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 https://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.

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 Stockholders' Equity .........................

4

Interim Condensed Consolidated Statements of Cash Flows .............................................................

5

Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated

Financial Statements.................................................................................................................................

6

1 Corporate Information ................................................................................................................

6

2 Basis of Preparation, Significant Accounting Policies.............................................................

6

3 Revenues from Contracts with Customers ..............................................................................

8

4 Income and Expenses.................................................................................................................

9

5 Business Combination ................................................................................................................

11

6 Income Taxes...............................................................................................................................

13

7 Financial Assets and Financial Liabilities ..................................................................................

15

8 Issued Capital and Reserves ......................................................................................................

19

9 Provisions .....................................................................................................................................

19

10 Contingent Liabilities...................................................................................................................

19

11 Related Party Disclosures ..........................................................................................................

27

12 Events after the Reporting Period .............................................................................................

##

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

Operating Results 28

Liquidity and Capital Resources 56

Risk Factors 60

‌Unaudited Interim Condensed Consolidated Financial Statements

‌Interim Condensed Consolidated Statements of Profit or Loss

Three months ended March 31,

2025

2024

(in millions €, except per share data)

Note

(unaudited)

(unaudited)

Revenues

3

182.8

187.6

Cost of sales

4.1

(83.8)

(59.1)

Research and development expenses

4.1

(525.6)

(507.5)

Sales and marketing expenses

(13.7)

(15.6)

General and administrative expenses

4.1

(106.9)

(117.0)

Other operating expenses

4.2

(48.5)

(23.9)

Other operating income

4.2

61.6

28.3

Operating loss

(534.1)

(507.2)

Finance income

4.3

122.6

180.1

Finance expenses

4.3

(33.9)

(4.7)

Loss before tax

(445.4)

(331.8)

Income taxes

6

29.6

16.7

Net loss

(415.8)

(315.1)

Loss per share

Basic and diluted loss per share

(1.73)

(1.31)

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

‌Interim Condensed Consolidated Statements of Comprehensive Income

Three months ended March 31,

2025

2024

(in millions €)

Note

(unaudited)

(unaudited)

Net loss

(415.8)

(315.1)

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

(30.9)

15.4

(30.9)

15.4

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

Other comprehensive loss that will not be reclassified to profit or loss in subsequent periods, net of tax

Net gain / (loss) on equity instruments designated at fair value

through other comprehensive income

7

(32.1)

6.9

Net other comprehensive income / (loss) that will not be reclassified to profit or loss in subsequent periods

(32.1)

6.9

Other comprehensive income / (loss), net of tax

(63.0)

22.3

Comprehensive loss, net of tax

(478.8)

(292.8)

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

‌Interim Condensed Consolidated Statements of Financial Position

March 31,

December 31,

(in millions €)

Assets

Note

2025

(unaudited)

2024

Non-current assets

Goodwill

375.9

380.6

Other intangible assets

5

1,511.2

790.4

Property, plant and equipment

1,026.1

935.3

Right-of-use assets

241.9

248.1

Contract assets

7.9

9.8

Other financial assets

7

2,285.8

1,254.0

Other non-financial assets

22.6

26.3

Deferred tax assets

6

85.5

81.7

Total non-current assets

5,556.9

3,726.2

Current assets

Inventories

254.4

283.3

Trade and other receivables

7

956.5

1,463.9

Contract assets

10.0

10.0

Other financial assets

7

3,924.9

7,021.7

Other non-financial assets

234.3

212.7

Income tax assets

6

60.5

50.0

Cash and cash equivalents

10,184.9

9,761.9

Total current assets

15,625.5

18,803.5

Total assets

21,182.4

22,529.7

Equity and liabilities

Equity

Share capital

8

248.6

248.6

Capital reserve

1,447.4

1,398.6

Treasury shares

(8.2)

(8.6)

Retained earnings

18,682.2

19,098.0

Other reserves

(1,443.4)

(1,325.5)

Total equity

18,926.6

19,411.1

Non-current liabilities

Lease liabilities, loans and borrowings

7

237.5

214.7

Other financial liabilities

7

150.9

46.9

Provisions

9

20.8

20.9

Contract liabilities

182.9

183.0

Other non-financial liabilities

85.1

87.5

Deferred tax liabilities

6

44.1

42.4

Total non-current liabilities

721.3

595.4

Current liabilities

Lease liabilities, loans and borrowings

7

55.5

39.5

Trade payables and other payables

7

443.8

426.7

Other financial liabilities

7

443.4

1,443.4

Income tax liabilities

6

5.4

4.5

Provisions

9

121.9

144.8

Contract liabilities

294.5

294.9

Other non-financial liabilities

170.0

169.4

Total current liabilities

1,534.5

2,523.2

Total liabilities

2,255.8

3,118.6

Total equity and liabilities

21,182.4

22,529.7

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

‌Interim Condensed Consolidated Statements of Changes in Stockholders' Equity

Equity attributable to equity holders of the parent

Share

Capital

Treasury

Retained

Other

Total

(in millions €)

Note

capital

reserve

shares

earnings

reserves

equity

As of January 1, 2024

248.6

1,229.4

(10.8)

19,763.3

(984.6)

20,245.9

Net loss

-

-

-

(315.1)

-

(315.1)

Other comprehensive income

-

-

-

-

22.3

22.3

Total comprehensive income / (loss)

-

-

-

(315.1)

22.3

(292.8)

Share-based payments

-

(0.5)

-

-

15.6

15.1

As of March 31, 2024

248.6

1,228.9

(10.8)

19,448.2

(946.7)

19,968.2

As of January 1, 2025

248.6

1,398.6

(8.6)

19,098.0

(1,325.5)

19,411.1

Net loss

-

-

-

(415.8)

-

(415.8)

Other comprehensive loss

-

-

-

-

(63.0)

(63.0)

Total comprehensive loss

-

-

-

(415.8)

(63.0)

(478.8)

Share-based payments

5

-

48.8

0.4

-

(54.9)

(5.7)

As of March 31, 2025

248.6

1,447.4

(8.2)

