bntx-6k_20210510.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 MAY 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 May 10, 2021, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three months ended March 31, 2021. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company, for the three months ended March 31, 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/ Dr. Sierk Poetting

 

 

Name: Dr. Sierk Poetting

 

 

Title:   Chief Financial Officer

Date: May 10, 2021



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

Quarterly Report for the Three Months Ended March 31, 2021.

 

 

 

 

 

 

 

bntx-ex991_6.htm

Exhibit 99.1

 

 

 

 

 

 

BioNTech SE

Quarterly Report for the Three Months Ended March 31, 2021

 

 


Exhibit 99.1

 

 

BioNTech SE

Quarterly Report for the Three Months Ended March 31, 2021

Index

Interim Condensed Consolidated Financial Statements

 

 

Interim Condensed Consolidated Statements of Financial Position

3

 

 

Interim Condensed Consolidated Statements of Profit or Loss

4

 

 

Interim Condensed Consolidated Statements of Comprehensive Income / (Loss)

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 and Research and Development Expenses

11

 

 

 

5

Other Operating Income

12

 

 

 

6

Finance Income and Expenses

12

 

 

 

7

Income Tax

13

 

 

 

8

Financial Assets and Financial Liabilities

13

 

 

 

9

Share-Based Payments

15

 

 

 

10

Related Party Disclosures

16

 

 

 

11

Events after the Reporting Period

17

 

 

 

Operating and Financial Review and Prospects

 

 

Operating Results

18

 

 

Liquidity and Capital Resources

32

 

 

Risk Factors

36

 

 

 

 

 

 

 

 


 

 

 

 

 

 

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Financial Position

 

 

 

March 31,

December 31,

(in millions)

 

 

2021

2020

Assets

 

Note

(unaudited)

 

Non-current assets

 

 

 

 

Intangible assets

 

 

€165.2

€163.5

Property, plant and equipment

 

 

242.4

227.0

Right-of-use assets

 

 

118.4

99.0

Other assets

 

 

1.0

1.0

Deferred tax assets

 

7

141.7

161.2

Total non-current assets

 

 

€668.7

€651.7

Current assets

 

 

 

 

Inventories

 

 

146.9

64.1

Trade and other receivables

 

8

2,395.1

165.5

Other financial assets

 

8

0.5

137.2

Other assets

 

 

69.6

61.0

Income tax assets

 

 

0.9

0.9

Deferred expenses

 

 

31.5

28.0

Cash and cash equivalents

 

 

891.5

1,210.2

Total current assets

 

 

€3,536.0

€1,666.9

Total assets

 

 

€4,204.7

€2,318.6

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity

 

 

 

 

Share capital

 

 

246.3

246.3

Capital reserve

 

 

1,514.5

1,514.5

Treasury shares

 

 

(4.8)

(4.8)

Retained earnings / (Accumulated losses)

 

 

718.5

(409.6)

Other reserves

 

9

45.1

25.4

Total equity

 

 

€2,519.6

€1,371.8

Non-current liabilities

 

 

 

 

Interest-bearing loans and borrowings

 

8

236.6

231.0

Other financial liabilities

 

7

73.0

31.5

Provisions

 

 

5.6

5.5

Contract liabilities

 

 

57.8

71.9

Other liabilities

 

 

1.0

0.6

Deferred tax liabilities

 

 

-

0.3

Total non-current liabilities

 

 

€374.0

€340.8

Current liabilities

 

 

 

 

Interest-bearing loans and borrowings

 

8

18.0

9.1

Trade payables

 

8

106.2

102.3

Other financial liabilities

 

8

329.2

74.1

Government grants

 

5

3.2

92.0

Tax provisions

 

7

494.9

-

Other provisions

 

 

0.9

0.9

Contract liabilities

 

 

295.2

299.6

Other liabilities

 

 

63.5

28.0

Total current liabilities

 

 

€1,311.1

€606.0

Total liabilities

 

 

€1,685.1

€946.8

Total equity and liabilities

 

 

€4,204.7

€2,318.6

 

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

3


 

 

 

 

 

Interim Condensed Consolidated Statements of Profit or Loss

 

 

 

Three months ended

March 31,

 

 

 

2021

2020

(in millions, except per share data)

 

Note

(unaudited)

(unaudited)

Revenues

 

 

 

 

Research & development revenues

 

3

€20.9

€21.2

Commercial revenues

 

3

2,027.5

6.5

Total revenues

 

 

2,048.4

27.7

 

 

 

 

 

Cost of sales

 

4

(233.1)

(5.9)

Research and development expenses

 

4

(216.2)

(65.1)

Sales and marketing expenses

 

 

(8.7)

(0.5)

General and administrative expenses

 

 

(38.9)

(15.8)

Other operating expenses*

 

 

(0.6)

(0.1)

Other operating income*

 

5

111.3

0.4

Operating income / (loss)

 

 

€1,662.2

€(59.3)

 

 

 

 

 

Finance income**

 

6

24.8

6.4

Finance expenses**

 

6

(44.0)

(0.1)

Interest expenses related to lease liabilities

 

 

(0.7)

(0.4)

Profit / (loss) before tax

 

 

€1,642.3

€(53.4)

 

 

 

 

 

Income taxes

 

7

(514.2)

-

Profit / (Loss) for the period

 

 

€1,128.1

€(53.4)

 

 

 

 

 

Earnings per share

 

 

 

 

Basic profit / (loss) for the period per share

€4.64

€(0.24)

Diluted profit / (loss) for the period per share

€4.39

€(0.24)

* Foreign exchange differences related to operating activities on a cumulative basis are either shown as other operating income or expenses and might switch between those two positions during the year-to-date reporting periods.

** Foreign exchange differences not related to operating activities on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods.

