SEC Filing | BioNTech

View:

Download DOC

Download PDF

Download XLS

Document

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF AUGUST 2023

COMMISSION FILE NUMBER 001-39081

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

An der Goldgrube 12

D-55131 Mainz

Germany

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

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

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

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

DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On August 7, 2023, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three and six months ended June 30, 2023. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company for the three and six months ended June 30, 2023 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 the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


			BioNTech SE


			By:			/s/ Jens Holstein
						Name: Jens Holstein
						Title: Chief Financial Officer

Date: August 7, 2023

EXHIBIT INDEX



Exhibit			Description of Exhibit

99.1			Quarterly Report for the Three and Six Months Ended June 3 0 , 2023

Document

Exhibit 99.1

https://cdn.kscope.io/1bfcf878c9d54285eda252d0c5ecac8c-image_1a.jpg

BioNTech SE

Quarterly Report of BioNTech SE for the Three And Six Months Ended June 30, 2023

Exhibit 99.1

Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, our website is not part of this document. Our agent for service solely for the purpose of notices and communications from the Securities and Exchange Commission in the United States is c/o BioNTech US Inc., 40 Erie Street, Suite 110, Cambridge, Massachusetts 02139, +1 (617) 337-4701.

Exhibit 99.1

Unaudited Interim Condensed Consolidated Financial Statements


			Interim Condensed Consolidated Statements of Profit or Loss			1
			Interim Condensed Consolidated Statements of Comprehensive Income			2
			Interim Condensed Consolidated Statements of Financial Position			3
			Interim Condensed Consolidated Statements of Changes in Stockholder s ' Equity			4
			Interim Condensed Consolidated Statements of Cash Flows			5
			S elected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements			6
			1 Corporate Information			6
			2 Basis of Preparation, Significant Accounting Policies and further Accounting Topics			6
			3 Revenues from Contracts with Customers			7
			4 Income and Expenses			8







			5 I ncome Taxes			11
			6 Intangible Assets			12
			7 Financial Assets and Financial Liabilities			12
			8 Inventories			14
			9 Issued Capital and Reserves			14
			10 Share-Based Payments			15
			11 Contingencies			16
			1 2 Related Party Disclosures			19
			1 3 Events after the Reporting Period			19

Operating and Financial Review and Prospects


Operating Results			21
Liquidity and Capital Resources			41
Risk Factors			45

Unaudited Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Profit or Loss


		Three months ended June 30,		Six months ended June 30,
		2023	2022	2023	2022
(in millions €, except per share data)	Note	(unaudited)	(unaudited)	(unaudited)	(unaudited)

Revenues
Commercial revenues	3	166.4	3,166.3	1,442.9	9,528.5
Research & development revenues	3	1.3	30.2	1.8	42.6
Total revenues		167.7	3,196.5	1,444.7	9,571.1

Cost of sales	4.1	(162.9)	(764.6)	(258.9)	(2,058.7)
Research and development expenses	4.2	(373.4)	(399.6)	(707.4)	(685.4)
Sales and marketing expenses		(18.1)	(17.8)	(30.3)	(32.1)
General and administrative expenses	4.3	(122.7)	(130.0)	(242.1)	(220.8)
Other operating expenses	4.4	(74.2)	(240.7)	(192.3)	(309.5)
Other operating income	4.5	20.3	565.8	77.4	697.7



Operating income / (loss)		(563.3)	2,209.6	91.1	6,962.3

Finance income	4.6	152.4	115.5	208.9	387.6
Finance expenses	4.7	(1.3)	(5.8)	(4.5)	(12.5)



Profit / (loss) before tax		(412.2)	2,319.3	295.5	7,337.4


Income taxes	5	221.8	(647.3)	16.3	(1,966.6)
Profit / (Loss) for the period		(190.4)	1,672.0	311.8	5,370.8






Earnings per share
Basic profit / (loss) for the period per share		(0.79)	6.86	1.29	22.00
Diluted profit / (loss) for the period per share		(0.79)	6.45	1.28	20.69

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

Interim Condensed Consolidated Statements of Comprehensive Income


		Three months ended June 30,		Six months ended June 30,
		2023	2022	2023	2022
(in millions €)	Note	(unaudited)	(unaudited)	(unaudited)	(unaudited)
Profit / (Loss) for the period		(190.4)	1,672.0	311.8	5,370.8

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		(2.2)	9.8	(4.3)	13.5
Net gain on cash flow hedges		6.0	—	7.7	—
Net other comprehensive income that may be reclassified to profit or loss in subsequent periods		3.8	9.8	3.4	13.5

Other comprehensive loss that will not be reclassified to profit or loss in subsequent periods, net of tax
Net gain on equity instruments designated at fair value through other comprehensive income		4.4	—	4.4	—
Remeasurement loss on defined benefit plans		—	—	—	(0.1)
Net other comprehensive income / (loss) that will not be reclassified to profit or loss in subsequent periods		4.4	—	4.4	(0.1)

Other comprehensive income for the period, net of tax		8.2	9.8	7.8	13.4

Comprehensive income / (loss) for the period, net of tax		(182.2)	1,681.8	319.6	5,384.2

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

Interim Condensed Consolidated Statements of Financial Position


		June 30,	December 31,
(in millions €)		2023	2022
Assets	Note	(unaudited)
Non-current assets
Intangible assets	6	501.4	219.7
Property, plant and equipment		691.1	609.2
Right-of-use assets		202.9	211.9
Other financial assets	7	1,374.3	80.2
Other non-financial assets		2.5	6.5

Deferred tax assets	5	239.5	229.6
Total non-current assets		3,011.7	1,357.1
Current assets
Inventories	8	448.9	439.6
Trade and other receivables	7	2,657.9	7,145.6
Contract assets		5.9	—
Other financial assets	7	1,390.7	189.4
Other non-financial assets		212.3	271.9
Income tax assets	5	331.6	0.4

Cash and cash equivalents		14,166.6	13,875.1

Total current assets		19,213.9	21,922.0
Total assets		22,225.6	23,279.1

Equity and liabilities
Equity
Share capital	9	248.6	248.6
Capital reserve	9	1,424.4	1,828.2
Treasury shares	9	(8.8)	(5.3)
Retained earnings		19,144.8	18,833.0
Other reserves	10	(902.5)	(848.9)


Total equity		19,906.5	20,055.6
Non-current liabilities
Lease liabilities, loans and borrowings	7	167.1	176.2
Other financial liabilities	7	6.1	6.1
Income tax liabilities	5	—	10.4
Provisions		8.6	8.6
Contract liabilities	3	302.1	48.4
Other non-financial liabilities		11.7	17.0
Deferred tax liabilities		4.5	6.2
Total non-current liabilities		500.1	272.9
Current liabilities
Lease liabilities, loans and borrowings	7	38.6	36.0
Trade payables and other payables	7	228.6	204.1
Other financial liabilities	7	172.5	785.1

Refund liabilities		—	24.4
Income tax liabilities	5	554.9	595.9
Provisions		374.8	367.2
Contract liabilities	3	201.2	77.1
Other non-financial liabilities		248.4	860.8
Total current liabilities		1,819.0	2,950.6
Total liabilities		2,319.1	3,223.5
Total equity and liabilities		22,225.6	23,279.1

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

Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity


(in millions €)	Note	Share capital	Capital reserve	Treasury shares	Retained earnings	Other reserves	Total equity
As of January 1, 2022		246.3	1,674.4	(3.8)	9,882.9	93.9	11,893.7
Profit for the period		—	—	—	5,370.8	—	5,370.8
Other comprehensive income		—	—	—	—	13.4	13.4
Total comprehensive income		—	—	—	5,370.8	13.4	5,384.2
Issuance of share capital		0.5	67.1	—	—	—	67.6
Redemption of convertible note		1.8	233.2	—	—	—	235.0
Share repurchase program		—	(284.8)	(2.1)	—	—	(286.9)
Transaction costs		—	(0.1)	—	—	—	(0.1)
Dividends		—	—	—	(484.3)	—	(484.3)
Share-based payments		—	—	—	—	21.5	21.5
As of June 30, 2022		248.6	1,689.8	(5.9)	14,769.4	128.8	16,830.7

As of January 1, 2023		248.6	1,828.2	(5.3)	18,833.0	(848.9)	20,055.6
Profit for the period		—	—	—	311.8	—	311.8
Other comprehensive income		—	—	—	—	7.8	7.8
Total comprehensive income		—	—	—	311.8	7.8	319.6


Share repurchase program	9	—	(432.2)	(3.8)	—	—	(436.0)


Share-based payments	10	—	28.4	0.3	—	(33.5)	(4.8)
Current and deferred taxes	5	—	—	—	—	(27.9)	(27.9)
As of June 30, 2023		248.6	1,424.4	(8.8)	19,144.8	(902.5)	19,906.5

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

Interim Condensed Consolidated Statements of Cash Flows


	Three months ended June 30,		Six months ended June 30,
	2023	2022	2023	2022
(in millions €)	(unaudited)	(unaudited)	(unaudited)	(unaudited)
Operating activities
Profit / (Loss) for the period	(190.4)	1,672.0	311.8	5,370.8
Income taxes	(221.8)	647.3	(16.3)	1,966.6
Profit / (Loss) before tax	(412.2)	2,319.3	295.5	7,337.4
Adjustments to reconcile profit before tax to net cash flows:
Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets	31.9	33.2	63.3	60.8
Share-based payment expenses	13.1	14.8	21.7	25.0
Net foreign exchange differences	(397.0)	(344.6)	(343.9)	(338.5)
Loss on disposal of property, plant and equipment	0.1	0.2	0.3	0.2
Finance income excluding foreign exchange differences	(126.6)	(1.5)	(208.9)	(218.8)
Finance expense excluding foreign exchange differences	1.3	5.8	2.5	12.5
Movements in government grants	—	—	(3.0)	—


Net loss on derivative instruments at fair value through profit or loss	12.0	86.5	88.2	84.6
Working capital adjustments:
Decrease in trade and other receivables, contract assets and other assets	5,123.6	3,174.8	6,017.4	2,771.3
Decrease / (increase) in inventories	(24.8)	91.6	(9.3)	134.8
(Decrease) / increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions	592.7	(663.1)	(268.9)	194.4
Interest received	42.5	1.5	96.1	2.2
Interest paid	(1.3)	(5.8)	(2.5)	(12.2)
Income tax paid	(437.3)	(791.4)	(1,282.2)	(2,081.4)
Share-based payments	(31.3)	(2.2)	(757.0)	(3.0)
Net cash flows from operating activities	4,386.7	3,919.1	3,709.3	7,969.3

Investing activities
Purchase of property, plant and equipment	(67.2)	(70.6)	(112.4)	(114.7)
Proceeds from sale of property, plant and equipment	—	—	—	—
Purchase of intangible assets and right-of-use assets	(242.1)	(4.8)	(251.7)	(21.5)

Investment in other financial assets	(1,982.5)	(3.0)	(2,663.1)	(30.0)
Proceeds from maturity of other financial assets	—	—	—	375.2
Net cash flows from / (used in) investing activities	(2,291.8)	(78.4)	(3,027.2)	209.0

Financing activities
Proceeds from issuance of share capital and treasury shares, net of costs	—	—	—	110.5
Proceeds from loans and borrowings	—	0.2	—	0.2
Repayment of loans and borrowings	—	—	—	(18.8)
Payments related to lease liabilities	(9.4)	(10.5)	(18.7)	(21.9)
Share repurchase program	(154.0)	(286.9)	(436.0)	(286.9)
Dividends	—	(484.3)	—	(484.3)
Net cash flows used in financing activities	(163.4)	(781.5)	(454.7)	(701.2)

Net increase in cash and cash equivalents	1,931.5	3,059.2	227.4	7,477.1
Change in cash and cash equivalents resulting from exchange rate differences	91.2	111.5	64.1	165.0
Cash and cash equivalents at the beginning of the period	12,143.9	6,164.1	13,875.1	1,692.7
Cash and cash equivalents as of June 30	14,166.6	9,334.8	14,166.6	9,334.8

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

Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements

1Corporate 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 are a global next-generation immunotherapy company pioneering novel medicines against cancer, infectious diseases and other serious diseases. Since our founding in 2008, we have focused on harnessing the power of the immune system to address human diseases with unmet medical need and major global health burden. Our fully integrated model combines decades of research in immunology, translational drug discovery and development, a technology agnostic innovation engine, GMP manufacturing, and commercial capabilities to rapidly discover, develop and commercialize our marketed products and other candidate vaccines and therapies. We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes mRNA vaccines and therapeutics, cell and gene therapies, targeted antibodies and small molecule immunomodulators.

Our unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023 were authorized for issuance in accordance with a resolution of the audit committee on August 4, 2023.

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

Basis of Preparation and Principles of Consolidation

The accompanying unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023 have been prepared in accordance with International Accounting Standard (IAS) 34 Interim Financial Reporting.

The unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in the consolidated financial statements, and should be read in conjunction with our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.

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

The unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

Significant Accounting Judgments, Estimates and Assumptions and Accounting Policies

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, 2022. 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. Our management continually evaluates judgments and estimates, including those related to the contingencies, 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.

