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 2023
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(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 6, 2023, BioNTech SE (the “Company”) provided a development update and reported its financial results for the three and nine months ended September 30, 2023. The interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company for the three and nine months ended September 30, 2023 are attached hereto as Exhibit 99.1 and shall be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and incorporated by reference herein.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BioNTech SE | ||||||||
| By: | /s/ Jens Holstein | |||||||
| Name: Jens Holstein | ||||||||
| Title: Chief Financial Officer | ||||||||
Date: November 6, 2023
EXHIBIT INDEX
| Exhibit | Description of Exhibit | ||||
| 99.1 | |||||
Exhibit 99.1
BioNTech SE
Quarterly Report of BioNTech SE for the Three And Nine Months Ended September 30, 2023
Exhibit 99.1
Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, our website is not part of this document. Our agent for service solely for the purpose of notices and communications from the Securities and Exchange Commission in the United States is c/o BioNTech US Inc., 40 Erie Street, Suite 110, Cambridge, Massachusetts 02139, +1 (617) 337-4701.
Exhibit 99.1
5 Business Combination | |||||
7 Intangible Assets | |||||
Operating and Financial Review and Prospects
Unaudited Interim Condensed Consolidated Financial Statements
Interim Condensed Consolidated Statements of Profit or Loss
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||||||
| (in millions €, except per share data) | Note | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||
| Revenues | ||||||||||||||||||||
| Commercial revenues | 3 | 893.7 | 3,394.8 | 2,336.6 | 12,923.3 | |||||||||||||||
| Research & development revenues | 3 | 1.6 | 66.4 | 3.4 | 109.0 | |||||||||||||||
| Total revenues | 895.3 | 3,461.2 | 2,340.0 | 13,032.3 | ||||||||||||||||
| Cost of sales | 4.1 | (161.8) | (752.8) | (420.7) | (2,811.5) | |||||||||||||||
| Research and development expenses | 4.2 | (497.9) | (341.8) | (1,205.3) | (1,027.2) | |||||||||||||||
| Sales and marketing expenses | (14.4) | (12.8) | (44.7) | (44.9) | ||||||||||||||||
| General and administrative expenses | 4.3 | (144.5) | (141.0) | (386.6) | (361.8) | |||||||||||||||
| Other operating expenses | 4.4 | (31.4) | (285.1) | (223.7) | (594.6) | |||||||||||||||
| Other operating income | 4.5 | 27.8 | 459.8 | 105.2 | 1,157.5 | |||||||||||||||
| Operating income | 73.1 | 2,387.5 | 164.2 | 9,349.8 | ||||||||||||||||
| Finance income | 4.6 | 156.3 | 60.9 | 363.2 | 448.5 | |||||||||||||||
| Finance expenses | (2.0) | (4.3) | (4.5) | (16.8) | ||||||||||||||||
| Profit before tax | 227.4 | 2,444.1 | 522.9 | 9,781.5 | ||||||||||||||||
| Income taxes | 6 | (66.8) | (659.2) | (50.5) | (2,625.8) | |||||||||||||||
| Profit for the period | 160.6 | 1,784.9 | 472.4 | 7,155.7 | ||||||||||||||||
| Earnings per share | ||||||||||||||||||||
| Basic earnings for the period per share | 0.67 | 7.43 | 1.96 | 29.47 | ||||||||||||||||
| Diluted earnings for the period per share | 0.67 | 6.98 | 1.94 | 27.70 | ||||||||||||||||
The accompanying notes form an integral part of these interim consolidated financial statements.
1
Interim Condensed Consolidated Statements of Comprehensive Income
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||||||
| (in millions €) | Note | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||
| Profit for the period | 160.6 | 1,784.9 | 472.4 | 7,155.7 | ||||||||||||||||
| 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 | 3.9 | 10.9 | (0.4) | 24.4 | ||||||||||||||||
| Net loss on cash flow hedges | (7.7) | — | — | — | ||||||||||||||||
| Net other comprehensive income / (loss) that may be reclassified to profit or loss in subsequent periods | (3.8) | 10.9 | (0.4) | 24.4 | ||||||||||||||||
| Other comprehensive loss that will not be reclassified to profit or loss in subsequent periods, net of tax | ||||||||||||||||||||
| Net gain / (loss) on equity instruments designated at fair value through other comprehensive income | (4.8) | — | (0.4) | — | ||||||||||||||||
| Remeasurement loss on defined benefit plans | — | — | — | (0.1) | ||||||||||||||||
| Net other comprehensive income / (loss) that will not be reclassified to profit or loss in subsequent periods | (4.8) | — | (0.4) | (0.1) | ||||||||||||||||
| Other comprehensive income / (loss) for the period, net of tax | (8.6) | 10.9 | (0.8) | 24.3 | ||||||||||||||||
| Comprehensive income for the period, net of tax | 152.0 | 1,795.8 | 471.6 | 7,180.0 | ||||||||||||||||
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
2
Interim Condensed Consolidated Statements of Financial Position
| September 30, | December 31, | |||||||||||||
| (in millions €) | 2023 | 2022 | ||||||||||||
| Assets | Note | (unaudited) | ||||||||||||
| Non-current assets | ||||||||||||||
| Intangible assets | 5, 7 | 665.5 | 158.5 | |||||||||||
| Goodwill | 5 | 365.6 | 61.2 | |||||||||||
| Property, plant and equipment | 728.9 | 609.2 | ||||||||||||
| Right-of-use assets | 197.0 | 211.9 | ||||||||||||
| Other financial assets | 8 | 1,292.7 | 80.2 | |||||||||||
| Other non-financial assets | 0.3 | 6.5 | ||||||||||||
| Deferred tax assets | 6 | 208.1 | 229.6 | |||||||||||
| Total non-current assets | 3,458.1 | 1,357.1 | ||||||||||||
| Current assets | ||||||||||||||
| Inventories | 9 | 415.7 | 439.6 | |||||||||||
| Trade and other receivables | 8 | 2,002.0 | 7,145.6 | |||||||||||
| Contract assets | 6.8 | — | ||||||||||||
| Other financial assets | 8 | 2,253.3 | 189.4 | |||||||||||
| Other non-financial assets | 286.2 | 271.9 | ||||||||||||
| Income tax assets | 6 | 289.3 | 0.4 | |||||||||||
| Cash and cash equivalents | 13,495.8 | 13,875.1 | ||||||||||||
| Total current assets | 18,749.1 | 21,922.0 | ||||||||||||
| Total assets | 22,207.2 | 23,279.1 | ||||||||||||
| Equity and liabilities | ||||||||||||||
| Equity | ||||||||||||||
| Share capital | 10 | 248.6 | 248.6 | |||||||||||
| Capital reserve | 10 | 1,228.4 | 1,828.2 | |||||||||||
| Treasury shares | 10 | (10.8) | (5.3) | |||||||||||
| Retained earnings | 19,305.4 | 18,833.0 | ||||||||||||
| Other reserves | 11 | (904.8) | (848.9) | |||||||||||
| Total equity | 19,866.8 | 20,055.6 | ||||||||||||
| Non-current liabilities | ||||||||||||||
| Lease liabilities, loans and borrowings | 8 | 161.9 | 176.2 | |||||||||||
| Other financial liabilities | 8 | 38.5 | 6.1 | |||||||||||
| Income tax liabilities | 6 | — | 10.4 | |||||||||||
| Provisions | 8.6 | 8.6 | ||||||||||||
| Contract liabilities | 3 | 268.0 | 48.4 | |||||||||||
| Other non-financial liabilities | 13.1 | 17.0 | ||||||||||||
| Deferred tax liabilities | 43.1 | 6.2 | ||||||||||||
| Total non-current liabilities | 533.2 | 272.9 | ||||||||||||
| Current liabilities | ||||||||||||||
| Lease liabilities, loans and borrowings | 8 | 40.0 | 36.0 | |||||||||||
| Trade payables and other payables | 8 | 222.7 | 204.1 | |||||||||||
| Other financial liabilities | 8 | 321.6 | 785.1 | |||||||||||
| Refund liabilities | — | 24.4 | ||||||||||||
| Income tax liabilities | 6 | 545.2 | 595.9 | |||||||||||
| Provisions | 318.0 | 367.2 | ||||||||||||
| Contract liabilities | 3 | 167.1 | 77.1 | |||||||||||
| Other non-financial liabilities | 192.6 | 860.8 | ||||||||||||
| Total current liabilities | 1,807.2 | 2,950.6 | ||||||||||||
| Total liabilities | 2,340.4 | 3,223.5 | ||||||||||||
| Total equity and liabilities | 22,207.2 | 23,279.1 | ||||||||||||
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
3
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, 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 | 0.5 | 67.1 | — | — | — | 67.6 | ||||||||||||||||||||
| Redemption of convertible note | 1.8 | 233.2 | — | — | — | 235.0 | ||||||||||||||||||||
| Share repurchase program | — | (924.2) | (6.5) | — | — | (930.7) | ||||||||||||||||||||
| Transaction costs | — | (0.1) | — | — | — | (0.1) | ||||||||||||||||||||
| Dividends | — | — | — | (484.3) | — | (484.3) | ||||||||||||||||||||
| Share-based payments | — | — | — | — | 33.1 | 33.1 | ||||||||||||||||||||
| Deferred taxes | — | — | — | — | 372.0 | 372.0 | ||||||||||||||||||||
