bntx-6k_20201110.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 NOVEMBER 2020

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 November 10, 2020, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three and nine months ended September 30, 2020. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company, for the three and nine months ended September 30, 2020, 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.

On May 6, 2020, the Company acquired Neon Therapeutics, Inc., a biotechnology company developing novel neoantigen-based T-cell therapies. Certain unaudited pro forma condensed combined financial information is attached hereto as Exhibit 99.2.

The information contained in Exhibit 99.2 is furnished only and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, unless expressly set forth by specific reference in such a filing.



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: November 10, 2020



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

Quarterly Report for the Three and Nine Months Ended September 30, 2020.

99.2

Unaudited pro forma condensed combined financial information for the year ended  December 31, 2019 and the nine months ended September 30, 2020.

 

 

 

 

 

bntx-ex991_6.htm

Exhibit 99.1

 

 

 

 

 

 

BioNTech SE

Quarterly Report for the Three and Nine Months ended September 30, 2020

 

 

 


Exhibit 99.1

 

BioNTech SE

Quarterly Report for the Three and Nine Months ended September 30, 2020

Index

Interim Condensed Consolidated Financial Statements

 

 

 

Interim Condensed Consolidated Statements of Financial Position

 

3

 

 

 

Interim Condensed Consolidated Statements of Operations

 

4

 

 

 

Interim Condensed Consolidated Statements of Comprehensive 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

Segment Information

 

11

 

 

 

 

4

Revenue from Contracts with Customers

 

14

 

 

 

 

5

Business Combinations

 

15

 

 

 

 

6

Research and Development Expenses

 

18

 

 

 

 

7

Income Tax

 

19

 

 

 

 

8

Intangible Assets

 

19

 

 

 

 

9

Property, Plant and Equipment

 

19

 

 

 

 

10

Financial Assets and Financial Liabilities

 

20

 

 

 

 

11

Other Assets

 

22

 

 

 

 

12

Issued Capital and Reserves

 

22

 

 

 

 

13

Share-Based Payments

 

24

 

 

 

 

14

Related Party Disclosures

 

28

 

 

 

 

15

Events after the Reporting Period

 

29

Operating and Financial Review and Prospects

 

 

 

Operating Results

 

31

 

 

 

Liquidity and Capital Resources

 

52

 

 

 

Risk Factors

 

56

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Financial Position

 

 

 

September 30,

December 31,

(in thousands)

 

 

2020

2019

Assets

 

Note

(unaudited)

 

Non-current assets

 

 

 

 

Intangible assets

 

8

€168,733

€89,434

Property, plant and equipment

 

9

127,739

93,044

Right-of-use assets

 

 

55,764

55,018

Other assets

 

11

5,177

-

Total non-current assets

 

 

€357,413

€237,496

Current assets

 

 

 

 

Inventories

 

 

12,368

11,722

Trade receivables

 

10

7,170

11,913

Other financial assets

 

10

17,843

1,680

Other assets

 

11

54,146

9,069

Income tax assets

 

 

724

756

Deferred expense

 

 

9,127

5,862

Cash and cash equivalents

 

 

990,461

519,149

Total current assets

 

 

€1,091,839

€560,151

Total assets

 

 

€1,449,252

€797,647

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity

 

 

 

 

Share capital

 

12

246,310

232,304

Capital reserve

 

12

1,441,631

686,714

Treasury shares

 

12

(5,525)

(5,525)

Accumulated losses

 

 

(776,541)

(424,827)

Other reserves

 

13

21,808

4,826

Total equity

 

 

€927,683

€493,492

Non-current liabilities

 

 

 

 

Financial liabilities

 

10

175,621

68,904

Other liabilities

 

 

695

-

Contract liabilities

 

 

76,773

97,109

Total non-current liabilities

 

 

€253,089

€166,013

Current liabilities

 

 

 

 

Tax provisions

 

 

150

150

Provisions

 

 

817

762

Financial liabilities

 

10

3,021

1,823

Trade payables

 

10

41,912

20,498

Contract liabilities

 

 

70,250

93,583

Other financial liabilities

 

10

132,157

13,836

Other liabilities

 

 

20,173

7,490

Total current liabilities

 

 

€268,480

€138,142

Total liabilities

 

 

€521,569

€304,155

Total equity and liabilities

 

 

€1,449,252

€797,647

 

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

3


 

 

 

 

 

Interim Condensed Consolidated Statements of Operations

 

 

 

Three months ended

September 30,

Nine months ended

September 30,

 

 

 

2020

2019

2020

2019

(in thousands, except per share data)

 

Note

(unaudited)

(unaudited)

 

 

 

 

 

 

 

Revenues from contracts with customers

 

4

€67,458

€28,662

€136,883

€80,601

Cost of sales

 

 

(6,840)

(4,230)

(18,344)

(12,925)

Gross profit

 

 

€60,618

€24,432

€118,539

€67,676

 

 

 

 

 

 

 

Research and development expenses

 

6

(227,706)

(50,396)

(388,017)

(161,039)

Sales and marketing expenses

 

 

