bntx-6k_20210809.DOCX.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF AUGUST 2021

COMMISSION FILE NUMBER 001-39081

BioNTech SE
(Translation of registrant’s name into English)

An der Goldgrube 12

D-55131 Mainz

Germany

+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F Form 40‑F

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7):



DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

 

On August 09, 2021, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three and six months ended June 30, 2021. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company, for the three and six months ended June 30, 2021, are attached hereto as Exhibit 99.1 and shall be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and incorporated by reference herein.



SIGNATURE

Pursuant to the requirements of s the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

BioNTech SE

 

 

 

 

 

 

 

By:

/s/ Sierk Poetting

 

 

Name: Sierk Poetting

 

 

Title:   Chief Operating Officer

Date: August 09, 2021



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

Quarterly Report for the Three and Six Months Ended June 30, 2021.

 

 

 

 

 

 

 

bntx-ex991_6.htm

Exhibit 99.1

 

 

 

 

 

 

BioNTech SE

Quarterly Report for the Three and Six Months Ended June 30, 2021

 

 

 


Exhibit 99.1

 

 

BioNTech SE

Quarterly Report for the Three and Six Months Ended June 30, 2021

Index

Interim Condensed Consolidated Financial Statements

 

 

Interim Condensed Consolidated Statements of Profit or Loss

3

 

 

Interim Condensed Consolidated Statements of Comprehensive Income / (Loss)

4

 

 

Interim Condensed Consolidated Statements of Financial Position

5

 

 

Interim Condensed Consolidated Statements of Changes in Stockholder’s Equity

6

 

 

Interim Condensed Consolidated Statements of Cash Flows

7

 

 

Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements

8

 

1

Corporate Information

8

 

 

 

2

Basis of Preparation, Significant Accounting Policies and further Accounting Topics

8

 

 

 

3

Revenues from Contracts with Customers

10

 

 

 

4

Cost of Sales

12

 

 

 

5

Research and Development Expenses

12

 

 

 

6

General and Administrative Expenses

12

 

 

 

7

Other Operating Income

13

 

 

 

8

Finance Income and Expenses

13

 

 

 

9

Income Tax

14

 

 

 

10

Financial Assets and Financial Liabilities

14

 

 

 

11

Inventories

16

 

 

 

12

Issued Capital and Reserves

16

 

 

 

13

Share-Based Payments

17

 

 

 

14

Provisions

19

 

 

 

15

Related Party Disclosures

19

 

 

 

16

Events after the Reporting Period

20

 

 

 

Operating and Financial Review and Prospects

 

 

Operating Results

23

 

 

Liquidity and Capital Resources

40

 

 

Risk Factors

45

 

 

 

 

 


 

 

 

 

 

 

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Profit or Loss

 

 

Three months ended

June 30,

Six months ended

June 30,

 

 

 

2021

2020

2021

2020

(in millions, except per share data)

 

Note

(unaudited)

(unaudited)

(unaudited)

(unaudited)

Revenues

 

 

 

 

 

 

Research & development revenues

 

3

€28.0

€32.5

€48.9

€53.7

Commercial revenues

 

3

5,280.5

9.2

7,308.0

15.7

Total revenues

 

 

5,308.5

41.7

7,356.9

69.4

 

 

 

 

 

 

 

Cost of sales

 

4

(883.8)

(5.6)

(1,116.9)

(11.5)

Research and development expenses

 

5

(201.1)

(95.2)

(417.3)

(160.3)

Sales and marketing expenses

 

 

(13.3)

(3.0)

(22.0)

(3.5)

General and administrative expenses

 

6

(47.8)

(18.8)

(86.7)

(34.6)

Other operating expenses

 

 

(0.3)

(0.8)

(0.9)

(0.9)

Other operating income

 

7

36.2

0.8

147.5

1.2

Operating income / (loss)

 

 

€4,198.4

€(80.9)

€5,860.6

€(140.2)

 

 

 

 

 

 

 

Finance income

 

8

0.3

0.2

24.8

0.6

Finance expenses

 

8

(175.4)

(9.3)

(219.1)

(3.4)

Interest expenses related to lease liabilities

 

 

(0.5)

(0.5)

(1.2)

(0.9)

Profit / (loss) before tax

 

 

€4,022.8

€(90.5)

€5,665.1

€(143.9)

 

 

 

 

 

 

 

Income taxes

 

9

(1,235.6)

2.2

(1,749.8)

2.2

Profit / (Loss) for the period

 

 

€2,787.2

€(88.3)

€3,915.3

€(141.7)

 

 

 

 

 

 

 

Earnings per share

 

 

 

 

 

 

Basic profit / (loss) for the period per share

€11.42

€(0.38)

€16.07

€(0.62)

Diluted profit / (loss) for the period per share

€10.77

€(0.38)

€15.14

€(0.62)

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

3


 

 

 

 

 

Interim Condensed Consolidated Statements of Comprehensive Income / (Loss)

 

  

 

 

Three months ended

June 30,

Six months ended

June 30,

 

 

 

2021

2020

2021

2020

(in millions)

 

Note

(unaudited)

(unaudited)

(unaudited)

(unaudited)

Profit / (Loss) for the period

 

 

€2,787.2

€(88.3)

€3,915.3

€(141.7)

 

 

 

 

 

 

 

Other comprehensive income / (loss)

 

 

 

 

 

 

Other comprehensive income / (loss) that may be reclassified to profit or loss in subsequent periods, net of tax

 

 

 

 

 

 

Exchange differences on translation of foreign operations

 

 

€(1.1)

€(3.4)

3.4

(3.5)

Net other comprehensive income / (loss) that may be reclassified to profit or loss in subsequent periods

 

 

€(1.1)

€(3.4)

3.4

(3.5)

 

 

 

 

 

 

 

Other comprehensive income / (loss) for the period, net of tax

 

 

€(1.1)

€(3.4)

3.4

(3.5)

 

 

 

 

 

 

 

Comprehensive income / (loss) for the period, net of tax

 

 

€2,786.1

€(91.7)

€3,918.7

€(145.2)

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


4


 

 

 

 

 

 

Interim Condensed Consolidated Statements of Financial Position

 

 

 

June 30,

December 31,

(in millions)

 

 

2021

2020

Assets

 

Note

(unaudited)

 

Non-current assets

 

 

 

 

Intangible assets

 

 

€164.1

€163.5

Property, plant and equipment

 

 

261.6

227.0

Right-of-use assets

 

 

119.5

99.0

Other assets

 

 

0.9

1.0

Deferred tax assets

 

9

163.2

161.2

Total non-current assets

 

 

€709.3

€651.7

Current assets

 

