BioNTech SE Files 20-F Annual Report for Fiscal Year 2023

TL;DR

<b>BioNTech SE submitted its 2023 annual report, detailing financial performance and business operations.</b>

AI Summary

BioNTech SE (BNTX) filed a Foreign Annual Report (20-F) with the SEC on March 20, 2024. BioNTech SE filed its 20-F annual report for the fiscal year ending December 31, 2023. The report covers the period from January 1, 2023, to December 31, 2023. The company's principal executive offices are located at An der Goldgrube 12, Mainz, Germany. BioNTech SE is classified under SIC code 2836 for Biological Products (No Diagnostic Substances). The filing includes data related to Commercial and Research and Development segments for 2023, 2022, and 2021.

Why It Matters

For investors and stakeholders tracking BioNTech SE, this filing contains several important signals. This filing provides a comprehensive overview of BioNTech's financial health and strategic direction for the past fiscal year, crucial for investors assessing the company's performance and future prospects. As a key player in the biotechnology sector, BioNTech's annual report offers insights into its ongoing research and development efforts, product commercialization, and overall market position.

Risk Assessment

Risk Level: medium — BioNTech SE shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology industry, facing risks related to drug development, clinical trials, and market adoption, as evidenced by its focus on R&D and commercial segments.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 20-F to understand BioNTech's performance drivers and potential challenges in the evolving biotech landscape.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the report)
• 2023-01-01 — Fiscal Year Start (Period covered by the report)
• 0001776985 — Central Index Key (Company identifier)
• 001-39081 — SEC File Number (SEC filing identifier)

Key Players & Entities

• BioNTech SE (company) — Filer of the 20-F report
• 20-F (filing) — Type of report filed
• 2023-12-31 (date) — Fiscal year end date
• An der Goldgrube 12, Mainz (location) — Company's business address
• 2836 (industry_code) — Standard Industrial Classification code

FAQ

Risk Factors

• Regulatory Environment [high — regulatory]: The company operates in a highly regulated industry, subject to stringent oversight from health authorities worldwide, which can impact product development and commercialization timelines.
• Market Competition [high — market]: The biotechnology market is intensely competitive, with numerous companies vying for market share and innovation, posing a risk to BioNTech's commercial success.
• Research and Development Risks [high — operational]: Drug development is inherently risky, with a high failure rate in clinical trials, potentially leading to significant financial losses and delays in product launches.

Key Dates

• 2024-03-20: Filing Date — Submission of the 2023 20-F annual report
• 2023-12-31: Fiscal Year End — End of the reporting period

Filing Documents

• bntx-20231231.htm (20-F) — 4985KB
• exhibit24descriptionofsecu.htm (EX-2.4) — 176KB
• exhibit447instadeepamendme.htm (EX-4.47) — 1288KB
• exhibit448oncoc4agreementr.htm (EX-4.48) — 715KB
• exhibit449oncoc4amendmentr.htm (EX-4.49) — 23KB
• exhibit450dualityher2agree.htm (EX-4.50) — 461KB
• exhibit451dualityb7h3agree.htm (EX-4.51) — 570KB
• exhibit452dualitytrop2agre.htm (EX-4.52) — 557KB
• exhibit453biotheusagreemen.htm (EX-4.53) — 672KB
• exhibit454autoluslicensean.htm (EX-4.54) — 718KB
• exhibit8subsidiariesfy2023.htm (EX-8) — 23KB
• exhibit121certification-us.htm (EX-12.1) — 12KB
• exhibit122certification-jh.htm (EX-12.2) — 12KB
• exhibit131certification-us.htm (EX-13.1) — 7KB
• exhibit132certification-jh.htm (EX-13.2) — 7KB
• exhibit151eyconsent20-f.htm (EX-15.1) — 4KB
• exhibit97biontechcompensat.htm (EX-97) — 24KB
• bntx-20231231_g1.jpg (GRAPHIC) — 169KB
• bntx-20231231_g2.jpg (GRAPHIC) — 102KB
• bntx-20231231_g3.jpg (GRAPHIC) — 123KB
• bntx-20231231_g4.jpg (GRAPHIC) — 55KB
• image_0.jpg (GRAPHIC) — 12KB
• image_01.jpg (GRAPHIC) — 32KB
• 0001776985-24-000027.txt (&nbsp;) — 25512KB
• bntx-20231231.xsd (EX-101.SCH) — 148KB
• bntx-20231231_cal.xml (EX-101.CAL) — 124KB
• bntx-20231231_def.xml (EX-101.DEF) — 599KB
• bntx-20231231_lab.xml (EX-101.LAB) — 1107KB
• bntx-20231231_pre.xml (EX-101.PRE) — 841KB
• bntx-20231231_htm.xml (XML) — 3230KB

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 7

OFFER STATISTICS AND EXPECTED TIMETABLE

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 7

KEY INFORMATION

ITEM 3. KEY INFORMATION 7 A. [ Reserved] 7 B. Capitalization and Indebtedness 7 C. Reasons for the Offer and Use of Proceeds 7 D. Risk Factors 7