18,682.2

(1,443.4)

18,926.6

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 March 31,

(in millions €)

2025

(unaudited)

Operating activities

(415.8)

(29.6)

(445.4)

42.8

22.1

48.3

(0.1)

(122.6)

7.9

(14.5)

(14.3)

(11.3)

520.7

33.8

(971.0)

118.6

(3.1)

(12.2)

(3.6)

23.2

(780.7)

(48.9)

0.5

(569.2)

(78.5)

(2,507.7)

4,450.6

1,246.8

(4.5)

(9.3)

(13.8)

452.3

(16.1)

(13.2)

9,761.9

10,184.9

Net loss

Income taxes

Loss before tax

Adjustments to reconcile profit before tax to net cash flows:

Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets

Share-based payment expenses

Net foreign exchange differences

(Gain) / Loss on disposal of property, plant and equipment

Finance income excluding foreign exchange differences

Finance expense excluding foreign exchange differences

Government grants

Other non-cash (income) / loss

Unrealized (gain) / loss on derivative instruments at fair value through profit or loss

Working capital adjustments:

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

Decrease in inventories

Decrease in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions

Interest received and realized gains from cash and cash equivalents

Interest paid and realized losses from cash and cash equivalents

Income tax paid

Share-based payments

Government grants received

Net cash flows used in operating activities

Investing activities

Purchase of property, plant and equipment

Proceeds from sale of property, plant and equipment

Purchase of intangible assets and right-of-use assets

Acquisition of subsidiaries and businesses, net of cash acquired

Investment in other financial assets

Proceeds from maturity of other financial assets

Net cash flows from / (used in) investing activities

Financing activities

Repayment of loans and borrowings

Payments related to lease liabilities

Net cash flows used in financing activities

Net increase / (decrease) in cash and cash equivalents

Change in cash and cash equivalents resulting from exchange rate differences

Change in cash and cash equivalents resulting from other valuation effects

Cash and cash equivalents at the beginning of the period

Cash and cash equivalents as of March 31

2024

(unaudited)

(315.1)

(16.7)

(331.8)

38.3

16.3

(28.7)

- (174.9)

4.7

(9.1)

-

1.7

498.2

12.3

(288.0)

199.4

(3.7)

(258.8)

(2.4)

9.2

(317.3)

(58.5)

- (78.4)

- (4,895.1)

2,727.6

(2,304.4)

- (7.8)

(7.8)

(2,629.5)

6.8

(64.4)

11,663.7

8,976.6

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

  1. ‌Corporate Information

    BioNTech SE is a limited company incorporated and domiciled in Germany. The registered office is located in Mainz, Germany (An der Goldgrube 12, 55131 Mainz). The accompanying unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries and have been prepared on a going concern basis in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. 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 needs. 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 product and other candidate vaccines and therapies.

    We have built a broad toolkit across multiple technology platforms with a focus on oncology, including investigational mRNA cancer immunotherapies, immunomodulators and targeted therapies. Our multi-technology combination of platforms positions us as pioneers in the field of individualized, patient-centric therapeutic approaches.

    Our approach has generated a robust and diversified product pipeline across a range of technologies in oncology and infectious disease, and has led to the approval of our first marketed product, Comirnaty.

    Our unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2025 were authorized for issuance in accordance with a resolution of the Audit Committee of our Supervisory Board on May 2, 2025.

  2. ‌Basis of Preparation, Significant Accounting Policies

    Basis of Preparation and Principles of Consolidation

    The accompanying unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2025 have been prepared in accordance with IFRS 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 audited 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, 2024.

    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 months ended March 31, 2025, 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, liabilities and contingent liabilities and the accompanying disclosures.

    This includes but is not limited to our judgment relating to our collaboration with Pfizer, Inc., or Pfizer, as described under the subheading "Pfizer Agreement Characteristics" in Note 3 to our audited consolidated financial statements as of and for the year ended December 31, 2024. 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 and certain other sharable expense items, some of which is based on preliminary data shared between the partners.

    This further includes but is not limited to judgments relating to the impairment tests of our goodwill and intangible assets, as the outcome of these tests is highly dependent on management's assumptions regarding future cash flow projections, which require significant judgments and assumptions about future developments. They can be affected by a variety of factors, including but not limited to peak sales assumptions, clinical trial success rates and/or estimation of weighted-average cost of capital. Changes to the assumptions underlying our goodwill and intangible assets impairment assessments could require material adjustments to the carrying amount of our recognized goodwill and intangible assets and may lead to impairment charges recognized in our condensed consolidated statements of profit or loss.

    Judgment is also required including, but not limited to, when accounting for business combinations. This includes determining whether an intangible asset is identifiable and whether it should be recorded separately from goodwill. Additionally, estimating the acquisition date fair values in conjunction with the purchase price allocation and with the settlement of pre-existing relationships involves estimation uncertainty and discretionary decisions. The necessary measurements are based on information available on the acquisition date and on expectations and assumptions that have been deemed reasonable by management. These judgments, estimates and assumptions can materially affect our financial position and our profit or loss statements .

    Management bases its judgments and estimates on parameters available at the time 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.

    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, 2024, except for income taxes, which are accounted for using the expected annual tax rate in our unaudited interim condensed consolidated financial statements (see Note 6).

    Standards Applied for the First Time

    The IFRS accounting standards applied for the first time as of January 1, 2025, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2024, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2025.

  3. ‌Revenues from Contracts with Customers

    Disaggregated information on revenues

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

    Three months ended March 31,

    (in millions €)

    2025

    2024

    COVID-19 vaccine revenues

    133.0

    124.2

    Other revenues

    49.8

    63.4

    Total

    182.8

    187.6

    COVID-19 Vaccine Revenues

    During the three months ended March 31, 2025 and 2024, COVID-19 vaccine revenues were recognized from the supply and sales of our COVID-19 vaccine worldwide, mainly comprising our share of the collaboration partner's gross profit derived from sales in the collaboration partner's territory. Overall, our COVID-19 vaccine revenues amounted to €133.0 million during the three months ended March 31, 2025, compared to €124.2 million for the comparative prior year period. The year-to-date change compared to the comparative prior year period was mainly driven by higher revenues derived from our COVID-19 vaccine collaboration during the three months ended March 31, 2025. Our COVID-19 vaccine revenues are subject to seasonal effects and are therefore higher in the fall / winter of the northern hemisphere.