 

 

 

Inventories

 

11

305.4

64.1

Trade and other receivables

 

10

7,051.7

165.5

Other financial assets

 

10

0.8

137.2

Other assets

 

 

113.1

61.0

Income tax assets

 

 

0.9

0.9

Deferred expenses

 

 

53.5

28.0

Cash and cash equivalents

 

 

914.1

1,210.2

Total current assets

 

 

€8,439.5

€1,666.9

Total assets

 

 

€9,148.8

€2,318.6

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity

 

 

 

 

Share capital

 

 

246.3

246.3

Capital reserve

 

 

1,674.4

1,514.5

Treasury shares

 

 

(3.8)

(4.8)

Retained earnings / (Accumulated losses)

 

 

3,505.7

(409.6)

Other reserves

 

13

60.2

25.4

Total equity

 

 

€5,482.8

€1,371.8

Non-current liabilities

 

 

 

 

Interest-bearing loans and borrowings

 

10

242.9

231.0

Other financial liabilities

 

10

243.4

31.5

Provisions

 

 

5.6

5.5

Contract liabilities

 

 

6.1

71.9

Other liabilities

 

 

4.7

0.6

Deferred tax liabilities

 

 

-

0.3

Total non-current liabilities

 

 

€502.7

€340.8

Current liabilities

 

 

 

 

Interest-bearing loans and borrowings

 

10

13.9

9.1

Trade payables

 

10

262.7

102.3

Other financial liabilities

 

10

698.9

74.1

Government grants

 

7

3.1

92.0

Tax provisions

 

9

1,750.6

-

Other provisions

 

14

98.0

0.9

Contract liabilities

 

 

241.0

299.6

Other liabilities

 

 

95.1

28.0

Total current liabilities

 

 

€3,163.3

€606.0

Total liabilities

 

 

€3,666.0

€946.8

Total equity and liabilities

 

 

€9,148.8

€2,318.6

 

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


 

5


 

 

 

 

 

 

Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity

 

 

(in millions)

 

Note

Share capital

Capital reserve

Treasury shares

Retained earnings / (Accumulated losses)

Other reserves

Total equity

As of January 1, 2020

 

 

€232.3

€686.7

€(5.5)

€(424.8)

€4.8

€493.5

Loss for the period

 

 

-

-

-

(141.7)

-

(141.7)

Other comprehensive loss

 

 

-

-

-

-

(3.5)

(3.5)

Total comprehensive income

 

 

-

-

-

€(141.7)

€(3.5)

€(145.2)

Share-based payments

 

13

-

-

-

-

16.3

16.3

As of June 30, 2020

 

 

€238.2

€918.2

€(5.5)

€(566.5)

€17.6

€602.0

 

 

 

 

 

 

 

 

 

As of January 1, 2021

 

 

€246.3

€1,514.5

€(4.8)

€(409.6)

€25.4

€1,371.8

Profit for the period

 

 

-

-

-

3,915.3

-

3,915.3

Other comprehensive income

 

 

-

-

-

-

3.4

3.4

Total comprehensive income

 

 

-

-

-

€3,915.3

€3.4

€3,918.7

Issuance of share capital

 

12

-

162.6

1.0

-

-

163.6

Transaction costs

 

12

-

(2.7)

-

-

-

(2.7)

Share-based payments

 

13

-

-

-

-

31.4

31.4

As of June 30, 2021

 

 

€246.3

€1,674.4

€(3.8)

€3,505.7

€60.2

€5,482.8

 

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

 

6


 

 

 

 

 

 

Interim Condensed Consolidated Statements of Cash Flows

 

 

Three months ended

June 30,

Six months ended

June 30,

 

 

2021

2020

2021

2020

(in millions)

 

(unaudited)

(unaudited)

(unaudited)

(unaudited)

 

 

 

 

 

 

Operating activities

 

 

 

 

 

Profit / (Loss) for the period

 

€2,787.2

€(88.3)

€3,915.3

€(141.7)

Income taxes

 

€1,235.6

€(2.2)

€1,749.8

€(2.2)

Profit / (loss) before tax

 

€4,022.8

€(90.5)

€5,665.1

€(143.9)

Adjustments to reconcile profit / (loss) before tax to net cash flows:

 

 

 

 

 

Depreciation and amortization of property, plant, equipment and intangible assets

 

16.4

8.8

29.4

17.4

Share-based payment expense

 

22.0

8.3

39.3

16.7

Net foreign exchange differences

 

(70.1)

0.2

(101.3)

(0.1)

Gain on disposal of property, plant and equipment

 

0.2

-

0.4

0.1

Finance income

 

(0.3)

(0.2)

(0.6)

(0.6)

Interest on lease liability

 

0.5

0.5

1.2

0.9

Finance expense

 

175.1

0.1

219.1

0.2

Movements in government grants

 

(20.9)

-

(88.8)

-

Other non-cash income

 

-

(0.2)

-

(0.2)

Working capital adjustments:

 

 

 

 

 

Increase in trade and other receivables, contract assets and other assets

 

(4,651.0)

(7.7)

(6,751.5)

(9.8)

Decrease / (Increase) in inventories

 

(158.5)

1.0

(241.3)

3.2

Increase in trade payables, other financial liabilities, other liabilities, contract liabilities and provisions

 

565.5

64.6

821.0

46.7

Interest received

 

0.3

0.3

0.6

0.6

Interest paid

 

(2.1)

(0.5)

(3.9)

(1.0)

Income tax paid

 

(0.2)

(0.2)

(0.3)

(0.4)

Net cash flows used in operating activities

 

€(100.3)

€(15.5)

€(411.6)

€(70.2)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchase of property, plant and equipment

 

(25.9)

(15.1)

(47.6)

(21.4)

Proceeds from sale of property, plant and equipment

 

0.3

-

1.2

-

Purchase of intangibles assets and right-of-use assets

 

(4.2)

(2.1)

(11.7)

(4.2)

Acquisition of subsidiaries and businesses, net of cash acquired

 

-

7.4

-

0.9

Net cash flows used in investing activities

 

€(29.8)

€(9.8)

€(58.1)

€(24.7)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from issuance of share capital, net of costs

 

160.9

147.8

160.9

147.8

Proceeds from loans and borrowings

 

-

-

-

2.9

Repayment of loans and borrowings

 

(0.7)

(0.3)

(1.4)

(0.3)

Payments related to lease liabilities

 

(7.3)

(1.3)

(11.1)

(2.2)

Net cash flows from financing activities

 

€152.9

€146.2

€148.4

€148.2

 

 

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

22.8

120.9

(321.3)

53.3

Change in cash and cash equivalents resulting from exchange rate differences

 

(0.2)

0.5

25.2

0.6

Cash and cash equivalents at the beginning of the period

 

891.5

451.6

1,210.2

519.1

Cash and cash equivalents at June 30

 

€914.1

€573.0

€914.1

€573.0

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

7


 

 

 

 

 

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 and certain other locations where we have received marketing approval.

