BioNTech SE Quarterly Report for the Three and Nine Months Ended

Quarterly Report for the Three and Nine Months Ended September 30, 2021

Quarterly Report for the Three and Nine Months Ended September 30, 2021

Interim Condensed Consolidated Financial Statements

Operating and Financial Review and Prospects

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Profit or Loss

The accompanying notes form an integral part of these interim consolidated financial statements.

Interim Condensed Consolidated Statements of Comprehensive Income (Loss)

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

Interim Condensed Consolidated Statements of Financial Position

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

Interim Condensed Consolidated Statements of Changes in Stockholders' Equity

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

Interim Condensed Consolidated Statements of Cash Flows

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements

1 Corporate Information

BioNTech SE is a limited company incorporated and domiciled in Germany. The registered office is located in Mainz, Germany (An der Goldgrube 12, 55131 Mainz). The accompanying unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries and have been prepared on a going concern basis in accordance with the International Financial Reporting Standards, or IFRS as issued by the International Accounting Standards Board, or IASB. References to the "Company", "BioNTech", "Group", "we", "us" and "our" refer to BioNTech SE and its consolidated subsidiaries.

We combine decades of groundbreaking research in immunology, a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. We leverage powerful new therapeutic mechanisms and exploit a diverse array of biological targets to harness the power of each patient's immune system to address the unique molecular signature of each patient's underlying disease. Our broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. The breadth of our immunotherapy technologies and expertise enables us to develop potential therapies and vaccines to address infectious diseases and a broad range of indications beyond. We rapidly mobilized these to address the COVID-19 pandemic with our COVID-19 vaccine, referred to as COMIRNATY in the European Union, the United States, and certain other locations where we have received marketing approval.

In March 2021, a new entity BioNTech Turkey T bbi r nler Ve Klinik Ara tirma Ticaret Anonim irketi, which translates into English as BioNTech Turkey Pharmaceutical Products and Clinical Trials Trading JSC, Istanbul, Turkey, was founded in Turkey and is a wholly owned consolidated subsidiary of BioNTech SE.

In July 2021, BioNTech Pharmaceuticals Co. Ltd., Shanghai, China, was founded and is a wholly owned subsidiary of BioNTech Pharmaceuticals Asia Pacific Pte. Ltd., a wholly owned consolidated subsidiary of BioNTech SE.

In September 2021, BioNTech Services Marburg GmbH was founded and is a wholly owned consolidated subsidiary of BioNTech SE.

Our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2021 were authorized for issuance in accordance with a resolution of the audit committee on November 9, 2021.

2 Basis of Preparation, Significant Accounting Policies and further Accounting Topics

Basis of Preparation and Principles of Consolidation

The accompanying unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2021 have been prepared in accordance with International Accounting Standard (IAS) 34 Interim Financial Reporting.

The unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in the consolidated financial statements, and should be read in conjunction with our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 20-F as of and for the year ended December 31, 2020.

We prepare and present our unaudited interim condensed consolidated financial statements in Euros. If not stated differently, amounts are rounded and presented in millions of Euros. Accordingly, numerical figures shown as totals in some tables may not be exact arithmetic aggregations of the figures that preceded them and figures presented in the explanatory notes may not add up to the rounded arithmetic aggregations.

The unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2021 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

Significant Accounting Judgments, Estimates and Assumptions

The preparation of the unaudited interim condensed consolidated financial statements requires our management to make judgments, estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities and the accompanying disclosures. This includes but is not limited to the judgment described as "Pfizer Agreement Characteristics" in the notes to our audited consolidated financial statements as of and for the year ended December 31, 2020. In order to determine our share of the collaboration partner's gross profits, we used certain information from the collaboration partner, including revenues from the sale of products, some of which is based on preliminary data shared between the partners. These estimated figures may change in future periods as we receive final data from our collaboration partner. Those changes in our share of the collaboration partner's gross profit are recognized prospectively as a change in estimates. Our management continually evaluates judgments and estimates, including such related to the fair value measurement of derivatives, revenues and expenses. Management bases its judgments and estimates on parameters available when the unaudited interim condensed consolidated financial statements were prepared. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Such changes are reflected in the assumptions when they occur.

Significant Accounting Policies

The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial statements are consistent with those followed in the preparation of our audited consolidated financial statements as of and for the year ended December 31, 2020. Certain policies have been described further below due to the activities related to and the transactions occurred during the three and nine months ended September 30, 2021.