(4,268)

(670)

(7,808)

(1,908)

General and administrative expenses

 

 

(23,324)

(10,582)

(57,952)

(34,481)

Other operating income

 

 

8,764

347

9,962

1,340

Other operating expenses

 

 

(466)

(5)

(1,325)

(163)

Operating loss

 

 

€(186,382)

€(36,874)

€(326,601)

€(128,575)

 

 

 

 

 

 

 

Finance income*

 

 

474

7,294

1,067

9,170

Finance expenses*

 

 

(21,081)

(82)

(24,455)

(233)

Interest expense related to lease liability

 

 

(552)

(433)

(1,432)

(1,283)

Loss before tax

 

 

€(207,541)

€(30,095)

€(351,421)

€(120,921)

 

 

 

 

 

 

 

Income taxes

 

7

(2,491)

(8)

(293)

(28)

Loss for the period

 

 

€(210,032)

€(30,103)

€(351,714)

€(120,949)

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

Equity holders of the parent

 

 

(210,032)

(30,103)

(351,714)

(120,833)

Non-controlling interests

 

 

-

-

-

(116)

 

 

 

€(210,032)

€(30,103)

€(351,714)

€(120,949)

 

 

 

 

 

 

 

Earnings per share

 

 

 

 

 

 

in EUR

 

 

 

 

 

 

Basic & diluted, loss per share for the period attributable to equity holders of the parent**

 

 

€(0.88)

€(0.14)

€(1.51)

€(0.59)

* Foreign exchange differences 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.

** Numbers of shares for calculating the earnings per share for the three and nine months ended September 30, 2019 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019.

 

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

4


 

 

 

 

 

Interim Condensed Consolidated Statements of Comprehensive Loss

 

 

 

Three months ended

September 30,

Nine months ended

September 30,

 

 

 

2020

2019

2020

2019

(in thousands)

 

Note

(unaudited)

(unaudited)

Loss for the period

 

 

€(210,032)

€(30,103)

€(351,714)

€(120,949)

 

 

 

 

 

 

 

Other comprehensive income

 

 

 

 

 

 

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

 

 

 

 

 

 

Exchange differences on translation of foreign operations

 

 

(3,673)

(8)

(7,166)

(2)

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

 

 

(3,673)

(8)

(7,166)

(2)

 

 

 

 

 

 

 

Other comprehensive income for the period, net of tax

 

 

(3,673)

(8)

(7,166)

(2)

 

 

 

 

 

 

 

Comprehensive loss for the period, net of tax

 

 

€(213,705)

€(30,111)

€(358,880)

€(120,951)

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

Equity holders of the parent

 

 

(213,705)

(30,111)

(358,880)

(120,835)

Non-controlling interests

 

 

-

-

-

(116)

Comprehensive loss for the period, net of tax

 

 

€(213,705)

€(30,111)

€(358,880)

€(120,951)

 

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


 

5


 

 

 

 

 

Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity

 

 

Nine months ended September 30, 2020

 

 

 

Equity attributable to equity holders of the parent

 

 

 

(in thousands)

 

Note

Share

capital

Capital

reserve

Treasury shares

Accumulated losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interest

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As of January 1, 2020

 

 

€232,304

686,714

(5,525)

(424,827)

4,762

64

493,492

-

493,492

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(351,714)

-

-

(351,714)

-

(351,714)

Other comprehensive loss

 

 

-

-

-

-

-

(7,166)

(7,166)

-

(7,166)

Total comprehensive loss

 

 

-

-

-

(351,714)

-

(7,166)

(358,880)

-

(358,880)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of share capital

 

12

14,006

785,150

-

-

-

-

799,156

-

799,156

Transaction costs

 

12

-

(30,233)

-

-

-

-

(30,233)

-

(30,233)

Share-based payments

 

13

-

-

-

-

24,148

-

24,148

-

24,148

 

 

 

 

 

 

 

 

 

 

 

 

As of September 30, 2020

 

 

€246,310

1,441,631

(5,525)

(776,541)

28,910

(7,102)

927,683

-

927,683

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended September 30, 2019

 

 

 

Attributable to the equity holders of the parent

 

 

 

(in thousands)

 

Note

Share

capital *

Capital

reserve *

Treasury shares *

Accumulated losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interest

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As of January 1, 2019

 

 

€193,296

344,115

-

(245,771)

(25,474)

(13)

266,153

847

267,000

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(120,833)

-

-

(120,833)

(116)

(120,949)

Other comprehensive income

 

 

-

-

-

-

-

(2)

(2)

-

(2)

Total comprehensive income / (loss)

 

 

-

-

-

(120,833)

-

(2)

(120,835)

(116)

(120,951)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of share capital

 

12

8,126

41,748

-

-

-

-

49,874

-

49,874

Capital increase Series B

 

12

17,990

186,390

(5,525)

-

-

-

198,855

-

198,855

Acquisition of non-controlling interest

 

12

2,375

(1,644)

-

-

-

-

731

(731)

-

Transaction costs

 

12

-

(858)

-

-

-

-

(858)

-

(858)

Share based payments

 

13

-

-

-

-

22,485

-

22,485

-

22,485

 

 

 

 

 

 

 

 

 

 

 

 

As of September 30, 2019

 

 

€221,787

569,751

(5,525)

(366,604)

(2,989)

(15)

416,405

-

416,405

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

* Numbers as of January 1, 2019 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019.

