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Quarterly Report of BioNTech SE for the Three And Nine Months Ended September 30, 2022
Unaudited Interim Condensed Consolidated Financial Statements
| Interim Condensed Consolidated Statements of Profit or Loss | 3 | |
| Interim Condensed Consolidated Statements of Comprehensive Income | 4 | |
| Interim Condensed Consolidated Statements of Financial Position | 5 | |
| Interim Condensed Consolidated Statements of Changes in Stockholder s ' Equity | 6 | |
| Interim Condensed Consolidated Statements of Cash Flows | 7 | |
| S elected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements | 8 | |
| 1 Corporate Information | 8 | |
| 2 Basis of Preparation, Significant Accounting Policies and further Accounting Topics | 8 | |
| 3 Revenues from Contracts with Customers | 11 | |
| 4 Income and Expenses | 12 | |
| 5 I ncome Tax | 14 | |
| 6 Financial Assets and Financial Liabilities | 15 | |
| 7 Inventories | 18 | |
| 8 Issued Capital and Reserves | 18 | |
| 9 Share-Based Payments | 19 | |
| 10 Provisions and Contingencies | 21 | |
| 11 Related Party Disclosures | 23 | |
| 12 Events after the Reporting Period | 23 |
Operating and Financial Review and Prospects
| Operating Results | 24 |
| Liquidity and Capital Resources | 47 |
| Risk Factors | 52 |
Unaudited Interim Condensed Consolidated Financial Statements
Interim Condensed Consolidated Statements of Profit or Loss
| Three months ended September 30, | Nine months ended September 30, | ||||||
| 2022 | 2021 | 2022 | 2021 | ||||
| (in millions, except per share data) | Note | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||
| Revenues | |||||||
| Commercial revenues | 3 | 3,394.8 | 6,040.1 | 12,923.3 | 13,348.1 | ||
| Research development revenues | 3 | 66.4 | 47.2 | 109.0 | 96.1 | ||
| Total revenues | 3,461.2 | 6,087.3 | 13,032.3 | 13,444.2 | |||
| Cost of sales | 4.1 | (752.8) | (1,211.4) | (2,811.5) | (2,328.3) | ||
| Research and development expenses | 4.2 | (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 | 4.5 | 459.8 | 213.1 | 1,157.5 | 360.6 | ||
| Operating income | 2,387.5 | 4,723.5 | 9,349.8 | 10,584.1 | |||
| Finance income | 4.6 | 60.9 | 26.6 | 448.5 | 51.4 | ||
| Finance expenses | 4.7 | (4.3) | (82.7) | (16.8) | (303.0) | ||
| Profit before tax | 2,444.1 | 4,667.4 | 9,781.5 | 10,332.5 | |||
| Income taxes | 5 | (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.
Interim Condensed Consolidated Statements of Comprehensive Income
| Three months ended September 30, | Nine months ended September 30, | ||||||
| 2022 | 2021 | 2022 | 2021 | ||||
| (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 operations | 10.9 | 2.9 | 24.4 | 6.3 | |||
| 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.
Interim Condensed Consolidated Statements of Financial Position
| September 30, | December 31, | |||
| (in millions) | 2022 | 2021 | ||
| Assets | Note | (unaudited) | ||
| Non-current assets | ||||
| Intangible assets | 226.2 | 202.4 | ||
| Property, plant and equipment | 488.5 | 322.5 | ||
| Right-of-use assets | 272.0 | 197.9 | ||
| Other financial assets | 6 | 52.8 | 21.3 | |
| Other assets | 1.1 | 0.8 | ||
| Deferred expenses | 7.5 | 13.6 | ||
| Deferred tax assets | 5 | 343.7 | - | |
| Total non-current assets | 1,391.8 | 758.5 | ||
| Current assets | ||||
| Inventories | 7 | 294.8 | 502.5 | |
| Trade and other receivables | 6 | 7,309.4 | 12,381.7 | |
| Other financial assets | 6 | 4.8 | 381.6 | |
| Other assets | 162.7 | 64.9 | ||
| Income tax assets | 0.4 | 0.4 | ||
| Deferred expenses | 73.0 | 48.5 | ||
| Cash and cash equivalents | 13,423.7 | 1,692.7 | ||
| Total current assets | 21,268.8 | 15,072.3 | ||
| Total assets | 22,660.6 | 15,830.8 | ||
| Equity and liabilities | ||||
| Equity | ||||
| Share capital | 8 | 248.6 | 246.3 | |
| Capital reserve | 8 | 1,050.4 | 1,674.4 | |
| Treasury shares | 8 | (10.3) | (3.8) | |
| Retained earnings | 16,554.3 | 9,882.9 | ||
| Other reserves | 9 | 523.3 | 93.9 | |
| Total equity | 18,366.3 | 11,893.7 | ||
| Non-current liabilities | ||||
| Loans and borrowings | 6 | 237.0 | 171.6 | |
| Other financial liabilities | 6 | 6.1 | 6.1 | |
| Income tax liabilities | 5 | 8.0 | 4.4 | |
| Provisions | 10 | 7.3 | 184.9 | |
| Contract liabilities | 53.8 | 9.0 | ||
| Other liabilities | 17.4 | 12.8 | ||
| Deferred tax liabilities | 7.0 | 66.7 | ||
| Total non-current liabilities | 336.6 | 455.5 | ||
| Current liabilities | ||||
| Loans and borrowings | 6 | 37.0 | 129.9 | |
| Trade payables | 6 | 296.5 | 160.0 | |
| Other financial liabilities | 6 | 686.9 | 1,190.4 | |
| Government grants | 3.0 | 3.0 | ||
| Refund liabilities | - | 90.0 | ||
| Income tax liabilities | 5 | 1,387.5 | 1,568.9 | |
| Provisions | 10 | 768.1 | 110.2 | |
| Contract liabilities | 3 | 673.9 | 186.1 | |
| Other liabilities | 104.8 | 43.1 | ||
| 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.
