Full Press Release Details
Quarterly Report of BioNTech SE for the
three and nine months ended September 30, 2024
A C T I N G T O G E T H E R - C R E A T I N G S Y N E R G I E S
Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, our website is not part of this document. Our agent for service solely for the purpose of notices and communications from the Securities and Exchange Commission in the United States is c o BioNTech US Inc., 40 Erie Street, Suite 110, Cambridge, Massachusetts 02139, +1 (617) 337-4701.
UNAUDITED INTERIM CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
| Interim Condensed Consolidated Statements of Profit or Loss | 1 | |
| Interim Condensed Consolidated Statements of Comprehensive Income | 2 | |
| Interim Condensed Consolidated Statements of Financial Position | 3 | |
| Interim Condensed Consolidated Statements of Changes in Stockholders ' Equity | 4 | |
| Interim Condensed Consolidated Statements of Cash Flows | 5 | |
| Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements | 6 | |
| 1 | Corporate Information | 6 |
| 2 | Basis of Preparation, Significant Accounting Policies and further Accounting Topics | 6 |
| 3 | Revenues from Contracts with Customers | 7 |
| 4 | Income and Expenses | 8 |
| 5 | I ncome Tax es | 10 |
| 6 | Other Intangible Assets | 11 |
| 7 | Financial Assets and Financial Liabilities | 12 |
| 8 | Issued Capital and Reserves | 15 |
| 9 | Share-Based Payments | 15 |
| 10 | Provisions | 16 |
| 11 | Contingencies | 16 |
| 12 | Related Party Disclosures | 21 |
OPERATING AND FINANCIAL REVIEW
| Operating Results | 23 |
| Liquidity and Capital Resources | 46 |
| Risk Factors | 50 |
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
Unaudited Interim Condensed Consolidated Financial Statements
Interim Condensed Consolidated Statements of Profit or Loss
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (in millions , except per share data) | Note | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||
| Revenues | 3 | 1,244.8 | 895.3 | 1,561.1 | 2,340.0 | |||||||||||
| Cost of sales | 4.1 | (178.9) | (161.8) | (297.8) | (420.7) | |||||||||||
| Research and development expenses | 4.1 | (550.3) | (497.9) | (1,642.4) | (1,205.3) | |||||||||||
| Sales and marketing expenses | (18.1) | (14.4) | (46.6) | (44.7) | ||||||||||||
| General and administrative expenses (1) | 4.1 | (132.4) | (139.1) | (420.3) | (370.7) | |||||||||||
| Other operating expenses (1) | 4.2 | (410.9) | (36.8) | (719.9) | (239.6) | |||||||||||
| Other operating income | 4.3 | 56.3 | 27.8 | 103.0 | 105.2 | |||||||||||
| Operating profit (loss) | 10.5 | 73.1 | (1,462.9) | 164.2 | ||||||||||||
| Finance income | 4.4 | 156.2 | 156.3 | 498.8 | 363.2 | |||||||||||
| Finance expenses | 4.4 | (8.0) | (2.0) | (14.8) | (4.5) | |||||||||||
| Profit (Loss) before tax | 158.7 | 227.4 | (978.9) | 522.9 | ||||||||||||
| Income taxes | 5 | 39.4 | (66.8) | 54.1 | (50.5) | |||||||||||
| Net profit (loss) | 198.1 | 160.6 | (924.8) | 472.4 | ||||||||||||
| Earnings (Loss) per share | ||||||||||||||||
| Basic earnings (loss) per share | 0.82 | 0.67 | (3.83) | 1.96 | ||||||||||||
| Diluted earnings (loss) per share | 0.81 | 0.66 | (3.83) | 1.94 |
(1) Adjustments to prior-year figures due to change in functional allocation of general and administrative expenses and other operating expenses (please see Note 4.2 for further details).