 

 

 

 

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

 

6


 

 

 

 

 

Interim Condensed Consolidated Statements of Cash Flows

 

 

Nine months ended

September 30,

 

 

2020

2019

(in thousands)

 

(unaudited)

 

 

 

 

Operating activities

 

 

 

Loss for the period

 

€(351,714)

€(120,949)

Income taxes

 

293

28

Loss before tax

 

€(351,421)

€(120,921)

Adjustments to reconcile loss before tax to net cash flows:

 

 

 

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

 

26,202

24,087

Share-based payment expense

 

24,148

22,485

Net foreign exchange differences

 

80

(170)

Loss on disposal of property, plant and equipment

 

716

11

Finance income

 

(1,068)

(1,102)

Interest on lease liability

 

1,432

1,283

Finance expense

 

7,275

233

Movements in government grants

 

(8,500)

-

Other non-cash income

 

(151)

-

Working capital adjustments:

 

 

 

Decrease/(Increase) in trade receivable and contract assets

 

(54,881)

4,575

Decrease/(Increase) in inventories

 

(508)

(4,945)

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

 

95,058

(60,003)

Interest received

 

784

1,102

Interest paid

 

(1,643)

(1,517)

Income tax received (paid), net

 

(261)

(28)

Net cash flows used in operating activities

 

€(262,738)

€(134,910)

 

 

 

 

Investing activities

 

 

 

Purchase of property, plant and equipment

 

(40,664)

(28,621)

Proceeds from sale of property, plant and equipment

 

8

568

Purchase of intangibles assets

 

(5,247)

(32,937)

Acquisition of subsidiaries and businesses, net of cash acquired

 

891

(6,056)

Net cash flows used in investing activities

 

€(45,012)

€(67,046)

 

 

 

 

Financing activities

 

 

 

Proceeds from issuance of share capital, net of costs

 

680,122

247,871

Proceeds from loans and borrowings

 

102,397

8,067

Repayment of loans and borrowings

 

(904)

-

Payments related to lease liabilities

 

(3,188)

(2,215)

Net cash flows from financing activities

 

€778,427

€253,723

 

 

 

 

Increase in cash and cash equivalents

 

470,677

51,767

Change in cash resulting from exchange rate differences

 

635

46

Cash and cash equivalents at January 1

 

519,149

411,495

Cash and cash equivalents at September 30

 

€990,461

€463,308

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. American Depositary Shares (“ADS”) representing BioNTech’s shares have been publicly traded on the Nasdaq Global Select Market since October 10, 2019. The registered office is located in Mainz, An der Goldgrube 12, 55131 Germany. The accompanying International Financial Reporting Standards, or IFRS, unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries, hereinafter also referred to as “BioNTech” or the “Group” and have been prepared on a going concern basis in accordance with the IFRS as issued by the International Accounting Standards Board, or IASB.

BioNTech combines decades of groundbreaking research in immunology, cutting-edge therapeutic platforms and a suite of patient profiling and bioinformatic tools to develop immunotherapies for cancer and other diseases. BioNTech leverages powerful new therapeutic mechanisms and exploits 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. The breadth of BioNTech’s immunotherapy technologies and expertise has enabled the Group to develop therapies to address a range of rare and infectious diseases, and BioNTech has recently rapidly mobilized these with the aim of addressing the COVID-19 pandemic.

During the nine months ended September 30, 2020, the following changes to the Group structure occurred:

 

On May 6, 2020 BioNTech SE acquired Neon Therapeutics, Inc., Cambridge, Massachusetts, United States (formerly Nasdaq: NTGN), or Neon. Under the merger agreement by and among BioNTech, Neon and BioNTech’s wholly-owned subsidiary, Endor Lights, Inc., New York, United States, Endor Lights, Inc. merged with and into Neon. The new subsidiary operates under the name BioNTech US Inc., a wholly-owned subsidiary of BioNTech SE, and serves as BioNTech’s headquarters in the United States.

 

On July 17, 2020, BioNTech IVAC GmbH was renamed to BioNTech Manufacturing GmbH and on August 7, 2020, BioNTech Small Molecules GmbH was renamed to BioNTech Europe GmbH.

 

On September 17, 2020, following the shareholder resolution, the liquidation process for BioNTech Austria Beteiligungen GmbH was initialized.

 

Two new real estate entities have been founded in Germany: BioNTech Real Estate An der Goldgrube GmbH & Co. KG and BioNTech Real Estate Adam-Opel-Straße GmbH & Co. KG, both Holzkirchen. Both are partnerships wholly-owned by its limited partner BioNTech Real Estate Holding GmbH, a wholly-owned subsidiary of BioNTech SE.

