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 MAY 2024

COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F Form 40‑F
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7):




DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On May 6, 2024, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three months ended March 31, 2024. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company for the three months ended March 31, 2024 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: May 6, 2024




EXHIBIT INDEX
ExhibitDescription of Exhibit
99.1




Document
Exhibit 99.1


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BioNTech SE
Quarterly Report of BioNTech SE for the Three Months Ended March 31, 2024



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
11 Events after the Reporting Period
Operating and Financial Review and Prospects
Risk Factors


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Unaudited Interim Condensed Consolidated Financial Statements
Interim Condensed Consolidated Statements of Profit or Loss
Three months ended
March 31,
20242023
(in millions €, except per share data)Note(unaudited)(unaudited)
Revenues3187.61,277.0
Cost of sales4.1(59.1)(96.0)
Research and development expenses4.1(507.5)(334.0)
Sales and marketing expenses4.1(15.6)(12.2)
General and administrative expenses (1)
4.1(117.0)(111.8)
Other operating expenses (1)
4.2(23.9)(125.7)
Other operating income 4.328.357.1
Operating income / (loss)(507.2)654.4
Finance income4.4180.182.3
Finance expenses4.4(4.7)(29.0)
Profit / (Loss) before tax(331.8)707.7
Income taxes516.7(205.5)
Profit / (Loss) for the period(315.1)502.2
Earnings / (Loss) per share
Basic earnings / (loss) for the period per share(1.31)2.07
Diluted earnings / (loss) for the period per share(1.31)2.05
(1)    Adjustments to prior-year figures due to change in functional allocation of general and administrative expenses and other operating expenses (please see Note 4.2 for further details).
The accompanying notes form an integral part of these interim consolidated financial statements.
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Interim Condensed Consolidated Statements of Comprehensive Income
Three months ended
March 31,
20242023
(in millions €)Note(unaudited)(unaudited)
Profit / (Loss) for the period(315.1)502.2
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 operations15.4(2.1)
Net gain on cash flow hedges1.7
Net other comprehensive income / (loss) that may be reclassified to profit or loss in subsequent periods 15.4(0.4)
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 income6.9
Net other comprehensive income that will not be reclassified to profit or loss in subsequent periods6.9
Other comprehensive income / (loss) for the period, net of tax 22.3(0.4)
Comprehensive income / (loss) for the period, net of tax(292.8)501.8
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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Interim Condensed Consolidated Statements of Financial Position

March 31, December 31,
(in millions €)20242023
Assets Note(unaudited)
Non-current assets
Goodwill368.7362.5
Other intangible assets 821.7804.1
Property, plant and equipment 802.6757.2
Right-of-use assets228.3214.4
Other financial assets61,587.21,176.1
Other non-financial assets83.283.4
Deferred tax assets 91.081.3
Total non-current assets 3,982.73,479.0
Current assets
Inventories 345.4357.7
Trade and other receivables 61,639.82,155.7
Contract assets 12.14.9
Other financial assets 66,689.94,885.3
Other non-financial assets337.0280.9
Income tax assets 273.3179.1
Cash and cash equivalents8,976.611,663.7
Total current assets 18,274.119,527.3
Total assets22,256.823,006.3
Equity and liabilities
Equity
Share capital248.6248.6
Capital reserve1,228.91,229.4
Treasury shares(10.8)(10.8)
Retained earnings19,448.219,763.3
Other reserves (946.7)(984.6)
Total equity 19,968.220,245.9
Non-current liabilities
Lease liabilities, loans and borrowings6205.0191.0
Other financial liabilities 640.638.8
Provisions8.88.8
Contract liabilities379.2398.5
Other non-financial liabilities9.613.1
Deferred tax liabilities39.439.7
Total non-current liabilities 682.6689.9
Current liabilities
Lease liabilities, loans and borrowings631.328.1
Trade payables and other payables6298.8354.0
Other financial liabilities 6152.4415.2
Income tax liabilities353.2525.5
Provisions247.0269.3
Contract liabilities361.3353.3
Other non-financial liabilities162.0125.1
Total current liabilities1,606.02,070.5
Total liabilities 2,288.62,760.4
Total equity and liabilities 22,256.823,006.3
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in millions €, unaudited)NoteShare capitalCapital reserveTreasury sharesRetained earningsOther reserves Total equity
As of January 1, 2023248.61,828.2(5.3)18,833.0(848.9)20,055.6
Profit for the period502.2502.2
Other comprehensive loss(0.4)(0.4)
Total comprehensive profit / (loss)502.2(0.4)501.8
Share repurchase program(279.7)(2.3)(282.0)
Share-based payments8(0.6)11.510.9
Deferred taxes(21.0)(21.0)
As of March 31, 2023248.61,547.9(7.6)19,335.2(858.8)20,265.3
As of January 1, 2024248.61,229.4(10.8)19,763.3(984.6)20,245.9
Loss for the period(315.1)(315.1)
Other comprehensive income22.322.3
Total comprehensive profit / (loss)(315.1)22.3(292.8)
Share-based payments8(0.5)15.615.1
As of March 31, 2024248.61,228.9(10.8)19,448.2(946.7)19,968.2
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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Interim Condensed Consolidated Statements of Cash Flows

Three months ended
March 31,
20242023
(in millions €)(unaudited)(unaudited)
Operating activities
Profit / (Loss) for the period(315.1)502.2
Income taxes(16.7)205.5
Profit / (Loss) before tax(331.8)707.7
Adjustments to reconcile profit before tax to net cash flows:
Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets38.331.4
Share-based payment expenses16.38.6
Net foreign exchange differences(28.7)53.1
Loss on disposal of property, plant and equipment0.2
Finance income excluding foreign exchange differences(174.9)(82.3)
Finance expense excluding foreign exchange differences4.71.2
Government grants(9.1)(3.0)
Net gain on derivative instruments at fair value through profit or loss1.776.2
Working capital adjustments:
Decrease in trade and other receivables, contract assets and other assets498.2893.8
Decrease in inventories12.315.5
Decrease in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions(288.0)(861.6)
Interest received and realized gains from cash and cash equivalents199.453.6
Interest paid and realized losses from cash and cash equivalents(3.7)(1.2)
Income tax paid(258.8)(844.9)
Share-based payments(2.4)(725.7)
Government grants received9.2
Net cash flows used in operating activities(317.3)(677.4)
Investing activities
Purchase of property, plant and equipment(58.5)(45.2)
Purchase of intangible assets and right-of-use assets(78.4)(9.6)
Investment in other financial assets(4,895.1)(680.6)
Proceeds from maturity of other financial assets2,727.6
Net cash flows used in investing activities(2,304.4)(735.4)
Financing activities
Payments related to lease liabilities(7.8)(9.3)
Share repurchase program(282.0)
Net cash flows used in financing activities(7.8)(291.3)
Net decrease in cash and cash equivalents(2,629.5)(1,704.1)
Change in cash and cash equivalents resulting from exchange rate differences6.8(27.1)
Change in cash and cash equivalents resulting from other valuation effects(64.4)
Cash and cash equivalents at the beginning of the period11,663.713,875.1
Cash and cash equivalents as of March 318,976.612,143.9
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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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, 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 product 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 investigational 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 months ended March 31, 2024, were authorized for issuance in accordance with a resolution of the audit committee on May 3, 2024.
2.Basis of Preparation, Significant Accounting Policies and further Accounting Topics
Basis of Preparation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2024, 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 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, 2023.
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, 2024, 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 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, 2023. 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.
Our management continually evaluates judgments and estimates, including those related to contingencies, fair value measurement of derivatives, revenues and expenses. Management bases its judgments and estimates on parameters available at the time when the unaudited interim condensed consolidated financial statements were prepared. Existing
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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, 2023, 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).
Furthermore, we recognize acquired contractual rights to cash flows from the sale of patent-protected biopharmaceutical products by unrelated biopharmaceutical companies as royalty assets. Since we do not own the intellectual property or have the right to commercialize the underlying products, royalty assets are recognized as financial assets measured at fair value through profit and loss. We recognize day one gains and losses only when the fair value is evidenced by a quoted price in an active market for the same instrument or is based on a valuation technique that only uses data from observable markets. In all other cases, we defer the difference between the fair value at initial recognition and the transaction price. After initial recognition, we recognize that deferred difference as a gain or loss only to the extent that it arises from a change in a factor that market participants would take into account when pricing the asset or liability.
Standards Applied for the First Time
The IFRS standards applied for the first time as of January 1, 2024, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2023, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2024.
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 €)20242023
COVID-19 vaccine revenues124.21,263.5
Other revenues63.413.5
Total187.61,277.0
COVID-19 Vaccine Revenues
During the three months ended March 31, 2024 and 2023, commercial 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 commercial COVID-19 vaccine revenues amounted to €124.2 million during the three months ended March 31, 2024, compared to €1,263.5 million for the comparative prior year period. The year-over-year change was mainly due to lower revenues from the sales of our COVID-19 vaccines worldwide resulting from lower sales demand during the three months ended March 31, 2024.
During the three months ended March 31, 2024, our other revenues were mainly derived from a pandemic preparedness contract effectively supplemented in the first quarter of 2024 with the German government.
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Revenues from contracts with customers were recognized as follows:
Three months ended
March 31,
(in millions €)20242023
Timing of revenue recognition
Goods and services transferred at a point in time33.5143.0
Goods and services transferred over time57.37.1
Revenue recognition applying the sales-based or usage-based royalty recognition constraint model(1)
96.81,126.9
Total187.61,277.0
(1)    Represents sales based on the share of the collaboration partners' gross profit.
4.Income and Expenses
4.1General Expenses
Cost of Sales
From the three months ended March 31, 2023, to the three months ended March 31, 2024, cost of sales decreased by €36.9 million or 38% from €96.0 million to €59.1 million, mainly due to recognizing lower cost of sales from our decreased COVID-19 vaccine sales, which included the share of gross profit that we owe our collaboration partner, Pfizer, and royalty expenses based on our sales. In addition, 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 €36.0 million, compared to €73.7 million in the previous period. The inventories valued at net realizable value in our consolidated statement of financial position as of March 31, 2024, take contractual compensation payments into consideration.
Research and Development Expenses
From the three months ended March 31, 2023, to the three months ended March 31, 2024, our research and development expenses increased by €173.5 million or 52%, from €334.0 million to €507.5 million, mainly influenced by progressing clinical studies for pipeline candidates and our newly acquired clinical stage antibody drug conjugate (ADC) and antibody product candidates which further expand our oncology pipeline. Further contributions to the increase coming from wages, benefits and social security expenses resulting from a significant increase in headcount.
General and Administrative Expenses
From the three months ended March 31, 2023, to the three months ended March 31, 2024, our general and administrative expenses increased by €5.2 million or 5%, from €111.8 million to €117.0 million, primarily driven by increased expenses for IT environment and wages, benefits, and social security expenses resulting from a significant increase in headcount.
4.2Other Operating Expenses
Other operating expenses recognized during the three months ended March 31, 2024 and 2023 are shown in the following table:
Three months ended
March 31,
(in millions €)20242023
Litigation costs(1)
21.27.6
Loss on derivative instruments at fair value through profit or loss2.7
Foreign exchange differences, net116.5
Other1.6
Total23.9125.7
(1)    Adjustments to prior-year figures relate to reclassifying legal costs in connection with certain litigation as other operating expenses, rather than general and administrative expenses, to reflect changes in reporting.
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During the three months ended March 31, 2024, other operating expenses decreased compared to the three months ended March 31, 2023, primarily because the foreign exchange differences arising on operating items changed from a negative effect to a positive effect, which is recorded in other operating income during the three months ended March 31, 2024 (see Note 4.3).
4.3Other Operating Income
Other operating income recognized during the three months ended March 31, 2024 and 2023 is shown in the following table:
Three months ended
March 31,
(in millions €)20242023
Foreign exchange differences, net17.1
Government grants9.1
Gain on derivative instruments at fair value through profit or loss41.9
Other2.115.2
Total28.357.1
During the three months ended March 31, 2024, other income decreased compared to the three months ended March 31, 2023, as the result on derivative instruments at fair value through profit or loss arising on foreign exchange forward contracts that did not qualify for hedge accounting changed from a gain to a loss, which is recorded in other operating expenses (see Note 4.2).