| As of September 30, 2022 | 248.6 | 1,050.4 | (10.3) | 16,554.3 | 523.3 | 18,366.3 | ||||||||||||||||||||
| As of January 1, 2023 | 248.6 | 1,828.2 | (5.3) | 18,833.0 | (848.9) | 20,055.6 | ||||||||||||||||||||
| Profit for the period | — | — | — | 472.4 | — | 472.4 | ||||||||||||||||||||
| Other comprehensive loss | — | — | — | — | (0.8) | (0.8) | ||||||||||||||||||||
| Total comprehensive profit / (loss) | — | — | — | 472.4 | (0.8) | 471.6 | ||||||||||||||||||||
| Share repurchase program | 10 | — | (731.6) | (6.9) | — | — | (738.5) | |||||||||||||||||||
| Share-based payments | 11 | — | 29.2 | 0.3 | — | (24.3) | 5.2 | |||||||||||||||||||
| Current and deferred taxes | 6 | — | — | — | — | (30.8) | (30.8) | |||||||||||||||||||
| Treasury shares used for acquisition of business combination | 5 | — | 102.6 | 1.1 | — | — | 103.7 | |||||||||||||||||||
| As of September 30, 2023 | 248.6 | 1,228.4 | (10.8) | 19,305.4 | (904.8) | 19,866.8 | ||||||||||||||||||||
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
4
Interim Condensed Consolidated Statements of Cash Flows
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| (in millions €) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Operating activities | |||||||||||||||||
| Profit for the period | 160.6 | 1,784.9 | 472.4 | 7,155.7 | |||||||||||||
| Income taxes | 66.8 | 659.2 | 50.5 | 2,625.8 | |||||||||||||
| Profit before tax | 227.4 | 2,444.1 | 522.9 | 9,781.5 | |||||||||||||
| Adjustments to reconcile profit before tax to net cash flows: | |||||||||||||||||
| Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets | 41.3 | 33.5 | 104.6 | 94.3 | |||||||||||||
| Share-based payment expenses | 15.5 | 61.4 | 37.2 | 86.4 | |||||||||||||
| Net foreign exchange differences | (20.4) | 116.2 | (364.3) | (222.3) | |||||||||||||
| Loss on disposal of property, plant and equipment | 3.3 | 0.2 | 3.6 | 0.4 | |||||||||||||
| Finance income excluding foreign exchange differences | (148.5) | (7.7) | (357.4) | (226.5) | |||||||||||||
| Finance expense excluding foreign exchange differences | 2.0 | 4.3 | 4.5 | 16.8 | |||||||||||||
| Movements in government grants | — | — | (3.0) | — | |||||||||||||
| Unrealized net (gain) / loss on derivative instruments at fair value through profit or loss | (3.5) | (2.3) | 84.7 | 82.3 | |||||||||||||
| Working capital adjustments: | |||||||||||||||||
| Decrease in trade and other receivables, contract assets and other assets | 631.2 | 2,245.4 | 6,648.6 | 5,016.7 | |||||||||||||
| Decrease in inventories | 33.2 | 72.9 | 23.9 | 207.7 | |||||||||||||
| (Decrease) / increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | (25.0) | 565.9 | (293.9) | 760.3 | |||||||||||||
| Interest received | 70.3 | 4.3 | 166.4 | 6.5 | |||||||||||||
| Interest paid | (1.2) | (4.3) | (3.7) | (16.5) | |||||||||||||
| Income tax paid | (10.2) | (753.3) | (1,292.4) | (2,834.7) | |||||||||||||
| Share-based payments | (4.2) | (1.7) | (761.2) | (4.7) | |||||||||||||
| Net cash flows from operating activities | 811.2 | 4,778.9 | 4,520.5 | 12,748.2 | |||||||||||||
| Investing activities | |||||||||||||||||
| Purchase of property, plant and equipment | (53.2) | (77.9) | (165.6) | (192.6) | |||||||||||||
| Proceeds from sale of property, plant and equipment | (0.8) | 0.4 | (0.8) | 0.4 | |||||||||||||
| Purchase of intangible assets and right-of-use assets | (97.2) | (4.7) | (348.9) | (26.2) | |||||||||||||
| Acquisition of subsidiaries and businesses, net of cash acquired | (336.9) | — | (336.9) | — | |||||||||||||
| Investment in other financial assets | (744.1) | (1.1) | (3,407.2) | (31.1) | |||||||||||||
| Proceeds from maturity of other financial assets | — | — | — | 375.2 | |||||||||||||
| Net cash flows from / (used in) investing activities | (1,232.2) | (83.3) | (4,259.4) | 125.7 | |||||||||||||
| Financing activities | |||||||||||||||||
| Proceeds from issuance of share capital and treasury shares, net of costs | — | — | — | 110.5 | |||||||||||||
| Proceeds from loans and borrowings | 0.1 | 0.4 | 0.1 | 0.6 | |||||||||||||
| Repayment of loans and borrowings | (0.1) | — | (0.1) | (18.8) | |||||||||||||
| Payments related to lease liabilities | (9.3) | (10.0) | (28.0) | (31.9) | |||||||||||||
| Share repurchase program | (301.7) | (643.8) | (737.7) | (930.7) | |||||||||||||
| Dividends | — | — | — | (484.3) | |||||||||||||
| Net cash flows used in financing activities | (311.0) | (653.4) | (765.7) | (1,354.6) | |||||||||||||
| Net increase / (decrease) in cash and cash equivalents | (732.0) | 4,042.2 | (504.6) | 11,519.3 | |||||||||||||
| Change in cash and cash equivalents resulting from exchange rate differences and other valuation effects | 61.2 | 46.7 | 125.3 | 211.7 | |||||||||||||
| Cash and cash equivalents at the beginning of the period | 14,166.6 | 9,334.8 | 13,875.1 | 1,692.7 | |||||||||||||
| Cash and cash equivalents as of September 30 | 13,495.8 | 13,423.7 | 13,495.8 | 13,423.7 | |||||||||||||
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.
5
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 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 products 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 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, 2023 were authorized for issuance in accordance with a resolution of the audit committee on November 3, 2023.
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, 2023 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, 2022.
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, 2023 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 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, 2022. In order to determine our share of the collaboration partner’s gross profits, we used certain information from the collaboration partner, including revenues from the sale of products and certain other sharable expense items some of which is based on preliminary data shared between the partners. Our management continually evaluates judgments and estimates, including those related to the contingencies, 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,
6
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.
Previously, we had assessed that inventory produced prior to successful regulatory approval did not meet the criteria for capitalization as an asset, and accordingly expensed the costs of pre-launch inventory as research and development costs. Based on the experience of the past years and the developments since our COVID-19 vaccine was first authorized or approved for emergency or temporary use, our assessment regarding the potential to produce economic benefits changed. Beginning with the second quarter of 2023, pre-launch products from the Comirnaty product family with their potential for economic benefit fulfill the recognition criteria for an asset under the IFRS Conceptual Framework. At each reporting date, the respective inventory is measured at the lower of cost and net realizable value. Until regulatory approval is obtained, we consider the net realizable value to be zero, as this is the probable amount expected to be realized from its sale until approval is obtained. The write-down is recognized in the statements of profit or loss as research and development expenses. Once regulatory approval for a product candidate is obtained, including for approved Comirnaty vaccines, the relevant write-down is reversed to a maximum of the original cost. Subsequently, inventory will be recognized as cost of sales. This reassessment made during the three month ended September 30, 2023, has been treated as a change in estimate and the impacts on current period inventories, cost of sales and research and development expenses is described in Note 4.1.
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, 2022, except for income taxes, which are accounted for using the expected annual tax rate in our unaudited interim condensed consolidated financial statements (see Note 6). Certain policies are described further below due to the activities and transactions during the three and nine months ended September 30, 2023.
Standards Applied for the First Time
The IFRS standards applied for the first time as of January 1, 2023, as disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2022, had no impact on our unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2023.