    Other Revenues

    During the three months ended March 31, 2025 and 2024, our other revenues were mainly derived from a pandemic preparedness contract with the German government which declined year-to-date due to lower contracted capacities.

    Revenues from contracts with customers were recognized as follows:

    Three months ended March 31,

    (in millions €)

    2025

    2024

    Timing of revenue recognition

    Goods and services transferred at a point in time

    66.8

    33.5

    Goods and services transferred over time

    45.7

    57.3

    Revenue recognition applying the sales-based or usage-based royalty recognition constraint model (1)

    Total

    70.3

    182.8

    96.8

    187.6

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

  4. ‌Income and Expenses

    1. General Expenses

      Cost of Sales

      From the three months ended March 31, 2024, to the three months ended March 31, 2025, cost of sales increased by €24.7 million, or 42%, from €59.1 million to €83.8 million, mainly due to the positive impact of an inventory revaluation on cost of sales during the three months ended March 31, 2024. During both periods, cost of sales was impacted by expenses arising from inventory write-downs to net realizable value due to inventories expected to be unsellable, not fulfilling the specification defined by our quality standards, shelf-life expiry or destruction of inventory amounting to €37.7 million, compared to €36.0 million in the previous period. The inventories valued at net realizable value in our consolidated statement of financial position as of March 31, 2025 take contractual compensation payments into consideration.

      Research and Development Expenses

      From the three months ended March 31, 2024, to the three months ended March 31, 2025, our research and development expenses increased by €18.1 million, or 4%, from €507.5 million to

      €525.6 million, mainly driven by progressing late-stage clinical studies for pipeline candidates in our antibody drug conjugate and antibody product portfolio.

      General and Administrative Expenses

      From the three months ended March 31, 2024, to the three months ended March 31, 2025, our general and administrative expenses decreased by €10.1 million, or 9%, from €117.0 million to €106.9 million, primarily driven by a reduction in external services.

    2. Other Operating Result

      The other operating result recognized during the three months ended March 31, 2025 and 2024 is shown in the following table:

      Three months ended March 31,

      (in millions €)

      2025

      2024

      Other operating result

      Other operating income

      61.6

      28.3

      Gain on derivative instruments at fair value through profit or loss

      26.2

      -

      Grants

      14.5

      9.1

      Bargain purchase

      14.3

      -

      Foreign exchange differences, net

      -

      17.1

      Other

      6.6

      2.1

      Other operating expenses

      (48.5)

      (23.9)

      Litigation costs

      (25.9)

      (21.2)

      Loss on derivative instruments at fair value through profit or loss

      -

      (2.7)

      Foreign exchange differences, net

      (13.8)

      -

      Other

      (8.8)

      -

      Total other operating result

      13.1

      4.4

      From the three months ended March 31, 2024, to the three months ended March 31, 2025, our other operating result increased by €8.7 million, or 198%, from a positive result of €4.4 million to a positive result of €13.1 million, mainly due to gains from our derivative instruments and a bargain purchase.

      As of March 31, 2025, the amount of our grants deferred in our unaudited interim condensed consolidated financial statements amounted to €89.4 million compared to €85.2 million as of December 31, 2024.

      4.4 Finance Result

      The finance result recognized during the three months ended March 31, 2025 and 2024, is shown in the following table:

      Three months ended March 31,

      (in millions €)

      2025

      2024

      Finance result

      Finance income

      122.6

      180.1

      Gains from financial instruments measured at amortized cost

      77.0

      118.9

      Gains from financial instruments measured at fair value

      45.6

      56.0

      Foreign exchange differences, net

      -

      5.2

      Finance expenses

      (33.9)

      (4.7)

      Loss from financial instruments measured at fair value

      (0.1)

      (1.2)

      Loss from financial instruments measured at amortized cost without expected credit losses

      (1.4)

      (0.9)

      Foreign exchange differences, net

      (26.0)

      -

      Other

      (6.4)

      (2.6)

      Total finance result

      88.7

      175.4

      During the three months ended March 31, 2025 and 2024, the finance result was mainly derived from returns such as interests and sales resulting from our financial investments as well as fair value adjustments of our money market funds. Compared to the three months ended March 31, 2024, our finance result decreased by €86.7 million, or 49%, from a positive finance result of €175.4 million to a positive finance result of €88.7 million during the three months ended March 31, 2025, mainly due to a lower interest income and a shift from positive to negative foreign exchange differences, primarily derived from our bank deposits and cash accounts held in foreign currency.

  5. ‌Business Combination

    Acquisition of Biotheus

    On November 13, 2024, our subsidiary, BioNTech Collaborations GmbH, entered into an agreement and plan of merger, or the Merger Agreement, with Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases, to acquire 100 percent of the issued share capital of Biotheus. The acquisition supports the global execution of our oncology strategy and provides full global rights to BNT327, an investigational PD-L1 x VEGF-A bispecific antibody, with potential to replace current checkpoint inhibitor standard of care treatments for solid tumors.

    By closing the acquisition, we gained full rights to Biotheus' other pipeline candidates and its in-house bispecific antibody-drug conjugate capability. The acquisition has expanded our footprint in China, adding a local research and development hub to conduct clinical trials. In addition, we have gained a biologics manufacturing facility to contribute to our future global manufacturing and supply, and more than 300 Biotheus employees in R&D, manufacturing and enabling functions have joined the BioNTech workforce.

    Following the satisfaction of several customary closing conditions and regulatory approvals as defined in the Merger Agreement, the acquisition closed on January 31, 2025.