Interim Condensed Consolidated Statements of Changes in Stockholders' Equity
| (in millions, unaudited) | Note | Share capital | Capital reserve | Treasury shares | Retained earnings | Other 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 period | - | - | - | 7,126.3 | - | 7,126.3 | ||||||
| Other comprehensive income | - | - | - | - | 6.3 | 6.3 | ||||||
| Total comprehensive income | - | - | - | 7,126.3 | 6.3 | 7,132.6 | ||||||
| Issuance of share capital and treasury shares | - | 162.6 | 1.0 | - | - | 163.6 | ||||||
| Transaction costs | - | (2.7) | - | - | - | (2.7) | ||||||
| Share-based payments | 9 | - | - | - | - | 46.2 | 46.2 | |||||
| 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 period | - | - | - | 7,155.7 | - | 7,155.7 | ||||||
| Other comprehensive income | - | - | - | - | 24.3 | 24.3 | ||||||
| Total comprehensive income | - | - | - | 7,155.7 | 24.3 | 7,180.0 | ||||||
| Issuance of share capital | 8 | 0.5 | 67.1 | - | - | - | 67.6 | |||||
| Redemption of convertible note | 6 | 1.8 | 233.2 | - | - | - | 235.0 | |||||
| Share repurchase program | 8 | - | (924.2) | (6.5) | - | - | (930.7) | |||||
| Transaction costs | - | (0.1) | - | - | - | (0.1) | ||||||
| Dividends | 8 | - | - | - | (484.3) | - | (484.3) | |||||
| Share-based payments | 9 | - | - | - | - | 33.1 | 33.1 | |||||
| Deferred Taxes | 5 | - | - | - | - | 372.0 | 372.0 | |||||
| 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.
Interim Condensed Consolidated Statements of Cash Flows
| Three months ended September 30, | Nine months ended September 30, | |||||
| 2022 | 2021 | 2022 | 2021 | |||
| (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 taxes | 659.2 | 1,456.4 | 2,625.8 | 3,206.2 | ||
| 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 assets | 33.5 | 19.8 | 94.3 | 49.2 | ||
| Share-based payment expense | 59.7 | 23.1 | 81.7 | 62.4 | ||
| Net foreign exchange differences | 116.2 | (194.2) | (222.3) | (295.5) | ||
| Loss on disposal of property, plant and equipment | 0.2 | - | 0.4 | 0.4 | ||
| Finance income | (7.7) | (0.6) | (226.5) | (1.2) | ||
| Finance expense | 4.3 | 82.7 | 16.8 | 303.0 | ||
| Movements in government grants | - | (20.8) | - | (109.6) | ||
| Net (gain) loss on derivative instruments at fair value through profit or loss | (2.3) | 24.9 | 82.3 | 24.9 | ||
| Working capital adjustments | ||||||
| Decrease (increase) in trade and other receivables, contract assets and other assets | 2,245.4 | (3,343.9) | 5,016.7 | (10,095.4) | ||
| Decrease (increase) in inventories | 72.9 | (88.0) | 207.7 | (329.3) | ||
| Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | 565.9 | 332.9 | 760.3 | 1,153.9 | ||
| Interest received | 4.3 | 0.4 | 6.5 | 1.0 | ||
| 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 equipment | 0.4 | 0.2 | 0.4 | 1.4 | ||
| 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 costs | - | - | 110.5 | 160.9 | ||
| Proceeds from loans and borrowings | 0.4 | - | 0.6 | - | ||
| 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 equivalents | 4,042.2 | 1,087.4 | 11,519.3 | 766.1 | ||
| Change in cash and cash equivalents resulting from exchange rate differences | 46.7 | 24.2 | 211.7 | 49.4 | ||
| Cash and cash equivalents at the beginning of the period | 9,334.8 | 914.1 | 1,692.7 | 1,210.2 | ||
| 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.