Previously, we had assessed that inventory produced prior to successful regulatory approval did not meet the criteria for capitalization as an asset, and accordingly expensed the costs of pre-launch inventory as research and development costs. Based on the experience of the past years and the developments since our COVID-19 vaccine was first authorized or approved for emergency or temporary use, our assessment regarding the potential to produce economic benefits changed. Beginning with the second quarter of 2023, pre-launch products from the Comirnaty product family with their potential for economic benefit fulfill the recognition criteria for an asset under the IFRS Conceptual Framework. At each reporting date, the respective inventory is measured at the lower of cost and net realizable value. However, because is not probable until regulatory approval is obtained, we consider the net realizable value to be zero, as this is the probable amount expected to be realized from its sale until approval is obtained. The write-down is recognized in the statements of profit or loss as research and development expenses. If regulatory approval for a product candidate is obtained, the relevant write-down would be reversed to a maximum of the original cost. Subsequently, inventory will be recognized as cost of sales. This reassessment has been treated as a change in estimate and has no impact on current period inventories or research and development expenses.

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, 2022, except for income taxes, which are accounted for using the expected annual tax rate in our unaudited interim condensed consolidated financial statements (see Note 5). Certain policies are described further below due to the activities and transactions during the three and six months ended June 30, 2023.

Standards Applied for the First Time

The IFRS standards applied for the first time as of January 1, 2023, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2022, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023.

3Revenues from Contracts with Customers

Disaggregated information on revenues

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


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Commercial revenues	166.4	3,166.3	1,442.9	9,528.5
COVID-19 vaccine revenues	158.2	3,152.7	1,421.7	9,505.8
Sales to collaboration partners(1)	75.2	608.3	146.6	1,211.5


Direct product sales to customers	—	557.0	65.2	1,720.1


Share of collaboration partners' gross profit	83.0	1,987.4	1,209.9	6,574.2


Other sales	8.2	13.6	21.2	22.7
Research & development revenues from collaborations	1.3	30.2	1.8	42.6






Total	167.7	3,196.5	1,444.7	9,571.1

(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.

Commercial Revenues

During the three and six months ended June 30, 2023, and 2022, commercial revenues were recognized from the supply and sales of our COVID-19 vaccine worldwide. During the three and six months ended June 30, 2023 our commercial revenues decreased corresponding with a lower COVID-19 vaccine market demand. Write-offs by our collaboration partner Pfizer Inc, or Pfizer, significantly reduced our gross profit share and hence negatively influenced our revenues for three months ended June 30, 2023. We are the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada and other countries, and holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer Inc., or Pfizer) and other countries; submissions to pursue regulatory approvals in countries where emergency use authorizations or equivalent were initially granted are ongoing. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Shanghai Fosun Pharmaceutical (Group) Co., Ltd, or Fosun Pharma, has marketing and distribution rights in China, Hong Kong

special administrative region, or SAR, Macau SAR and the region of Taiwan. The allocation of marketing and distribution rights defines territories in which the collaboration partners act as a principal.

Sales to Collaboration Partners

Sales to collaboration partners represent sales of products manufactured by us to collaboration partners. 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. Under the collaboration with Pfizer, from time to time, those sales are significantly influenced by amounts due to write-offs of inventories as well as costs related to production capacities derived from contracts with Contract Manufacturing Organizations (CMOs) that became redundant. Those costs represent accrued manufacturing variances and are charged to our partner once finally materialized. These manufacturing variances are reflected as transfer price adjustment once identified and assessed highly probable. Sales to collaboration partners during the three and six months ended June 30, 2023, amounted to €75.2 million and €146.6 million, respectively. During the three and six months ended June 30, 2022 the sales to collaboration partners amounted to €608.3 million and €1,211.5 million, respectively. During the three and six months ended June 30, 2023 those sales included €69.1 million and €116.9 million, respectively, related to the aforementioned manufacturing variances (€427.6 million and €795.2 million with respect to sales during the three and six months ended June 30, 2022).

Direct Product Sales to Customers

By supplying our territories during the three and six months ended June 30, 2023, we recognized nil and €65.2 million of revenues, respectively, from direct COVID-19 vaccine sales in Germany. During the three and six months ended June 30, 2022, recognized revenues derived from those sales amounted to €557.0 million and €1,720.1 million, respectively. The share of gross profit that we owe our collaboration partner Pfizer based on our sales is recognized as cost of sales. Alongside with amending the COVID-19 Vaccine Purchase Agreement with the European Commission, an amount of €437.7 million was recognized as contract liability in our unaudited interim condensed consolidated statements of financial position. The amount will be recognized over the expanded term of the agreement.

Share of Collaboration Partners' Gross Profit

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 seasonally-affected net figure and is recognized as collaboration revenue during the commercial phase. When determining the gross profit, manufacturing cost variances either reflected as transfer price adjustment as described above, or resulting from costs highly probable to be incurred by the partner were considered. During the three and six months ended June 30, 2023, €83.0 million and €1,209.9 million, respectively, in gross profit share was recognized as revenues. During the three and six months ended June 30, 2022, €1,987.4 million and €6,574.2 million, respectively, in gross profit share was recognized as revenues.

Revenues from contracts with customers were recognized as follows:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Timing of revenue recognition
Goods and services transferred at a point in time	82.5	1,177.6	225.5	2,951.0
Goods and services transferred over time	2.2	31.5	9.3	45.9
Revenue recognition applying the sales-based or usage-based royalty recognition constraint model(1)	83.0	1,987.4	1,209.9	6,574.2
Total	167.7	3,196.5	1,444.7	9,571.1

(1) Represents sales based on the share of the collaboration partners' gross profit.

4Income and Expenses

4.1Cost of Sales

The cost of sales recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Cost of sales related to COVID-19 vaccine revenues	162.7	753.3	251.1	2,041.6
Cost related to other sales	0.2	11.3	7.8	17.1
Total	162.9	764.6	258.9	2,058.7

4.2Research and Development Expenses

The research and development expenses recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Purchased services	141.8	230.0	339.0	361.4
Wages, benefits and social security expense	98.0	85.5	184.6	156.3
Laboratory supplies	88.9	48.1	102.8	105.7
Depreciation and amortization	13.8	11.6	28.4	22.4







Other	30.9	24.4	52.6	39.6
Total	373.4	399.6	707.4	685.4

4.3General and Administrative Expenses

The general and administrative expenses recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Wages, benefits and social security expense	43.1	43.0	81.1	70.5
IT and office equipment	33.6	22.5	61.1	33.8
Purchased services	34.6	34.6	58.8	64.9


Depreciation and amortization	8.0	3.3	14.9	5.8






Other	3.4	26.6	26.2	45.8
Total	122.7	130.0	242.1	220.8

4.4Other Operating Expenses

The other operating expenses recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Foreign exchange differences, net	71.2	—	187.7	—
Loss on derivative instruments at fair value through profit or loss	—	229.7	—	299.0


Other	3.0	11.0	4.6	10.5
Total	74.2	240.7	192.3	309.5

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

The loss on derivative instruments at fair value through profit or loss in the prior year comparable period related to foreign exchange forward contracts that were entered into to manage some of our transaction exposures but were not designated as hedging instruments under IFRS (see Note 7).

4.5Other Operating Income

The other operating income recognized during the three and six months ended June 30, 2023, and 2022 is shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022

Gain on derivative instruments at fair value through profit or loss	12.6	—	54.5	—


Foreign exchange differences, net	—	517.0	—	641.0
Other	7.7	48.8	22.9	56.7
Total	20.3	565.8	77.4	697.7

The gain on derivative instruments at fair value through profit or loss related to foreign exchange forward contracts that did not qualify for hedge accounting (see Note 7).

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

4.6Finance Income

The finance income recognized during the three and six months ended June 30, 2023, and 2022 is shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Interest income	84.6	1.5	144.7	2.0
Fair value adjustments of financial instruments measured at fair value	42.0	—	64.2	216.8
Foreign exchange differences, net	25.8	114.0	—	168.8
Total	152.4	115.5	208.9	387.6

During the three and six months ended June 30, 2023, interest income was mainly derived from our debt security investments as well as bank deposits and the fair value adjustments were derived from remeasuring our money market funds. During the three and six months ended June 30, 2022, the fair value adjustments were mainly derived from remeasuring the derivative embedded in our convertible note and foreign exchange differences were mainly derived from our foreign exchange bank deposits and cash accounts, respectively.

4.7Finance Expenses

The finance expenses recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Foreign exchange differences, net	—	—	2.0	—





Other	1.3	5.8	2.5	12.5
Total	1.3	5.8	4.5	12.5

5Income Taxes

For the six months ended June 30, 2023 and 2022, income taxes were calculated based on the best estimate of the weighted average annual income tax rates expected for the full financial years (estimated annual effective income tax rates) on ordinary income before tax adjusted by the tax effect of any discrete items. The income tax asset represents the portion of prepayments for Corporate Income Taxes and Trade Taxes in Germany that have been estimated for the full financial year 2023 but not yet offset by income tax expenses calculated for the six month ended June, 30, 2023. For the six months ended June 30, 2023 and 2022, our effective income tax rates were approximately (5.5)% and 26.8%, respectively. The decrease of the effective income tax rate was mainly driven by the transaction within the BioNTech Group described below. During the six months ended June 30, 2023 and 2022, current income taxes were recognized with respect to the German tax group. Deferred tax effects were recognized with respect to identified discrete items as well as share-based payments programs during the three and six months ended June 30, 2023 and 2022.

A reorganization of the intellectual property rights within the group has become effective June 30, 2023 which led to deferred tax effects in Germany and the US. As a result BioNTech SE recognized deferred tax assets and deferred tax income at the time of the transaction. In addition this transaction led to a revaluation of previously unrecognized U.S. federal and state deferred tax assets, including unused tax losses and unused tax credits. As of December 31, 2022, there were unrecognized U.S. federal and state deferred tax assets of €128.9 million. As of June 30, 2023, it is now considered highly probable that taxable profits for the U.S. tax group will be available against which the deferred tax assets can be utilized in the near future fulfilling the requirements set out by IAS 12. Therefore we no longer continue to maintain the full non-recognition of deferred tax assets of our U.S. tax group as there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized. As of June, 30, 2023, we maintain the non-recognition of deferred tax assets for unused U.S. federal and state tax losses at amount of €20.1 million and €1.6 million, respectively, as there is not sufficient probability in terms of IAS 12 that there will be future taxable income available against which these unused tax losses can be utilized.

The income taxes recognized during the three and six months ended June 30, 2023, and 2022 are shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Current income taxes	(199.7)	597.8	43.5	1,932.9

Deferred taxes	(22.1)	49.5	(59.8)	33.7
Income taxes	(221.8)	647.3	(16.3)	1,966.6

6Intangible Assets

The increase in intangible assets by €281.7 million from December 31, 2022 to June 30, 2023 was mainly related to licenses acquired fulfilling the definition of identifiable assets in the amount of €283.2 million in connection with the license and collaboration agreements entered into between us and Duality Biologics (Suzhou) Co. Ltd., Shanghai, China, in March 2023 as well as the license and collaboration agreement entered into between us and OncoC4 Inc., Rockville (Maryland), United States, in April 2023.

7Financial Assets and Financial Liabilities

Financial Assets

Set out below is an overview of financial assets, other than cash and cash equivalents, held as of June 30, 2023 and December 31, 2022.


(in millions €)	June 30, 2023	December 31, 2022
Derivatives not designated as hedging instruments
Foreign exchange forward contracts	0.5	183.7


Equity instruments designated at fair value through OCI
Non-listed equity investments	57.2	57.1
Listed equity investments	26.0	20.0
Financial assets at amortized cost
Trade and other receivables	2,657.9	7,145.6
Security investments	2,667.0	—
Other financial assets	14.3	8.8

Total	5,422.9	7,415.2
Total current	4,048.6	7,335.0
Total non-current	1,374.3	80.2

Derivatives Not Designated as Hedging Instruments

Derivatives not designated as hedging instruments related to foreign exchange forward contracts that were entered, to manage some of our foreign currency exposures. The foreign exchange forward contracts are measured at fair value through profit or loss and are intended to reduce the exposure to foreign currency risk resulting from trade receivables denominated in U.S. dollar.

Equity Instruments Designated at Fair Value through Other Comprehensive Income

Equity investments are mainly made in conjunction with our existing collaboration partnerships. In accordance with IFRS 9 we elected to present gains and losses on our equity investments in other comprehensive income to avoid fluctuations in our unaudited interim condensed consolidated statements of profit or loss.

Financial Assets at Amortized Cost

Trade and other receivables predominantly comprised trade receivables from our COVID-19 collaboration with Pfizer where the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. As Pfizer’s fiscal quarter for subsidiaries outside the United States differs from ours, there is an additional time lag between the recognition of revenues and the payment receipt. Consequently, as of June 30, 2023, our trade receivables

included, in addition to the profit share for the second quarter of 2023, trade receivables which related to the gross profit share for the first quarter of 2023.

Our investments in different debt securities with a remaining term of more or less than twelve months are presented as non-current or current security investments, respectively, and measured at amortized cost. Within our interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023, €1,277.2 million are presented as non-current and €1,389.8 million as current security investments as part of the financial assets.

Financial Liabilities

Set forth below is an overview of loans and borrowings and other financial liabilities held as of June 30, 2023 and December 31, 2022.