    Since the completion of the acquisition took place in January 2025, we performed an allocation of the total consideration and the underlying assets acquired and liabilities assumed based on their fair values using the information available as of the acquisition date. Due to the complexity of the transaction, this allocation is still preliminary and might be subject to change. The total consideration and the fair values determined in accordance with IFRS 3 of the identified net assets acquired of Biotheus as of January 31, 2025, are as follows:

    Fair value recognized

    (in millions €)

    on acquisition

    Biotheus

    Assets

    Intangible assets

    172.8

    Property, plant and equipment

    70.7

    Cash and cash equivalents

    122.4

    Other assets non-current and current

    20.6

    Total assets

    386.5

    Liabilities

    Non-current liabilities

    36.3

    Current liabilities

    55.1

    Total liabilities

    91.4

    Total identifiable net assets at fair value

    295.2

    Bargain from the acquisition

    (14.3)

    Total consideration

    280.9

    Consideration

    Total purchase price

    848.2

    Upfront payment

    768.5

    Contingent consideration (milestones)

    79.6

    Payments in connection with pre-existing relationships

    (567.3)

    Total consideration

    280.9

    Upon closing and under the terms of the agreement, we paid Biotheus shareholders an upfront payment of €768.5 million in cash, which is still subject to customary purchase price adjustments. Furthermore, we agreed to pay additional performance-based contingent payments, if certain milestones are met. At the acquisition date, the contingent consideration was recognized at its fair value of €79.6 million based on discounted cash flow projections in connection with performance-based contingent payments. The lower end of the bandwidth of possible outcomes of the contingent consideration is zero, and the upper limit is €144.3 million.

    Under the terms of the agreement, we also transferred American Depositary Shares, or ADSs, to eligible shareholders who will provide services to the Group. Under IFRS 3, this is considered

    remuneration and will be recognized as equity-settled share-based payment, based on the grant date fair value (€49.2 million) as personnel expense over a four-year service period.

    The purchase price is mainly allocated to the settlement of our pre-existing relationship in connection with the License and Collaboration Agreement with Biotheus entered into in November 2023, which comprised exclusive rights to the development, manufacturing and commercialization of BNT327/ PM8002 ex-Greater China. The amount is separated from the remaining purchase price to be transferred for the acquired business of Biotheus and amounts to €565.1 million. This amount for the settlement of the pre-existing relationship is identified based on the fair value of the settled rights of Biotheus in connection with contingent payments in relation to the License and Collaboration Agreement, including development, regulatory and sales milestones and royalties. This fair value was determined using a Discounted Cash flow model based on a business plan for the compound, using an appropriate WACC. The fair value of these rights is recorded as subsequent acquisition cost to our BNT327/PM8002 ex-Greater China rights. As the requirements under IAS 12 for the initial recognition exemption are fulfilled, we did not record a correspondent deferred tax liability. We did not identify a gain or a loss in connection with the settlement of the pre-existing relationship.

    The consideration for the acquired business of Biotheus is allocated to net assets acquired, which mainly include identified intangible assets in connection with Biotheus' BNT327/PM8002 Greater China rights and other clinical pipeline candidates, property, plant and equipment, cash and liabilities assumed. The fair values of the BNT327/PM8002 Greater China rights and other clinical pipeline candidates were determined based on the direct cash flow approach and amount to €167.7 million.

    A bargain purchase of €14.3 million was recognized in other operating income, which technically results from the separation of the identified amount in connection with the settlement of the preexisting relationships and the application of the initial recognition exemption under IAS 12.

    Transaction costs of €6.1 million were expensed and are included in general and administrative expenses. Since the acquisition, Biotheus' impact on our revenue and profit and loss for the period has been immaterial. Accordingly, pro-forma amounts for our revenue and profit and loss for the financial year, which were calculated on the assumption that the acquisition had taken place at the beginning of the year, would not materially differ from the actual figures reported.

  6. ‌Income Taxes

    For the three months ended March 31, 2025 and 2024, 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. For the three months ended March 31, 2025, our effective income tax rate was approximately 6.6%. For the three months ended March 31, 2024, our effective income tax rate was approximately 5.0%.

    The effective income tax rate was mainly driven by the expected negative result for 2025 and management's assessment of the requirements in International Accounting Standards, or IAS, 12, including on the character and amounts of taxable future profits, the periods in which those profits are expected to occur, and the availability of tax planning opportunities. Thus, in countries where the requirements of IAS 12 were not fulfilled, no deferred tax asset was recognized. Such assessment takes into account the fact that there is an inherent risk of failure in pharmaceutical development and

    uncertainty of approvals that depend on external regulatory agencies' opinions. As of March 31, 2025, it is 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.

    We apply the mandatory exception to recognizing and disclosing information about deferred tax assets and liabilities arising from Pillar Two income taxes. Furthermore, we reviewed the corporate structure with regard to the Pillar Two Model Rules in various jurisdictions. Since the Group's relevant effective tax rate for Pillar Two purposes is expected mainly above 15% in all jurisdictions in which it operates, it has been determined that the Group is not materially subject to Pillar Two "top-up" taxes. Therefore, the consolidated financial statements for the three months ended March 31, 2025 do not include further information otherwise required by paragraphs 88B and 88C of IAS 12.

    The income taxes recognized during the three months ended March 31, 2025 and 2024, are shown in the following table:

    Three months ended March 31,

    (in millions €)

    2025

    2024

    Current income taxes

    2.7

    (7.8)

    Deferred taxes

    (32.3)

    (8.9)

    Income taxes expenses / (income)

    (29.6)

    (16.7)

  7. ‌Financial Assets and Financial Liabilities

    Financial Assets and Liabilities at Amortized Cost and at Fair Value through OCI and Profit or Loss

    Set out below is an overview of financial assets and liabilities at amortized cost and at fair value through OCI and profit or loss, as of the dates indicated:

    (in millions €)

    Financial assets subsequently measured at fair value through profit or loss

    Foreign exchange forward contracts

    Security investments disclosed as cash and cash equivalents

    Other financial assets

    Financial assets subsequently measured at fair value through OCI

    Security investments disclosed as other financial assets

    Security investments disclosed as cash and cash equivalents

    Cash at banks and on hand Trade and other receivables Reimbursement asset

    Other financial assets

    Financial liabilities subsequently measured at fair value

    Non-listed equity investments

    -

    1.5

    1.5

    -

    - 1.5

    1.5

    Listed equity investments

    -

    60.6

    60.6

    60.6

    - -

    60.6

    Financial assets subsequently measured at amortized costs(1)