4.4Finance Result
The finance result recognized during the three months ended March 31, 2024 and 2023 is shown in the following table:
Three months ended
March 31,
(in millions €)20242023
Finance result
Finance income180.182.3
Gains from financial instruments174.982.3
Foreign exchange differences, net5.2
Finance expenses(4.7)(29.0)
Foreign exchange differences, net(27.8)
Other(4.7)(1.2)
Total finance result175.453.3
During the three months ended March 31, 2024 and 2023, the finance result was mainly derived from interest income in relation to bank deposits and debt security investments as well as fair value adjustments of our money market funds.
5.Income Taxes
For the three months ended March 31, 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. The income tax asset represents the portion of prepayments for corporate income taxes and trade taxes in Germany that have been paid for the first quarter of 2024 but not yet offset by income tax expenses calculated for such quarter. For the three months ended March 31, 2024, our effective income tax rate was approximately 5.0% applicable on our negative income and for the three months ended March 31, 2023, our effective income tax rate was approximately 29.0%, on our positive income. The decrease in the effective income tax rate was mainly driven by the expected negative result for 2024 and management’s assessment of the requirements in 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
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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, 2024, 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 in light of the introduction of Pillar Two Model Rules in various jurisdictions. Since the Group’s relevant effective tax rate calculated for Pillar Two Purposes is 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, 2024, do not include information required by paragraphs 88A-88D of IAS 12.
Income taxes recognized during the three months ended March 31, 2024 and 2023 are shown in the following table:
Three months ended
March 31,
(in millions €)20242023
Current income taxes(7.8)243.2
Deferred taxes(8.9)(37.7)
Income taxes(16.7)205.5
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6.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:
March 31, 2024
(in millions €)
Category(1)
Carrying amountLevel 1 (Fair value)Level 2 (Fair value)Level 3 (Fair value)Total
Financial assets measured at fair value
Foreign exchange forward contractsFVTPL3.63.63.6
Money market fundsFVTPL4,059.34,059.34,059.3
Non-listed equity investmentsFVTOCI27.127.127.1
Listed equity investmentsFVTOCI221.3221.3221.3
Royalty assetsFVTPL43.343.343.3
Financial assets not measured at fair value
Trade and other receivables AC1,639.81,639.8
Security investmentsAC7,962.77,962.7
Other financial assetsAC19.119.1
Bank depositsAC3,865.03,865.0
Reverse RepoAC400.0400.0
Cash at banks and on handAC652.3652.3
Financial liabilities measured at fair value
Foreign exchange forward contractsFVTPL5.05.05.0
Contingent considerationFVTPL40.640.640.6
Financial liabilities not measured at fair value
Lease liabilitiesn/a234.0234.0
Loans and borrowingsAC2.32.3
Trade payables and other payablesAC298.8298.8
Other financial liabilitiesAC147.4147.4
(1)    Financial assets and liabilities categorized at amortized costs mainly correspond to fair value. Fair values are not disclosed because the book values represent a reasonable approximation of fair value.
The €195.3 million increase in listed equity investments compared to year-end 2023 mainly reflects our investment in Autolus Therapeutics plc (Autolus) in February 2024.
Under the terms of the license and option agreement with Autolus we acquired a royalty asset in connection with Autolus’ lead cell therapy candidate, obe-cel, and we are eligible to receive a royalty on obe-cel net sales. Autolus will retain full rights to and control of the development and commercialization of obe-cel. We deferred a day one gain amounting to €5.6 million based as the difference of the measured fair value of the instrument at initial recognition based on the present value of expected future cash flows and the transaction price.
Additional developments in our financial assets and liabilities mainly resulted from growth and reallocation of existing capital. This led to a decrease of €3,386.8 million in money market funds and increases of €1,973.0 million in security investments and €1,275.5 million in bank deposits compared to year-end 2023.
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December 31, 2023
(in millions €)
Category(1)
Carrying amountLevel 1 (Fair value)Level 2 (Fair value)Level 3 (Fair value)Total
Financial assets measured at fair value
Money market fundsFVTPL7,446.17,446.17,446.1
Non-listed equity investmentsFVTOCI27.127.127.1
Listed equity investmentsFVTOCI26.026.026.0
Financial assets not measured at fair value
Trade and other receivables AC2,155.72,155.7
Security investmentsAC5,989.75,989.7
Other financial assetsAC18.618.6
Bank depositsAC2,589.52,589.5
Reverse RepoAC1,175.01,175.0
Cash at banks and on handAC453.1453.1
Financial liabilities measured at fair value
Foreign exchange forward contractsFVTPL0.40.40.4
Contingent considerationFVTPL38.838.838.8
Financial liabilities not measured at fair value
Lease liabilitiesn/a216.7216.7
Loans and borrowingsAC2.32.3
Trade payables and other payablesAC354.0354.0
Other financial liabilitiesAC414.9414.9
(1)    Financial assets and liabilities categorized at amortized costs mainly correspond to fair value. We do not make a disclosure for cash and cash equivalents, trade receivables and trade payables. Fair values are not disclosed because the book values represent a reasonable approximation of fair value.
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,
(in millions €)20242023
Net gain on equity instruments designated at fair value through other comprehensive income6.9
Total6.9
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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.
TypeValuation techniqueSignificant unobservable inputs
Forward exchange contractsDiscounted 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.n/a
Non-listed equity investments
Quantitative and qualitative factors such as actual and forecasted results, cash position and financing round valuations.
Actual and forecasted results
Cash position
Nature and pricing indication of latest financing round

Listed equity investmentsStock prices of the listed companies and applicable exchange rates, if the listing is in a foreign currency.n/a
Money market fundsQuoted prices on an active marketn/a
Contingent considerationPresent value of expected future payments and reflecting changes in expected achievement of underlying performance parameters and compounding effects.
Expected future payments
Applied cost of capital
Royalty assets
Present value of expected future cash flows
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.
Financial assetsFinancial liabilities
(in millions €)Royalty assetsContingent consideration
As of January 1, 2023(6.1)
As of March 31, 2023(6.1)
As of January 1, 2024(38.8)
Purchases37.7
Net effect on profit or loss - Finance income / (expense)
Net change in fair value(1.8)
Net deferred effects on other non-financial liabilities
Net change in fair value5.6
As of March 31, 202443.3(40.6)
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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 factorChange in assumptionsChange in fair value with increasing input factor (in millions €)Change in fair value with decreasing input factor (in millions €)
Cash flow projections10 %3.8(3.8)
Discount rate%(0.9)0.9
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 factorChange in assumptionsChange in fair value with increasing input factor (in millions €)Change in fair value with decreasing input factor (in millions €)
Cash flow projections10 %5.2(5.2)
Discount rate%(3.7)4.2
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, 2023.
7.Issued Capital and Reserves
As of March 31, 2024 and December 31, 2023, the number of shares outstanding was 237,725,735. This amount excludes 10,826,465 shares held in treasury.
8.Share-Based Payments
Expenses Arising from Share-Based Payment Arrangements
During the three months ended March 31, 2024 and 2023, 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
March 31,
(in millions €)20242023
Expense arising from equity-settled share-based payment arrangements15.610.7
Expense / (Income) arising from cash-settled share-based payment arrangements0.7(2.5)
Total16.38.2
Recognized in:
Cost of sales1.91.5
Research and development expenses9.86.5
Sales and marketing expenses0.40.1
General and administrative expenses 4.20.1
Total16.38.2
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9.Contingencies
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 March 31, 2024, 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 March 31, 2024, 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. 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 proceedings have been consolidated and 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
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 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.
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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 suspended its infringement ruling with respect to EP’122 until 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. 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. On December 28, 2023, the Düsseldorf Regional Court 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.
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 the EP’755 Patent, and two Utility Models DE202021004123U1, and DE202021004130U1.
Nullity Proceedings – EP’122
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 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. 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.
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 27, 2023, the German Patent Office issued a preliminary opinion that DE’974 is likely to be cancelled. On January 23, 2024, the German Patent Office issued a preliminary opinion that DE’961 is likely to be cancelled. On March 7, 2024, the German Patent Office issued a preliminary opinion that DE’575 is likely to be cancelled.
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.
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. On December 18, 2023, we amended our pleadings to further allege non-infringement and invalidity against EP’755.
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.
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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 the EP’949 Patent, and 3718565B1, or the EP’565 Patent. On November 7, 2023, the European Patent Office, or the EPO, Opposition Division revoked EP’565 after a one-day oral hearing. The Opposition Division issued a preliminary opinion on December 8, 2023 noting that it believes EP’949 is likely invalid. As a result of these EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringement, originally scheduled for December 12, 2023, to January 21, 2025.
United Kingdom
In August 2022, Moderna filed a 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
U.S. District Court Litigation
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. On April 12, 2024, the United States 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.
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 the EP ’565 Patent. The District Court of the Hague held a hearing on October 6, 2023 on infringement and validity with respect to the EP ’949 Patent. On December 6, 2023, the Court found EP’949 to be invalid. On March 5, 2024, Moderna appealed this decision. 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 the EP’949 Patent and EP’565 Patent 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 the EP’949 Patent and the EP’565 Patent in the Brussels Dutch-speaking Enterprise Court.
All of the above proceedings are currently pending.
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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 filed a lawsuit against Pfizer and us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. in the United States 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.
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.
10.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, 2024, 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, 2023.
11.Events after the Reporting Period
As previously disclosed, we are in discussions with the National Institutes of Health (“NIH”) concerning royalties and other amounts allegedly owed under a license agreement on sales of our COVID-19 vaccine since commercialization. While we believe we have a strong legal position and disagree with the opinion being taken by the NIH, the ultimate outcome of the matter is uncertain, and we cannot guarantee that our interpretation of the license agreement will prevail.
On March 22, 2024, we received a notice of default from the NIH relating to alleged amounts owed and breaches under such license. In April 2024, we shared a non-binding proposal with the NIH to amend and restate our agreement, including a possible financial resolution of the applicable NIH claim and facilitating continued collaboration. Neither of the parties is bound by the proposal, and the ultimate outcome remains subject to significant uncertainties.
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We will continue to evaluate the discussion with the NIH. As of today, we are unable to estimate a potential financial effect. If we ultimately may pay some or all of the amounts in dispute, it could cause a material adverse effect on our results of operations and/or our cash flows.
Any such assessments require management to make significant judgments, as described in Note 3 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2023.
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Operating and Financial Review and Prospects
In this report, unless stated or the context otherwise requires, references to the “Company”, “BioNTech”, “Group”, “we”, “us” and “our” refer to BioNTech SE and its consolidated subsidiaries. The following “Operating and Financial Review and Prospects” should be read together with the unaudited interim condensed consolidated financial statements and related notes as presented above. The following discussion is based on our financial information prepared in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described in the “Risk Factors” section further below. Please also see “Forward-Looking Statements” included elsewhere in this quarterly report for the three months ended March 31, 2024.
Operating Results
Overview
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 and major global health burdens. Our fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science and artificial intelligence, or AI, and machine learning, or ML, capabilities to discover, develop and commercialize our marketed product and product candidates.
We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes investigational messenger ribonucleic acid, or mRNA vaccines, protein-based therapeutics (including targeted antibodies such as monoclonal, bispecific and antibody-drug conjugates, or ADCs), cell therapies and small molecules.
We expect each platform to yield a pipeline of product candidates for further development. Our multi-technology combination of platforms and product candidates positions us as pioneers in the field of individualized, patient-centric therapeutic approaches in oncology and infectious diseases. We aim to expand this status into other disease areas in the future.
In oncology, we endeavor to address the continuum of cancer patients. The root causes of cancer treatment failure are cancer heterogeneity and interindividual variability. Driven by random sequential mutations, every patient’s cancer is unique and within one patient’s tumor, every cell is different. Addressing these two challenges is the core of our strategy. To augment anti-tumor activity and to counteract resistance mechanisms we seek to combine compounds with non-overlapping, synergistic mechanisms of action.
In infectious diseases, our product strategy is rooted in global social responsibility and our goal of contributing to equitable access to medicine.
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.
Corporate Development
A key component of our corporate strategy is strengthening our clinical pipeline, technology platforms, digital capabilities and infrastructure through select strategic partnerships and acquisitions.