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
Interim Condensed Consolidated Statements of Comprehensive Income
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (in millions ) | Note | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||
| Net profit (loss) | 198.1 | 160.6 | (924.8) | 472.4 | ||||||||||||
| Exchange differences on translation of foreign operations | (12.0) | 3.9 | 11.7 | (0.4) | ||||||||||||
| Net gain (loss) on cash flow hedges | - | (7.7) | - | - | ||||||||||||
| Net other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods | (12.0) | (3.8) | 11.7 | (0.4) | ||||||||||||
| Net gain (loss) on equity instruments designated at fair value through other comprehensive income | 0.7 | (4.8) | (108.3) | (0.4) | ||||||||||||
| Net other comprehensive income (loss) that will not be reclassified to profit or loss in subsequent periods | 0.7 | (4.8) | (108.3) | (0.4) | ||||||||||||
| Other comprehensive loss, net of tax | (11.3) | (8.6) | (96.6) | (0.8) | ||||||||||||
| Comprehensive income (loss), net of tax | 186.8 | 152.0 | (1,021.4) | 471.6 |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
Interim Condensed Consolidated Statements of Financial Position
| September 30, | December 31, | ||||||||
| (in millions ) | 2024 | 2023 | |||||||
| Assets | Note | (unaudited) | |||||||
| Non-current assets | |||||||||
| Goodwill | 6 | 374.0 | 362.5 | ||||||
| Other intangible assets | 6 | 873.9 | 804.1 | ||||||
| Property, plant and equipment | 917.4 | 757.2 | |||||||
| Right-of-use assets | 242.0 | 214.4 | |||||||
| Other financial assets | 7 | 1,332.2 | 1,176.1 | ||||||
| Other non-financial assets | 84.8 | 83.4 | |||||||
| Deferred tax assets | 90.7 | 81.3 | |||||||
| Total non-current assets | 3,915.0 | 3,479.0 | |||||||
| Current assets | |||||||||
| Inventories | 303.1 | 357.7 | |||||||
| Trade and other receivables | 7 | 988.0 | 2,155.7 | ||||||
| Other financial assets | 7 | 7,084.7 | 4,885.3 | ||||||
| Other non-financial assets | 275.8 | 285.8 | |||||||
| Income tax assets | 210.0 | 179.1 | |||||||
| Cash and cash equivalents | 9,624.6 | 11,663.7 | |||||||
| Total current assets | 18,486.2 | 19,527.3 | |||||||
| Total assets | 22,401.2 | 23,006.3 | |||||||
| Equity and liabilities | |||||||||
| Equity | |||||||||
| Share capital | 8 | 248.6 | 248.6 | ||||||
| Capital reserve | 1,373.0 | 1,229.4 | |||||||
| Treasury shares | (8.8) | (10.8) | |||||||
| Retained earnings | 18,838.5 | 19,763.3 | |||||||
| Other reserves | (1,336.8) | (984.6) | |||||||
| Total equity | 19,114.5 | 20,245.9 | |||||||
| Non-current liabilities | |||||||||
| Lease liabilities, loans and borrowings | 7 | 206.3 | 191.0 | ||||||
| Other financial liabilities | 7 | 44.3 | 38.8 | ||||||
| Provisions | 10 | 8.5 | 8.8 | ||||||
| Contract liabilities | 376.9 | 398.5 | |||||||
| Other non-financial liabilities | 90.4 | 13.1 | |||||||
| Deferred tax liabilities | 37.8 | 39.7 | |||||||
| Total non-current liabilities | 764.2 | 689.9 | |||||||
| Current liabilities | |||||||||
| Lease liabilities, loans and borrowings | 7 | 37.4 | 28.1 | ||||||
| Trade payables and other payables | 7 | 762.6 | 354.0 | ||||||
| Other financial liabilities | 7 | 241.6 | 415.2 | ||||||
| Income tax liabilities | 363.6 | 525.5 | |||||||
| Provisions | 10 | 731.5 | 269.3 | ||||||
| Contract liabilities | 236.0 | 353.3 | |||||||
| Other non-financial liabilities | 149.8 | 125.1 | |||||||
| Total current liabilities | 2,522.5 | 2,070.5 | |||||||