In March 2021 a new entity BioNTech Turkey Tıbbi Ürünler Ve Klinik Araştirma Ticaret Anonim Şirketi, 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.

Our unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2021 were authorized for issuance in accordance with a resolution of the audit committee on August 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 six months ended June 30, 2021 have been prepared in accordance with 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.

8


 

 

 

 

 

The unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 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 further described further below due to the activities related to and the transactions occurred during the three and six months ended June 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 six months ended June 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), BNT161 (Influenza) and BNT171 (Rare Disease), delays in the commencement of trials were experienced, due to slowed patient enrollment and other delays as a result of the COVID-19

9


 

 

 

 

 

pandemic. After several months of delay to focus efforts on our COVID-19 vaccine in 2020, we started two Phase 2 clinical trials for our FixVac product candidates BNT111 and BNT113 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). These 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 six months ended June 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:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Research & development revenues from collaborations

 

€28.0

€32.5

€48.9

€53.7

Genentech Inc.

 

13.3

11.3

25.9

26.9

Pfizer Inc.

 

14.3

20.6

14.3

24.2

Shanghai Fosun Pharmaceutical (Group) Co., Ltd

 

-

0.4

7.4

0.9

Other

 

0.4

0.2

1.3

1.7

Commercial revenues

 

5,280.5

9.2

7,308.0

15.7

COVID-19 vaccine revenues

 

5,266.0

-

7,281.6

-

Sales to collaboration partners*

 

138.1

-

202.0

-

Direct product sales to customers

 

1,035.6

-

1,235.4

-

Share of collaboration partner's gross profit and sales milestones

 

4,092.3

-

5,844.2

-

Other sales

 

14.5

9.2

26.4

15.7

Total

 

€5,308.5

€41.7

€7,356.9

€69.4

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

 

Research & Development Revenues from Collaborations

During the three and six months ended June 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 six months ended June 30, 2021, our Influenza collaboration with Pfizer was progressed and €14.3 million research and development revenues were derived from deferred upfront payments based on progress incurred. In comparison, during the three and six months ended June 30, 2020, research and development revenues from our collaboration with Pfizer were mainly related to ourCOVID-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

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during the three months ended March 31, 2021. No further research and development revenues were recognized during the three months ended June 30, 2021. In comparison, during the three and six months ended June 30, 2020, research and development revenues were derived from a non-refundable upfront cash payment received under the collaboration.

Commercial Revenues

During the three and six months ended June 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 European Union, and holder of emergency use authorizations or similar authorizations in the United States (together with Pfizer), the United Kingdom, Canada, Turkey and other countries in advance of a planned application for full marketing authorizations in these countries. 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 months ended June 30, 2021, we recognized €138.1 million of revenues from selling drug product batches manufactured by us to our partners. During the six months ended June 30, 2021, €202.0 million of revenues were recognized from selling drug product batches manufactured by us to our partners.

By supplying our territories during the three and six months ended June 30, 2021, we recognized €1,035.6 million and €1,235.4 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 June 30, 2021, €3,923.7 million gross profit share and €168.6 million of sales milestones have been recognized as revenues. During the six months ended June 30, 2021, €5,428.4 million gross profit share and €415.8 million of sales milestones have been recognized as revenues. In order to determine our share of our collaboration partner’s 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. Based on updated information received from the collaboration partner, we identified a revenue catch-up of €39.9 million which had been recognized prospectively in the commercial revenues during the three months ended June 30, 2021.

The revenues from contracts with customers were recognized as follows:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Timing of revenue recognition

 

 

 

 

 

Goods and services transferred at a point in time

 

€1,187.1

€7.9

€1,460.9

€12.9

Goods and services transferred over time

 

4,121.4

33.8

5,896.0

56.5

Total

 

€5,308.5

€41.7

€7,356.9

€69.4

 

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4

Cost of Sales

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

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Cost of sales related to COVID-19 vaccine revenues

 

€872.1

-

€1,095.3

-

Cost related to other sales

 

11.7

5.6

21.6

11.5

Total

 

€883.8

€5.6

€1,116.9

€11.5

 

5

Research and Development Expenses

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

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Purchased services

 

€99.9

€39.6

€241.8

€58.0

Wages, benefits and social security expense

 

68.2

32.4

115.7

59.5

Laboratory supplies

 

16.5

13.0

27.9

21.2

Depreciation and amortization

 

7.1

6.8

14.6

13.9

Other

 

9.4

3.4

17.3

7.7

Total

 

€201.1

€95.2

€417.3

€160.3

 

6

General and Administrative Expenses

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

 

  

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Wages, benefits and social security expense

 

€17.1

€7.7

€31.4

€14.2

Purchased services

 

11.5

4.1

23.5

8.3

Insurance premiums

 

4.4

0.8

8.7

1.6

IT and office equipment

 

5.4

1.4

8.0

2.7

Depreciation and amortization

 

1.3

1.6

2.6

2.7

Other

 

8.1

3.2

12.5

5.1

Total

 

€47.8

€18.8

€86.7

€34.6

 

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7

Other Operating Income

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

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Government grants

 

€0.1

-

€68.0

-

Foreign exchange differences, net

 

34.4

-

75.1

-

Other

 

1.7

0.8

4.4

1.2

Total

 

€36.2

€0.8

€147.5

€1.2

 

During the three and six months ended June 30, 2021, €67.1 million other operating income was derived from a 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 für Bildung und Forschung, or the BMBF) to support our COVID-19 vaccine program, BNT162.

The foreign exchange differences included in operating income arose from valuing our trade receivables and trade payables that are denominated in U.S. dollar and specifically incur under our COVID-19 collaboration with Pfizer.

8

Finance Income and Expenses

The finance income recognized during the three and six months ended June 30, 2021 and 2020 is shown in the following table:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Foreign exchange differences, net

 

-

-

€24.2

-

Interest income

 

0.3

0.2

0.6

0.6

Total

 

€0.3

€0.2

€24.8

€0.6

 

The finance expenses recognized during the three and six months ended June 30, 2021 and June 30, 2020 are shown in the following table:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Fair value adjustments of financial instruments measured at fair value

 

€170.4

-

€211.9

-

Amortization of financial instruments

 

4.7

0.1

7.2

0.2

Foreign exchange differences, net

 

0.3

9.2

-

3.2

Total

 

€175.4

€9.3

€219.1

€3.4

 

During the three and six months ended June 30, 2021,€170.4 million and €211.9 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.

