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We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, or the Exchange Act , is (i) recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
−Removed: Based on an evaluation under the supervision and with the participation of our management, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, were not effective as of June 30, 2025 due to the material weakness in internal control over financial reporting described below.
+Added: Based on an evaluation under the supervision and with the participation of our management, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, were not effective as of September 30, 2025 due to the material weakness in internal control over financial reporting described below.
As previously disclosed in our Annual Report on Form 10-K, that was filed with the SEC on March 13, 2025, or 2024 Form 10-K , as of December 31, 2024, our management identified a material weakness in our internal control over financial reporting.
Specifically, we did not effectively document controls that operated with a sufficient level of precision to evaluate the completeness, accuracy and reasonableness of the product sales forecast, which is used in the evaluation of excess inventory, including the calculation of excess firm purchase commitments and the classification of current and non-current inventory, or the Remaining Control Deficiencies .
−Removed: Remediation Efforts of the Material Weakness — Inventories
−Removed: Our management has taken and plans to continue to take actions to remediate the Remaining Control Deficiencies in our internal control over financial reporting.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 45
+Added: Remediation Efforts of the Material Weakness — Inventories
+Added: Our management has taken and plans to continue to take actions to remediate the Remaining Control Deficiencies in our internal control over financial reporting.
We have begun the following remediation plan:
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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.