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Item 9A. Controls and Procedures

2023-03-10 compared with 2022-03-01 · 59 added, 78 removed, 237 unchanged (37% of the section changed)

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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, 2021, our management, with the participation of 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.

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, 2021, our disclosure controls and procedures were not effective because of a material weakness in our internal control over financial reporting relating to our inventory process which is described in more detail below.

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.

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.

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:

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;

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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 the material weakness in our internal control over financial reporting relating to our inventory process as reported in our Annual Report on Form 10-K for the year ended December 31, 2020 remains un-remediated as of December 31, 2021 and that, our internal control over financial reporting as of December 31, 2021 was not effective due to the following material weakness:

the Company did not design and maintain effective controls over the completeness, accuracy, existence and presentation and disclosure of inventory.

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 periodic assessment of excess and obsolete inventory related reserves and (iv) verification that the existence of all inventories subject to physical inventory counts were correctly counted as of December 31, 2021.

Although during 2021 we strengthened our controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing and (iii) the periodic assessment of excess and obsolete inventory related reserves, further remediation is needed.

The control deficiencies described above resulted in certain accounting errors, including in our internal preliminary consolidated financial statements for the year ended December 31, 2021 that were corrected prior to the issuance of such annual consolidated financial statements.

Management has taken actions to remediate the deficiencies in its internal control over financial reporting and implemented additional processes and controls designed to address the underlying causes associated with the material weakness.

Management is committed to finalizing the remediation of the material weakness during 2022.

Management’s internal control remediation efforts include the following:

• We have designed and implemented more robust controls throughout 2021 and will continue to improve the precision of our controls in 2022.

• We provided training to individuals within the supply chain, manufacturing, quality and inventory processes, including review documentation requirements, during 2021, and will continue to do so in 2022 including training of all new employees and written standard operating procedures for all key inventory processes.

• We designed controls to address the completeness and accuracy of any key reports utilized in the execution of internal controls.

• Implementing an inventory count policy and standard operating procedures to ensure consistent communication of the inventory count process and adherence to these policies at facilities managed by third party logistics and contract manufacturing organizations.

• We reported regularly during 2021, and will continue to report regularly in 2022, to the audit committee on the progress and results of control remediation.

• We continued to engage an outside firm to assist with performing sufficient testing in 2021 and executed upon a monitoring protocol to allow the Company to validate the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed.

We will continue 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.

As management continues to evaluate and work to improve its 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.

Management will monitor the progress of the remediation plan and report regularly to the audit committee on the progress and results of the remediation plan, including the identification, status and resolution of internal control deficiencies.

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.

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.

Changes in Internal Control over Financial Reporting

Except 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 2021, 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.

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.

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We have audited Akebia Therapeutics, Inc.’s internal control over financial reporting as of December 31, 2022, 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, 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, 2021, 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 deficiencies in internal controls included within the Company’s inventory process.

Specifically, the Company did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing (iii) the periodic assessment of excess and obsolete inventory related reserves and (iv) verification that the existence of all inventories subject to physical inventory counts were correctly counted.

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, 2021 and 2020, 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, 2021, 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 2021 consolidated financial statements, and this report does not affect our report dated March 1, 2022, which expressed an unqualified opinion thereon.

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.

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 Management’s Annual Report on Internal Control over Financial Reporting.

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.

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Other Information

Amendment to Lease Agreement with CLPF One Marina Park Drive LLC

On February 24, 2022, we entered into an Assignment and Assumption Agreement with Keryx, pursuant to which we assumed all of the rights and responsibilities of Keryx with respect to the One Marina Park Drive Office Lease, dated April 29, 2015, by and between Keryx and Fallon Cornerstone One MPD LLC, or Fallon, or the Boston Lease, for the entire twelfth floor of the building located at One Marina Park Drive, Boston, Massachusetts, or the Premises.

On February 24, 2022,we entered into a First Amendment to Lease, or the First Lease Amendment, with CLPF One Marina Park Drive LLC (successor-in-interest to Fallon), or the Landlord, amending the Boston Lease for the Premises.

Pursuant to the First Lease Amendment, we have agreed to extend the term of the Boston Lease, as amended, until July 31, 2031.