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9

Income Tax

For the six months ended June 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 six months ended June 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 six months ended June 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 June 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 six months ended June 30, 2021 and 2020 are shown in the following table:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Current income taxes

 

€1,257.0

€0.1

€1,752.1

€0.1

Deferred taxes

 

€(21.4)

€(2.3)

(2.3)

(2.3)

Income taxes

 

€1,235.6

€(2.2)

€1,749.8

€(2.2)

 

10

Financial Assets and Financial Liabilities

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

 

Financial assets at amortized cost

(in millions)

 

June 30,

2021

December 31,

2020

Trade and other receivables

 

€7,051.7

€165.5

Other financial assets

 

0.8

137.2

Total

 

€7,052.5

€302.7

Total current

 

7,052.5

302.7

Total non-current

 

-

-

 

Trade and other receivables significantly increased mainly due to the trade receivables from our own sales and our COVID-19 collaboration with Pfizer. 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 June 30, 2021, our trade receivables included in addition to the profit share for the second quarter of 2021, trade receivables which related to the gross profit share for the first quarter of 2021. The payment settling our gross profit share for the first quarter of 2021 (as defined by the contract) was received from our collaboration partner subsequent to the end of the reporting period in July 2021. Other financial assets decreased as the advance-payment which had been received by our collaboration partner on future deliveries was paid to us during the six months ended June 30, 2021.

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

 

Interest-bearing loans and borrowings

(in millions)

Maturity

June 30,

2021

December 31,

2020

Lease liabilities

 

€97.7

€84.2

Convertible note - host contract

08/28/2024

91.2

87.5

3.50% € 50,000,000 secured bank loan

12/21/2026

47.9

47.2

2.15% € 10,000,000 secured bank loan

12/30/2027

8.4

9.0

2.08% € 9,450,000 secured bank loan

09/30/2028

8.2

8.7

1.90% € 3,528,892.48 secured bank loan

05/30/2039

3.4

3.5

Total

 

€256.8

€240.1

Total current

 

13.9

9.1

Total non-current

 

242.9

231.0

 

Trade payables and other financial liabilities

(in millions)

 

June 30,

2021

December 31,

2020

Derivatives not designated as hedging instrument

 

 

 

Convertible note - embedded derivative

 

€242.8

€30.9

Financial liabilities at fair value through profit or loss

 

 

 

Contingent consideration

 

0.6

0.6

Total financial liabilities at fair value

 

€243.4

€31.5

 

 

 

 

Trade payables and other financial liabilities at amortized cost, other than interest-bearing loans and borrowings

 

 

Trade payables

 

262.7

102.3

Other financial liabilities

 

698.9

74.1

Total trade payables and other financial liabilities at amortized cost, other than interest-bearing loans and borrowings

€961.6

€176.4

 

 

 

 

Total trade payables and other financial liabilities

 

€1,205.0

€207.9

Total current

 

961.6

176.4

Total non-current

 

243.4

31.5

 

Total financial liabilities

(in millions)

 

June 30,

2021

December 31,

2020

Interest-bearing loans and borrowings

 

€256.8

€240.1

Trade payables and other financial liabilities

 

1,205.0

207.9

Total

 

€1,461.8

€448.0

Total current

 

975.5

185.5

Total non-current

 

486.3

262.5

 

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

Risk management activities

No changes have occurred regarding our risk management activities as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2020.

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Fair values

Fair values of cash and cash equivalents, trade receivables, trade payables, and other current financial assets and liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.

The financial liabilities measured at amortized cost include four fixed-interest rate loans as well as our issued convertible note. As of June 30, 2021 and December 31, 2020, the carrying value approximates their fair values as there have been no significant changes in relevant interest rates since the inception of the respective loans and note.

The fair values of financial instruments measured at fair value are reassessed on a quarterly basis. Unchanged to December 31, 2020, we used the Cox-Rubinstein binomial tree model to determine the fair value of the embedded derivative as of June 30, 2021. The valuation technique is based on significant observable inputs (Level 2) and described in further detail in Note 12 our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2020. The fair value adjustment derived from remeasuring the embedded derivative was mainly driven by the increase in our share price, amounted to €170.4 million for the three months ended June 30, 2021 and €211.9 million for the six months ended June 30, 2021, respectively, and was recognized as finance expenses in profit or loss (see Note 8). The initial fair value of the contingent consideration determined at acquisition remains valid since no changes of the underlying performance criteria have occurred.

11

Inventories

Set out below, is an overview of inventories held as of June 30, 2021 and December 31, 2020:

 

(in millions)

 

June 30,

2021

December 31,

2020

Raw materials and supplies

 

€169.3

€44.3

Unfinished goods

 

55.8

19.4

Finished goods

 

80.3

0.4

Total

 

€305.4

€64.1

 

The inventories increased mainly due to our production ramp-up.

12

Issued Capital and Reserves

At-The-Market Offering Program

In November 2020, we entered into a sales agreement, or the Sales Agreement, with Jefferies LLC and SVB Leerink LLC, as sales agents, to establish an at-the-market offering program, pursuant to which we may sell, from time to time, ADSs representing ordinary shares for aggregate gross proceeds of up to $500.0 million. During the three months ended June 30, 2021, we sold 995,890 ADSs, each representing one of our ordinary shares that had previously been held in treasury, under the Sales Agreement for aggregate gross proceeds of $200.0 million (€163.6 million). Reissuing 995,890 ordinary shares was registered as decrease of €1.0 million in treasury shares. As a result of the transaction the capital reserve increased by €162.6 million offset by €2.7 million transaction costs, net of tax.

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13

Share-Based Payments

Expense arising from share-based payment arrangements

During the three and six months ended June 30, 2021 and 2020, the following share-based payment arrangements led to the expenses recognized for services received during the respective periods as shown in the following table:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Expense arising from equity-settled share-based payment arrangements

 

€17.3

€8.1

€32.5

€16.3

Employee Stock Ownership Plan

 

7.1

4.3

11.6

8.6

Chief Executive Officer Grant

 

1.6

3.2

3.3

6.4

Management Board Grant*

 

0.4

0.6

0.9

1.3

BioNTech 2020 Employee Equity Plan for employees based in Europe

 

8.2

-

16.7

-

Expense arising from cash-settled share-based payment arrangements

 

9.8

0.2

11.9

0.4

Management Board Grant*

 

1.2

0.2

1.3

0.4

BioNTech 2020 Restricted Stock Unit Plan for North America Employees

 

8.6

-

10.6

-

Total

 

€27.1

€8.3

€44.4

€16.7

 

 

 

 

 

 

Cost of sales

 

€1.9

€0.2

€3.6

€0.4

Research and development expenses

 

18.8

6.4

30.9

13.0

General and administrative expenses

 

6.1

1.7

9.6

3.3

Total

 

€27.1

€8.3

€44.4

€16.7

* In May 2021, phantom options were granted under the Management Board Grant for the 2021 year which led to a modification from equity-settled to cash-settled share-based payment arrangement and a reclassification of €1.1 million between equity and non-current other liabilities, respectively. Expenses incurred before and after the modification date have been disclosed as equity-settled or cash-settled share-based payment arrangement, respectively.