Loans and borrowings
(in millions €)	June 30, 2023	December 31, 2022


Lease liabilities	203.6	210.1

Loans and borrowings	2.1	2.1




Total	205.7	212.2
Total current	38.6	36.0
Total non-current	167.1	176.2


Other financial liabilities
(in millions €)	June 30, 2023	December 31, 2022
Derivatives not designated as hedging instruments

Foreign exchange forward contracts	15.6	—
Derivatives designated as hedging instruments
Foreign exchange forward contracts	0.7	—
Financial liabilities at fair value through profit or loss
Contingent consideration	5.5	6.1
Total financial liabilities at fair value	21.8	6.1

Trade payables and other payables as well as financial liabilities at amortized cost, other than loans and borrowings
Trade payables and other payables	228.6	204.1



Other financial liabilities	156.8	785.1
Total trade payables and other payables as well as financial liabilities at amortized cost, other than loans and borrowings	385.4	989.2

Total other financial liabilities	407.2	995.3
Total current	401.1	989.2
Total non-current	6.1	6.1


Total financial liabilities
(in millions €)	June 30, 2023	December 31, 2022
Lease liabilities, loans and borrowings	205.7	212.2
Other financial liabilities	407.2	995.3
Total	612.9	1,207.5
Total current	439.7	1,025.2
Total non-current	173.2	182.3

Derivatives Not Designated as Hedging Instruments

Derivatives not designated as hedging instruments related to foreign exchange forward contracts that were entered to manage some of our foreign currency exposures. The foreign exchange forward contracts are measured at fair value through profit or loss and are intended to reduce the exposure to foreign currency risk resulting from trade receivables denominated in U.S. dollar.

Derivatives Designated as Hedging Instruments

Derivatives designated as hedging instruments related to foreign exchange forward contracts that were entered into during the six months ended June 30, 2023, to hedge the cash flow risk associated with the purchase price in British pound (GBP) of the intended acquisition (forecasted transaction) of InstaDeep Ltd.

Other Financial Liabilities at Amortized Cost

Other financial liabilities at amortized cost mainly included obligations derived from license agreements which are being incurred with respect to our COVID-19 vaccine sales in our and our collaboration partners’ territories where we and our partners are using third party intellectual property.

Risk Management Activities

No changes have occurred regarding our risk management activities as disclosed in the notes to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.

Fair Values

The financial instruments at fair value are measured at fair value on a quarterly basis. Money market funds, or MMFs, which were recognized as cash and cash equivalents in the amount of €7,194.7 million as of June 30, 2023 (€3,148.9 million as of December 31, 2022), were valued using quoted prices on the valuation date in active markets (Level 1). The foreign exchange forward contracts were valued using valuation techniques, which involved the use of foreign exchange spot and forward rates (Level 2). The fair values of listed equity investments were measured based on the stock prices of the listed companies (Level 1). The fair values of non-listed equity investments were measured based on observable inputs, e.g., used for multiple analyses (Level 2). The initial fair value of contingent considerations determined at acquisition was based on cash flow projections (unobservable Level 3 input factors) and remained unchanged since no material changes of the underlying performance criteria had occurred.

8Inventories

Below is an overview of inventories held as of June 30, 2023 and December 31, 2022.


(in millions €)	June 30, 2023	December 31, 2022
Raw materials and supplies	407.5	409.7
Unfinished goods	9.6	21.0
Finished goods	31.8	8.9
Total	448.9	439.6

During the three and six months ended June 30, 2023 expenses from inventory write-downs to net realizable value and inventory write-offs due to inventories expected to be unsaleable, not fulfilling the specification defined by our quality standards, shelf-life expiry or disposals resulted in €40.2 million and €113.9 million, respectively, included in cost of sales. (€247.1 million and €403.1 million with respect to write-offs during the three and six months ended June 30, 2022).

9Issued Capital and Reserves

As of June 30, 2023, the number of shares outstanding was 239,771,156. This amount excludes 8,781,044 shares held in treasury. As of December 31, 2022, the number of shares outstanding was 243,215,169, excluding 5,337,031 shares held in treasury.

Second Tranche Share Repurchase Program

In November 2022, our Management Board and Supervisory Board authorized the second tranche of our share repurchase program of ADSs, with a value of up to $0.5 billion, commencing on December 7, 2022. Between January 1,

2023 and March 17, 2023, the date on which the trading plan for the second tranche of our share repurchase program expired, the following repurchases under the program occurred:


Second Tranche ($0.5 billion)
Period	Number of ADSs purchased	Average price paid per ADS	Net amount spent (in millions)
January 2023	618,355	$142.26 (€131.12)	$88.0 (€81.1)
February 2023	857,620	$138.05 (€129.06)	$118.4 (€110.7)
March 2023(1)	745,196	$128.49 (€121.08)	$95.7 (€90.2)
Total	2,221,171		$302.1(€282.0)

(1) Ending March 17, 2023.

2023 Share Repurchase Program

On March 27, 2023, our Management Board and Supervisory Board authorized a new share repurchase program under which we may purchase ADSs, each representing one ordinary share, with a value of up to $0.5 billion until the end of 2023. During the three months ended June 30, 2023 the following repurchases under the program occurred:


Program 2023 ($0.5 billion)
Period	Number of ADSs purchased	Average price paid per ADS	Net amount spent (in millions)
June 2023	1,532,685	$108.92 (€100.45)	$166.9 (€154.0)
Total	1,532,685		$166.9 (€154.0)

10Share-Based Payments

Expenses Arising from Share-Based Payment Arrangements

During the three and six months ended June 30, 2023, and 2022, the following share-based payment arrangements led to the expenses recognized for services received during the respective periods as shown in the following table:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Expense arising from equity-settled share-based payment arrangements	11.3	12.8	22.0	25.0
Employee Stock Ownership Plan	—	4.5	0.1	9.2
Chief Executive Officer Grant	0.4	0.9	0.8	1.8
Management Board Grant	1.6	1.7	2.7	2.7
BioNTech 2020 Employee Equity Plan for Employees Based Outside North America	9.3	5.7	18.4	11.3
Expense / (Income) arising from cash-settled share-based payment arrangements	2.2	2.0	(0.3)	—
Employee Stock Ownership Plan	1.0	0.5	(1.4)	0.3
Management Board Grant	(0.5)	(0.4)	(1.8)	(1.2)
BioNTech Restricted Stock Unit Plan for North America Employees	1.7	1.9	2.9	0.9
Total	13.5	14.8	21.7	25.0

Cost of sales	1.6	0.7	3.1	1.5
Research and development expenses	8.7	9.7	15.2	17.0
Sales and marketing expenses	—	0.3	0.1	0.4
General and administrative expenses	3.2	4.1	3.3	6.1
Total	13.5	14.8	21.7	25.0

During the three and six months ended June 30, 2023, our share-based payment arrangements led to a cash outflow of €31.3 million and €757.0 million, respectively. During the six months ended June 30, 2023, the cash outflows included wage tax payments (including solidarity surcharge thereon and church tax, if applicable) and social security contributions of €724.0 million related to the exercise of rights under the Employee Stock Ownership Plan in 2022 (please see Note 16.5 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022 for further details of the exercise). During the three and six months ended June 30, 2022, our share-based payment arrangements led to a cash outflow of €2.2 million and €3.0 million, respectively.

Changes in Share-Based Payment Arrangements

In May 2023, the allocation date in 2023, options were allocated to the Management Board under the Management Board Grant. A detailed description of our share-based payment arrangements is included in Note 16 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.

11Contingencies

Our contingencies include, but are not limited to, intellectual property disputes and product liability and other product-related litigation. From time to time, in the normal course and conduct of our business, we may be involved in discussions with third parties about considering, for example, the use and/or remuneration for use of such third party’s intellectual property. As of June 30, 2023, none of such intellectual property-related considerations that we have been notified of, and for which potential claims could be brought against us or our subsidiaries in the future, fulfill the criteria for recording a provision. We are subject to an increasing number of product liability claims. Such claims often involve highly complex issues related to medical causation, correctness and completeness of product information (Summary of Product Characteristics/package leaflet) as well as label warnings and reliance thereon, scientific evidence and findings, actual and provable injury, and other matters. These complexities vary from matter to matter. As of June 30, 2023, none of these claims fulfill the criteria for recording a provision. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions. We currently do not believe that any of these matters will have a material adverse effect on our financial position, and will continue to monitor the status of these and other claims that may arise. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid. We will continue to evaluate whether, if circumstances were to change in the future, the recording of a provision may be needed and whether potential indemnification entitlements exist against any such claim.

Certain pending matters to which we are a party are discussed below.

Alnylam Proceedings

In March 2022, Alnylam Pharmaceuticals, Inc., or Alnylam, filed a lawsuit against Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that an existing patent owned by Alnylam, U.S. Patent No. 11,246,933, or the ‘933 Patent, is infringed by the cationic lipid used in Comirnaty, and seeking monetary relief, which is not specified in their filings. We filed a counterclaim to become party to the Alnylam proceeding, and in June 2022, Alnylam added to its claims allegations that we induced infringement of the ‘933 Patent. Additionally, in July 2022, Alnylam filed a lawsuit against us, our wholly owned subsidiary, BioNTech Manufacturing GmbH, Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that we also induced infringement of a newly issued patent, U.S. Patent No. 11,382,979, or the ‘979 Patent, which is a continuation of the ‘933 Patent. The two lawsuits were consolidated on July 28, 2022 and are currently pending. In May 2023, Alnylam filed a third lawsuit against Pfizer Inc. and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480; 11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. All of the proceedings are currently pending.

We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Alnylam’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the

balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

CureVac Proceedings

Germany

In July 2022, CureVac AG, or CureVac, filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP1857122B1, or the EP’122 Patent, and three Utility Models DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac added European Patent EP3708668B1, or the EP’668 Patent, to its German lawsuit. In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that the EP’122 Patent is invalid. In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in the German Patent and Trademark Office. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122 nullity action in support of the validity of the EP’122 Patent. The preliminary opinion did not address any infringement of the EP’122 Patent, is a preliminary assessment by the court of the merits of a claim, and is non-binding. The first instance decision of the court in the EP’122 nullity action is expected in December 2023, and is appealable.

United States

In July 2022, we and Pfizer filed a complaint for a declaratory judgment in the U.S. District Court for the District of Massachusetts, seeking a judgment of non-infringement by Comirnaty of U.S. Patent Nos. 11,135,312, 11,149,278 and 11,241,493. In May 2023, the action in the U.S. District Court for the District of Massachusetts was transferred to the U.S. District Court for the Eastern District of Virginia, where CureVac filed counterclaims asserting infringement of six additional U.S. patents, U.S. Patent Nos. 10,760,070; 11,286,492; 11,345,920; 11,471,525; 11,576,966; and 11,596,686.

United Kingdom

In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against the EP’122 Patent and the EP’668 Patent in the Business and Property Courts of England and Wales. In October 2022, CureVac responded by filing a counterclaim alleging infringement of the EP’122 and EP’668 patents in the Business And Property Courts of England and Wales.

All of the above proceedings are currently pending.

We believe we have strong defenses against the allegations claimed relative to each of the patents and utility models and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of CureVac’s claims is ongoing and complex, and we believe the ultimate outcomes remain substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

Moderna Proceedings

Germany

In August 2022, Moderna filed a lawsuit against us and Pfizer and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Manufacturing Belgium NV, Pfizer Ireland Pharmaceuticals and Pfizer Inc. in the Düsseldorf Regional Court alleging Comirnaty’s infringement of two European Patents, 3590949B1, or the EP’949 Patent, and 3718565B1, or the EP’565 Patent.

United Kingdom

In August 2022, Moderna filed a second lawsuit asserting Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the Business and Property Courts of England and Wales. In September 2022, we and Pfizer filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of the EP’949 Patent and EP’565 Patent.

United States

In August 2022, Moderna filed a lawsuit in the United States District Court for the District of Massachusetts against us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging Comirnaty’s infringement of U.S. Patent Nos. 10,898,574, 10,702,600 and 10,933,127 and seeking monetary relief.

Netherlands

In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc. in the District Court of The Hague alleging Comirnaty’s infringement of the EP ‘949 Patent and EP’565 Patent.

Ireland

In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals International C.V. alleging Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent in the High Court of Ireland.

Belgium

In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc. and Pfizer Manufacturing Belgium alleging Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent in the Brussels Dutch-speaking Enterprise Court.

All of the above proceedings are currently pending.

We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

Arbutus and Genevant Proceedings

In April 2023, Arbutus Biopharma Corp., or Arbutus, and Genevant Sciences GmbH, or Genevant, filed a lawsuit against Pfizer and us in the U.S. District Court for the District of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid nanoparticle technology and methods for producing such lipids in Comirnaty, and seeking monetary relief.

We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

Promosome Proceedings

In June 2023, Promosome LLC filed a lawsuit against Pfizer, us, and BioNTech Manufacturing GmbH in the U.S. District Court for the Southern District of California alleging that Pfizer and our Comirnaty vaccine has infringed U.S. Patent No. 8,853,179, and seeking monetary relief. The proceeding is currently pending.

