and CLPF One Marina Park Drive LLC (successor-in-interest to Fallon Cornerstone One MPD LLC)

10.10 March 1, 2022

10.11 Assignment and Assumption Agreement, dated February 24, 2022, by and between Keryx Biopharmaceuticals, Inc.

and Akebia Therapeutics, Inc.

(incorporated by reference to Exhibit 10.11 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

10.11 March 1, 2022

10.12 Sublease, dated as of September 9, 2019, by and between Keryx Biopharmaceuticals, Inc.

and Foundation Medicine, Inc.

(incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on November 12, 2019)

10.13† Amended and Restated 2008 Equity Incentive Plan (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (333-193969), filed on February 14, 2014)

10.1 November 12, 2019

10.13† Amended and Restated 2008 Equity Incentive Plan

10.5 February 14, 2014

10.14† Amendment No.

1 to Amended and Restated 2008 Equity Incentive Plan (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (333-193969), filed on February 14, 2014)

1 to Amended and Restated 2008 Equity Incentive Plan

10.6 February 14, 2014

10.15† Executive Employment Agreement with John P.

Butler, dated September 16, 2013 (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (333-193969), filed on February 14, 2014)

10.16† Offer Letter to David Spellman, dated as of June 13, 2020 (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on August 10, 2020)

10.17† Form of Non-Statutory Stock Option Agreement for officers (incorporated by reference to Exhibit 10.24 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.18† Form of Non-Statutory Stock Option Agreement for Non-Employee Directors (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.19† Non-Employee Director Compensation Program, effective January 26, 2021 (incorporated by reference to Exhibit 10.19 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.20† Form of Executive Severance Agreement for officers (incorporated by reference to Exhibit 10.27 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.21† 2014 Incentive Plan (incorporated by reference to E xhibit 10.29 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

Butler, dated September 16, 2013

10.7 February 14, 2014

10.16† Offer Letter to David Spellman, dated as of June 13, 2020

10.1 August 10, 2020

10.17† Form of Non-Statutory Stock Option Agreement for O fficers

10.24 March 4, 2014

10.18† Form of Non-Statutory Stock Option Agreement for Non-Employee Directors

10.25 March 4, 2014

A mended and Restated Non-Employee Director Compensation Program, effective April 27, 2 023

10.1 May 8, 2023

S econd A mended and Restated Non-Employee Director Compensation Program, effec tive June 6, 2023

10.8 August 28, 2023

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Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

Third Amended and Res tated Non-Employee Director Compensation Program, effective January 1 , 202 4

Form of Executive Severance Agreement for O fficers

10.27 March 4, 2014

2014 Incentive Plan

10.29 March 4, 2014

Amendment No.

1 to the Akebia Therapeutics, Inc.

2014 Incentive Plan (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-8 (333-229366), filed on January 25, 2019)

Number Description of Exhibit

10.23† Amended and Restated 2014 Employee Stock Purchase Plan (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (001-36352), filed with the Securities and Exchange Commission on April 26, 2019)

10.24† Amended and Restated Cash Incentive Plan, effective January 19, 2022 (incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

10.25† Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (incorporated by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K (001-36352), filed on March 12, 2018)

10.26† Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (incorporated by reference to Exhibit 10.29 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

10.27† Form of Officer Inducement Award Non-Statutory Stock Option Agreement (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-8 (333-222728), filed on January 26, 2018)

10.28† Form of Inducement Award Non-Statutory Stock Option Agreement for non-officers (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-8 (333-222728), filed on January 26, 2018)

10.29† Form of Officer Performance-Based Stock Option Award, under the Company's 2014 Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on November 4, 2021)

10.30† Form of Officer Performance-Based Stock Restricted Stock Unit Award, under the Company's 2014 Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on November 4, 2021)

10.31† Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (Retention Awards) (incorporated by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on August 4, 2022)

10.32† Form of Officer Non-Statutory Stock Option Agreement under 2014 Incentive Plan (Retention Awards) (incorporated by reference to Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on August 4, 2022)

Form of Officer Cash Bonus Letter Agreement (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on November 4, 2021)

2014 Incentive Plan

4.4 January 25, 2019

Amended and Restated 2014 Employee Stock Purchase Plan

DEF 14A 001-36352

Appendix A April 26, 2019

Amended and Restated Cash Incentive Plan, effective January 19, 2022

10.28 March 1, 2022

Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan

10.18 March 12, 2018

Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan

10.29 March 26, 2019

Form of Officer Inducement Award Non-Statutory Stock Option Agreement

4.4 January 26, 2018

Form of Inducement Award Non-Statutory Stock Option Agreement for N on- O fficers