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

4


 

 

 

 

 

Interim Condensed Consolidated Statements of Comprehensive Income / (Loss)

 

 

 

Three months ended

March 31,

 

 

 

2021

2020

(in millions)

 

Note

(unaudited)

(unaudited)

Profit / (Loss) for the period

 

 

€1,128.1

€(53.4)

 

 

 

 

 

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

 

 

4.5

(0.1)

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

 

 

4.5

(0.1)

 

 

 

 

 

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

 

 

4.5

(0.1)

 

 

 

 

 

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

 

 

€1,132.6

€(53.5)

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

 

 

-

-

-

(53.4)

-

(53.4)

Other comprehensive loss

 

 

-

-

-

-

(0.1)

(0.1)

Total comprehensive income

 

 

-

-

-

€(53.4)

€(0.1)

€(53.5)

Share-based payments

 

8

-

-

-

-

8.2

8.2

As of March 31, 2020

 

 

€232.3

€686.7

€(5.5)

€(478.2)

€12.8

€448.1

 

 

 

 

 

 

 

 

 

As of January 1, 2021

 

 

€246.3

€1,514.5

€(4.8)

€(409.6)

€25.4

€1,371.8

Profit for the period

 

 

-

-

-

1,128.1

-

1,128.1

Other comprehensive income

 

 

-

-

-

-

4.5

4.5

Total comprehensive income

 

 

-

-

-

€1,128.1

€4.5

€1,132.6

Share-based payments

 

8

-

-

-

-

15.2

15.2

As of March 31, 2021

 

 

€246.3

€1,514.5

€(4.8)

€718.5

€45.1

€2,519.6

 

 

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

March 31,

 

 

2021

2020

(in millions)

 

(unaudited)

(unaudited)

 

 

 

 

Operating activities

 

 

 

Profit / (Loss) for the period

 

€1,128.1

€(53.4)

Income taxes

 

€514.2

-

Profit / (loss) before tax

 

€1,642.3

€(53.4)

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

 

 

 

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

 

13.0

8.6

Share-based payment expense

 

17.3

8.4

Net foreign exchange differences

 

(31.2)

(0.3)

Gain on disposal of property, plant and equipment

 

0.2

0.1

Finance income

 

(0.3)

(0.4)

Interest on lease liability

 

0.7

0.4

Finance expense

 

44.0

0.1

Movements in government grants

 

(67.9)

-

Working capital adjustments:

 

 

 

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

 

(2,100.5)

(2.1)

Decrease / (Increase) in inventories

 

(82.8)

2.2

(Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities and provisions

 

255.5

(17.9)

Interest received

 

0.3

0.3

Interest paid

 

(1.8)

(0.5)

Income tax paid

 

(0.1)

(0.2)

Net cash flows used in operating activities

 

€(311.3)

€(54.7)

 

 

 

 

Investing activities

 

 

 

Purchase of property, plant and equipment

 

(21.7)

(6.3)

Proceeds from sale of property, plant and equipment

 

0.9

-

Purchase of intangibles assets and right-of-use assets

 

(7.5)

(2.1)

Acquisition of subsidiaries and businesses, net of cash acquired

 

-

(6.5)

Net cash flows used in investing activities

 

€(28.3)

€(14.9)

 

 

 

 

Financing activities

 

 

 

Proceeds from loans and borrowings

 

-

2.9

Repayment of loans and borrowings

 

(0.7)

-

Payments related to lease liabilities

 

(3.8)

(0.9)

Net cash flows from/(used in) financing activities

 

€(4.5)

€2.0

 

 

 

 

Net decrease in cash and cash equivalents

 

(344.1)

(67.6)

Change in cash and cash equivalents resulting from exchange rate differences

 

25.4

0.1

Cash and cash equivalents at January 1

 

1,210.2

519.1

Cash and cash equivalents at March 31

 

€891.5

€451.6

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 to address a range of rare and infectious diseases, and 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.

During the three months ended March 31, 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 months ended March 31, 2021 were authorized for issuance in accordance with a resolution of the audit committee on May 10, 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 months ended March 31, 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 months ended March 31, 2021 include BioNTech SE and our 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 months ended March 31, 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 the three months ended March 31, 2021.

Impact 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), the commencement of trials has been delayed, due to slowed patient enrollment and other delays as a result of the COVID-19 pandemic.

9


 

 

 

 

 

After several months of delay to focus efforts on our COVID-19 vaccine, we started Phase 1 clinical trials for BNT211 (CARVac), BNT151 (RiboCytokines)and BNT 411 (TLR-agonist) until March 2021 and started a Phase 1 clinical trial for BNT221 (NEO-PTC-01, a neoantigen-based T-cell therapy) in April 2021. These disruptions, even temporary, may negatively impact our operations and overall business by delaying the progress of the 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 months ended March 31, 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

March 31,

(in millions)

 

2021

2020

Research & development revenues from collaborations

 

€20.9

€21.2

Genentech Inc.

 

12.6

15.6

Shanghai Fosun Pharmaceutical (Group) Co., Ltd

 

7.4

0.4

Other

 

0.9

5.2

Commercial revenues

 

2,027.5

6.5

COVID-19 vaccine revenues

 

2,015.6

-

Sales to collaboration partners*

 

63.9

-

Direct product sales to customers

 

199.8

-

Share of collaboration partner's gross profit and sales milestones

 

1,751.9

-

Other sales

 

11.9

6.5

Total

 

€2,048.4

€27.7

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

 

Research & Development Revenues from Collaborations

As part of our BNT162 vaccine program against COVID-19, we are collaborating with Pfizer Inc., or Pfizer, and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, or Fosun Pharma. The collaboration with Fosun Pharma to develop a COVID-19 vaccine in China progressed during the three months ended March 31, 2021. 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.

Our collaboration with Genentech Inc., or Genentech, and other collaboration programs have progressed during the three months ended March 31, 2021 and revenues of €13.5 million compared to €20.8 million of revenues during the three months ended March 31, 2020, have been derived from deferred upfront payments measured based on the costs or time incurred under the respective research programs.

Commercial Revenues

During the three months ended March 31, 2021 commercial revenues increased due to rapidly increasing the supply 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), 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

10


 

 

 

 

 

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 March 31, 2021, we recognized €63.9 million revenues from selling drug product batches manufactured by us to our partners.