In February 2024, in line with our goal of scaling up innovation, we and Autolus Therapeutics plc, or Autolus, announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. As part of the strategic collaboration, we have the option to access Autolus’s commercial and clinical site network, manufacturing capacities in the United Kingdom, or UK, and commercial supply infrastructure in a cost-efficient set-up, allowing for the accelerated development of our product candidate BNT211.
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Environmental, Social, and Governance (ESG)
BioNTech was founded out of a responsibility to patients and to society and this is still the vision that drives the Company. It gives grounds for BioNTech’s enhanced responsibility: for translating the Company’s science into the health of people worldwide and democratizing access to innovative medicines, for environmental and climate protection, for respecting human rights and for fostering the full potential of all employees.
In February 2024, the Company’s near-term science-based emissions reduction targets were approved by the Science Based Targets initiative, or SBTi. This validation underscores the ambitious nature of BioNTech’s scope 1 and scope 2 climate targets and is intended to align with the United Nations’ Paris Climate Agreement to limit global warming to 1.5 degrees Celsius above pre-industrial levels.
BioNTech’s performance on environmental, social, and governance matters is regularly assessed by external rating agencies. The Institutional Shareholder Services Group, or ISS, currently assigns BioNTech a “Prime” ESG rating: the Company has received an overall corporate rating of B-, which is among the top 10% of all rated companies in the pharmaceutical and biotechnology sector. In the ISS Governance Quality Score, BioNTech stands at 5 on a risk scale of 1 (low risk) to 10 (high risk). S&P Global Ratings has rated BioNTech in the S&P Corporate Sustainability Assessment 2023, or CSA, with an S&P Global CSA score of 45 (2022: 32) out of 100. Morningstar Sustainalytics has given BioNTech a Sustainalytics ESG rating of 24.1 (2022: 22.3), which corresponds to a “medium risk”, the third of five risk levels (negligible, low, medium, high and severe).
In March 2024, we published our annual ESG report (Sustainability Report 2023). The report highlights the Company’s progress in developing novel medicines and introducing scalable technological innovations. It describes our science-based climate goals (under SBTi review), actions and climate risk management as well as the status of our human rights strategy and due diligence. The report addresses diversity, inclusion, equity and belonging, and highlights the importance of our values and culture.
BioNTech recognizes its responsibility as a corporate citizen and is committed to supporting its local communities and beyond through donations, sponsorships and volunteer activities.
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. Our commercial product, Comirnaty, was the first-ever approved mRNA-based product, and, to our knowledge, represents the fastest ever developed prophylactic vaccine from viral sampling to approval. As of December 2023, our COVID-19 vaccine products have been authorized or approved for emergency or temporary use or granted marketing authorization in more than 180 countries and regions worldwide. Our efforts have resulted in more than 4.8 billion doses shipped globally. We are now focused on preparing for vaccine adaptation to be ready to launch ahead of the upcoming 2024/2025 season, pending approvals.
Under our collaboration with Pfizer, we are the Marketing Authorization Holder in the United States, the European Union, or EU, the UK, Canada and other countries. Additionally, we are the holder of emergency use authorizations, or EUAs, or equivalents in the United States (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide apart from Greater China, Germany, and Türkiye. We have the marketing and distribution rights to Comirnaty in Germany and Türkiye.
Under our collaboration with Fosun Pharmaceutical Industrial Development, Co., Ltd, or Fosun Pharma, Fosun Pharma has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR and Taiwan.
A. Commercial Updates
Our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine is available in pharmacies, hospitals, and clinics across the U.S. following a recommendation by the Centers for Disease Control and Prevention, or the CDC, for the use of the vaccine for the 2023-2024 fall and winter season. The 2023-2024 formulation for individuals 12 years of age and older can be ordered as either a pre-filled syringe or a single-dose vial.
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 continue the transition from an advanced purchase agreement environment to commercial market ordering in additional geographies, driven by regulatory recommendations to adapt COVID-19 vaccines to newly circulating variants or sublineages of SARS-CoV-2.
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B. Clinical Development, Regulatory and Manufacturing Updates
A Phase 2/3 study (NCT05997290) is ongoing to investigate the safety, tolerability and immunogenicity of our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in healthy people 12 years and older. In January 2024, a manuscript was published reporting the safety and immunogenicity one month after vaccination with our monovalent Omicron XBB.1.5-adapted COVID-19 vaccine in COVID-19 experienced individuals 12 years of age and older (Gayed et al., 2024). These data support a favorable benefit-risk profile of our XBB.1.5-adapted COVID-19 vaccine. In this analysis, the XBB.1.5-adapted vaccine demonstrated a safety and tolerability profile similar to that seen with original and the BA.4/5-adapted and BA.1-adapted COVID-19 vaccines and induced substantial increases in neutralizing antibody responses against Omicron XBB.1.5 (overall geometric mean fold rises, or GMFR: 7.0), EG.5.1 (GMFR: 8.7), and BA.2.86 (GMFR: 4.5). We believe the safety and immunogenicity data support administration of the XBB.1.5-adapted BNT162b2 in vaccine-experienced individuals 12 years of age and older.
Real world data showed high vaccine effectiveness of the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine against current variants of concern, with 63% (95%CI: 33-80%) vaccine effectiveness against hospitalization observed in adults aged 18 years and older approximately 30 days post vaccination in the United States against XBB.1.5, XBB.1.16, EG.5.1, and BA.2.86. Similar real world evidence trends have been reported in EU countries. In Denmark, vaccination was associated with a 75.3% reduced risk of COVID-19 hospitalization nine days post-immunization with a monovalent XBB.1.5 in people over 65 years of age. In the Netherlands, early estimates demonstrated a high vaccine effectiveness against hospitalization (70.7%) and ICU admission (73.3%) in people over 60 years of age in the two months post vaccination with XBB.1.5 vaccine.
Our and Pfizer’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine received multiple regulatory approvals, including approvals, authorizations for emergency or temporary use or marketing authorizations in more than 40 countries and regions.
In 2024, BioNTech has been, and expects to continue, preparing for COVID-19 vaccine adaptation and, pending regulatory approval, commercial launch ahead of the upcoming 2024/2025 fall and winter season.
Pipeline of Product Candidates: First Quarter 2024 and Post Period-End Updates
Below is a summary of our authorized product and clinical product candidates, organized by platform and indication.
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Oncology
Drug class PlatformProduct candidateIndication (target)Phase 1Phase 1/2Phase 2Phase 3
BioNTech rights(1)
Collaborator/Partner
mRNAFixVacBNT111 
Advanced, R/R melanoma
Fully owned(2)
BNT113 
Metastatic/ R/R HPV16+ head and neck cancer
BNT116 1L metastatic NSCLC
Advanced/metastatic NSCLC
iNeSTBNT122
(autogene cevumeran)
1L advanced melanoma
Collaboration
Genentech(3)
Adjuvant colorectal cancer
Adjuvant pancreatic ductal adenocarcinoma
Multiple solid tumors
RiboMabsBNT142 Multiple solid tumors (CD3×CLDN6)Fully owned
RiboCytokinesBNT151 Multiple solid tumors (IL-2 variant)Fully owned
BNT152 + BNT153Multiple solid tumors (IL-7, IL-2)
Cell
therapies
CAR T cells + CARVacBNT211Multiple solid tumors (CLDN6)Fully owned
Neoantigen-based T cellsBNT221Refractory metastatic melanomaFully owned
Protein-based therapeuticsNext-generation
immune checkpoint modulators 
BNT311 / GEN1046
(acasunlimab)
aPD(L)1-R/R metastatic NSCLC
(PD-L1×4-1BB)
Collaboration
Genmab
Multiple solid tumors (PD-L1×4-1BB)
 
BNT312 / GEN1042
Multiple solid tumors (CD40×4-1BB)(4)
BNT313 / GEN1053Multiple solid tumors (CD27)
BNT314 / GEN1059
Multiple solid tumors (EpCAM×4-1BB)
BNT322 / GEN1056Multiple solid tumors
BNT316 / ONC-392 (gotistobart)
aPD(L)1-R/R metastatic NSCLC (CTLA-4)
Collaboration
OncoC4
Platinum-resistant ovarian cancer (CTLA-4)
Metastatic castration-resistant prostate cancer (CTLA-4)
Multiple solid tumors (CTLA-4)
Targeted cancer antibodiesBNT321
Adjuvant pancreatic ductal adenocarcinoma (sLea)
Fully owned
Metastatic pancreatic cancer (sLea)
Antibody-drug conjugatesBNT323 / DB-1303
2L+, HR+/HER2-low metastatic breast cancer (HER2)
Collaboration
Duality Biologics
Multiple solid tumors (HER2)
BNT324 / DB-1311Multiple solid tumors (B7H3)
BNT325 / DB-1305Multiple solid tumors (TROP2)
BNT326 / YL202Multiple solid tumors (HER3)
Collaboration
MediLink Therapeutics
 SMI(5)
Toll-like receptor bindingBNT411Multiple solid tumors (TLR7)Fully owned
Infectious Diseases
Drug class Product candidateIndication (target)Phase 1Phase 1/2Phase 2Phase 3Commercial
BioNTech rights
Collaborator/Partner
mRNA
BNT162b2
COVID-19
Collaboration
Pfizer
Fosun Pharma
BNT162b2+BNT162b4
(T-cell enhancing)
BNT162b5/6/7
(Stabilized spike antigen)
BNT162b2+BNT161(6)
COVID-19 – Influenza combination
Collaboration
Pfizer
BNT161Influenza
Collaboration(7)
Pfizer
BNT163HSVCollaboration
University of Pennsylvania
BNT164
Tuberculosis(8)
Fully owned
Funded by Bill & Melinda Gates Foundation
BNT165
Malaria(9)
Fully owned
BNT166
Mpox
Fully owned
Funded by CEPI(10)
BNT167ShinglesCollaboration
Pfizer
(1)    For further details about BioNTech’s rights see quarterly reports under https://investors.biontech.de/financials-filings/quarterly-reports.
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(2)    FixVac platform is fully owned by BioNTech. The BNT111 and BNT116 Phase 2 trials are jointly conducted with Regeneron as part of a cost-sharing strategic collaboration.
(3)    A member of the Roche group.
(4)    Two Phase 1/2 clinical trials in patients with solid tumors are ongoing in combination with ICI+/- chemotherapy.
(5)    Small Molecule Immunomodulators.
(6)    The COVID-19-Influenza combination is a Phase 3 trial in partnership with Pfizer. Further development is subject to entering into a definitive agreement.
(7)    Out-licensed to Pfizer.
(8)    Two Phase 1 clinical trials are ongoing (NCT05537038, Germany and NCT05547464, Republic of South Africa).
(9)    A Phase 1 clinical trial (NCT05581641) and a Phase 1/2 clinical trial (NCT06069544) are ongoing.
(10)    Coalition for Epidemic Preparedness Innovations (“CEPI”).
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 non-nucleoside optimized uridine-RNA delivered in our proprietary RNA-LPX formulation for intravenous administration. Proprietary RNA-LPX is designed to deliver RNA to dendritic cells, or DCs, and protects RNA from degradation by RNAse and is designed for RNA delivery into antigen-presenting cells in lymphoid organs. FixVac candidates are designed to target shared antigens that have been identified to be frequently expressed across patients with a specific cancer type. These product candidates are designed to trigger both innate and adaptive immune responses.
BNT111 in advanced melanoma.
A global, randomized three-arm Phase 2 clinical trial (NCT04526899) is being conducted in collaboration with Regeneron Pharmaceuticals Inc., or Regeneron, and is evaluating BNT111 in combination with cemiplimab (Regeneron’s Libtayo) versus both agents as monotherapy in 184 enrolled patients with anti-PD-1-/anti-PD-L1 refractory/relapsed, unresectable Stage III or IV melanoma. The primary endpoint is objective response rate, or ORR. Secondary endpoints include duration of response, or DOR, disease control rate, or DCR, time to response, or TTR, progression-free survival, or PFS, overall survival, or OS, and safety.
BNT112 in prostate cancer.
A first-in-human Phase 1/2a, open-label dose titration and expansion clinical trial (NCT04382898) to evaluate the safety, immunogenicity and preliminary efficacy of BNT112 monotherapy and in combination with cemiplimab in patients with metastatic castration resistant prostate cancer, or mCRPC, and high-risk localized prostate cancer, or LPC, who are eligible for treatment with androgen deprivation therapy, or ADT, followed by radical prostatectomy has been discontinued and the follow-up period ended in January 2024. Final data of the trial are being gathered and evaluated and are expected to be compiled into a clinical study report.