    March 31, 2025

    Carrying amount Fair value

    Current

    Non-current

    Total

    Level 1 (Fair value)

    Level 2 (Fair value)

    Level 3 (Fair value)

    Total

    12.2

    -

    12.2

    -

    12.2

    -

    12.2

    5,177.0

    -

    5,177.0

    5,177.0

    -

    -

    5,177.0

    -

    38.0

    38.0

    -

    -

    38.0

    38.0

    3,542.0

    2,127.5

    5,669.5

    - - -

    5,669.5

    4,389.4

    -

    4,389.4

    - - -

    4,389.4

    618.5

    -

    618.5

    - - -

    618.5

    956.5

    -

    956.5

    - - -

    956.5

    370.7

    39.3

    410.0

    - - -

    410.0

    -

    18.9

    18.9

    - - -

    18.9

    Loans and borrowings

    14.3

    31.9

    46.2

    - - -

    46.2

    Trade payables and other payables

    443.8

    -

    443.8

    - - -

    443.8

    Other financial liabilities

    437.3

    19.2

    456.5

    - - -

    456.5

    Financial liabilities subsequently not measured according to IFRS 9

    Lease liabilities

    41.2 205.6 246.8 - - - 246.8

    Foreign exchange forward contracts

    5.2

    -

    5.2

    - 5.2

    -

    5.2

    Contingent consideration

    0.9

    131.7

    132.6

    - -

    132.6

    132.6

    Financial liabilities subsequently measured at amortized costs(1)

    (1)Fair values for financial assets and liabilities at amortized costs are not disclosed as the book values represent a reasonable approximation.

    During the three months ended March 31, 2025, the non-listed and listed equity investments decreased by €32.1 million compared to year-end 2024 mainly due to a lower fair value valuation during this time period.

    During the three months ended March 31, 2025, additional developments in our financial assets and liabilities mainly resulted from a reallocation of existing capital and the usage of financial funds for our business combination outlined in Note 5 and the settlement of the contractual disputes outlined in our Annual Report on Form 20-F as of and for the year ended December 31, 2024. This led to a decrease of €1,770.5 million in security investments subsequently measured at fair value through profit and loss

    (money market funds) and a decrease of €1,927.8 million in security investments disclosed as other financial assets subsequently measured at amortized costs (e.g. bonds, commercial paper) compared to year-end 2024. Security investments disclosed as cash and cash equivalents subsequently measured at amortized cost increased by €2,025.0 million during the three months ended March 31, 2025 due to a focus on short-term investments. In total, our cash and security investments decreased by €1,504.8 million compared to December 31, 2024.

    The other financial liabilities decreased by €969.7 million during the three months ended March 31, 2025, which is essentially related to the settlement of contractual disputes.

    December 31, 2024

    Carrying amount Fair value

    Non-

    Level 1

    Level 2

    Level 3

    (in millions €)

    Current

    current

    Total

    (Fair value)

    (Fair value)

    (Fair value)

    Total

    Financial assets subsequently measured at fair value through profit or loss

    Foreign exchange forward contracts

    11.9

    -

    11.9

    -

    11.9

    -

    11.9

    Security investments disclosed as cash and cash equivalents

    6,947.5

    -

    6,947.5

    6,947.5

    -

    -

    6,947.5

    Other financial assets

    -

    39.6

    39.6

    -

    -

    39.6

    39.6

    Financial assets subsequently measured at fair value through OCI

    Non-listed equity investments

    -

    1.5

    1.5

    -

    - 1.5

    1.5

    Listed equity investments

    -

    92.7

    92.7

    92.7

    - -

    92.7

    Financial assets subsequently measured at amortized costs(1)

    Security investments disclosed as other

    financial assets

    6,536.2

    1,061.1

    7,597.3

    - - -

    7,597.3

    Security investments disclosed as cash and cash equivalents

    2,364.4

    -

    2,364.4

    - - -

    2,364.4

    Cash at banks and on hand

    450.0

    -

    450.0

    - - -

    450.0

    Trade and other receivables

    1,463.9

    -

    1,463.9

    - - -

    1,463.9

    Reimbursement asset

    473.6

    40.9

    514.5

    - - -

    514.5

    Other financial assets

    -

    18.2

    18.2

    - - -

    18.2

    Financial liabilities subsequently measured at fair value

    Foreign exchange forward contracts

    16.3

    -

    16.3

    - 16.3

    -

    16.3

    Contingent consideration

    0.9

    46.9

    47.8

    - -

    47.8

    47.8

    Financial liabilities subsequently measured at amortized costs(1)

    Trade payables and other payables

    426.7

    -

    426.7

    - - -

    426.7

    Other financial liabilities

    1,426.2

    -

    1,426.2

    - - -

    1,426.2

    Financial liabilities subsequently not measured according to IFRS 9

    Lease liabilities 39.5 214.7 254.2 - - - 254.2

    (1)Fair values for financial assets and liabilities at amortized costs are not disclosed as the book values represent a reasonable approximation.

    Equity investments designated at Fair Value through OCI

    Financial investments in equity securities measured at fair value through other comprehensive income comprise the following effects:

    Three months ended March 31,

    Net gain / (loss) on equity instruments designated at fair value through other

    comprehensive income

    6.9

    2025

    (32.1)

    (32.1)

(in millions €) 2024

Total 6.9

Measurement of fair values

The following table shows the valuation techniques used in measuring fair values for financial instruments in our consolidated statements of financial position, as well as the significant unobservable inputs used.

Type Valuation technique Significant unobservable inputs

Forward exchange contracts

Non-listed equity investments

Discounted cash flow using par method. Expected future cash flows based on foreign exchange forwards discounted over the respective remaining term of the contracts using the respective deposit interest rates and spot rates.