By supplying our territories during the three months ended March 31, 2021, we recognized €199.8 million of revenues from direct COVID-19 vaccine sales. The share of gross profit that Pfizer as collaboration partner has earned based on these 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 March 31, 2021, €1,504.7 million gross profit share and €247.2 million sales milestones have been recognized. 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.

The revenues from contracts with customers were recognized as follows:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Timing of revenue recognition

 

 

 

Goods and services transferred at a point in time

 

€273.7

€4.9

Goods and services transferred over time

 

1,774.7

22.8

Total

 

€2,048.4

€27.7

 

4

Cost of Sales and Research and Development Expenses

In addition to cost of sales that incur as we expand our commercial activities, our nature of business and primary focus of activities, including the development of our platforms and manufacturing technologies, generate a significant amount of research and development expenses.

The cost of sales recognized during the three months ended March 31, 2021 and March 31, 2020 are shown in the following table:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Cost of sales related to COVID-19 vaccine revenues

 

€223.2

-

Cost related to other sales

 

9.9

5.9

Total

 

€233.1

€5.9

11


 

 

 

 

 

 

The research and development expenses recognized during the three months ended March 31, 2021 and March 31, 2020 are shown in the following table:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Purchased services

 

€141.9

€18.4

Wages, benefits and social security expense

 

47.5

27.1

Laboratory supplies

 

11.4

8.2

Depreciation and amortization

 

7.5

7.1

Other

 

7.9

4.3

Total

 

€216.2

€65.1

 

5

Other Operating Income

The other operating income recognized during the three months ended March 31, 2021 and March 31, 2020 is shown in the following table:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Government grants

 

€67.9

-

Foreign exchange differences, net

 

40.7

-

Other

 

2.7

0.4

Total

 

€111.3

€0.4

 

During the three months ended March 31, 2021 other operating income was mainly derived from a government grant for which we became eligible 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 proportion of the grant that related to expenses incurred is recognized as other operating income with an amount of €67.1 million.

6

Finance Income and Expenses

The finance income and expenses recognized during the three months ended March 31, 2021 and March 31, 2020 are shown in the following table:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Foreign exchange differences, net

 

€24.5

€6.0

Interest income

 

0.3

0.4

Total

 

€24.8

€6.4

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Fair value adjustments of financial instruments measured at fair value

 

€41.5

-

Amortization of financial instruments

 

2.5

0.1

Total

 

€44.0

€0.1

 

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7

Income Tax

For the three months ended March 31, 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 31.3% for the three months ended March 31, 2021. Income taxes were recognized with respect to the German tax group and BioNTech Manufacturing Marburg GmbH. For the German tax group, 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 months ended March 31, 2021, a proportionate amount of the deferred tax assets related to the tax loss carryforward was utilized. As of March 31, 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 months ended March 31, 2021 and March 31, 2020 are shown in the following table:

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Current income taxes

 

€495.1

-

Deferred taxes

 

19.1

-

Income taxes

 

€514.2

-

 

8

Financial Assets and Financial Liabilities

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

 

Financial assets at amortized cost

(in millions)

 

March 31,

2021

December 31,

2020

Trade and other receivables

 

€2,395.1

€165.5

Other financial assets

 

0.5

137.2

Total

 

€2,395.6

€302.7

Total current

 

2,395.6

302.7

Total non-current

 

-

-

 

Trade and other receivables significantly increased mainly due to the trade and other receivables from our COVID-19 collaboration with Pfizer, under which the settlement of receivables is dependent upon their quarterly financial reporting cycle. As Pfizer’s fiscal quarter for subsidiaries outside the United States differ from ours, it creates a time lag between the recognition of revenues and payment receipt. Therefore, certain trade and other receivables are outstanding that mainly relate to gross profit shared from COVID-19 vaccine sales in territories outside the United States. The 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 three months ended March 31, 2021.

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Set forth below is an overview of financial liabilities, other financial liabilities and trade payables held by the Group as of March 31, 2021 and December 31, 2020:

 

Interest-bearing loans and borrowings

(in millions)

Maturity

March 31,

2021

December 31,

2020

Lease liabilities

 

€98.0

€84.2

Convertible note - host contract

08/28/2024

88.2

87.5

3.50% € 50,000,000 secured bank loan

12/21/2026

47.6

47.2

2.15% € 10,000,000 secured bank loan

12/30/2027

8.7

9.0

2.08% € 9,450,000 secured bank loan

09/30/2028

8.6

8.7

1.90% € 3,528,892.48 secured bank loan

05/30/2039

3.5

3.5

Total

 

€254.6

€240.1

Total current

 

18.0

9.1

Total non-current

 

236.6

231.0

 

Trade payables and other financial liabilities

(in millions)

 

March 31,

2021

December 31,

2020

Derivatives not designated as hedging instrument

 

 

 

Convertible note - embedded derivative

 

€72.4

€30.9

Financial liabilities at fair value through profit or loss

 

 

 

Contingent consideration

 

0.6

0.6

Total financial liabilities at fair value

 

€73.0

€31.5

 

 

 

 

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

 

 

Trade payables

 

106.2

102.3

Other financial liabilities

 

329.2

74.1

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

€435.4

€176.4

 

 

 

 

Total trade payables and other financial liabilities

 

€508.4

€207.9

Total current

 

435.4

176.4

Total non-current

 

73.0

31.5

 

Total financial liabilities

(in millions)

 

March 31,

2021

December 31,

2020

Interest-bearing loans and borrowings

 

€254.6

€240.1

Trade payables and other financial liabilities

 

508.4

207.9

Total

 

€763.0

€448.0

Total current

 

453.4

185.5

Total non-current

 

309.6

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 March 31, 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 March 31, 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 recognized as finance expenses in profit or loss and amounted to €41.5 million during the three months ended March 31, 2021. The initial fair value of the contingent consideration determined at acquisition remains valid since no changes of the underlying performance criteria have occurred.