These unaudited interim condensed consolidated financial statements of the Group as of and for the three and nine months ended September 30, 2020 were authorized for issuance in accordance with a resolution of the audit committee on November 10, 2020.

2

Basis of Preparation, Significant Accounting Policies and further Accounting Topics

Basis of Preparation and Principles of Consolidation

The accompanying unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting.

8


 

 

 

 

 

The unaudited interim condensed consolidated financial statements do not include all the in-formation and disclosures required in the consolidated financial statements and should be read in conjunction with the Group’s consolidated financial statements and accompanying notes included in the Group’s Annual Report on Form 20-F as of and for the year ended December 31, 2019.

BioNTech prepares and presents its unaudited interim condensed consolidated financial statements in Euros. Numbers have been rounded, may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures.

The unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2020 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates

The preparation of the unaudited interim condensed consolidated financial statements requires management to make judgments, estimates and assumptions that affect the reported amounts. Management continually evaluates its judgments and estimates in relation to assets, liabilities, which also includes the fair value measurement of derivatives, contingent liabilities, revenue and expenses. Management bases its judgments and estimates on historical experience and on other various factors it believes to be reasonable under the circumstances, the result of which forms the basis of the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions and may materially affect the financial results or the financial position reported in future periods.

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 the Group’s consolidated financial statements for the year ended December 31, 2019. Certain policies have been further specified as described below due to the activities related to and the progress made in the Covid-19 vaccine development.

Research and Development Expenses

Research and development expenses consist of costs incurred in performing research and development activities, including personnel-related expenses, contract services and costs for purchased materials, laboratory supplies and non-capital equipment used in the research and development process. Research and development expenses include BioNTech’s share of expenses under the terms of collaboration agreements and 100% of the expenses for wholly-owned product candidates. Research and development expenses shared under collaboration agreements which are initially incurred by the collaboration partners and subsequently charged to BioNTech are recorded as purchased services classified within research and development. Cost reimbursements from partners for research and development expenses initially incurred by BioNTech and due to BioNTech under the agreements, are recorded as a reduction to purchased services classified within research and development expenses. The value of goods and services received from contract research organizations and contract manufacturing organizations in the reporting period are estimated based on the level of services performed and progress made in the respective period. Amounts are recorded as accrued expenses in cases where BioNTech has not received an invoice from the service provider. Advance payments for goods or services that will be used or rendered for future research and development activities are recognized as other current assets or other current financial assets respectively. The amounts are currently expensed as the related goods are delivered or the services performed. Management’s estimates are based on the best information available at the time. However, additional information may become available in the future and management may adjust the estimate in such future periods. In this event, BioNTech may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes

9


 

 

 

 

 

more certain. BioNTech considers resulting increases or decreases in cost as changes in estimates and reflects such changes in research and development expenses in the period identified.

Research costs are expensed as incurred. Development expenditures on an individual project are recognized as an intangible asset if, and only if, all of the following six criteria can be demonstrated by the Group:

 

the technical feasibility of completing the intangible asset so that the asset will be available for use or sale;

 

its intention to complete the project;

 

the ability and intention to use or sell the asset;

 

how the asset will generate future economic benefits;

 

the availability of resources to complete the asset; and

 

the ability to reliably measure the expenditure during development.

Due to the inherent risk of failure in drug development and the uncertainty of approval, management has determined that these criteria are not met in the Biotech business sector until regulatory approval has been obtained. Therefore, as the Group has not yet obtained regulatory approval for any of its programs, or product candidates, no development expenditures have been capitalized. The related expenditure is reflected in the statements of operations in the period in which the expenditure is incurred.

Pre-launch products

Prior to initial regulatory approval, costs relating to production of products are expensed as research and development expenses in the period incurred. If pre-launch products are sold, the respective product gross margin may be higher compared to the expected recurring margin as the underlying costs will not be included in cost of sales. For the three and nine months ended September 30, 2020 and 2019, no revenues have been recorded related to pre-launch products.

Government grants

The Group has specified its accounting for government grant with respect to the presentation of grants related to assets. In September 2020, in connection with becoming eligible for funding from an initiative by the German Federal Ministry of Education (Bundesministerium für Bildung und Forschung, or the BMBF), the Group elected to present grants received related to assets as deferred income within the statements of financial position. Income is subsequently recognized in profit or loss over the useful live of the underlying asset subject to funding.

The standards applied for the first time as of January 1, 2020, as disclosed in the notes to the consolidated financial statements as of December 31, 2019, had no impact on the unaudited interim condensed consolidated financial statements of the Group as of September 30, 2020. In the course of 2020 an amendment to IFRS 16 Leases with an effective date June 1, 2020 was issued by the International Accounting Standards Board addressing COVID-19-related rent concessions which does not have an impact on the interim condensed consolidated financial statements of the Group.

Impact of COVID-19

On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a pandemic, which continues to spread around the world.

