Amendment: SEC Form 20-F/A filed by BioNTech SE
$BNTX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F/A
(Amendment No. 1)
OF 1934
OR
For the fiscal year ended December 31 , 2025
OR
OR
Commission file number: 001-39081
(Exact name of Registrant as specified in its charter)
Federal Republic of Germany
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
c/o BioNTech SE
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered, pursuant to Section 12(b) of the Act
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
— | ||||||||||||||
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number of outstanding shares of each of the issuer’s classes of capital stock or common stock as of the close of business covered by the annual report.
Ordinary shares, no par value, with a notional amount attributable to each share of €1 outstanding up until March 27, 2026, the most recent practicable date, no par value: 252,884,261
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☒ | Accelerated filer | ☐ | Non-accelerated filer | ☐ | Emerging growth company | ||||||||||||||||||
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐ | Other ☐ | |||||||||||||
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
* Listed not for trading or quotation purposes, but only in connection with the registration of American Depositary Shares representing such ordinary shares pursuant to the requirements of the Securities and Exchange Commission. The American Depositary Shares are registered under the Securities Act of 1933, as amended, pursuant to a separate registration statement on Form F-6 (File No. 333-233898).
EXPLANATORY NOTE
This Amendment No. 1 on Form 20-F/A (the “Amendment”) amends the Annual Report on Form 20-F for the year ended December 31, 2025 of BioNTech SE (the “Company”), as originally filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 10, 2026 (the “Original Filing”).
This Amendment is being filed solely to correct a typographical error in the Original Filing in which an incorrect date of the opinions of EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft (PCAOB ID: 1251 ) was inadvertently included on pages F-7 and F-9. The updated opinions are included in this Amendment with the date corrected from March 10, 2025 to March 10, 2026. The Exhibit 15.1 that was filed with the Original Filing is not affected by this update.
Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment No. 1 also includes, as Exhibits 12.1 and 12.2, the certifications of the Principal Executive Officer and Principal Financial Officer of the Company pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, and, as Exhibits 13.1 and 13.2, the certifications of the Chief Executive Officer and the Chief Financial Officer of the Company pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
Except as described above, and to update the most recent practicable share count on the cover page of this Amendment, no changes have been made to the Original Filing, and this Amendment does not modify, amend or update the financial or other information contained in the Original Filing. This Amendment does not reflect any events that have occurred on or after the Original Filing date.
Item 19. Exhibits
Exhibit Number | Description | |||||||
| 12.1* | ||||||||
| 12.2* | ||||||||
| 13.1* | ||||||||
| 13.2* | ||||||||
| 101.INS | XBRL Instance Document | |||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
* Filed herewith.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Supervisory Board of BioNTech SE.
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of BioNTech SE (the Company) as of December 31, 2025 and 2024, the related consolidated statements of profit or loss, comprehensive income, changes in stockholders’ equity 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 International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board and in conformity with IFRS as adopted by the European Union.
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 March 10, 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 Matters
The critical audit matters communicated below are matters arising from the current period audit of the 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 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 separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Revenue recognition from collaboration partner’s COVID-19 vaccine sales | |||||
Description of the Matter | As described in more detail in Note 6 to the consolidated financial statements, the Company recognized revenues associated with COVID-19 vaccine sales of €2.0 billion, mainly comprising the Company’s share of its collaboration partner´s gross profit. The Company was contractually eligible to receive a share of the collaboration partner’s gross profit from vaccine sales in the collaboration partner’s territories. Such gross profit share was recognized as collaboration revenue. In order to determine the gross profit share, the Company used certain information from the collaboration partner, including vaccine sales outside of the United States and associated production costs, some of which was based on preliminary data shared by the partner and might differ once final data is available. Auditing revenue recognition specific to the gross profit share was complex due to the significant estimation uncertainty in inputs to the calculation. Specifically, the collaboration partner’s vaccine sales outside of the United States and associated manufacturing and shipping costs are partially estimated for the last month in the period based on historical information and could change based on the actual vaccine sales and costs incurred. | ||||