| Total liabilities | 3,286.7 | 2,760.4 | |||||||
| Total equity and liabilities | 22,401.2 | 23,006.3 |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
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, 2023 | 248.6 | 1,828.2 | (5.3) | 18,833.0 | (848.9) | 20,055.6 | |||||||||||||||||||
| Net income | - | - | - | 472.4 | - | 472.4 | |||||||||||||||||||
| Other comprehensive loss | - | - | - | - | (0.8) | (0.8) | |||||||||||||||||||
| Total comprehensive profit (loss) | - | - | - | 472.4 | (0.8) | 471.6 | |||||||||||||||||||
| Treasury shares used for acquisition of business combination | - | 102.6 | 1.1 | - | - | 103.7 | |||||||||||||||||||
| Share repurchase program | - | (731.6) | (6.9) | - | - | (738.5) | |||||||||||||||||||
| Share-based payments | - | 29.2 | 0.3 | - | (24.3) | 5.2 | |||||||||||||||||||
| Deferred taxes | - | - | - | - | (30.8) | (30.8) | |||||||||||||||||||
| As of September 30, 2023 | 248.6 | 1,228.4 | (10.8) | 19,305.4 | (904.8) | 19,866.8 | |||||||||||||||||||
| As of January 1, 2024 | 248.6 | 1,229.4 | (10.8) | 19,763.3 | (984.6) | 20,245.9 | |||||||||||||||||||
| Net loss | - | - | - | (924.8) | - | (924.8) | |||||||||||||||||||
| Other comprehensive loss | - | - | - | - | (96.6) | (96.6) | |||||||||||||||||||
| Total comprehensive loss | - | - | - | (924.8) | (96.6) | (1,021.4) | |||||||||||||||||||
| Share-based payments | 9 | - | 143.6 | 2.0 | - | (255.6) | (110.0) | ||||||||||||||||||
| As of September 30, 2024 | 248.6 | 1,373.0 | (8.8) | 18,838.5 | (1,336.8) | 19,114.5 |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
Interim Condensed Consolidated Statements of Cash Flows
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| (in millions ) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||
| Operating activities | |||||||||||||
| Net profit (loss) | 198.1 | 160.6 | (924.8) | 472.4 | |||||||||
| Income taxes | (39.4) | 66.8 | (54.1) | 50.5 | |||||||||
| Profit (Loss) before tax | 158.7 | 227.4 | (978.9) | 522.9 | |||||||||
| Adjustments to reconcile profit before tax to net cash flows | |||||||||||||
| Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets | 44.4 | 41.3 | 132.6 | 104.6 | |||||||||
| Share-based payment expenses | 40.9 | 15.5 | 77.4 | 37.2 | |||||||||
| Net foreign exchange differences | (35.5) | (20.4) | (77.4) | (364.3) | |||||||||
| (Gain) Loss on disposal of property, plant and equipment | - | 3.3 | (0.2) | 3.6 | |||||||||
| Finance income excluding foreign exchange differences | (156.2) | (148.5) | (498.8) | (357.4) | |||||||||
| Finance expense excluding foreign exchange differences | 5.3 | 2.0 | 14.8 | 4.5 | |||||||||
| Government grants | (14.6) | - | (26.8) | (3.0) | |||||||||
| Unrealized (gain) loss on derivative instruments at fair value through profit or loss (1) | (6.0) | (3.5) | 0.7 | 196.7 | |||||||||
| Working capital adjustments | |||||||||||||
| Decrease (Increase) in trade and other receivables, contract assets and other assets (1) | (830.2) | 631.2 | 1,267.6 | 5,662.0 | |||||||||
| Decrease in inventories | 37.0 | 33.2 | 54.6 | 23.9 | |||||||||
| (Decrease) Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | 117.9 | (25.0) | 590.7 | (293.9) | |||||||||
| Interest received and realized gains from cash and cash equivalents | 73.1 | 70.3 | 353.3 | 166.4 | |||||||||
| Interest paid and realized losses from cash and cash equivalents | (1.6) | (1.2) | (6.9) | (3.7) | |||||||||
| Income tax received (paid), net (1) | 1.6 | (10.2) | (190.8) | (417.8) | |||||||||
