Akebia Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Feb 26, 2026.
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FY2025 · Filed Feb 26, 2026
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Akebia Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Akebia Therapeutics, Inc. (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 26, 2026, expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
| Product Revenue, Net | |
| Description of the Matter | During the year ended December 31, 2025, the Company recorded net product revenue of $227.3 million. As described in Note 2 to the consolidated financial statements under the caption “Product Revenue, net”, revenue from product sales includes estimates of variable consideration for which provisions are established, including provisions for commercial rebates.Auditing the Company’s accounting for variable consideration related to commercial rebates on product sales was especially challenging due to the varying contractual terms within each customer contract and because the amounts are material to the consolidated financial statements and related disclosures. |
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| How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated and tested the design and the operating effectiveness of internal controls over the Company’s process to determine provisions for commercial rebates on product sales. This included testing controls over the Company’s process to evaluate the contractual terms of contracts with customers, including evaluation of commercial rebates and determining the appropriate revenue recognition. We also tested the Company’s controls over evaluating the completeness and accuracy of the data used in the process.To test the Company’s accounting for provisions for commercial rebates on product sales, our audit procedures included, among others, inspecting agreements with significant customers to validate the contractual terms of contracts with customers, including the identification of commercial rebates. We also tested the completeness and accuracy of the underlying data used in the calculations, including testing the mathematical accuracy of the Company’s calculations, and testing the accuracy of variable consideration by tracing key terms to the contracts with customers. |
/s/Ernst & Young LLP
We have served as the Company’s auditor since 2013.
Boston, Massachusetts
February 26, 2026
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