Quantitative and qualitative factors such as actual and forecasted results, cash position and financing round valuations.

n/a

  • Actual and forecasted results

  • Net Asset Value

  • Cash position

  • Nature and pricing indication of latest financing round

    Listed equity investments Stock prices of the listed companies and

    applicable exchange rates, if the listing is in a foreign currency.

    n/a

    Money market funds Quoted prices on an active market. n/a

    Contingent consideration Present value of expected future payments

    and reflecting changes in expected achievement of underlying performance parameters and compounding effects.

    Royalty assets Present value of expected future cash flows.

  • Expected future payments

  • Applied cost of capital

  • Expected future cash flows

  • Applied cost of capital

Recurring Fair Values (Level 3)

The following table shows the recurring fair value measurement of contingent consideration and royalty assets as well as the effect of the measurements on our unaudited interim condensed consolidated statements of profit or loss for the current period.

(in millions €)

Financial assets

Other financial assets

Financial liabilities

Contingent consideration

As of January 1, 2024

-

(38.8)

Additions

37.7

-

Net effect on profit or loss - Finance income / (expense)

Net change in fair value

5.6

(1.8)

As of March 31, 2024

43.3

(40.6)

As of January 1, 2025

39.6

(47.8)

Additions

-

(79.6)

Net effect on profit or loss - Other operating income /

(expense)

Net change in fair value

-

(1.4)

Net effect on profit or loss - Finance income / (expense)

Net change in fair value

(1.6)

(3.8)

As of March 31, 2025

38.0

(132.6)

The sensitivity of the fair values of royalty assets to the significant, unobservable, variable input factors, with all other factors remaining constant, is shown in the following table:

Royalty assets

Input factor

Change in fair value with increasing input factor

Cash flow projections

4.1

(4.1)

Change in assumptions

10%

1%

(in millions €)

Change in fair value with decreasing input factor

(in millions €)

Discount rate (3.2) 3.6

The sensitivity of the fair values of contingent consideration to the significant, unobservable, variable input factors, with all other factors remaining constant, is shown in the following table:

Contingent consideration

Input factor

Change in fair value with increasing input factor

Cash flow projections

12.3

(12.3)

Change in assumptions

10%

1%

(in millions €)

Change in fair value with decreasing input factor

(in millions €)

Discount rate (3.6) 3.8

The estimated fair value of non-listed equity investments would, for example, increase (decrease) if the price of the latest financing round of the respective investment were to increase (decrease) and the overall company value were higher (lower).

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, 2024.

  1. ‌Issued Capital and Reserves

As of March 31, 2025, the number of shares outstanding was 240,392,622. This amount excludes 8,159,578 shares held in treasury. As of December 31, 2024, the number of shares outstanding was 239,970,804, excluding 8,581,396 shares held in treasury.

‌9. Provisions

(in millions €)

March 31, 2025

December 31, 2024

Contractual disputes / settlements

72.8

85.7

Obligations from onerous CMO contracts

50.7

50.7

Other

19.2

29.3

Total

142.7

165.7

Total current

121.9

144.8

Total non-current

20.8

20.9

As of March 31, 2025, our current provisions included €72.8 million in contractual disputes mainly related to collaborators regarding, among other things, the interpretation of each party's obligations or the amounts payable under the respective agreements. Acknowledging a decrease in obligations identified as contractual disputes, the change compared to the previous period related entirely to consumption.

As of March 31, 2025, our current provisions included €50.7 million (€50.7 million as of December 31, 2024) of obligations for production capacities derived from contracts with contract manufacturing organizations, or CMOs, that became redundant.

As of March 31, 2025, our current provisions included €19.2 million in other obligations mainly comprising cost share effects as well as inventor remunerations (€29.3 million as of December 31, 2024, mainly comprising employee related obligations). The change of €10.1 million compared to December 31, 2024, related mainly to consumption.

  1. ‌Contingent Liabilities

    Our contingent liabilities include, but are not limited to, intellectual property disputes and contractual disputes regarding, among other things, the interpretation of each party's obligations or the amounts payable under the respective agreements, product-related disputes and actions by or on behalf of our shareholders.

    From time to time, in the normal course and conduct of our business, we may be involved in proceedings with third parties about considering, for example, the use and/or remuneration for use of such third party's intellectual property. As of March 31, 2025, none of the intellectual property-related

    considerations outlined below, of which we have either been notified, or 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-related disputes. Our product liability 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 defectiveness and injury, and other matters. These complexities vary from matter to matter. As of March 31, 2025, none of these claims fulfill the criteria for recording a provision.

    We are currently subject to certain claims by or on behalf of our shareholders. As of March 31, 2025, these claims do not fulfill the criteria for recording a provision.

    Substantially all of our contingent liabilities 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, the amount of 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. 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. We filed a counterclaim to become party to the new proceeding, and in July 2023, Alnylam added to its claims allegations that we induced infringement of the four new patents. All of the lawsuits have been consolidated into a

    single proceeding. On February 24, 2025, Alnylam voluntarily dismissed U.S. Patent No. 11,633,480, with prejudice, from the lawsuit. A five-day trial is set to begin on July 7, 2025.

    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

    Infringement Proceedings - EP'122, DE'961, DE'974, DE'575, and EP'668

    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 EP'122, and three Utility Models DE202015009961U1, DE202015009974U1, and DE202021003575U1. In

    August 2022, CureVac added European Patent EP3708668B1, or EP'668, to its German lawsuit.

    On August 15, 2023, the Düsseldorf Regional Court held a hearing on infringement with respect to all five IP rights. At the hearing, the Court stated it would render its infringement ruling with respect to EP'122 on December 28, 2023. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the remaining four IP rights (DE'961, DE'974, DE'575, and EP'668) pending validity decisions in the DE'961, DE'974, and DE'575 cancellation proceedings before the German Patent and Trademark Office and in the EP'668 opposition proceedings before the Opposition Division of the European Patent Office, or the EPO. In the September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions are reached, while contemporaneously noting concerns regarding the validity of DE'961, DE'974, DE'575, and EP'668. After EP'122 was declared invalid in the first-instance nullity proceedings by the Federal Patent Court on December 19, 2023 (see below), on December 27, 2023, the Düsseldorf Regional Court canceled the December 28, 2023 decision date and stayed the infringement proceedings as to EP'122 until a final appellate decision is rendered as to the validity of EP'122 by the Federal Court of Justice. On June 7, 2024, CureVac waived DE'575 and withdrew this utility model from the infringement proceedings.