4.5 January 26, 2018

Form of Officer Performance-Based Stock Option Award, under the Company's 2014 Incentive Plan, as amended

10.1 November 4, 2021

Form of Officer Performance-Based Stock Restricted Stock Unit Award, under the Company's 2014 Incentive Plan, as amended

10.2 November 4, 2021

Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (Retention Awards)

10.6 August 4, 2022

Form of Officer Non-Statutory Stock Option Agreement under 2014 Incentive Plan (Retention Awards)

10.7 August 4, 2022

Form of Officer Cash Bonus Letter Agreement

10.3 November 4, 2021

Form of Officer Stock Appreciation Rights Award Agreement un der 2014 Incentive Plan

10.3 May 8, 2023

Akebia Therapeutics, Inc.

2023 Stock Incentive Plan

99.1 June 6, 2023

Form of Non-Employee Director Stock Option Agreement under 2023 Stock Incentive Plan

August 28, 2023

Akebia Therapeutics, Inc.

| Form 10-K | Page 174

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

Form of Non-Employee Director Restricted Stock Unit Agreement under 2023 Stock Incentive Plan

10.12 August 28, 2023

Form of Officer Stock Option Agreement under 2023 Stock Incentive Plan

10.11 August 28, 2023

Form of Officer Restricted Stock Unit Agreement under 2023 Stock Incentive Plan

10.13 August 28, 2023

Form of Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan

10.14 August 28, 2023

Form of Officer Executive Severance Agreement ( Refle cting Clawback Policy)

Form of Officer Cash Bonus Agreement ( Reflecting Clawback Policy)

Form of Officer Stock Option Agreement under 2023 Stock Incentive Plan ( Reflecting Clawback Policy)

Form of Officer Restricted Stock Unit Agreement under 2023 Stock Incentive Plan ( Reflecting Clawback Policy)

Form of Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan (Reflecting Clawback Polic y)

Keryx Biopharmaceuticals, Inc.

1999 Stock Option Plan (incorporated by reference to Exhibit 10.2 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (001-30929), filed on March 21, 2003)

1999 Stock Option Plan

10.2 March 21, 2003

Keryx Biopharmaceuticals, Inc.

2004 Long-Term Incentive Plan (incorporated by reference to Annex C to Keryx Biopharmaceuticals, Inc.’s Definitive Proxy Statement on Schedule 14A (000-30929) , filed on April 29, 2004)

2004 Long-Term Incentive Plan

DEF 14A 000-30929

April 29, 2004

Amendment to the Keryx Biopharmaceuticals, Inc.

2004 Long-Term Incentive Plan dated April 11, 2006 (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (000-30929) , filed on August 9, 2006)

2004 Long-Term Incentive Plan dated April 11, 2006

10.1 August 9, 2006

Keryx Biopharmaceuticals, Inc.

2007 Incentive Plan, (incorporated by reference to Annex D to Keryx Biopharmaceuticals, Inc.’s Definitive Proxy Statement on Schedule 14A (000-30929) , filed on April 30, 2007)

Number Description of Exhibit

2007 Incentive Plan

April 30, 2007

Keryx Biopharmaceuticals, Inc.

Amended and Restated 2013 Incentive Plan (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Current Report on Form 8-K (000-30929) , filed on May 27, 2016)

Amended and Restated 2013 Incentive Plan

10.1 May 27, 2016

Keryx Biopharmaceuticals, Inc.

2018 Equity Incentive Plan (incorporated by reference to Exhibit 99.1 to Keryx Biopharmaceuticals, Inc.’s Registration Statement on Form S-8 (333-226005), filed on June 29, 2018)

2018 Equity Incentive Plan

99.1 June 29, 2018

Form of Indemnification Agreement between Keryx Biopharmaceuticals, Inc.

and its directors and officers (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (000-30929) , filed on November 9, 2016)

10.41† Form of Employee Agreement (Confidentiality, Non-Competition, Non-Solicitation and Development Agreement) applicable to officers (incorporated by reference to Exhibit 10.56 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

and its D irectors and O fficers

10.1 November 9, 2016

Form of Employee Agreement (Confidentiality, Non-Competition, Non-Solicitation and Development Agreement) applicable to O fficers

10.56 March 26, 2019

Akebia Therapeutics, Inc.

| Form 10-K | Page 175

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

Keryx Biopharmaceuticals, Inc.