 

Changes in share-based payment arrangements

New share-based payment arrangements and material changes to arrangements that occurred during the three and six months ended June 30, 2021 are shown below. A detailed description of our share-based payment arrangements is included in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2020.

BioNTech 2020 Employee Equity Plan for employees based in Europe (Equity-Settled)

In December 2020, we adopted the BioNTech 2020 Employee Equity Plan for employees based in Europe, or the European Plan. Under the European Plan Restricted Cash Units, or RSUs, are offered to our employees. As of the grant date in February 2021, with implementing the European Plan for the calendar year 2020, award agreements were entered into with all of our employees who are eligible under the European Plan, or the LTI 2020 program. In addition, further award agreements were entered into with employees who did not participate in the Employee Stock Ownership Plan, or ESOP, or the LTI-plus program. The LTI 2020 program vests annually in equal installments after four years and the LTI-plus program vests annually in equal installments after two years, with both programs commencing in December 2020. Moreover, the LTI-plus program contains a non-vesting condition concerning 50% of the granted RSUs; these units will be awarded to the participants after the U.S. Food and Drug Administration, or the FDA, fully approves BNT162b2, our COVID-19 vaccine. As we have the ability to determine the method of settlement, both programs were classified as equity-settled. The cost of the awards will be recognized over the relevant service period, applying the graded vesting method.

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Set out below is an overview of the RSU’s granted and subsequent changes to RSU’s outstanding during the six months ended June 30, 2021.

 

 

Restricted Stock Units

Weighted average fair value (€)

Granted

 

627,486

89.41

Forfeited

 

(789)

88.70

As of June 30, 2021

 

626,697

89.41

 

The fair value of the awards is based upon the price of our ADSs representing ordinary shares at grant date. A retention assumption is applied when estimating the number of equity instruments for which service conditions are expected to be satisfied and will be revised in case material differences arise. Ultimately, a true-up to the number satisfied until settlement date will be recorded.

BioNTech 2020 Restricted Stock Unit Plan for North America Employees (Cash-Settled)

In December 2020, we adopted the BioNTech 2020 Restricted Stock Unit Plan for North America Employees, or the North American Plan. Under the North American Plan, RSUs are offered to our employees. These RSUs generally vest over four years, with 25% vesting one year after the service commencement date and the remainder vesting in equal quarterly installments thereafter. The first awards under the North American Plan were granted in February 2021. The service date for these awards is the date as of which the employee became employed by BioNTech US. As these RSUs are intended to be cash-settled upon vesting, the awards were defined as a cash-settled share-based payment arrangement. The liability related to these awards is measured, initially and at the end of each reporting period until settled, at the fair value of the award considering the price of the ADSs representing our ordinary shares. The cost of the awards will be recognized over the relevant service period, applying the graded vesting method.

Management Board Grant (partly Equity-Settled, partly Cash-Settled)

Effective from the beginning of 2020, the first year following the completion of our IPO, until the end of the term each of the Management Board members’ employment agreements, such employment agreements provide for a long-term incentive compensation in the form of yearly grants of options to purchase our ordinary shares.

In May 2021, the grant date, phantom options equivalent to the number of options the Management Board members would have been entitled to receive for the 2021 year were granted under the Management Board Grant which led to a modification from equity-settled to cash-settled share-based payment arrangement and a reclassification of €1.1 million between equity and non-current other liabilities. The rights to receive options in 2022 remain determined as equity-settled share-based payment arrangements.

The phantom options allocated to BioNTech’s Management Board as of May 2021 allocation date are presented in the tables below.

 

Phantom options outstanding

 

 

Allocation date May 2021

Prof. Ugur Sahin, M.D.

 

 

17,780

Sean Marett

 

 

7,112

Dr. Sierk Poetting

 

 

7,112

Dr. Özlem Türeci, M.D.

 

 

7,112

Ryan Richardson

 

 

6,163

 

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Measurement of Fair Values

Under this cash-settled share-based payment arrangement, the fair values of the liabilities will be remeasured until the settlement date continuously using a Monte-Carlo simulation model which incorporates the impact of the performance criteria regarding share price and index development as described in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2020. Continuously, the fair values are recognized over the award’s vesting period beginning as of the service commencement date (January 1, 2020) until four years commencing on the first anniversary of the allocation date have lapsed.

14

Provisions

From time to time, we may be involved in legal proceedings arising out of the normal course and conduct of our business. As of June 30, 2021, certain proceedings were pending or threatened against us or our subsidiaries, mainly related to purported obligations arising out of use or alleged use of third party intellectual property. As it is not possible to predict the outcome of such proceedings, particularly given the early stage of such proceedings, our best estimate of potential outflow of economic resources amounts to €96.8 million, which is included in current other provisions in our unaudited interim condensed consolidated statements of financial position as of June 30, 2021. We do not currently believe that any of these matters will have a material effect on our financial position or results of operations. However, this assessment is based on assumptions deemed reasonable by management including those about future events and uncertainties. The outcome of these matters is ultimately uncertain, such that unanticipated events and circumstances might occur that might cause us to change those assumptions and give rise to a material adverse effect on our financial position in the future.

15

Related Party Disclosures

ATHOS KG, Holzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and beneficial owner of our ordinary shares. Entities controlled by ATHOS KG mainly provide rental and property management activities and sell property, plant and equipment to us. The total amount of transactions with ATHOS KG or entities controlled by them was as follows for the periods indicated:

 

 

Three months ended

June 30,

Six months ended

June 30,

(in millions)

 

2021

2020

2021

2020

Purchases of various goods and services from entities controlled by ATHOS KG

 

€0.2

€1.0

€0.4

€1.5

Purchases of property and other assets from entities controlled by ATHOS KG

 

-

2.3

-

2.3

Total

 

€0.2

€3.3

€0.4

€3.8

 

The outstanding balances of transactions with ATHOS KG or entities controlled by them were as follows as of the dates indicated:

 

(in millions)

 

 

 

June 30,

2021

December 31,

2020

ATHOS KG

 

 

 

€0.6

€0.5

Total

 

 

 

€0.6

€0.5

 

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None of the balances are secured and no bad debt expense has been recognized in respect of amounts owed by related parties.