| Share-based payments | (134.4) | (4.2) | (143.6) | (761.2) | |||||||||
| Government grants received | 60.7 | - | 102.7 | - | |||||||||
| Net cash flows from (used in) operating activities | (638.9) | 811.2 | 671.0 | 4,520.5 | |||||||||
| Investing activities | |||||||||||||
| Purchase of property, plant and equipment | (72.8) | (53.2) | (219.9) | (165.6) | |||||||||
| Proceeds from sale of property, plant and equipment | 0.3 | (0.8) | 0.5 | (0.8) | |||||||||
| Purchase of intangible assets and right-of-use assets | (10.2) | (97.2) | (141.3) | (348.9) | |||||||||
| Acquisition of subsidiaries and businesses, net of cash acquired | - | (336.9) | - | (336.9) | |||||||||
| Investment in other financial assets (1) | (2,958.2) | (1,047.1) | (10,301.5) | (3,710.2) | |||||||||
| Proceeds from maturity of other financial assets (1) | 2,898.8 | 303.0 | 7,974.3 | 303.0 | |||||||||
| Net cash flows used in investing activities | (142.1) | (1,232.2) | (2,687.9) | (4,259.4) | |||||||||
| Financing activities | |||||||||||||
| Proceeds from loans and borrowings | - | 0.1 | - | 0.1 | |||||||||
| Repayment of loans and borrowings | - | (0.1) | (2.3) | (0.1) | |||||||||
| Payments related to lease liabilities | (7.9) | (9.3) | (36.3) | (28.0) | |||||||||
| Share repurchase program | - | (301.7) | - | (737.7) | |||||||||
| Net cash flows used in financing activities | (7.9) | (311.0) | (38.6) | (765.7) | |||||||||
| Net decrease in cash and cash equivalents | (788.9) | (732.0) | (2,055.5) | (504.6) | |||||||||
| Change in cash and cash equivalents resulting from exchange rate differences | (2.3) | 61.2 | 1.2 | 125.3 | |||||||||
| Change in cash and cash equivalents resulting from other valuation effects | 39.1 | - | 15.2 | - | |||||||||
| Cash and cash equivalents at the beginning of the period | 10,376.7 | 14,166.6 | 11,663.7 | 13,875.1 | |||||||||
| Cash and cash equivalents as of September 30 | 9,624.6 | 13,495.8 | 9,624.6 | 13,495.8 |
(1) Adjustments to prior-year figures relate to reclassifications within the cash flows from operating and investing activities, respectively.
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements
1. Corporate Information
BioNTech SE is a limited company incorporated and domiciled in Germany. The registered office is located in Mainz, Germany (An der Goldgrube 12, 55131 Mainz). The accompanying unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries and have been prepared on a going concern basis in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. References to the "Company", "BioNTech", "Group", "we", "us" and "our" refer to BioNTech SE and its consolidated subsidiaries.
We are a global next-generation immunotherapy company pioneering novel medicines against cancer, infectious diseases and other serious diseases. Since our founding in 2008, we have focused on harnessing the power of the immune system to address human diseases with unmet medical need and major global health burden. Our fully integrated model combines decades of research in immunology, translational drug discovery and development, a technology agnostic innovation engine, GMP manufacturing, and commercial capabilities to rapidly discover, develop and commercialize our marketed product and other candidate vaccines and therapies. We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes investigational mRNA vaccines and therapeutics, cell and gene therapies, targeted antibodies and small molecule immunomodulators.