We believe we have strong defenses against the allegation claimed relative to the patent and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Promosome’s claim is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

12Related Party Disclosures

ATHOS KG, Holzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and beneficial owner of our ordinary shares. Entities controlled by ATHOS KG mainly provide rental and property management activities and sell property, plant and equipment to us. The total amount of transactions with ATHOS KG or entities controlled by them had no significant impact on our unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 2023 compared to the details disclosed in Note 20 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.

13Events after the Reporting Period

Acquisition of InstaDeep Ltd.

On January 10, 2023, we and InstaDeep Ltd., London, or InstaDeep, a leading global technology company in the field of artificial intelligence, or AI, and machine learning, announced that we entered a share purchase agreement, or SPA, under which we will acquire 100% of the remaining shares in InstaDeep not already owned by us (see Note 12.2 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022). After the closing of the acquisition, InstaDeep will operate as our UK-based global subsidiary and will continue to provide its services to clients around the world in diverse industries, including in the Technology, Transport & Logistics, Industrial and Financial Services sectors. Additionally, the acquisition is intended to create a fully integrated, enterprise-wide capability that leverages AI and machine learning technologies across our therapeutic platforms and operations.

The completion of the acquisition will be accounted for as a business combination using the acquisition method of accounting and was conditional on the satisfaction of several customary closing conditions and regulatory approvals as defined in the SPA. As regulatory approvals were received and all closing conditions were satisfied in July, we obtained control of InstaDeep in July 2023.

We performed a preliminary allocation of the total consideration and the underlying assets acquired (including certain identified intangible assets) and liabilities assumed based on their estimated fair values using the information available as of the acquisition date. This allocation is preliminary and subject to change. The preliminary total consideration to be transferred and the preliminary fair values and values in accordance with IFRS 3 of the identifiable net assets of InstaDeep are as follows:


			Preliminary estimated fair values to be recognized on acquisition
(in millions €)			InstaDeep Ltd.
Assets
Intangible assets			176.8
Cash and cash equivalents			57.5
Other identifiable assets			17.8
Total assets			252.1

Liabilities
Deferred tax liabilities			43.3
Other identifiable liabilities			8.2
Total liabilities			51.5

Total preliminary identifiable net assets at fair value			200.6

Preliminary goodwill			314.8
Total preliminary consideration			515.4

Consideration
Previously-held non-listed equity investment (stake of 5.3%)			27.8
Shares to be transferred (approx. 1.1 million shares)			105.6
Contingent consideration liability			31.2
Cash payment			350.9
Total preliminary consideration			515.4

At the acquisition date, the contingent consideration was recognized with its fair value of €31.2 million, and is valued based on cash flow projections in connection with performance-based future milestone payments to eligible shareholders after the earn-out period. The lower end of the bandwidth of possible outcomes of the contingent consideration is zero; the upper limit is €124.3 million.

The goodwill mainly comprises the value of expected synergies arising from including AI and machine learning technologies across our therapeutic platforms and operations and intangible assets that are not recognized separately, e.g., the acquired skilled workforce and its know-how. Goodwill is not tax deductible.

All amounts mentioned for this acquisition are preliminary and the disclosures are limited to the information provided as the accounting for the business combination is still in progress and incomplete.

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 elsewhere in this quarterly report for the three and six months ended June 30, 2023.

Operating Results

Overview

BioNTech was founded in 2008 with the goal to develop treatments for patients that address diseases with high unmet medical need. As a next generation immunotherapy company, it is our vision to harness the power of the immune system to develop novel therapies against cancer and infectious diseases. To realize this vision, we combine decades of groundbreaking research in immunology, a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. At present, we have expanded our team to more than 5,500 employees worldwide.

We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes mRNA vaccines, cell and gene therapies, targeted antibodies, small molecule immunomodulators, Ribologicals, next generation immunomodulators and antibody-drug conjugates. Our approach has created a robust and diversified product pipeline across infectious diseases and oncology, including our first commercial product, BNT162b2 (Comirnaty), the first ever approved mRNA therapy. The clinical pipeline currently includes over 25 clinical stage product candidates and more than 30 research programs.

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

Core to our business practices is ensuring that people all around the globe benefit from our efforts. As part of this effort, we intend to maintain our focus on high medical needs and democratizing access to novel medicines. 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 substantially improve clinical outcomes for patients. We support the United Nations Sustainable Development Goals, or SDGs. Our research and product development efforts make a relevant contribution to supporting the third United Nations Sustainable Development Goal (SDG 3): ensuring healthy lives and promoting well-being for all people of all ages. This aligns with our commitment to global social responsibility.

On the research and development front, we are focused on developing next-generation COVID-19 vaccines to enable rapid response, maintain leadership and strengthen pandemic preparedness as well as broaden the label of and access to the vaccine.

Additionally, we are accelerating clinical development, bolstering mid- and late-stage oncology product candidates and broadening our pipeline through the start of new programs in oncology and infectious diseases. We are also diversifying our therapeutic area footprint which will enable us to fully leverage the potential of all technology platforms across autoimmune diseases, inflammatory diseases, cardiovascular disease, neurodegenerative diseases, and regenerative medicines. Moreover, we plan to invest to build out our global development organization bringing in talent with the clinical, regulatory and commercial launch expertise needed to rapidly advance our diversified clinical pipeline.

Our mergers and acquisitions activity and business development efforts are focused on strengthening technology platforms and digital capabilities through selected strategic partnerships and acquisitions. We also plan to enhance capabilities through complementary acquisitions, technologies, infrastructure and manufacturing.

Corporate Development

A key component of our corporate strategy is strengthening our technology platforms, digital capabilities and infrastructure through select strategic partnerships and acquisitions.

In the first half of 2023, we entered into new collaboration and research agreements with OncoC4, Inc. as previously reported in our Annual Report on Form 20-F for the year ended December 31, 2022 and in our Quarterly Report on Form 6-K for the three months ended March 31, 2023.

In the same period, we also successfully completed our previously-announced acquisition of InstaDeep Ltd., following the satisfaction of all customary closing conditions. The acquisition supports our strategy, aiming to build world-leading capabilities in AI-driven drug discovery and development of next-generation immunotherapies and vaccines to address diseases with high unmet medical need. InstaDeep will operate as a UK-based global subsidiary of BioNTech. The transaction adds approximately 290 highly skilled professionals to BioNTech’s workforce, including teams in AI, ML, bioengineering, data science, and software development.

In April 2023, we entered into exclusive license and collaboration agreements with Duality Biologics (Suzhou) Co. Ltd. to develop, manufacture and commercialize two antibody-drug conjugates, or ADC, therapeutics, BNT323 (DB-1303) and BNT324 (DB-1311) as previously reported in our Quarterly Report on Form 6-K for the three months ended March 31, 2023. In August 2023, we signed another agreement with Duality Biologics to develop, manufacture and commercialize an additional antibody-drug conjugate, DB-1305.

In April 2023, our exclusive research collaboration agreement with Matinas BioPharma Holdings, Inc. to evaluate novel delivery technology for mRNA-based vaccines expired after a twelve-month period.

In July 2023, following a memorandum of understanding announced in January 2023, we signed a long-term partnership agreement with the government of the United Kingdom, National Health Service England, and Genomics England with the aim to provide access to personalized treatments for up to 10,000 patients by 2030, either in clinical trials or as authorized treatment. To achieve this, we plan to set up new laboratories in Cambridge, United Kingdom with an expected capacity of more than 70 highly skilled scientists as well as a new regional hub for the United Kingdom.

In March 2023, we initiated a new share repurchase program pursuant to which we may purchase American Depositary Shares, or ADSs, each representing one ordinary share of the Company, in the amount of up to $0.5 billion during the remainder of 2023. During the three months ended June 30, 2023, 1,532,685 American Depositary Shares, or ADSs, were repurchased under our share repurchase program at an average price of €100.45 ($108.92), for total consideration of €154.0 million ($166.9 million).

At our Annual General Meeting, or AGM, which took place on May 25, 2023, our shareholders voted to appoint Baroness Nicola Blackwood as a member of the Supervisory Board. She succeeds Prof. Christoph Huber, M.D., who left our Supervisory Board after reaching the retirement age limit set by the Supervisory Board. Michael Motschmann and Ulrich Wandschneider, Ph.D. were reappointed by shareholders. All three members were appointed to serve in their roles until the 2027 AGM. In addition, all other resolutions of the AGM were passed by our shareholders.

Environmental, Social, and Governance (ESG)

BioNTech was founded out of a responsibility to patients and to society. This motive, still present today, gives grounds for our enhanced responsibility: for environmental and climate protection, for respecting human rights and for fostering the full potential of all employees as an attractive employer.

We are proud of our progress in developing novel medicines and introducing scalable technological innovations to improve the health of people worldwide. In our Sustainability Report, we outline our science-based climate targets (under SBTi review), actions, and climate risk management, as well as the status of our human rights strategy and due diligence. We are addressing with increasing intensity diversity, inclusion, equity and belonging, and emphasize the importance of our values and culture in the context of our continued growth as a company. Through donations, sponsorships, and volunteering, we strive to support our local communities and beyond.

Marketed Product: Comirnaty, our COVID-19 Vaccine Program (BNT162)

COVID-19 vaccination has played an important role in saving lives and livelihoods across the world. In the first year of their rollout, vaccines were estimated to have averted over 4 million COVID-19-related deaths in Europe and 6 million hospitalizations globally as well as saving hospital resources worth an estimated €56 billion. The vaccination

campaign in Europe helped reopen millions of large and small businesses across the region and helped stabilize the wider European economy, which saw an average 7% reduction in GDP by country during the first pandemic year, 2020.

Under our collaboration with Pfizer Inc., or Pfizer, we are the Marketing Authorization Holder in the U.S., the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations, or EUAs, or equivalents in the U.S. (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide with the exception of Greater China, Germany, and Turkey. Fosun Pharmaceutical Industrial Development, Co., Ltd, or Fosun Pharma, has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR and the region of Taiwan. We have the marketing and distribution rights to Comirnaty in Germany and Turkey.

A. Commercial Updates

In May 2023, we and Pfizer announced an agreement had been reached with the European Commission, or the EC, to amend the previous COVID-19 Vaccine Purchase Agreement to deliver COVID-19 vaccines to the European Union, or the EU. The amended agreement reflects ours and Pfizer’s commitment to working collaboratively to help address ongoing public health needs, while respecting the principles of the original agreement. The agreement rephased delivery of doses annually through 2026. In addition, the agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses, in alignment with the original agreement.

We expect that as SARS-CoV-2 continues to evolve, and the risk of severe COVID-19 disease and deaths continues, especially for high risk populations, there will be continued demand for vaccine boosting and vaccinations, especially for at-risk and immunocompromised groups. We also expect to begin the transition from an advanced purchase agreement environment to commercial market ordering in some geographies, driven by regulatory recommendations to adapt COVID-19 vaccines to newly circulating variants or sublineages of SARS-CoV-2, namely XBB.1.5 for the fall and winter seasons in 2023 and 2024.

B. Clinical Development, Regulatory and Manufacturing Updates

In April 2023, we and Pfizer received an update to the EUA to simplify the vaccination schedule for most individuals. This included authorizing the current Omicron BA.4-5-adapted bivalent COVID-19 vaccine to be used for all doses administered to individuals 6 months of age and older.

The Omicron XBB sublineages currently account for the majority of COVID-19 cases globally and are antigenically distant from prior circulating SARS-CoV-2 lineages, including Omicron BA.4/BA.5 and the original SARS-CoV-2 strain. Although Omicron BA.4-5-adapted bivalent vaccines provide some protection against a range of outcomes from XBB-related COVID-19, evidence suggests that vaccines better matched to currently circulating sublineages should further improve protection against symptomatic disease and severe COVID-19.

In May 2023, the European Medicines Agency, or the EMA, and other health authorities provided guidance highlighting that updated vaccines targeting Omicron XBB.1. sublineages may contribute to maintaining protection against COVID-19 during the upcoming fall and winter season, when COVID-19 case rates and hospitalizations are expected to increase. On June 15, 2023, the U.S. Food and Drug Administration's, or FDA’s, Vaccines and Related Biological Products Advisory Committee (VRBPAC) issued guidance recommending manufacture of an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter seasons. On June 23, 2023, we and Pfizer submitted regulatory applications to the EMA and the FDA for our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older.

These filings are based on the full body of clinical, pre-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccines. Following guidance from regulatory authorities on the requirements for strain changes, the applications include data suggesting that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine may generate improved responses against circulating XBB sublineages, compared to the current Omicron BA.4-5-adapted bivalent COVID-19 vaccine.

We and Pfizer have manufactured Omicron XBB.1.5-adapted monovalent COVID-19 vaccines at risk to ensure readiness ahead of the fall and winter season. The companies plan to prepare shipments of Omicron XBB.1.5-adapted monovalent COVID-19 vaccines for fast delivery following potential regulatory approval, currently expected in September 2023.

Should the applications be approved, the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine will be distributed under the brand name Comirnaty Omicron XBB.1.5 for individuals 6 months of age and older.