9

Share-Based Payments

Expense arising from share-based payment arrangements

During the three months ended March 31, 2021 and March 31, 2020, the following share-based payment arrangements existed leading to the expenses recognized for services received during the respective periods as shown in the following table:

 

 

 

Three months ended

March 31,

(in millions)

 

2021

2020

Expense arising from equity-settled share-based payment arrangements

 

€15.2

€8.2

Employee Stock Ownership Plan

 

4.5

4.3

Chief Executive Officer Grant

 

1.7

3.2

Management Board Grant

 

0.5

0.7

BioNTech 2020 Employee Equity Plan for employees based in Europe

 

8.5

-

Expense arising from cash-settled share-based payment arrangements

 

2.1

0.2

Management Board Grant

 

0.1

0.2

BioNTech 2020 Restricted Stock Unit Plan for North America Employees

 

2.0

-

Total

 

€17.3

€8.4

 

 

 

 

Cost of sales

 

€1.7

€0.2

Research and development expenses

 

12.1

6.6

General and administrative expenses

 

3.5

1.6

Total

 

€17.3

€8.4

 

Changes in share-based payment arrangements

New share-based payment arrangements and material changes to arrangements that occurred during the three months ended March 31, 2021 are shown below. A detailed description of our share-based

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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.

The following tables displays the RSU’s granted during the three months ended March 31, 2021.

 

 

Restricted Stock Units

Weighted average fair value (€)

Granted under LTI 2020 program

 

245,926

78.38

Granted under LTI-plus program

 

381,560

78.77

As of March 31, 2021

 

627,486

78.62

 

The fair value of the awards is based upon the price of our ADSs representing ordinary shares at grant date. An estimate for the number of equity instruments for which service conditions are expected to be satisfied is calculated including a retention assumption 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.

10

Related Party Disclosures

ATHOS KG, Holzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and beneficial owner of our ordinary shares. ATHOS KG via AT Impf GmbH has de facto control over us based on its substantial shareholding, which enabled it to exercise the majority of voting rights to pass resolutions at our Annual General Meeting. Entities controlled by ATHOS KG mainly provide rental

16


 

 

 

 

 

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

March 31,

(in millions)

 

2021

2020

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

 

€0.2

€0.5

Total

 

€0.2

€0.5

 

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

 

(in millions)

 

March 31,

2021

December 31,

2020

ATHOS KG

 

-

€0.5

Total

 

-

€0.5

 

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

11

Events after the Reporting Period

On May 9, 2021, we have agreed the heads of terms with Fosun Pharma to establish a 50/50 Joint Venture, or JV, to manufacture our 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.


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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 months ended March 31, 2021.

Operating Results

Overview

BioNTech was founded in 2008 with the goal to reduce the suffering of people. 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 to address a range of rare and infectious diseases, and 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 2,200 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

 

On May 9, 2021, we agreed the heads of terms with Fosun Pharma to establish a 50/50 Joint Venture, or JV, to manufacture the COVID-19 vaccine in Mainland China. The establishment

18


 

 

 

 

 

 

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 (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.

Key Pipeline Updates

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

Infectious Disease Immunotherapies

COVID-19 Vaccine Program – BNT162b2

In March 2021 we announced our full year 2020 financial results and corporate update as a part of our Annual Report filed on Form 20-F, highlighting developments relating to our COVID-19 vaccine program between January 1 and March 30, 2021. A summary of these developments as well as full details of subsequent developments that occurred after March 30, 2021 is provided below.

As of May 6, 2021 we and Pfizer have shipped approximately 450 million doses of BNT162b2 to 91 countries and territories around the world. To date, we and Pfizer have signed orders of approximately 1.8 billion doses for delivery in 2021, and we have also signed the first contracts for 2022 and beyond. Further discussions for additional dose commitments are ongoing for 2021 and beyond. We expect BNT162b2 annual manufacturing capacity to reach 3 billion doses by the end of 2021, and expect to have capacity to manufacture more than 3 billion doses in 2022.

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

To date, there is no evidence that an adaptation of our current COVID-19 vaccine against key identified emerging variants is necessary. Despite this, we have developed a comprehensive strategy to address these variants should the need arise in the future. As part of our strategy to contend with the variant challenge, we have submitted to the U.S. Food and Drug Administration, or the FDA, and the FDA has approved an additional amendment to the study protocol of the global Phase 1/2/3 trial 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. The aim of this study is to explore the regulatory pathway that we and Pfizer would pursue if SARS-CoV-2 were to change enough to require an updated vaccine. This trial started in March 2021.

In the first quarter of 2021, we also advanced our work to broaden access through improvements to our cold chain distribution systems and processes. Both the FDA and the European Medicines Agency, or

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EMA, have approved the transportation and storage of undiluted frozen vials of BNT162b2 at temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. Further stability data have been assessed and formulation optimization activities are ongoing, including a study to evaluate a lyophilized (or freeze-dried) and ready-to-use formulation of BNT162b2.

BNT162b2 Clinical Development Updates

 

On March 31, 2021, we and Pfizer announced that BNT162b2 demonstrated 100% efficacy and robust antibody responses in a Phase 3 trial in adolescents aged 12 to 15 with or without prior evidence of SARS-CoV-2 infection. The trial enrolled 2,260 adolescents in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited high SARS-CoV-2 neutralizing antibody titers, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. BNT162b2 administration was well tolerated.

 

On March 31, 2021, we and Pfizer began evaluating the administration of a single booster dose five to seven months after receiving the second dose of BNT162b2. To demonstrate duration of protection, and protection against the emerging variants of concern, an additional dose of BNT162b2 or of BNT162b2SA is being given to about 600 Phase 3 participants. About 30 participants that received BNT162b2SA will be given another dose of BNT162b2SA. A new cohort of approximately 300 participants will be enrolled who are COVID-19 vaccine-naïve (i.e., including BNT162b2-naïve) and have not been infected with COVID-19. They will receive BNT162b2SA given as a two-dose series, separated by 21 days. The objective of this Phase 1/2/3 protocol amendment is to describe the safety and tolerability profile of BNT162b2SA, to evaluate its non-inferiority compared to BNT162b2, and to analyze the immune response generated by BNT162b2SA. By evaluating BNT162b2SA as a prototype vaccine, the companies aim to inform the development of an efficient regulatory pathway for testing future modified mRNA vaccines, using the current pathways for flu vaccines as models.