In response, BioNTech’s BNT162 program is evaluating several vaccine candidates against COVID-19, including BNT162b2 as the lead candidate currently being developed in a global Phase 3 trial. As part of the program, BioNTech executed two strategic collaborations with large pharmaceutical companies to globally develop BioNTech’s vaccine candidates and to support a global supply of a vaccine upon approval. The collaboration with Pfizer Inc. (NYSE: PFE), or Pfizer, aims to rapidly advance multiple COVID-19 vaccine candidates based on BioNTech’s proprietary mRNA vaccine technology. As part of their strategic collaboration, BioNTech and Shanghai Fosun Pharmaceutical (Group) Co.,

10


 

 

 

 

 

Ltd (Stock Symbol: 600196.SH, 02196.HK), or Fosun Pharma, will jointly conduct clinical trials in China, leveraging BioNTech’s proprietary mRNA vaccine technology and Fosun Pharma’s clinical development and commercialization capabilities in China. Fosun Pharma will commercialize the vaccine in China upon regulatory approval.

As BioNTech advances its clinical programs, it is in close contact with its principal investigators and clinical sites, which are located in jurisdictions affected by the COVID-19 pandemic, and is assessing the impact of the COVID-19 pandemic on its clinical trials, expected timelines and costs on an ongoing basis. BioNTech has modified its 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), BNT221, BNT161 (Influenza) and BNT171 (Rare Disease), 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 delay had an impact on revenue recognition related to non-COVID-19 collaborations. The partial disruption, even temporary, may severely impact BioNTech’s operations and overall business by delaying the progress of its clinical trials and preclinical studies. BioNTech’s operations, including research and manufacturing, could also be disrupted due to the potential of the impact of staff absences as a result of self-isolation procedures or extended illness. Such factors were evaluated and considered carefully when preparing these unaudited interim condensed consolidated financial statements. BioNTech will continue to evaluate potential effects of the COVID-19 pandemic.

3

Segment Information

For the three and nine months ended September 30, 2020 and 2019, respectively, the following tables present revenue and operating results for the Group’s operating segments consistent with the presentation in the notes to the consolidated financial statements as of December 31, 2019. The tables below reconcile segment figures to Group figures for the periods indicated.

 

 

Biotech Business Unit

External 

Services Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External

Services

Total

Adjustments

Group

Three months ended September 30, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€41,777

€4,118

€13,754

-

-

€59,649

-

€59,649

Revenues from other sales transactions

 

216

66

32

-

7,495

7,809

-

7,809

Cost of sales

 

-

-

-

-

(6,463)

(6,463)

(377)

(6,840)

Gross Profit

 

€41,993

€4,184

€13,786

-

€1,032

€60,995

€(377)

€60,618

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(124,275)

(51,036)

(52,132)

(493)

(145)

(228,081)

375

(227,706)

Sales and marketing expenses

 

-

-

-

(3,772)

(496)

(4,268)

-

(4,268)

General and administrative expenses

 

-

-

(1,281)

(21,241)

(802)

(23,324)

-

(23,324)

Other result

 

4,129

1,882

2,223

34

33

8,301

(3)

8,298

Segment operating loss

 

€(78,153)

€(44,970)

€(37,404)

€(25,472)

€(378)

€(186,377)

€(5)

€(186,382)

 

11


 

 

 

 

 

 

Biotech Business Unit

External 

Services Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Three months ended September 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€7,174

€1,972

€13,091

-

-

€22,237

-

€22,237

Revenues from other sales transactions

 

-

142

-

-

6,283

6,425

-

6,425

Cost of sales

 

-

-

-

-

(4,166)

(4,166)

(64)

(4,230)

Gross Profit

 

€7,174

€2,114

€13,091

-

€2,117

€24,496

€(64)

€24,432

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(21,948)

(14,289)

(12,668)

(1,397)

(158)

(50,460)

64

(50,396)

Sales and marketing expenses

 

-

-

-

(355)

(315)

(670)

-

(670)

General and administrative expenses

 

-

-

(883)

(8,702)

(859)

(10,444)

(138)

(10,582)

Other result

 

47

101

28

35

131

342

-

342

Segment operating loss

 

€(14,727)

€(12,074)

€(432)

€(10,419)

€916

€(36,736)

€(138)

€(36,874)

 

 

Biotech Business Unit

External 

Services Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Nine months ended September 30, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€60,740

€11,543

€41,112

-

-

€113,395

-

€113,395

Revenues from other sales transactions

 

319

311

32

-

22,826

23,488

-

23,488

Cost of sales

 

-

-

-

-

(16,897)

(16,897)

(1,447)

(18,344)

Gross profit

 

€61,059

€11,854

€41,144

-

€5,929

€119,986

€(1,447)

€118,539

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(182,719)

(113,740)

(88,987)

(3,563)

(453)

(389,462)

1,445

(388,017)

Sales and marketing expenses

 

-

-

-

(6,395)

(1,413)

(7,808)

-

(7,808)

General and administrative expenses

 

-

(5)

(3,457)

(52,215)

(2,275)

(57,952)

-

(57,952)

Other result

 

4,114

1,950

2,265

264

47

8,640

(3)

8,637

Segment operating income / (loss)

 

€(117,546)

€(99,941)

€(49,035)

€(61,909)