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of the Company’s controls related to revenue recognition from the collaboration partner’s vaccine sales outside of the United States. For example, we tested controls over management’s review of the significant assumptions used to determine the gross profit share the Company is eligible to receive. Our audit procedures included, among others, reading the contract with the collaboration partner to understand key terms and obtaining an understanding of management’s methodology and assumptions used to calculate the estimated gross profit share. We performed a hindsight analysis to assess management’s accuracy in estimating the collaboration partner’s vaccine sales outside of the United States and manufacturing and shipping costs. We obtained a confirmation directly from the collaboration partner regarding vaccine sales and cost inputs used to estimate the profit share and tested the completeness and accuracy of the Company’s gross profit share calculation. We performed a sensitivity analysis of the significant assumptions to evaluate the change in the gross profit share resulting from changing the assumptions, as well as an analysis of previous estimation compared to the actual payments obtained to date. We evaluated the Company’s related disclosures in the consolidated financial statements. | ||||
Revenue recognition from out-licensing to collaboration partner | |||||
Description of the Matter | The Company recorded €0.6 billion in revenues from a collaboration agreement with Bristol-Myers Squibb (the BMS Collaboration Agreement) for the year ended December 31, 2025. As discussed in Note 6 to the consolidated financial statements, the terms of the BMS Collaboration Agreement include a license for the Company’s intellectual property. Amounts received under such arrangement include a non-refundable upfront payment, non-contingent anniversary payments and other contingent payments for the achievement of certain development, regulatory and commercial milestones. Based on the terms of the contract, the Company identified material rights relating to options to cancel the contract. Each material right is recognized as revenue at the point in time the collaboration partner makes use of its option or when such right expires. Auditing the Company's revenue recognition for the BMS Collaboration Agreement was complex because it required significant judgement in determining the nature of the license and the appropriate timing of revenue recognition, including assessing whether the license is distinct from the development activities, how consideration should be allocated to performance obligations, and when material rights associated with cancellation options should be recognized as revenue. These judgements had a significant impact on the amount and timing of revenue recognized. | ||||
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s process for revenue recognition from the collaboration partner, including controls assessing the accounting treatment of the BMS Collaboration Agreement. Our audit procedures included, among others, reading the relevant contracts related to the BMS Collaboration Agreement to understand key terms and purpose and design of the collaboration arrangement, evaluating management’s application of IFRS 15 to determine the timing of revenue recognition, including the treatment of the license and the allocation of consideration to material rights. We assessed the reasonableness of management’s judgments by comparing the underlying inputs and analyses of those judgements to the terms of the BMS Collaboration Agreement, relevant accounting guidance and the Company’s historical practices for collaboration arrangements. We also evaluated the Company’s related disclosures in the consolidated financial statements. | ||||
Claims and legal contingencies | |||||
Description of the Matter | As described in more detail in Note 18 to the consolidated financial statements, the Company is involved in various claims and litigation specifically related to patent infringements matters. The Company, assisted by their internal and external legal counsel, assesses the need to record a provision or disclose a contingency on a case-by-case basis considering the underlying facts of each matter. The Company discloses contingent liabilities in circumstances where a cash outflow is probable, but management is unable to make a reasonable estimate of the expected financial effect that will result from ultimate resolution of the proceeding, or a cash outflow is reasonably possible. A provision is recorded when a cash outflow is deemed probable and reasonably estimable. Auditing management's determination of whether a loss of such patent liability matters is probable and reasonably estimable, reasonably possible or remote, and the related disclosures, is highly subjective and requires significant judgement. | ||||
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of the Company’s controls in assessing the completeness, valuation, presentation and disclosures with respect to such claims and legal proceedings. For example, this included testing controls related to the Company’s process for identification, recognition, measurement and disclosure of claims and legal contingencies. Our substantive procedures included, among others, assessing the completeness of the claims and legal proceedings subject to evaluation by the Company and the determination of the probability of their outcomes through review of presentations for board meetings and inspection of letters addressing the matters from both internal and external legal counsel. Further, we held discussions with internal counsel to confirm our understanding of the allegations, reviewed legal expenses incurred, evaluated resolutions of claims concluded against management’s historical assessments and obtained written representations from executives of the Company confirming the completeness and accuracy of the information provided. We evaluated the adequacy of the Company’s disclosures in relation to these matters. | ||||
Acquisition of Biotheus – Accounting and Valuation of the Settlement of Pre-Existing Relationships and Valuation of Intangible Assets | |||||