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 €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Commercial revenues | 893.7 | 3,394.8 | 2,336.6 | 12,923.3 | |||||||||||||
| COVID-19 vaccine revenues | 885.0 | 3,378.1 | 2,306.7 | 12,883.9 | |||||||||||||
Sales to collaboration partners(1) | (17.7) | 259.4 | 128.9 | 1,470.9 | |||||||||||||
| Direct product sales to customers | 195.7 | 564.5 | 260.9 | 2,284.6 | |||||||||||||
| Share of collaboration partners' gross profit | 707.0 | 2,554.2 | 1,916.9 | 9,128.4 | |||||||||||||
| Other sales | 8.7 | 16.7 | 29.9 | 39.4 | |||||||||||||
| Research & development revenues from collaborations | 1.6 | 66.4 | 3.4 | 109.0 | |||||||||||||
| Total | 895.3 | 3,461.2 | 2,340.0 | 13,032.3 | |||||||||||||
(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.
Commercial Revenues
During the three and nine months ended September 30, 2023, and 2022, commercial revenues were recognized from the supply and sales of our COVID-19 vaccine worldwide. During the three and nine months ended September 30, 2023 our commercial revenues decreased corresponding with a lower COVID-19 vaccine market demand. Write-downs by our collaboration partner Pfizer Inc, or Pfizer, significantly reduced our gross profit share and hence negatively influenced our revenues for three months ended September 30, 2023.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. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. Shanghai Fosun
7
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.
Sales to Collaboration Partners
Sales to collaboration partners represent sales of products manufactured by us to collaboration partners. Whenever responsibilities in the manufacturing and supply process of the COVID-19 vaccine shift and the COVID-19 vaccine is transferred, the vaccine is sold from one partner to the other. Under the collaboration with Pfizer, from time to time, those sales are significantly influenced by amounts due to write-downs of inventories as well as costs related to production capacities derived from contracts with Contract Manufacturing Organizations (CMOs) that became redundant. Those costs represent accrued manufacturing variances and are charged to our partner once finally materialized. These manufacturing variances are reflected as transfer price adjustment once identified. The regular reassessment of these manufacturing variances might result in minor reversals of the respective prior period revenues. Sales to collaboration partners during the three and nine months ended September 30, 2023, amounted to €(17.7) million and €128.9 million, respectively. During the three and nine months ended September 30, 2022 the sales to collaboration partners amounted to €259.4 million and €1,470.9 million, respectively. During the three and nine months ended September 30, 2023 those sales included €(72.5) million and €44.4 million, respectively, related to the aforementioned manufacturing variances (€161.6 million and €956.8 million with respect to sales during the three and nine months ended September 30, 2022).
Direct Product Sales to Customers
By supplying our territories during the three and nine months ended September 30, 2023, we recognized €195.7 million and €260.9 million of revenues, respectively, from direct COVID-19 vaccine sales in Germany. During the three and nine months ended September 30, 2022, recognized revenues derived from those sales amounted to €564.5 million and €2,284.6 million, respectively. The share of gross profit that we owe our collaboration partner Pfizer based on our sales is recognized as cost of sales. Alongside with the amended COVID-19 Vaccine Purchase Agreement with the European Commission, an amount of €372.3 million remained as contract liability in our unaudited interim condensed consolidated statements of financial position. The amount will be recognized over the term of the agreement.
Share of Collaboration Partners' Gross Profit
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 seasonally-affected net figure and is recognized as collaboration revenue during the commercial phase. When determining the gross profit, manufacturing cost variances either reflected as transfer price adjustment as described above, or resulting from costs expected to be incurred by the partner were considered. During the three and nine months ended September 30, 2023, €707.0 million and €1,916.9 million, respectively, in gross profit share was recognized as revenues. During the three and nine months ended September 30, 2022, €2,554.2 million and €9,128.4 million, respectively, in gross profit share was recognized as revenues.
Revenues from contracts with customers were recognized as follows:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Timing of revenue recognition | |||||||||||||||||
| Goods and services transferred at a point in time | 184.9 | 839.0 | 410.4 | 3,790.0 | |||||||||||||
| Goods and services transferred over time | 3.4 | 68.0 | 12.7 | 113.9 | |||||||||||||
Revenue recognition applying the sales-based or usage-based royalty recognition constraint model(1) | 707.0 | 2,554.2 | 1,916.9 | 9,128.4 | |||||||||||||
| Total | 895.3 | 3,461.2 | 2,340.0 | 13,032.3 | |||||||||||||
(1) Represents sales based on the share of the collaboration partners' gross profit.
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4Income and Expenses
4.1Cost of Sales
The cost of sales recognized during the three and nine months ended September 30, 2023, and 2022 are shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Cost of sales related to COVID-19 vaccine revenues | 160.9 | 737.8 | 412.0 | 2,779.4 | |||||||||||||
| Cost related to other sales | 0.9 | 15.0 | 8.7 | 32.1 | |||||||||||||
| Total | 161.8 | 752.8 | 420.7 | 2,811.5 | |||||||||||||
Based on the regulatory approval obtained during the three and nine months ended September 30, 2023, we reversed the initial write-down of prelaunch inventory recorded in research and development expenses to a maximum of the original cost of €46.9 million. Thereof €27.3 million resulted in cost of sales of the period as the respective inventory has been either sold or written-down. The remainder is presented in inventories as of September 30, 2023 and amounted to €19.6 million. With respect to the prior year period the amount was nil.
4.2Research and Development Expenses
The research and development expenses recognized during the three and nine months ended September 30, 2023, and 2022 are shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Purchased services | 319.9 | — | 658.9 | 361.4 | |||||||||||||
| Wages, benefits and social security expense | 103.3 | 122.8 | 287.9 | 279.1 | |||||||||||||
| Laboratory supplies | 28.8 | 191.3 | 131.6 | 297.0 | |||||||||||||
| Depreciation and amortization | 18.3 | 13.6 | 46.7 | 36.0 | |||||||||||||
| Other | 27.6 | 14.1 | 80.2 | 53.7 | |||||||||||||
| Total | 497.9 | 341.8 | 1,205.3 | 1,027.2 | |||||||||||||
4.3General and Administrative Expenses
The general and administrative expenses recognized during the three and nine months ended September 30, 2023, and 2022 are shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Wages, benefits and social security expense | 44.2 | 37.8 | 125.3 | 108.3 | |||||||||||||
| IT and office equipment | 41.5 | 23.7 | 102.6 | 57.5 | |||||||||||||
| Purchased services | 28.6 | 38.7 | 87.4 | 103.6 | |||||||||||||
| Depreciation and amortization | 8.1 | 4.6 | 23.0 | 10.5 | |||||||||||||
| Other | 22.1 | 36.2 | 48.3 | 81.9 | |||||||||||||
| Total | 144.5 | 141.0 | 386.6 | 361.8 | |||||||||||||
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4.4Other Operating Expenses
The other operating expenses recognized during the three and nine months ended September 30, 2023, and 2022 are shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Foreign exchange differences, net | 26.1 | — | 213.8 | — | |||||||||||||
| Loss on derivative instruments at fair value through profit or loss | — | 282.7 | — | 581.7 | |||||||||||||
| Other | 5.3 | 2.4 | 9.9 | 12.9 | |||||||||||||
| Total | 31.4 | 285.1 | 223.7 | 594.6 | |||||||||||||
The foreign exchange differences included in operating expenses 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 loss on derivative instruments at fair value through profit or loss in the prior year comparable period related to foreign exchange forward contracts that were entered into to manage some of our transaction exposures but were not designated as hedging instruments under IFRS (see Note 8).
4.5Other Operating Income
The other operating income recognized during the three and nine months ended September 30, 2023, and 2022 is shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Gain on derivative instruments at fair value through profit or loss | 17.3 | — | 71.8 | — | |||||||||||||
| Foreign exchange differences, net | — | 449.1 | — | 1,090.1 | |||||||||||||
| Other | 10.5 | 10.7 | 33.4 | 67.4 | |||||||||||||
| Total | 27.8 | 459.8 | 105.2 | 1,157.5 | |||||||||||||
The gain 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 8).
The foreign exchange differences in the prior year comparable period included in operating income primarily arose from valuing our U.S. dollar denominated trade receivables which mainly relate to our COVID-19 collaboration with Pfizer, U.S. dollar denominated trade payables as well as our U.S. dollar denominated other financial liabilities which mainly relate to 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, 2023, and 2022 is shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Interest income | 92.5 | 7.7 | 237.2 | 9.7 | |||||||||||||
| Fair value adjustments of financial instruments measured at fair value | 56.0 | — | 120.2 | 216.8 | |||||||||||||
| Foreign exchange differences, net | 7.8 | 53.2 | 5.8 | 222.0 | |||||||||||||
| Total | 156.3 | 60.9 | 363.2 | 448.5 | |||||||||||||
During the three and nine months ended September 30, 2023, interest income was mainly derived from our debt security investments as well as bank deposits and the fair value adjustments were derived from remeasuring our money market funds.