€1,835

€(326,596)

€(5)

€(326,601)

 

12


 

 

 

 

 

 

Biotech Business Unit

External 

Services Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Nine months ended September 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€25,605

€1,972

€36,683

-

-

€64,260

-

€64,260

Revenues from other sales transactions

 

-

605

2

8

15,726

16,341

-

16,341

Cost of sales

 

-

-

-

-

(12,770)

(12,770)

(155)

(12,925)

Gross profit

 

€25,605

€2,577

€36,685

€8

€2,956

€67,831

€(155)

€67,676

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(65,634)

(52,503)

(38,905)

(3,732)

(420)

(161,194)

155

(161,039)

Sales and marketing expenses

 

-

-

-

(924)

(984)

(1,908)

-

(1,908)

General and administrative expenses

 

-

-

(2,741)

(29,398)

(2,204)

(34,343)

(138)

(34,481)

Other result

 

307

389

42

61

378

1,177

-

1,177

Segment operating loss

 

€(39,722)

€(49,537)

€(4,919)

€(33,985)

€(274)

€(128,437)

€(138)

€(128,575)

 

The segments are managed based on external sales and operating profit/loss, which represents the operating profit/loss incurred within each segment. Segment figures are reported consolidated, which reflects the way management steers the business.

BioNTech’s internal reporting is generally in accordance with IFRS and in line with the Group’s accounting policies, except for deviations in classification between cost of sales and research and development cost. In order to reconcile the segment figures to the Group’s unaudited interim condensed consolidated financial statements, some of the research and development expenses are reclassified to cost of sales. Whenever revenues are attributable to different segments, these revenues are split based on the cost incurred. Internal overhead costs are allocated to segments based on revenues when they are directly attributable to a service rendered. Sales and marketing expenses, general and administrative expenses and other results that are not directly attributable to one of the segments are allocated to Business Service.

Revenue at BioNTech is differentiated between revenues resulting from collaboration and license agreements and revenues from other sales transactions. The Company collaborates with pharmaceutical and healthcare companies and several global academic collaborators. During the three and nine months ended September 30, 2020, revenue generated from the Genentech, Inc., or Genentech, and Pfizer collaboration agreements each represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements. Revenues were partly recorded in the Clinical and the Manufacturing segment and, with respect to Pfizer, in the Technology Platform segment as well. During the three and nine months ended September 30, 2019, revenue generated from the Genentech and Pfizer collaboration agreements represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements. Revenues were recorded in the Clinical segment and, with respect to Genentech, also in the Manufacturing segment. Total amounts of revenues from these collaboration and license agreements in the periods presented are disclosed in Note 4.

Revenues from other sales transactions are from the sale of medical products (e.g., peptides and retroviral vectors) for clinical supply. Research and development activities are managed on a worldwide basis while manufacturing facilities and sales offices are located and managed in Germany. External sales originate in Germany.

13


 

 

 

 

 

4

Revenues from Contracts with Customers

Disaggregated revenue information

Set out below is the disaggregation of the Group’s revenues from contracts with customers:

 

 

Three months ended

September 30,

Nine months ended

September 30,

(in thousands)

 

2020

2019

2020

2019

Revenues resulting from collaboration and license agreements

 

€59,649

€22,237

€113,395

€64,260

Pfizer Inc.

 

45,643

3,587

69,843

10,761

Genentech Inc.

 

11,991

16,677

38,877

47,620

Shanghai Fosun Pharmaceutical (Group) Co., Ltd

 

1,697

-

2,598

-

Sanofi S.A.

 

318

152

2,077

4,058

Eli Lilly and Company

 

-

1,821

-

1,821

Revenues from other sales transactions

 

7,809

6,425

23,488

16,341

Total

 

€67,458

€28,662

€136,883

€80,601

 

During the nine months ended September 30, 2020, revenues from BioNTech’s two new collaboration agreements aimed at developing a COVID 19 vaccine were recognized for the first time.

On March 13, 2020, BioNTech entered into a collaboration and license agreement with Fosun Pharma. Fosun Pharma paid BioNTech a non-refundable upfront cash payment of k€901 (k$1,000) upon signing the agreement in addition to an equity investment of k€45,568 (k$50,000) (see Note 12 for the capital contribution). BioNTech is eligible to receive future milestone payments of up to k$84,000 for potential aggregate consideration of k$135,000.

The non-refundable upfront cash payment received from Fosun Pharma was subsequently fully recognized as revenue. In addition, during the three months ended September 30, 2020, revenue of k€1,697 was recognized by achieving a development milestone. In total, during the nine months ended September 30, 2020, k€2,598 revenue was recognized from the Fosun Pharma collaboration and license agreement.

On April 9, 2020, BioNTech entered into a collaboration and license agreement with Pfizer in which BioNTech and Pfizer equally share development costs. Pfizer agreed to pay BioNTech k€170,146 (k$185,000), including an equity investment of k€103,890 (k$113,000) (see Note 12 for the capital contribution) and a non-refundable upfront cash payment of k€66,256 (k$72,000) which were received in late April 2020 and May 2020, respectively. BioNTech is eligible to receive future milestone payments of up to k$563,000 for potential aggregate consideration of k$748,000.