 

On April 1, 2021, we and Pfizer announced updated topline results confirming high efficacy and no serious safety concerns through up to six months following the second dose. Topline efficacy was based on an analysis of 927 confirmed symptomatic cases of COVID-19 observed in the pivotal Phase 3 study through March 13, 2021. BNT162b2 was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was also 100% effective against severe disease, as that term is defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as that term is defined by the FDA. Safety data collected from more than 12,000 vaccinated participants who had a follow-up time of at least six months after the second dose demonstrated a favorable safety and tolerability profile.

In an additional exploratory analysis of 800 trial participants enrolled in South Africa, where the B.1.351 lineage is prevalent, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%. Of these cases, eight were of the B.1.351 lineage, confirming efficacy against B.1.351 virus. These data support previous results from immunogenicity studies demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B1.351 variant, and although lower than to the wild-type strain, it does not appear to affect the observed high efficacy against COVID-19 caused by this variant, as published in the New England Journal of Medicine.1

 

On April 1, 2021, we and Pfizer started a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and immunogenicity of multiple formulations of BNT162b2, administered on a two-dose (separated by 21 days) schedule in adults aged 18 to 55. Part 1 of the study is comparing the safety and tolerability of lyophilized (or freeze-dried) BNT162b2 to the current frozen-liquid formulation of BNT162b2 and is evaluating non

 

1 

New England Journal of Medicine. Neutralizing Activity of BNT162b2-Elicited Serum; March 8, 2021. Available at https://www.nejm.org/doi/full/10.1056/NEJMc2102017

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-inferiority of the immune response. Part 2 of the study will evaluate the safety and immunogenicity of a ready-to-use formulation of BNT162b2, and will be initiated in May 2021. The study, which is being conducted in the United States, will enroll approximately 610 participants. We and Pfizer expect to obtain results from both study parts in the third quarter of 2021.

Regulatory Updates

 

On April 9, 2021, we and Pfizer requested amendments to the U.S. Emergency Use Authorization, or EUA, to expand the use of BNT162b2 to adolescents aged 12 to 15.

 

On April 30, 2021, we and Pfizer submitted to EMA a variation to the Conditional Marketing Authorization, or CMA, for COMIRNATY® to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the European Union.

 

On April 30 and May 4, 2021, we and Pfizer submitted new stability data of BNT162b2 to the FDA and EMA in order to update the product’s label to extend the storage at standard refrigerator temperatures of 2°C to 8°C to four weeks.

 

On May 5, 2021, we and Pfizer Canada announced that Health Canada has expanded the Interim Order authorization for BNT162b2 to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.

 

On May 7, 2021, we and Pfizer announced the initiation of a Biologics License Application (BLA) with the FDA for approval of BNT162b2 to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. We are the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Commercial Updates

 

More than 445 million doses of BNT162b2 supplied as of May 6, 2021, with signed commitments for over 1.8 billion doses in 2021.

 

On April 19, 2021, we and Pfizer announced an agreement with the European Commission, or the EC, to supply an additional 100 million doses of our COVID-19 vaccine, as a result of the EC’s decision to exercise its option. The total number of doses to be delivered to the European Union by the end of 2021 is now 600 million.

 

In April 2021, we and Pfizer entered into an agreement with Israel to supply millions of doses in 2022, with an option to purchase millions of additional doses. We and Pfizer also entered into an agreement with Canada to supply up to 125 million doses in 2022 and 2023, with options to purchase up to 60 million additional doses in 2024. Discussions for additional dose commitments with governments and territories worldwide are also ongoing for 2021 and beyond.

 

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

 

On May 7, 2021, the EC announced that we and Pfizer plan to supply the EC with 900 million doses of COMIRNATY®, our and Pfizer’s COVID-19 vaccine, to the 27 European Union (EU) member states beginning December 2021 through 2023, with an option for the EC to request up to an additional 900 million doses. This contract is expected to close upon final confirmation by the EC.

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Manufacturing Updates

 

We expect manufacturing capacity to reach approximately 3 billion doses by end of 2021 and expect to have capacity to manufacture more than 3 billion doses in 2022.

 

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

 

We plan to produce up to 250 million doses of BNT162b2 in the first half of 2021.

Flu Vaccine

We are also collaborating with Pfizer to develop an influenza vaccine based on our suite of mRNA platforms. The product candidate, BNT161, will be designed to encode influenza virus antigens selected by the WHO in advance of a given flu season. Phase 1 clinical testing is expected to start in the third quarter of 2021.

Infectious Diseases

We have a research collaboration with the University of Pennsylvania, or UPenn, under which we have the exclusive option to develop and commercialize prophylactic mRNA immunotherapies for the treatment of up to 10 infectious disease indications. On September 20, 2019, UPenn announced positive preclinical results of a vaccine product candidate using our mRNA technology. UPenn reported that the immunization led to “mostly sterilizing immunity” from the virus. In addition to our collaboration with UPenn, our infectious diseases portfolio also includes HIV, Tuberculosis vaccines and immunotherapies (in collaboration with the Bill & Melinda Gates foundation) and additional 6 undisclosed programs.

Oncology

We are accelerating the development of a broad oncology pipeline which has now advanced 14 product candidates in 15 ongoing trials. In April 2021 we started a first-in-human Phase 1 trial for the T cell therapy, targeting personalized neoantigens, BNT221. Additional important milestones in the advancement of our immuno-oncology pipeline in the first quarter of 2021 included the initiation of first-in-human trials for CARVac (BNT211) and RiboCytokines (BNT151). We also expect to further advance our oncology pipeline in 2021 with up to three additional programs expected to move into randomized Phase 2 trials. Additionally, three preclinical programs are expected to move into Phase 1 trials in the second half of 2021.

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.