During the three and nine months ended September 30, 2022, foreign exchange differences were mainly derived from our foreign exchange bank deposits and cash accounts, respectively. In addition, during the nine months ended September 30, 2022, the fair value adjustments derived from remeasuring the derivative embedded in our convertible note significantly affected our finance result.
In the interim condensed consolidated statements of cash flows, the change in cash and cash equivalents resulting from exchange rate differences amounted to €5.8 million and €5.6 million during the three and nine months ended September 30, 2023, respectively.
In the interim condensed consolidated statements of cash flows, the change in cash and cash equivalents resulting from exchange rate differences amounted to €46.7 million and €211.7 million during the three and nine months ended September 30, 2022, respectively.
5Business Combination
Acquisition of InstaDeep Ltd.
In July 2023, we acquired InstaDeep Ltd., London, or InstaDeep, a leading global technology company in the field of artificial intelligence, or AI, and machine learning, by purchasing 100% of the remaining shares in InstaDeep not already owned by us. The acquisition is intended to create a fully integrated, enterprise-wide capability that leverages AI and machine learning technologies across our therapeutic platforms and operations. InstaDeep also continues to provide its services to clients around the world in diverse industries, including in the Technology, Transport & Logistics, Industrial and Financial Services sectors.
The completion of the acquisition in July 2023 was accounted for as a business combination using the acquisition method of accounting. We performed an allocation of the total consideration and the underlying assets acquired (including certain identified intangible assets as InstaDeep's DeepChain technology and customer relationships) and liabilities assumed based on their fair values using the information available as of the acquisition date. The total consideration and the fair values in accordance with IFRS 3 of the identified net assets acquired of InstaDeep as of July 31, 2023 are as follows:
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| Fair value recognized on acquisition | |||||
| (in millions €) | InstaDeep Ltd. | ||||
| Assets | |||||
| Intangible assets | 187.6 | ||||
| Property, plant and equipment | 2.1 | ||||
| Right-of-use assets | 0.7 | ||||
| Trade receivables | 2.4 | ||||
| Financial assets - current | 52.5 | ||||
| Cash and cash equivalents | 21.2 | ||||
| Other assets non-current and current | 8.7 | ||||
| Total assets | 275.0 | ||||
| Liabilities | |||||
| Deferred tax liabilities | 45.8 | ||||
| Other liabilities long-term and short-term | 18.2 | ||||
| Total liabilities | 64.0 | ||||
| Total identifiable net assets at fair value | 211.0 | ||||
| Goodwill from the acquisition | 306.5 | ||||
| Total consideration | 517.5 | ||||
| Consideration | |||||
| Cash paid | 358.1 | ||||
| Cash to be paid in 2024 | 4.0 | ||||
| Designated FX-Hedge | (8.1) | ||||
| Shares transferred (approx. 1.1 million shares) | 103.7 | ||||
| Contingent consideration | 31.8 | ||||
| Previously-held non-listed equity investment (stake of 5.3%) | 27.9 | ||||
| Total consideration | 517.5 | ||||
The intangible assets acquired comprise DeepChain technology and customer relationships. Their fair values were determined based on the multi-period excess earnings method (MEEM) and amount to €176.0 million and €7.8 million respectively.
The fair value of the shares transferred is determined based on the number of shares transferred and our closing stock price as of July 31, 2023.
The acquisition of InstaDeep is a step-acquisition according to IFRS 3.41-3.42A since we already held 5.3% prior to the acquisition. In prior reporting periods, we recognized changes in the value of this equity interest in other comprehensive income. The amount of the remeasurement to fair value that was recognized in other comprehensive income is recognized on the same basis as would be required if we disposed directly of the previously held equity interest. Based on the total consideration for the acquired shares (94.7%) the value of the already held shares is €27.9 million, which results in a loss of €2.2 million shown in other comprehensive income in the three and nine months ended September 30, 2023.
At the acquisition date, the contingent consideration was recognized with its fair value of €31.8 million based on cash flow projections in connection with performance-based future milestone payments to eligible shareholders after a three-year earn-out period. The lower end of the bandwidth of possible outcomes of the contingent consideration is zero; the upper limit is €124.6 million. In addition, €12.5 million of potential earn-out payments are considered remuneration and will be recognized as personnel expense over a three-year period in which services are to be provided.
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The goodwill mainly comprises the value of expected synergies from including AI and machine learning technologies across our therapeutic platforms and operations and intangible assets that are not recognized separately, e.g., the acquired skilled workforce and its know-how. Therefore, the goodwill is almost fully allocated to the CGU immunotherapies and a minor part to a CGU comprising the external InstaDeep business. The goodwill is not tax deductible.
Deferred tax liabilities relating to temporary differences of the assets acquired in the business combination were recognized at an amount of €45.8 million. To the extent of those deferred tax liabilities assumed, deferred tax assets relating to temporary differences and tax loss carryforwards which existed as of the acquisition date were recognized. To the extent the conditions to offset were fulfilled, the deferred tax assets and liabilities were offset.
6Income Taxes
For the nine months ended September 30, 2023 and 2022, income taxes were calculated based on the best estimate of the weighted average annual income tax rates expected for the full financial years (estimated annual effective income tax rates) on ordinary income before tax adjusted by the tax effect of any discrete items. The income tax asset represents the portion of prepayments for corporate income taxes and trade taxes in Germany that have been paid for the full financial year 2023 but not yet offset by income tax expenses calculated for the nine months ended September 30, 2023. For the nine months ended September 30, 2023 and 2022, our effective income tax rates were approximately 9.7% and 26.8%, respectively. The decrease of the effective income tax rate was mainly driven by the transaction within the BioNTech Group described below. During the nine months ended September 30, 2023 and 2022, current income taxes were mainly recognized with respect to the German tax group. Deferred tax effects were recognized with respect to identified discrete items as well as share-based payments programs during the nine months ended September 30, 2023 and 2022.
A reorganization of the intellectual property rights within the group has become effective June 30, 2023 and July 1, 2023 which led to deferred tax effects in Germany, the US and Austria. As a result BioNTech SE recognized deferred tax assets and deferred tax income at the time of the transaction. In addition this transaction led to a revaluation of previously unrecognized U.S. federal and state deferred tax assets, including unused tax losses and unused tax credits. As of December 31, 2022, there were unrecognized U.S. federal and state deferred tax assets of €128.9 million. As of September 30, 2023, 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. Therefore we no longer continue to maintain the full non-recognition of deferred tax assets of our U.S. tax group as there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized. As of September 30, 2023, we maintain the non-recognition of deferred tax assets for unused U.S. federal and state tax losses at an amount of €20.1 million and €1.6 million, respectively, as there is not sufficient probability in terms of IAS 12 that there will be future taxable income available against which these unused tax losses can be utilized.
The income taxes recognized during the three and nine months ended September 30, 2023, and 2022 are shown in the following table:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| (in millions €) | 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Current income taxes | 44.0 | 724.3 | 87.5 | 2,657.2 | |||||||||||||
| Deferred taxes | 22.8 | (65.1) | (37.0) | (31.4) | |||||||||||||
| Income taxes | 66.8 | 659.2 | 50.5 | 2,625.8 | |||||||||||||
7Intangible Assets
The increase in intangible assets by €507.0 million from December 31, 2022 to September 30, 2023 was mainly related to the acquisition of InstaDeep (see Note 5) and licenses fulfilling the definition of identifiable assets in the amount of €328.9 million acquired in connection with the license and collaboration agreements entered into between us and Duality Biologics (Suzhou) Co. Ltd., Shanghai, China, in March 2023 and August 2023 as well as the license and collaboration agreement entered into between us and OncoC4 Inc., Rockville (Maryland), United States, in April 2023.