The non-refundable upfront cash payment received from Pfizer that was initially classified as a contract liability was fully recognized as revenue during the nine months ended September 30, 2020 based on costs incurred. During the three and nine months ended September 30, 2020, revenues of k€45,643 and k€66,256 were recorded respectively.

As services are performed under a collaboration agreement, revenue recognition will be continued in future periods in accordance with BioNTech’s accounting policy as described in “—Critical Accounting Policies and Use of Estimates” and Note 2.3.4 to BioNTech’s consolidated financial statements included in its Annual Report on Form 20-F as of and for the year ended December 31, 2019.

14


 

 

 

 

 

Product sales included within revenue from other sales transactions are displayed below:

 

 

Three months ended

September 30,

Nine months ended

September 30,

(in thousands)

 

2020

2019

2020

2019

Product sales of JPT Peptide Technologies GmbH

 

€4,831

€3,057

€13,868

€8,892

 

5

Business Combinations

Lipocalyx GmbH

In December 2019, BioNTech Delivery Technologies GmbH (previously BioNTech Protein Therapeutics GmbH), or BioNTech Delivery Technologies, a wholly-owned subsidiary of BioNTech SE, entered into an agreement to acquire all assets, employees and proprietary know-how of Lipocalyx GmbH, or Lipocalyx, and its related parties in exchange for a total consideration of cash at an amount of k€6,516 and additional contingent consideration estimated at the closing date of January 6, 2020 at an amount of k€572. The employees of Lipocalyx were transferred automatically to BioNTech Delivery Technologies with effect as of the closing date.

The Group acquired the assets of Lipocalyx and its related parties to combine the acquired technologies and the related know-how with already existing product candidates of the Group to improve their functionality and performance.

The final fair values of the identifiable net assets of Lipocalyx as at the date of acquisition were:

 

  

Fair value

recognized on

acquisition

(in thousands)

Lipocalyx GmbH

Assets

 

Goodwill

€896

Other intangible assets

5,978

Property, plant and equipment

75

Inventories

139

Total identifiable net assets at fair value

€7,088

 

 

Consideration

 

Cash paid

€6,516

Contingent consideration liability

572

Total consideration

€7,088

 

The interim condensed consolidated statements of operations include the result of Lipocalyx since the acquisition date. From the date of acquisition through September 30, 2020, Lipocalyx contributed k€1,082 to operating loss in the Technology Platform business segment of the Group. From the date of acquisition through September 30, 2020, Lipocalyx generated k€176 in revenues. Given the timing of closing, the contribution to operating loss and revenues, if the transaction had occurred at the beginning of the reporting period, would not differ materially. Goodwill recognized is primarily attributed to the expected synergies and other benefits from combining the assets and activities of Lipocalyx with those of the Group. The goodwill resulting from the Lipocalyx acquisition during the nine months ended September 30, 2020 was allocated to the Technology Platform segment.

15


 

 

 

 

 

Transaction costs of k€17 relating to the acquisition have been expensed and are included in the general and administrative expenses in the interim condensed consolidated statements of operations and are included in cash flows used in operating activities in the interim condensed consolidated statements of cash flows.

The purchase agreement with Lipocalyx includes the following contingent cash considerations to the previous owners:

 

k€1,000 upon successful completion of a Phase 1 clinical trial designed to show and establish a sufficient safety margin justifying further development of the first pharmaceutical product relating to acquired technologies formulated in a manner covered by a valid granted claim in a major country of a patent within the assigned IP rights; and

 

k€1,000 upon successful completion of the first Phase 2 clinical trial of the first pharmaceutical product relating to acquired technologies formulated in a manner covered by a valid granted claim in a major country of a patent within the assigned IP rights.

At the acquisition date, the fair value of the contingent consideration was k€572. The contingent consideration is presented in ‘non-current financial liabilities’ in the interim condensed consolidated statements of financial position (see Note 10).

BioNTech US Inc. (formerly Neon Therapeutics, Inc.)

On May 6, 2020, BioNTech acquired Neon, a biotechnology company developing novel neoantigen-based T-cell therapies (“the Merger”). Through the acquisition, BioNTech will be able to leverage Neon’s expertise in the development of neoantigen therapies, with both vaccine and T cell capabilities.

Based on the acquisition date share price, the aggregate value of the merger consideration was k€89,890 (k$97,144) financed by issuing 1,935,488 American Depositary Shares representing BioNTech’s ordinary shares as a stock transaction and including a de minimis cash consideration which was paid to settle Neon’s outstanding stock options.

The fair values and values in accordance with IFRS 3 of the identifiable net assets of BioNTech US Inc. as at the date of acquisition were as follows:

 

Fair value

recognized on

acquisition

(in thousands)

BioNTech US Inc.