 

In collaboration with Regeneron, a randomized Phase 2 trial for the treatment of patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor, utilizing a combination of BNT111 and Regeneron and Sanofi’s Libtayo (cemiplimab) is planned to start in the first half of 2021.

 

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

 

BNT113 is in a Phase 2 trial for the treatment of HPV16+ head and neck cancers.

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A Phase 2 trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC) expressing PD-L1, is planned to start in the first half of 2021 in the United States and the European Union. BNT113 has not been combined with anti-PD1 before and the Phase 2 trial will start with a run-in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. These data are required to address the partial clinical hold on the subsequent randomized part of the Phase 2 trial. 

 

BNT114 is in a Phase 1 trial for the treatment of triple negative breast cancer (TNBC).

 

BNT115 is in an ongoing Phase 1 trial for the treatment of ovarian cancer.

 

BNT116 is in preclinical development for the treatment of non-small cell lung cancer.

Individualized Neoantigen Specific Immunotherapy (iNeST)

iNeST is an individualized cancer immunotherapy that targets specific neoantigens that are present on a patient’s tumor. Our iNeST immunotherapies contain pharmacologically optimized uridine mRNA encoding up to 20 patient-specific neoantigens, delivered in our proprietary RNA-LPX formulation. We are developing our iNeST cancer immunotherapy in collaboration with Genentech.

 

An open-label Phase 1a/1b trial evaluating the safety, tolerability, immune response and pharmacokinetics of autogene cevumeran (BNT122) as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors (basket trial) is ongoing.

 

A Phase 2 open-label trial evaluating the efficacy and safety of autogene cevumeran (BNT122) in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated advanced melanoma is ongoing.

 

For the adjuvant treatment of colorectal cancer, first patient dosing in a randomized Phase 2 trial in circulating tumor DNA positive, surgically resected Stage 2 (high risk)/Stage 3 colorectal cancer is now planned in the second half of 2021.

mRNA Intratumoral Immunotherapy

We, in collaboration with Sanofi, are developing intratumoral immunotherapies utilizing our proprietary mRNA technology. These immunotherapies are designed to be administered directly into the tumor in order to alter the tumor microenvironment and enhance the immune system’s ability to recognize and fight cancer within the tumor (proximal) as well as in other untreated locations (distal).

 

SAR441000 (BNT131) is a novel intratumoral immunotherapy for the treatment of solid tumors, and consists of modified mRNA encoding immunomodulatory cytokines for direct intratumoral injection. SAR441000 (BNT131) is being studied in a Sanofi-sponsored Phase 1 clinical trial as monotherapy and in combination with an anti-PD-1/PD-L1 checkpoint inhibitor in patients with advanced solid tumors.

RiboCytokines

Our RiboCytokine product candidates utilize mRNA that encodes the desired cytokines for expression in vivo by the patient’s cells. RiboCytokine product candidates consist of modified mRNA designed to encode secreted cytokines that are formulated to use liver-targeting LNP for intravenous delivery.

 

BNT151 is a nucleoside-modified mRNA encoding for an IL-2 variant, a key cytokine in T cell immunity supporting the differentiation, proliferation, survival and effector functions of T cells. BNT151 is designed to stimulate anti-tumoral T cells without extensively triggering immunosuppressive regulatory T cells. A first-in-human, open-label, multicenter Phase 1/2a trial is ongoing. The trial evaluates dose escalation, safety, pharmacokinetics and pharmacodynamics of BNT151 with expansion cohorts in multiple solid tumor indications,

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including HNSCC, hepatocellular carcinoma (HCC), renal cell cancer (RCC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC). The monotherapy dose escalation will enroll patients with tumors that are metastatic or unresectable with no available standard therapy likely to confer clinical benefit. In the combined treatment dose escalation, patients with different solid tumors will be enrolled and treated with BNT151 and the respective standard of care.

 

We plan to start a Phase 1 trial for BNT152 (encoding IL-7) plus BNT153 (encoding IL-2) in multiple solid tumors in the first half of 2021.

RiboMabs

Our RiboMab product candidates, BNT141 and BNT142, are designed to encode secreted antibodies, consisting of our proprietary nucleoside-modified mRNA that is designed to minimize the immunomodulatory activity of the mRNA. RiboMab product candidates are formulated using liver-targeting LNPs for intravenous delivery.

 

In February 2021, the FDA approved the IND for a Phase 1 first-in-human clinical trial for BNT141. We expect to start the trial in the second half of 2021.

 

We expect to start a Phase 1 clinical trial for BNT142 in the second half of 2021.

CAR-T Cell Immunotherapy

We are developing a proprietary chimeric antigen receptor T cell, or CAR-T, product candidate, BNT211, targeting Claudin-6, or CLDN6, a novel solid tumor-specific antigen. We developed BNT211 utilizing our target discovery engine, and we plan to administer it along with a CARVac “primer” to boost the immune response and promote CAR-T cell persistence.

 

A first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T cells as monotherapy, or in combination of Claudin-6 CAR-T cells with Claudin-6 CARVac, is ongoing. The trial is enrolling patients with CLDN6-positive relapsed or refractory advanced solid tumors including ovarian, testicular, lung, gastric and endometrial cancers. The combination of CLDN6 CAR-T cell immunotherapy and CARVac is expected to improve expansion and persistence of CLDN6 CAR-T. A data update for this trial is planned in the second half of 2021.

 

We plan to present early data from the ongoing BNT211 Phase 1/2a trial on three patients treated with a starting dose of CLDN6 CAR-T cells at the upcoming 18th Association for Cancer Immunotherapy Annual Meeting 2021, or CIMT 2021. In these heavily pretreated patients with solid tumors, neither acute nor dose-limiting toxicities were observed and all adverse events were transient and mild to moderate. Robust CAR-T cell engraftment could be detected in all three patients, as well as early signs of clinical activity. Following completion of the first dose level with CAR-T cell monotherapy, the trial is now progressing to the next dose level and a combination treatment involving CAR-T cells with an RNA vaccine, which we refer to as CARVac. A data update is planned in the second half of 2021.