Foreign Currency Translation

Foreign currency translation effects related to operating activities include foreign exchange differences arising on operating items such as trade receivables and trade payables and are either shown as other operating income or expenses on a cumulative basis and might switch between those two positions during the year-to-date reporting periods. Foreign currency translation effects presented within finance income and expenses include foreign exchange differences arising on financing items such as loans and borrowings as well as foreign exchange differences arising on cash and cash equivalents and are either shown as finance income or expenses on a cumulative basis and might switch between those two positions during the year-to-date reporting periods.

The IFRS standards applied for the first time as of January 1, 2021, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2020, had no

impact on our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2021.

Operational Impacts of COVID-19

As we advance our clinical programs, we are in close contact with our principal investigators and clinical sites, and are assessing the impact on the clinical trials, expected timelines and costs on an ongoing basis. We have modified the business practices in response to the spread of COVID-19, including restricting employee travel, developing social distancing plans for employees and cancelling physical participation in meetings, events and conferences. In addition, for certain programs, including BNT111, BNT113, BNT122, BNT141 and BNT142 (RiboMabs), BNT151 and BNT152 153 (RiboCytokines) and BNT161 (Influenza), delays in the commencement of trials were experienced, due to slowed patient enrollment and other delays as a result of the COVID-19 pandemic. After several months of delay to focus efforts on our COVID-19 vaccine in 2020, in 2021 we have started three Phase 2 clinical trials for our FixVac product candidates BNT111 and BNT113 and in our iNeST program BNT122 as well as Phase 1 clinical trials for BNT211 (CARVac), BNT221 (NEO-PTC-01, a neoantigen-based T-cell therapy), BNT151 and BNT152+153 (RiboCytokines) as well as BNT411 (TLR-agonist). The delays, even though they were temporary, may negatively impact our operations and overall business by delaying further progress of these clinical trials and preclinical studies. Our operations, including research and manufacturing, could also be negatively impacted due to the potential impact of staff absences as a result of self-isolation procedures or extended illness. Such factors were evaluated and considered when preparing these unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2021. We will continue to evaluate observed and potential effects of the COVID-19 pandemic.

3 Revenues from Contracts with Customers

Disaggregated information on revenues

Set out below is the disaggregation of our revenues from contracts with customers

*Represents sales to our collaboration partners of products manufactured by us.

Research Development Revenues from Collaborations

During the three and nine months ended September 30, 2021, our collaborations with Genentech Inc., or Genentech, Pfizer Inc., or Pfizer, Shanghai Fosun Pharmaceutical (Group) Co., Ltd, or Fosun Pharma, and other collaboration partners were progressed and respective research and development revenues were derived from deferred upfront payments as well as upon achieving development and regulatory milestones.

During the three and nine months ended September 30, 2021, our Influenza collaboration with Pfizer was progressed and research and development revenues of 29.1 million and 43.4 million were derived from deferred upfront payments based on progress incurred and development milestones achieved. In comparison, during the three and nine months ended September 30, 2020, research and development revenues from our collaboration with Pfizer were mainly related to our COVID-19 vaccine collaboration.

As part of our BNT162 vaccine program against COVID-19, we are additionally collaborating with Fosun Pharma to develop a COVID-19 vaccine in China. Upon receiving the authorization for emergency use and launching our COVID-19 vaccine in Hong Kong, development and regulatory milestones of 7.4 million have been achieved and recognized as research and development revenues during the three months ended March 31, 2021. No further research and development revenues were recognized during the nine months ended September 30, 2021. In comparison, during the three and nine months ended September 30, 2020, 1.7 million and 2.6 million research and development revenues were derived from a non-refundable upfront cash payment received as well as development milestones achieved under the collaboration, respectively.

During the three and nine months ended September 30, 2021 commercial revenues increased due to rapid increases in the supply and sales of our COVID-19 vaccine worldwide. We are the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada and holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries, submissions to pursue regulatory approvals on those countries where emergency use authorizations or equivalent were initially granted are ongoing. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Fosun Pharma has marketing and distribution rights in China. The allocation of marketing and distribution rights defines territories in which the collaboration partners act as a principal.

Whenever responsibilities in the manufacturing and supply process of the COVID-19 vaccine shift and the COVID-19 vaccine is transferred, the vaccine is sold from one partner to the other. During the three and nine months ended September 30, 2021, we recognized 312.3 million and 514.3 million of revenues, respectively, from selling drug product batches manufactured by us to our partners.

By supplying our territories during the three and nine months ended September 30, 2021, we recognized 1,350.8 million and 2,586.2 million of revenues, respectively, from direct COVID-19 vaccine sales in Germany and Turkey. The share of gross profit that we owe our collaboration partner Pfizer based on our sales is recognized as cost of sales.

