Autolus Therapeutics plc
For the period ended Dec 31, 2025. Filed Mar 27, 2026.
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FY2025 · Filed Mar 27, 2026
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Item 8. Report of Independent Registered Public Accounting Firm
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Autolus Therapeutics plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Autolus Therapeutics plc (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations and comprehensive loss, changes in shareholders’ equity and cash flows, for each of the two 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 two years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
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 Public Company Accounting Oversight Board (United States) (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. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
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 Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate 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 matters 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 matters below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to which they relate.
Liabilities related to future royalties and milestones, net (the “Liabilities”)
| Description of the matter | As explained in Note 12 to the consolidated financial statements, the Company entered into a collaboration agreement with BXLS V- Autobahn L.P (“Blackstone”) in 2021 for the development of certain CAR T therapy products for which the Company received an upfront payment and subsequently certain milestone payments, which were initially recognized as a liability. In 2024, the Company entered into a similar arrangement with BioNTech SE (“BioNTech”), as detailed in Note 1 to the consolidated financial statements. As disclosed in Note 2 to the consolidated financial statements, the Liabilities are remeasured when significant assumptions associated with the underlying cashflows change. These assumptions include significant unobservable inputs, such as the probability of success of the clinical trial and regulatory approval (“POS”), patient population and the estimated selling prices of products in different territories. Auditing the Company's measurement of the Liabilities was especially challenging, because the measurement involves significant management judgments about future events, which are inherently uncertain. In particular, the measurement of the Liabilities was sensitive to the Company’s estimates of POS, patient volumes, and pricing of the products on which royalties will be paid. |
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| How we addressed the matter in our audit | To test the measurement of the Liabilities, our audit procedures included, among others, meeting with management to understand the basis for changes in the POS, patient volumes, and forecast selling prices. We evaluated the POS assumption, with the assistance of our life sciences specialist, by assessing industry benchmarks for similar products and analysts’ reports. We evaluated management’s patient population model, including assessing inputs to the model and the reasonableness of the outputs, with the assistance of our life sciences specialist, by performing procedures such as examining published data from third party sources and reperforming calculations. We evaluated management’s selling price assumptions by comparing them to competitor prices from publicly available information. With the assistance of our financial modeling specialist, we evaluated the underlying financial model by performing recalculations and sensitivity analyses on significant assumptions and comparing them to those used by management. |
Revenue recognition – Product revenue, net
| Description of the matter | The Company began to recognize product revenue during 2025. As discussed in Note 2 to the consolidated financial statements, the Company’s AUCATZYL treatment comprises two separately administered doses. The Company determined that the two doses constitute a single performance obligation under ASC 606, Revenue from Contracts with Customers, and that the performance obligation is satisfied when the patient receives the second, final dose. Auditing the Company's revenue recognition for the AUCATZYL treatment was especially challenging, because it required significant judgment in evaluating whether the two doses represented a single performance obligation or two separate performance obligations, and in determining the point at which the Company satisfies the performance obligation. |
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| How we addressed the matter in our audit | To evaluate the Company’s revenue recognition policy and its determination of performance obligations, our audit procedures included, among others, reviewing the relevant contractual arrangements with the Authorized Treatment Centers and the US wholesaler, and evaluating the terms of these arrangements against the criteria in ASC 606 for identifying performance obligations, including the requirements for a promised good or service to be distinct. We evaluated the point at which the AUCATZYL performance obligation is satisfied, by analyzing the indicators of transfer of control under ASC 606. |
/s/Ernst & Young LLP
We have served as the Company’s auditor since 2017.
Reading, United Kingdom
March 27, 2026
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.