Neo-Antigen Targeting T Cell Therapy

Our neoantigen-targeting T cell stimulation platform can be utilized to develop product candidates across several neoantigen-targeting non-engineered and engineered T cell therapies. Our lead product candidate BNT221 (NEO-PTC-01) is a personal neoantigen-targeted T cell therapy candidate derived from patients` peripheral blood cells. The product consists of multiple CD8+ and CD4+ T cell populations targeting multiple selected neoantigens unique to each patient's tumor. The proprietary stimulation process allows for the induction of T cells from the naïve, as well as expansion of T cells from the memory compartment.

 

In April 2021, the first patient was dosed in a first-in-human Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to

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checkpoint inhibitors. Part one consists of the monotherapy dose escalation of BNT221. In part two, BNT221 will be added on to αPD-1 after first-line therapy. The primary objectives of the trial are to evaluate the safety and feasibility of administering BNT221, in addition to an evaluation of immunogenicity and clinical efficacy.

Next-Generation Checkpoint Immunomodulators

We are developing, in collaboration with Genmab, bispecific antibodies that function as tumor-targeted and dual immunomodulators, applying Genmab’s proprietary DuoBody® technology in combination with our joint target identification and product concept expertise. These next-generation checkpoint immunomodulators are thought to induce beneficial co-stimulation, promoting specific T cell activation, survival, proliferation and T cell effector functions.

 

BNT311 (GEN1046) is a PD-L1x4-1BB bispecific antibody that induces activation of T cells through conditional 4-1BB stimulation which is dependent on simultaneous binding to PD-L1. In addition, the PD-L1-specific arm of DuoBody-PD-L1x4-1BB functions as a classical immune checkpoint inhibitor by blocking the PD-1/PD-L1 axis, even in the absence of 4-1BB binding.

 

A Phase 1/2a dose escalation trial with multiple expansion cohorts in patients with malignant solid tumors is ongoing. A data update for the trial is planned in the second half of 2021.

 

BNT312 (GEN1042) is a bispecific antibody designed to enhance an anti-tumor immune response by crosslinking CD-40 on antigen presenting cells with 4-1BB+ T cells to induce conditional stimulation and co-stimulatory activity in both types of cells. It has demonstrated increased tumor infiltrating lymphocyte expansion in human tumor tissue cultures ex vivo, and induces activation of B cells in the presence of 4-1BB+ cells.

 

A Phase 1/2a dose escalation trial with expansion cohorts in patients with solid tumors is ongoing. The first data disclosure for the trial is planned in the second half of 2021.

Targeted Cancer Antibodies

BNT321 (MVT-5873) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope on CA19-9 that is expressed in pancreatic and other solid tumors that plays a role in tumor adhesion and metastasis formation, and is a marker of an aggressive cancer phenotype.

 

BNT321 is currently in Phase 1 clinical development in pancreatic cancer. Next clinical results from this study are anticipated in early 2022.

Small Molecule Immunomodulators

BNT411 is our novel small molecule TLR7 agonist product candidate. BNT411 is designed to activate both the adaptive and innate immune system through the TLR7 pathway.

 

A Phase 1/2a dose-escalation trial of BNT411 as a monotherapy in patients with solid tumors, and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) is ongoing. A data update from this trial is planned in the second half of 2021.

Rare Disease Protein Replacement Therapies

We are collaborating with Genevant in order to combine our mRNA technology with Genevant’s LNP delivery technology, to create up to five mRNA protein replacement therapies for the treatment of rare diseases with high unmet medical needs. The first product candidate under the Genevant collaboration, BNT171, is being developed for Ornithine Transcarbamylase (OTC) Deficiency. Our mRNA replacement product candidate is associated with a favorable tolerability profile and good protein

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expression (in mice) and demonstrated phenotype rescue in a mouse disease model. Currently, we have put the programs under review in order to focus on other disease areas.

Financial Operations Overview

The following table shows our interim condensed consolidated statements of profit or loss for each period presented:

 

 

 

Three months ended

March 31,

 

 

 

2021

2020

(in millions)

 

 

(unaudited)

(unaudited)

Revenues

 

 

 

 

Research & development revenues

 

 

€20.9

€21.2

Commercial revenues

 

 

2,027.5

6.5

Total revenues

 

 

2,048.4

27.7

 

 

 

 

 

Cost of sales

 

 

(233.1)

(5.9)

Research and development expenses

 

 

(216.2)

(65.1)

Sales and marketing expenses

 

 

(8.7)

(0.5)

General and administrative expenses

 

 

(38.9)

(15.8)

Other operating expenses *

 

 

(0.6)

(0.1)

Other operating income *

 

 

111.3

0.4

Operating income / (loss)

 

 

€1,662.2

€(59.3)

 

 

 

 

 

Finance income**

 

 

24.8

6.4

Finance expenses**

 

 

(44.0)

(0.1)

Interest expenses related to lease liabilities

 

 

(0.7)

(0.4)

Profit / (loss) before tax

 

 

€1,642.3

€(53.4)

 

 

 

 

 

Income taxes

 

 

(514.2)

-

Profit / (Loss) for the period

 

 

€1,128.1

€(53.4)

* Foreign exchange differences related to operating activities on a cumulative basis are either shown as other operating income or expenses and might switch between those two positions during the year-to-date reporting periods.

** Foreign exchange differences not related to operating activities on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods.

 

Important financial and operating terms and concepts are described in Item 5 of our Annual Report on Form 20-F as of and for the year ended December 31, 2020.

Impact of COVID-19

The impact of COVID-19 during the three months ended March 31, 2021 and 2020 is explained in Note 2 to the unaudited interim condensed consolidated financial statements.

COVID-19 Collaborations

In response to the COVID-19 pandemic, we initiated our COVID-19 vaccine development program, BNT162, in late January 2020, leveraging our proprietary mRNA platform, and assembled a global consortium of partners including Pfizer (worldwide collaboration outside of China) and Fosun Pharma (China).

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Details about our COVID-19 collaborations are described further in our Key Pipeline Updates above, Items 4 and 5 of our Annual Report on Form 20-F as of and for the year ended December 31, 2020 as well as the notes to our audited consolidated financial statements included in that Annual Report.