Assets

 

Intangible assets

€29,867

Property, plant and equipment

5,617

Right-of-use assets

6,896

Other assets non-current and current

2,704

Cash

7,749

Total assets

€52,833

 

 

Liabilities

 

Trade payables

1,723

Other liabilities non-current and current

17,793

Total liabilities

€19,516

 

 

Total identifiable net assets at fair value

€33,317

 

16


 

 

 

 

 

 

Fair value

recognized on

acquisition

(in thousands)

BioNTech US Inc.

Total identifiable net assets at fair value

€33,317

 

 

Goodwill from the acquisition

56,573

Consideration transferred

€89,890

 

 

Consideration

 

Shares issued, at fair value

89,548

Cash paid

342

Total consideration

€89,890

 

As at the date of acquisition, k€8,043 of deferred tax liabilities had been provisionally recorded arising from the assets acquired in the business combination. Provisionally, tax benefits acquired as part of the business combination were assessed as not satisfying the criteria for separate recognition. During the three months ended September 30, 2020, BioNTech finalized its assessment of deferred taxes related to the acquisition of Neon and determined that loss carryforwards which existed as of the acquisition date, should be recognized to the extent of acquired deferred tax liabilities (k€8,043) and therefore recorded a deferred tax asset of k€8,043 against goodwill. Since the conditions to offset were fulfilled, the deferred tax assets and liabilities were offset. Additionally, the deferred tax asset on tax losses incurred since acquisition through June 30, 2020 (k€2,317) which had been offset against the acquired deferred tax liability as of June 30, 2020, was reversed through income tax expense during the three months ended September 30, 2020 as this deferred tax asset was no longer deemed recoverable as the entire acquired deferred tax liability was offset with the acquired deferred tax asset with the finalization of the purchase price allocation. The net impact on income tax expense in the nine months ended September 30, 2020 is nil.

The interim condensed consolidated statements of operations include the results of BioNTech US since the acquisition date. From the date of acquisition through September 30, 2020, BioNTech US contributed k€17,912 to the operating loss in all biotech business unit operating segments of the Group, primarily in the Technology Platform segment. If the transaction had occurred at the beginning of the reporting period, k€49,202 would have contributed to the operating loss. This amount includes expenses resulting from the Merger and should not necessarily be considered representative of the future consolidated results of operations or financial condition on a consolidated basis. From the date of acquisition, BioNTech US did not generate any revenue and no revenue would have been generated if the transaction had occurred at the beginning of the reporting period.

Goodwill recognized is primarily attributable to the expected synergies and other benefits from combining two organizations with a common culture of pioneering translational science and a shared vision for the future of cancer immunotherapy as described above. The goodwill resulting from the BioNTech US acquisition during the nine months ended September 30, 2020 was allocated to the Technology Platform segment.

Transaction costs of k€1,073 relating to the acquisition have been expensed and are included in the general and administrative expenses in the interim condensed consolidated statements of operations. In the interim condensed consolidated statements of cash flows they are included in cash flows used in operating activities. The attributable costs of the issuance of the shares of k€1,320 were recorded in equity as a deduction from the capital reserve and are included in cash flows from financing activities in the interim condensed consolidated statements of cash flows.

17


 

 

 

 

 

Reconciliation of goodwill

The reconciliation of the carrying amount of goodwill at the beginning and end of the reporting period is presented below

 

(in thousands)

Goodwill

Acquisition costs

 

As of January 1, 2020

€2,978

Acquisition of subsidiaries and businesses

57,469

Currency differences

(4,355)

As of September 30, 2020

€56,092

 

 

Carrying amount

Goodwill

As of January 1, 2020

€2,978

As of September 30, 2020

€56,092

 

The amount of goodwill recognized from acquiring subsidiaries and businesses includes the measurement period adjustment of k€8,043 resulting from the subsequent recognition of deferred tax assets during the reporting period (see above and Note 7).

6

Research and Development Expenses

BioNTech’s nature of business and primary focus of activities, including development of its platforms and manufacturing technologies, generate a significant amount of research and development expenses which are the largest component of total operating expenses.

The research and development expenses recognized during the three and nine months ended September 30, 2020 and September 30, 2019 are shown in the following table:

 

 

 

Three months ended

September 30,

Nine months ended

September 30,

(in thousands)

 

2020

2019

2020

2019

Purchased services

 

€143,104

€15,121

€201,142

€45,434

Wages, benefits and social security expense

 

29,177

16,422

88,694

60,869

Laboratory supplies

 

43,971

9,407

65,148

27,701

Depreciation and amortization

 

7,211

6,799

21,122

19,150

IT costs

 

1,064

580

3,493

1,449

Lease and lease related cost

 

1,167

605

2,832

1,868

Transport costs

 

397

356

1,216

876

Other

 

1,615

1,106

4,370

3,692

Total

 

€227,706

€50,396

€388,017

€161,039

 

During the three and nine months ended September 30, 2020, research and development expenses increased mainly due to an increase in development expenses from BioNTech’s BNT162 program, the vaccine program against COVID-19. Research and development expenses include BioNTech’s share of expenses derived from the collaboration with Pfizer under which shared development costs are shared equally between the partners.

18


 

 

 

 

 

7

Income Tax