Our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024 were authorized for issuance in accordance with a resolution of the Audit Committee of our Supervisory Board on October 31, 2024.
2. Basis of Preparation, Significant Accounting Policies and further Accounting Topics
Basis of Preparation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024 have been prepared in accordance with International Accounting Standard (IAS) 34 Interim Financial Reporting.
The unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in the audited consolidated financial statements, and should be read in conjunction with our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 20-F as of and for the year ended December 31, 2023.
We prepare and present our unaudited interim condensed consolidated financial statements in Euros and round numbers to millions of Euros. Accordingly, numerical figures shown as totals in some tables may not be exact arithmetic aggregations of the figures that preceded them and figures presented in the explanatory notes may not add up to the rounded arithmetic aggregations.
The unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
Significant Accounting Judgments, Estimates and Assumptions and Accounting Policies
The preparation of the unaudited interim condensed consolidated financial statements requires our management to make judgments, estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities and the accompanying disclosures. This includes but is not limited to our judgment relating to our collaboration with Pfizer, Inc., or Pfizer, as described under the subheading "Pfizer Agreement Characteristics" in Note 3 to our audited consolidated financial statements as of and for the year ended December 31, 2023. In order to determine our share of the collaboration partner's gross profits, we used certain information from the collaboration partner, including revenues from the sale of products and
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
certain other sharable expense items, some of which is based on preliminary data shared between the partners.
This further includes but is not limited to judgments relating to the impairment tests of our goodwill and intangible assets, as the outcome of these tests is highly dependent on management's assumptions regarding future cash flow projections, which require significant judgments and assumptions about future developments. They can be affected by a variety of factors, including but not limited to peak sales assumptions, clinical trial success rates and or estimation of weighted-average cost of capital. Changes to the assumptions underlying our goodwill and intangible assets impairment assessments could require material adjustments to the carrying amount of our recognized goodwill and intangible assets and may lead to impairment charges recognized in our condensed consolidated statements of profit or loss.
Our management continually evaluates judgments and estimates, including those related to contingencies, revenues and expenses. Management bases its judgments and estimates on parameters available at the time when the unaudited interim condensed consolidated financial statements were prepared. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Such changes are reflected in the assumptions when they occur.
The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial statements are consistent with those followed in the preparation of our audited consolidated financial statements as of and for the year ended December 31, 2023, except for income taxes, which are accounted for using the expected annual tax rate in our unaudited interim condensed consolidated financial statements (see Note 5).
Furthermore, we recognize acquired contractual rights to cash flows from the sale of patent-protected biopharmaceutical products by unrelated biopharmaceutical companies as royalty assets. Since we do not own the intellectual property or have the right to commercialize the underlying products, royalty assets are recognized as financial assets measured at fair value through profit and loss. We recognize day one gains and losses only when the fair value is evidenced by a quoted price in an active market for the same instrument or is based on a valuation technique that only uses data from observable markets. In all other cases, we defer the difference between the fair value at initial recognition and the transaction price. After initial recognition, we recognize that deferred difference as a gain or loss only to the extent that it arises from a change in a factor that market participants would take into account when pricing the asset or liability.
Standards Applied for the First Time
The IFRS standards applied for the first time as of January 1, 2024, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2023, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024.
