Akebia Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 13, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 13, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
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, 2024 and 2023, 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, 2024, 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, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, 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, 2024, 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 March 13, 2025 expressed a qualified 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.
| Valuation of Excess Firm Purchase Commitment Liability | |
| Description of the Matter | As of December 31, 2024, the Company’s liability for excess firm purchase commitments related to its commercial supply agreement with a third-party contract manufacturing organizations was $3.6 million. As described in Note 2 and Note 10, the Company records a liability for its firm purchase commitment that exceeded the Company’s estimates of future demand and expiry of inventory. The Company re-evaluates its liability for excess firm purchase commitments each reporting period to assess whether any adjustments are necessary. The Company’s evaluations of purchase commitments for Auryxia resulted in the Company recording charges to cost of product and other revenue sold of $2.1 million during the year ended December 31, 2024.Auditing management's estimate for its excess firm purchase commitment liability is especially challenging because the estimate relies on subjective management assumptions about the estimates of future product demand, which is affected by current and future market conditions and the impact of the Company’s loss of exclusivity that can have a material effect on the liability. |
|---|---|
| How We Addressed the Matter in Our Audit | To test the Company’s determination of its excess firm purchase commitment liability, our audit procedures included, among other procedures, testing the completeness and accuracy of the underlying data used in the evaluation of the Company’s excess firm purchase commitment liability, including evaluating the reasonableness of the Company’s estimates of future product demand. We compared the expectations of demand to contractual arrangements with customers, industry trends, historical financial results, and evaluated the consistency of the forecast with those used by management for other purposes. We also performed sensitivity analyses over the significant assumptions used to measure the excess firm purchase commitment liability and evaluated any contrary evidence identified when considering the reasonableness of the significant assumptions. |
/s/Ernst & Young LLP
We have served as the Company’s auditor since 2013.
Boston, Massachusetts
March 13, 2025
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.