16

Events after the Reporting Period

With effect as of July 1, 2021, the Supervisory Board appointed Jens Holstein to the Management Board as Chief Financial Officer (CFO). Jens Holstein takes over the CFO role from Dr. Sierk Poetting who will fully focus on his tasks as Chief Operating Officer (COO).

On July 9, 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 subsidiary of BioNTech SE.


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Forward-Looking Statements

This quarterly report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: our expected revenues and net profit related to sales of our COVID-19 vaccine, referred to as COMIRNATY® in the European Union as authorized for use under conditional marketing approval, in territories controlled by our collaboration partners, particularly for those figures that are derived from preliminary estimates provided by our partners; our pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after our initial sales to national governments; the extent to which a COVID-19 vaccine continues to be necessary in the future; competition from other COVID-19 vaccines or related to our other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the rate and degree of market acceptance of our COVID-19 vaccine and our investigational medicines, if approved; the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the timing of and our ability to obtain and maintain regulatory approval for our product candidates; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; our ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of our third-party collaborators to continue research and development activities relating to our development candidates and investigational medicines; the impact of the COVID-19 pandemic on our development programs, supply chain, collaborators and financial performance; unforeseen safety issues and claims for personal injury or death arising from the use of our COVID-19 vaccine and other products and product candidates developed or manufactured by us; our Malaria, Tuberculosis and HIV programs, and timing for selecting clinical candidates for these programs and the commencement of a clinical trial, as well as any data readouts; the nature of the collaboration with the African Union and the Africa CDC; the nature and duration of support from WHO, the European Commission and other organizations with establishing infrastructure; the development of sustainable vaccine production and supply solutions on the African continent and the nature and feasibility of these solutions; our estimates of our expenses, ongoing losses, future revenue and capital requirements and our needs for or ability to obtain additional financing; our ability to identify, recruit and retain key personnel; our and our collaborators’ ability to protect and enforce our intellectual property protection for our proprietary and collaborative product candidates, and the scope of such protection; the development of and projections relating to our competitors or our industry; our ability and that of our collaborators to commercialize and market our product candidates, if approved, including our COVID-19 vaccine; the amount of and our ability to use net operating losses and research and development credits to offset future taxable income; our ability to manage our development and expansion; regulatory developments in the United States and foreign countries; our ability to effectively scale our production capabilities and manufacture our products, including our target COVID-19 vaccine production levels, and our product candidates; our ability to implement, maintain and improve effective internal controls; our plans for expansion in southeast Asia and China, including our planned regional headquarters and manufacturing facility in Singapore as well as the joint venture JV with Fosun Pharma; and other factors not known to us at this time. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this quarterly report are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and

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uncertainties described under the heading “Risk Factors” in this quarterly report and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any for-ward-looking statements contained in this quarterly report in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.


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Operating and Financial Review and Prospects

In this report, unless stated or the context otherwise requires, references to the “Company”, “BioNTech”, “Group”, “we”, “us” and “our” refer to BioNTech SE and its consolidated subsidiaries. The following “Operating and Financial Review and Prospects” should be read together with the unaudited interim condensed consolidated financial statements and related notes as presented above. The following discussion is based on our financial information prepared in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described in the “Risk Factors” section further below. Please also see “Forward-Looking Statements” included at the end of this quarterly report for the three and six months ended June 30, 2021.

Operating Results

Overview

BioNTech was founded in 2008 with the goal to develop treatments for patients that address diseases with high unmet medical need. As a next generation immunotherapy company it is our vision to harness the power of the immune system to develop novel therapies against cancer and infectious diseases. To realize this vision, 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 and other locations where we have received marketing approval.

We believe our successful development of a first-in-class COVID-19 mRNA vaccine in less than one year validates our execution capabilities and the power of our technologies to change lives.

We intend to invest the proceeds we generate from sales of our COVID-19 vaccine to accelerate the maturation of our oncology and infectious disease pipeline and the expansion into additional therapeutic areas, such as autoimmunity, allergy, regenerative medicine and inflammatory diseases.

We believe we are well-positioned to develop and commercialize the next generation of immunotherapies with the potential to transform treatment paradigms for many severe diseases and significantly improve clinical outcomes for patients.

We have assembled an exceptional team of over 2,500 employees and have established relationships with eight pharmaceutical collaborators, including Bayer AG, or Bayer, Genentech, Inc., or Genentech, Genevant Sciences GmbH, or Genevant, Genmab A/S, or Genmab, Pfizer Inc., or Pfizer, Regeneron Pharmaceuticals, Inc., or Regeneron, Sanofi S.A., or Sanofi and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., or Fosun Pharma.

Corporate Development

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On May 9, 2021, we agreed on the terms with Fosun Pharma to establish a 50/50 Joint Venture, or JV, to manufacture the COVID-19 vaccine in Mainland China. The establishment of a JV will be conditional on us receiving approval for our COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive JV agreement, in addition to other conditions. As part of our global supply strategy, we believe that establishing local manufacturing capacity for the COVID-19 vaccine could substantially increase our ability to supply vaccines to China upon approval.

 

On May 10, 2021, we announced plans to expand our global footprint to Asia with the establishment of the first regional headquarters for southeast Asia in Singapore. In addition to selecting Singapore as the future regional headquarters, we plan to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singaporean Economic Development Board, or the EDB. The new facility will leverage cutting-edge manufacturing and digital infrastructure and will be equipped to produce a range of novel mRNA vaccines and therapeutics. The envisioned site will bring highly automated and end-to-end mRNA production capabilities. The facility, with an estimated annual capacity of several hundred million doses, shall provide regional and global supply capacity, as well as a rapid response capability for southeast Asia to address potential pandemic threats. We plan to open our Singapore office and initiate construction of the manufacturing facility in 2021, subject to planning approval, and anticipate the site could be operational as early as 2023.

 

With effect as of July 1, 2021, the Supervisory Board appointed Jens Holstein to the Management Board as Chief Financial Officer (CFO). Jens Holstein joined the Management Board to help strengthen our growth trajectory as a global, fully integrated immunotherapy company with an approved or authorized product. He previously served as CFO for MorphoSys AG and in various CFO and general management roles within the Fresenius SE Group. Jens Holstein takes over the CFO role from Dr. Sierk Poetting who will fully focus on his tasks as Chief Operating Officer (COO) going forward.