3. Revenues from Contracts with Customers
Disaggregated information on revenues
Set out below is the disaggregation of our revenues from contracts with customers
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| (in millions ) | 2024 | 2023 | 2024 | 2023 | |||||||||
| COVID-19 vaccine revenues | 1,113.9 | 885.0 | 1,310.0 | 2,306.7 | |||||||||
| Other revenues | 130.9 | 10.3 | 251.1 | 33.3 | |||||||||
| Total | 1,244.8 | 895.3 | 1,561.1 | 2,340.0 |
COVID-19 Vaccine Revenues
During the three and nine months ended September 30, 2024, and 2023, COVID-19 vaccine revenues were recognized from the supply and sales of our COVID-19 vaccine worldwide, mainly comprising our share of
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
the collaboration partner's gross profit derived from sales in the collaboration partner's territory. Overall, our COVID-19 vaccine revenues amounted to 1,113.9 million and 1,310.0 million during the three and nine months ended September 30, 2024, respectively. During the three and nine months ended September 30, 2023, COVID-19 vaccine revenues amounted to 885.0 million and 2,306.7 million, respectively. The year-to-date change compared to the comparative prior year period was mainly due to lower revenues from the sales of our COVID-19 vaccines worldwide resulting from lower sales demand during the nine months ended September 30, 2024. During the three months ended September 30, 2024, our sales were higher compared to the prior year period, which were largely driven by the earlier approvals received for our variant-adapted COVID-19 vaccines in 2024. Our COVID-19 vaccine revenues are subject to seasonal effects in the fall winter of the northern hemisphere.
During the three and nine months ended September 30, 2024, our other revenues were mainly derived from a pandemic preparedness contract with the German government effectively supplemented in the three months ended March 31, 2024.
Revenues from contracts with customers were recognized as follows
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| (in millions ) | 2024 | 2023 | 2024 | 2023 | |||||||||
| Timing of revenue recognition | |||||||||||||
| Goods and services transferred at a point in time | 247.0 | 184.9 | 301.6 | 410.4 | |||||||||
| Goods and services transferred over time | 124.8 | 3.4 | 231.7 | 12.7 | |||||||||
| Revenue recognition applying the sales-based or usage-based royalty recognition constraint model (1) | 873.0 | 707.0 | 1,027.8 | 1,916.9 | |||||||||
| Total | 1,244.8 | 895.3 | 1,561.1 | 2,340.0 |
(1) Represents sales based on the share of the collaboration partners' gross profit.
4. Income and Expenses
4.1 General Expenses
Our cost of sales increased by 17.1 million, or 11%, from 161.8 million during the three months ended September 30, 2023 to 178.9 million during the three months ended September 30, 2024, and decreased by 122.9 million, or 29%, from 420.7 million during the nine months ended September 30, 2023 to 297.8 million during the nine months ended September 30, 2024. While we recognized lower cost of sales from our decreased COVID-19 vaccine sales in our territories, particularly Germany, changes in our cost of sales were additionally impacted by expenses arising from inventory write-downs to net realizable value amounting to 39.7 million and 103.3 million during the three and nine months ended September 30, 2024, respectively, compared to 46.2 million and 96.1 million during the three and nine months ended September 30, 2023, respectively (adjustments to prior-year figures relate to reclassifications). The inventories valued at net realizable value in our consolidated statement of financial position as of September 30, 2024 take contractual compensation payments into consideration.
Research and Development Expenses
Our research and development expenses increased by 52.4 million, or 11%, from 497.9 million during the three months ended September 30, 2023 to 550.3 million during the three months ended September 30, 2024, and increased by 437.1 million, or 36%, from 1,205.3 million during the nine months ended September 30, 2023 to 1,642.4 million during the nine months ended September 30, 2024. The increase was mainly driven by advancing key pipeline candidates, such as our antibody drug conjugate, or ADC, antibody and individualized cancer-immunotherapy product candidates. Further contributions to the increase came from higher personnel expenses resulting from an increase in headcount.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
General and Administrative Expenses
Our general and administrative expenses decreased by 6.7 million, or 5%, from 139.1 million during the three months ended September 30, 2023 to 132.4 million during the three months ended September 30, 2024, and increased by 49.6 million, or 13%, from 370.7 million during the nine months ended September 30, 2023 to 420.3 million during the nine months ended September 30, 2024. The year-to-date increase compared to the comparative prior year period was primarily due to increased headcount and higher personnel expenses as a result. A reduction in external services led to a slight decrease in total general and administrative expenses during the three months ended September 30, 2024, compared to the comparative prior year period.