INFORMATION ON THE COMPANY

ITEM 4. INFORMATION ON THE COMPANY 82 A. History and Development of the Company 82 B. Business Overview 83 C. Organizational Structure 160 D. Property, Plant and Equipment 160

UNRESOLVED STAFF COMMENTS

ITEM 4A. UNRESOLVED STAFF COMMENTS 163

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 163 A. Operating Results 164 B . Liquidity and Capital Resources 169 C . Research and Development, Patents and Licenses, etc . 173 D . Trend Information 173 E. C ritical Accounting Estimates 173

DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 173 A. Directors and Senior Management 173 B. Compensation 177 C. Board Practices 186 D. Employees 192 E. Share Ownership 193 F. Disclosure of a Registrant ' s Action to Recover Erroneously Awarded Compensation 193

MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 193 A. Major Shareholders 193 B. Related Party Transactions 195 C. Interests of Experts and Counsel 195

FINANCIAL INFORMATION

ITEM 8. FINANCIAL INFORMATION 195 A. Consolidated Statements and Other Financial Information 195 B. Significant Changes 195

THE OFFER AND LISTING

ITEM 9. THE OFFER AND LISTING 195 A. Offer and Listing Details 195 B. Plan Of Distribution 195 1 Table of Content s C. Markets 195 D. Selling Shareholders 195 E. Dilution 195 F. Expenses of the Issue 195

ADDITIONAL INFORMATION

ITEM 10. ADDITIONAL INFORMATION 195 A. Share C apital 195 B. Memorandum and Articles of Association 196 C. Material Contracts 201 D. Exchange Controls 201 E. Taxation 201 F. Dividends and Paying Agents 211 G. Statement by Experts 211 H. Documents on Display 211 I. Subsidiary Information 212

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 212

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 212 A. Debt Securities 212 B. Warrants and Rights 213 C. Other Securities 213 D. American Depositary Shares 213 PART II

DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 214

MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 214

CONTROLS AND PROCEDURES

ITEM 15. CONTROLS AND PROCEDURES 214

[R ESERVED ]

ITEM 16. [R ESERVED ] 215

Audit Committee Financial Expert

ITEM 16A. Audit Committee Financial Expert 215

Code of Ethics

ITEM 16B. Code of Ethics 215

Principal Accountant Fees and Services

ITEM 16C. Principal Accountant Fees and Services 216

Exemptions from the Listing Standards for Audit Committees

ITEM 16D. Exemptions from the Listing Standards for Audit Committees 216

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers 217

Changes in Registrant's Certifying Accountant

ITEM 16F. Changes in Registrant's Certifying Accountant 218

Corporate Governance

ITEM 16G. Corporate Governance 218

Mine Safety Disclosure

ITEM 16H. Mine Safety Disclosure 229

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

ITEM 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 229 ITEM 16J. Insider Trading Policies 229 ITEM 16K. Cybersecurit y 229 2 Table of Content s PART III

FINANCIAL STATEMENTS

ITEM 17. FINANCIAL STATEMENTS 231

FINANCIAL STATEMENTS

ITEM 18. FINANCIAL STATEMENTS 231

EXHIBITS

ITEM 19. EXHIBITS 232 3 Table of Content s GENERAL INFORMATION In this Annual Report on Form 20-F ("Annual Report"), "BioNTech," the "Group," the "Company," "we," "us," and "our" refer to BioNTech SE and its consolidated subsidiaries, except where the context otherwise requires. In response to the fact that our consolidated financial statements are published in Euro, the selected consolidated financial data is presented in Euro as well. Amounts in U.S. dollar are translated into Euro using the exchange rates as per period end or average exchange rates for the periods indicated as published by the German Central Bank ( Deutsche Bundesbank ). All references in this Annual Report to "

Identity of Directors, Senior Management and Advisers

Item 1. Identity of Directors, Senior Management and Advisers Not applicable .

Offer Statistics and Expected Timetable

Item 2. Offer Statistics and Expected Timetable Not applicable.

Key Information

Item 3. Key Information A. [Reserved] B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors Our business is subject to various risks, including those described below. You should consider carefully the risks and uncertainties described below and in our future filings. If any such risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. Additionally, risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations and/or prospects. Risk Factor Summary Demand for our COVID-19 vaccine, though difficult to predict, is expected to continue to decrease in the near future. Changing market dynamics will impact our revenue, which currently depends heavily on sales of our COVID-19 vaccine, and result in challenges relating to production of our COVID-19 vaccine. Our reported commercial revenue is partially based on preliminary estimates of COVID-19 vaccine sales and costs from Pfizer Inc., or Pfizer, that are likely to change in future periods, which may impact our reported financial results. We may be unsuccessful in adapting our COVID-19 vaccine or developing future versions of our COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus and, even if we are successful, a market for vaccines against these variants may not develop. Significant adverse events may occur during our clinical trials or even after receiving regulatory approval, which could delay or terminate clinical trials, delay or prevent regulatory approval or market acceptance of any of our product candidates. Since commercialization, we have received, and expect to continue to receive, product liability claims related to our COVID-19 vaccine. If we are unable to continue to increase our marketing and sales capabi

View Full Filing

View this 20-F filing on SEC EDGAR