Fourth Amended and Restated Directors Equity Compensation Plan (incorporated by reference to Exhibit 10.2 to Keryx Biopharmaceuticals, Inc.’s Current Report on Form 8-K (000-30929) , filed on May 27, 2016)

Fourth Amended and Restated Directors Equity Compensation Plan

10.2 May 27, 2016

Keryx Biopharmaceuticals, Inc.

Third Amended and Restated Directors Equity Compensation Plan (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (000-30929) , filed on August 7, 2014)

Third Amended and Restated Directors Equity Compensation Plan

10.1 August 7, 2014

Keryx Biopharmaceuticals, Inc.

Director Non-Statutory Stock Option Award Terms and Conditions under the Third Amended and Restated Directors Equity Compensation Plan (incorporated by reference to Exhibit 10.59 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

10.45† Form of Officer Retention Letter Agreement (incorporated by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on May 9, 2022)

Director Non-Statutory Stock Option Award Terms and Conditions under the Third Amended and Restated Directors Equity Compensation Plan

10.59 March 26, 2019

Form of Officer Retention Letter Agreement

10.6 May 9, 2022

Form of Retention and Separation Agreement for Michel Dahan and Nicole R.

Hadas (incorporated by reference to Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on May 9, 2022)

10.7 May 9, 2022

Form of Amendment to Retention and Separation Agreement for Michel Dahan and Nicole R.

Hadas (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on November 3, 2022)

10.48† Separation Agreement with Dell Faulkingham, dated May 5, 2022 (incorporated by reference to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on May 9, 2022)

10.49† Retention Agreement with David Spellman, dated June 22, 2022 (incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on August 4, 2022)

10.50# Master Services Agreement, between Akebia Therapeutics, Inc., and Quintiles, Inc., dated as of June 8, 2015 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 11, 2015)

10.2 November 3, 2022

Form of May 2023 Amendment to Retention and Separation Agreement for Michel Dahan and Nicole R.

10.4 August 28, 2023

July 2023 Amendment to Retention and Separation Agreement for Michel Dahan

10.5 August 28, 2023

July 2023 Amendment to Retention and Separation Agreement for Nicole R.

10.6 August 28, 2023

October 2023 Amendment to Retention and Separation Agreement for Nicole R.

10.3 November 8, 2023

February 2024 Amendment to Retention and Separation Agreement for Nicole R.

February 2024 Amendment to Retention and Separation Agreement for Michel Dahan

Retention Agreement with David Spellman, dated June 22, 2022

10.5 August 4, 2022

Separation Agreement with David Spellman, dated June 9, 2023 and Amendment to Separation Agreement dated July 6, 2023

10.7 August 28, 2023

Collaboration Agreement between Akebia Therapeutics, Inc.

and Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015 (incorporated by reference to Exhibit 10.49 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

and Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015

10.49 March 1, 2022

Letter Agreement between Akebia Therapeutics, Inc.

and Mitsubishi Tanabe Pharma Corporation, dated September 26, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on November 8, 2017)

and Mitsubishi Tanabe Pharma Corporation, dated September 26, 2017

10.1 November 8, 2017

Akebia Therapeutics, Inc.

| Form 10-K | Page 176

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

Amendment No.

1 unchanged sentence

and Mitsubishi Tanabe Pharma Corporation

Number Description of Exhibit

10.54# Collaboration and License Agreement, between Akebia Therapeutics, Inc.

and Otsuka Pharmaceutical Co.

Ltd., dated December 18, 2016 (incorporated by reference to Exhibit 10.26 to the Company’s Annual Report on Form 10-K (001-36352) and filed on March 6, 2017)

10.55# Collaboration and License Agreement between Akebia Therapeutics, Inc.

and Otsuka Pharmaceutical Co.

Ltd., dated April 25, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2017)

Termination and Settlement Agreement, dated June 30, 2022, by and between the Company and Otsuka Pharmaceutical Co.

Ltd (incorporated by reference to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on August 4, 2022)

10.53 March 10, 2022

Termination and Sett lement Agreement , dated June 30, 2022, by and between the Company and Otsuka P harmaceutical Co.

10.8 August 4, 2022

Packaging Validation Transfer Agreement, dated April 20, 2023, by and between the Company and Otsuka Pharmaceutical Co.

10.3 August 28, 2023

Second Amended and Restated License Agreement, dated February 18, 2022, by and between Akebia Therapeutics, Inc.

and Vifor (International) Ltd.

(incorporated by reference to Exhibit 10.54 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

10.54 March 1, 2022

Open Market Sale Agreement SM , dated April 7, 2022, by and between Akebia Therapeutics, Inc.

and Jefferies LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K (001-36352), filed on April 7, 2022)

and Jefferies LLC

1.1 April 7, 2022

Second Amended and Restated License Agreement dated April 17, 2019, by and between Akebia Therapeutics, Inc.

and Panion & BF Biotech, Inc.

(incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2019)

10.1 August 8, 2019

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 (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (000-30929) , filed on November 7, 2017)

and Torii Pharmaceutical Co., Ltd

10.1 November 7, 2017

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 (incorporated by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

10.58 March 1, 2022

Product Agreement, dated August 29, 2017, by and between Keryx Biopharmaceuticals, Inc.

1 unchanged sentence

(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 (incorporated by reference to Exhibit 10.2 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (000-30929) , filed on November 7, 2017)

and Patheon Manufacturing Services LLC and certain of its affiliates dated November 12, 2016

10.2 November 7, 2017

Master Manufacturing Services and Supply Agreement, dated December 20, 2017, by and between Keryx Biopharmaceuticals, Inc.

and Siegfried Evionnaz SA (incorporated by reference to Exhibit 10.13 to Keryx Biopharmaceuticals, Inc.’s Annual Report on Form 10-K (000-30929) , filed on February 21, 2018)

and Siegfried Evionnaz SA

10.13 February 21, 2018

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.

(incorporated by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.57 February 25, 2021

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.

(incorporated by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.58 February 25, 2021

Akebia Therapeutics, Inc.

| Form 10-K | Page 177

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

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.

(incorporated by reference to Exhibit 10.59 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.59 February 25, 2021

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.

(incorporated by reference to Exhibit 10.64 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

Number Description of Exhibit

10.64 March 1, 2022

Amendment No.

5 to Master Manufacturing Services and Supply Agreement, dated February 28, 2023, by and between Keryx Biopharmaceuticals, Inc.

and Siegfried Evionnaz SA

10.2 May 8, 2023

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 (incorporated by reference to Exhibit 10.60 to the Company’s Annual Report on Form 10-K (001-36352), filed on March 26, 2019)

10.69# Manufacture and Supply Agreement between Keryx Biopharmaceuticals, Inc.

and BioVectra Inc., dated May 26, 2017 and Amendment to Manufacture and Supply Agreement between Keryx Biopharmaceuticals, Inc.

and BioVectra Inc., dated December 11, 2017 (incorporated by reference to Exhibit 10.61 to the Company’s Annual Report on Form 10-K (001-36352), filed on March 26, 2019)

10.70!* Termination and Settlement Agreement, dated December 22, 2022, by and between Keryx Biopharmaceuticals, Inc.

and Cardinal Health 105, Inc., dated April 14, 2015

10.60 March 26, 2019

Termination and Settlement Agreement, dated December 22, 2022, b y and between Keryx Biopharmaceuticals, Inc.

and BioVectra Inc.

Loan Agreement, dated November 11, 2019, by and among the Company, Keryx Biopharmaceuticals, Inc., Biopharma Credit plc and Biopharma Credit Investments V (Master) LP (incorporated by reference to Exhibit 10.62 to the Company's Annual Report on Form 10-K (001-36352) , filed on March 12, 2020)

First Amendment and Waiver, dated February 18, 2022, by and among the Company, Biopharma Credit plc, BCPR Limited Partnership and Biopharma Credit Investments V (Master) LP (incorporated by reference to Exhibit 10.69 to the Company's Annual Report on Form 10-K (001-36352), filed on March 1, 2022)

Second Amendment and Waiver, dated July 15, 2022, by and among the Company, Biopharma Credit plc, BCPR Limited Partnership and Biopharma Credit Investments V (Master) LP (incorporated by reference to Exhibit 10.9 to the Company’s Quarterly Report on Form 10-Q (001-36352), filed on August 4, 2022)

10.70 March 10, 2023

Loan Agreement, dated November 11, 2019, by and among the Company, Keryx Biopharmaceuticals, Inc., Biopharma Credit plc and Biopharma Credit Investments V (Master) LP

10.62 March 12, 2020

First Amendment and Waiver, dated February 18, 2022, by and among the Company, Biopharma Credit plc, B P C R Limited Partnership and Biopharma Credit Investments V (Master) LP

10.69 March 1, 2022

Second Amendment and Waiver, dated July 15, 2022, by and among the Company, Biopharma Credit plc, B P C R Limited Partnership and Biopharma Credit Investments V (Master) LP

10.9 August 4, 2022

Third Amendment to Loan Agreement, dated as of June 30, 2023, by and among the Company, Biopharma Credit plc, BPCR Limited Partnership and Biopharma Credit Investments V (Master) LP