Pipeline of Product Candidates: First Quarter and Second Quarter 2023 and Post Period-End Updates

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

https://cdn.kscope.io/1bfcf878c9d54285eda252d0c5ecac8c-screenshot2023-08x04124627a.jpg

https://cdn.kscope.io/1bfcf878c9d54285eda252d0c5ecac8c-screenshot2023-08x04124815a.jpg

A. Oncology Programs

1. mRNA Product Candidates in Oncology

a) FixVac

FixVac is our wholly owned, systemic, off-the-shelf, mRNA-based cancer immunotherapy approach, from which we are developing several first-in-human and potential first-in-class product candidates. FixVac product candidates contain our pharmacologically optimized uridine-RNA based nanoparticles delivered in our proprietary RNA-LPX formulation for intravenous administration, which are designed to trigger both innate and adaptive immune responses.

i.BNT111 in advanced melanoma.

•A global, three-arm, randomized Phase 2 clinical trial (NCT04526899) evaluating BNT111 in combination with cemiplimab (Regeneron’s Libtayo), versus both agents as monotherapy, in patients with anti-PD1/anti-PD-L1-refractory/relapsed, unresectable Stage III or IV melanoma is ongoing. The trial is being conducted in collaboration with Regeneron.

•A first-in-human, open-label Phase 1 dose escalation clinical trial (NCT02410733) evaluating BNT111 in patients with advanced melanoma has been completed. The trial started in 2015, enrollment was achieved in 2020 with 115 patients, and the last patient visit under the follow-up period took place in June 2023. Final biomarker and clinical data of the trial are being gathered and evaluated.

ii. BNT112 in prostate cancer.

•A first-in-human Phase 1/2 clinical trial (NCT04382898) to evaluate safety, immunogenicity and preliminary efficacy of BNT112 monotherapy and in combination with cemiplimab is ongoing in patients with metastatic castration resistant prostate cancer (mCRPC) and in patients with high-risk localized prostate cancer (LPC) who are eligible for treatment with androgen deprivation therapy (ADT) followed by radical prostatectomy.

iii. BNT113 in HPV16+ head and neck cancer.

•A randomized Phase 2 clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab (Merck’s Keytruda) versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC) expressing programmed cell death ligand-1 (PD-L1) is ongoing.

•An investigator-initiated and sponsored Phase 1/2 dose escalation basket trial evaluating BNT113 in patients with HPV16+ head and neck (in the post-adjuvant and metastatic setting) and other cancers is ongoing.

iv. BNT114 in triple negative breast cancer (TNBC).

•A multi-center, open-label, three-arm Phase 1 clinical trial to evaluate BNT114 as a monotherapy and in combination with our individualized neoantigen specific immunotherapy in TNBC patients who had previously received the standard of care therapy (i.e., surgery, chemotherapy and/or radiotherapy) had its last patient visit in June 2023. The trial results of the main study phase were summarized in a clinical trial report (CTR) in 2021. The data generated within the three year long-term follow-up period will now be described in an addendum to the CTR.

v. BNT115 in ovarian cancer.

• An exploratory investigator-initiated, single-center Phase 1 clinical trial "OLIVIA-UMCG-01" (NCT04163094) was conducted and sponsored by the University Medical Center Groningen, or UMCG, Netherlands, in collaboration with us. The trial investigated BNT115 in patients with primary epithelial ovarian cancer in combination with (neo-)adjuvant chemotherapy. Recruitment of 10 patients was concluded in June 2022, and 8 were ultimately dosed. The follow-up phase for the enrolled patients was completed in June 2023. The clinical data of the trial will be evaluated by UMCG and recorded accordingly. No follow-up studies are planned with BNT115.

vi. BNT116 in advanced non-small-cell lung cancer (NSCLC).

•A Phase 1 clinical trial (NCT05142189) is ongoing to evaluate the safety, tolerability and preliminary efficacy of BNT116 alone and in combination with cemiplimab (Regeneron’s Libtayo) in patients who have progressed on prior PD-1 inhibitor treatment or are not eligible for chemotherapy, and in combination with docetaxel in patients who have received prior PD-1 inhibitor therapy and platinum-based chemotherapy.

•In July 2023, we and our partner Regeneron initiated a randomized, controlled, Phase 2 clinical trial (NCT05557591) to evaluate BNT116 in combination with cemiplimab (Regeneron’s Libtayo) and cemiplimab alone as first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells.

b) Individualized Neoantigen Specific Immunotherapy (iNeST)

iNeST is an individualized cancer immunotherapy product candidate based on specific neoantigens that are present on a patient’s tumor. Similar to our FixVac programs, our iNeST approach is also based on a pharmacologically optimized uridine mRNA (uRNA) delivered in our proprietary RNA-LPX formulation. Each patient is treated with a vaccine informed by the mutation profile of their personal cancer and manufactured on-demand. The RNA encodes a unique composition of the patient’s own tumor mutations and results in generation of neoantigen specific CD4+ and CD8+ T-cell responses.

i.BNT122/ Autogene cevumeran is our lead iNeST product candidate and is being developed as part of a co-development and co-commercialization collaboration with Genentech, a member of the Roche Group.

•A randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran (BNT122) as an adjuvant treatment of circulating tumor DNA (ctDNA) positive, surgically resected Stage II (high risk)/Stage III colorectal cancer is ongoing. The trial is expected to enroll about 200 patients to evaluate the efficacy and safety of autogene cevumeran (BNT122) compared to watchful waiting after surgery and chemotherapy, the current standard of care for these high-risk patients. The primary endpoint for the study is disease-free survival, or DFS. Secondary objectives include overall survival, or OS, and safety.

•A randomized Phase 2 clinical trial (NCT03815058) evaluating the efficacy and safety of autogene cevumeran (BNT122) in combination with pembrolizumab (Merck’s Keytruda) versus pembrolizumab alone as first line in patients with previously untreated advanced melanoma is ongoing. The primary endpoint is progression-free survival, or PFS, of patients treated with autogene cevumeran (BNT122) combination compared with patients receiving pembrolizumab alone, according to RECIST v1.1. Secondary endpoints include objective response rate, or ORR, OS, duration of response, or DOR, and safety.

•An open-label, fully enrolled, Phase 1 basket trial (NCT03289962) evaluating the safety, immunogenicity and preliminary anti-tumor activity of autogene cevumeran (BNT122) as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors is fully enrolled and follow-up is ongoing.

•We and Genentech plan to initiate a randomized Phase 2 clinical trial (NCT05968326) in the second half of this year to further evaluate the efficacy and safety of autogene cevumeran (BNT122) in the adjuvant setting in combination with atezolizumab (Genentech’s Tecentriq) followed by chemotherapy in patients with resected pancreatic ductal adenocarcinoma, or PDAC, supported by data from a recently published investigator-initiated Phase 1 trial. In May 2023, results from this trial were published in the peer-reviewed journal Nature (Rojas, L.A et al. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer). The paper reported preliminary evidence that adjuvant autogene cevumeran in combination with atezolizumab and mFOLFIRINOX induces substantial T cell activity in patients with surgically resected PDAC that correlates with delayed recurrence.

c) mRNA Intratumoral Immunotherapy

We have been developing intratumoral immunotherapies in collaboration with Sanofi.

i.BNT131/SAR441000 consists of modified mRNA encoding immunomodulatory cytokines for direct intratumoral injection.

•A Sanofi-sponsored, first-in-human, open-label, multi-center dose escalation and expansion clinical trial (NCT03871348) investigating BNT131 as monotherapy and in combination with cemiplimab in patients with advanced/metastatic solid tumors has stopped recruitment and follow-up is ongoing.

•Based on interim analysis results, Sanofi and we have jointly decided to discontinue the development of the mRNA coding for cytokines BNT131/SAR441000 as intratumoral therapy.

d) RiboMabs

Our RiboMab product candidates are mRNAs that encode cancer cell targeting antibodies. These fully-owned product candidates leverage our proprietary optimized mRNA technology combining nucleoside modifications to minimize immunogenicity with our improved mRNA backbone designs with the aim of maximizing protein expression. RiboMab product candidates are formulated using liver-targeting lipid nanoparticles (LNPs) for intravenous delivery.

i.BNT141 codes for an IgG1 antibody targeting the cancer cell surface marker CLDN18.2 and was being studied in a first-in-human, open-label, multi-site Phase 1/2 clinical trial (NCT04683939) with expansion cohorts in patients with CLDN18.2-positive tumors. Last patient visit occurred in July 2023. Based on results from an interim analysis, we have decided to discontinue the study, and we are working on an optimized version of the product candidate for further clinical development.

ii. BNT142 codes for a T cell engaging bispecific antibody targeting Claudin 6 (CLDN6) and is being studied in an ongoing, open-label, multi-center Phase 1/2 clinical trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors that have exhausted available standard therapy or are not eligible for such available therapy. A Trial-in-Progress poster was presented at the 2023 American Society of Clinical Oncology, or ASCO, Annual Meeting. The study is actively recruiting patients in Europe, the United States and Singapore.

e) RiboCytokines

Our RiboCytokine product candidates are designed to address the limitations of recombinantly expressed cytokines, including limited serum half-life and production costs. BNT151 and BNT152+153 are nucleoside-modified mRNAs encoding human cytokines fused to human serum albumin. The modified mRNA is formulated with liver-targeting LNPs for intravenous delivery. BNT151 encodes an IL-2 variant, BNT152 encodes IL-7 and BNT153 encodes IL-2.

i.BNT151 – A first-in-human, open-label, multi-center Phase 1/2 clinical trial (NCT04455620) in multiple solid tumor indications is ongoing.

ii. BNT152+153 – A first-in-human, open-label, multi-center Phase 1 clinical trial (NCT04710043) evaluating a combination of BNT152 and BNT153 in patients with various solid tumors is ongoing.

2. Cell Therapy Product Candidates in Oncology

a) Chimeric antigen receptor (CAR) T-cell therapy - CAR-T

i.BNT211 consists of two investigational medicinal products: our first CAR-T cell (CAR-T) product candidate, which targets Claudin-6 (CLDN6)-positive solid tumors, in combination with a CAR-T cell-amplifying RNA vaccine (CARVac) encoding CLDN6. As with FixVac and iNest, CARVac is also based on a pharmacologically optimized uRNA backbone delivered in our proprietary RNA-LPX formulation. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity for the tumor-specific carcino-embryonic antigen CLDN6. CARVac is intended to support in vivo expansion of transferred CAR-T cells to increase their persistence and efficacy. BNT211 has been granted Priority Medicines (PRIME) designation by the European Medical Agency for the third- or later-line treatment of testicular germ cell tumors.

•A first-in-human, open-label, multi-center Phase 1/2 dose escalation and dose expansion basket trial (NCT04503278) evaluating CLDN6 CAR-T cells as monotherapy or in combination with CLDN6 CARVac in patients with CLDN6-positive relapsed or refractory solid tumors is ongoing. A data update from the ongoing clinical trial was provided at the 2023 ASCO Annual Meeting describing the new dose escalation of CLDN6 CAR-T cells with and without CLDN6-encoding mRNA vaccine using an automated manufacturing process for treatment of relapsed/refractory solid tumors. CLDN6 CAR-T cells ± CLDN6 CARVac showed a moderate safety profile in line with that of manually produced CLDN6 CAR-T cells. Encouraging signs of activity, with dose-dependent expansion of CAR-T cells translating into ORR of 41% with 7 responses in 17 evaluable patients (ORR 75% at dose level, or DL, 2). Follow-up on treated patients and further recruitment to DL2 and DL3 is ongoing. After determination of the recommended Phase 2 dose for CLDN6 CAR-T cells, we plan to initiate a pivotal trial in germ cell tumors in 2024.

b) Neoantigen-Targeting T-Cell therapy

i.BNT221 is our individualized neoantigen-targeting T-cell therapy which targets selected sets of individualized neoantigens.

•A first-in-human Phase 1 dose escalation clinical trial in patients with checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. Part 1 of the trial consists of a monotherapy dose escalation of BNT221. Recruitment and treatment of patients in Part 1 is complete. In Part 2, BNT221 will be dosed in combination with anti-PD-1 therapy after first-line treatment.

3. Antibody Product Candidates in Oncology

a) Next-Generation Immune Checkpoint Modulators

We are developing, in collaboration with Genmab, antibodies that function as tumor-targeted and dual immunomodulators, applying Genmab’s proprietary technologies in combination with our joint target identification and product concept expertise.

i.BNT311 (GEN1046) is a potential first-in-class bispecific antibody product candidate combining PD-L1 checkpoint inhibition with 4-1BB checkpoint activation.

•An open-label, multi-center, randomized Phase 2 clinical trial of BNT311 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC after treatment with standard of care therapy with an immune checkpoint inhibitor is ongoing. The primary endpoint of the study is ORR according to RECIST v1.1. Secondary endpoints include DOR, time to response, PFS, OS, and safety.

•An open-label, single-arm Phase 1/2 clinical trial with expansion cohorts in patients with solid tumors is ongoing.

ii. BNT312 (GEN1042) is a potential first-in-class bispecific antibody product candidate designed to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells.

•Two Phase 1/2 clinical trials (NCT05491317; NCT04083599) in patients with solid tumors is ongoing evaluating BNT312 in combination with pembrolizumab (Merck’s Keytruda) with or without chemotherapy. We continue to actively recruit patients into the expansion cohorts across a range of solid tumors.

iii. BNT313 (GEN1053) - A Phase 1/2 clinical trial to evaluate the safety, tolerability, and preliminary efficacy of CD27-targetting antibody BNT313 on solid tumors as monotherapy is ongoing.

iv. BNT322 (GEN1056) is an antibody product candidate being co-developed with Genmab for the treatment of solid tumors and for use in combination with other products.