Comparison of the three months ended March 31, 2021 and 2020

Revenues

The following is a summary of revenues recognized for the periods indicated:

 

Three months ended

March 31,

 

Change

(in millions)

2021

2020

 

%

Revenues

 

 

 

 

 

Research & development revenues from collaborations

€20.9

€21.2

 

€(0.3)

(1)

Genentech Inc.

12.6

15.6

 

(3.0)

(19)

Shanghai Fosun Pharmaceutical (Group) Co., Ltd

7.4

0.4

 

7.0

1,750

Other

0.9

5.2

 

(4.3)

(83)

Commercial revenues

2,027.5

6.5

 

2,021.0

31,092

COVID-19 vaccine revenues

2,015.6

-

 

2,015.6

-

Sales to collaboration partners*

63.9

-

 

63.9

-

Direct product sales to customers

199.8

-

 

199.8

-

Share of collaboration partner's gross profit and sales milestones

1,751.9

-

 

1,751.9

-

Other sales

11.9

6.5

 

5.4

83

Total revenues

€2,048.4

€27.7

 

€2,020.7

7,295

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

 

From the three months ended March 31, 2020 to the three months ended March 31, 2021, our total revenues from contracts with customers increased by €2,020.7 million from €27.7 million to €2,048.4 million. Since December 2020, our COVID-19 vaccine has been authorized or approved for emergency or temporary use or granted conditional marketing authorization in over 70 countries worldwide, which resulted in recognition of revenues from the sale of pharmaceutical products for the first time.

Research & Development Revenues from Collaborations

From the three months ended March 31, 2020 compared to the three months ended March 31, 2021, research and development revenues from collaborations decreased by €0.3 million or 1% from €21.2 million to €20.9 million. This was mainly due to a decrease in revenues from collaboration programs where the commencement of trials has been delayed, partially due to slowed patient enrollment or other delays as a result of the COVID-19 pandemic. This decrease was partially offset by recognizing €7.4 million development and regulatory milestones under our collaboration with Fosun Pharma upon receiving authorization for emergency use and launching our COVID-19 vaccine in Hong Kong.

Commercial Revenues

From the three months ended March 31, 2020 compared to the three months ended March 31, 2021, commercial revenues increased by €2,021.0 million from €6.5 million to €2,027.5 million, mainly due to rapidly increasing the supply 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), 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 principal.

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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 March 31, 2021, we recognized €63.9 million revenues from selling drug product batches manufactured by us to our partners.

By supplying our territories during the three months ended March 31, 2021, we recognized €199.8 million of revenues from direct COVID-19 vaccine sales. The share of gross profit that Pfizer, as collaboration partner, has earned based on these 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 respective 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 March 31, 2021, €1,504.7 million gross profit share and €247.2 million sales milestones have been recognized. In order to determine our share of 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.

Cost of Sales

The following table summarizes our cost of sales for the periods indicated:

 

Three months ended

March 31,

 

Change

(in millions)

2021

2020

 

%

Cost of sales

 

 

 

 

 

Cost of sales related to COVID-19 vaccine revenues

€223.2

-

 

€223.2

-

Cost related to other sales

9.9

5.9

 

4.0

68

Total cost of sales

€233.1

€5.9

 

€227.2

3,851

 

From the three months ended March 31, 2020 to the three months ended March 31, 2021, our cost of sales increased by €227.2 million from €5.9 million to €233.1 million, mainly due to recognizing cost of sales from our COVID-19 vaccine sales which included Pfizer’s share of gross profit earned by us in transactions, where we are the principal.

Research and Development Expenses

The following table summarizes our research and development expenses for the periods indicated:

 

Three months ended

March 31,

 

Change

(in millions)

2021

2020

 

%

Research and development expenses

 

 

 

 

 

Purchased services

€141.9

€18.4

 

€123.5

671

Wages, benefits and social security expense

47.5

27.1

 

20.4

75

Laboratory supplies

11.4

8.2

 

3.2

39

Depreciation and amortization

7.5

7.1

 

0.4

6

Other

7.9

4.3

 

3.6

84

Total research and development expenses

€216.2

€65.1

 

€151.1

232

 

From the three months ended March 31, 2020 to the three months ended March 31, 2021, our research and development expenses increased by €151.1 million or 232% from €65.1 million to €216.2 million, mainly due to an increase in research and development expenses from our BNT162 program, recorded as purchased services with respect to those expenses, which are initially incurred by Pfizer and subsequently charged to us under our collaboration agreement with Pfizer. The increase was further

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driven by an increase in wages, benefits and social security expenses from due to increases in headcounts and recognizing expenses incurred under the new share-based-payment arrangements.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the periods indicated:

 

Three months ended

March 31,

 

Change

(in millions)

2021

2020

 

%

General and administrative expenses

 

 

 

 

 

Wages, benefits and social security expense

€14.3

€6.5

 

€7.8

120

Purchased services

12.0

4.2

 

7.8

186

Insurance premiums

4.3

0.8

 

3.5

438

IT and office equipment

2.6

1.3

 

1.3

100

Other

5.7

3.0

 

2.7

90

Total general and administrative expenses

€38.9

€15.8

 

€23.1

146

 

From the three months ended March 31, 2020 to the three months ended March 31, 2021, our general and administrative expenses increased by €23.1 million or 146% from €15.8 million to €38.9 million, mainly due to an increase in expenses for purchased management consulting and legal services, an increase in wages, benefits and social security expenses from increasing headcounts and recognizing expenses incurred under the new share-based-payment arrangements as well as higher insurance premiums.

Other Operating Income / Expenses

The following table summarizes our other result, including other operating income and expenses, for the periods indicated:

 

Three months ended

March 31,

 

Change

(in millions)

2021

2020

 

%

Other result

 

 

 

 

 

Government grants

€67.9

-

 

€67.9

-

Foreign exchange differences, net

40.7

-

 

40.7

-

Other

2.7

0.4

 

2.3

575

Other operating income