 

With effect as of August 4, 2021, we entered into a purchase agreement with Kite Pharma Inc., Santa Monica, California, United States to acquire their clinical manufacturing facility in Gaithersburg, Maryland, United States and their T Cell Receptor (TCR) R&D platform. The acquired Gaithersburg facility and employees will provide production capacity to support clinical trials in the United States and will complement our existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of our expanding pipeline of novel cell therapies, including cancer product candidates based on our CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program. Under the terms of the agreement, Kite received a one-time upfront payment from us. The asset acquisition is an important step in our goal to build a global biotechnology company for individualized cancer medicine by further strengthening our footprint in the United States.

Key Pipeline Updates

Below is a summary of our authorized product and clinical product candidates, organized by platform and indication.

Infectious Disease

COVID-19 Vaccine Program – BNT162b2

BNT162b2 Clinical Development Updates

 

Multiple clinical trials are ongoing to expand access to and authorization of BNT162b2 to additional regions and population groups such as the studies in children from 6 months to 11 years of age, and in healthy pregnant women.

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On April 1, 2021, we and Pfizer announced updated topline results from the global Phase 3 trial of BNT162b2 which showed high efficacy and no serious safety concerns through up to six months following the second dose. The data were published on the medRxiv preprint server on July 29, 2021. Topline efficacy was based on an analysis of 971 confirmed symptomatic cases of COVID-19 observed in the pivotal Phase 3 trial through March 13, 2021. BNT162b2 was 91.2% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was also 95.7% effective against severe COVID-19 as defined by the Food and Drug Administration (FDA) as measured seven days after the second dose. Safety data collected demonstrated a favorable safety and tolerability profile. An additional exploratory analysis of 800 trial participants enrolled in South Africa confirmed 100% efficacy against SARS-CoV-2 lineage B.1.351 (Beta variant). These data support previous results from immunogenicity studies published on April 15, 2021 demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B.1.351 lineage. The updated results have been submitted to the regulatory authorities and are currently under review.

 

On April 1, 2021, we and Pfizer started a randomized Phase 3 trial to evaluate the safety, tolerability and immunogenicity of a lyophilized and ready-to-use formulation of BNT162b2, administered on a two-dose (separated by 21 days) schedule in adults aged 18 to 55.

 

A clinical trial within the global Phase 1/2/3 trial is ongoing which includes: (1) an assessment of the impact of a third dose of BNT162b2 in prolonging immunity against COVID-19 and in protecting against COVID-19 caused by potential newly emerging SARS-CoV-2 variants, and (2) an assessment of a modified, variant-specific version of BNT162b2 that targets the full spike protein of the Beta variant. The aim of these studies is to explore the development, manufacturing and regulatory pathway that we and Pfizer would pursue if SARS-CoV-2 were to change enough to require an updated vaccine.

 

In July 2021, we and Pfizer provided an update on our comprehensive booster dose strategy. In initial data from the ongoing Phase 1/2/3 booster trial of a third dose of our current BNT162b2 vaccine we have observed that a booster dose given six months after the second dose has a consistent tolerability profile while eliciting high neutralization titers in both younger and older adults compared to those observed after two primary doses. The immune sera elicited neutralizing titers against the original SARS-CoV-2 wild-type strain that are more than 5 to 8-fold, and more than 15 to 21-fold against the B.1.351 lineage (Beta-variant) than after two primary doses. In addition, a third dose of BNT162b2 elicited neutralizing titers against the Delta variant that are more than 5 to 11-fold than after two doses.  We expect to publish more definitive data about the analysis and plan to submit the data to the FDA, European Medicines Agency, or the EMA, and other regulatory authorities in the coming weeks.

While we believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently tested variants, including Delta. We and Pfizer are remaining vigilant, and we are developing and will clinically test an updated version of the COVID-19 vaccine that targets the full spike protein of the Delta variant. This trial, aimed at studying the Delta variant, is part of ours and Pfizer´s comprehensive strategy to address variants should the need arise in the future. We anticipate the clinical study to begin in August 2021, subject to regulatory approvals.

 

As discussed above, in July 2021, we and Pfizer began a Phase 3 clinical trial to evaluate the safety, tolerability and efficacy of a 30µg booster dose of BNT162b2 versus placebo in approximately 10,000 participants aged 16 years and older who have previously received two doses of BNT162b2 at least six months prior to randomization. Participants will be followed for up to twelve months. The trial is being conducted in the United States, Brazil and South Africa.

Regulatory Updates

 

In May 2021, we and Pfizer announced the expansion of emergency use authorizations, conditional marketing authorizations or equivalents for adolescents 12 years of age and older

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in the United States, European Union and Canada. Authorizations for adolescents 12 years of age and older have been also granted in additional countries.

 

On May 17, 2021, we announced that the FDA and the EMA approved the transportation and storage of thawed, undiluted vials of BNT162b2 at fridge temperatures of 2°C to 8°C for up to one month (31 days).

 

On July 16, 2021, the FDA granted Priority Review designation for the Biologics License Application (BLA) for BNT162b2 to prevent COVID-19 in individuals 16 years of age and older. This follows the completion of the rolling submission of the BLA in May 2021, which includes data from the pivotal Phase 3 clinical trial of the vaccine. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022. Additional submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalents were initially granted are ongoing or planned.

Commercial Updates

We and Pfizer have shipped over one billion doses of BNT162b2 vaccine to more than 100 countries or territories around the world as of July 21, 2021.

The companies have signed orders of approximately 2.2 billion doses for delivery in 2021 and more than one billion doses for 2022 and beyond as of July 21, 2021. Further discussions for additional dose commitments are ongoing for 2021 and beyond.

 

On May 6, 2021, we and Pfizer announced that we signed a Memorandum of Understanding with the International Olympic Committee to donate doses of COVID-19 vaccine to vaccinate athletes, and their delegations, participating in the Tokyo Olympic and Paralympic Games 2020.

 

On May 20, 2021, we and Pfizer announced an agreement with the European Commission, or the EC, to supply 900 million doses to the European Union with an option for the EC to request up to an additional 900 million doses of our COVID-19 vaccine. This brings the total number of potential doses delivered to the EC, inclusive of all agreements, to up to 2.4 billion. The EC also has the option to purchase an updated version of the vaccine that includes new formulations or addresses potential viral variants, if available and approved. All doses for the EC are planned to be manufactured in the European Union.