4.2 Other Operating Expenses
Other operating expenses recognized during the three and nine months ended September 30, 2024, and 2023, are shown in the following table
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| (in millions ) | 2 | 2024 | 2023 | 2024 | 2023 | ||||||||
| Contractual disputes | 365.9 | - | 605.0 | - | |||||||||
| Litigation costs (1) | 41.2 | 5.4 | 84.1 | 15.9 | |||||||||
| Loss on derivative instruments at fair value through profit or loss | - | - | 26.2 | - | |||||||||
| Foreign exchange differences, net | - | 26.1 | - | 213.8 | |||||||||
| Other | 3.8 | 5.3 | 4.6 | 9.9 | |||||||||
| Total | 410.9 | 36.8 | 719.9 | 239.6 |
(1) Adjustments to prior-year figures relate to reclassifying legal costs in connection with certain litigation as other operating expenses, rather than general and administrative expenses, to reflect changes in reporting.
During the three and nine months ended September 30, 2024, other operating expenses increased compared to each of the three and nine months ended September 30, 2023, primarily due to expenses incurred in connection with contractual disputes (see Note 10).
4.3 Other Operating Income
Other operating income recognized during the three and nine months ended September 30, 2024, and 2023, are shown in the following table
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| (in millions ) | 2024 | 2023 | 2024 | 2023 | |||||||||
| Foreign exchange differences, net | 30.8 | - | 65.2 | - | |||||||||
| Grants | 14.7 | - | 26.9 | - | |||||||||
| Gain on derivative instruments at fair value through profit or loss | 5.7 | 17.3 | - | 71.8 | |||||||||
| Other | 5.1 | 10.5 | 10.9 | 33.4 | |||||||||
| Total | 56.3 | 27.8 | 103.0 | 105.2 |
The foreign exchange differences in the prior year comparative period included in operating income primarily arose from remeasuring our U.S. dollar-denominated trade receivables, which mainly relate to our COVID-19 collaboration with Pfizer, our U.S. dollar-denominated trade payables and our U.S. dollar-denominated other financial liabilities, which mainly relate to obligations incurred from our license agreements.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
As of September 30, 2024, the amount of our grants deferred in our unaudited interim condensed consolidated financial statements amounted to 86.5 million compared to 5.9 million as of December 31, 2023.
The finance result recognized during the three and nine months ended September 30, 2024, and 2023, is shown in the following table
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||
| (in millions ) | 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Finance result | |||||||||||||||||||
| Finance income | 156.2 | 156.3 | 498.8 | 363.2 | |||||||||||||||
| Gains from financial instruments | 156.2 | 148.5 | 498.8 | 357.4 | |||||||||||||||
| Foreign exchange differences, net | - | 7.8 | - | 5.8 | |||||||||||||||
| Finance expenses | (8.0) | (2.0) | (14.8) | (4.5) | |||||||||||||||
| Foreign exchange differences, net | (2.7) | - | - | - | |||||||||||||||
| Other | (5.3) | (2.0) | (14.8) | (4.5) | |||||||||||||||
| Total finance result | 148.2 | 154.3 | 484.0 | 358.7 |
During the three and nine months ended September 30, 2024, and 2023, the finance result was mainly derived from returns such as interests and sales resulting from our financial investments as well as fair value adjustments of our money market funds.
For the nine months ended September 30, 2024 and 2023, income taxes were calculated based on the best estimate of the weighted average annual income tax rates expected for the full financial years (estimated annual effective income tax rates) on ordinary income before tax adjusted by the tax effect of any discrete items. The income tax asset represents the portion of prepayments for corporate income taxes and trade taxes in Germany that have been estimated for the full financial year 2024 but not yet offset by income tax expenses calculated for the nine months ended September 30, 2024. For the nine months ended September 30, 2024, our effective income tax rate was approximately 5.5%. For the nine months ended September 30, 2023, our effective income tax rate was approximately 9.7%.