The monthly lease payment for the Premises pursuant to the First Lease Amendment will be $200,122.00 commencing on August 1, 2023, with an annual rent escalation of approximately 2% commencing on August 1, 2024.

The First Lease Amendment also includes a Landlord’s allowance for certain leasehold improvements to the Premises in an amount of up to $1,954,680.00, provided that such allowance must be used prior to August 1, 2024.

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

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

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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 2022 Annual Meeting of Stockholders and is incorporated herein by reference.

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 2023 Annual Meeting of Stockholders and, other than the information required by Item 402(v) of Regulation S-K, is incorporated herein by reference.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

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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 2023 Annual Meeting of Stockholders and is incorporated herein by reference.

Exhibits, Financial Statement Schedules

Exhibits and Financial Statement Schedules

(a) Documents filed as part of this Annual Report on Form 10-K.

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Investment Agreement between Akebia Therapeutics, Inc.

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

4.6 Common Stock Purchase Warrant between Akebia Therapeutics, Inc.

and Janssen Pharmaceutica NV, dated February 9, 2017 (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on May 9, 2017)

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)

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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 Ann ua l Report on Form 10-K (001-36352) , filed on March 4, 2015)

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)

Number Description of Exhibit

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)

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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)

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)

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)

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

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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† Amended and Restated Non-Employee Director Compensation Program, effective January 1, 2018 (incorporated by reference to Exhibit 10.13 to the Company’s 10-K (001-36352) , filed on March 12, 2018)

10.20† Amended and Restated Non-Employee Director Compensation Program, effective January 30, 2019 (incorporated by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

Number Description of Exhibit

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)

10.23† 2014 Incentive Plan (incorporated by reference to exhibit 10.29 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)

10.22† Amendment No.

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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)

10.25† 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.30 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

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)

10.27† Cash Incentive Plan , effective February 28, 2014 (incorporated by reference to Exhibit 10.31 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.28*† Amended and Restated Cash Incentive Plan, effective January 19, 2022

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)

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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)

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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)

Number Description of Exhibit

10.37† 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

10.38† Keryx Biopharmaceuticals, Inc.

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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)

10.47† Master Consulting Services Agreement by and between the Company and Jason A.

Amello, dated August 7, 2020 (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on November 5, 2020)

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)

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)

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)

Collaboration Agreement between Akebia Therapeutics, Inc.

and Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015

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)

10.52# 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)

10.53!* Amendment No.

1 to Collaboration Agreement, dated December 2, 2022, by and between Akebia Therapeutics, Inc.

and Mitsubishi Tanabe Pharma Corporation

Number Description of Exhibit

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

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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)

10.53# Research and License Agreement between Akebia Therapeutics, Inc.

and Janssen Pharmaceutica NV, dated February 9, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on May 9, 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)

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

and Vifor (International) Ltd.

Number Description of Exhibit

10.55 Amended and Restated Controlled Equity Offering SM Sales Agreement, dated November 12, 2019, by and between Akebia Therapeutics, Inc.

and Cantor Fitzgerald & Co.

(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K (001-36352) , filed on November 12, 2019)

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

10.58 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)

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

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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)

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

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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

10.68# Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc.

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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)

Supply Agreement, dated as of April 9, 2019, by and between Akebia Therapeutics, Inc.

and Esteve Química, S.A.

(incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2019)

10.70!* Termination and Settlement Agreement, dated December 22, 2022, by 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)

Number Description of Exhibit

10.69!* First Amendment and Waiver, dated February 18, 2022, by and among the Company, Biopharma Credit p l c, BCPR Limited Partnership and Biopharm a Credit Investments V (Master ) LP

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)

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

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

10.81!* 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

23.1* Consent of Ernst & Young LLP

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101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document

Number Description of Exhibit

104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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March 10, 2023 By:

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

March 1, 2022 By:

/s/ Violetta Cotreau

Violetta Cotreau

Senior Vice President, Chief Accounting Officer (Principal Accounting Officer)

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

March 10, 2023 By:

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March 10, 2023 By:

/s/ Michael T.

March 1, 2022 By:

/s/ Michael Rogers

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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