 

On June 10, 2021, we and Pfizer announced an agreement to provide the U.S. government with 500 million doses at a not-for-profit price, of which 200 million doses will be provided in 2021 and 300 million doses in the first half of 2022. The U.S. government will donate vaccine doses to low- and lower middle-income countries and organizations that support them. These doses are part of our and Pfizer’s previously announced pledge to provide two billion doses of the COVID-19 vaccine to low- and middle-income countries over the next 18 months.

 

On July 23, 2021, we and Pfizer announced that the U.S. government purchased an additional 200 million doses, bringing the total number of doses under the existing supply agreement to 500 million. The companies expect to deliver 110 million of the additional doses by December 31, 2021, and the remaining 90 million doses no later than April 20, 2022. The U.S. government also has the option to acquire an updated version of the vaccine to address potential variants and also new formulations, if available and authorized.

Manufacturing Updates

 

We and Pfizer expect BNT162b2 annual manufacturing capacity to reach three billion doses by the end of 2021 and expect to have capacity to manufacture up to four billion doses in 2022.

 

In the second quarter of 2021, the EMA approved the manufacturing of our COVID-19 vaccine drug product at our facility in Marburg, Germany. This manufacturing facility is one of the largest mRNA vaccine manufacturing sites worldwide with an annual production capacity of

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up to one billion doses of COVID-19 vaccine, once fully operational. The first batches of vaccines manufactured at the Marburg facility were delivered in mid-April 2021.

 

On May 10, 2021, we announced plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the EDB, as well as plans to establish our first regional headquarters for southeast Asia. The new facility will leverage cutting-edge manufacturing and digital infrastructure and will be equipped to produce a range of novel mRNA vaccines and therapeutics. The envisioned site will bring highly automated and end-to-end mRNA production capabilities. The facility, with an estimated annual capacity of several hundred million doses, will provide regional and global supply capacity, as well as a rapid response capability for southeast Asia to address potential pandemic threats. We anticipate the site could be operational as early as 2023.

 

On July 21, 2021, we and Pfizer announced the signing of a letter of intent with the Biovac Institute (Pty) Ltd., or Biovac, a Cape Town-based, South African biopharmaceutical company, for the manufacture of vaccine for distribution within the African Union. Biovac will perform fill and finish manufacturing and distribution activities within our and Pfizer’s global COVID-19 vaccine supply chain and manufacturing network. Biovac’s Cape Town facility is expected to be incorporated into the vaccine supply chain by the end of 2021. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55-member states that make up the African Union.

Influenza Vaccine Program – BNT161

We are also collaborating with Pfizer to develop an influenza vaccine based on our suite of mRNA platforms. A Phase 1 clinical trial is expected to start in the third quarter of 2021. The clinical trial will evaluate modified RNA influenza vaccine candidates based on the proven BNT162b2 COVID-19 vaccine platform. The product candidate, BNT161, is designed to encode influenza virus antigens selected by the WHO in advance of a given flu season.

Other Infectious Diseases

Currently, we and our partners are developing vaccines against nine different infectious diseases.

 

On July 26, 2021, we announced plans to develop sustainable solutions to address infectious diseases on the African continent. As part of the plans, we aim to develop a well-tolerated and highly effective Malaria vaccine, beginning with the initiation of a clinical trial by end of 2022. We will assess multiple vaccine candidates featuring known targets such as circumsporozoite protein (CSP) as well as new antigens discovered in the pre-clinical research phase. The second objective is dedicated to the development of sustainable vaccine production and supply solutions on the African continent. To this end, we are exploring possibilities to set up state-of-the-art mRNA manufacturing facilities, either with partners or on our own. This strategy aims to expand the capacity of low- and middle-income countries to manufacture contemporary vaccines end-to-end and scale up production to increase global access. Our efforts are supported by the World Health Organization and the Africa Centers for Disease Control and Prevention. Besides the WHO, the European Commission and other organizations have been involved in the early planning phase of our Malaria project and have offered their support to identify and set up the necessary infrastructure.

 

Our Malaria project is part of the ‘eradicateMalaria’ initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria.

 

On July 26, 2021, we announced that clinical trials for our first tuberculosis vaccine candidate are planned to begin in 2022, just two years after the program was initiated. We have collaborated with the Bill and Melinda Gates Foundation since 2019 to provide affordable access to vaccines to low- and middle-income countries. The antigen discovery programs for both Malaria and Tuberculosis are being conducted by specialized teams at our headquarters in Mainz, Germany.

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We have a research collaboration with the University of Pennsylvania under which we have the exclusive option to develop and commercialize prophylactic mRNA immunotherapies for the treatment of up to 10 infectious disease indications.

 

There are an additional five undisclosed programs.

Oncology

We are advancing the development of a broad oncology pipeline which has now progressed 15 product candidates in 18 ongoing trials. Six clinical trials, including two randomized Phase 2 clinical trials for FixVac programs, BNT111 and BNT113, have started in 2021. In the second quarter of 2021, we started first-in-human Phase 1 trials for the neoantigen specific T cell therapy, BNT221 and for a second RiboCytokine program BNT152+153. We expect to further advance our oncology pipeline in the second half of 2021 with BNT122 expected to move into a randomized Phase 2 trial and two further preclinical programs to move into Phase 1 trials.

During the remainder of 2021, we expect at least four data updates from our ongoing clinical trials in oncology.

FixVac

Our FixVac product candidates contain selected combinations of pharmacologically optimized uridine mRNA encoding known cancer-specific shared antigens. FixVac product candidates also feature our proprietary immunogenic mRNA backbone and proprietary RNA-LPX delivery formulation, which are designed to enhance stability and translation as well as trigger both innate and adaptive immune responses.

 

BNT111 in advanced melanoma.

 

BNT111 is in an ongoing Phase 1 trial for the treatment of advanced melanoma

 

In collaboration with Regeneron we are conducting a randomized Phase 2 trial for the treatment of patients with advanced melanoma.

On June 18, 2021, we announced that the first patient was dosed in a randomized global, three-arm Phase 2 trial evaluating BNT111 in combination with cemiplimab, versus both agents as monotherapy, in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.

The open-label randomized trial is expected to enroll a total of 120 patients. The primary endpoint is overall response rate of BNT111 in combination with cemiplimab. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety.

Melanoma remains one of the deadliest types of skin cancer with a 5-year survival for Stage IV metastatic disease of only 22.5%. In the refractory or relapsed setting, survival can be as short as six months depending on risk factors. Up to 50% of patients progress after treatment with checkpoint inhibitors.

 

BNT112 is in an ongoing Phase 1/2 trial for the treatment of prostate cancer.

 

BNT113 in advanced HPV16+ head and neck cancer.

 

BNT113 is in an ongoing Phase 1/2 basket trial for the treatment of HPV16+ head and neck cancer.