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8Financial 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, 2023 and December 31, 2022.
| (in millions €) | September 30, 2023 | December 31, 2022 | ||||||
| Derivatives not designated as hedging instruments | ||||||||
| Foreign exchange forward contracts | 4.0 | 183.7 | ||||||
| Equity instruments designated at fair value through OCI | ||||||||
| Non-listed equity investments | 27.1 | 57.1 | ||||||
| Listed equity investments | 26.0 | 20.0 | ||||||
| Financial assets at amortized cost | ||||||||
| Trade and other receivables | 2,002.0 | 7,145.6 | ||||||
| Security investments | 3,471.8 | — | ||||||
| Other financial assets | 17.1 | 8.8 | ||||||
| Total | 5,548.0 | 7,415.2 | ||||||
| Total current | 4,255.3 | 7,335.0 | ||||||
| Total non-current | 1,292.7 | 80.2 | ||||||
Derivatives Not Designated as Hedging Instruments
Derivatives not designated as hedging instruments related to foreign exchange forward contracts that were entered, to manage some of our foreign currency exposures. The foreign exchange forward contracts are measured at fair value through profit or loss and are intended to reduce the exposure to foreign currency risk resulting from trade receivables denominated in U.S. dollar.
Equity Instruments Designated at Fair Value through Other Comprehensive Income
Equity investments are mainly made in conjunction with our existing collaboration partnerships. In accordance with IFRS 9 we elected to present gains and losses on our equity investments in other comprehensive income to avoid fluctuations in our unaudited interim condensed consolidated statements of profit or loss. In connection with the acquisition of InstaDeep we remeasured our 5.3% stake in InstaDeep which was initially acquired during the year ended December 31, 2021, based on the final purchase price.
Financial Assets at Amortized Cost
Trade and other receivables predominantly comprised trade receivables from our COVID-19 collaboration with Pfizer where 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, there is an additional time lag between the recognition of revenues and the payment receipt. Consequently, as of September 30, 2023, our trade receivables included, in addition to the profit share for the third quarter of 2023, trade receivables which related to the gross profit share for the second quarter of 2023.
Our investments in different debt securities with a remaining term of more or less than twelve months are presented as non-current or current security investments, respectively, and measured at amortized cost. Within our interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2023, €1,223.8 million are presented as non-current and €2,248.0 million as current security investments as part of the financial assets.
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Financial Liabilities
Set forth below is an overview of loans and borrowings and other financial liabilities held as of September 30, 2023 and December 31, 2022.
| Loans and borrowings | ||||||||
| (in millions €) | September 30, 2023 | December 31, 2022 | ||||||
| Lease liabilities | 199.7 | 210.1 | ||||||
| Loans and borrowings | 2.2 | 2.1 | ||||||
| Total | 201.9 | 212.2 | ||||||
| Total current | 40.0 | 36.0 | ||||||
| Total non-current | 161.9 | 176.2 | ||||||
| Other financial liabilities | ||||||||
| (in millions €) | September 30, 2023 | December 31, 2022 | ||||||
| Derivatives not designated as hedging instruments | ||||||||
| Foreign exchange forward contracts | 25.0 | — | ||||||
| Financial liabilities at fair value through profit or loss | ||||||||
| Contingent consideration | 38.5 | 6.1 | ||||||
| Total financial liabilities at fair value | 63.5 | 6.1 | ||||||
| Trade payables and other payables as well as financial liabilities at amortized cost, other than loans and borrowings | ||||||||
| Trade payables and other payables | 222.7 | 204.1 | ||||||
| Other financial liabilities | 296.6 | 785.1 | ||||||
| Total trade payables and other payables as well as financial liabilities at amortized cost, other than loans and borrowings | 519.3 | 989.2 | ||||||
| Total other financial liabilities | 582.8 | 995.3 | ||||||
| Total current | 544.3 | 989.2 | ||||||
| Total non-current | 38.5 | 6.1 | ||||||
| Total financial liabilities | ||||||||
| (in millions €) | September 30, 2023 | December 31, 2022 | ||||||
| Lease liabilities, loans and borrowings | 201.9 | 212.2 | ||||||
| Other financial liabilities | 582.8 | 995.3 | ||||||
| Total | 784.7 | 1,207.5 | ||||||
| Total current | 584.3 | 1,025.2 | ||||||
| Total non-current | 200.4 | 182.3 | ||||||
Derivatives Not Designated as Hedging Instruments
Derivatives not designated as hedging instruments related to foreign exchange forward contracts that were entered to manage some of our foreign currency exposures. The foreign exchange forward contracts are measured at fair value through profit or loss and are intended to reduce the exposure to foreign currency risk resulting from trade receivables denominated in U.S. dollar.
Other Financial Liabilities at Amortized Cost
Other financial liabilities at amortized cost mainly included obligations derived from license agreements which are being incurred with respect to our COVID-19 vaccine sales in our and our collaboration partners’ territories where we and our partners are using third party intellectual property.
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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, 2022.
Fair Values
The financial instruments at fair value are measured at fair value on a quarterly basis. Money market funds, or MMFs, which were recognized as cash and cash equivalents in the amount of €7,279.5 million as of September 30, 2023 (€3,148.9 million as of December 31, 2022), were valued using quoted prices on the valuation date in active markets (Level 1). The foreign exchange forward contracts were valued using valuation techniques, which involved the use of foreign exchange spot and forward rates (Level 2). The fair values of listed equity investments were measured based on the stock prices of the listed companies (Level 1). The fair values of non-listed equity investments were measured based on observable inputs, e.g., used for multiple analyses (Level 2). The initial fair value of contingent considerations determined at acquisition was based on cash flow projections (unobservable Level 3 input factors). The fair value amount was adjusted only for compounding effects since no material changes of the underlying performance criteria had occurred.
9Inventories
Below is an overview of inventories held as of September 30, 2023 and December 31, 2022.
| (in millions €) | September 30, 2023 | December 31, 2022 | ||||||
| Raw materials and supplies | 385.5 | 409.7 | ||||||
| Unfinished goods | 9.7 | 21.0 | ||||||
| Finished goods | 20.5 | 8.9 | ||||||
| Total | 415.7 | 439.6 | ||||||
During the three and nine months ended September 30, 2023 expenses from inventory write-downs to net realizable value due to inventories expected to be unsaleable, not fulfilling the specification defined by our quality standards, shelf-life expiry or disposals resulted in €46.2 million and €96.7 million, respectively, included in cost of sales (€138.4 million and €559.4 million with respect to write-downs during the three and nine months ended September 30, 2022).
10Issued Capital and Reserves
As of September 30, 2023, the number of shares outstanding was 237,715,500. This amount excludes 10,836,700 shares held in treasury. As of December 31, 2022, the number of shares outstanding was 243,215,169, excluding 5,337,031 shares held in treasury.
Second Tranche Share Repurchase Program
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. Between January 1, 2023 and March 17, 2023, the date on which the trading plan for the second tranche of our share repurchase program expired, the following repurchases under the program occurred:
Second Tranche ($0.5 billion) | |||||||||||
| Period | Number of ADSs purchased | Average price paid per ADS | Net amount spent (in millions) | ||||||||
| January 2023 | 618,355 | $142.26 (€131.12) | $88.0 (€81.1) | ||||||||
| February 2023 | 857,620 | $138.05 (€129.06) | $118.4 (€110.7) | ||||||||
March 2023(1) | 745,196 | $128.49 (€121.08) | $95.7 (€90.2) | ||||||||
| Total | 2,221,171 | $302.1(€282.0) | |||||||||
(1) Ending March 17, 2023.