•A first-in-human Phase 1 clinical trial in patients with advanced solid tumors is ongoing and recruiting.

BNT311, BNT312, BNT313 and BNT322 are partnered with Genmab as part of a 50:50 collaboration in which development costs and future profits are shared.

v. BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc., or OncoC4. BNT316/ONC-392 (gotistobart) offers a potentially differentiated safety profile that may allow for higher dosing and longer duration of treatment both as monotherapy and in combination with other therapies. The program received Fast Track Designation from the FDA in 2022.

•In June 2023, the first patient was dosed as part of a two-stage, open-label, randomized Phase 3 clinical trial, PRESERVE-003 (NCT05671510), to evaluate the efficacy and safety of BNT316/ONC-392 (gotistobart) as monotherapy in metastatic NSCLC patients who have progressed on anti-PD-1/PD-L1 antibody-based therapy compared to standard-of-care chemotherapy (docetaxel). A Trial in Progress poster was presented at the 2023 ASCO Annual Meeting.

•A Phase 2 clinical trial (NCT04140526) evaluating BNT316/ONC-392 (gotistobart) therapy in combination with pembrolizumab in platinum-resistant ovarian cancer is ongoing.

•A first-in-human Phase 1/2 open-label dose escalation clinical trial (NCT04140526) evaluating BNT316/ONC-392 (gotistobart) as single agent and in combination with pembrolizumab in patients with advanced or metastatic solid tumors is ongoing. We and OncoC4 presented data from NSCLC patients from the ongoing Phase 1/2 trial at the 2023 ASCO Annual Meeting. BNT316/ONC-392 (gotistobart) was generally safe and tolerated and treatment-related adverse events were manageable. Early readout of the expansion cohort showed encouraging clinical activity in patients with immunotherapy-resistant NSCLC.

b) Targeted Cancer Antibodies & Antibody-Drug Conjugates

i.BNT321 is a fully human IgG1 monoclonal antibody product candidate 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.

•An open-label, multi-center, non-randomized dose escalation and expansion Phase 1 clinical trial of BNT321 monotherapy and in combination with modified FOLFIRINOX in pancreatic cancer and other CA19-9 expressing solid tumors is ongoing.

ii. BNT323/DB-1303 is a topoisomerase-1 inhibitor-based HER2-targeted ADC candidate, being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd., or DualityBio.

•BNT323/DB-1303 is being evaluated in an ongoing Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. BioNTech and DualityBio provided a data update from the ongoing trial at the 2023 ASCO Annual Meeting.

•BNT323/DB-1303 was well tolerated with no dose limiting toxicity, or DLT, and no treatment-emergent adverse events, or TEAEs, associated with death. Preliminary antitumor activity was observed in heavily pretreated HER2-expressing patients with a median of 7 prior systemic treatment regimes, including other HER2 antibody drug conjugates, or ADCs.

iii. BNT324/DB-1311 is a topoisomerase-1 inhibitor-based ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd.

•A first-in-human, open-label Phase 1/2a clinical trial evaluating BNT324/DB-1311 in multiple advanced solid tumors is planned to start this year.

4. Small Molecule Immunomodulator Candidates in Oncology

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

•A first-in-human, open-label Phase 1/2 dose-escalation clinical 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.

B. Infectious Disease Programs

1. Next-generation COVID-19 Vaccine Programs - BNT162b5 and BNT162b2 + BNT162b4

i.BNT162b5 – This is one of multiple vaccine candidates with an engineered design aimed to increase the magnitude and breadth of antibody neutralization response to better protect against COVID-19.

•A randomized, active controlled, observer-blind Phase 2 clinical trial to evaluate the safety, tolerability and immunogenicity of an stabilized spike antigen vaccine candidate is ongoing.

ii. BNT162b2 + BNT162b4 – The aim of this program is to develop a vaccine candidate that enhances and broadens SARS-CoV-2 T-cell responses. BNT162b4 is a next-generation COVID-19 vaccine component designed to elicit T-cell immunity across epitopes. BNT162b4 encodes variant-conserved, immunogenic segments of the SARS-CoV-2 nucleocapsid, membrane, and ORF1ab proteins, targeting diverse human leukocyte antigen (HLA) alleles.

•A Phase 1 clinical trial to evaluate the safety, tolerability and immunogenicity of BNT162b4, in combination with BNT162b2 is ongoing.

Both programs are being developed in collaboration with Pfizer.

2. Combination Vaccine Programs

We and Pfizer are investigating various respiratory combination vaccine approaches that aim to simplify immunization practices for health care providers and recipients, while helping to reduce the burden of these diseases. Combination vaccines have been an effective approach in overcoming barriers to vaccination by allowing for simple scheduling and fewer injections compared to vaccinations administered separately and/or at different visits to healthcare providers.

i.COVID-19 – Influenza Combination mRNA Vaccine Program – BNT162b2 + BNT161

The combination vaccine candidate consists of our Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine and Pfizer’s quadrivalent modified RNA (modRNA) influenza vaccine candidate. The ongoing Phase 1 trial is in partnership with Pfizer and has received Fast Track designation from the U.S. FDA. Further development is subject to reaching agreement.

•An open-label, dose-finding Phase 1 clinical trial to evaluate the safety, tolerability and immunogenicity of a combination of the COVID-19 and influenza mRNA vaccines in healthy subjects 18 to 64 years of age is ongoing. A data update is expected in 2023.

3. Influenza Vaccine Program - BNT161

In 2018, we and Pfizer entered into an agreement to collaborate on an mRNA program in influenza for an initial period of three years, which ended in 2021. Pfizer has since had the sole responsibility, authority and control of the

development, manufacturing and commercialization of all candidates and products related to the program. Upon potential approval and commercialization, BioNTech is eligible to receive a royalty on Pfizer’s sales.

•A Pfizer-initiated randomized Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of a quadrivalent modRNA influenza vaccine candidate is ongoing.

4. HSV Vaccine Program – BNT163

We have a research collaboration with the University of Pennsylvania under which we have the exclusive option to develop and commercialize mRNA vaccine candidates against up to 10 infectious disease indications. As part of this collaboration, we are developing a Herpes Simplex Virus (HSV) vaccine candidate.

•A first-in-human, controlled, dose-escalation Phase 1 clinical trial evaluating the safety, tolerability and immunogenicity of BNT163, an HSV vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1, is ongoing. A data update is expected in the second half of 2023.

5. Tuberculosis Vaccine Program – BNT164

We have collaborated with the Bill and Melinda Gates Foundation since 2019 to develop vaccine candidates aimed at preventing tuberculosis infection and disease.

•In April 2023, BioNTech initiated a randomized, controlled, dose-finding Phase 1 clinical trial of BNT164 in partnership with the Bill and Melinda Gates Foundation. The clinical trial will evaluate the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against tuberculosis.

6. Malaria Vaccine Program – BNT165

Our Malaria program aims to develop a well-tolerated and highly effective mRNA vaccine with durable immunity to prevent blood-stage malaria infection, thereby reducing morbidity and mortality as well as onward transmission, and to develop sustainable vaccine production and supply solutions on the African continent. We plan to assess several vaccine candidates, featuring known targets such as circumsporozoite protein (CSP) as well as other antigens.

•A first-in-human Phase 1 clinical trial to evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1, the first candidate from our BNT165 program, is ongoing. A data update is expected in the second half of 2023.

7. Shingles Vaccine Program - BNT167

We are collaborating with Pfizer to develop the first mRNA-based vaccine candidate against shingles (also known as herpes zoster). While there are currently approved vaccines for shingles, the goal is to develop an mRNA vaccine candidate that potentially shows high efficacy and better tolerability and is more efficient to produce globally.

•In February 2023, we and Pfizer initiated a randomized, controlled, dose-selection Phase 1/2 clinical trial to evaluate the safety, tolerability, and immunogenicity of BNT167 in healthy volunteers 50 through 69 years of age.

8. Anti-bacterial Programs

BioNTech R&D (Austria) GmbH is a wholly owned subsidiary of BioNTech SE focused on developing novel anti-bacterial drugs to treat persistent bacterial infections. The development programs are based on our proprietary LysinBuilder platform, which allows the targeted development of precision anti-bacterials. Our development pipeline focuses on chronic bacterial infections where antibiotics fail to cure or destroy the natural microbiomes.

Financial Operations Overview

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


	Three months ended June 30,		Six months ended June 30,
	2023	2022	2023	2022
(in millions €, except per share data)	(unaudited)	(unaudited)	(unaudited)	(unaudited)

Revenues
Commercial revenues	166.4	3,166.3	1,442.9	9,528.5
Research & development revenues	1.3	30.2	1.8	42.6
Total revenues	167.7	3,196.5	1,444.7	9,571.1

Cost of sales	(162.9)	(764.6)	(258.9)	(2,058.7)
Research and development expenses	(373.4)	(399.6)	(707.4)	(685.4)
Sales and marketing expenses	(18.1)	(17.8)	(30.3)	(32.1)
General and administrative expenses	(122.7)	(130.0)	(242.1)	(220.8)
Other operating expenses	(74.2)	(240.7)	(192.3)	(309.5)
Other operating income	20.3	565.8	77.4	697.7

Operating income / (loss)	(563.3)	2,209.6	91.1	6,962.3

Finance income	152.4	115.5	208.9	387.6
Finance expenses	(1.3)	(5.8)	(4.5)	(12.5)



Profit / (loss) before tax	(412.2)	2,319.3	295.5	7,337.4


Income taxes	221.8	(647.3)	16.3	(1,966.6)
Profit / (Loss) for the period	(190.4)	1,672.0	311.8	5,370.8






Earnings per share
Basic profit / (loss) for the period per share	(0.79)	6.86	1.29	22.00
Diluted profit / (loss) for the period per share	(0.79)	6.45	1.28	20.69

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, 2022.

Comparison of the three and six months ended June 30, 2023, and 2022

Revenues

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


	Three months ended June 30,		Change
(in millions €)	2023	2022	€	%
Revenues
Commercial revenues	166.4	3,166.3	(2,999.9)	(95)
COVID-19 vaccine revenues	158.2	3,152.7	(2,994.5)	(95)
Sales to collaboration partners(1)	75.2	608.3	(533.1)	(88)



Direct product sales to customers	—	557.0	(557.0)	(100)


Share of collaboration partners' gross profit	83.0	1,987.4	(1,904.4)	(96)


Other sales	8.2	13.6	(5.4)	(40)
Research & development revenues from collaborations	1.3	30.2	(28.9)	(96)



Total revenues	167.7	3,196.5	(3,028.8)	(95)

(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
Revenues
Commercial revenues	1,442.9	9,528.5	(8,085.6)	(85)
COVID-19 vaccine revenues	1,421.7	9,505.8	(8,084.1)	(85)
Sales to collaboration partners(1)	146.6	1,211.5	(1,064.9)	(88)


Direct product sales to customers	65.2	1,720.1	(1,654.9)	(96)


Share of collaboration partners' gross profit	1,209.9	6,574.2	(5,364.3)	(82)


Other sales	21.2	22.7	(1.5)	(7)
Research & development revenues from collaborations	1.8	42.6	(40.8)	(96)




Total revenues	1,444.7	9,571.1	(8,126.4)	(85)

(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.

Commercial Revenues

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, commercial revenues decreased by €2,999.9 million, or 95%, from €3,166.3 million to €166.4 million as well as decreased by €8,085.6 million, or 85%, from €9,528.5 million during the six months ended June 30, 2022 to €1,442.9 million during the six months ended June 30, 2023, corresponding with a lower COVID-19 vaccine market demand. Write-offs by our collaboration partner Pfizer Inc, or Pfizer, significantly reduced our gross profit share and hence negatively influenced our revenues for three months ended June 30, 2023. We are the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada and other countries, and holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries; submissions to pursue regulatory approvals in countries where emergency use authorizations or equivalent were initially granted are ongoing. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Fosun Pharma, has marketing and distribution rights in China, Hong Kong special administrative region, or SAR, Macau SAR and the region of Taiwan. The allocation of marketing and distribution rights defines territories in which the collaboration partners act as a principal.

manufacturing variances are reflected as transfer price adjustment once identified and assessed highly probable. Sales to collaboration partners during the three and six months ended June 30, 2023, amounted to €75.2 million and €146.6 million, respectively. During the three and six months ended June 30, 2022 the sales to collaboration partners amounted to €608.3 million and €1,211.5 million, respectively. During the three and six months ended June 30, 2023 those sales included €69.1 million and €116.9 million, respectively, related to the aforementioned manufacturing variances (€427.6 million and €795.2 million with respect to sales during the three and six months ended June 30, 2022).