BNT113 in Human Papilloma Virus, or HPV16+ head and neck cancer.
A global, randomized Phase 2 clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab (Merck & Co., Inc.’s Keytruda) versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma expressing PD-L1 is ongoing. Part A comprises the completed non-randomized run-in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. Part B is the randomized portion of the trial designed to generate efficacy and safety data and which is recruiting patients. The trial plans to enroll a total of 285 participants.
BNT116 in advanced non-small-cell lung cancer, or NSCLC.
A randomized, controlled Phase 2 clinical trial (NCT05557591) is ongoing to evaluate BNT116 in combination with cemiplimab (Regeneron’s Libtayo) versus cemiplimab alone as first-line treatment of
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patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of their tumor cells. The primary objective of the Phase 2 trial is to assess the ORR per blinded-independent review committee. Secondary endpoints include other measures of clinical activity per investigator assessment, overall survival, or OS, and safety.
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, in combination with docetaxel in patients who have received prior PD-1 inhibitor therapy and platinum-based chemotherapy, in patients with unresectable Stage III NSCLC who have undergone chemoradiotherapy and also in the neoadjuvant and adjuvant settings in patients with resectable Stage II and III NSCLC.
In April 2024, data from cohort 3 of the Phase 1 trial described above were presented at the Annual Meeting of the American Association for Cancer Research, or AACR. Patients were treated with BNT116 in combination with docetaxel after progression on a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy. Preliminary data of BNT116 in combination with docetaxel show encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Combination therapy with BNT116 and docetaxel was observed to have an ORR of 30% and a DCR of 85%.
b) Autogene Cevumeran (BNT122), an Individualized Neoantigen Specific Immunotherapy, or iNeST
Autogene cevumeran (BNT122) 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-backbone equipped uridine mRNA, or uRNA, delivered in our proprietary RNA-LPX formulation. Proprietary RNA-LPX is designed to deliver RNA to DCs and protects RNA from degradation by RNAse and is designed for RNA delivery into antigen-presenting cells in lymphoid organs. Each patient is treated with a vaccine informed by the mutation profile of their unique 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. Each autogene cevumeran dose includes up to 20 different neoantigens selected on a patient-by-patient basis (up to 10 neoantigens on 1 RNA). We believe this modality may be well-suited for use in the adjuvant setting. iNeST is partnered with Genentech as part of a 50:50 collaboration in which development costs and future profits are shared.
Autogene Cevumeran (BNT122) in adjuvant colorectal cancer.
A randomized, multi-site, open-label Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III colorectal cancer, or CRC, is ongoing. The trial is expected to enroll about 200 patients to evaluate the efficacy of autogene cevumeran 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 OS and safety. The trial is currently enrolling in the United States, Germany, Spain, Belgium, Sweden and the UK. Epidemiologic data, including post-operative ctDNA prevalence and prognostic value, from an observational study (NCT04813627) in patients with resected high-risk Stage II/III CRC is expected to be presented at the 2024 Annual Meeting of the American Society of Clinical Oncology, or ASCO.
Autogene Cevumeran (BNT122) in pancreatic ductal adenocarcinoma, or PDAC.
A randomized Phase 2 clinical trial (NCT05968326) evaluating the safety and efficacy of autogene cevumeran in combination with atezolizumab (Genentech’s Tecentriq) followed by standard-of-care chemotherapy (mFOLFIRINOX) in patients with resected PDAC compared to chemotherapy alone is recruiting. The Phase 2 study is expected to enroll 260 patients with resected PDAC who have not received prior systemic anti-cancer treatment and showed no evidence of disease after surgery. The primary endpoint is DFS. Secondary endpoints include OS and safety. The trial has been initiated in the United States and enrollment is planned in approximately 10 countries in total.
In April 2024, at the AACR Annual Meeting, long-term follow-up data were presented from an investigator-initiated Phase 1 trial (NCT04161755) in patients with resected PDAC indicating that the individualized mRNA cancer vaccine candidate autogene cevumeran continues to show polyspecific T cell responses up to three years after vaccination and that vaccine response correlates with delayed tumor
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recurrence. At three years, autogene cevumeran was observed to induce de novo neoantigen-specific, functional and durable CD8 T cells at substantial magnitudes for multiple neoantigens. After a median follow-up of three years, eight patients with vaccine-induced T-cell responses continued to have longer median recurrence-free survival (not reached) compared with those who did not experience an immune response (13.4 months). The investigator-initiated, single center Phase 1 trial evaluated the safety of autogene cevumeran in sequential combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard-of-care chemotherapy in 16 patients with resected PDAC. Data from the 1.5-year median follow-up had been previously published in Nature (Rojas, L.A et al. 2023).
Autogene Cevumeran (BNT122) in first-line melanoma.
A randomized Phase 2 clinical trial (NCT03815058) evaluating the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone as first-line in patients with previously untreated advanced melanoma is fully enrolled and follow-up is ongoing. The primary endpoint is PFS and is events-based. Secondary endpoints include ORR, OS, DOR and safety.
Autogene Cevumeran (BNT122) in multiple solid tumors.
An open-label Phase 1a monotherapy/1b in combination with atezolizumab clinical trial (NCT03289962) of autogene cevumeran in patients with locally advanced or metastatic solid tumors, including patients with melanoma, NSCLC, bladder cancer, colorectal cancer, triple negative breast cancer, or TNBC, renal cancer, head and neck cancer and sarcomas as well as other solid tumors is fully enrolled and follow-up is ongoing.
c) RiboMab
Our RiboMab product candidate is an mRNA that encodes cancer cell targeting antibodies. This fully-owned product candidate leverages our proprietary optimized mRNA technology combining nucleoside modifications to minimize immunogenicity with our improved mRNA backbone designs with the aim of maximizing protein expression. Our RiboMab product candidate is formulated using liver-targeting lipid nanoparticles, or LNPs, for intravenous delivery.
BNT142 encodes a T cell engaging bispecific antibody targeting Claudin 6, or CLDN6.
BNT142 in multiple solid tumors.
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 is ongoing. The study is actively recruiting patients in the EU, the UK, the United States and Singapore.
d) 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.
BNT151 in multiple solid tumors.
A first-in-human, open-label, multi-center Phase 1/2 clinical trial (NCT04455620) in multiple solid tumor indications has been discontinued after the completion of enrollment for the Part 1 monotherapy dose escalation. The follow-up phase for enrolled patients is expected to be completed this year, after which the clinical data of the trial are expected to be evaluated and reported accordingly.
BNT152+BNT153 in multiple solid tumors.
An open-label, multi-site, first-in-human Phase 1 clinical trial (NCT04710043) in multiple solid tumor indications is ongoing to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of a combination of BNT152 and BNT153. The clinical trial consists of two parts: Part 1, the separate mono dose escalation of BNT152 and BNT153, was completed in May 2023, in which a maximum tolerated dose, or MTD, was defined for each product. Part 2 is currently investigating the
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combination treatment of BNT152 and BNT153. Since September 2023, clinical sites in the United States and Czechia have been enrolling patients to evaluate the combination of BNT152 and BNT153.
2. Oncology Cell Therapy Product Candidates
a) Chimeric antigen receptor, or CAR, T-cell therapy – CAR-T
BNT211 consists of two investigational medicinal products: our first CAR-T-cell product candidate, which targets CLDN6-positive solid tumors, in combination with an mRNA named CARVac encoding CLDN6. 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. As with FixVac and iNeST, CARVac is also based on a pharmacologically optimized-backbone equipped uRNA delivered in our proprietary RNA-LPX formulation. BNT211 has been granted Priority Medicines, or PRIME, designation by the European Medicines Agency, or EMA 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, including ovarian and testicular cancers, is ongoing. The primary outcome measure of the trial is safety, with secondary efficacy outcome measures to include ORR, DCR and DOR. After determination of the recommended Phase 2 dose, we plan to initiate a pivotal trial in patients with germ cell tumors. We plan to present real world evidence of overall survival and treatment patterns of this patient population in the U.S. at the 2024 ASCO Annual Meeting.
b) Neoantigen-Targeting T-Cell therapy
BNT221 is our autologous, fully individualized, polyspecific T-cell therapy directed against selected sets of individual neoantigens. BNT221 is based on expanded neoantigen-specific memory T cells and induced naive T cells.
A first-in-human Phase 1 dose escalation clinical trial (NCT04625205) in patients with checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. The first portion of the trial consists of a monotherapy dose escalation of BNT221, for which recruitment and treatment of patients is complete. Currently, BNT221 is being dosed in combination with anti-PD-1 therapy after first-line treatment. Major objectives of this study include evaluation of the safety and feasibility of administering BNT221, as well as evaluations of immunogenicity and preliminary efficacy.
3. Antibody Product Candidates in Oncology
a) Next-Generation Immune Checkpoint Modulators
We are developing, in collaboration with Genmab A/S, or Genmab, antibodies that are designed to function as tumor-targeted and dual immunomodulators, applying Genmab’s proprietary technologies in combination with our joint target identification and product concept expertise.
BNT311/GEN1046 (acasunlimab) is our jointly owned PD-L1x4-1BB product candidate, a potential first-in-class bispecific antibody combining PD-L1 checkpoint inhibition with 4-1BB stimulation. BNT311/GEN1046 (acasunlimab) is being developed for the treatment of solid tumors using Genmab’s proprietary DuoBody technology platform. We and Genmab are currently evaluating BNT311/GEN1046 (acasunlimab) in multiple clinical trials.
A Phase 2, multi-center, randomized, open-label clinical trial (NCT05117242) of BNT311/GEN1046 (acasunlimab) as monotherapy and in combination with pembrolizumab in patients with relapsed/refractory metastatic NSCLC and a tumor PD-L1 expression of tumor proportion score, or TPS, of ≥1% after treatment with standard of care therapy with an immune checkpoint inhibitor is ongoing. The primary endpoint is ORR according to Response Evaluation Criteria in Solid Tumors, or RECIST v1.1. Secondary endpoints include DOR, TTR, PFS, OS and safety. Data from this trial are expected to be presented at the 2024 ASCO Annual Meeting.
An open-label, single-arm Phase 1/2 clinical trial (NCT03917381) with multiple expansion cohorts evaluating BNT311/GEN1046 (acasunlimab) as monotherapy and in combination therapies in patients with solid tumors is ongoing.
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A Phase 1 open-label, dose escalation clinical trial (NCT04937153) in Japan evaluating the safety and pharmacokinetics of BNT311/GEN1046 (acasunlimab) as monotherapy and in combination with pembrolizumab in patients with multiple solid tumors is ongoing.
BNT312/GEN1042 is a jointly owned, novel, agonistic, bispecific antibody that combines targeting and conditional activation of the costimulatory molecules CD40 and 4-1BB on immune cells. BNT312/GEN1042 is being developed for the treatment of solid cancers using Genmab’s proprietary DuoBody technology platform and our CD40 and 4-1BB antibodies. We and Genmab are currently evaluating BNT312/GEN1042 in multiple clinical trials. We and Genmab anticipate having the data needed to determine next steps for this program this year.
Two Phase 1/2 clinical trials (NCT05491317; NCT04083599) in patients with solid tumors are ongoing evaluating BNT312/GEN1042 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.
A Phase 1 clinical trial (NCT06057038) is ongoing in Japan to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of BNT312/GEN1042 monotherapy and in combination with pembrolizumab with or without chemotherapy in patients with multiple solid tumors
BNT313/GEN1053 is a novel CD27 antibody with an IgG Fc domain engineered to induce clustering of CD27 on the plasma membrane of T cells with the aim of enhancing T-cell activation, proliferation and differentiation without depleting T cells. In preclinical studies, BNT313/GEN1053 was observed to increase T-cell activation, proliferation, cytokine secretion and cytotoxic activity.
A Phase 1/2 clinical trial (NCT05435339) evaluating the safety, tolerability, and preliminary efficacy of CD27-targeting antibody BNT313/GEN1053 on solid tumors as monotherapy is ongoing.
BNT314/GEN1059 is a potential first-in-class bispecific antibody product candidate designed to boost antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity.