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2023 Share Repurchase Program
On March 27, 2023, our Management Board and Supervisory Board authorized a new share repurchase program under which we may purchase ADSs, each representing one ordinary share, with a value of up to $0.5 billion. Between June 2, 2023, the commencing date and September 18, 2023, the date on which the trading plan 2023 of our share repurchase program concluded, the following repurchases under the program occurred:
Program 2023 ($0.5 billion) | |||||||||||
| Period | Number of ADSs purchased | Average price paid per ADS | Net amount spent (in millions) | ||||||||
| June 2023 | 1,532,685 | $108.92 (€100.45) | $166.9 (€154.0) | ||||||||
| July 2023 | 1,738,061 | $107.92 (€97.57) | $187.6 (€169.6) | ||||||||
| August 2023 | 1,261,706 | $105.07 (€95.85) | $132.6 (€120.9) | ||||||||
| September 2023 | 114,513 | $112.22 (€105.07) | $12.9 (€12.0) | ||||||||
| Total | 4,646,965 | $500.0 (€456.5) | |||||||||
11Share-Based Payments
Expenses Arising from Share-Based Payment Arrangements
During the three and nine months ended September 30, 2023, and 2022, 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 €) | 2023 | 2022 | 2023 | 2022 | ||||||||||
| Expense arising from equity-settled share-based payment arrangements | 10.7 | 11.7 | 32.7 | 36.7 | ||||||||||
| Employee Stock Ownership Plan | (0.1) | 4.6 | — | 13.8 | ||||||||||
| Chief Executive Officer Grant | 0.4 | 0.9 | 1.2 | 2.7 | ||||||||||
| Management Board Grant | 1.2 | 0.6 | 3.9 | 3.3 | ||||||||||
| BioNTech 2020 Employee Equity Plan for Employees Based Outside North America | 9.2 | 5.6 | 27.6 | 16.9 | ||||||||||
| Expense / (Income) arising from cash-settled share-based payment arrangements | 4.8 | 49.7 | 4.5 | 49.7 | ||||||||||
| Employee Stock Ownership Plan | 1.0 | 46.8 | (0.4) | 47.1 | ||||||||||
| Management Board Grant | — | — | (1.8) | (1.2) | ||||||||||
| BioNTech Restricted Stock Unit Plan for North America Employees | 3.8 | 2.9 | 6.7 | 3.8 | ||||||||||
| Total | 15.5 | 61.4 | 37.2 | 86.4 | ||||||||||
| Recognized in: | ||||||||||||||
| Cost of sales | 1.4 | 0.5 | 4.5 | 2.0 | ||||||||||
| Research and development expenses | 7.7 | 52.7 | 22.9 | 69.7 | ||||||||||
| Sales and marketing expenses | 0.2 | 0.2 | 0.3 | 0.6 | ||||||||||
| General and administrative expenses | 6.2 | 8.0 | 9.5 | 14.1 | ||||||||||
| Total | 15.5 | 61.4 | 37.2 | 86.4 | ||||||||||
During the three and nine months ended September 30, 2023, our share-based payment arrangements led to a cash outflow of €4.2 million and €761.2 million, respectively. During the nine months ended September 30, 2023, the cash outflows included wage tax payments (including solidarity surcharge thereon and church tax, if applicable) and social security contributions of €724.0 million related to the exercise of rights under the Employee Stock Ownership Plan in 2022 (please see Note 16.5 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022 for further details of the exercise). During the three and nine months ended September 30, 2022, our share-based payment arrangements led to a cash outflow of €1.7 million and €4.7 million, respectively.
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Changes in Share-Based Payment Arrangements
In May 2023, the allocation date in 2023, options were allocated to the Management Board under the Management Board Grant. A detailed description of our share-based payment arrangements is included in Note 16 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.
12Contingencies
Our contingencies include, but are not limited to, intellectual property disputes and product liability and other product-related litigation. From time to time, in the normal course and conduct of our business, we may be involved in discussions with third parties about considering, for example, the use and/or remuneration for use of such third party’s intellectual property. As of September 30, 2023, none of such intellectual property-related considerations that we have been notified of, and for which potential claims could be brought against us or our subsidiaries in the future, fulfill the criteria for recording a provision. We are subject to an increasing number of product liability claims. Such claims often involve highly complex issues related to medical causation, correctness and completeness of product information (Summary of Product Characteristics/package leaflet) as well as label warnings and reliance thereon, scientific evidence and findings, actual and provable injury, and other matters. These complexities vary from matter to matter. As of September 30, 2023, none of these claims fulfill the criteria for recording a provision. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions. We currently do not believe that any of these matters will have a material adverse effect on our financial position, and will continue to monitor the status of these and other claims that may arise. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid. We will continue to evaluate whether, if circumstances were to change in the future, the recording of a provision may be needed and whether potential indemnification entitlements exist against any such claim.
Certain pending matters to which we are a party are discussed below.
Alnylam Proceedings
In March 2022, Alnylam Pharmaceuticals, Inc., or Alnylam, filed a lawsuit against Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that an existing patent owned by Alnylam, U.S. Patent No. 11,246,933, or the ‘933 Patent, is infringed by the cationic lipid used in Comirnaty, and seeking monetary relief, which is not specified in their filings. We filed a counterclaim to become party to the Alnylam proceeding, and in June 2022, Alnylam added to its claims allegations that we induced infringement of the ‘933 Patent. Additionally, in July 2022, Alnylam filed a lawsuit against us, our wholly owned subsidiary, BioNTech Manufacturing GmbH, Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that we also induced infringement of a newly issued patent, U.S. Patent No. 11,382,979, or the ‘979 Patent, which is a continuation of the ‘933 Patent. The two lawsuits were consolidated on July 28, 2022 and are currently pending. In May 2023, Alnylam filed a third lawsuit against Pfizer Inc. and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480; 11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. We filed a counterclaim to become party to the new proceeding, and in July 2023, Alnylam added to its claims allegations that we induced infringement of the four new patents. All of the proceedings have been consolidated and are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Alnylam’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
CureVac Proceedings
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Germany
Infringement Proceedings – EP’122, DE’961, DE‘974, DE’575, and EP’668
In July 2022, CureVac AG, or CureVac, filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP1857122B1, or the EP’122 Patent, and three Utility Models DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac added European Patent EP3708668B1, or the EP’668 Patent, to its German lawsuit.
On August 15, 2023, the Düsseldorf Regional Court held a hearing on the issue of alleged infringement with respect to all five IP rights. At the hearing, the Court suspended its infringement ruling with respect to EP’122 until December 28, 2023, after the Federal Patent Court is expected to issue its validity decision on EP’122 in the related ongoing nullity proceeding. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the remaining four IP rights (DE’961, DE’974, DE’575, and EP’668) pending validity decisions in the DE’961, DE’974, and DE’575 cancellation proceedings before the German Patent and Trademark Office and in the EP’668 opposition proceedings before the Opposition Division of the European Patent Office. In the September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions are reached, while contemporaneously noting concerns regarding the validity of DE’961, DE’974, DE’575, and EP’668.
Infringement Proceedings – EP’755, DE’123, and DE’130
In July 2023, CureVac SE filed a second lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP4023755B1, or the EP’755 Patent, and two Utility Models DE202021004123U1, and DE202021004130U1.
Nullity Proceedings – EP’122
In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that the EP’122 Patent is invalid. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122 nullity action in support of the validity of the EP’122 Patent. The preliminary opinion did not address any infringement of the EP’122 Patent. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non-binding. The first instance decision of the court in the EP’122 nullity action is expected in December 2023, and is appealable.
Cancellation Proceedings– DE’961, DE‘974, and DE’575
In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in the German Patent and Trademark Office.
United States
In July 2022, we and Pfizer filed a complaint for a declaratory judgment in the U.S. District Court for the District of Massachusetts, seeking a judgment of non-infringement by Comirnaty of U.S. Patent Nos. 11,135,312, 11,149,278 and 11,241,493. In May 2023, the action in the U.S. District Court for the District of Massachusetts was transferred to the U.S. District Court for the Eastern District of Virginia, where CureVac filed counterclaims asserting infringement of six additional U.S. patents, U.S. Patent Nos. 10,760,070; 11,286,492; 11,345,920; 11,471,525; 11,576,966; and 11,596,686. In July 2023, CureVac filed amended counterclaims to assert an additional U.S. patent, U.S. Patent No. 11,667,910.
United Kingdom
In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against the EP’122 Patent and the EP’668 Patent in the Business and Property Courts of England and Wales. In October 2022, CureVac responded by filing a counterclaim alleging infringement of the EP’122 and EP’668 patents in the Business And Property Courts of England and Wales.
All of the above proceedings are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility models and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of CureVac’s claims is ongoing and complex, and we believe the ultimate outcomes remain substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be
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sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Moderna Proceedings
Germany
Infringement Proceedings – EP’949 and EP’565
In August 2022, Moderna filed a lawsuit against us and Pfizer and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Manufacturing Belgium NV, Pfizer Ireland Pharmaceuticals and Pfizer Inc. in the Düsseldorf Regional Court alleging Comirnaty’s infringement of two European Patents, 3590949B1, or the EP’949 Patent, and 3718565B1, or the EP’565 Patent. Opposition proceedings against the EP'949 Patent and EP'565 Patent are currently pending.
United Kingdom
In August 2022, Moderna filed a lawsuit asserting Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the Business and Property Courts of England and Wales. In September 2022, we and Pfizer filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of the EP’949 Patent and EP’565 Patent.
United States
U.S. District Court Litigation
In August 2022, Moderna filed a lawsuit in the United States District Court for the District of Massachusetts against us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging Comirnaty’s infringement of U.S. Patent Nos. 10,898,574, 10,702,600 and 10,933,127 and seeking monetary relief.
Inter Partes Review
In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127 before the United States Patent Trial and Appeal Board.
Netherlands
In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc. in the District Court of The Hague alleging Comirnaty’s infringement of the EP ‘949 Patent and the EP ’565 Patent. The District Court of the Hague held a hearing on October 6, 2023 on infringement and validity with respect to the EP ’949 Patent. A first instance decision is expected in January 2024.
Ireland
In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals International C.V. alleging Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent in the High Court of Ireland.