The change in the effective income tax rate was mainly driven by the expected negative result for 2024 and management's assessment of the requirements in IAS 12, including on the character and amounts of taxable future profits, the periods in which those profits are expected to occur, and the availability of tax planning opportunities. Thus, in countries where the requirements of IAS 12 were not fulfilled, no deferred tax asset was recognized. Such assessment takes into account the fact that there is an inherent risk of failure in pharmaceutical development and uncertainty of approvals that depend on external regulatory agencies' opinions. As of September 30, 2024, it is considered highly probable that taxable profits for the U.S. tax group will be available against which the deferred tax assets can be utilized in the near future, fulfilling the requirements set out by IAS 12. In accordance with IAS 12, a total deferred tax income of 38.2 million was recognized in the interim condensed consolidated statements of profit or loss with respect to share-based payment programs during the nine months ended September 30, 2024.
We apply the mandatory exception to recognizing and disclosing information about deferred tax assets and liabilities arising from Pillar Two income taxes. Furthermore, we reviewed the corporate structure in light of the introduction of Pillar Two Model Rules in various jurisdictions. Since the Group's relevant effective tax rate calculated for Pillar Two Purposes is mainly above 15% in all jurisdictions in which it operates, it has been determined that the Group is not materially subject to Pillar Two "top-up" taxes. Therefore, the consolidated financial statements for the three and nine months ended September 30, 2024 do not include further information otherwise required by paragraphs 88B and 88C of IAS 12.
Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024
The income taxes recognized during the three and nine months ended September 30, 2024, and 2023, are shown in the following table
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||
| (in millions ) | 2024 | 2023 | 2024 | 2023 | |||||||||
| Current income taxes | (8.5) | 44.0 | (2.0) | 87.5 | |||||||||
| Deferred taxes | (30.9) | 22.8 | (52.1) | (37.0) | |||||||||
| Income taxes expenses (income) | (39.4) | 66.8 | (54.1) | 50.5 |
6. Other Intangible Assets
We examine the existence of indications of impairment using various factors, particularly deviations from sales forecasts and the analysis of changes in medium-term planning. The identification of indications of impairment takes place with the involvement of the responsible departments, taking external and internal information sources into consideration.
On August 15, 2024, the U.S. Food and Drug Administration, or FDA, lifted the partial clinical hold that was placed on the Phase 1 trial of our partner, MediLink Therapeutics (Suzhou) Co., Ltd, or MediLink, evaluating BNT326 YL202 (NCT05653752), which was announced on June 17, 2024. BNT326 YL202 is a Human Epidermal Growth Factor Receptor 3, or HER3,-targeting antibody-drug conjugate, or ADC, candidate that is being developed in collaboration between us and MediLink. Trial recruitment was re-initiated.
Based on this information, we determined that the triggering event previously identified during the three months ended June 30, 2024 in connection with the asset related to the product candidate BNT326 YL202 no longer existed.
We and our partner OncoC4, Inc., or OncoC4, collaborating in the development of a next-generation anti-CTLA-4 antibody candidate, or BNT316 ONC-392 (gotistobart), decided to proactively pause enrollment of new patients in the OncoC4-sponsored two-stage, open-label, randomized Phase 3 trial, PRESERVE-003 (NCT05671510), and informed the FDA of a possible variance in population results for further alignment. The decision was based on the recent assessment of the trial data by the independent data monitoring committee. The trial evaluates the efficacy and safety of the antibody candidate BNT316 ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Patients already enrolled in this trial continue to receive treatments. In addition, trials evaluating BNT316 ONC-392 in other indications remain unaffected.
Based on this information, during the three months ended September 30, 2024, we identified a triggering event in connection with the asset related to the product candidate BNT316 ONC-392 and performed an impairment test. As a result of the analysis, we did not identify an impairment for this asset.