Cost of Sales

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


	Three months ended June 30,		Change
(in millions €)	2023	2022	€	%
Cost of sales
Cost of sales related to COVID-19 vaccine revenues	162.7	753.3	(590.6)	(78)
Cost related to other sales	0.2	11.3	(11.1)	(98)
Total cost of sales	162.9	764.6	(601.7)	(79)


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
Cost of sales
Cost of sales related to COVID-19 vaccine revenues	251.1	2,041.6	(1,790.5)	(88)
Cost related to other sales	7.8	17.1	(9.3)	(54)
Total cost of sales	258.9	2,058.7	(1,799.8)	(87)

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, our cost of sales decreased by €601.7 million, or 79%, from €764.6 million to €162.9 million as well as decreased by €1,799.8 million, or 87%, from €2,058.7 million during the six months ended June 30, 2022 to €258.9 million during the six months ended June 30, 2023 in line with decreasing COVID-19 vaccine sales.

Research and Development Expenses

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


	Three months ended June 30,		Change
(in millions €)	2023	2022	€	%
Research and development expenses
Purchased services	141.8	230.0	(88.2)	(38)
Wages, benefits and social security expense	98.0	85.5	12.5	15
Laboratory supplies	88.9	48.1	40.8	85
Depreciation and amortization	13.8	11.6	2.2	19




Other	30.9	24.4	6.5	27
Total research and development expenses	373.4	399.6	(26.2)	(7)


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
Research and development expenses
Purchased services	339.0	361.4	(22.4)	(6)
Wages, benefits and social security expense	184.6	156.3	28.3	18
Laboratory supplies	102.8	105.7	(2.9)	(3)
Depreciation and amortization	28.4	22.4	6.0	27




Other	52.6	39.6	13.0	33
Total research and development expenses	707.4	685.4	22.0	3

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, our research and development expenses decreased by €26.2 million, or 7%, from €399.6 million to €373.4 million as well as increased by €22.0 million, or 3%, from €685.4 million during the six months ended June 30, 2022 to €707.4 million during the six months ended June 30, 2023 mainly influenced by progressing clinical studies for pipeline candidates, the development of variant adapted as well as next generation COVID-19 vaccines and expanding R&D headcount.

General and Administrative Expenses

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


	Three months ended June 30,		Change
(in millions €)	2023	2022	€	%
General and administrative expenses
Wages, benefits and social security expense	43.1	43.0	0.1	—
Purchased services	34.6	34.6	—	—
IT and office equipment	33.6	22.5	11.1	49


Depreciation and amortization	8.0	3.3	4.7	142






Other	3.4	26.6	(23.2)	(87)
Total general and administrative expenses	122.7	130.0	(7.3)	(6)


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
General and administrative expenses
Wages, benefits and social security expense	81.1	70.5	10.6	15
IT and office equipment	61.1	33.8	27.3	81
Purchased services	58.8	64.9	(6.1)	(9)

Depreciation and amortization	14.9	5.8	9.1	157
Other	26.2	45.8	(19.6)	(43)
Total general and administrative expenses	242.1	220.8	21.3	10

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, our general and administrative expenses decreased by €7.3 million, or 6%, from €130.0 million to €122.7 million and increased by €21.3 million, or 10%, from €220.8 million during the six months ended June 30, 2022 to €242.1 million during the six

months ended June 30, 2023 mainly influenced by increased expenses for IT services as well as expanding the G&A headcount.

Other Operating Income / Expenses

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


	Three months ended June 30,		Change
(in millions €)	2023	2022	€	%
Other operating result
Other operating income	20.3	565.8	(545.5)	(96)
Gain on derivative instruments at fair value through profit or loss	12.6	—	12.6	—
Foreign exchange differences, net	—	517.0	(517.0)	(100)


Other	7.7	48.8	(41.1)	(84)
Other operating expenses	(74.2)	(240.7)	166.5	(69)
Foreign exchange differences, net	(71.2)	—	(71.2)	—
Loss on derivative instruments at fair value through profit or loss	—	(229.7)	229.7	(100)


Other	(3.0)	(11.0)	8.0	(73)
Total other operating result	(53.9)	325.1	(379.0)	(117)


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
Other operating result
Other operating income	77.4	697.7	(620.3)	(89)
Gain on derivative instruments at fair value through profit or loss	54.5	—	54.5	—
Foreign exchange differences, net	—	641.0	(641.0)	(100)


Other	22.9	56.7	(33.8)	(60)
Other operating expenses	(192.3)	(309.5)	117.2	(38)
Foreign exchange differences, net	(187.7)	—	(187.7)	—
Loss on derivative instruments at fair value through profit or loss	—	(299.0)	299.0	(100)


Other	(4.6)	(10.5)	5.9	(56)
Total other operating result	(114.9)	388.2	(503.1)	(130)

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, our total other operating result decreased by €379.0 million from a positive operating result of €325.1 million to a negative operating result of €53.9 million, as well as by €503.1 million from a positive operating result of €388.2 million during the six months ended June 30, 2022 to a negative operating result of €114.9 million during the six months ended June 30, 2023. The other operating result reflected the change in foreign exchange rates and included net negative foreign exchange differences during three and six months ended June 30, 2023 compared to net positive foreign exchange differences during the previous year period that related to our U.S. dollar denominated trade receivables which were mainly incurred under our COVID-19 collaboration with Pfizer, U.S. dollar denominated trade payables as well as U.S. dollar denominated other financial liabilities which mainly relate to obligations incurred from our license agreements. The amounts were offset by recording the change in fair value of foreign exchange forward contracts that were entered to manage some of our transaction exposures but were not designated as hedging instruments under IFRS.

Finance Income / Expenses

The following table summarizes our finance result for the periods indicated:


	Three months ended June 30,		Change
(in millions)	2023	2022	€	%
Finance result
Finance income	152.4	115.5	36.9	32

Interest income	84.6	1.5	83.1	n.m.
Fair value adjustments of financial instruments measured at fair value	42.0	—	42.0	—
Foreign exchange differences, net	25.8	114.0	(88.2)	(77)
Finance expenses	(1.3)	(5.8)	4.5	(78)


Other	(1.3)	(5.8)	4.5	(78)


Total finance result	151.1	109.7	41.4	38


	Six months ended June 30,		Change
(in millions €)	2023	2022	€	%
Finance result
Finance income	208.9	387.6	(178.7)	(46)
Interest income	144.7	2.0	142.7	n.m.
Fair value adjustments of financial instruments measured at fair value	64.2	216.8	(152.6)	(70)
Foreign exchange differences, net	—	168.8	(168.8)	(100)
Finance expenses	(4.5)	(12.5)	8.0	(64)
Foreign exchange differences, net	(2.0)	—	(2.0)	—
Other	(2.5)	(12.5)	10.0	(80)
Total finance result	204.4	375.1	(170.7)	(46)

From the three months ended June 30, 2022 compared to the three months ended June 30, 2023, our total finance result increased by €41.4 million from €109.7 million to €151.1 million as well as decreased by €170.7 million from €375.1 million during the six months ended June 30, 2022 to €204.4 million during the six months ended June 30, 2023. During the three and six months ended June 30, 2023, our finance result was driven by interest income mainly derived from our security investments as well as bank deposits and the fair value adjustments derived from remeasuring our money market funds. During the three and six months ended June 30, 2022 our finance result was mainly influenced by the fair value adjustments derived from remeasuring the derivative embedded in our convertible note and foreign exchange differences arising on financing items (i.e. U.S. dollar denominated bank deposits and cash accounts).

Income Taxes

considered highly probable that taxable profits for the U.S. tax group will be available against which the deferred tax assets can be utilized in the near future fulfilling the requirements set out by IAS 12. Therefore we no longer continue to maintain the full non-recognition of deferred tax assets of our U.S. tax group as there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized. As of June, 30, 2023, we maintain the non-recognition of deferred tax assets for unused U.S. federal and state tax losses at amount of €20.1 million and €1.6 million, respectively, as there is not sufficient probability in terms of IAS 12 that there will be future taxable income available against which these unused tax losses can be utilized.

Related Party Transactions

Related party transactions that occurred during the three and six months ended June 30, 2023, and 2022 are explained in Note 12 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report.

Critical Accounting Policies and Use of Estimates

Our unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2023 have been prepared in accordance with IAS 34 Interim Financial Reporting.

Our critical accounting policies and the use of estimates are explained in Note 2 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report and further discussed in Note 3 to our audited consolidated financial statements of our Annual Report on Form 20-F as of and for the year ended December 31, 2022.

Legal Proceedings

Certain pending matters to which we are a party are discussed below.

Alnylam Proceedings

the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480; 11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. All of the proceedings are currently pending.

CureVac Proceedings

Germany

United States

United Kingdom

All of the above proceedings are currently pending.

Moderna Proceedings

Germany

Belgium NV, Pfizer Ireland Pharmaceuticals and Pfizer Inc. in the Düsseldorf Regional Court alleging Comirnaty’s infringement of two European Patents, 3590949B1, or the EP’949 Patent, and 3718565B1, or the EP’565 Patent.

United Kingdom

United States

Netherlands

Ireland

Belgium

All of the above proceedings are currently pending.

We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

Arbutus and Genevant Proceedings

balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.

Promosome Proceedings

Liquidity and Capital Resources

Overview

Given our strong financial, scientific and operational accomplishments, we believe we have the resources to diligently allocate our current capital to drive a multi-platform strategy as a fully integrated global biotechnology company. On the research and development (R&D) front, we continue to be committed to rapidly advancing our oncology pipeline towards late-stage development. Furthermore, we are focused on developing our infectious disease vaccine pipeline including the development of variant-adapted and next generation COVID-19 vaccines to maintain leadership and pandemic preparedness as well as broaden the label of and access to the COVID-19 vaccine. We also plan to invest heavily to build out our global development organization, bringing in talent with clinical and regulatory expertise needed to rapidly advance our diversified clinical pipeline. We are also diversifying our therapeutic area footprint which will enable us to fully leverage the potential of all technology platforms across autoimmune diseases, inflammatory diseases, cardiovascular disease, neurodegenerative diseases, and regenerative medicines. In addition, we plan to enhance capabilities through complementary acquisitions, technologies, infrastructure and manufacturing. To support our future trajectory, growing the organization and expanding our team is of utmost importance. We are on the way to develop our global footprint in key regions including Europe, the United States, Asia and Africa. Additionally, investing in manufacturing capabilities for key technologies and deploying our pandemic response capabilities remain priorities for us. As of June 30, 2023, we had cash and cash equivalents of €14,166.6 million and security investments of €2,667.0 million. When analyzing our liquidity, we anticipate certain significant balance sheet items that are expected to improve our cash and cash equivalents balance subsequent to the end of the reporting period. Our trade receivables remained outstanding as of June 30, 2023 mainly due to the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer as described in Note 7 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report. As of June 30, 2023, our trade receivables included, in addition to the profit share for the second quarter of 2023, trade receivables which related to the gross profit share for the first quarter of 2023. The payment settling our gross profit share for the first quarter of 2023 (as defined by the contract) in the amount of €1,059.2 million was received from our collaboration partner subsequent to the end of the reporting period on July 17, 2023. In addition, until early August 2023, €437.7 million were received through amending the COVID-19 Vaccine Supply Agreement with the European Commission.

Cash and cash equivalents and financial securities are invested in accordance with our asset management and investment policy, primarily with a focus on liquidity and capital preservation, and consist primarily of cash in bank accounts and on hand as well as long- and short-term financial investments.

In November 2020, we entered into a sales agreement, or the Sales Agreement, with Jefferies LLC and SVB Leerink LLC (now known as Leerink Partners LLC), as sales agents, to establish an at-the-market offering program, pursuant to which we may sell, from time to time, ADSs representing ordinary shares for aggregate gross proceeds of up to $500.0 million. We did not sell any ADS during three and six months ended June 30, 2023. As of June 30, 2023, the remaining capacity under the Sales Agreement is $207.1 million. Under the at-the-market offering program ADSs are sold via the stock exchange and therefore no shareholders’ subscription rights are affected.

In November 2022, our Management Board and Supervisory Board authorized the second tranche of our share repurchase program of ADSs, with a value of up to $0.5 billion.

On March 27, 2023, our Management Board and Supervisory Board authorized a new share repurchase program under which we may purchase ADSs, each representing one ordinary share, with a value of up to $0.5 billion until the end of 2023. The spending during three months ended June 30, 2023 amounted to €154.0 million.

Cash Flow

The following table summarizes the primary sources and uses of cash for each period presented:


	Three months ended June 30,		Six months ended June 30,
(in millions €)	2023	2022	2023	2022
Net cash flows from / (used in):
Operating activities	4,386.7	3,919.1	3,709.3	7,969.3
Investing activities	(2,291.8)	(78.4)	(3,027.2)	209.0
Financing activities	(163.4)	(781.5)	(454.7)	(701.2)
Total cash inflow	1,931.5	3,059.2	227.4	7,477.1

Operating Activities

We derive cash flows from operations primarily from the sale of products and services rendered. Our cash flows from operating activities are significantly influenced by our use of cash for operating expenses and working capital to support the business. During the three and six months ended June 30, 2023, our cash flows from operating activities include the settlement payments of our gross profit share from our collaboration partner Pfizer as scheduled by the contractual arrangement. As described in Note 7 to the unaudited interim condensed consolidated financial statement included elsewhere in this Quarterly Report, the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. Therefore, subsequent to the end of the reporting period, as of July 17, 2023, we further improved our cash position as we received the settlement payment of our gross profit share for the first quarter of 2023 (as defined by the contract).