Belgium
In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc. and Pfizer Manufacturing Belgium alleging Comirnaty’s infringement of the EP’949 Patent and the EP’565 Patent in the Brussels Dutch-speaking Enterprise Court.
All of the above proceedings are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the
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balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Arbutus and Genevant Proceedings
In April 2023, Arbutus Biopharma Corp., or Arbutus, and Genevant Sciences GmbH, or Genevant, filed a lawsuit against Pfizer and us in the U.S. District Court for the District of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid nanoparticle technology and methods for producing such lipids in Comirnaty, and seeking monetary relief. This proceeding is currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Promosome Proceedings
In June 2023, Promosome LLC filed a lawsuit against Pfizer, us, and BioNTech Manufacturing GmbH in the U.S. District Court for the Southern District of California alleging that Pfizer and our Comirnaty vaccine has infringed U.S. Patent No. 8,853,179, and seeking monetary relief. On October 4, 2023, the parties filed a joint stipulation of dismissal, dismissing the lawsuit with prejudice. As part of this stipulation of dismissal, Promosome agreed to a covenant not to assert U.S. Patent No. 8,853,179 against Pfizer and us or any of their products, including Comirnaty. This matter is considered closed.
13Related 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, 2023 compared to the details disclosed in Note 20 to our audited consolidated financial statements included in our Annual Report on Form 20-F as of and for the year ended December 31, 2022.
14Events after the Reporting Period
Strategic collaboration with MediLink Therapeutics (Suzhou) Co., Ltd.
On October 11, 2023, we and MediLink Therapeutics (Suzhou) Co., Ltd., or MediLink, signed a strategic research collaboration and worldwide license agreement to develop a next-generation ADC candidate against Human Epidermal Growth Factor Receptor 3 (HER3). Under the terms of the agreement, MediLink will grant us exclusive global rights for the development, manufacturing, and commercialization of this ADC asset excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, we will provide MediLink with an upfront payment totaling of $70 million and additional development, regulatory and commercial milestone payments potentially totaling over $1 billion. The completion of the agreement is subject to customary closing conditions.
Strategic collaboration with Biotheus Inc.
On October 26, 2023, we and Biotheus Inc., or Biotheus, a biopharmaceutical company focused on the discovery and development of novel drugs to treat cancer and inflammatory diseases, signed an exclusive global license and collaboration agreement under which BioNTech will have the rights to develop, manufacture and commercialize PM8002, a bispecific antibody candidate targeting PD-L1 and VEGF, globally except in Greater China, where Biotheus retains the rights to PM8002. Furthermore, Biotheus granted options to an exclusive license with respect to the development and commercialization of a trispecific clinical-stage antibody and multispecific preclinical antibodies. The parties will collaborate in the development and commercialization of novel antibodies for the treatment of cancer. Biotheus will receive a $55.0 million upfront payment as well as a $10.0 million technology transfer fee and is eligible to receive development, regulatory and commercial milestone payments as well as tiered royalties. The parties will bear the development costs in their respective territories and will share development costs of any clinical trial that is enrolled
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globally. The transaction is expected to close during the fourth quarter of 2023, subject to customary closing conditions and regulatory clearances.
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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, 2023.
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. At present, we have expanded our team to more than 5,700 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, next generation immunomodulators and antibody-drug conjugates. Our approach has created a robust and diversified product pipeline across infectious diseases and oncology, including our first commercial product, BNT162b2 (Comirnaty), the first ever approved mRNA therapy. The clinical pipeline currently includes over 25 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 a 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 product candidates 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, regulatory and commercial launch expertise needed to rapidly advance our diversified clinical pipeline.
Our 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
A key component of our corporate strategy is strengthening our technology platforms, digital capabilities and infrastructure through select strategic partnerships and acquisitions.
In July 2023, we successfully completed our previously-announced acquisition of InstaDeep Ltd., following the satisfaction of all customary closing conditions. The acquisition supports our strategy of aiming to build world-leading capabilities in artificial intelligence (AI)-driven drug discovery and development of next-generation immunotherapies and vaccines to address diseases with high unmet medical need. InstaDeep operates as a United Kingdom-based global subsidiary of BioNTech. The transaction added approximately 290 highly skilled professionals to BioNTech’s existing bioinformatics and data science workforce, including teams in AI, machine learning, bioengineering, data science, and software development.
In July 2023, following a memorandum of understanding announced in January 2023, we signed a long-term partnership agreement with the government of the United Kingdom, National Health Service England, and Genomics England with the aim of providing access to personalized treatments for up to 10,000 patients by 2030, either in clinical trials or as authorized treatment. To achieve this, we will implement together with our partners a framework to accelerate clinical trial recruitment and plan to set up new laboratories in Cambridge, United Kingdom with an expected capacity of more than 70 highly skilled scientists, as well as a new regional hub for the United Kingdom.
In August 2023, we signed another agreement with Duality Biologics (Suzhou) Co. Ltd. (DualityBio) to develop, manufacture and commercialize an additional antibody-drug conjugate (ADC), BNT325 (DB-1305). We had previously announced in April 2023 that we had entered into exclusive license and collaboration agreements with DualityBio to develop, manufacture and commercialize two antibody-drug conjugates therapeutics, BNT323 (DB-1303) and BNT324 (DB-1311).
In August 2023, James Ryan, Ph.D. was appointed to the Management Board as Chief Legal Officer (CLO), effective September 1, 2023. As part of the Management Board, James Ryan continues to lead the legal aspects of our strategy as well as global legal affairs, including transactions, corporate governance, securities, intellectual property (IP), insurance and data protection. He has over 20 years of global legal and IP expertise in the pharmaceutical industry and joined BioNTech in 2018. Prior to his appointment to the Board, James Ryan served as our General Counsel and Senior Vice President, Legal & IP.
In September 2023, we and the Coalition for Epidemic Preparedness Innovations (CEPI) announced a partnership to advance an mRNA mpox vaccine development program. CEPI will commit funding of up to $90 million for the development of vaccine candidates. Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral threats with pandemic potential.
In September 2023, our previously announced share repurchase program pursuant to which we were able to purchase American Depositary Shares (ADSs), each representing one ordinary share of the Company, in the amount of up to $0.5 billion, ended. 4,646,965 ADSs were repurchased from June 2, 2023 to September 18, 2023 under our share repurchase program at an average price of €98.24 ($107.58), for total consideration of €456.5 million ($500.0 million).
Post period-end, in October, we and MediLink Therapeutics (Suzhou) Co., Ltd. (MediLink) entered into a strategic research collaboration and worldwide license agreement to develop a next-generation ADC candidate against Human Epidermal Growth Factor Receptor 3 (HER3). Under the terms of the agreement, MediLink will grant us exclusive global rights for the development, manufacturing, and commercialization of this ADC asset excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, we will provide MediLink with an upfront payment totaling of $70 million and additional development, regulatory and commercial milestone payments potentially totaling over $1 billion. The completion of the agreement is subject to customary closing conditions.
Also, post period-end in November, we and Biotheus Inc. (Biotheus) announced an exclusive global license and collaboration agreement under which BioNTech will have the rights to develop, manufacture and commercialize PM8002, a bispecific antibody candidate targeting PD-L1 and VEGF, globally except in Greater China, where Biotheus retains the rights to PM8002. PM8002 is currently being tested in a Phase 2/3 study in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with non-small cell lung cancer. This partnership on PM8002 follows a strategic research and worldwide license agreement that the parties entered into in July 2023, under which BioNTech was granted exclusive options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody, both for cancer therapy, and exclusive licenses to existing panels of VHH binders against multiple targets along with options to request Biotheus to generate new panels of VHH binders against targets nominated by BioNTech.
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Environmental, Social, and Governance (ESG)
BioNTech was founded out of a responsibility to patients and to society and this is still the vision that drives the Company. It gives grounds for BioNTech’s enhanced responsibility: for translating the Company’s science into the health of people worldwide and democratizing access to innovative medicines, for environmental and climate protection, for respecting human rights and for fostering the full potential of all employees.
In March 2023, we published our third ESG report (Sustainability Report 2022). The report highlights the Company’s progress in developing novel medicines and introducing scalable technological innovations. It describes our science-based climate goals (under SBTi review), actions and climate risk management as well as the status of the our human rights strategy and due diligence. The report addresses diversity, inclusion, equity and belonging, and highlights the importance of our values and culture.
BioNTech recognizes its responsibility as a corporate citizen and is committed to supporting its local communities and beyond through donations, sponsorships and volunteer activities.