Description of the Matter | As described in Note 5 to the consolidated financial statements, in 2025 the Company completed its acquisitions of Biotheus for total consideration of €280.1 million (the Biotheus Acquisition). The acquisition was accounted for as business combination, and the Company recorded intangible assets, primarily consisting of in-process research and development, of €172.8 million. The Biotheus Acquisition also included the settlement of a pre-existing relationship of €567.3 million which has been accounted for outside of the business combination and purchase price allocation. Auditing management’s accounting for the Biotheus Acquisition was subjective and complex given the high degree of judgement and significant estimation uncertainty applied in determining the total consideration from the purchase price net of amounts attributable to the settlement of the pre existing relationship, as well as the fair value of the intangible assets acquired. The significant estimation uncertainty was primarily due to the sensitivity of the respective fair values of the intangible assets acquired and measurement of the pre-existing relationship to underlying assumptions, including estimated probabilities of successful development, revenue projections, and discount rates. These significant assumptions were forward-looking and could be affected by future market and economic conditions. | ||||
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s business combination process including controls over the accounting conclusions reached and the development and approval of the significant assumptions used in the discounted cash-flow models to determine the valuation for the settlement of the pre-existing relationship and the intangible assets acquired. To audit the accounting for the Biotheus Acquisition, our procedures included, among others, assessing management’s documentation on the accounting treatment, reading the relevant purchase agreement and assessing the settlement of the identified pre-existing relationship. We evaluated the reasonableness of estimated probabilities of successful development and revenue projections by comparing them to observable industry and economic trends and standards, external data sources, and historical product trends, including those of similar products, where applicable. With the assistance of our valuation specialists, we evaluated the methodologies utilized by the Company and tested the discount rates by comparing to independently developed ranges and assessing underlying data against external sources. We also performed sensitivity analyses of the significant assumptions to evaluate the change in the fair values resulting from changes in the assumptions and assessed the adequacy of the Company’s disclosures. | ||||
Acquisition of CureVac N.V. – Valuation of Intangible Assets | |||||
Description of the Matter | As described in Note 5 to the consolidated financial statements, in 2025 the Company completed its acquisition of CureVac N.V. for total consideration of €400.1 million (“the CureVac Acquisition”). The CureVac Acquisition was accounted for as business combination, and the Company recorded intangible assets, primarily consisting of intellectual property rights, licenses and similar rights, of €240.3 million. Auditing the valuation of acquired intangible assets was complex due to the significant estimation uncertainty, primarily attributable to the sensitivity of fair values of the intangible assets to underlying assumptions, including estimated probabilities of successful development, revenue projections, and discount rates. These significant assumptions were forward-looking and could be affected by future market and economic conditions. | ||||
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s business combination process including controls over the accounting conclusions reached and the development and approval of the significant assumptions used in the discounted cash-flow models to determine the valuation of the intangible assets acquired. To audit the valuation for acquired intangible, our procedures included, among others, assessing the reasonableness of estimated probabilities of successful development and revenue projections by comparing them to observable industry and economic trends and standards, external data sources, and historical product trends, including those of similar products, where applicable. With the assistance of our valuation specialists, we evaluated the methodologies utilized by the Company and tested the discount rates by comparing to independently developed ranges and assessing underlying data against external sources. We also performed sensitivity analyses of the significant assumptions to evaluate the change in the fair values resulting from changes in the assumptions and assessed the adequacy of the Company’s disclosures. | ||||
/s/ EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft
We have served as the Company’s auditor since 2018
March 10, 2026
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Supervisory Board of BioNTech SE.
Opinion on Internal Control Over Financial Reporting
We have audited BioNTech SE’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),” (the COSO criteria). In our opinion, BioNTech SE (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
As indicated in the accompanying Management’s Annual Report on Internal Control over Financial Reporting, management’s assessment of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Biotheus Inc. and Curevac B.V., which are included in the 2025 consolidated financial statements of the Company and constituted approximately 6% of total assets as of December 31, 2025 and 0% of revenues for the year then ended. Our audit of internal control over financial reporting of the Company also did not include an evaluation of the internal control over financial reporting of Biotheus Inc. and Curevac B.V.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated statements of financial position of the Company as of December 31, 2025 and 2024, the related consolidated statements of profit or loss, comprehensive income, changes in stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and our report dated March 10, 2026 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft
March 10, 2026
SIGNATURES
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F/A and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.
BioNTech SE | ||||||||||||||
Date: April 1, 2026 | By: | /s/ Prof. Ugur Sahin, M.D. | ||||||||||||
Prof. Ugur Sahin, M.D. | ||||||||||||||
Chief Executive Officer | ||||||||||||||
Date: April 1, 2026 | By: | /s/ Ramón Zapata Gomez | ||||||||||||
Ramón Zapata Gomez | ||||||||||||||
Chief Financial Officer | ||||||||||||||