In January 2024, the first patient was dosed in a first-in-human Phase 1/2 clinical trial (NCT06150183), which we are sponsoring, to investigate the safety and preliminary antitumor activity of BNT314/GEN1059 in patients with advanced or metastatic solid tumors.
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 (NCT05586321) in patients with advanced solid tumors is ongoing.
BNT311/GEN1046, BNT312/GEN1042, BNT313/GEN1053, BNT314/GEN1059 and BNT322/GEN1056 are partnered with Genmab as part of a 50:50 collaboration in which development costs and future profits are shared.
BNT327/PM8002 is an anti-vascular endothelial growth factor A, or VEGF-A, antibody candidate fused to a humanized anti-PD-L1 VHH being developed in collaboration with Biotheus Inc, or Biotheus. BNT327/PM8002 is currently being evaluated in Phase 1 and Phase 2/3 clinical trials in China to assess the efficacy and safety of the candidate as monotherapy or in combination with chemotherapy in various indications. An Investigational New Drug application has been accepted by the U.S. Food and Drug Administration, or FDA, for further studies in the United States and global trials are planned to start this year. Monotherapy data from Phase 1/2 trials are planned to be presented at the 2024 ASCO Annual Meeting. More data readouts, both in monotherapy and combination, are expected across a range of solid tumors in 2024.
BNT316/ONC-392 (gotistobart) is an anti-cytotoxic T-lymphocyte associated protein 4, or CTLA-4, monoclonal antibody candidate being developed in collaboration with OncoC4, Inc., or OncoC4. BNT316/ONC-392 (gotistobart) is designed to offer a 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 U.S. FDA in 2022.
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
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chemotherapy (docetaxel) is ongoing. The trial initiation followed the U.S. FDA Fast Track Designation granted in 2022 and is based on Phase 1/2 safety and efficacy data for the monotherapy in metastatic, immunotherapy-resistant NSCLC. The two-stage Phase 3 clinical trial will assess the efficacy and safety of BNT316/ONC-392 (gotistobart) as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. The primary endpoint is OS. Secondary endpoints include ORR, PFS and safety. Approximately 600 patients are planned to be enrolled at clinical sites in the United States, China, Australia, South Korea, Türkiye, Canada, the UK and the EU countries Germany, Spain, Italy, Belgium and the Netherlands.
A Phase 2 clinical trial (NCT05446298) evaluating BNT316/ONC-392 (gotistobart) therapy in combination with pembrolizumab in platinum-resistant ovarian cancer is ongoing. The clinical trial is evaluating two doses of BNT316/ONC-392 (gotistobart) in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy and have disease progression after one line of therapy containing bevacizumab. The primary endpoints are ORR and safety. Secondary endpoints include DOR, DCR, PFS and OS.
A Phase 2 clinical trial (NCT05682443) to evaluate the safety and efficacy of BNT316/ONC-392 (gotistobart) in combination with lutetium Lu-177 vipivotide tetraxetan (Novartis’s Pluvicto) in metastatic castration resistant prostate cancer patients who have disease progressed on androgen receptor pathway inhibition is recruiting. The trial is expected to enroll approximately 144 patients at clinical trial sites in the United States. The primary endpoint is PFS.
A first-in-human Phase 1/2 open-label dose escalation clinical trial (NCT04140526) evaluating BNT316/ONC-392 (gotistobart) as a single agent and in combination with pembrolizumab in patients with advanced or metastatic solid tumors is ongoing.
b) Targeted Cancer Antibodies & Antibody-Drug Conjugates
BNT321 is a fully human immunoglobulin G1, or IgG1, monoclonal antibody product candidate targeting sialyl Lewis A, or 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 (NCT02672917) of BNT321 monotherapy and in combination with modified FOLFIRINOX in pancreatic cancer and other CA19-9 expressing solid tumors is ongoing. Data from the trial were presented at the ASCO Gastrointestinal Cancer Symposium 2024. Preclinically, BNT321 binding was observed to be highly specific and restricted to cancer tissues with sLea expression. The most frequent dose-limiting toxicities, or DLTs, for both monotherapy and for mFOLFIRINOX combination therapy were hepatic transaminase elevations. DLTs generally occurred in cycle 1 and did not preclude subsequent BNT321 administration at reduced doses. BNT321 in combination with mFOLFIRINOX was tolerable for multiple cycles. Clinical activity (27% PR, RECIST) was observed in patients receiving the combination as first or subsequent line therapy for advanced disease.
In April 2024, the first patient was dosed in a Phase 1/2 trial (NCT06069778) evaluating the safety, tolerability, and efficacy of BNT321 in combination with mFOLFIRINOX as an adjuvant therapy following curative resection in patients with PDAC.
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. The program has been granted Breakthrough Therapy Designation by the U.S. FDA or the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.
An ongoing randomized, multi-center, open-label Phase 3 clinical trial (NCT06018337) is recruiting to evaluate BNT323/DB1303 versus the investigator’s choice of chemotherapy in advanced or metastatic HR+, HER2-low breast cancer subjects whose disease has progressed on at least two lines of prior endocrine therapy or within six months of first-line endocrine therapy + cyclin-dependent 4/6 (CDK4/6) inhibitor and no prior chemotherapy. The first patient was dosed in January 2024. The trial aims to enroll
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approximately 532 patients. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DCR, DOR and safety, as well as patient-reported outcomes.
BNT323/DB-1303 is being evaluated in an ongoing multicenter, non-randomized, open-label, multiple dose, first-in-human Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. A potential registrational cohort is enrolling HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with advanced/recurrent endometrial carcinoma and aims to recruit 140 patients. A confirmatory Phase 3 trial (NCT06340568) in this patient population is planned to start this year.
BNT324/DB-1311 is a topoisomerase-1 inhibitor-based B7H3-directed ADC candidate being developed in collaboration with DualityBio.
A first-in-human, open-label Phase 1/2a clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors is ongoing.
BNT325/DB-1305 is a topoisomerase-1 inhibitor-based TROP2-targeted ADC candidate being developed in collaboration with DualityBio.
A Phase 1/2a clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing.
In January 2024, we and DualityBio received Fast Track designation for BNT325/DB-1305 from the U.S. FDA for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
BNT326/YL202 is a topoisomerase-1 inhibitor-based HER3-targeted ADC candidate being developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. HER3 is a target that is overexpressed in various cancer types, such as NSCLC and breast cancer and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment resistance.
A multicenter, open-label, first-in-human Phase 1 clinical trial (NCT05653752) evaluating BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic epidermal growth factor receptor, or EGFR, -mutated NSCLC or hormone receptor, or HR, -positive and HER2-negative breast cancer is ongoing in the United States and China. Preliminary data from this study are expected to be presented at the 2024 ASCO Annual Meeting.
4. Small Molecule Immunomodulator Candidates in Oncology
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 Phase 1/2, first-in-human, open-label, dose escalation trial (NCT04101357) with expansion cohorts evaluating safety, pharmacokinetics, progression of disease and preliminary efficacy of BNT411 as monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve ES-SCLC is ongoing.
B. Infectious Disease Programs
1. Next-generation COVID-19 Vaccine
BNT162b5/6/7 – 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 (NCT04368728) to evaluate the safety, tolerability and immunogenicity of a stabilized spike antigen vaccine candidate has been completed and data are being gathered.
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 candidate component designed to
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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, or HLA, alleles.
A Phase 1 clinical trial (NCT05541861) 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 respiratory combination vaccine approaches that aim to simplify immunization practices for health care providers and recipients, 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.
COVID-19 – Influenza Combination mRNA Vaccine Program – BNT162b2 + BNT161
In October 2022, we and Pfizer initiated a Phase 1/2 open-label, dose-finding trial (NCT05596734) to evaluate the safety, tolerability and immunogenicity of a combination of the COVID-19 and influenza mRNA vaccines in 180 healthy adults 18 to 64 years of age. The combination vaccine consists of our Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine and Pfizer’s quadrivalent modified RNA (modRNA) influenza vaccine.
In December 2022, we and Pfizer announced that the companies received Fast Track Designation from the U.S. FDA for the mRNA-based combination vaccine candidate for influenza and COVID-19.
In October 2023, we and Pfizer announced top-line results from a Phase 1/2 clinical trial (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to licensed influenza vaccines and the Pfizer-BioNTech COVID-19 Omicron BA.4-5 adapted bivalent vaccine given separately at the same visit. The data from the trial demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains, as well as a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine.
A pivotal Phase 3 clinical trial (NCT06178991) was initiated in December 2023 and aims to enroll 9,000 healthy subjects 18 to 64 years old of age. Further development of this product candidate is subject to our entering into a definitive agreement with Pfizer.
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 (NCT05540522) to evaluate the efficacy, safety, tolerability and immunogenicity of a quadrivalent modRNA influenza vaccine candidate has been completed.
4. Herpes Simplex Virus, or 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 an HSV vaccine candidate.
A first-in-human, controlled, dose-escalation Phase 1 clinical trial (NCT05432583) 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. Dose escalation Part A has been completed and Part B (safety and dose evaluation) is enrolling across sites in the United States.
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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.
Two randomized, controlled, dose-finding Phase 1 clinical trials (NCT05537038, Germany and NCT05547464, Republic of South Africa) evaluating BNT164 are ongoing. Both clinical trials are designed to assess the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against tuberculosis. This program is run in partnership with the Bill & Melinda Gates Foundation.
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. We plan to assess several vaccine candidates, featuring known targets such as circumsporozoite protein, or CSP, conserved, immunogenic segments of liver stage-expressed proteins as well as other antigens.
A first-in-human Phase 1 clinical trial (NCT05581641) to evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1, the first candidate from our BNT165 program, is fully enrolled and follow-up is ongoing.
A randomized, dose escalation Phase 1/2 trial (NCT06069544) to evaluate the safety, tolerability, immunogenicity and efficacy of a second investigational RNA-based vaccine candidate in a controlled human malaria infection model is recruiting.
7. Mpox Vaccine Program – BNT166
Our fully-owned BNT166 program aims to deliver an effective, well-tolerated and accessible vaccine for the prevention of mpox. The multivalent BNT166 mRNA vaccine candidates encode surface antigens that are expressed in the two infectious forms of the monkeypox virus to efficiently fight virus replication and infectivity. The program is supported through a partnership with the Coalition for Epidemic Preparedness Innovations, or CEPI, to provide equitable access to the vaccine, if successfully developed and approved, in low- and middle-income countries.
A Phase 1/2 trial clinical trial (NCT05988203) evaluating the safety, tolerability, reactogenicity and immunogenicity of two mRNA-based multivalent vaccine candidates is ongoing. The trial aims to enroll 64 healthy participants with and without prior history of known or suspected smallpox vaccination.
8. 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.
A randomized, controlled, dose-selection Phase 1/2 clinical trial (NCT05703607) to evaluate the safety, tolerability, and immunogenicity of BNT167 in up to 900 healthy volunteers 50 through 69 years of age is ongoing.
9. Anti-bacterial Programs
BioNTech R&D (Austria) GmbH, a wholly owned subsidiary of BioNTech SE, is focused on developing novel anti-bacterial drugs to treat persistent bacterial infections. Its development programs are based on our proprietary LysinBuilder platform, which allows for 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.


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Financial Operations Overview
The following table shows our unaudited interim condensed consolidated statements of profit or loss for each period presented:
Three months ended
March 31,
20242023
(in millions €, except per share data)(unaudited)(unaudited)
Revenues187.61,277.0
Cost of sales(59.1)(96.0)
Research and development expenses(507.5)(334.0)
Sales and marketing expenses(15.6)(12.2)
General and administrative expenses (1)
(117.0)(111.8)
Other operating expenses (1)
(23.9)(125.7)
Other operating income 28.357.1
Operating income / (loss)(507.2)654.4
Finance income180.182.3
Finance expenses(4.7)(29.0)
Profit / (Loss) before tax(331.8)707.7
Income taxes16.7(205.5)
Profit / (Loss) for the period(315.1)502.2
Earnings / (Loss) per share
Basic earnings / (loss) for the period per share(1.31)2.07
Diluted earnings / (loss) for the period per share(1.31)2.05
(1)    Adjustments to prior-year figures due to change in functional allocation of general and administrative expenses and other operating expenses (please see Note 4.2 for further details).
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, 2023.
Comparison of the three months ended March 31, 2024 and 2023
Revenues
Three months ended
March 31,
Change
(in millions €)20242023%
COVID-19 vaccine revenues124.21,263.5(1,139.3)(90)
Other revenues63.413.549.9370
Total revenues187.61,277.0(1,089.4)(85)
COVID-19 Vaccine Revenues
From the three months ended March 31, 2023, compared to the three months ended March 31, 2024, COVID-19 vaccine revenues decreased by €1,139.3 million, or 90%, from €1,263.5 million to €124.2 million, in line with lower sales demand during the three months ended March 31, 2024. three months ended March 31, 2023 were favorably impacted by contractual purchasing obligations (e.g., of the European Commission) and approvals of BA4/5 variant-adapted vaccines in upper middle income countries later than anticipated, which led to an increase in sales in the prior year period.
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Other Revenues
During the three months ended March 31, 2024, our other revenues were mainly derived from a pandemic preparedness contract effectively supplemented in the first quarter of 2024 with the German government.
Cost of Sales
From the three months ended March 31, 2023, to the three months ended March 31, 2024, cost of sales decreased by €36.9 million or 38% from €96.0 million to €59.1 million, mainly due to recognizing lower cost of sales from our decreased COVID-19 vaccine sales, which included the share of gross profit that we owe our collaboration partner, Pfizer, and royalty expenses based on our sales. In addition, 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 €36.0 million, compared to €73.7 million in the previous period. The inventories valued at net realizable value in our consolidated statement of financial position as of March 31, 2024, take contractual compensation payments into consideration.
Research and Development Expenses
Three months ended
March 31,
Change
(in millions €)20242023%
Research and development expenses
COVID-19 vaccine56.687.6(31.0)(35)
Non-COVID-19 vaccine450.9246.4204.583 
Total research and development expenses507.5334.0173.552 
From the three months ended March 31, 2023, compared to the three months ended March 31, 2024, research and development expenses increased by €173.5 million, or 52%, from €334.0 million to €507.5 million, mainly influenced by progressing clinical studies for pipeline candidates and our newly acquired clinical stage antibody drug conjugate (ADC) and antibody product candidates which further expand our oncology pipeline. Further contributions to the increase coming from wages, benefits and social security expenses resulting from a significant increase in headcount.
General and Administrative Expenses
From the three months ended March 31, 2023, compared to the three months ended March 31, 2024, our general and administrative expenses increased by €5.2 million, or 5%, from €111.8 million to €117.0 million, primarily driven by increased expenses for IT environment and wages, benefits, and social security expenses resulting from a significant increase in headcount.
Other Operating Income / Expenses
From the three months ended March 31, 2023, compared to the three months ended March 31, 2024, our total other operating result increased by €73.0 million from a negative operating result of €68.6 million to a positive operating result of €4.4 million. This is mainly due to the previous year including net negative foreign exchange differences 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
From the three months ended March 31, 2023, compared to the three months ended March 31, 2024, our total finance result increased by €122.1 million from €53.3 million to €175.4 million. During the three months ended March 31, 2024, our finance result mainly derived from interest income in relation to bank deposits and debt security investments as well as fair value adjustments of our money market funds. During the three months ended March 31, 2023, our finance result was driven by interest income mainly derived from our bank deposits and the fair value adjustments which were derived from remeasuring our money market funds as well as offsetting foreign exchange differences arising on financing items (i.e. U.S. dollar denominated cash and cash equivalents).
Income Taxes
For the three months ended March 31, 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. The income tax asset represents the portion of prepayments for corporate income taxes and trade taxes in Germany that have been paid for the first quarter of 2024
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but not yet offset by income tax expenses calculated for such quarter. For the three months ended March 31, 2024, our effective income tax rate was approximately 5.0% applicable on our negative income and for the three months ended March 31, 2023, our effective income tax rate was approximately 29.0%, on our positive income. The decrease in the effective income tax rate was mainly driven by the expected negative result for 2024 and management’s assessment of the requirements in 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, 2024, 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 in light of the introduction of Pillar Two Model Rules in various jurisdictions. Since the Group’s relevant effective tax rate calculated for Pillar Two Purposes is 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 three months ended March 31, 2024, do not include information required by paragraphs 88A-88D of IAS 12.
Related Party Transactions
Related party transactions that occurred during the three months ended March 31, 2024 and 2023 are explained in Note 10 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 months ended March 31, 2024, 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, 2023.
Legal Proceedings
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 March 31, 2024, 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 March 31, 2024, 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.
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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. 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 proceedings have been consolidated and 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
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 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.
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 suspended its infringement ruling with respect to EP’122 until 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. 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. On December 28, 2023, the Düsseldorf Regional Court 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.
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 the EP’755 Patent, and two Utility Models DE202021004123U1, and DE202021004130U1.
Nullity Proceedings – EP’122
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 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. The preliminary opinion is a preliminary assessment by the court of the merits of a
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claim, and is non-binding. On December 19, 2023, the Federal Patent Court held an oral hearing, after which it nullified EP’122.
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 27, 2023, the German Patent Office issued a preliminary opinion that DE’974 is likely to be cancelled. On January 23, 2024, the German Patent Office issued a preliminary opinion that DE’961 is likely to be cancelled. On March 7, 2024, the German Patent Office issued a preliminary opinion that DE’575 is likely to be cancelled.
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.
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. On December 18, 2023, we amended our pleadings to further allege non-infringement and invalidity against EP’755.
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
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 the EP’949 Patent, and 3718565B1, or the EP’565 Patent. On November 7, 2023, the European Patent Office, or the EPO, Opposition Division revoked EP’565 after a one-day oral hearing. The Opposition Division issued a preliminary opinion on December 8, 2023 noting that it believes EP’949 is likely invalid. As a result of these EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringement, originally scheduled for December 12, 2023, to January 21, 2025.
United Kingdom
In August 2022, Moderna filed a 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
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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
U.S. District Court Litigation
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. On April 12, 2024, the United States 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.
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 the EP ’565 Patent. The District Court of the Hague held a hearing on October 6, 2023 on infringement and validity with respect to the EP ’949 Patent. On December 6, 2023, the Court found EP’949 to be invalid. On March 5, 2024, Moderna appealed this decision. 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 the EP’949 Patent and EP’565 Patent 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 the EP’949 Patent and the 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. 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
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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 filed a lawsuit against Pfizer and us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. in the United States 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.
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.
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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 and deliver a fully integrated global biotechnology company. We focus our research and development, or R&D, on rapidly advancing our diversified clinical oncology pipeline with synergistic potential, developing next generation COVID-19 vaccines to maintain leadership and pandemic preparedness, as well as broadening the label of and access to the existing vaccine. We also plan to invest heavily to build out our global development organization, bringing in talent with clinical and regulatory expertise needed to accelerate our pipeline development. 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 a science and innovation driven company, we will continue to focus investments on R&D and scaling the business for commercial readiness in oncology in multiple countries by the end of 2025.
As of March 31, 2024, we had cash and cash equivalents of €8,976.6 million and security investments of €7,962.7 million, accumulating to €16,939.3 million in cash, cash equivalents and security investments.
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.
Cash Flow
The following table summarizes the primary sources and uses of cash for each period presented:
Three months ended
March 31,
(in millions €)20242023
Net cash flows used in:
Operating activities(317.3)(677.4)
Investing activities(2,304.4)(735.4)
Financing activities(7.8)(291.3)
Total cash outflow(2,629.5)(1,704.1)
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 cash we generated as settlement payments of our gross profit as well as our use of cash for operating expenses and working capital to support the business.
Net cash used in operating activities for the three months ended March 31, 2024, was €317.3 million, comprising a loss before tax of €331.8 million, negative non-cash adjustments of €151.7 million, and a net positive change in assets and liabilities of €222.5 million. Non-cash items primarily included finance income as well as depreciation of property, plant and equipment and other intangible assets without cash-effect. The net positive change in assets and liabilities was primarily due to a decrease in trade receivables related to our COVID-19 vaccine collaboration with Pfizer which developed in line with our revenues, as described in Note 3 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report.
Net cash used from operating activities for the three months ended March 31, 2023, was €677.4 million, comprising a profit before tax of €707.7 million, positive non-cash adjustments of €85.4 million, a net positive change in assets and liabilities of €47.7 million and income taxes paid of €844.9 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 other financial liabilities and other liabilities mainly including wage tax and social security payments from our share-based payment settlement and royalty payments.
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Investing Activities
Net cash used in investing activities for the three months ended March 31, 2024 was €2,304.4 million. The amount includes €2,167.5 million mainly spent on security investments. The capital expenditures supporting our operating activities amounted to €62.5 million, whereof the majority was related to investments in building our laboratory and office facilities in Mainz, Germany.
Net cash used in investing activities for the three months ended March 31, 2023 was €735.4 million, mainly attributable to financial security investments in accordance with our asset management and investment policy.
Financing Activities
Net cash used in financing activities for the three months ended March 31, 2024 was €7.8 million, mainly related to our lease payments.
During the three months ended March 31, 2023, net cash used in financing activities was €291.3 million, primarily in connection with to our share repurchase program.
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 new and expanded sites 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 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 enter into contracts in the normal course of business with contract research organizations, or CROs, for clinical trials
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and clinical and commercial supply manufacturing, and with vendors for preclinical research studies and for other services and products for operating purposes. We work together with contract manufacturing organizations, or 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 cancellable, have been considered when defining our guidance for future cash commitments. Most of the committed cash outflow within the remaining months in 2024 is related to lease payments amounting to €38.6 million and commitments under purchase agreements and contractual obligations amounting to €356.5 million. Further, we have lease payment obligation with an amount of €226.3 million and commitments under purchase agreements and contractual obligations of €1,472.7 million for the years 2025 and beyond.
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.
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.
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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 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.
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.
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,
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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 reimbursement 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-downs and cancellations of contract manufacturing orders. Our business and financial condition could be materially affected by
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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 financial 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.
We depend on Pfizer to determine and provide estimates of the costs and profits to be shared with us in the countries where it is commercializing our COVID-19 vaccine under our collaboration agreement with Pfizer for our COVID-19 vaccine, which we refer to as the Pfizer Agreement. Because the information supplied by Pfizer is preliminary and subject to change, the commercial revenue we report based on such information is also subject to finalization. This is particularly true for vaccine sales outside of the United States, where Pfizer has a different reporting cycle than ours. As a result, we may not have the complete sales and costs results outside of the United States for months not covered by the reporting period, but we are nonetheless required to report estimated figures.
Pfizer has historically provided us with profit figures for our COVID-19 vaccine sales in the United States using standard U.S. transfer prices and manufacturing and shipping cost variances (as far as those have been identified) that could be subject to adjustment (e.g., due to changes in manufacturing costs or the price of our COVID-19 vaccine). Pfizer has also provided estimated profits for COVID-19 vaccine sales outside of the United States that were preliminary in nature for the last month of a quarter, as Pfizer’s subsidiaries outside of the United States have a different reporting cycle than ours. These estimated figures have changed, and in the future such estimated figures are likely to change, as we receive final data from Pfizer for the applicable period in accordance with the reporting cycle of Pfizer’s ex-U.S. subsidiaries and as actual costs become known. Further, to the extent that Pfizer does not provide such preliminary information in the future, our provisional sales figures for territories outside of the United States will be subject to an even greater level of estimate and judgment. Any changes to the preliminary data we report herein may have an impact on our reported revenues and expenses, profitability or financial position.
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 and our ability to continue to generate income from sales of our COVID-19 vaccine is uncertain.
The COVID-19 disease itself is unpredictable and each variant comes with varying levels of transmissibility and severity. Consequently, the burden of the disease may wane or dissipate such that our and other COVID-19 vaccines may be less essential from individual and public health perspectives.
Our COVID-19 vaccine was initially developed based upon the genetic sequence of the original SARS-CoV-2 virus that was first detected. The SARS-CoV-2 virus continues to evolve, and new strains of the virus or those that are already in circulation may prove more transmissible or cause more severe forms of COVID-19 disease than the predominant strains observed to date. Our vaccine may not be as effective in protecting against existing and future variant strains of the SARS-CoV-2 virus as it is against the original virus. While we continue to monitor emerging SARS-CoV-2 strains, undertake investigations into the immunogenicity of our COVID-19 vaccine against new variants as they emerge and develop modified versions of our COVID-19 vaccine against new variants, these efforts may be unsuccessful, and failure to timely and successfully adapt our vaccine to variants of the SARS-CoV-2 virus could lead to significant reputational harm and adversely affect our financial results. It is also possible that we may expend significant resources adapting our COVID-19 vaccine to protect against certain variants of the SARS-CoV-2 virus, but that a market for adapted vaccines does not develop for one or more variants or that demand does not align with our projections or cost expenditures. Moreover, even if we are successful in developing an adapted vaccine and there is a market for the new vaccine, new variants continue to emerge and any adapted vaccine may not be as effective in protecting against such future variant strains.
If we discover safety issues with our products, including our COVID-19 vaccine, that were not known at the time of approval, commercialization efforts for our products could be negatively affected, approved products could
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lose their approval or sales could be suspended, we could be subject to product liability claims and our business and reputation could be materially harmed.
Our COVID-19 vaccine and any other product candidates for which we receive approval or emergency use authorization are subject to continuing regulatory oversight, including the review of additional safety information. Billions of doses of our COVID-19 vaccination have now been delivered worldwide, and our COVID-19 vaccine is being more widely used by patients as an authorized product than it was used in clinical trials. As a result, undesirable effects and other problems may be observed that were not seen or anticipated, or were not as prevalent or severe, during clinical trials. We cannot provide assurance that newly discovered or developed safety issues will not arise, and we have received, and expect to continue to receive, product liability claims relating to our COVID-19 vaccine. With the use of any vaccine by a wide patient population, serious adverse events may occur from time to time that did not arise in clinical trials or that initially appeared to be unrelated to the vaccine itself and only with the collection of subsequent information were found to be causally related to the product. Safety events that arise outside of a clinical trial setting are difficult to monitor, and given the widespread use of our COVID-19 vaccine, we have experienced difficulty tracking potential treatment-related adverse events on a global basis. Any safety issues could cause us to suspend or cease marketing of our approved products, possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial condition. The subsequent discovery of previously unknown problems with a product could negatively affect commercial sales of the product, result in restrictions on the product or lead to the withdrawal of the product from the market. The reporting of adverse safety events involving our products or public speculation about such events could cause the price of the ADSs representing our ordinary shares to decline or experience periods of volatility.
Unexpected safety issues, including any that we have not yet observed in our clinical trials for our COVID-19 vaccine or in real world data, could lead to significant reputational damage for us and our product development platforms going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.
Failure to comply with continuing regulatory requirements by us or our collaboration partners could adversely impact regulatory approvals for our products, result in product recalls or suspensions, subject us to fines and/or other types of liabilities.
If we or our collaborators fail to comply with applicable continuing regulatory requirements, including good industry practices, such as good manufacturing practices, or GMP, we or our collaborators may be subject to fines, suspension or withdrawal of regulatory approvals for specific drugs, product recalls and seizures, operating restrictions and/or criminal prosecutions. We and the manufacturers we engage to make our products and the manufacturing facilities in which our products are made are subject to periodic review and inspection by the U.S. FDA and other regulatory authorities. If problems are identified during a review or inspection, we or our collaborators may be the subject of adverse regulatory action, including the issuance of untitled or warning letters, which could result in our inability to use the facility to make our product or a determination that inventories are not safe for commercial sale. Any of these factors could adversely affect our business prospects and our financial position could be materially harmed.
The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage and adequate reimbursement levels and implement pricing policies favorable to our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, and/or delayed payments from government authorities could limit our ability to market those products and decrease our ability to generate revenue.
The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford certain treatments, including our COVID-19 vaccine and other product candidates we may develop and sell. In addition, because our mRNA product candidates represent an entirely new therapeutic modality, we cannot accurately estimate how future products we may develop and sell would be priced, whether reimbursement could be obtained, or any potential revenue. Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit, and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment in any of our products. Additionally, even if pricing terms with governmental authorities are agreed upon, there may be delayed or denied payments.
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There is significant uncertainty related to the insurance coverage and reimbursement for newly approved products in particular in the United States, including genetic medicines. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors tend to follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel products such as ours. Reimbursement agencies in Europe may be more conservative than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States but have not been approved for reimbursement in certain European countries.
Outside the United States, certain countries, including a number of member states of the European Union, set prices and reimbursement for pharmaceutical products, with limited participation from the marketing authorization holders. We cannot be sure that such prices and reimbursement will be acceptable to us or our collaborators. If the regulatory authorities in these jurisdictions set prices or reimbursement levels that are not commercially attractive for us or our collaborators, our revenues from sales by us or our collaborators, and the potential profitability of our drug products, in those countries would be negatively affected. An increasing number of countries are taking initiatives to attempt to reduce large budget deficits by focusing cost-cutting efforts on pharmaceuticals for their state-run health care systems. These international price control efforts have impacted all regions of the world but have been most drastic in the European Union. Additionally, some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then may experience delays in the reimbursement approval of our product or be subject to price regulations that would delay our commercial launch of the product, possibly for lengthy time periods, which could negatively impact the revenues we are able to generate from the sale of the product in that particular country.
Moreover, increasing efforts by governmental and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our product candidates. The Inflation Reduction Act, or IRA, enacted in August 2022 allows the U.S. Department of Health and Human Services, or HHS, to negotiate the price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D. The IRA’s negotiation program will apply to high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics), among other negotiation selection criteria. The negotiated prices, which will become effective in 2026 for the first round of selected drugs, will be capped at a statutorily-determined ceiling price. The IRA also penalizes drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, once the out-of-pocket maximum has been reached. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. These IRA provisions will take effect progressively starting in 2023, although the drug negotiation provisions of the IRA are currently the subject of legal challenges. The effects of the IRA on our business and the healthcare industry in general are not yet known. These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importing from other countries and bulk purchasing.
We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs, surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products in the marketplace.
Government policies, including relating to manufacturing or export controls, and negative public perception regarding vaccines and mRNA-based therapeutics could severely and adversely impact the manufacturing and sales of our COVID-19 vaccine and other product candidates we may develop, if approved.
There is a heightened risk that vaccines could be subject to export controls, adverse emergency actions or supply requirements by governmental and other authorities. In the past, the European Union and other regions have imposed, or
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threatened to impose, export controls that would limit or block the delivery of COVID-19 vaccines manufactured in or outside their territories in instances where manufacturers have been delayed or have not fully satisfied their delivery obligations to such governments, which could have prohibited us from delivering our COVID-19 vaccine to other jurisdictions. Vaccines are also at risk of being subject to adverse emergency actions taken by governmental entities in certain countries, including intellectual property expropriation, compulsory licenses, strict price controls or other actions, such as the requirement that specific quantities of vaccine doses be set aside for designated purposes or geographic areas.
Furthermore, public sentiment regarding commercialization of vaccines, the safety and efficacy of our COVID-19 vaccine, other COVID-19 vaccines and treatments, and other public perceptions and misinformation relating to COVID-19, mRNA technology, and our and other COVID-19 vaccines may limit our ability to generate income from sales of our COVID-19 vaccine and other product candidates we may develop and sell, and cause reputational damage.
We face significant competition with other makers of COVID-19 vaccines and may be unable to maintain a competitive market share for our COVID-19 vaccine.
A large number of vaccine manufacturers, academic institutions and other organizations currently have programs to develop COVID-19 vaccine candidates and more than thirty other vaccines have been authorized for emergency use or approved in various countries, including vaccines developed by Moderna, Inc., Johnson & Johnson and University of Oxford/AstraZeneca plc. Our competitors pursuing vaccine candidates may have greater financial, product candidate development, manufacturing and marketing resources than we do. Larger pharmaceutical and biotechnology companies have extensive experience in clinical testing and obtaining regulatory approval for their products, and may have the resources to invest heavily to accelerate discovery and development of their vaccine candidates.
Our efforts to continue successful commercialization of our COVID-19 vaccine may fail if competitors develop and commercialize COVID-19 vaccines that are safer, more effective, produce longer immunity against COVID-19, require fewer administrations, have fewer or less severe undesirable effects, have broader market acceptance, are more convenient to administer or distribute or are less expensive than any vaccine candidate that we have developed or we may develop.
We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine to obtain permanent regulatory approval in jurisdictions where it has been authorized for emergency use or granted conditional marketing approval.
Our COVID-19 vaccine has been granted full U.S. FDA approval for individuals 12 years and older, emergency or limited use authorization in a number of countries and in the United States for individuals 6 months to 12 years of age and approval for use in certain other countries. Our COVID-19 vaccine has not yet received full approval by regulatory authorities in certain countries where it has been authorized for emergency or temporary use. We and Pfizer intend to continue to observe our COVID-19 vaccine, including vaccine candidates that we may develop for other variants of COVID-19, in global clinical trials. It is possible that subsequent data from these clinical trials may not be as favorable as data we submitted to regulatory authorities to support our applications for emergency use authorization or marketing or conditional marketing approval or that concerns about the safety of our COVID-19 vaccine will arise from the widespread use of our COVID-19 vaccine outside of clinical trials. Our COVID-19 vaccine may not receive approval outside of the emergency use setting in the countries where it is not currently approved, which could adversely affect our business prospects.
Our COVID-19 vaccine is sensitive to temperature, shipping and storage conditions and could be subject to risk of loss or damage.
Our COVID-19 vaccine is, and other product candidates we develop could be, sensitive to temperature, storage and handling conditions. In particular, while we have improved the required shipping and storage conditions of our COVID-19 vaccine, it must be shipped and stored at cold temperatures. Loss in supply of our COVID-19 vaccine and our product candidates could occur if the product or product intermediates are not stored or handled properly. Shelf life for our product candidates may vary by product, and it is possible that supply of our COVID-19 vaccine or our product candidates could be lost due to expiration prior to use. This has in the past led, and could in the future lead, to additional manufacturing costs and delays in our ability to supply required quantities for clinical trials or for commercial purposes. Such distribution challenges may make our COVID-19 vaccine a less attractive product than other COVID-19 vaccines that do not require as cold storage, and our COVID-19 vaccine may become increasingly less competitive as additional other vaccines become authorized for emergency use. If we, our partners and customers are unable to adequately manage these issues, we may be exposed to product liability claims and the market opportunity for our COVID-19 vaccine may be reduced, each of which could adversely affect our business prospects and materially harm our financial condition.
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We are developing other product candidates and services in an environment of rapid technological and scientific change, and our failure to effectively compete would prevent us from achieving significant market penetration. Most of our competitors have significantly greater resources than we do and we may not be able to compete successfully.
The pharmaceutical market is intensely competitive and rapidly changing. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and other public and private research organizations are pursuing the development of novel drugs for the same diseases that we are targeting or expect to target. Many of our competitors have:
greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization of products;
more extensive experience in preclinical testing, conducting clinical trials, obtaining regulatory approvals and manufacturing, marketing and selling drug products;
product candidates that are based on previously tested or accepted technologies;
products that have been approved or are in late stages of development; and
collaborative arrangements in our target markets with leading companies and research institutions.
We will continue to face intense competition from products that have already been approved and accepted by the medical community for the treatment of the conditions for which we may develop products in the future. We also expect to face competition from new products that enter the market. There are a number of products currently under development, which may become commercially available in the future, for the treatment of conditions for which we are trying, or may in the future try, to develop drugs. These drugs may be more effective, safer, less expensive, or marketed and sold more effectively than any products we develop.
We anticipate competing with the largest pharmaceutical companies in the world, many of which are currently conducting research in the fields of infectious diseases, immuno-oncology, rare genetic diseases and cancer immunotherapies. Some of these companies have greater financial and human resources than we currently have. In addition to these large pharmaceutical companies, we may directly compete with fully-integrated biopharmaceutical companies and other immunotherapy-focused oncology companies, as well as a number of companies focused on immunotherapies or shared tumor antigen and neoantigen therapeutics, some of which have entered into collaboration and funding agreements with larger pharmaceutical or biotechnology companies.
If we successfully develop other product candidates, and obtain approval for them, we will face competition based on many different factors, including:
the safety and effectiveness of our products relative to alternative therapies, if any;
the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration;
the timing and scope of regulatory approvals for these products;
the availability and cost of manufacturing, marketing and sales capabilities;
the price of any approved immunotherapy;
reimbursement coverage; and
intellectual property position.
Following our acquisition of InstaDeep Ltd., we also face competition in the rapidly growing and developing artificial intelligence industry. Our competitors may develop or commercialize products and services with significant advantages over any products we develop based on any of the factors listed above or on other factors. In addition, our competitors may develop collaborations with or receive funding from larger pharmaceutical, biotechnology or technology companies, providing them with an advantage over us. Our competitors therefore may be more successful in commercializing their products and services than we are, which could adversely affect our competitive position and
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business. Competitive products and services may make any products and services we develop obsolete or non-competitive before we can recover the expenses of developing and commercializing such products, if approved, and services.
The market opportunities for some of our product candidates may be small due to the rarity of the disease, or limited to those patients who are ineligible for or have failed prior treatments. As the target patient populations for some of our programs are small, we may be unable to achieve or maintain profitability in future periods without obtaining regulatory approval for additional indications.
The FDA often approves new cancer therapies initially only for use by patients with relapsed or refractory advanced cancer. We expect to seek approval initially for some of our product candidates in this context. Subsequently, for those products that prove to be sufficiently beneficial, we would expect to seek approval in earlier lines of treatment and potentially as a first-line therapy but there is no guarantee that our product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals, we may have to conduct additional clinical trials. We are also developing product candidates for the treatment of rare diseases.
Our projections of the number of people who have or will have the diseases we may be targeting may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of trial participants may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates. Even if we obtain significant market share for our products, if approved, because the potential target populations may be small, we may be unable to achieve or maintain profitability in future periods without obtaining regulatory approval for additional indications.
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 sufficient product sales revenue.
We have only relatively recently developed our sales, distribution or marketing capabilities in Germany and Türkiye, and, other than for our COVID-19 vaccine, we have not historically designed our preclinical studies and clinical trials with specific commercialization or marketing considerations in mind. In addition, with respect to our COVID-19 vaccine, we rely heavily on the sales, distribution, and marketing capabilities of our partners, except in Germany and Türkiye. To successfully commercialize any other products that may result from our development programs, several of which are undergoing pivotal clinical trials, we will need to continue developing sales and marketing capabilities in the United States, Europe and other regions, either on our own or with others. We may enter into collaborations with other entities to utilize their mature marketing and distribution capabilities, but we may be unable to enter into marketing agreements on favorable terms, if at all. If our current and future collaborators do not commit sufficient resources to further commercialize our COVID-19 vaccine and our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we may be unable to generate sufficient product sales revenue to sustain our business. We compete with many companies that currently have extensive and well-funded marketing and sales operations. Without continuing to grow our internal team or obtaining the support of third parties to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.
Our ability to achieve or maintain profitability in future periods depends in part on our and our collaborators’ ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties associated with international operations that could materially adversely affect our business.
Our ability to achieve or maintain profitability in future periods will depend in part on our ability and the ability of our collaborators to commercialize any products that we or our collaborators may develop in markets throughout the world. Commercialization of products in various markets could subject us to risks and uncertainties, including:
obtaining, on a country-by-country basis, the applicable marketing authorization from the competent regulatory authority;
the burden of complying with complex and changing regulatory, tax, accounting, labor and other legal requirements in each jurisdiction that we or our collaborators pursue;
reduced protection for intellectual property rights;
differing medical practices and customs affecting acceptance in the marketplace;
import or export licensing requirements;
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governmental controls, trade restrictions or changes in tariffs;
economic weakness, including inflation, or political instability, particularly in non-U.S. economies and markets;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
longer accounts receivable collection times;
longer lead times for shipping;
language barriers;
foreign currency exchange rate fluctuations;
the impact of epidemics, pandemics and other public health developments, such as COVID-19, on employees and the global economy;
reimbursement, pricing and insurance regimes; and
the interpretation of contractual provisions governed by local laws in the event of a contract dispute.
We do not have prior experience in all of these areas, and the experience we do have in some of these areas is limited. Our collaborators may have limited experience in these areas as well. Failure to successfully navigate these risks and uncertainties may limit or prevent market penetration for any products that we or our collaborators may develop, which would limit their commercial potential and our revenues.
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.
Even with the requisite approvals, the commercial success of our products will depend in part on the medical community, patients, and third-party or governmental payors accepting immunotherapies in general, and our products in particular, as medically useful, cost-effective and safe.
Any product that we bring to the market may not gain market acceptance by physicians, trial participants, third-party payors, and others in the medical community. Additionally, ethical, social and legal concerns about research involving mRNA could result in additional regulations restricting or prohibiting the products and processes we may use. If these products do not achieve an adequate level of acceptance, we may not generate significant product sales revenue and may not be able to achieve or maintain profitability in future periods. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:
the potential efficacy and potential advantages over alternative treatments;
the ability to offer our products, if approved, at competitive prices;
the prevalence and severity of any undesirable effects, including any limitations or warnings contained in a product’s approved labeling;
the prevalence and severity of any undesirable effects resulting from checkpoint inhibitors or other drugs or therapies with which our products are administered;
the relative convenience and ease of transportation, storage and administration;
any restrictions on the use of our products, if approved, together with other medications;
the willingness of the target patient population to try new therapies, such as mRNA vaccines and therapies, and of physicians to prescribe these therapies;
the strength of marketing and distribution support and timing of market introduction of competitive products;
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publicity concerning our products or competing products and treatments; and
sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement.
Even if a potential product displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of the products may require significant resources and may never be successful. Our efforts to educate the marketplace may require more resources than are required by the conventional technologies marketed by our competitors due to the complexity and uniqueness of our programs.
In addition, for our products that are approved for marketing, we and/or our collaborator are subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports for such product, and will need to continue to comply (or ensure that our third-party providers comply) with current good manufacturing practices, or GMP, and current good clinical practices, or GCP, for any clinical trials that we or a collaborator conduct post-approval. In addition, there is always the risk that we or a collaborator or regulatory authority might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any such failure to comply or other issues with our product candidates identified post-approval could have a material adverse impact on our business, financial condition and results of operations.
Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if approved, profitably.
Successful sales of our product candidates, if approved, depend on the availability of coverage and adequate reimbursement from third-party payors including governmental healthcare programs, such as Medicare and Medicaid in the United States, managed care organizations and commercial payors, among others. Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In addition, because certain of our product candidates represent new approaches to the treatment of cancer, we cannot accurately estimate the potential revenue from our product candidates.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from third-party payors is critical to new product acceptance.
Third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time- consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. Even if we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product for use in their facility or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our product candidates. Separate reimbursement for the product itself may or may not be available. Instead, the hospital or administering physician may be reimbursed only for providing the treatment or procedure in which our product is used. Further, from time to time, CMS revises the reimbursement systems used to reimburse healthcare providers, including the Medicare Physician Fee Schedule and Outpatient Prospective Payment System, which may result in reduced Medicare payments. In some cases, private third-
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party payors rely on all or portions of Medicare payment systems to determine payment rates. Changes to government healthcare programs that reduce payments under these programs may negatively impact payments from private third-party payors, and reduce the willingness of physicians to use our product candidates.
In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.
We intend to seek approval to market our product candidates in the United States, the European Union and other selected jurisdictions. If we obtain approval for our product candidates in any particular jurisdiction, we will be subject to rules and regulations in that jurisdiction. In some countries, particularly those in Europe, the pricing of biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. Some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new products into the marketplace. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. We expect downward pressure on pharmaceutical pricing to continue. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
The advancement of healthcare reform legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any product candidates we or our collaborators develop and may adversely affect the prices for such product candidates.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or the ACA, was passed, which substantially changes the way health care is financed by both governmental and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA, among other things, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs, and promoted a new Medicare Part D coverage gap discount program. Considerable uncertainty remains regarding the implementation and impact of the ACA.
In August 2022, the IRA was enacted, which sets forth meaningful changes to drug product reimbursement by Medicare. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products in the United States, among other effects. Any reduction in reimbursement from Medicare resulting from the IRA or other legislative or policy changes, or from other government programs may result in a similar reduction in payments from private payers. We cannot be sure whether additional legislative changes will be enacted, or the effect of forthcoming guidance implementing the IRA, or what the impact of such changes on our products and product candidates may be.
The delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than European Union, law and policy. National governments and health service providers have different priorities and approaches to the delivery of healthcare and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing European Union and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect our ability to commercialize any products for which we obtain marketing approval.
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We expect that additional healthcare reform measures or proposals will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our products and product candidates or additional pricing pressures. In the event that the pricing structures for healthcare products, such as the product candidates we are developing, change materially and limit payments for such product candidates, our business will be adversely impacted as our products may no longer be commercially viable based on their expected net present value; we may have invested significant resources in product candidates that cannot be commercially developed; or we may determine that assets that have reached an early phase of development cannot or will not be taken into further development, notwithstanding their clinical viability. In addition, development assets or clinical programs that are part of our collaborations may no longer be deemed commercially viable to pursue based on our collaborators’ assessments of the impact of any proposed, announced, or legislated pricing reforms.
We cannot predict what healthcare reform initiatives may be adopted in the future. Further legislative and regulatory developments are likely, and we expect ongoing initiatives to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues from our approved products and from product candidates that we may successfully develop and for which we may obtain regulatory approval, and may affect our overall financial condition and ability to develop product candidates.
Drug marketing and reimbursement regulations in the European Union and elsewhere may materially affect our ability to market and receive coverage for our products in the member states of the European Union and elsewhere.
Our COVID-19 vaccine is currently approved in the United States, the European Union, and other jurisdictions, and we intend to seek approval to market other product candidates in the United States, the European Union and other selected jurisdictions. If we obtain approval for our products or product candidates in a particular jurisdiction, we will be subject to rules and regulations in that jurisdiction. In some countries, particularly those in the European Union, the pricing of biologics is subject to governmental control and other market regulations that could put pressure on the pricing and usage of our products or product candidates. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for our product candidates and may be affected by existing and future healthcare reform measures.
In addition, in most countries outside the United States, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Reference pricing used by various member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. In some countries, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of any of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price structures of the United States and, generally, prices tend to be significantly lower in the European Union. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or limited in scope or amount, our revenues from sales by us or our collaborators and the potential profitability of any of our product candidates in those countries would be negatively affected.
Risks Related to our Financial Condition and Capital Requirements
Long-term sustainable profitability is difficult to achieve and maintain over time and is highly dependent on various factors.
Our ability to continue to generate revenue and achieve and maintain long-term sustainable profitability depends on our ability, alone or with collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, our product candidates. Although we generate revenue from sales of our COVID-19 vaccine and additional limited revenue from other transactions, we expect that future revenues from sales of our COVID-19 vaccine will decrease as demand for vaccination wanes. The amount of long-term revenue from such sales,
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including the sales of our COVID-19 vaccine, is uncertain at this time. Our ability to generate future revenues from pharmaceutical product sales and sales of our other products and services depends heavily on our success in:
completing research and preclinical and clinical development of our product candidates;
seeking and obtaining U.S. and non-U.S. marketing approvals for product candidates for which we complete clinical trials;
seeking and obtaining market access and favorable pricing terms in the United States, the European Union, and other key geographies;
furthering the development of our own manufacturing capabilities and manufacturing relationships with third parties in order to provide adequate (in amount and quality) products and services to support clinical development and the market demand for our approved products and product candidates, if approved;
obtaining market acceptance of our approved products and product candidates as a treatment option;
launching and commercializing products for which we obtain marketing approval and reimbursement, either through collaborations or, if launched independently, by establishing a sales force, marketing and distribution infrastructure;
addressing any competing technological and market developments, in particular, declining demand for any of our approved products;
implementing additional internal systems and infrastructure;
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
managing our expenses;
maintaining, defending, protecting, enforcing and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and
attracting, hiring and retaining qualified personnel.
Additionally, we have incurred significant costs associated with the commercialization of our COVID-19 vaccine. Our expenses could increase beyond our expectations if we are required by the FDA, the European Medicines Agency, or EMA, or other regulatory agencies to perform clinical and other trials or make changes to our manufacturing or quality systems in addition to those that we currently anticipate. Accordingly, such costs could adversely affect our future ability to achieve and maintain profitability.
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 ordinary shares could decline.
Our financial condition and operating results have varied in the past and will continue to fluctuate from one financial period to the next due to a variety of factors, many of which are beyond our control.
Factors relating to our business that may contribute to these fluctuations include the following, as well as other fac