10.2 August 28, 2023

Fourth Amendment to Loan Agreement dated as of October 31, 2023, by and among the Company, BioPharma Credit PLC, BPCR Limted Partnership, and BioPharma Credit Investments V (Master) LP

Guaranty and Security Agreement, dated November 25, 2019, by and between the Company, Keryx Biopharmaceuticals, Inc.

and Biopharma Credit plc (incorporated by reference to Exhibit 10.63 to the Company's Annual Report on Form 10-K (001-36352) , filed on March 12, 2020)

and Biopharma Credit plc

10.63 March 12, 2022

Supply Agreement, dated as of March 11, 2020, by and between Akebia Therapeutics, Inc.

and Patheon, Inc.

(incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on May 5, 2020)

10.1 May 5, 2020

Akebia Therapeutics, Inc.

| Form 10-K | Page 178

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

Supply Agreement, dated as of April 2, 2020, by and between Akebia Therapeutics, Inc.

and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on August 10, 2020)

Amendment #1 to the Supply Agreement, dated as of April 15, 2021, by and between Akebia Therapeutics, Inc, and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on August 5, 2021)

Amended and Restated Product Manufacture and Supply and Facility Construction Agreement between BioVectra, Inc.

and Keryx Biopharmaceuticals, Inc., dated September 4, 2020 (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K (001-36352), filed on September 11, 2020)

Supply Agreement, dated February 10, 2021, by and between the Company and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on May 10, 2021)

and STA Pharmaceutical Hong Kong Limited

10.2 August 10, 2020

Amendment No.

1 to the Supply Agreement, dated as of April 15, 2021, by and between Akebia Therapeutics, Inc, and STA Pharmaceutical Hong Kong Limited

10.1 August 5, 2021

Supply Agreement, dated February 10, 2021, by and between the Company and STA Pharmaceutical Hong Kong Limited

10.4 May 10, 2021

Royalty Interest Acquisition Agreement, dated February 25, 2021, by and between the Company and HealthCare Royalty Partners IV, L.P.

(incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on May 10, 2021)

10.5 May 10, 2021

License Agreement, dated December 22, 2022, by and among Akebia Therapeutics, Inc., Keryx Biopharmaceuticals, Inc.

and Averoa SAS

21.1 List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

Number Description of Exhibit

10.81 March 10, 2023

License Agreement, dated May 24, 2023, by and between the Company and MEDICE Arzneimittel Pütter GmbH & Co.

10.1 August 28, 2023

A greement for the Provi sion of a Loan Facility dated January 2 9 , 202 4 between the Company and Kreos Capital VII (UK) Limited

Warra nt Agreement dated January 29, 2024 by and between the Compa ny and Kreos Capital VII Aggregator SCSp

21.1 List of Subsidiaries

21.1 February 25, 2021

23.1* Consent of Ernst & Young LLP

2 unchanged sentences

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.

Akebia Therapeutics, Inc.

Dodd-Frank Compensation Recovery Policy

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)

Akebia Therapeutics, Inc.

| Form 10-K | Page 179

Table of Content s

Incorporated by Reference

Number Description of Exhibit Schedule/ Form

Filed Date/ Period End Date

101.SCH* Inline XBRL Taxonomy Extension Schema Document

11 unchanged sentences

Form 10-K Summary

Akebia Therapeutics, Inc.

| Form 10-K | Page 180

Table of Content s

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.

March 10, 2023 By:

March 14, 2024

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.

March 10, 2023 By:

Akebia Therapeutics, Inc.

| Form 10-K | Page 181

Table of Content s

March 14, 2024

Director, President and Chief Executive Officer (Principal Executive Officer)

March 10, 2023 By:

Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)

March 10, 2023 By:

March 14, 2024

Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer)

March 14, 2024

/s/ Richard C.

Chief Accounting Officer (Principal Accounting Officer)

March 14, 2024

/s/ Adrian Adams

Chairperson and Director

March 10, 2023 By:

March 14, 2024

/s/ Ron Frieson

March 10, 2023 By:

March 14, 2024

/s/ Steven C.

March 10, 2023 By:

March 14, 2024

/s/ Michael Rogers

Michael Rogers

March 10, 2023 By:

March 14, 2024

/s/ Cynthia Smith

Cynthia Smith

March 10, 2023 By:

March 14, 2024

/s/ Myles Wolf

March 10, 2023 By:

March 14, 2024

/s/ LeAnne M.

Akebia Therapeutics, Inc.

| Form 10-K | Page 182

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures