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 NOVEMBER 2022

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

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




DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On November 7, 2022, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three and nine months ended September 30, 2022. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company, for the three months and nine months ended September 30, 2022, are attached hereto as Exhibit 99.1 and shall be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and incorporated by reference herein.




SIGNATURE
Pursuant to the requirements of s the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE
By:/s/ Jens Holstein
Name: Jens Holstein
Title: Chief Financial Officer
Date: November 7, 2022




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 And Nine Months Ended September 30, 2022


Exhibit 99.1
Unaudited Interim Condensed Consolidated Financial Statements
12 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
September 30,
Nine months ended
September 30,
2022202120222021
(in millions, except per share data)Note(unaudited)(unaudited)(unaudited)(unaudited)
Revenues
Commercial revenues3€3,394.8€6,040.1€12,923.3€13,348.1
Research & development revenues366.447.2109.096.1
Total revenues€3,461.2€6,087.3€13,032.3€13,444.2
Cost of sales4.1(752.8)(1,211.4)(2,811.5)(2,328.3)
Research and development expenses4.2(341.8)(260.4)(1,027.2)(677.7)
Sales and marketing expenses(12.8)(10.5)(44.9)(32.5)
General and administrative expenses 4.3(141.0)(68.2)(361.8)(154.9)
Other operating expenses 4.4(285.1)(26.4)(594.6)(27.3)
Other operating income 4.5459.8213.11,157.5360.6
Operating income€2,387.5€4,723.5€9,349.8€10,584.1
Finance income4.660.926.6448.551.4
Finance expenses4.7(4.3)(82.7)(16.8)(303.0)
Profit before tax€2,444.1€4,667.4€9,781.5€10,332.5
Income taxes5(659.2)(1,456.4)(2,625.8)(3,206.2)
Profit for the period€1,784.9€3,211.0€7,155.7€7,126.3
Earnings per share
Basic profit for the period per share€7.43€13.14€29.47€29.22
Diluted profit for the period per share€6.98€12.35€27.70€27.46
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
September 30,
Nine months ended
September 30,
2022202120222021
(in millions)Note(unaudited)(unaudited)(unaudited)(unaudited)
Profit for the period€1,784.9€3,211.0€7,155.7€7,126.3
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 operations10.92.924.46.3
Net other comprehensive income / (loss) that may be reclassified to profit or loss in subsequent periods €10.9€2.9€24.4€6.3
Other comprehensive loss that will not be reclassified to profit or loss in subsequent periods, net of tax
Remeasurement loss on defined benefit plans(0.1)
Net other comprehensive loss that will not be reclassified to profit or loss in subsequent periods€—€—€(0.1)€—
Other comprehensive income / (loss) for the period, net of tax €10.9€2.9€24.3€6.3
Comprehensive income for the period, net of tax€1,795.8€3,213.9€7,180.0€7,132.6
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

September 30, December 31,
(in millions)20222021
Assets Note(unaudited)
Non-current assets
Intangible assets €226.2€202.4
Property, plant and equipment 488.5322.5
Right-of-use assets272.0197.9
Other financial assets652.821.3
Other assets1.10.8
Deferred expenses7.513.6
Deferred tax assets 5343.7
Total non-current assets €1,391.8€758.5
Current assets
Inventories 7294.8502.5
Trade and other receivables 67,309.412,381.7
Other financial assets 64.8381.6
Other assets162.764.9
Income tax assets 0.40.4
Deferred expenses73.048.5
Cash and cash equivalents13,423.71,692.7
Total current assets €21,268.8€15,072.3
Total assets€22,660.6€15,830.8
Equity and liabilities
Equity
Share capital8248.6246.3
Capital reserve81,050.41,674.4
Treasury shares8(10.3)(3.8)
Retained earnings16,554.39,882.9
Other reserves 9523.393.9
Total equity €18,366.3€11,893.7
Non-current liabilities
Loans and borrowings6237.0171.6
Other financial liabilities 66.16.1
Income tax liabilities58.04.4
Provisions107.3184.9
Contract liabilities53.89.0
Other liabilities 17.412.8
Deferred tax liabilities7.066.7
Total non-current liabilities €336.6€455.5
Current liabilities
Loans and borrowings637.0129.9
Trade payables6296.5160.0
Other financial liabilities 6686.91,190.4
Government grants3.03.0
Refund liabilities90.0
Income tax liabilities51,387.51,568.9
Provisions10768.1110.2
Contract liabilities3673.9186.1
Other liabilities104.843.1
Total current liabilities€3,957.7€3,481.6
Total liabilities €4,294.3€3,937.1
Total equity and liabilities €22,660.6€15,830.8
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in millions, unaudited)NoteShare capitalCapital reserveTreasury sharesRetained earningsOther reserves Total equity
As of January 1, 2021€246.3€1,514.5€(4.8)€(409.6)€25.4€1,371.8
Profit for the period7,126.37,126.3
Other comprehensive income6.36.3
Total comprehensive income€—€—€—€7,126.3€6.3€7,132.6
Issuance of share capital and treasury shares162.61.0163.6
Transaction costs(2.7)(2.7)
Share-based payments 946.246.2
As of September 30, 2021€246.3€1,674.4€(3.8)€6,716.7€77.9€8,711.5
As of January 1, 2022€246.3€1,674.4€(3.8)€9,882.9€93.9€11,893.7
Profit for the period7,155.77,155.7
Other comprehensive income24.324.3
Total comprehensive income€—€—€—€7,155.7€24.3€7,180.0
Issuance of share capital80.567.167.6
Redemption of convertible note61.8233.2235.0
Share repurchase program8(924.2)(6.5)(930.7)
Transaction costs(0.1)(0.1)
Dividends8(484.3)(484.3)
Share-based payments933.133.1
Deferred Taxes5372.0372.0
As of September 30, 2022€248.6€1,050.4€(10.3)€16,554.3€523.3€18,366.3
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
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Interim Condensed Consolidated Statements of Cash Flows

Three months ended
September 30,
Nine months ended
September 30,
2022202120222021
(in millions)(unaudited)(unaudited, restated)(unaudited)(unaudited, restated)
Operating activities
Profit for the period€1,784.9€3,211.0€7,155.7€7,126.3
Income taxes659.21,456.42,625.83,206.2
Profit before tax€2,444.1€4,667.4€9,781.5€10,332.5
Adjustments to reconcile profit before tax to net cash flows:
Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets33.519.894.349.2
Share-based payment expense59.723.181.762.4
Net foreign exchange differences116.2(194.2)(222.3)(295.5)
Loss on disposal of property, plant and equipment0.20.40.4
Finance income(7.7)(0.6)(226.5)(1.2)
Finance expense4.382.716.8303.0
Movements in government grants(20.8)(109.6)
Net (gain) / loss on derivative instruments at fair value through profit or loss(2.3)24.982.324.9
Working capital adjustments:
Decrease / (increase) in trade and other receivables, contract assets and other assets2,245.4(3,343.9)5,016.7(10,095.4)
Decrease / (increase) in inventories72.9(88.0)207.7(329.3)
Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions565.9332.9760.31,153.9
Interest received4.30.46.51.0
Interest paid(4.3)(2.2)(16.5)(6.1)
Income tax paid(753.3)(0.7)(2,834.7)(1.0)
Net cash flows from operating activities€4,778.9€1,500.8€12,748.2€1,089.2
Investing activities
Purchase of property, plant and equipment(77.9)(40.5)(192.6)(88.1)
Proceeds from sale of property, plant and equipment0.40.20.41.4
Purchase of intangible assets and right-of-use assets(4.7)(0.8)(26.2)(12.5)
Purchase of financial instruments(1.1)(31.1)
(Investment) / proceeds from maturity of other financial assets(367.0)375.2(367.0)
Net cash flows from / (used in) investing activities€(83.3)€(408.1)€125.7€(466.2)
Financing activities
Proceeds from issuance of share capital and treasury shares, net of costs110.5160.9
Proceeds from loans and borrowings0.40.6
Repayment of loans and borrowings(0.5)(18.8)(1.9)
Payments related to lease liabilities(10.0)(4.8)(31.9)(15.9)
Share repurchase program(643.8)(930.7)
Dividends(484.3)
Net cash flows from / (used in) financing activities€(653.4)€(5.3)€(1,354.6)€143.1
Net increase in cash and cash equivalents4,042.21,087.411,519.3766.1
Change in cash and cash equivalents resulting from exchange rate differences46.724.2211.749.4
Cash and cash equivalents at the beginning of the period9,334.8914.11,692.71,210.2
Cash and cash equivalents at September 30€13,423.7€2,025.7€13,423.7€2,025.7
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements. For more information regarding the restated periods see note 6.
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Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements
1Corporate Information
BioNTech SE is a limited company incorporated and domiciled in Germany. The registered office is located in Mainz, Germany (An der Goldgrube 12, 55131 Mainz). The accompanying unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries and have been prepared on a going concern basis in accordance with the International Financial Reporting Standards, or IFRS as issued by the International Accounting Standards Board, or IASB. References to the “Company”, “BioNTech”, “Group”, “we”, “us” and “our” refer to BioNTech SE and its consolidated subsidiaries.
We are a fully integrated global biotechnology company specializing in the development of novel medicines at the intersection of immunology and synthetic biology. 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 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 develop and commercialize potential vaccines and therapies to address a range of serious indications on a global scale. We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes mRNA vaccines, cell and gene therapies, targeted antibodies, small molecule immunomodulators, Ribologicals, and next generation immunomodulators.
In February 2022, BioNTech Innovation GmbH, Mainz, Germany, was established and is a wholly owned consolidated subsidiary of BioNTech SE.
In June 2022, at the Annual General Meeting, or AGM, our shareholders voted to reappoint Helmut Jeggle as a member of the Supervisory Board and appointed two additional Supervisory Board members, Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl. In a meeting following the AGM, the Supervisory Board re-elected Helmut Jeggle as its Chairman. All three members will serve in their roles until the 2026 AGM.
In July 2022, BioNTech BioNTainer Holding GmbH, Mainz, Germany, was founded and is a wholly owned consolidated subsidiary of BioNTech SE.
In August 2022, BioNTech Rwanda Ltd., Kigali, Rwanda, was founded and is a wholly owned subsidiary of BioNTech BioNTainer Holding GmbH, a wholly owned consolidated subsidiary of BioNTech SE.
In September 2022, BioNTech Idar-Oberstein Services GmbH, Idar-Oberstein, Germany, was founded and is a wholly owned consolidated subsidiary of BioNTech SE.
In September 2022, New Technologies Security and Services GmbH i.G. (in establishment), Mainz, Germany, was founded and is a wholly owned consolidated subsidiary of BioNTech SE.
Our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022 were authorized for issuance in accordance with a resolution of the audit committee on November 4, 2022.
2Basis of Preparation, Significant Accounting Policies and further Accounting Topics
Basis of Preparation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022 have been prepared in accordance with International Accounting Standard (IAS) 34 Interim Financial Reporting.
The unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in the consolidated financial statements, and should be read in conjunction with our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021.
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
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arithmetic aggregations of the figures that preceded them and figures presented in the explanatory notes may not add up to the rounded arithmetic aggregations.
The unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
Significant Accounting Judgments, Estimates and Assumptions
The preparation of the unaudited interim condensed consolidated financial statements requires our management to make judgments, estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities and the accompanying disclosures. This includes but is not limited to the judgment described as “Pfizer Agreement Characteristics” in the notes to our audited consolidated financial statements as of and for the year ended December 31, 2021. In order to determine our share of the collaboration partner’s gross profits, we used certain information from the collaboration partner, including revenues from the sale of products, some of which is based on preliminary data shared between the partners. These estimated figures may change in future periods as we receive final data from our collaboration partner. Those changes in our share of the collaboration partner’s gross profit are recognized prospectively as a change in estimates. Our management continually evaluates judgments and estimates, including such related to the fair value measurement of derivatives, revenues and expenses. Management bases its judgments and estimates on parameters available when the unaudited interim condensed consolidated financial statements were prepared. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Such changes are reflected in the assumptions when they occur.
Significant Accounting Policies
The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial statements are consistent with those followed in the preparation of our audited consolidated financial statements as of and for the year ended December 31, 2021, except for income taxes which are accounted for using the expected annual tax rate in our unaudited interim condensed consolidated financial statements (see Note 5). Certain policies have been described further below due to the activities related to and the transactions occurred during the three and nine months ended September 30, 2022.
Foreign Exchange Forward Contracts
Effects from foreign exchange forward contracts are either shown as other operating income or expenses on a cumulative basis and might switch between those two positions during the year-to-date reporting periods.
Standards Applied for the First Time
The IFRS standards applied for the first time as of January 1, 2022, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2021, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022.
Revenue
We record revenues from product sales when there is a transfer of control of a product from us to the customer. We typically determine transfer of control based on when the product is shipped or delivered and title passes to the customer. For certain contracts, the finished product may temporarily be stored at our location under a bill-and-hold arrangement. Revenue is recognized on bill-and-hold arrangements at the point in time when the customer obtains control of the product and all of the following criteria have been met: the arrangement is substantive; the product is identified separately as belonging to the customer; the product is ready for physical transfer to the customer; and we do not have the ability to use the product or direct it to another customer. In determining when the customer obtains control of the product, we consider certain indicators, including whether title and significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received.
Cash & Cash Equivalents
Cash and cash equivalents comprise cash at banks and on hand and short-term investments we consider to be highly liquid (including deposits and money market funds) with an original maturity of three months or less, that are readily convertible to a known amount of cash and subject to an insignificant risk of changes in value. Deposits with an original maturity of more than three months are recognized as other financial assets.
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Share Repurchase Program
We apply the par value method to our repurchases of outstanding American Depositary Shares, or ADSs. Accordingly, the nominal value of such acquired treasury shares is deducted from equity shown in a separate category, Treasury Shares. Any premium paid in excess of the nominal value of a repurchased ADS is deducted from capital reserves. On the trade date, we recognize a liability and on the settlement date, we settle in cash. We recognize as profit or loss the foreign exchange differences that may occur between trade and settlement date.
Operational Impacts of COVID-19
As we advance our clinical programs, we are in close contact with our principal investigators and clinical sites, and are assessing the impact on the clinical trials, expected timelines and costs on an ongoing basis. For certain programs, including BNT111, BNT113, BNT122, BNT141 and BNT142 (RiboMabs), BNT151 and BNT152/153 (RiboCytokines) and BNT161 (Influenza), delays in the commencement of trials were experienced, due to slowed patient enrollment and other delays as a result of the COVID-19 pandemic. After several months of delay to focus efforts on our COVID-19 vaccine in 2020, in 2021 we started four Phase 2 clinical trials: two for our FixVac product candidates BNT111 and BNT113, one each for our iNeST program BNT122 as well as for our bispecific antibody program BNT311. In addition, we have started multiple Phase 1 clinical trials in 2021 and 2022 that include product candidates for BNT211 (CARVac), BNT221 (NEO-PTC-01, a neoantigen-based T-cell therapy), BNT151 and BNT152+153 (RiboCytokines), BNT116 (FixVac), BNT141 (RiboMab) and BNT142 (RiboMab). The delays, even though they were temporary, may negatively impact our operations and overall business by delaying further progress of these clinical trials and preclinical studies. Our operations, including research and manufacturing, could also be negatively impacted due to the potential impact of staff absences as a result of self-isolation procedures or extended illness. Such factors were evaluated and considered when preparing these unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022. We will continue to evaluate observed and potential effects of the COVID-19 pandemic.
Operational Impacts of Gas Supply Situation
We continue to monitor the natural gas supply situation as part of our regular business continuity management and continue to evaluate possible additional energy supply measures. We have evaluated our ongoing mitigation efforts to ensure business continuity in light of potential energy supply issues in Europe and elsewhere worldwide. Our manufacturing supply chain remains stable, and we do not anticipate energy-related disruptions. Our commercial production of our COVID-19 vaccine continues to run on natural gas, but we expect that it could be powered by alternative fuel sources without interruption, if needed. According to our most recent information and analyses, commercial mRNA manufacturing in our facilities is not expected to be impacted by a natural gas shortage, such as the current one. Nonetheless, we cannot predict with certainty the impact that a continuing or more severe natural gas shortage would have on our operations. Our R&D and clinical development activities continue to be dependent on gas, and we continue to put measures in place to mitigate related risks. We continue to evaluate the impact to our partners, including Pfizer, suppliers and other service providers.
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3Revenues from Contracts with Customers
Disaggregated information on revenues
Set out below is the disaggregation of our revenues from contracts with customers:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Commercial revenues€3,394.8€6,040.1€12,923.3€13,348.1
COVID-19 vaccine revenues3,378.16,021.612,883.913,303.2
Sales to collaboration partners(1)
259.4312.31,470.9514.3
Direct product sales to customers564.51,350.82,284.62,586.2
Share of collaboration partners' gross profit and sales milestones2,554.24,358.59,128.410,202.7
Other sales16.718.539.444.9
Research & development revenues from collaborations€66.4€47.2€109.0€96.1
Total€3,461.2€6,087.3€13,032.3€13,444.2
(1)    Represents sales to our collaboration partners of products manufactured by us.
Commercial Revenues
During the three and nine months ended September 30, 2022 and 2021, commercial revenues were recognized from the supply and sales of our COVID-19 vaccine worldwide. We are the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada and other countries, and holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer Inc., or Pfizer) and other countries; submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Shanghai Fosun Pharmaceutical (Group) Co., Ltd, or Fosun Pharma, has marketing and distribution rights in China, Hong Kong special administrative region, or SAR, Macau SAR and the region of Taiwan. The allocation of marketing and distribution rights defines territories in which the collaboration partners act as a principal.
Whenever responsibilities in the manufacturing and supply process of the COVID-19 vaccine shift and our COVID-19 vaccine is transferred, the vaccine is sold from one partner to the other. During the three and nine months ended September 30, 2022, we recognized €259.4 million and €1,470.9 million of revenues, respectively, from selling drug product batches manufactured by us to our partners. During the comparative periods, three and nine months ended September 30, 2021, the revenues derived from sales to collaboration partners amounted to €312.3 million and €514.3 million were recognized, respectively.
By supplying our territories during the three and nine months ended September 30, 2022, we recognized €564.5 million and €2,284.6 million of revenues, respectively, from direct COVID-19 vaccine sales in our territory. During the comparative periods, three and nine months ended September 30, 2021, recognized revenues derived from those sales amounted to €1,350.8 million and €2,586.2 million, respectively. The share of gross profit that we owe our collaboration partner Pfizer based on our sales is recognized as cost of sales. During the three months ended September 30, 2022 an upfront payment of €593.1 million became due and was recognized as current contract liability in our unaudited interim condensed consolidated statements of financial position.
Based on COVID-19 vaccine sales in the collaboration partners’ territories, we are eligible to receive a share of their gross profit which represents a net figure and is recognized as collaboration revenues during the commercial phase together with sales milestones that are recorded once the underlying thresholds are met. During the three months ended September 30, 2022, €2,554.2 million gross profit share was recognized as revenues. During the comparative period, three months ended September 30, 2021, €4,189.9 million gross profit share and €168.6 million of sales milestones were recognized as revenues. During the nine months ended September 30, 2022, €9,128.4 million of gross profit share were recognized. During the comparative period, nine months ended September 30, 2021, €9,786.9 million of gross profit share and €415.8 million of sales milestones were recognized as revenues. In order to determine our share of our collaboration partners’ gross profits, we used certain information from the collaboration partners, some of which is based on preliminary data shared between the partners and might vary once final data is available. The true-up recognized prospectively during the three and nine months ended September 30, 2022 and 2021, with respect to the previous period, was not material.
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Research & Development Revenues from Collaborations
During the three and nine months ended September 30, 2022 and 2021, research and development revenues were mainly derived from our collaborations with Pfizer, Genentech Inc., or Genentech, and Sanofi S.A, or Sanofi. In addition, during the nine months ended September 30, 2022, we entered into a new research, development and commercialization collaboration with Pfizer to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV).
Revenues from contracts with customers were recognized as follows:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Timing of revenue recognition
Goods and services transferred at a point in time€839.0€1,677.1€3,790.0€3,138.7
Goods and services transferred over time68.051.7113.9102.8
Revenue recognition applying the sales-based or usage-based royalty recognition constraint model(1)
2,554.24,358.59,128.410,202.7
Total€3,461.2€6,087.3€13,032.3€13,444.2
(1)    Represents sales based on the share of the collaboration partners' gross profit and sales milestones.
4Income and Expenses
4.1Cost of Sales
The cost of sales recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Cost of sales related to COVID-19 vaccine revenues€737.8€1,194.8€2,779.4€2,290.1
Cost related to other sales15.016.632.138.2
Total€752.8€1,211.4€2,811.5€2,328.3
4.2Research and Development Expenses
The research and development expenses recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Purchased services€—€160.8€361.4€402.6
Laboratory supplies191.310.2297.038.1
Wages, benefits and social security expense122.870.0279.1185.7
Depreciation and amortization13.68.536.023.1
Other14.110.953.728.2
Total€341.8€260.4€1,027.2€677.7
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4.3General and Administrative Expenses
The general and administrative expenses recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Wages, benefits and social security expense€37.8€22.5€108.3€53.9
Purchased services38.714.6103.638.1
IT and office equipment23.76.357.514.3
Insurance premiums17.714.732.223.4
Other23.110.160.225.2
Total€141.0€68.2€361.8€154.9
4.4Other Operating Expenses
The other operating expenses recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Loss on derivative instruments at fair value through profit or loss€282.7€24.9€581.7€24.9
Other2.41.512.92.4
Total€285.1€26.4€594.6€27.3
The loss on derivative instruments at fair value through profit or loss related to foreign exchange forward contracts that did not qualify for hedge accounting (see Note 6).
4.5Other Operating Income
The other operating income recognized during the three and nine months ended September 30, 2022 and 2021 is shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Foreign exchange differences, net€449.1€190.3€1,090.1€265.4
Government grants0.220.90.288.9
Other10.51.967.26.3
Total€459.8€213.1€1,157.5€360.6
The foreign exchange differences included in operating income primarily arose from valuing our U.S. dollar denominated trade receivables which mainly resulted from our COVID-19 collaboration with Pfizer, compensated by the foreign exchange rate effects of our U.S. dollar denominated trade payables as well as our U.S. dollar denominated other financial liabilities which mainly resulted from obligations incurred from our license agreements.
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4.6Finance Income
The finance income recognized during the three and nine months ended September 30, 2022 and 2021 is shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Foreign exchange differences, net€53.2€26.0€222.0€50.2
Interest income7.70.69.71.2
Fair value adjustments of financial instruments measured at fair value216.8
Total€60.9€26.6€448.5€51.4
The foreign exchange differences included in finance income primarily arose from valuing our U.S. dollar denominated cash and cash equivalents.
The fair value adjustments were derived from remeasuring the derivative embedded in our convertible note (see Note 6) and are reflecting the change in the derivative's fair value related to the equity investment of Pfizer mainly derived from our share price development between contract signing and closing (see Note 8).
4.7Finance Expenses
The finance expenses recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Interest expenses related to financial assets€2.5€—€10.8€—
Interest expenses related to lease liabilities1.70.83.32.0
Amortization of financial instruments0.10.42.77.6
Fair value adjustments of financial instruments measured at fair value81.5293.4
Total€4.3€82.7€16.8€303.0
The fair value adjustments were derived from remeasuring the derivative embedded in our convertible note (see Note 6).
5Income Tax
For the nine months ended September 30, 2022 and 2021, 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 plus the tax effect of any discrete items. For the nine months ended September 30, 2022 and 2021, our effective income tax rates were approximately 26.8% and 31.0%, respectively. The effective income tax rate decreased in part due to average trade tax rates in Mainz, Marburg and Idar-Oberstein decreasing from 2022 onward. During the three and nine months ended September 30, 2022, current income taxes were recognized with respect to the German tax group. Deferred tax effects were recognized with respect to identified discrete items. In addition, the non-tax effective fair value measurement of the convertible note was considered as permanent difference for the nine months ended September 30, 2022. As of September 30, 2022, we continue to maintain a valuation allowance against deferred tax assets of our U.S. tax group as there is not sufficient probability in terms of IAS 12 that there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized.
On November 15, 2018, we established a share option program pursuant to which we were permitted to grant selected employees and our Management Board options to receive shares in the Company. The program is designed as an Employee Stock Ownership Plan, or ESOP. We offered the participants a certain number of rights, or Option Rights, subject to their explicit acceptance. Grants under the ESOP took place from November 2018 until December 2019. An exercise of Option Rights in accordance with the terms of the ESOP gives a participant the right to obtain shares against payment of the exercise price. By way of an updated decision of the Supervisory Board at the end of September 2022 compared to the initial settlement mechanism, an ESOP settlement may be made by delivery to the participant of such
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number of ADSs equal to the net value of the exercised Option Rights after deduction of (i) the exercise price and (ii) the applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social security contributions resulting from such exercise. The respective number of ADS shall be settled with ADS acquired in the course of the share repurchase program. The applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social security contributions resulting from such exercise are paid in cash directly to the respective authorities. Tax expenses on the settlement are only recognized once the Option Rights have been exercised. The updated decision of the Supervisory Board on the settlement mechanism of Option Rights end of September 2022 led based on IAS 12 to a deferred tax asset in the total amount of €395.2 million as of September 30, 2022. Thereof a deferred tax asset in the amount of €23.2 million is recognized as income taxes in our unaudited interim condensed consolidated statements of profit or loss to the extend expenses have been recognized with an effect of profit and loss in the past. In accordance with IAS 12.68c the remainder in the amount of €372.0 million is recognized directly in equity with in as other reserves in our unaudited interim condensed consolidated statements of changes in stockholders’ equity.
The income taxes recognized during the three and nine months ended September 30, 2022 and 2021 are shown in the following table:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Current income taxes€724.3€1,368.5€2,657.2€3,120.6
Deferred taxes(65.1)87.9(31.4)85.6
Income taxes€659.2€1,456.4€2,625.8€3,206.2
6Financial Assets and Financial Liabilities
Financial Assets
Set out below is an overview of financial assets, other than cash and cash equivalents, held as of September 30, 2022 and December 31, 2021.
(in millions)September 30,
2022
December 31,
2021
Derivatives not designated as hedging instruments
Foreign exchange forward contracts€0.5€5.7
Equity instruments designated at fair value through OCI
Non-listed equity investments46.519.5
Financial assets at amortized cost
Trade and other receivables 7,309.412,381.7
Cash deposit with an original term of six months375.2
Other financial assets10.62.5
Total€7,367.0€12,784.6
Total current7,314.212,763.3
Total non-current52.821.3
Equity Instruments Designated at Fair Value through Other Comprehensive Income
Equity investments generally are made in conjunction with our existing commercial partnerships. In accordance with IFRS 9 we elected to present gains and losses on our equity investments in other comprehensive income to avoid fluctuation to be disclosed in our unaudited interim condensed consolidated statements of profit or loss. During the nine months ended September 30, 2022, no material gains and losses on our equity investments have occurred.
Financial Assets at Amortized Cost
Trade and other receivables significantly decreased and predominantly comprise trade receivables from our COVID-19 collaboration with Pfizer as well as our direct product sales to customers in our territory. The contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. As Pfizer’s fiscal quarter for subsidiaries outside the United States differs from ours, it creates an additional time lag between the recognition of revenues and the payment receipt. Consequently, as of September 30, 2022, our trade receivables included trade receivables which related to the gross profit share for the second and third quarter of 2022. The payment settling our
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gross profit share for the second quarter of 2022 (as defined by the contract) was received from our collaboration partner in October 2022, subsequent to the end of the reporting period. Of our trade receivables outstanding as of September 30, 2022, we collected €3,185.9 million in cash as of October 15, 2022.
Cash deposits with an original term of more than three months are presented as other financial assets. Within our interim condensed consolidated financial statements as of, and for the three and nine months ended, September 30, 2021, cash deposits in an amount of €367.0 million with a term of six months at inception had been classified as cash and cash equivalents. The presentation of these deposits as other financial assets rather than as cash and cash equivalents in the consolidated statements of financial position as of December 31, 2021 and in the cash flow used in investing activities in our unaudited interim condensed consolidated statements of cash flows for the comparative periods presented was restated accordingly.
Financial Liabilities
Set forth below is an overview of financial liabilities, other financial liabilities and trade payables held as of September 30, 2022 and December 31, 2021.
Loans and borrowings
(in millions)September 30,
2022
December 31,
2021
Lease liabilities€272.1€181.6
Convertible note – host contract(1)
99.7
Loans and borrowings1.920.2
Total€274.0€301.5
Total current37.0129.9
Total non-current237.0171.6
(1)    The convertible note was fully redeemed by exercising our early redemption option as of March 1, 2022, the redemption date.
Other financial liabilities
(in millions)September 30,
2022
December 31,
2021
Derivatives not designated as hedging instruments
Convertible note – embedded derivative(1)
€—€308.7
Foreign exchange forward contracts140.163.0
Financial liabilities at fair value through profit or loss
Contingent consideration6.16.1
Total financial liabilities at fair value€146.2€377.8
Trade payables and other financial liabilities at amortized cost, other than loans and borrowings
Trade payables296.5160.0
Other financial liabilities546.8818.7
Total trade payables and other financial liabilities at amortized cost, other than loans and borrowings€843.3€978.7
Total other financial liabilities€989.5€1,356.5
Total current983.41,350.4
Total non-current6.16.1
(1)    The convertible note was fully redeemed by exercising our early redemption option as of March 1, 2022, the redemption date.
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Total financial liabilities
(in millions)September 30,
2022
December 31,
2021
Loans and borrowings€274.0€301.5
Other financial liabilities989.51,356.5
Total€1,263.5€1,658.0
Total current1,020.41,480.3
Total non-current243.1177.7
Loans and Borrowings and Derivatives Not Designated as Hedging Instrument
Convertible Note
In February 2022, we gave notice to a fund associated with Temasek Capital Management Pte. Ltd., or Temasek, of the exercise of our early redemption option and the full redemption of our convertible note as of March 1, 2022, the redemption date. As of the redemption date, the conversion features provided for in the contract initially identified as a combined embedded derivative were finally measured at fair value through profit and loss and recognized as finance income in our unaudited interim condensed consolidated statements of profit or loss (see Note 4.6). During April 2022, the early redemption was fulfilled by issuing the number of our ordinary shares calculated pursuant to the early redemption provisions of the convertible note (see Note 8), plus paying a fractional share and accrued but unpaid interest up to (but excluding) the redemption date.
Foreign Exchange Forward Contracts
Derivatives not designated as hedging instruments reflect the fair value of those foreign exchange forward contracts that were outstanding as of September 30, 2022 and were entered into to manage some of our transaction exposures. The foreign exchange forward contracts are intended to reduce the level of foreign currency risk related to trade receivables denominated in U.S. dollar. The fair value adjustments derived from remeasuring the foreign exchange forward contracts during the three and nine months ended September 30, 2022 were recognized as other operating expenses in our unaudited interim condensed consolidated statements of profit or loss (see Note 4.4).
Other Financial Liabilities at Amortized Cost
Other financial liabilities comprises mainly obligations incurred from our license agreements.
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, 2021.
Fair Values
Fair values of cash and cash equivalents, trade receivables, trade payables, and other current financial assets and liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.
The fair values of financial instruments measured at fair value are reassessed on a quarterly basis. The money market funds, or MMFs, which are recognized as cash and cash equivalents in the amount of €4,492.8 million as of September 30, 2022, are valued using quoted prices on the valuation date in active markets (Level 1). The change in the derivative's fair value related to the equity investment of Pfizer (see Note 8) was derived from our share price development between contract signing and closing (Level 1). As described above, as of the redemption date, the fair value of the derivative embedded in our convertible note was finally assessed by applying the Cox-Rubinstein binomial tree model which is based on significant observable inputs (Level 2) and described in further detail in Note 12 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021. The foreign exchange forward contracts are valued using valuation techniques, which employ the use of foreign exchange spot and forward rates (Level 2). The fair values of non-listed equity investments are measured based on observable inputs e.g. based on multiple analyses (Level 2). The initial fair value of the contingent consideration determined at acquisition was based on cash flow projections (unobservable Level 3 input factors) and remains valid since no changes of the underlying performance criteria have occurred.
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7Inventories
Set out below is an overview of inventories held as of September 30, 2022 and December 31, 2021.
(in millions)September 30,
2022
December 31,
2021
Raw materials and supplies€206.6€248.3
Unfinished goods77.484.5
Finished goods10.8169.7
Total€294.8€502.5
During three and nine months ended September 30, 2022, inventory write-offs and reserves related to our COVID-19 vaccine amounting to €138.4 million and €559.4 million, respectively, were recognized in cost of sales due to the switch from the BNT162b2 vaccine to an Omicron-adapted bivalent vaccine and further raw materials reserves. During the comparative periods, three and nine months ended September 30, 2021, inventory write-offs amounting to €88.0 million and €107.8 million, respectively, were recognized in cost of sales.
8Issued Capital and Reserves
In January 2022, we announced a new research, development and commercialization collaboration with Pfizer to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV). In connection with this collaboration, Pfizer agreed to make an equity investment in us, acquiring 497,727 ordinary shares paying a total amount of €110.6 million. The issuance of 497,727 ordinary shares with the nominal amount of €0.5 million was registered with the commercial register (Handelsregister) on March 24, 2022. The equity investment which was issued in a foreign currency represents a derivative from the date of signing until the date of closing of the transaction. From the fair value measurement of this derivative €43.0 million were recognized in finance income in our unaudited interim condensed consolidated statements of profit or loss during the nine months ended September 30, 2022. At closing date, in February 2022, this derivative and the agreed investment amount were recognized in our capital reserve and, taking an increase in share capital of €0.5 million into account, led to a net increase of the capital reserve of €67.1 million in our unaudited interim condensed consolidated statements of financial position.
In March 2022, we redeemed our convertible note by exercising our early redemption option and reclassified the convertible note host contract as well as the embedded derivative which previously were recognized as separate financial liabilities into our capital reserve (see Note 6). In April 2022, the early redemption was fulfilled by issuing 1,744,392 ordinary shares. The nominal amount of €1.7 million was recorded in share capital and, finally, as a result of the transaction, the capital reserve increased by €233.2 million in our unaudited interim condensed consolidated statements of financial position. The declaratory registration with the commercial register (Handelsregister) was made on May 20, 2022.
In March 2022, our Management Board and Supervisory Board authorized a share repurchase program of American Depositary Shares, or ADSs, pursuant to which we may repurchase ADSs in the amount of up to $1.5 billion over the next two years. On May 2, 2022, the first tranche of our share repurchase program of ADSs, with a value of up to $1.0 billion, commenced. During the nine months ended September 30, 2022, 6,545,030 ADSs were repurchased at an average price of $144.44, for total consideration of $945.4 million (€930.7 million). As a result of these repurchases, treasury shares changed by €6.5 million and the capital reserve decreased by €924.2 million.
In June 2022, at the Annual General Meeting, our shareholders approved the proposed special cash dividend of €2.00 per ordinary share (including those held in the form of ADSs), which led to an aggregate payment of €484.3 million.
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9Share-Based Payments
Expenses Arising from Share-Based Payment Arrangements
During the three and nine months ended September 30, 2022 and 2021, 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
September 30,
Nine months ended
September 30,
(in millions)2022202120222021
Expense arising from equity-settled share-based payment arrangements€11.7€14.8€36.7€47.3
Employee Stock Ownership Plan4.64.313.815.9
Chief Executive Officer Grant0.91.72.75.0
Management Board Grant0.60.73.31.6
BioNTech 2020 Employee Equity Plan for Employees Based Outside North America5.68.116.924.8
(Income) / expense arising from cash-settled share-based payment arrangements49.714.649.726.5
Employee Stock Ownership Plan46.84.847.14.8
Management Board Grant1.8(1.2)3.1
BioNTech Restricted Stock Unit Plan for North America Employees2.98.03.818.6
Total€61.4€29.4€86.4€73.8
Cost of sales0.51.92.05.5
Research and development expenses52.717.169.748.0
Sales and marketing expenses0.20.10.60.4
General and administrative expenses 8.010.314.119.9
Total€61.4€29.4€86.4€73.8
Changes in Share-Based Payment Arrangements
New share-based payment arrangements and material changes to arrangements that occurred during the three and nine months ended September 30, 2022 are shown below. A detailed description of our share-based payment arrangements is included in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021.
BioNTech 2020 Employee Equity Plan for Employees Based Outside North America (Equity-Settled)
In December 2020, we approved the BioNTech 2020 Employee Equity Plan for employees based outside North America, or the European Plan. Under the European Plan, Restricted Cash Units, or RSUs, are offered to our employees. Following the initial issuance of RSUs for the calendar year 2020 in what we refer to as the LTI 2020 program, and, for employees who did not participate in the ESOP, the LTI-plus program, as of the grant date in January 2022, the European Plan was implemented again for the calendar year 2021 by entering into award agreements with our employees, which we refer to as the LTI 2021 program. RSUs issued under the LTI 2021 program vest annually in equal installments after four years commencing in December 2021. As we have the ability to determine the method of
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settlement, the program was classified as equity-settled. The cost of the awards will be recognized over the service period, applying the graded vesting method.
Set out below is an overview of the RSUs granted and subsequent changes to RSUs outstanding during the nine months ended September 30, 2022.
Restricted stock unitsWeighted average fair value (€)
Outstanding under LTI 2020 and LTI-plus program as of January 1, 2022614,42778.61
Granted under LTI 2021 program109,202203.22
Forfeited(13,192)103.96
As of September 30, 2022710,43797.30
The fair value of the awards is based upon the price of our ADSs representing ordinary shares at grant date. A retention assumption is applied when estimating the number of equity instruments for which service conditions are expected to be satisfied and will be revised in case material differences arise. Ultimately, a true-up to the number satisfied until settlement date will be recorded.
Management Board Grant (partly Equity-Settled, partly Cash-Settled)
With effect as of March 1, 2022, the service agreement with Prof. Özlem Türeci, M.D. (Chief Medical Officer (CMO)) was renewed until May 31, 2025. With effect as of April 1, 2022, the service agreement with Sean Marett (Chief Business Officer (CBO) and Chief Commercial Officer (CCO)) was renewed until December 31, 2024. The short-term and long-term incentive compensation provided for by the extended term of the service agreements is in line with the provisions of the original terms and those of our other Management Board members as described in further detail in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021 and has been reflected when accounting for the share-based payment arrangements during the three and nine months ended September 30, 2022.
In May 2022, the allocation date, phantom options equivalent to the number of options the Management Board members would have been entitled to receive for the 2022 year were allocated under the Management Board Grant which led to a modification from equity-settled to cash-settled share-based payment arrangement and a reclassification of €3.5 million between equity and non-current other liabilities. The awards were granted to the Management Board via individual grant agreements during the three months ended September 30, 2022, which outline specific terms relating to the exercise of the Phantom Options. Those agreements include the provisions that are in line with general provisions of our Management Board Grant as outlined in our Annual Report on Form 20-F as of and for the year ended December 31, 2021. The rights to receive options in future years remain determined as equity-settled, share-based payment arrangements.
The phantom options allocated to BioNTech’s Management Board as of May 2022 allocation date are presented in the tables below.
Phantom options outstandingAllocation date May 2022
Prof. Ugur Sahin, M.D.19,997
Sean Marett14,664
Dr. Sierk Poetting14,664
Prof. Özlem Türeci, M.D.14,664
Ryan Richardson7,465
Jens Holstein14,664
Measurement of Fair Values
Under this cash-settled, share-based payment arrangement, the fair values of the liabilities will be remeasured until the settlement date continuously using a Monte-Carlo simulation model which incorporates the impact of the performance criteria regarding share price and index development as described in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021. Continuously, the fair values are recognized over the award’s vesting period beginning as of the service commencement
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dates (dates when the respective service agreements became effective) until four years commencing on the first anniversary of the allocation date have lapsed.
Employee Stock Ownership Plan (partly Equity-Settled, partly Cash-Settled)
As of September 30, 2022 11,537,404 Equity-Settled Option Rights were outstanding under the ESOP. During the three and nine months ended September 30, 2022, the waiting period for 6,340,588 Option Rights ended under the ESOP. The waiting period for an additional 5,002,902 Option Rights will end on November 15, 2022. Those Option Rights were awarded to our Management Board and employees eligible to participate in the ESOP and will be or become exercisable during certain exercise windows. End of September the Supervisory Board decided on the ESOP settlement mechanism (for details see Note 5). The decision did neither change the rights as such nor did it change the classification as Equity-Settled Option Rights. In addition, certain phantom options were issued under the ESOP. The liability related to these awards is measured, initially and at the end of each reporting period until settled, at the fair value of the award using the valuation model as described in Note 17 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2021.
10Provisions and Contingencies
Provisions
As of September 30, 2022, certain claims were pending or threatened against us, mainly related to purported obligations arising out of certain contractual disputes unrelated to the below mentioned patent proceedings. Our best estimate of potential outflow of economic resources from such proceedings amounts to €359.1 million as of September 30, 2022 (€177.9 million as of December 31, 2021), which was reclassified into current provisions during the nine months ended September 30, 2022 in our consolidated statements of financial position due to the current estimated timing of the proceeding and was recognized in cost of sales in our unaudited interim condensed consolidated statements of profit or loss. This assessment is based on assumptions deemed reasonable by management including those about future events and uncertainties. Although we believe our position is strong, the outcome of these matters is ultimately uncertain, such that unanticipated events and circumstances might occur that might cause us to change those assumptions and give rise to a material adverse effect on our financial position in the future.
As of September 30, 2022, our current provisions include €321.2 million (nil as of December 31, 2021) of obligations for production capacities derived from contracts with Contract Manufacturing Organizations, or CMOs, that became redundant as a direct result of the introduction of a new COVID-19 vaccine formulation, the switch from the BNT162b2 vaccine to an Omicron-adapted bivalent vaccine and due to increased internal manufacturing capacities during the three and nine months ended September 30, 2022. The related expenses were recognized in cost of sales in our unaudited interim condensed consolidated statements of profit or loss.
As of September 30, 2022, our current provisions include €43.0 million (€58.5 million as of December 31, 2021) of international trade obligations, including customs value calculation, customs tariff number classification and other related securities requirements. The majority of related expenses related to our commercial sales and were recognized as cost of sales in our unaudited interim condensed financial statements as of and for the three and nine months ended September 30, 2022.
Contingencies
In addition to the above, 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 September 30, 2022, 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 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. It is currently impractical for us to estimate the respective contingent liabilities.
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
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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.
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. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
CureVac Proceedings
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. Later 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 August 2022, CureVac added European Patent, EP3708668B1, or the EP’668 Patent, to its German lawsuit. 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 addition, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that the EP’122 Patent is invalid.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility models and intend to vigorously defend itself in the proceedings mentioned above. However, our analysis of CureVac’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Moderna Proceedings
In August 2022, ModernaTX, Inc., or Moderna, filed three patent infringement lawsuits against us and Pfizer related to COMIRNATY. 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. Moderna filed a second lawsuit asserting 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. Additionally, 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 infringement of U.S. Patent Nos. 10,898,574; 10,702,600; and 10,933,127, and seeking monetary relief, which was not specified in the filings. 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. Later in September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V., and Pfizer Inc. in the District Court of The Hague alleging COMIRNATY’s infringement of the EP ‘949 Patent and EP’565 Patent.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourself 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. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities
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11Related Party Disclosures
ATHOS KG, Holzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and beneficial owner of our ordinary shares. Entities controlled by ATHOS KG mainly provide rental and property management activities and sell property, plant and equipment to us. The total amount of transactions with ATHOS KG or entities controlled by them had no significant impact on our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2022 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, 2021.
12Events after the Reporting Period
In October 2022, BioNTech Australia Pty Ltd, Victoria, Australia, was founded and is a wholly owned subsidiary of BioNTech BioNTainer Holding GmbH, a wholly owned consolidated subsidiary of BioNTech SE.
In November 2022, our Management Board and Supervisory Board authorized the second tranche of our share repurchase program of ADSs, with a value of up to $0.5 billion, commencing on December 7, 2022.
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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 and nine months ended September 30, 2022.
Operating Results
Overview
BioNTech was founded in 2008 with the goal to develop treatments for patients that address diseases with high unmet medical need. As a next generation immunotherapy company, it is our vision to harness the power of the immune system to develop novel therapies against cancer and infectious diseases. To realize this vision, we combine decades of groundbreaking research in immunology, a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. To date we have expanded our team to more than 4,000 employees worldwide.
We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes mRNA vaccines, cell and gene therapies, targeted antibodies, small molecule immunomodulators, Ribologicals, and next generation immunomodulators. Our approach has created a robust and diversified product pipeline across infectious diseases and oncology, comprised of our first commercial product, BNT162b2 (COMIRNATY), the first ever approved mRNA therapy, and that includes three commercial stage products (original vaccine, original/BA.1- and BA.4/5.-adapted bivalent vaccines). The clinical pipeline includes over 19 clinical stage product candidates and more than 30 research programs.
We believe our successful development of a first-in-class COVID-19 mRNA vaccine in less than one year validates our execution capabilities and the power of our technologies to change lives. We leverage powerful new therapeutic mechanisms and exploit a diverse array of biological targets to harness the power of each patient’s immune system to address the unique molecular signature of each patient’s underlying disease.
Core to our business practices is ensuring that people all around the globe benefit from our efforts. As part of this effort, we intend to maintain our focus on high medical needs and democratizing access to novel medicines. We believe we are well positioned to develop and commercialize the next generation of immunotherapies with the potential to transform treatment paradigms for many severe diseases and substantially improve clinical outcomes for patients. We support the United Nations Sustainable Development Goals, or SDGs. Our research and product development efforts make a relevant contribution to supporting the third United Nations Sustainable Development Goal (SDG 3): ensuring healthy lives and promoting well-being for all people of all ages. This aligns with our commitment to global social responsibility.
On the research and development front, we are focused on developing next-generation COVID-19 vaccines to enable rapid response, maintain leadership and strengthen pandemic preparedness as well as broaden the label of and access to the vaccine.
Additionally, we are accelerating clinical development, bolstering mid- and late-stage oncology presence and broadening our pipeline through the start of new programs in oncology and infectious diseases. We are also diversifying our therapeutic area footprint which will enable us to fully leverage the potential of all technology platforms across autoimmune diseases, inflammatory diseases, cardiovascular disease, neurodegenerative diseases, and regenerative medicines. Moreover, we plan to invest to build out our global development organization bringing in talent with the clinical and regulatory expertise needed to rapidly advance our diversified clinical pipeline.
Mergers and acquisitions activity and business development efforts are focused on strengthening technology platforms and digital capabilities through selected strategic partnerships and acquisitions. We also plan to enhance capabilities through complementary acquisitions, technologies, infrastructure and manufacturing.
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Corporate Development
We continue to facilitate equitable access to our medicines. As part of this commitment, construction of our first Africa-based mRNA vaccine manufacturing facility in Kigali, Rwanda is progressing with the first BioNTainer being ready for shipment by the end of 2022. The facility is planned to be able to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, such as the COVID-19 vaccine and investigational malaria and tuberculosis vaccine candidates pending authorization by respective regulatory authorities. Implementation of a Rwandan manufacturing team is also advancing with first senior team members already onboarded.
In October 2022, we signed a Letter of Intent with the State of Victoria in Australia for a strategic partnership to collaborate on the research and development of potential mRNA-based vaccines and therapies. Together we will establish a research and innovation center in Melbourne where we plan to set up a clinical scale end-to-end mRNA manufacturing facility based on our BioNTainer solution to support the design, manufacture and clinical testing of product candidates.
In September 2022, our affiliate BioNTech Pharmaceuticals Asia Pacific Pte. Ltd. acquired a GMP-certified manufacturing facility in Singapore which is planned to serve as BioNTech’s Regional Headquarters. We anticipate that the site could become operational in late 2023. The first payment has been made and the transaction is expected to close in early 2024.
We value and respect valid and enforceable intellectual property rights of others and remain confident in our intellectual property. During the course of the third quarter of 2022, CureVac AG and ModernaTX Inc. filed patent infringement lawsuits against us and our partner, Pfizer. We and our partner Pfizer have also filed actions against both CureVac and Moderna. We are evaluating these lawsuits and intend to determine the appropriate further actions in response to these lawsuits.
We continue to monitor the natural gas supply situation as part of our regular business continuity management and we continue to evaluate possible additional energy supply measures. We have evaluated our ongoing mitigation efforts to ensure business continuity in light of potential energy supply issues in Europe and elsewhere. Our manufacturing supply chain remains stable, and we do not anticipate energy-related disruptions. The commercial production of our COVID-19 vaccine continues to run on natural gas, but we expect it could be powered by alternative fuel sources without interruption, if needed. According to our most recent information and analyses, commercial mRNA manufacturing in our facilities is not expected to be impacted by a natural gas shortage, such as the current one. Nonetheless, we cannot predict with certainty the impact that a continuing or more severe natural gas shortage would have on our operations. Our R&D and clinical development activities continue to be dependent on gas, and we are putting measures in place to mitigate related risks. We continue to evaluate the impact to our partners, including Pfizer, suppliers and other service providers.
In November 2022, BioNTech’s CEO and Co-Founder Prof. Ugur Sahin, M.D. was part of German Chancellor Olaf Scholz’s delegation for a visit to China. During this visit, an exchange occurred between Chinese and German governmental representatives about a potential authorization of our COVID-19 vaccine for expatriates in China. At the time of filing this third quarter 2022 report, any formal notification regarding a potential authorization of the COVID-19 vaccine is pending.
The first tranche of our share repurchase program of ADSs, with a value of up to $1.0 billion, was executed from May 2, 2022 to October 10, 2022. We repurchased 6,945,513 ADSs at an average price of $143.98. In November 2022, our Management Board and Supervisory Board authorized the second tranche of BioNTech´s share repurchase program of ADSs, with a value of up to $0.5 billion, commencing on December 7, 2022.
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Key Pipeline Updates
Below is a summary of our authorized product and clinical product candidates, organized by platform and indication.
Pipeline overview
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Infectious Disease
We are expanding our infectious disease pipeline of mRNA vaccines to address global health challenges. In addition to our COVID-19, influenza and shingles vaccine programs, which are partnered with Pfizer, we have active research and preclinical development programs targeting more than 10 additional distinct infectious diseases, spanning both prophylactic vaccine and therapeutic approaches. As demonstrated with our COVID-19 vaccine, our infectious disease product strategy is rooted in our belief that it is our responsibility to make a global and social impact with our medicines. Our goal is to advance and expand our infectious disease pipeline to combat major health burdens while democratizing access to mRNA medicines.
COVID-19 Vaccine Program – BNT162 (COMIRNATY)
COMIRNATY (BNT162b2), the first ever approved mRNA-based product has paved the way for a new class of medicines. We and Pfizer continue to build on our global COVID-19 vaccine leadership with first-to-market Original/Omicron BA.4/BA.5-adapted vaccine launches. We and Pfizer have now three commercial stage COVID-19 vaccine products on the market that include original COVID-19 vaccine and two Omicron adapted vaccines: Original/BA.1- and BA.4/5.-adapted bivalent vaccines.
We will continue to innovate to advance a diverse pipeline of follow-on and next generation product candidates. We believe that our COVID-19 vaccine franchise will remain a long-term sustainable business opportunity.
In the third quarter of 2022, we successfully launched our Original/Omicron adapted bivalent COVID-19 vaccines after receiving Emergency Use Authorization (EUA) in the U.S. for the Original/Omicron BA.4/BA.5-adapted bivalent vaccine and European Union approval for the Original/Omicron BA.1- and BA.4/BA.5-adapted bivalent vaccines. As part of our long-term and science-driven COVID-19 vaccine strategy, we have established a diverse pipeline of follow-on and next generation vaccine candidates and initiated the first clinical trial for a next generation vaccine candidate and for a COVID-19 / influenza combination mRNA vaccine.
Commercial updates
Following regulatory approvals, we and Pfizer immediately began shipping Original/Omicron BA.1- and BA.4/BA.5-adapted bivalent COVID-19 vaccines in September 2022 in time for fall and winter booster campaigns. Shipments in the United States began approximately two months after the U.S. Food and Drug Administration (FDA) provided its guidance for the BA.4/BA.5-adapted bivalent COVID-19 vaccine.
As of mid-October 2022, we and Pfizer have invoiced approximately 300 million doses of Original/Omicron adapted bivalent vaccine.
As part of our and Pfizer's 2-billion-doses-pledge to support equitable access to medicines, we and Pfizer have delivered approximately 1.6 billion doses of our COVID-19 vaccine in total to low- and middle-income countries in line with demand.
We expect to invoice up to 2.1 billion doses of our COVID-19 vaccine in 2022. Some dose deliveries have been shifted into 2023 due to the evolving dynamics in demand.
We believe that we and Pfizer believe are well positioned to supply the quantities required by global market demand.
Clinical development and regulatory updates
During the third quarter of 2022, our and Pfizer’s COVID-19 vaccine received multiple regulatory approvals including for Omicron adapted bivalent vaccines, label expansions for pediatric vaccinations and ongoing conversions from conditional or emergency approvals to full regulatory approvals across various regions worldwide. Our and Pfizer’s Original/Omicron BA.4/BA.5-adapted bivalent vaccine has received approvals in more than 45 countries and regions, as of October 25, 2022.
Adapted bivalent vaccine boosters
With occurrence of Omicron BA.1 end of 2021 we and Pfizer started evaluating variant-adapted COVID-19 vaccines, including monovalent and bivalent vaccines directed against Omicron sublineages and other strains of SARS-CoV-2. Data from these studies were presented to regulatory agencies in June and July 2022, which supported the
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regulators’ discussions for the development of Omicron adapted vaccines and definition of the most appropriate regulatory pathways. We and Pfizer will continue to submit available data to regulatory authorities worldwide.
In June 2022 clinical data from a Phase 2/3 trial evaluating Omicron BA.1-adapted vaccine candidates showed that a booster dose of our and Pfizer’s Original/Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 sublineage compared to the original vaccine.
Given that the Omicron BA.4 and BA.5 sublineages displaced Omicron BA.1 and became the prevalent variants of concern in the United States, in June 2022, the U.S. FDA advised vaccine manufacturers to develop modified vaccines that add an Omicron BA.4/5 spike protein encoding component to the original vaccine composition to create a bivalent booster vaccine. Based on this guidance we and Pfizer accelerated the development of a bivalent vaccine containing mRNA encoding the wild-type spike protein of SARS-CoV-2, present in the original vaccine, and mRNA encoding the spike protein of the BA.4/BA.5 sublineage, which we had already started developing in line with our ongoing pandemic preparedness program.
In August 2022, we and Pfizer started a randomized Phase 2/3 trial evaluating the safety, tolerability and immunogenicity of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in individuals aged 12 years and older. First data from this trial were reported in October 2022. A 30-µg booster dose of the vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken seven days after administration, with similar responses seen across individuals aged 18 to 55 years and those older than 55 years of age (40 participants in each age group). The Original/Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine.
On August 31, 2022, the U.S. FDA granted EUA of a 30-µg booster dose of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine for individuals aged 12 years and older. The authorization of the bivalent vaccine is based on clinical data from our and Pfizer’s Original/Omicron BA.1-adapted bivalent vaccine as well as preclinical and manufacturing data from the companies’ Original/Omicron BA.4/BA.5-adapted bivalent vaccine. 
On September 1, 2022, we and Pfizer received a positive Committee for Medicinal Products for Human Use (CHMP) opinion and subsequent EC approval for a 30-µg booster dose of Original/Omicron BA.1-adapted bivalent vaccine for individuals aged 12 years and older. The recommendation of the European Medicines Agency (EMA) CHMP was based on safety, tolerability and immunogenicity data from a Phase 2/3 trial of the Original/Omicron BA.1-adapted bivalent vaccine and follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities to work towards introducing an Omicron adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2. The candidate elicited a superior immune response against Omicron BA.1 as compared to our and Pfizer’s original COVID-19 vaccine and was well-tolerated with a favorable safety profile.
On September 12, 2022, the EMA CHMP recommended a 30-µg booster dose of Original/Omicron BA.4/BA.5 bivalent-adapted vaccine for conditional Marketing Authorization (cMA) for individuals aged 12 years and older, followed by EC approval. The CHMP recommendation was based on data from our and Pfizer’s Original/Omicron BA.1-adapted bivalent vaccine as well as preclinical and manufacturing data from the Original/Omicron BA.4/BA.5-adapted bivalent vaccine described above. The Original/Omicron BA.4/BA.5-adapted bivalent vaccine was distributed immediately following positive European Union decision. Local supply may vary based on individual country government requests.
In September 2022, we and Pfizer initiated a Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in children 6 months through 11 years of age. This pediatric study follows a previous Phase 1/2/3 trial in these age groups that demonstrated the original vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent.
In September 2022, we and Pfizer submitted a request to the U.S. FDA for EUA for Original/Omicron BA.4/BA.5-adapted bivalent vaccine booster and also completed a submission for cMA in the European Union for children 5 through 11 years of age. These filings are supported by safety and immunogenicity data from our and Pfizer’s Original/Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from our and Pfizer’s 10-µg Original/Omicron BA.4/BA.5-adapted bivalent vaccine and preclinical data from our and Pfizer’s Original/Omicron BA.4/BA.5-adapted bivalent vaccine.
In October 2022, we and Pfizer received U.S. FDA EUA for the 10-µg booster dose of Original/Omicron BA.4/BA.5-adapted bivalent vaccine in children 5 through 11 years of age. The Centers for Disease Control and Prevention has added COVID-19 vaccines to the agency's lists of recommended regular immunizations
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and recommends that people ages 5 years and older receive one updated bivalent booster if it has been at least 2 months since their last COVID-19 vaccine dose
In November 2022, we and Pfizer reported updated 30-day clinical data from the randomized Phase 2/3 trial evaluating the safety, tolerability and immunogenicity of the companies’ Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, given as a 30-µg booster dose, which started in August 2022. The data demonstrate a robust and broadly neutralizing immune response one month after a 30-µg booster dose. Immune responses were markedly higher for those who received the bivalent vaccine compared to the original COVID-19 vaccine, with similar favorable safety and tolerability profile demonstrated between both vaccines. Clinical data demonstrated that Omicron BA.4/BA.5-neutralizing antibody titers rose 13.2-fold from pre-booster levels in adults over 55 years and 9.5-fold for adults 18 to 55 years, one month post bivalent booster compared to 2.9-fold rise in titers elicited in the same time frame by the original vaccine booster. These results reinforce the early clinical data measured seven days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Original/Omicron BA.4/BA.5 bivalent vaccine may induce higher level of protection against the Omicron BA.4 and BA.5 subvariants than the original vaccine. We and Pfizer have shared these data with the U.S. FDA and plan to share with the EMA and other global health authorities as soon as possible.
In summary, the achievement of these important milestones further underlines the strength of our rapidly adaptable mRNA vaccines against this continuously evolving virus. The flexibility of our mRNA platform and production infrastructure, together with extensive clinical experience with our and Pfizer’s COVID-19 vaccine has allowed us to respond to regulatory requirements for vaccine adaption and develop and manufacture Omicron adapted vaccines at unprecedented speed.
Original COVID-19 vaccine
In July 2022, the U.S. FDA approved the supplemental Biologics License Application to include individuals 12 through 15 years of age in the approved indication, expanding licensure of the vaccine to this age group, which was previously included under U.S. EUA.
In July 2022, we and Pfizer submitted a variation to the EMA requesting to update the cMA in the European Union with data supporting the vaccination of children 6 months through four years of age with the 3-µg dose of the original COVID-19 vaccine as a three-dose series. The submission included data from a Phase 2/3 trial that included 4,526 children of this age group. At the end of treatment, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. The U.S. FDA granted EUA of COVID-19 vaccine as a three 3-µg dose series in this age group in June 2022.
In August 2022, we and Pfizer announced updated efficacy data from a Phase 2/3 trial evaluating a 3-µg dose series of the original COVID-19 vaccine in children 6 months through four years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022. Participants in the study received either the COVID-19 vaccine (3-μg) as a three-dose series or placebo (2:1 randomization). Vaccine efficacy, a secondary endpoint in the trial, was 73.2% without evidence of prior COVID-19 infection. This analysis was based on 13 cases in the Pfizer-BioNTech COVID-19 vaccine group (n=794) and 21 cases in the placebo group (n=351), diagnosed from March to June 2022. Sequencing of observed COVID-19 cases confirmed the majority were caused by Omicron BA.2, consistent with the time period when the cases occurred, broadening the evidence for efficacy across COVID-19 variants.  The vaccine previously received EUA from the U.S. FDA and we and Pfizer submitted for extension of the then cMA in the European Union for this age group.
In September 2022, we and Pfizer were granted approval in the European Union for COMIRNATY as a 10-µg booster (third) dose of the original vaccine given at least 6 months after completion of a primary series for children 5 through 11 years of age. The EMA CHMP recommendation is based on Phase 2/3 clinical data from participants of this age group who received a 10-µg booster dose approximately 6 months after completing the two-dose primary series. The third dose was well tolerated with a favorable safety profile, and generated neutralizing antibodies against both Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis. The U.S. FDA expanded the EUA to include a booster dose in children 5 through 11 years of age in May 2022.
In October 2022, we and Pfizer received EC approval for the conversion of the cMA to full Marketing Authorization (MA). The conversion applies to all existing and upcoming indications and formulations of the COMIRNATY product group authorized in the European Union, including Original/Omicron adapted BA.1- and BA.4/BA.5-adapted bivalent vaccines as booster doses for individuals aged 12 years and older.
In October 2022, we and Pfizer received EC approval for full MA for a 3-µg dose of COMIRNATY as a three-dose series for children aged 6 months through four years.
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In October 2022, we and Pfizer received EC approval for a fourth dose booster of COMIRNATY in individuals 12 years of age and older at an interval of at least three months between the administration of COMIRNATY and the last prior dose of a COVID-19 vaccine.
Our COVID-19 vaccine continues to offer protection post booster vaccination against severe disease, hospitalization and deaths for circulating Omicron sublineages.
We and Pfizer continue to monitor protection offered by the original and Original/Omicron adapted bivalent vaccines against emerging SARS-CoV-2 variants.
Recently published data (Muik et al. Exposure to BA.4/BA.5 Spike glycoprotein drives pan-Omicron neutralization in vaccine-experienced humans and mice; bioRxiv 2022.09.21.508818) suggest that when administered as boosters, mono- and bivalent Original/Omicron BA.4/BA.5-adapted vaccines may enhance neutralization breadth against Omicron sublineages BA.1, BA.2, BA.2.12.1 and BA.4/BA.5. The preclinical data support the assumption that boosting with an Original/Omicron BA.4/5-adapted bivalent vaccine is a suitable strategy to confer a broader neutralization and address both currently circulating Omicron variants as well as potential future emerging Omicron sublineages or new variants of concern that are closer to the wild-type strain.
Next generation COVID-19 vaccines
In addition to variant adapted vaccines, we and Pfizer are identifying and investigating novel next generation vaccine approaches to maintain a broad and longer lasting immune response and high levels of protection against COVID-19 as SARS-CoV-2 evolves. The long-term strategy takes a multipronged approach devised to develop multiple engineered vaccine candidates to enable us and Pfizer to achieve the goal of delivering a pan-SARS-CoV-2-type vaccine that will help to better manage future variants of concern. We and Pfizer expect that scientific data derived from these different approaches will support the selection of the vaccine candidate for evaluation in a pivotal trial.
We and Pfizer plan to test several novel vaccine constructs that have been engineered to engage multiple arms of the immune system, including antibodies and T cells.
In July 2022, a randomized, active controlled, observer-blind Phase 2 study was initiated to evaluate the safety, tolerability and immunogenicity of a 30-µg dose of an enhanced spike antigen vaccine candidate. This is the first 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. Further enhanced spike antigen vaccine candidates that may be combined with T cell enhancing vaccine candidates are expected to enter the clinic in the fourth quarter of 2022.
The first T cell enhancing SARS-CoV-2 vaccine product candidate (BNT164b4) in combination with the Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is expected to enter the clinic in the fourth quarter of 2022. The phase I trial will evaluate the safety, tolerability and the humoral and cell mediated immune response of the T cell enhancing vaccine given in combination with the Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. The T cell enhancing vaccine has been designed to broaden the cellular mediated immunity against SARS-CoV-2 and will be used to complement humoral immunity from the mRNA variant vaccine encoding SARS-CoV-2 S-protein.
COVID-19 – Influenza Combination mRNA Vaccine Program (BNT162b2 + BNT161)
In October 2022, we and Pfizer initiated a Phase 1 open-label, dose-finding study to evaluate the safety, tolerability and immunogenicity of a combination of the COVID-19 and influenza mRNA vaccines to help protect individuals against two severe respiratory viral diseases. The combination vaccine consists of our Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and Pfizer's quadrivalent modified RNA (modRNA) influenza vaccine. The combination vaccine will be tested at different dose levels in approximately 180 healthy adults 18 to 64 years of age Given that annual vaccine programs against both influenza and SARS-CoV-2 may be conducted at a similar time of the year in the future, developing a combined vaccine targeting both viruses has the potential to generate overall higher vaccination rates for both viruses by allowing for more convenient scheduling compared to separate administrations. We and Pfizer are building on the experiences made in the BNT161 program, which pursues development of an influenza vaccine based on our suite of mRNA platforms.
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Influenza Vaccine Program – BNT161
We are collaborating with Pfizer to develop an influenza vaccine based on our suite of mRNA platforms to better address the burden of influenza and further reduce the yearly rates of the severe outcomes of viral disease like influenza, including hospitalization and death.
BNT161 – A Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of a single dose of BNT161, a quadrivalent nucleoside-modRNA influenza vaccine candidate, is ongoing.
In July 2022, positive immunogenicity data from the Phase 2 expansion study of BNT161 were reported.
In September 2022, Pfizer announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of a quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults. Upon potential approval and commercialization, we are eligible to receive milestone payments and a royalty on Pfizer’s worldwide sales.
Shingles Vaccine Program
We are collaborating with Pfizer to develop the first mRNA-based shingles vaccine candidate. The goal is to develop an mRNA vaccine candidate with a favorable safety profile and high efficacy, utilizing a scalable manufacturing technology to support global access. Clinical trials are expected to start in the fourth quarter of 2022.
Further Infectious Disease Programs
Prevention and treatment of infectious diseases is a long-term growth pillar for us, and our objective is to be a leader in mRNA vaccines for infectious diseases. With investments in multiple programs to address diseases with a major impact on global population health and on people in lower income countries, we are advancing our pipeline of mRNA vaccines and therapeutics to address multiple high-need indications. In 2023 we expect to start up to five vaccine clinical trials in infectious diseases.
Tuberculosis Vaccine Program – BNT164
We have collaborated with the Bill & Melinda Gates Foundation since 2019 to develop vaccine candidates to protect against tuberculosis infection and disease. A first-in-human clinical trial for one such candidate, BNT164, is expected to enter the clinic in early 2023.
Malaria Vaccine Program – BNT165
We are developing an mRNA vaccine candidate to protect against malaria and disease-associated mortality. We will assess several vaccine candidates, featuring known targets such as circumsporozoite protein (CSP) as well as other antigens. We are on track to start a clinical trial in the fourth quarter of 2022 or early 2023.
HSV 2 Vaccine Program – BNT163
As part of the collaboration with the University of Pennsylvania, we are developing a Herpes Simplex Virus Type 2 (HSV 2) vaccine candidate. We are on track to start a clinical trial in the fourth quarter of 2022.
Research Collaboration with University of Pennsylvania
We have a research collaboration with the University of Pennsylvania under which we have the exclusive option to develop and commercialize prophylactic mRNA immunotherapies for the treatment of up to 10 infectious disease indications.
Oncology
Our immuno-oncology strategy is based on pioneering approaches that harness the immune response to treat cancer. We have multiple clinical stage assets across different therapeutic classes which have the potential to tackle tumors using complementary strategies, either by targeting tumor cells directly or by modulating the immune response against the tumor. These drug classes include mRNA therapeutic vaccines, cell therapies (CAR-, TCR-, and neoantigen-specific T-cell therapies), mRNA-encoded effector molecules (RiboMabs and RiboCytokines), next generation immune checkpoint inhibitors and agonists, anti-tumor antibodies and immune-modulatory small molecules. Many product candidates have the potential to be combined with other pipeline assets or already approved therapies.
This diverse toolkit of different technologies and modes of action has the potential to address a broad range of solid tumors in different disease stages, using both off-the-shelf and individualized approaches. For our antigen-specific
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immune therapies, we have assembled libraries of more than 300 proprietary or known shared antigens and have developed predictive algorithms capable of efficiently identifying multiple neoantigens on an individualized basis for any patient. Our clinical stage oncology pipeline includes a total of 19 product candidates in 24 ongoing clinical trials, including five randomized Phase 2 clinical trials: two FixVac programs (BNT111 and BNT113), two indications for our iNeST product candidate autogene cevumeran (BNT122/RO7198457), and the bispecific antibody immune checkpoint modulator BNT311 (GEN1046).
In the third quarter of 2022, we started three first-in-human clinical trials: BNT116, a FixVac program for non-small cell lung cancer (NSCLC), BNT142, a bispecific RiboMab targeting CD3 on T cells and Claudin-6 (CLDN6) in solid tumors and most recently BNT313, a HexaBody targeting C27, a new product candidate from our collaboration with Genmab being evaluated in solid tumors.
We expect continued pipeline advancement and expansion as well as one more data readout from an ongoing trial for the remainder of 2022. In 2023, we expect to provide up to ten clinical trial updates in Oncology.
FixVac
Our off-the-shelf cancer immunotherapy approach, FixVac, leverages our proprietary uridine mRNA (uRNA) technology to prime T cells and booster T cell immunity against common tumor-specific non-mutated antigens, resulting in a strong antigen-specific immune response.
FixVac product candidates are designed to trigger both innate and adaptive immune responses and may be of clinical utility in combination with anti-PD1 in patients with lower mutational burden tumors, including those who have already experienced checkpoint inhibitor, or CPI, therapy.
BNT111 in advanced melanoma.
A global, randomized three-arm Phase 2 trial evaluating BNT111 in combination with cemiplimab (Regeneron's Libtayo®) versus both agents as monotherapy in patients with anti-PD1-/anti-PD-L1 refractory/relapsed, unresectable Stage III or IV melanoma is ongoing. The primary endpoint is overall response rate of BNT111 in combination with cemiplimab. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety. The trial is being conducted in collaboration with Regeneron.
BNT111 is also in an ongoing Phase 1 trial for the treatment of advanced melanoma.
BNT112 in prostate cancer.
BNT112 is being evaluated in an ongoing first-in-human Phase 1/2 dose titration and expansion trial to evaluate safety, immunogenicity and preliminary efficacy of BNT112 monotherapy and in combination with cemiplimab in patients with prostate cancer.
The recruitment of new patients to this clinical trial, which we refer to as PRO-MERIT, is temporarily halted until further notice due to unforeseen supply issues with the BNT112 investigational medicinal product. For patients who are currently enrolled in the trial, the treatment is continuing per protocol.
BNT113 in HPV16+ head and neck cancer.
A randomized Phase 2 trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma, or HNSCC, expressing PD-L1 is ongoing. Primary endpoints include safety, overall survival and objective response rate. Secondary endpoints include progression free survival, durable complete responses, duration of response, patient reported outcomes and quality of life measures. Preliminary safety data from the non-randomized safety run-in part that precedes the randomized part of the Phase 2 trial are planned to be presented at the ESMO-Immuno-Oncology annual congress in December 2022.
An investigator sponsored Phase 1/2 dose escalation trial of BNT113 in patients with HPV16+ head and neck and other cancers is ongoing.
BNT116 in advanced or metastatic non-small-cell lung cancer, or NSCLC.
BNT116 is being evaluated in a Phase 1 clinical trial. The FixVac product candidate encodes for six tumor-associated antigens that cover up to 100% of patients in all major histologic subtypes of NSCLC and aims to elicit a tumor-antigen-specific immune response.
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In July 2022, the first participant was dosed in a first-in-human clinical trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combination with cemiplimab (anti-PD-1, Regeneron's Libtayo) in patients with advanced or metastasized NSCLC. The trial is intended to establish a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab in patients who have progressed on prior PD-1 inhibitor treatment or are not eligible for chemotherapy, and in combination with docetaxel in patients who have received prior platinum-based chemotherapy.
A second trial evaluates BNT116 alone and in combination with cemiplimab (Regeneron's Libtayo) as first-line treatment of patients with advanced NSCLC whose tumors express programmed cell death ligand-1 (PD-L1) in ≥ 50% of tumor cells. The primary objective of the Phase 1/2 is to assess the safety and tolerability as well as the objective response rate (ORR) and tumor burden reduction. The trial is expected to dose the first patient in the fourth quarter of 2022 and is sponsored by Regeneron.
Individualized Neoantigen Specific Immunotherapies, or iNeST
Our iNeST approach is also based on a pharmacologically optimized uRNA delivered in our proprietary RNA-LPX formulation.
Each patient is treated with a vaccine informed by the mutation profile of their personal cancer and manufactured on-demand. The RNA encodes a unique composition of the patient’s own tumor mutations and results in generation of neoantigen specific CD4+ and CD8+ T-cell responses. We believe this modality is well-suited for use in early-stage cancers and the adjuvant setting.
Autogene cevumeran (BNT122) – Our lead iNeST product candidate, autogene cevumeran, is being developed as part of a co-development and co-commercialization collaboration with Genentech, a member of the Roche Group.
An open-label Phase 2 trial evaluating the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated advanced melanoma is ongoing. The primary endpoint is progression-free survival, or PFS, of patients treated with autogene cevumeran compared with patients receiving pembrolizumab alone, according to RECIST v1.1. Secondary endpoints include objective response rate, or ORR, overall survival, or OS, duration of response, or DOR, and safety. A data update is expected in the first half of 2023.
A randomized Phase 2 trial of autogene cevumeran in the adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III colorectal cancer is ongoing. The trial is expected to enroll about 200 patients to evaluate the efficacy 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 medical need for novel therapies to treat colorectal cancer, the second deadliest cancer worldwide, remains high. The current standard of care in this indication is watchful waiting to see if tumors recur after removal of the primary tumor and adjuvant chemotherapy. A proportion of these patients are expected to have a recurrence of their tumor within 2-3 years after their surgery. For this clinical trial, patients at high risk for recurrence will be selected with a highly sensitive blood test detecting ctDNA.
An open-label Phase 1a/1b trial evaluating the safety, tolerability, immune response and pharmacokinetics of autogene cevumeran (BNT122) as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors (basket trial) is ongoing.
Preliminary data from an investigator-initiated Phase 1 clinical trial of autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with surgically removed pancreatic ductal adenocarcinoma (PDAC) presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting showed a tolerable safety profile and in eight out of 16 treated patients encouraging immune responses. Based on these data, we and Genentech are planning a randomized study to further evaluate the efficacy and safety of autogene cevumeran in combination with atezolizumab and chemotherapy in patients with resected PDAC.
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mRNA Intratumoral Immunotherapy
We, in collaboration with Sanofi, are developing intratumoral immunotherapies utilizing our proprietary mRNA technology. The product candidate SAR441000 (BNT131) consists of modified mRNA encoding immunomodulatory cytokines for direct intratumoral injection.
SAR441000 (BNT131) – A Sanofi-sponsored Phase 1 clinical trial as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor in patients with advanced solid tumors is ongoing.
RiboMabs
Our RiboMab product candidates, BNT141 and BNT142, are mRNAs that encode cancer cell targeting antibodies. These product candidates leverage our proprietary optimized mRNA technology combining nucleoside modifications to minimize immunogenicity with our improved mRNA backbone designs with the aim of maximizing protein expression.
RiboMabs may address the limitations of recombinant antibodies, including costly manufacturing processes and unfavorable pharmacokinetics.
BNT141 encodes an antibody targeting Claudin18.2, expressed in high unmet medical need tumors, including multiple epithelial solid tumors, such as gastric, biliary and pancreatic cancers. BNT142 encodes a bispecific T cell engaging antibody that targets CD3, a T cell receptor component, and CLDN6, an oncofetal cell surface antigen found in solid tumors such as testicular and ovarian cancers.
BNT141 – An open-label, multi-site Phase 1/2 dose escalation, safety and pharmacokinetic trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors is ongoing. The trial is evaluating dose escalation as monotherapy in patients with unresectable or metastatic cancers, followed by dose escalation in combination with chemotherapy in patients with advanced unresectable or metastatic CLDN18.2-positive pancreatic adenocarcinoma or cholangiocarcinoma. After dose escalation, expansion cohorts will be evaluated.
BNT142 – In July 2022, the first patient was dosed in an open-label, multi-center Phase 1/2 dose escalation, safety, and pharmacokinetic trial of BNT142 followed by expansion cohorts in patients with CLDN6-positive advanced solid tumors. The trial is evaluating BNT142 as monotherapy in patients that have exhausted therapy or are not eligible for standard of care therapy. After dose escalation, BNT142 will be evaluated in expansion cohorts in testicular cancer, ovarian cancer, and non-squamous NSCLC.
RiboCytokines
BNT151 and BNT152+153 are nucleoside-modified mRNAs encoding human cytokines fused to human serum albumin. The modified mRNA is formulated with liver-targeting lipid nanoparticles, or LNP, for intravenous delivery. BNT151 encodes an IL-2 variant, BNT152 encodes IL-7 and BNT153 encodes IL-2.
Our RiboCytokine product candidates aim to address the limitations of recombinantly expressed cytokines, including toxicity, limited serum half-life and production costs.
BNT151 – A first-in-human, open-label, multi-center Phase 1/2 trial of BNT151 (encoding an IL-2 variant) in multiple solid tumor indications is ongoing. Part 1 of the trial is the monotherapy dose escalation and will enroll patients with tumors that are metastatic or unresectable with no available standard therapy likely to confer clinical benefit. In Part 2, the combined treatment dose escalation, patients with different solid tumors will be enrolled and treated with BNT151 and other potential combination agents.
BNT152+153 – A first-in-human Phase 1 trial evaluating a combination of BNT152 (encoding IL-7) and BNT153 (encoding IL-2) in patients with various solid tumors is ongoing. In parallel, BNT152 and BNT153 monotherapy dose escalation in Part 1 will determine the Part 2 starting dose of each compound in combination. Part 2 will be the combination dose finding of BNT152 and BNT153.
CAR-T Cell Immunotherapy
BNT211 is a chimeric antigen receptor (CAR) directing T cells against the novel target CLDN6 that is tested alone and in combination with a CAR-T cell-amplifying RNA vaccine, or CARVac, encoding CLDN6. CARVac is also based on a pharmacologically optimized uRNA backbone delivered in our proprietary RNA-LPX formulation. CLDN6 CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity for the tumor-specific
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carcino-embryonic antigen CLDN6. CARVac drives in vivo expansion of transferred CAR-T cells, aiming to increase their persistence and efficacy. BNT211 aims to overcome CAR-T cell therapy limitations in patients with solid tumors.
A Phase 1/2 open-label dose escalation and dose expansion trial evaluating BNT211 in patients with CLDN6 positive solid tumors is ongoing. The trial evaluates CLDN6 CAR-T cells dosed as monotherapy and in combination with CLDN6 CARVac.
In September 2022, encouraging follow-up data from the ongoing trial evaluating the safety and preliminary efficacy of BNT211 in patients with relapsed or refractory solid tumors were presented at the European Society for Medical Oncology (ESMO) Congress 2022. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. Efficacy assessment of the 21 evaluable patients showed a best overall response rate (ORR) of 33% and a disease control rate (DCR) of 67% with one complete response, six partial responses and seven patients with stable disease. In line with the earlier data presented, particularly encouraging clinical responses were seen in patients with testicular cancer treated with dose level 2 after lymphodepletion (n=7), where one complete response, three partial responses and two stable diseases were observed, representing an ORR of 57% and a DCR of 85%. 
These encouraging results build on the positive interim data presented earlier at the American Association for Cancer Research, or AACR, Conference in April 2022 and at the annual meeting of the Association for Cancer Immunotherapy, or CIMT, in May 2022, reinforcing our strategy to combine two of our key technology platforms in hard-to-treat tumor indications.
In June 2022, the EMA granted Priority Medicines (PRIME) designation to BNT211 for the third- or later-line treatment of testicular germ cell tumors.
Neoantigen-Targeting T Cell Therapy
BNT221 (NEO-PTC-01) is our individualized neoantigen-targeting T cell therapy which targets selected sets of individualized tumor neoantigens.
A first-in-human Phase 1 dose escalation trial evaluating BNT221 in patients with checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. Part 1 of the trial consists of a monotherapy dose escalation of BNT221. In Part 2, BNT221 will be dosed in combination with anti-PD1 therapy after first-line treatment.
Next Generation Immunomodulators
We are developing, in collaboration with Genmab, bispecific antibodies that function as tumor-targeted and dual immunomodulators, applying Genmab’s proprietary DuoBody technology in combination with our joint target identification and product concept expertise.
These next generation immune checkpoint modulators are designed to prime and activate anti-tumor T cell and Natural Killer cell function.
BNT311 and BNT312 are partnered with Genmab as part of a 50/50 collaboration in which development costs and future profit are shared.
BNT311 (GEN1046) is a first-in-class bispecific antibody combining PD-L1 checkpoint inhibition with 4-1BB checkpoint activation. BNT312 (GEN1042) is a first-in-class bispecific antibody aiming to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells.
BNT311 (GEN1046) – A Phase 2, multicenter, randomized, open-label trial of BNT311 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC after treatment with standard of care therapy with an immune checkpoint inhibitor is ongoing. The primary endpoint of the study is ORR according to RECIST v1.1. Secondary endpoints include DOR, time to response, PFS, OS and safety. Preliminary safety data from the non-randomized safety run-in that precedes the randomized part of the Phase 2 trial are planned to be presented at the ESMO-Immuno-Oncology annual congress in December 2022.
A Phase 1/2 trial with expansion cohorts in patients with solid tumors is ongoing. Multiple expansion cohorts are ongoing, including patients with NSCLC, triple negative breast cancer or TNBC, urothelial cancer, squamous cell carcinoma of the head and neck, or SCCHN, and cervical cancer.
BNT312 (GEN1042) - A Phase 1/2 trial in patients with solid tumors is ongoing. Expansion cohorts in melanoma, NSCLC, pancreatic and head and neck carcinoma are recruiting for combination regimens of BNT312 in these indications. Safety and preliminary efficacy data of BNT312 combination therapy in patients
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with advanced solid tumors are planned to be presented at the ESMO-Immuno- Oncology annual congress in December 2022.
In August 2022, we announced the expansion of our global strategic collaboration with Genmab for the joint development of BNT313 (GEN1053), a monospecific antibody candidate targeting CD27 to address malignant solid tumors. It is based on Genmab's HexaBody technology and is engineered to induce clustering of CD27 on the plasma membrane of T cells with the aim to enhance T cell activation, proliferation and differentiation without depleting T cells. Under this 50/50 collaboration, the development costs and potential future profits for BNT313 will be shared equally.
BNT313 (GEN1053) – In November 2022, a Phase 1 trial was initiated to evaluate the safety, tolerability, and preliminary efficacy of BNT313 as a monotherapy for the treatment of malignant solid tumors. The dose escalation part will explore the safety of escalating doses of BNT313. The expansion part is planned to provide additional safety and initial antitumor activity information on the selected dose regimen in selected tumor indications, as well as more detailed data related to the mode of action.
At the 37th Annual meeting of the Society for Immunotherapy of Cancer (SITC) in November 2022, we intend to present preclinical data that characterize the mechanism of action of HexaBody-CD27. In the in vitro experiments, HexaBody-CD27 exhibited CD27 agonist activity independently of Fc gamma receptor-mediated crosslinking. HexaBody-CD27 enhanced activation, proliferation, and proinflammatory cytokine secretion of human CD4+ and CD8+ T cells as well as CD8+ T -cell mediated cytotoxic activity towards tumor cells in vitro. In mice expressing human CD27 protein, it enhanced expansion and IFN-γ secretion of antigen-specific CD8+ T cells in vivo. Overall, the data demonstrated a unique potential mechanism of action that distinguishes HexaBody-CD27 from benchmark monoclonal antibodies targeting CD27.
Targeted Cancer Antibodies
BNT321 (MVT-5873) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope on CA19-9 that is expressed in pancreatic and other solid tumors that plays a role in tumor adhesion and metastasis formation and is a marker of an aggressive cancer phenotype.
BNT321 is currently in Phase 1 clinical development in pancreatic cancer and other CA19-9 expressing solid tumors.
Small Molecule Immunomodulators
BNT411 is our novel small molecule TLR7 agonist product candidate designed to activate both the adaptive and innate immune system through the TLR7 pathway.
A Phase 1/2 dose-escalation trial of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer, or ES-SCLC, is ongoing.
Rare Disease Protein Replacement Therapies
We are collaborating with Genevant to combine our mRNA technology with Genevant’s LNP delivery technology, to create up to five mRNA protein replacement therapies for the treatment of rare diseases with high unmet medical needs. Currently, we have placed the programs on hold in order to focus on other disease areas.
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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
September 30,
Nine months ended
September 30,
2022202120222021
(in millions, except per share data)(unaudited)(unaudited)(unaudited)(unaudited)
Revenues
Commercial revenues€3,394.8€6,040.1€12,923.3€13,348.1
Research & development revenues66.447.2109.096.1
Total revenues€3,461.2€6,087.3€13,032.3€13,444.2
Cost of sales(752.8)(1,211.4)(2,811.5)(2,328.3)
Research and development expenses(341.8)(260.4)(1,027.2)(677.7)
Sales and marketing expenses(12.8)(10.5)(44.9)(32.5)
General and administrative expenses (141.0)(68.2)(361.8)(154.9)
Other operating expenses (285.1)(26.4)(594.6)(27.3)
Other operating income 459.8213.11,157.5360.6
Operating income€2,387.5€4,723.5€9,349.8€10,584.1
Finance income60.926.6448.551.4
Finance expenses(4.3)(82.7)(16.8)(303.0)
Profit before tax€2,444.1€4,667.4€9,781.5€10,332.5
Income taxes(659.2)(1,456.4)(2,625.8)(3,206.2)
Profit for the period€1,784.9€3,211.0€7,155.7€7,126.3
Earnings per share
Basic profit for the period per share€7.43€13.14€29.47€29.22
Diluted profit for the period per share€6.98€12.35€27.70€27.46
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, 2021.
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Operational Impacts of COVID-19
As we advance our clinical programs, we are in close contact with our principal investigators and clinical sites, and are assessing the impact on the clinical trials, expected timelines and costs on an ongoing basis. For certain programs, including BNT111, BNT113, BNT122, BNT141 and BNT142 (RiboMabs), BNT151 and BNT152/153 (RiboCytokines) and BNT161 (Influenza), delays in the commencement of trials were experienced, due to slowed patient enrollment and other delays as a result of the COVID-19 pandemic. After several months of delay to focus efforts on our COVID-19 vaccine in 2020, in 2021 we started four Phase 2 clinical trials: two for our FixVac product candidates BNT111 and BNT113, one each for our iNeST program BNT122 as well as for our bispecific antibody program BNT311. In addition, we have started multiple Phase 1 clinical trials in 2021 and 2022 that include product candidates for BNT211 (CARVac), BNT221 (NEO-PTC-01, a neoantigen-based T-cell therapy), BNT151 and BNT152+153 (RiboCytokines), BNT116 (FixVac), BNT141 (RiboMab) and BNT142 (RiboMab). The delays, even though they were temporary, may negatively impact our operations and overall business by delaying further progress of these clinical trials and preclinical studies. Our operations, including research and manufacturing, could also be negatively impacted due to the potential impact of staff absences as a result of self-isolation procedures or extended illness. Such factors were evaluated and considered when preparing this Quarterly Report as of and for the three and nine months ended September 30, 2022. We will continue to evaluate observed and potential effects of the COVID-19 pandemic.
COVID-19 Collaborations
In response to the COVID-19 pandemic, we initiated our COVID-19 vaccine development program, BNT162, in late January 2020, leveraging our proprietary mRNA platform, and assembled a global consortium of partners including Pfizer (marketing and distribution rights worldwide with the exception of China, Germany and Turkey) and Fosun Pharma (marketing and distribution rights in China, Hong Kong special administrative region, or SAR, Macau SAR and the region of Taiwan).
Details about our COVID-19 collaborations are described further in our Key Pipeline Updates above, Items 4 and 5 of our Annual Report on Form 20-F as of and for the year ended December 31, 2021, as well as the notes to our audited consolidated financial statements included in that Annual Report.
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Comparison of the three and nine months ended September 30, 2022 and 2021
Revenues
The following is a summary of revenues recognized for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
Revenues
Commercial revenues€3,394.8€6,040.1€(2,645.3)(44)
COVID-19 vaccine revenues3,378.16,021.6(2,643.5)(44)
Sales to collaboration partners(1)
259.4312.3(52.9)(17)
Direct product sales to customers564.51,350.8(786.3)(58)
Share of collaboration partners' gross profit and sales milestones2,554.24,358.5(1,804.3)(41)
Other sales16.718.5(1.8)(10)
Research & development revenues from collaborations€66.4€47.2€19.241
Total revenues€3,461.2€6,087.3€(2,626.1)(43)
(1)    Represents sales to our collaboration partners of products manufactured by us.
Nine months ended
September 30,
Change
(in millions)20222021%
Revenues
Commercial revenues€12,923.3€13,348.1€(424.8)(3)
COVID-19 vaccine revenues12,883.913,303.2(419.3)(3)
Sales to collaboration partners(1)
1,470.9514.3956.6186
Direct product sales to customers2,284.62,586.2(301.6)(12)
Share of collaboration partners' gross profit and sales milestones9,128.410,202.7(1,074.3)(11)
Other sales39.444.9(5.5)(12)
Research & development revenues from collaborations€109.0€96.1€12.913
Total revenues€13,032.3€13,444.2€(411.9)(3)
(1)    Represents sales to our collaboration partners of products manufactured by us.
For the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our total revenues from contracts with customers decreased by €2,626.1 million from €6,087.3 million to €3,461.2 million, whereas our total revenues on a year-to-date basis slightly decreased by €411.9 million from €13,444.2 million during the nine months ended September 30, 2021 to €13,032.3 million during the nine months ended September 30, 2022. We believe the development of the pandemic remains dynamic which influences the switch from the BNT162b2 vaccine to an Omicron-adapted bivalent vaccine, thereby causing a re-phasing of orders from those made earlier in the year to a later time in the year. These developments are leading to fluctuations in quarterly revenues which we expect to remain over the rest of the financial year with an uptake in demand in our key markets in the fourth quarter of 2022 related to the Omicron-adapted bivalent vaccine.
We are the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada and other countries, and holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries; submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Shanghai Fosun Pharmaceutical (Group) Co., Ltd, or Fosun Pharma, has marketing and distribution rights in China, Hong Kong special administrative region, or SAR, Macau SAR and the region of Taiwan. The allocation of marketing and distribution rights defines territories in which the collaboration partners act as a principal.
Whenever responsibilities in the manufacturing and supply process of the COVID-19 vaccine shift and our COVID-19 vaccine is transferred, the vaccine is sold from one partner to the other. During the three and nine months ended September 30, 2022, we recognized €259.4 million and €1,470.9 million of revenues, respectively, from selling
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drug product batches manufactured by us to our partners. During the comparative periods, three and nine months ended September 30, 2021, the revenues derived from sales to collaboration partners amounted to €312.3 million and €514.3 million were recognized, respectively.
By supplying our territories during the three and nine months ended September 30, 2022, we recognized €564.5 million and €2,284.6 million of revenues, respectively, from direct COVID-19 vaccine sales in our territory. During the comparative periods, three and nine months ended September 30, 2021, recognized revenues derived from those sales amounted to €1,350.8 million and €2,586.2 million, respectively. The share of gross profit that we owe our collaboration partner Pfizer based on our sales is recognized as cost of sales.
Based on COVID-19 vaccine sales in the collaboration partners’ territories, we are eligible to receive a share of their gross profit which represents a net figure and is recognized as collaboration revenues during the commercial phase together with sales milestones that are recorded once the underlying thresholds are met. During the three months ended September 30, 2022, €2,554.2 million gross profit share was recognized as revenues. During the comparative period, three months ended September 30, 2021, €4,189.9 million gross profit share and €168.6 million of sales milestones were recognized as revenues. During the nine months ended September 30, 2022, €9,128.4 million of gross profit share were recognized. During the comparative period, nine months ended September 30, 2021, €9,786.9 million of gross profit share and €415.8 million of sales milestones were recognized as revenues. In order to determine our share of our collaboration partners’ gross profits, we used certain information from the collaboration partners, some of which is based on preliminary data shared between the partners and might vary once final data is available. The true-up recognized prospectively during the three and nine months ended September 30, 2022 and 2021, with respect to the previous period, was not material.
Cost of Sales
The following table summarizes our cost of sales for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
Cost of sales
Cost of sales related to COVID-19 vaccine revenues€737.8€1,194.8€(457.0)(38)
Cost related to other sales15.016.6(1.6)(10)
Total cost of sales€752.8€1,211.4€(458.6)(38)
Nine months ended
September 30,
Change
(in millions)20222021%
Cost of sales
Cost of sales related to COVID-19 vaccine revenues€2,779.4€2,290.1€489.321
Cost related to other sales32.138.2(6.1)(16)
Total cost of sales€2,811.5€2,328.3€483.221
From the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our cost of sales decreased by €458.6 million from €1,211.4 million to €752.8 million but on a year-to-date basis still increased by €483.2 million from €2,328.3 million during the nine months ended September 30, 2021 to €2,811.5 million during the nine months ended September 30, 2022. The change in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues which included the share of gross profit owed to our collaboration partner Pfizer. In addition, cost of sales was impacted by expenses arising from inventory write-offs and expenses for production capacities derived from contracts with Contract Manufacturing Organizations, or CMOs, that became redundant as a direct result of the introduction of a new COVID-19 vaccine formulation, the switch from the BNT162b2 vaccine to an Omicron-adapted bivalent vaccine and due to increased internal manufacturing capacities during the three and nine months ended September 30, 2022.
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Research and Development Expenses
The following table summarizes our research and development expenses for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
Research and development expenses
Laboratory supplies€191.3€10.2€181.1n.m.
Wages, benefits and social security expense122.870.052.875
Depreciation and amortization13.68.55.160
Purchased services160.8(160.8)(100)
Other14.110.93.229
Total research and development expenses€341.8€260.4€81.431
Nine months ended
September 30,
Change
(in millions)20222021%
Research and development expenses
Purchased services€361.4€402.6€(41.2)(10)
Laboratory supplies297.038.1258.9680
Wages, benefits and social security expense279.1185.793.450
Depreciation and amortization36.023.112.956
Other53.728.225.590
Total research and development expenses€1,027.2€677.7€349.552
From the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our research and development expenses increased by €81.4 million or 31% from €260.4 million to €341.8 million as well as by €349.5 million from €677.7 million during the nine months ended September 30, 2021 to €1,027.2 million during the nine months ended September 30, 2022 mainly due to increased research and development expenses in the period incurred as well as an increase in wages, benefits and social security expenses resulting from an increase in headcount and higher expenses in the context of the share based payments. Purchased services also include costs related to the manufacturing of pre-launch Omicron vaccine candidates charged from collaboration partners. Until regulatory approval is obtained, if ever, it is not clear whether these costs will be finally shared as research and development expenses or if these costs are finally part of the partner's gross profit share. Accordingly, research and development expenses are impacted by write-down expenses charged by collaboration partners and may change before respective regulatory approval has been obtained, if ever.
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General and Administrative Expenses
The following table summarizes our general and administrative expenses for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
General and administrative expenses
Purchased services€38.7€14.6€24.1165
Wages, benefits and social security expense37.822.515.368
IT and office equipment23.76.317.4276
Insurance premiums17.714.73.020
Other23.110.113.0129
Total general and administrative expenses €141.0€68.2€72.8107
Nine months ended
September 30,
Change
(in millions)20222021%
General and administrative expenses
Wages, benefits and social security expense€108.3€53.9€54.4101
Purchased services103.638.165.5172
IT and office equipment57.514.343.2302
Insurance premiums32.223.48.838
Other60.225.235.0139
Total general and administrative expenses €361.8€154.9€206.9134
From the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our general and administrative expenses increased by €72.8 million or 107% from €68.2 million to €141.0 million as well as by €206.9 million from €154.9 million during the nine months ended September 30, 2021 to €361.8 million during the nine months ended September 30, 2022 mainly due to recognizing increased expenses for purchased external services as well as an increase in wages, benefits and social security expenses resulting from an increase in headcount.
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Other Operating Income / Expenses
The following table summarizes our other result, including other operating income and expenses, for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
Other result
Other operating income€459.8€213.1€246.7116
Foreign exchange differences, net449.1190.3258.8136
Government grants0.220.9(20.7)(99)
Other10.51.98.6453
Other operating expenses€(285.1)€(26.4)€(258.7)980
Loss on derivative instruments at fair value through profit or loss(282.7)(24.9)(257.8)n.m.
Other(2.4)(1.5)(0.9)60
Total other result€174.7€186.7€(12.0)(6)
Nine months ended
September 30,
Change
(in millions)20222021%
Other result
Other operating income€1,157.5€360.6€796.9221
Foreign exchange differences, net1,090.1265.4824.7311
Government grants0.288.9(88.7)(100)
Other67.26.360.9967
Other operating expenses€(594.6)€(27.3)€(567.3)n.m.
Loss on derivative instruments at fair value through profit or loss(581.7)(24.9)(556.8)n.m.
Other(12.9)(2.4)(10.5)438
Total other result€562.9€333.3€229.669
From the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our total other result decreased by €12.0 million from €186.7 million to €174.7 million but increased by €229.6 million from €333.3 million during the nine months ended September 30, 2021 to €562.9 million during the nine months ended September 30, 2022 mainly due to recording higher other income from foreign exchange differences arising on operating items. The increase reflects the change in foreign exchange rate and primarily related to our U.S. dollar denominated trade receivables which mainly resulted from our COVID-19 collaboration with Pfizer, compensated by the foreign exchange rate effects of our U.S. dollar denominated trade payables as well as U.S. dollar denominated other financial liabilities which mainly resulted from obligations incurred from our license agreements. The increasing effect was offset by recording changes in fair values of foreign exchange forward contracts that we entered into to manage some of our transaction exposures but were not designated as hedging instruments under IFRS. In addition, other income related to government grants recognized in the prior year period did not re-occur during the three and nine months ended September 30, 2022.
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Finance Income / Expenses
The following table summarizes our finance result for the periods indicated:
Three months ended
September 30,
Change
(in millions)20222021%
Finance result
Finance income€60.9€26.6€34.3129
Foreign exchange differences, net53.226.027.2105.0
Interest income7.70.67.1n.m.
Finance expenses€(4.3)€(82.7)€78.4(95)
Interest expenses related to financial assets(2.5)(2.5)
Interest expenses related to lease liabilities(1.7)(0.8)(0.9)113
Amortization of financial instruments(0.1)(0.4)0.3(75)
Fair value adjustments of financial instruments measured at fair value(81.5)81.5(100)
Total finance result€56.6€(56.1)€112.7(201)
Nine months ended
September 30,
Change
(in millions)20222021%
Finance result
Finance income€448.5€51.4€397.1773
Foreign exchange differences, net222.050.2171.8342
Fair value adjustments of financial instruments measured at fair value216.8216.8
Interest income9.71.28.5708
Finance expenses€(16.8)€(303.0)€286.2(94)
Interest expenses related to financial assets(10.8)(10.8)
Amortization of financial instruments(2.7)(7.6)4.9(64)
Interest expenses related to lease liabilities(3.3)(2.0)(1.3)65
Fair value adjustments of financial instruments measured at fair value(293.4)293.4(100)
Total finance result€431.7€(251.6)€683.3(272)
From the three months ended September 30, 2022 compared to the three months ended September 30, 2021, our total financial result increased by €112.7 million from a negative financial result of €56.1 million to a positive financial result of €56.6 million as well as by €683.3 million from a negative financial result of €251.6 million during the nine months ended September 30, 2021 to a positive financial result of €431.7 million during the nine months ended September 30, 2022, mainly due to increased income arising from the final fair value measurement adjustments of the derivative embedded within the convertible note upon early redeeming the convertible note as of March 1, 2022, the redemption date (see Note 6 of our unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report). In addition, finance income was increased with respect to recognizing foreign exchange differences arising on financing items (i.e. U.S. dollar denominated cash and cash equivalents).
Income Taxes
For the nine months ended September 30, 2022 and 2021, 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 plus the tax effect of any discrete items. For the nine months ended September 30, 2022 and 2021, our effective income tax rates were approximately 26.8% and 31.0%, respectively. The effective income tax rate decreased in part due to average trade tax rates in Mainz, Marburg and Idar-Oberstein decreasing from 2022 onward. During the three and nine months ended September 30, 2022, current income taxes were recognized with respect to the German tax group. Deferred tax effects were recognized with respect to identified discrete items. In addition, the non-tax effective fair value measurement of the convertible note was considered as permanent difference for the nine months ended September 30, 2022. As of September 30, 2022, we continue to
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maintain a valuation allowance against deferred tax assets of our U.S. tax group as there is not sufficient probability in terms of IAS 12 that there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized.
On November 15, 2018, we established a share option program pursuant to which we were permitted to grant selected employees and our Management Board options to receive shares in the Company. The program is designed as an Employee Stock Ownership Plan, or ESOP. We offered the participants a certain number of rights, or Option Rights, subject to their explicit acceptance. Grants under the ESOP took place from November 2018 until December 2019. An exercise of Option Rights in accordance with the terms of the ESOP gives a participant the right to obtain shares against payment of the exercise price. By way of an updated decision of the Supervisory Board at the end of September 2022 compared to the initial settlement mechanism, an ESOP settlement may be made by delivery to the participant of such number of ADSs equal to the net value of the exercised Option Rights after deduction of (i) the exercise price and (ii) the applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social security contributions resulting from such exercise. The respective number of ADS shall be settled with ADS acquired in the course of the share repurchase program. The applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social security contributions resulting from such exercise are paid in cash directly to the respective authorities. Tax expenses on the settlement are only recognized once the Option Rights have been exercised. The updated decision of the Supervisory Board on the settlement mechanism of Option Rights end of September 2022 led based on IAS 12 to a deferred tax asset in the total amount of €395.2 million as of September 30, 2022. Thereof a deferred tax asset in the amount of €23.2 million is recognized as income taxes in our unaudited interim condensed consolidated statements of profit or loss to the extend expenses have been recognized with an effect of profit and loss in the past. In accordance with IAS 12.68c the remainder in the amount of €372.0 million is recognized directly in equity with in as other reserves in our unaudited interim condensed consolidated statements of changes in stockholders’ equity.
Related Party Transactions
Related party transactions that occurred during the three and nine months ended September 30, 2022 and 2021 are explained in Note 11 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report.
Critical Accounting Policies and Use of Estimates
Our unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2022 have been prepared in accordance with IFRS, as issued by the IASB.
The preparation of the unaudited interim condensed consolidated financial statements in accordance with IFRS requires the use of estimates and assumptions by the management that affect the value of assets and liabilities as reported on the balance sheet date, and revenues and expenses arising during the respective reporting period. As described in Item 5 of our Annual Report on Form 20-F as of and for the year ended December 31, 2021 as well as the Note 3 to our audited consolidated financial statements included in that Annual Report, the area where our management needed to apply judgment the most relates to the recognition of revenues. This includes but is not limited to determining commercial revenues under our collaboration agreement, which is recognized based on the collaboration partners’ gross profit from COVID-19 vaccine sales where we used certain information from the collaboration partner, including revenues from the sale of products, some of which is based on preliminary data shared between the partners. These estimated figures may change in future periods as we receive final data from our collaboration partner. Those changes in our share of the collaboration partner’s gross profit are recognized prospectively as change in estimates.
Further areas in which assumptions, estimates and the exercising of a degree of discretion are appropriate relate to establishing the fair value of intangibles and derivatives, the formation of provisions, as well as income taxes. We base our assumptions and estimates on parameters available when the unaudited interim condensed consolidated financial statements are prepared. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, our estimates may vary from the actual values.
Our critical accounting policies and the use of estimates are discussed further in Item 5 of our Annual Report on Form 20-F as of and for the year ended December 31, 2021 as well as Note 2.3 and Note 3 to our audited consolidated financial statements included in that Annual Report and include those related to revenue recognition, research and development expenses, share-based compensation, fair value measurement of share-based awards as well as taxes. Actual results in the areas related to critical accounting estimates could differ from management’s estimates.
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Legal Proceedings
As of September 30, 2022, certain claims were pending or threatened against us, mainly related to purported obligations arising out of certain contractual disputes unrelated to the below mentioned patent proceedings. Our best estimate of potential outflow of economic resources from such proceedings amounts to €359.1 million as of September 30, 2022 (€177.9 million as of December 31, 2021), which was reclassified into current provisions during the nine months ended June 30, 2022 in our consolidated statements of financial position due to the current estimated timing of the proceeding and was recognized in cost of sales in our unaudited interim condensed consolidated statements of profit or loss. This assessment is based on assumptions deemed reasonable by management including those about future events and uncertainties. Although we believe our position is strong, the outcome of these matters is ultimately uncertain, such that unanticipated events and circumstances might occur that might cause us to change those assumptions and give rise to a material adverse effect on our financial position in the future.
In addition to the above, 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 September 30, 2022, 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 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. It is currently impractical for us to estimate the respective contingent liabilities.
For a description of the risks relating to these and other legal proceedings we face and may in the future face, see “Risk Factors” elsewhere in this Quarterly Report.
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.
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. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
CureVac Proceedings
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. Later 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 August 2022, CureVac added European Patent, EP3708668B1, or the EP’668 Patent, to its German lawsuit. 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 addition, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that the EP’122 Patent is invalid.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility models and intend to vigorously defend itself in the proceedings mentioned above. However, our analysis of CureVac’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have
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determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Moderna Proceedings
In August 2022, ModernaTX, Inc., or Moderna, filed three patent infringement lawsuits against us and Pfizer related to COMIRNATY. 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. Moderna filed a second lawsuit asserting 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. Additionally, 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 infringement of U.S. Patent Nos. 10,898,574; 10,702,600; and 10,933,127, and seeking monetary relief, which was not specified in the filings. 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. Later in September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V., and Pfizer Inc. in the District Court of The Hague alleging COMIRNATY’s infringement of the EP ‘949 Patent and EP’565 Patent.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourself 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. In light of the foregoing, as well as discussions with our outside counsel, we believe the probability of a loss, if any, being sustained by us and the estimate of the amount of any possible loss to us remains difficult to ascertain. As a result, we have determined that this matter represents a contingency at this time. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
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. On the R&D front, we are focused on developing next generation COVID-19 vaccines to maintain leadership and pandemic preparedness as well as broaden the label of and access to the vaccine. We also plan to invest heavily to build out our global development organization, bringing in talent with clinical and regulatory expertise needed to rapidly advance our diversified clinical pipeline. We are also diversifying our therapeutic area footprint which will enable us to fully leverage the potential of all technology platforms across autoimmune diseases, inflammatory diseases, cardiovascular disease, neurodegenerative diseases, and regenerative medicines. In addition, we plan to enhance capabilities through complementary acquisitions, technologies, infrastructure and manufacturing. To support our future trajectory, growing the organization and expanding our team is of utmost importance. We are on the way to develop our global footprint in key regions including Europe, the United States, Asia and Africa. Additionally, investing in manufacturing capabilities for key technologies and deploying our pandemic response capabilities remain priorities for us. As of September 30, 2022, we had cash and cash equivalents of €13,423.7 million. When analyzing our liquidity, we anticipate certain significant balance sheet items that are expected to improve our cash and cash equivalents balance subsequent to the end of the reporting period. Our trade receivables remained outstanding as of September 30, 2022 mainly due to the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer as described in Note 6 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report. As of September 30, 2022, our trade receivables included trade receivables which related to the gross profit share for the second and third quarter of 2022. The payment settling our gross profit share for the second quarter of 2022 (as defined by the contract) was received from our collaboration partner in October 2022, subsequent to the end of the reporting period. Of our trade receivables outstanding as of September 30, 2022, we collected €3,185.9 million in cash. In total, our cash and cash equivalents as of October 15, 2022 amounted to €16,130.4 million.
Cash and cash equivalents are invested in accordance with our 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 short-term investments, including time deposits and money market funds with an original maturity of three months or less, which are stated at fair value.
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During the nine months ended September 30, 2022, we repaid large parts of our outstanding loans (see Note 6 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report).
On July 27, 2020, we offered 5,500,000 American Depositary Shares, or ADSs, each representing one of our ordinary shares, in a public, underwritten offering on the Nasdaq Global Select Market at a public offering price of $93.00 per ADS, or the Underwritten Offering. On August 27, 2020, following the Underwritten Offering, we issued 16,124 ADSs each representing one of our ordinary shares, in a rights offering at the same public offering price of $93.00 per ADS, or the Rights Offering. The Underwritten Offering and the Rights Offering are part of a single, global offering which we refer to as the Global Offering. The gross proceeds of the Global Offering were $513.0 million (€436.3 million).
A fund associated with Temasek Capital Management Pte. Ltd. and another accredited investor participated in a private investment which we refer to as the June 2020 Private Placement. The private placement included an investment in a four-year mandatory convertible note and an investment in ordinary shares. The €100.0 million four-year mandatory convertible note with a coupon of 4.5% per annum and a conversion premium of 20% above the reference price was early redeemed during the nine months ended September 30, 2022. During April 2022, the early redemption was fulfilled by issuing 1,744,392 ordinary shares (see Notes 6 and 8 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report).
In November 2020, we entered into a sales agreement, or the Sales Agreement, with Jefferies LLC and SVB Leerink LLC (now known as SVB Securities LLC), as sales agents, to establish an at-the-market offering program, pursuant to which we may sell, from time to time, ADSs representing ordinary shares for aggregate gross proceeds of up to $500.0 million. During the years ended December 31, 2020 and 2021, we sold 735,490 ADS and 995,890 ADS, respectively, each representing one of our ordinary shares and previously held in treasury, under the Sales Agreement. During the years ended December 31, 2020 and 2021, the aggregate gross proceeds were $92.9 million (€76.5 million) and $200.0 million (€163.6 million), respectively. As of September 30, 2022, the remaining capacity under the Sales Agreement is $207.1 million. Under the at-the-market offering program, ADSs are sold at-the-market, via the stock exchange, and therefore no shareholders’ subscription rights are affected.
In January 2022, we announced a new research, development and commercialization collaboration with Pfizer to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV). In connection with this collaboration, Pfizer agreed to make an equity investment in us, acquiring 497,727 ordinary shares paying a total amount of €110.6 million. The issuance of 497,727 ordinary shares with the nominal amount of €0.5 million was registered with the commercial register (Handelsregister) on March 24, 2022 (see Note 8 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report).
In March 2022, our Management Board and Supervisory Board authorized a share repurchase program of ADSs, pursuant to which we may repurchase ADSs in the amount of up to $1.5 billion over the next two years. On May 2, 2022, the first tranche of our share repurchase program of ADSs, with a value of up to $1.0 billion, commenced. During the nine months ended September 30, 2022, 6,545,030 ADSs were repurchased at an average price of $144.44, for total consideration of $945.4 million (€930.7 million).
In June 2022, at the Annual General Meeting, our shareholders approved the proposed special cash dividend of €2.00 per ordinary share (including those held in the form of ADSs), which led to an aggregate payment of €484.3 million in the same period.
Cash Flow
The following table summarizes the primary sources and uses of cash for each period presented:
Three months ended
September 30,
Nine months ended
September 30,
(in millions)20222021
(restated)
20222021
(restated)
Net cash flows from (used in):
Operating activities€4,778.9€1,500.8€12,748.2€1,089.2
Investing activities(83.3)(408.1)125.7(466.2)
Financing activities(653.4)(5.3)(1,354.6)143.1
Total cash inflow€4,042.2€1,087.4€11,519.3€766.1
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Operating Activities
We derive cash flows from operations primarily from the sale of products and services rendered. Our cash flows from operating activities are significantly influenced by our use of cash for operating expenses and working capital to support the business. During the three and nine months ended September 30, 2022, our cash flows from operating activities include the settlement payments of our gross profit share from our collaboration partner Pfizer as scheduled by the contractual arrangement. As described in Note 6 to the unaudited interim condensed consolidated financial statement included elsewhere in this Quarterly Report, the contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. Therefore, subsequent to the end of the reporting period, in October 2022, we further improved our cash position as we received the settlement payment of our gross profit share for the second quarter of 2022 (as defined by the contract).
Net cash generated from operating activities for the three months ended September 30, 2022 was €4,778.9 million, comprising a profit before tax of €2,444.1 million, positive non-cash adjustments of €203.9 million, a net positive change in assets and liabilities of €2,884.2 million and income taxes paid of €753.3 million. Non-cash items primarily included net foreign exchange differences as well as share-based payment expenses without cash-effect. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables related to our COVID-19 collaboration with Pfizer.
Net cash generated in operating activities for the three months ended September 30, 2021 was €1,500.8 million, comprising a profit before tax of €4,667.4 million, negative non-cash adjustments of €65.1 million, and a net negative change in assets and liabilities of €3,099.0 million. The net negative change in assets and liabilities was primarily due to an increase in trade and other receivables related to our COVID-19 collaboration with Pfizer.
Net cash generated from operating activities for the nine months ended September 30, 2022 was €12,748.2 million, comprising a profit before tax of €9,781.5 million, negative non-cash adjustments of €173.3 million, a net positive change in assets and liabilities of €5,984.7 million and income taxes paid of €2,834.7 million. Non-cash items primarily included net foreign exchange differences and finance income related to our convertible bond fair value update. The net positive change in assets and liabilities was primarily due to a decrease in trade and other receivables related to our COVID-19 collaboration with Pfizer.
Net cash generated in operating activities for the nine months ended September 30, 2021 was 1,089.2 million, comprising a profit before tax of €10,332.5 million, positive non-cash adjustments of €33.6 million, and a net negative change in assets and liabilities of €9,270.8 million. Non-cash items primarily included finance expenses related to our convertible bond fair value update which were offset by net foreign exchange differences and movements in government grants. The net negative change in assets and liabilities was primarily due to an increase in trade and other receivables related to our COVID-19 collaboration with Pfizer.
Investing Activities
Net cash used in investing activities for the three months ended September 30, 2022 was €83.3 million, of which €77.9 million was attributable to the purchase of property, plant and equipment.
Net cash used in investing activities restated for the three months ended September 30, 2021 was €408.1 million, of which cash deposits in an amount of €367.0 million with a term of six months at inception had been classified from cash and cash equivalents.
Net cash generated from investing activities for the nine months ended September 30, 2022 was €125.7 million, mainly derived from €375.2 million proceeds from cash deposit which returned to cash upon maturity of their original investments' term offsetted by €192.6 million attributable to the purchase of property, plant and equipment.
Net cash used in investing activities restated for the nine months ended September 30, 2021 was €466.2 million, of which cash deposits in an amount of €367.0 million with a term of six months at inception had been classified from cash and cash equivalents and of which €88.1 million was attributable to the purchase of property, plant and equipment.
Financing Activities
During the three months ended September 30, 2022, net cash used in financing activities was 653.4 million, primarily with respect to a share repurchase program.
During the nine months ended September 30, 2022, we had a cash outflow from financing activities of €1,354.6 million, primarily with respect to a share repurchase program and a special cash dividend.
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During the three months ended September 30, 2021, net cash used in financing activities was €5.3 million, primarily with respect to a payments related to lease liabilities.
During the nine months ended September 30, 2021, we generated cash from financing activities of €143.1 million, primarily from the sale of treasury shares under the at-the-market offering program net of transaction cost.
Operation and Funding Requirements
Prior to December 2020, we incurred significant losses and negative cash flows from operations due to our significant research and development expenses and our investment in our manufacturing capabilities. As of December 31, 2020, our accumulated losses amounted to €409.6 million. Those have been offset by the profit generated during the year ended December 31, 2021 and the nine months ended September 30, 2022 and our retained earnings as of September 30, 2022 amounted to €16,554.3 million.
As part of our capital allocation strategy, we expect to continue to incur significant and increasing operating expenses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we and our collaborators:
continue or expand our research or development of our programs in preclinical development;
continue or expand the scope of our clinical trials for our product candidates;
initiate additional preclinical, clinical, or other trials for our product candidates, including under our collaboration agreements;
continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;
change or increase our manufacturing capacity or capability;
change or add additional suppliers;
add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as a public company and our product development and commercialization efforts, including expansion of sites in Germany and new sites in the United States, and potentially others globally;
attract and retain skilled personnel;
seek marketing approvals and reimbursement for our product candidates;
develop our sales, marketing, and distribution infrastructure for our COVID-19 vaccine and any other products for which we may obtain marketing approval or emergency use authorization;
seek to identify and validate additional product candidates;
acquire or in-license other product candidates and technologies;
acquire other companies;
make milestone or other payments under any in-license agreements;
maintain, protect, defend, enforce and expand our intellectual property portfolio; and
experience any delays or encounter issues with any of the above
We are 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 CROs for clinical trials, clinical and commercial supply manufacturing, with vendors for preclinical research studies and for other services and products for operating purposes. We work together with CMOs, who manufacture our product candidates and products and enter into lease agreements to lease laboratory, GMP manufacturing, storage and office spaces. Purchase obligations under our agreements to the extent that they are quantifiable and not cancelable have been considered when defining our guidance for future cash commitments. Most of the committed cash outflow within the remaining months in 2022 is related to CMO purchase obligations amounting to €30.7 million and lease payments amounting to €10.6 million. Further, we have CMO purchase obligations with an amount of €182.6 million and lease payment obligations of €298.8 million for the years 2023 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.
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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
Our revenue depends heavily on sales of our COVID-19 vaccine, and our future revenues from our COVID-19 vaccine are uncertain.
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.
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.
We face significant competition from other makers of COVID-19 vaccines and may be unable to maintain a competitive market share for our COVID-19 vaccine.
We have only recently built our marketing and sales organization. If we are unable to continue to increase our marketing and sales capabilities on our own or through third parties, we may not be able to market and sell our product candidates effectively in the United States and other jurisdictions, if approved, or generate product sales revenue.
Other companies or organizations may challenge our intellectual property rights or may assert intellectual property rights that prevent us from developing and commercializing our COVID-19 vaccine or our product candidates and other technologies.
Even if we obtain regulatory approval for our product candidates, the products may not gain the market acceptance among physicians, patients, hospitals, treatment centers and others in the medical community necessary for commercial success.
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict. If our operating results fall below expectations, the price of the ADSs representing our shares could decline.
We may require substantial additional financing to achieve our goals, and a failure to obtain this capital on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
We have in the past identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we identify material weaknesses in the future 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 the U.S. securities laws, as well as Nasdaq rules, and we are permitted to file less information with the SEC than U.S. companies. This may limit the information available to holders of the ADSs and may make our ordinary shares and the ADSs less attractive to investors.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety of reasons outside of our control. Clinical trials of our product candidates may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which can affect our ability to fund our company and would have a material adverse impact on our business.
mRNA drug development has substantial clinical development and regulatory risks due to limited regulatory experience with mRNA immunotherapies.
Our approved product and product candidates are based on novel technologies and they may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping. If we or any of the third-party manufacturers we work with encounter such difficulties, our ability to supply materials for clinical trials or any approved product could be delayed or stopped.
If our efforts to obtain, maintain, protect, defend and/or enforce the intellectual property related to our COVID-19 vaccine or our product candidates and technologies are not adequate, we may not be able to compete effectively in our market.
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