Item 5. Other Information
Item 5. Other Information.
Rule 10b5-1—Director and Officer Trading Arrangements
From time to time, the Company's directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended (Exchange Act)) engage in open-market transactions with respect to Company securities, including to satisfy tax withholding obligations when equity awards vest or are exercised, and for diversification or other personal reasons.
Transactions in Company securities by directors and officers are required to be made in accordance with the Company’s insider trading policy, which requires that the transactions be in accordance with applicable U.S. federal securities laws that prohibit trading while in possession of material nonpublic information. Rule 10b5-1 under the Exchange Act provides an affirmative defense that enables directors and officers to prearrange transactions in the Company’s securities in a manner that avoids concerns about initiating transactions while in possession of material nonpublic information.
None of the Company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.
Immaterial Correction of Prior Period Financial Statements
As discussed in Note 3 to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Form 10-Q, the Company identified certain accounting errors relating to the recording and reporting of reserves for returns of the Company’s commercial product, Auryxia® (ferric citrate) at the time the Company acquired Keryx Biopharmaceuticals, Inc. on December 12, 2018 and when calculating the product return reserves for subsequent annual and quarterly periods through March 31, 2023. The Company determined that the errors were not material to any prior annual or interim period; however, the Company determined that the effect of correcting the errors in the quarter ended June 30, 2023, would materially misstate the Company’s unaudited condensed consolidated financial statements for the three and six months ended June 30, 2023. As a results, the Company has revised the historical consolidated financial statements it previously issued with respect to the fiscal years ended December 31, 2022, 2021 and 2020 and interim periods.
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Item 6. Exhibits.
Exhibits
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, filed on 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, filed on June 9, 2020).
3.3 Second Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed on April 28, 2023).
10.1*# License Agreement, dated May 24, 2023, by and between the Company and MEDICE Arzneimittel Pütter GmbH & Co. KG
10.2*# Third Amendment to Loan Agreement, dated as of June 30, 2023, by and among the Company, Biopharma Credit plc, B PC R Limited Partnership and Biopharma Credit Investments V (Master) LP
10.3*# Packaging Validation Transfer Agreement, dated April 20, 2023, by and between the Company and Otsuka Pharmaceutical Co. Ltd.
10.4*†#
Form of May 2023 Amendment to Retention and Separation Agreement for Michel Dahan and Nicole R. Hadas
10.5*†#
July 2023 Amendment to Retention and Separation Agreement for Michel Dahan
10.6*†#
July 2023 Amendment to Retention and Separation Agreement for Nicole R. Hadas
10.7*†
Separation Agreement with David Spellman, dated June 9, 2023 and Amendment to Separation Agreement dated July 6, 2023.
10.8*†
Second Amended and Restated Non-Employee Director Compensation Program, effective June 6, 2023.
10.9*†
Akebia Therapeutics, Inc. 2023 Stock Incentive Plan (incorporated by reference to Exhibit 99.1 to the Registrant’s Registration Statement on Form S-8 (File No. 333-272453) filed on June 6, 2023)
10.10*†
Form of Non-Employee Director Stock Option Agreement under 2023 Stock Incentive Plan.
10.11*†
Form of Officer Stock Option Agreement under 2023 Stock Incentive Plan.
10.12*†
Form of Non-Employee Director Restricted Stock Unit Agreement under 2023 Stock Incentive Plan.
10.13*†
Form of Officer Restricted Stock Unit Agreement under 2023 Stock Incentive Plan.
10.14*†
Form of Officer Inducement Award Stock Option Agreement under 2023 Stock Incentive Plan.
31.1* Certification of Principal Executive Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.
31.2* Certification of Principal Financial Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.
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32.1* Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350.
101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document)
101.SCH* Inline XBRL Taxonomy Extension Schema Document
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB* Inline XBRL Taxonomy Extension Labels Linkbase Document
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document
104* Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Filed, or submitted electronically, herewith
# Indicates portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K
† Indicates management contract or compensatory plan.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
AKEBIA THERAPEUTICS, INC.
Date: August 28, 2023
By: /s/ John P. Butler
John P. Butler
President and Chief Executive Officer (Principal Executive Officer)
Date: August 28, 2023
By: /s/ Ellen E. Snow
Ellen E. Snow
Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
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