Based on COVID-19 vaccine sales in the collaboration partners' territories, we are eligible to receive a share of their gross profit which represents a net figure and is recognized as collaboration revenues during the commercial phase together with sales milestones that are recorded once the underlying thresholds are met. During the three months ended September 30, 2021, 4,341.5 million gross profit share and 17.0 million of sales milestones have been recognized as revenues. During the nine months ended September 30, 2021, 9,769.9 million gross profit share and 432.8 million of sales milestones have been recognized as revenues. In order to determine our share of our collaboration partners' gross

profits, we used certain information from the collaboration partners, including revenues from the sale of products, some of which is based on preliminary data shared between the partners and might vary once final data is available.

Revenues from contracts with customers were recognized as follows

The cost of sales recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

5 Research and Development Expenses

The research and development expenses recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

6 General and Administrative Expenses

The general and administrative expenses recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

7 Other Operating Income and Expenses

The other operating income recognized during the three and nine months ended September 30, 2021 and 2020 is shown in the following table

The foreign exchange differences included in operating income primarily arose from valuing our U.S. dollar denominated trade receivables which mainly relate to our COVID-19 collaboration with Pfizer, U.S. dollar denominated trade payables as well as our U.S. dollar denominated other financial liabilities which mainly relate to obligations incurred from our license agreements.

The other operating income derived from government grants mainly relates to the government grant for which we became eligible during the year ended December 31, 2020 as part of an initiative by the German Federal Ministry of Education (Bundesministerium f r Bildung und Forschung, or the BMBF) to support our COVID-19 vaccine program, BNT162.

The other operating expenses recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

The loss on derivative instruments at fair value through profit or loss relates to foreign exchange forward contracts that did not qualify for hedge accounting (see Note 10).

8 Finance Income and Expenses

The finance income recognized during the three and nine months ended September 30, 2021 and 2020 is shown in the following table

The finance expenses recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

During the three and nine months ended September 30, 2021, 81.5 million and 293.4 million, finance expenses were recognized, respectively, from remeasuring the derivative embedded in our convertible note (see Note 10).

The foreign exchange differences included in finance income and expenses arose from valuing our U.S. dollar bank accounts.

For the nine months ended September 30, 2021, income taxes are calculated based on the best estimate of the weighted average annual income tax rates expected for the full financial year (estimated annual effective income tax rate) on ordinary income before tax plus the tax effect of any discrete items. Our effective income tax rate was approximately 31% for the nine months ended September 30, 2021. Current income taxes were recognized with respect to the German tax group. For the German entities, the estimated annual effective income tax rate anticipates the full use of the tax loss carry forwards resulting in an expense of the deferred tax assets over the fiscal year 2021. Consequently, during the three and nine months ended September 30, 2021, a proportionate amount of the deferred tax assets related to the tax loss carryforward was utilized. The change in deferred tax assets was partly compensated by deferred tax effects of identified discrete items. As of September 30, 2021, we continue to maintain a valuation allowance against deferred tax assets of our U.S. tax group as there is not sufficient probability in terms of IAS 12 that there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized.

The income taxes recognized during the three and nine months ended September 30, 2021 and 2020 are shown in the following table

10 Financial Assets and Financial Liabilities

Set out below is an overview of financial assets, other than cash and cash equivalents, held as of September 30, 2021 and December 31, 2020

Trade and other receivables significantly increased mainly due to the trade receivables from our COVID-19 collaboration with Pfizer as well as our own sales. The contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. As Pfizer's fiscal quarter for subsidiaries outside the United States differs from ours, it creates an additional time lag between the recognition of revenues and the payment receipt. Consequently, as of September 30, 2021, our trade receivables included in addition to the profit share for the third quarter of 2021, trade receivables which related to the gross profit share for the second quarter of 2021. The payment settling our gross profit share for the second quarter of 2021 (as defined by the contract) was received from our collaboration partner subsequent to the end of the reporting period in October 2021.

Set forth below is an overview of financial liabilities, other financial liabilities and trade payables held as of September 30, 2021 and December 31, 2020

Derivatives not designated as hedging instruments reflect the change in fair value of those foreign exchange forward contracts that were entered into during the three months ended September 30, 2021

to manage some of our transaction exposures. The foreign exchange forward contracts are intended to reduce the level of foreign currency risk related to trade receivables denominated in U.S. dollar.

Other financial liabilities increased mainly due to obligations incurred from our license agreements.

Risk management activities