    On July 1, 2024, the EPO Opposition Division issued a preliminary opinion noting that it believes EP'668 is likely invalid. The EPO Opposition Division held an oral hearing regarding the validity of EP'668 between March 25-27, 2025. At the conclusion of this hearing, the Opposition Division upheld EP'668 in amended form, but only after finding that the alleged technical effect - increased protein expression - was not achieved across the broad scope of the amended claim. The written decision by the Opposition Division to uphold EP'668 in amended form is expected to issue within a few months, and BioNTech and Pfizer intend to appeal this written decision upon issuance. An oral hearing with respect to infringement of EP'668 has been scheduled by the Düsseldorf Regional Court for July 1, 2025.

    Infringement Proceedings - EP'755, DE'123, and DE'130

    In July 2023, CureVac SE filed a second 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, EP4023755B1, or EP'755, and two Utility Models DE202021004123U1, and DE202021004130U1. On June 7, 2024, CureVac waived DE'123 and withdrew this utility model from the infringement proceedings. A hearing on infringement with respect to EP'755 and DE'130 was to occur in the Düsseldorf Regional Court on September 10, 2024, but was rescheduled to occur on July 1, 2025 for EP'755 only, as the Court stayed the infringement proceedings with respect to DE'130 pending a validity decision in the co-pending cancellation proceeding before the German Patent and Trademark Office. On July 24, 2024, the EPO Opposition Division issued a preliminary opinion noting that it believes EP'755 is likely invalid, and set a three-day oral hearing beginning on May 13, 2025.

    Nullity Proceedings - EP'122

    In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that EP'122 is invalid. 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 EP'122. The preliminary opinion does not address any infringement of EP'122. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non-binding. On December 19, 2023, the Federal Patent Court held an oral hearing, after which it nullified EP'122. On April 25, 2024, the Federal Patent Court issued a judgment containing its written reasons for nullifying EP'122. On May 6, 2024, CureVac appealed the judgment, which is currently pending. An oral hearing on this appeal is scheduled for July 2026.

    Cancellation Proceedings - DE'961, DE'974, and DE'575

    In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in the German Patent and Trademark Office. On December 20, 2023, the German Patent and Trademark Office issued a preliminary opinion that DE'974 is likely to be cancelled. On January 23, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE'961 is likely to be cancelled. Both preliminary opinions are based on invalidity pursuant to para. 1 (2) no. 5 Utility Model Act. On March 7, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE'575 is likely to be cancelled. On June 6, 2024, CureVac submitted a written statement to the German Patent and Trademark Office waiving DE'575. On June 12, 2024, we withdrew our request for cancellation of DE'575. On June 25 and 26, 2024, the German Patent and Trademark Office heard oral arguments regarding DE'961 and DE'974, and at the conclusion of the hearing on June 26, 2024, confirmed that both DE'961 and DE'974 were cancelled. In November 2024, the German Patent and Trademark Office issued its written decisions cancelling DE'961 and DE'974. CureVac has filed an appeal in both cancellation proceedings, which are currently pending.

    Cancellation Proceedings- DE'123 and DE'130

    In November 2023, we filed cancellation actions seeking the cancellation of German Utility Models DE'123 and DE'130 in the German Patent and Trademark Office. On June 6, 2024, CureVac submitted a written statement to the German Patent and Trademark Office waiving DE'123. On June 12, 2024, we withdrew our request for cancellation of DE'123. On December 5, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE'130 is likely to be cancelled. An oral hearing

    regarding the validity of DE'130 before the German Patent and Trademark Office is scheduled for July 8, 2025.

    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. In July 2023, CureVac filed

    amended counterclaims to assert an additional U.S. patent, U.S. Patent No. 11,667,910. In June 2024, CureVac voluntarily dismissed with prejudice its claims of infringement with respect to the '493, '525, and '966 patents. A three-week trial was set to begin on March 3, 2025, but the Court has rescheduled it to begin on September 8, 2025.

    United Kingdom

    In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against EP'122 and EP'668 in the Business and Property Courts of England and Wales, in the UK High Court of Justice, or the UK High Court. 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, in the UK High Court of Justice. On December 18, 2023, we and Pfizer amended our pleadings to add a claim for revocation and declarations of invalidity and non-infringement with respect to EP'755. The UK High Court held a trial on EP'668 and EP'755 between July 10, 2024 and July 24, 2024. On October 8, 2024, the UK High Court released a judgment finding both EP'668 and EP'755 invalid. The UK High Court held a hearing on November 15, 2024, during which it denied CureVac permission to appeal the judgment. On December 5, 2024, CureVac sought permission from the UK Appeals Court to appeal the judgment. On January 27, 2025, the UK Appeals Court denied CureVac's application to appeal; accordingly, the UK designations of EP'668 and EP'755 are finally revoked with no further opportunity to appeal in UK. On October 25, 2024, CureVac agreed to a final and unappealable revocation of the UK designation of EP'122 and to discontinue its counterclaim for infringement.