Net cash generated from operating activities for the three months ended June 30, 2023 was €4,386.7 million, comprising a loss before tax for the period of €412.2 million, negative non-cash adjustments of €465.2 million, a net positive change in assets and liabilities of €5,691.5 million and income taxes paid of €437.3 million. Non-cash items primarily included net foreign exchange differences as well as fair value adjustments of derivatives without cash-effect. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables mainly including the settlement payment of our gross profit for the fourth quarter 2022.

Net cash generated in operating activities for the three months ended June 30, 2022 was €3,919.1 million, comprising a profit before tax for the period of €2,319.3 million, negative non-cash adjustments of €205.6 million, a net positive change in assets and liabilities of €2,603.3 million and income taxes paid of €791.4 million. Non-cash items primarily included net foreign exchange differences. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables related to our COVID-19 collaboration with Pfizer.

Net cash generated from operating activities for the six months ended June 30, 2023 was €3,709.3 million, comprising a profit before tax of €295.5 million, negative non-cash adjustments of €379.8 million, a net positive change in assets and liabilities of €5,739.2 million and income taxes paid of €1,282.2 million. Non-cash items primarily included net foreign exchange differences as well as non-cash fair value adjustments of derivatives. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables, other financial liabilities and other liabilities mainly including the settlement payment of our gross profit for the fourth quarter 2022, wage tax and social security payments from our share-based payment settlement and royalty payments.

Net cash generated from operating activities for the six months ended June 30, 2022 was €7,969.3 million, comprising a profit before tax of €7,337.4 million, negative non-cash adjustments of €374.2 million, a net positive change in assets and liabilities of €3,100.5 million and income taxes paid of €2,081.4 million. Non-cash items primarily included net foreign exchange differences and finance income related to our convertible bond fair value update. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables related to our COVID-19 collaboration with Pfizer.

Investing Activities

Net cash used in investing activities for the three months ended June 30, 2023 was €2,291.8 million, mainly attributable to financial security investments in accordance with our asset management and investment policy. The

amount caused by or driven from collaborations amounted to €237.8 million mainly related to licenses acquired in connection with license and collaboration agreements.

Net cash used in investing activities for the three months ended June 30, 2022 was €78.4 million, of which €70.6 million was attributable to the purchase of property, plant and equipment.

Net cash used in investing activities for the six months ended June 30, 2023 was €3,027.2 million, mainly attributable to financial security investments in accordance with our asset management and investment policy. The amount caused by or driven from collaborations amounted to €237.8 million mainly related to licenses acquired in connection with license and collaboration agreements.

Net cash generated from investing activities for the six months ended June 30, 2022 was €209.0 million, mainly derived from €375.2 million proceeds from cash deposit which returned to cash upon maturity of their original investments' term.

Financing Activities

During the three months ended June 30, 2023, net cash used in financing activities was 163.4 million, primarily resulting from the share repurchase program.

During the three months ended June 30, 2022, net cash used in financing activities was €781.5 million, primarily resulting from the share repurchase program and a special cash dividend.

During the six months ended June 30, 2023, net cash used in financing activities was €454.7 million, primarily resulting from the share repurchase program.

During the six months ended June 30, 2022, net cash used in financing activities was 701.2 million, primarily resulting from the share repurchase program and a special cash dividend.

Operation and Funding Requirements

As part of our capital allocation strategy, we expect to continue to incur significant and increasing operating expenses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we and our collaborators:

•continue or expand our research or development of our programs in preclinical development;

•continue or expand the scope of our clinical trials for our product candidates;

•initiate additional preclinical, clinical, or other trials for our product candidates, including under our collaboration agreements;

•continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;

•change or increase our manufacturing capacity or capability;

•change or add additional suppliers;

•add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as a public company and our product development and commercialization efforts, including expansion of sites in Germany and new sites in the United States, and potentially others globally;

•attract and retain skilled personnel;

•seek marketing approvals and reimbursement for our product candidates;

•develop our sales, marketing, and distribution infrastructure for our COVID-19 vaccine and any other products for which we may obtain marketing approval or emergency use authorization;

•seek to identify and validate additional product candidates;

•acquire or in-license other product candidates and technologies;

•acquire other companies;

•make milestone or other payments under any in-license agreements;

•maintain, protect, defend, enforce and expand our intellectual property portfolio; and

•experience any delays or encounter issues with any of the above.

We are subject to all of the risks related to the development and commercialization of pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We are a party to license and research and development agreements with universities and other third parties, as well as patent assignment agreements, under which we have obtained rights to patents, patent applications and know-how. We are in ongoing discussions with two such third parties, the University of Pennsylvania and the National Institute of Health, or NIH, concerning additional royalties allegedly owed on sales of our COVID-19 vaccine since commercialization. While we disagree with the positions being taken by the University of Pennsylvania and NIH, we cannot guarantee that our interpretation of the applicable license agreements will prevail or that we will not ultimately need to pay some or all of the royalty amounts in dispute.

We enter into contracts in the normal course of business with CROs for clinical trials, clinical and commercial supply manufacturing, with vendors for preclinical research studies and for other services and products for operating purposes. We work together with CMOs, who manufacture our product candidates and products and enter into lease agreements to lease laboratory, GMP manufacturing, storage and office spaces. Purchase obligations under our agreements to the extent that they are quantifiable and not cancelable have been considered when defining our guidance for future cash commitments. Most of the committed cash outflow within the remaining months in 2023 is related to lease payments amounting to €43.1 million. Further, we have lease payment obligations of €182.1 million for the years 2024 and beyond.

Our future funding requirements, both near and long term, will depend on many factors, including, but not limited to:

•the initiation, progress, timing, costs, and results of preclinical or nonclinical studies and clinical trials for our product candidates;

•the amount and timing of revenues and associated costs from sales of our COVID-19 vaccine;

•the results of research and our other platform activities;

•the clinical development plans we establish for our product candidates;

•the terms of any agreements with our current or future collaborators, and the achievement of any milestone payments under such agreements to be paid to us or our collaborators;

•the number and characteristics of product candidates that we develop or may in-license;

•the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and other comparable regulatory authorities;

•the cost of filing, prosecuting, obtaining, maintaining, protecting, defending and enforcing our patent claims and other intellectual property rights, including actions for patent and other intellectual property infringement, misappropriation and other violations brought by third parties against us regarding our product candidates or actions by us challenging the patent or intellectual property rights of others;

•the effect of competing technological and market developments, including other products that may compete with one or more of our product candidates;

•the cost and timing of completion and further expansion of clinical and commercial scale manufacturing activities sufficient to support all of our current and future programs;

•the cost of establishing sales, marketing, and distribution capabilities for any product candidates for which we may receive marketing approval and reimbursement in regions where we choose to commercialize our products on our own;

•and the terms of any ADS repurchases we make.

Risk Factors

Our business is subject to various risks, including those described below. You should consider carefully the risks and uncertainties described below and in our future filings. If any such risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. Additionally, risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations and/or prospects.

Risk Factor Summary

•Demand for our COVID-19 vaccine, though difficult to predict, is expected to continue to decrease in the near future. Changing market dynamics will impact our revenue, which currently depends heavily on sales of our COVID-19 vaccine, and result in challenges relating to production of our COVID-19 vaccine.

•Our reported commercial revenue is partially based on preliminary estimates of COVID-19 vaccine sales and costs from Pfizer Inc., or Pfizer, that are likely to change in future periods, which may impact our reported financial results.

•We may be unsuccessful in adapting our COVID-19 vaccine or developing future versions of our COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus and, even if we are successful, a market for vaccines against these variants may not develop.

•Significant adverse events may occur during our clinical trials or even after receiving regulatory approval, which could delay or terminate clinical trials, delay or prevent regulatory approval or market acceptance of any of our product candidates. Since commercialization, we have received, and expect to continue to receive, product liability claims related to our COVID-19 vaccine.

•We face significant competition from other makers of COVID-19 vaccines and may be unable to maintain a competitive market share for our COVID-19 vaccine.

•We have only recently built our marketing and sales organization. If we are unable to continue to increase our marketing and sales capabilities on our own or through third parties, we may not be able to market and sell our product candidates effectively in the United States and other jurisdictions, if approved, or generate product sales revenue.

•Other companies or organizations may challenge our intellectual property rights or may assert intellectual property rights that prevent us from developing and commercializing our COVID-19 vaccine or our product candidates and other technologies, or that negatively affect our results of operations.

•Even if we obtain regulatory approval for our product candidates, the products may not gain the market acceptance among physicians, patients, hospitals, treatment centers and others in the medical community necessary for commercial success.

•Our operating results may fluctuate significantly, which makes our future operating results difficult to predict. If our operating results fall below expectations, the price of the ADSs representing our shares could decline.

•We may require substantial additional financing to achieve our goals, and a failure to obtain this capital on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.

•If we identify material weaknesses in our internal control over financial reporting and fail to remediate such material weaknesses, we may not be able to report our financial results accurately or to prevent fraud.

•As a “foreign private issuer,” we are exempt from a number of rules under U.S. securities laws, as well as Nasdaq rules, and we are permitted to file less information with the SEC than U.S. companies. This may limit the information available to holders of the ADSs and may make our ordinary shares and the ADSs less attractive to investors.

•Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety of reasons outside of our control. Clinical trials of our product candidates may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which can affect our ability to fund our company and would have a material adverse impact on our business.

•mRNA drug development has substantial clinical development and regulatory risks due to limited regulatory experience with mRNA immunotherapies.

•Our approved product and product candidates are based on novel technologies and they may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping. If we or any of the third-party manufacturers we work with encounter such difficulties, our ability to supply materials for clinical trials or any approved product could be delayed or stopped.

•If our efforts to obtain, maintain, protect, defend and/or enforce the intellectual property related to our COVID-19 vaccine or our product candidates and technologies are not adequate, we may not be able to compete effectively in our market.

•We have experienced and may continue to experience significant volatility in the market price of the ADSs representing our ordinary shares.

•Our principal shareholders and management own a significant percentage of our ordinary shares and will be able to exert significant control over matters subject to shareholder approval.

Risks Related to our COVID-19 Vaccine and the Commercialization of our Pipeline

Demand for our COVID-19 vaccine, though difficult to predict, is expected to continue to decrease in the near future. Changing market dynamics will impact our revenue, which currently depends heavily on sales of our COVID-19 vaccine, and result in challenges relating to production of our COVID-19 vaccine.

Prior to the commercialization of our COVID-19 vaccine, we had not sold or marketed any products in our pipeline. As a result, a majority of our total revenues to date are attributable to sales of our COVID-19 vaccine. However, we have experienced and we expect to continue to experience increasing reductions in demand for COVID-19 vaccination generally, including for our vaccine, as the virus becomes endemic and as a growing proportion of the population becomes vaccinated. We expect that future revenues from sales of our COVID-19 vaccine will decrease as demand for vaccination wanes. Such revenues will depend on numerous factors, including:

•the extent to which a COVID-19 vaccine, including any booster shot, continues to be necessary as COVID-19 becomes an endemic virus;

•competition from other COVID-19 vaccines, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response;

•our ability to successfully and timely develop effective vaccines targeting new variants and mutations of COVID-19;

•our ability to receive full regulatory approvals where we currently have emergency use authorizations or equivalents;

•our ability to expand our geographic customer base;

•our pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after our initial sales to national governments, including the transition towards ordinary-course insurance coverage in the public and private sectors;

•the ability of countries and jurisdictions to store and distribute doses of our COVID-19 vaccine to end users at cold temperatures;

•the safety profile of our COVID-19 vaccine, including if previously unknown undesirable effects or increased incidence or severity of known undesirable effects are identified with our COVID-19 vaccine;

•intellectual property litigation involving our COVID-19 vaccine and COVID-19 vaccines in general; and

•our manufacturing and distribution capabilities for our COVID-19 vaccine.

We cannot accurately predict the revenues our COVID-19 vaccine will generate in future periods or for how long our COVID-19 vaccine will continue to generate material revenues and we cannot ensure it will maintain its competitive position. Uncertainty in the demand for our COVID-19 vaccine and difficulties in targeting appropriate supply of our COVID-19 vaccines have in the past resulted, and may in the future result, in significant inventory write-offs and cancellations of contract manufacturing orders. Our business and financial condition could be materially affected by lowered COVID-19 vaccine revenues resulting from any of the above factors, or by production and supply chain difficulties. In addition, if our revenues or market share of, or other financial metrics relating to our COVID-19 vaccine do not meet the expectations of investors or securities analysts, the market price of the ADSs representing our ordinary shares may decline.

Our reported commercial revenue is based on preliminary estimates of COVID-19 vaccine sales and costs from Pfizer that are likely to change in future periods, which may impact our reported financial results.

Our reported commercial revenue is based on preliminary estimates from Pfizer, and other assumptions and judgments that we have made, which may be subject to significant uncertainties. Our commercial revenue includes preliminary estimates in part due to a difference in Pfizer’s fiscal quarter for subsidiaries outside the United States, which consequently creates an additional time lag between the recognition of revenues and the receipt of payment. Although our revenue recognition policy is based on facts and circumstances known to us and various other assumptions that we believe to be reasonable under the circumstances, our actual results may deviate from such reported revenue.