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
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.
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.
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.
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) | 2022 | 2021 | 2022 | 2021 | ||
| Commercial revenues | 3,394.8 | 6,040.1 | 12,923.3 | 13,348.1 | ||
| COVID-19 vaccine revenues | 3,378.1 | 6,021.6 | 12,883.9 | 13,303.2 | ||
| Sales to collaboration partners (1) | 259.4 | 312.3 | 1,470.9 | 514.3 | ||
| Direct product sales to customers | 564.5 | 1,350.8 | 2,284.6 | 2,586.2 | ||
| Share of collaboration partners' gross profit and sales milestones | 2,554.2 | 4,358.5 | 9,128.4 | 10,202.7 | ||
| Other sales | 16.7 | 18.5 | 39.4 | 44.9 | ||
| 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.
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.
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) | 2022 | 2021 | 2022 | 2021 | ||
| 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 time | 68.0 | 51.7 | 113.9 | 102.8 | ||
| Revenue recognition applying the sales-based or usage-based royalty recognition constraint model (1) | 2,554.2 | 4,358.5 | 9,128.4 | 10,202.7 | ||
| 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
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) | 2022 | 2021 | 2022 | 2021 | ||
| Cost of sales related to COVID-19 vaccine revenues | 737.8 | 1,194.8 | 2,779.4 | 2,290.1 | ||
| Cost related to other sales | 15.0 | 16.6 | 32.1 | 38.2 | ||
| 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) | 2022 | 2021 | 2022 | 2021 | ||
| Purchased services | - | 160.8 | 361.4 | 402.6 | ||
| Laboratory supplies | 191.3 | 10.2 | 297.0 | 38.1 | ||
| Wages, benefits and social security expense | 122.8 | 70.0 | 279.1 | 185.7 | ||
| Depreciation and amortization | 13.6 | 8.5 | 36.0 | 23.1 | ||
| Other | 14.1 | 10.9 | 53.7 | 28.2 | ||
| Total | 341.8 | 260.4 | 1,027.2 | 677.7 |
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) | 2022 | 2021 | 2022 | 2021 | ||
| Wages, benefits and social security expense | 37.8 | 22.5 | 108.3 | 53.9 | ||
| Purchased services | 38.7 | 14.6 | 103.6 | 38.1 | ||
| IT and office equipment | 23.7 | 6.3 | 57.5 | 14.3 | ||
| Insurance premiums | 17.7 | 14.7 | 32.2 | 23.4 | ||
| Other | 23.1 | 10.1 | 60.2 | 25.2 | ||
| 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) | 2022 | 2021 | 2022 | 2021 | ||
| Loss on derivative instruments at fair value through profit or loss | 282.7 | 24.9 | 581.7 | 24.9 | ||
| Other | 2.4 | 1.5 | 12.9 | 2.4 | ||
| 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) | 2022 | 2021 | 2022 | 2021 | ||
| Foreign exchange differences, net | 449.1 | 190.3 | 1,090.1 | 265.4 | ||
| Government grants | 0.2 | 20.9 | 0.2 | 88.9 | ||
| Other | 10.5 | 1.9 | 67.2 | 6.3 | ||
| 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.
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) | 2022 | 2021 | 2022 | 2021 | ||
| Foreign exchange differences, net | 53.2 | 26.0 | 222.0 | 50.2 | ||
| Interest income | 7.7 | 0.6 | 9.7 | 1.2 | ||
| Fair value adjustments of financial instruments measured at fair value | - | - | 216.8 | - | ||
| 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).
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) | 2022 | 2021 | 2022 | 2021 | ||
| Interest expenses related to financial assets | 2.5 | - | 10.8 | - | ||
| Interest expenses related to lease liabilities | 1.7 | 0.8 | 3.3 | 2.0 | ||
| Amortization of financial instruments | 0.1 | 0.4 | 2.7 | 7.6 | ||
| Fair value adjustments of financial instruments measured at fair value | - | 81.5 | - | 293.4 | ||
| 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).
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
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) | 2022 | 2021 | 2022 | 2021 | ||
| 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