    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

    Infringement Proceedings - EP'949 and EP'565

    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 EP'949, and 3718565B1, or EP'565. With respect to EP'565, on November 7, 2023, the Opposition Division of the EPO revoked EP'565 after a one-day oral hearing held in the co-pending opposition proceeding, and on December 7, 2023, it issued the written decision revoking EP'565. On February 7, 2024, Moderna appealed the Opposition Division's revocation decision on EP'565, and the appeal is currently pending, with an oral hearing scheduled for January 27, 2026. The EP'565 infringement proceedings are currently stayed pending an appellate decision in the opposition proceedings. With respect to EP'949, on December 8, 2023, the Opposition Division issued a preliminary opinion noting that it believes EP'949 is likely invalid. As a result of those developments in the EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringement with respect to EP'949, originally scheduled for December 12, 2023, to January 21, 2025. On May 16, 2024, the EPO Opposition Division decided that EP'949 is valid, in amended form, and issued its written decision regarding the same on July 8, 2024. We appealed this decision, and the appeal is currently pending. The Düsseldorf Regional Court held an infringement hearing on January 21, 2025, and on March 5, 2025, the Düsseldorf Regional Court issued a first-instance decision declining to stay the infringement proceedings and finding infringement of EP'949 by us and Pfizer. We and Pfizer have appealed the Düsseldorf Regional Court's infringement decision, and the appeal is currently pending. The court has not ruled on the invalidity of EP'949, which will be decided in a next step by the EPO in the opposition appeal proceedings. Moderna has not yet taken steps to enforce the Düsseldorf Regional Court's first-instance decision on infringement.

    United Kingdom

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

    The UK High Court held a trial between April 22, 2024, and May 21, 2024. On July 2, 2024, the UK High Court released two judgments. The first judgment concerns the validity of EP'949 and EP'565. In this first judgment, the UK High Court found that EP'565 is invalid and therefore not infringed, while EP'949 is valid and infringed. The second judgment concerns whether Moderna's October 2020 commitment not to "enforce [its] COVID-19 related patents against those making vaccines intended to combat the pandemic," or the Patent Pledge, amounted to a consent under UK law to carry out any acts that would otherwise amount to patent infringement. With respect to this judgment, the UK High Court found that Moderna's Patent Pledge amounted to consent to carry out activities that might otherwise infringe its patents prior to March 2022, but not after March 2022.

    The UK High Court held a hearing on September 25, 2024, during which the Court granted Pfizer and BioNTech permission to appeal its judgment regarding the validity of EP'949, and declined Moderna's permission to appeal its judgment regarding validity of EP'565. The UK Appeals Court has set an oral hearing on the appeal of EP'949 for July 10-11, 2025. On October 16, 2024, Moderna sought permission from the UK Appeals Court to appeal the EP'565 judgment. On November 11, 2024, the UK Appeals Court denied Moderna's application to appeal; accordingly, the UK designation of EP'565 is

    finally revoked with no further opportunity to appeal in UK. No party sought permission to appeal the UK High Court's judgment on the patent pledge.

    United States

    U.S. District Court Litigation

    In August 2022, Moderna filed a lawsuit in the U.S. 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. On April 12, 2024, the U.S. District Court for the District of Massachusetts stayed the litigation pending resolution of the inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127.

    Inter Partes Review

    In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127 before the United States Patent Trial and Appeal Board, or the PTAB. On March 6, 2024, the PTAB issued decisions instituting inter partes review proceedings on all challenged claims of U.S. Patent Nos. 10,702,600 and 10,933,127. An oral hearing on the merits occurred on December 10, 2024. On March 5, 2025, the PTAB found all challenged claims of Moderna's U.S. Patent Nos. 10,933,127 and 10,702,600 to be unpatentable and thus invalid. Moderna may appeal this decision.

    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 EP'949 and EP'565. The District Court of the Hague held a hearing on October 6, 2023, on infringement and validity with respect to EP'949. On December 6, 2023, the Court found EP'949 to be invalid. On March 5, 2024, Moderna appealed this decision, and the appeal is pending. A hearing on the EP'949 appeal has been set for September 22, 2025. The EP'565 case has been stayed pending the outcome of Moderna's appeal of the Opposition Division's revocation of EP'565.

    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 EP'949 and EP'565 in the High Court of Ireland. On February 26, 2024, the High Court of Ireland stayed the lawsuit pending the final determination of the EPO opposition proceedings for EP'949 and EP'565 (in each case including any appeals).

    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 EP'949 and EP'565 in the Brussels Dutch-speaking Enterprise Court. On May 29, 2024, the parties filed a joint request to stay the proceedings, which was entered by the 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. This proceeding is 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 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.

    GlaxoSmithKline Proceedings

    In April 2024, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC, or GSK, filed a lawsuit against Pfizer and us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. in the U.S. District Court for the District of Delaware alleging that the cationic lipid used in Comirnaty infringes U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467; and seeking monetary relief. On August 14, 2024, GSK filed an amended complaint to assert infringement of three additional patents, U.S. Patent Nos. 11,759,422; 11,655,475; and 11,851,660. This proceeding is 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 lawsuit mentioned above. However, our analysis of GlaxoSmithKline'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 January 2025, Promosome LLC, or Promosome, filed a lawsuit against us and Pfizer in the Unified Patent Court, or UPC, Munich Division, alleging that Comirnaty infringes EP 2 401 365 and seeking monetary relief. This proceeding is currently pending.

    We believe we have strong defenses against the allegations 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, this matter constitute a contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liability.

    Ladewig Proceedings

    In January 2024, we and certain of our officers and directors were named as defendants in a securities class action complaint captioned Ladewig v. BioNTech SE filed in the U.S. District Court for the Central District of California brought on behalf of a putative class of investors who purchased our securities from March 30, 2022 through October 13, 2023. Plaintiffs allege that we violated Sections 10(b) and 20(a) of the Exchange Act by stating that we were "well positioned" to remain a "market leader" in vaccines for the prevention of COVID-19 and by purportedly overstating demand for Comirnaty. Plaintiffs further allege that we failed to adapt our inventory to reflect the emergence of new COVID variants. On July 15, 2024, the case was transferred to the U.S. District Court for the Southern District of New York.

    We believe we have strong defenses against the allegations claimed and intend to vigorously defend ourselves in the lawsuit mentioned above. We cannot reasonably estimate the maximum potential exposure or the range of possible loss for this matter. 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.

  2. ‌Related Party Disclosures

ATHOS KG, Holzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and a 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 months ended March 31, 2025, compared to the details disclosed in Note 21 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2024.

Members of the Management Board and the Supervisory Board of BioNTech SE are related parties as key management personnel having authority and responsibility for planning, directing, and controlling the activities of BioNTech SE directly or indirectly.

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BioNTech SE published this content on May 05, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 05, 2025 at 18:54 UTC.