Marketed Product: Comirnaty, our COVID-19 Vaccine Program (BNT162)
COVID-19 vaccination has played an important role in saving lives and livelihoods across the world. In the first year of their rollout, vaccines were estimated to have averted over 4 million COVID-19-related deaths in Europe and 6 million hospitalizations globally, as well as saving hospital resources worth an estimated €56 billion. The vaccination campaign in Europe helped reopen millions of large and small businesses across the region and helped stabilize the wider European economy, which saw an average 7% reduction in Gross Domestic Product (GDP) by country during the first pandemic year, 2020.
Under our collaboration with Pfizer Inc., or Pfizer, we are the Marketing Authorization Holder in the U.S., the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations, or EUAs, or equivalents in the U.S. (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide with the exception of Greater China, Germany, and Turkey. Fosun Pharmaceutical Industrial Development, Co., Ltd, or Fosun Pharma, has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR and the region of Taiwan. We have the marketing and distribution rights to Comirnaty in Germany and Turkey.
A. Commercial Updates
Our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine is available in pharmacies, hospitals, and clinics across the U.S. following a recommendation by the Centers for Disease Control and Prevention (CDC) for the use of the vaccine for the 2023-2024 fall and winter season. The 2023-2024 formulation for individuals 12 years of age and older can be ordered as either a pre-filled syringe or a single-dose vial.
In October, we and Pfizer announced an agreement between the Japanese government and Pfizer Japan Co., Ltd. to supply an additional 9 million doses of the Omicron XBB.1.5-adapted COVID-19 vaccine as a vaccine for the special vaccination program in Japan which started this autumn. This follows an agreement between the Japanese government and Pfizer Inc. in July to supply 20 million doses and additional supplies as needed, and an agreement announced in September to provide additional 10 million doses of the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine for the special vaccination program in Japan.
We expect that as SARS-CoV-2 continues to evolve, and the risk of severe COVID-19 disease and deaths continues, especially for high risk populations, there will be continued demand for vaccine boosting and vaccinations, especially for at-risk and immunocompromised groups. We also expect to begin the transition from an advanced purchase agreement environment to commercial market ordering in some geographies, driven by regulatory recommendations to adapt COVID-19 vaccines to newly circulating variants or sublineages of SARS-CoV-2, namely XBB.1.5 for the fall and winter seasons in 2023 and 2024.
B. Clinical Development, Regulatory and Manufacturing Updates
In August, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted BioNTech and Pfizer full marketing authorisation for the monovalent XBB.1.5-adapted vaccine administered as a single dose in individuals 5 years of age and older, regardless of prior COVID-19 vaccination history; and for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.
In September, the U.S. FDA approved a supplemental Biologics License Application for the monovalent XBB.1.5-adapted vaccine recommended for use in the 2023-2024 fall and winter season for individuals 12 years of age and older; and granted an EUA for children 6 months through 11 years of age. This season’s vaccine is indicated as a
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single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. Children under the age of 12, including those with certain kinds of immunocompromised conditions, may be eligible to receive more than one dose depending on their vaccination history and consultation with their doctor.
Other national healthcare regulatory bodies, including in the UK, Japan, Canada and South Korea, have approved the BioNTech and Pfizer monovalent XBB.1.5-adapted vaccine.
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Pipeline of Product Candidates: Third Quarter 2023 and Post Period-End Updates
Below is a summary of our authorized product and clinical product candidates, organized by platform and indication.
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A. Oncology Programs
1. mRNA Product Candidates in Oncology
a) FixVac
FixVac is our wholly owned, systemic, off-the-shelf, mRNA-based cancer immunotherapy approach, from which we are developing several first-in-human and potential first-in-class product candidates. FixVac product candidates contain our pharmacologically optimized-backbone equipped uridine-RNA based nanoparticles delivered in our proprietary RNA-LPX formulation for intravenous administration, which are designed to trigger both innate and adaptive immune responses.
i.BNT111 in advanced melanoma.
•An ongoing, global, three-arm, randomized Phase 2 clinical trial (NCT04526899) 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 achieved full enrollment in September. The trial is being conducted in collaboration with Regeneron Pharmaceuticals Inc. (Regeneron). BNT111 encodes the tumor-associated antigens (TAAs) tyrosinase, MAGE-A3, NY-ESO-1 and TPTE.
•In October, at the International Society of Pediatric Oncology Annual Meeting our collaborators from the University Hospital Tübingen presented data on the expression of the four TAAs whithin BNT111 in pediatric melanoma and their correlation with prognosis. The TAAs analyzed were all expressed in pediatric melanoma, albeit to a lesser extent than in adult melanoma. No TAAs correlated with prognosis in pediatric melanoma. The data presented support the exploration of BNT111 in the treatment of pediatric melanoma.
ii. BNT112 in prostate cancer.
•A first-in-human Phase 1/2 clinical trial (NCT04382898) to evaluate safety, immunogenicity and preliminary efficacy of BNT112 (RNA-LPX encoding 5 different prostate differentiation antigens) monotherapy and in combination with cemiplimab is ongoing in patients with metastatic castration resistant prostate cancer and in patients with high-risk localized prostate cancer who are eligible for treatment with androgen deprivation therapy followed by radical prostatectomy.
iii. BNT113 in HPV16+ head and neck cancer.
•A randomized Phase 2 clinical trial (NCT04534205) evaluating BNT113 (encoding E6 and E7 proteins of HPV16) in combination with pembrolizumab (Merck’s Keytruda) versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma expressing PD-L1 is ongoing.
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•A Phase 1/2 dose escalation trial evaluating BNT113 in the post-adjuvant and metastatic setting in patients with HPV16+ head and neck and other cancers has been terminated and the follow up period ended in July 2023. This was an investigator-initiated trial sponsored by the University Hospital Southampton NHS Foundation Trust.
vi. BNT116 in advanced non-small-cell lung cancer (NSCLC).
•In July 2023, we and our partner Regeneron initiated a randomized, controlled, Phase 2 clinical trial (NCT05557591) to evaluate BNT116 (RNA-LPX encoding six different NSCLC-associated antigens) in combination with cemiplimab (Regeneron’s Libtayo) and cemiplimab alone as first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells. A Trial-in-Progress poster was presented at the European Society of Medical Oncology (ESMO) Congress in October.
•A Phase 1 clinical trial (NCT05142189) is ongoing to evaluate the safety, tolerability and preliminary efficacy of BNT116 alone and in combination with cemiplimab (Regeneron’s Libtayo) in patients who have progressed on prior PD-1 inhibitor treatment or are not eligible for chemotherapy, in combination with docetaxel in patients who have received prior PD-1 inhibitor therapy and platinum-based chemotherapy, in patients with unresectable Stage III NSCLC who have undergone chemoradiotherapy and also studied in the neoadjuvant and adjuvant settings in patients with resectable Stage II and III NSCLC. In November, first data from the trial were presented at the Society for Immunotherapy of Cancer (SITC). In this trial, BNT116 was generally well tolerated with an expected safety profile as monotherapy and in combination with cemiplimab. In heavily pretreated NSCLC patients, treatment with BNT116 with optional addition of cemiplimab from cycle 3 onwards showed early clinical activity.
b) Individualized Neoantigen Specific Immunotherapy (iNeST)
iNeST is an individualized cancer immunotherapy product candidate based on specific neoantigens that are present on a patient’s tumor. As the FixVac programs, our iNeST approach is also based on a pharmacologically optimized-backbone equipped uridine mRNA (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.
i.BNT122/autogene cevumeran is our lead iNeST product candidate and is being developed as part of a co-development and co-commercialization collaboration with Genentech, a member of the Roche Group.
•In October, the first patient was dosed as part of a recently initiated randomized Phase 2 clinical trial (NCT05968326) evaluating the safety and efficacy of BNT122/autogene cevumeran in combination with atezolizumab (Genentech’s Tecentriq) followed by standard-of-care chemotherapy (mFOLFIRINOX) in patients with resected pancreatic ductal adenocarcinoma compared to chemotherapy alone. The Phase 2 study is expected to enroll 260 patients with resected PDAC who have not received prior systemic anti-cancer treatment and showed no evidence of disease after surgery.
•A randomized Phase 2 clinical trial (NCT04486378) evaluating BNT122/autogene cevumeran as an adjuvant treatment of circulating tumor DNA (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 and safety of BNT122/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. Secondary objectives include overall survival (OS) and safety.
•A randomized Phase 2 clinical trial (NCT03815058) evaluating the efficacy and safety of BNT122/autogene cevumeran in combination with pembrolizumab (Merck’s Keytruda) versus pembrolizumab alone as first line in patients with previously untreated advanced melanoma is fully enrolled and follow-up is ongoing.
•An open-label, fully enrolled, Phase 1 basket trial (NCT03289962) evaluating the safety, immunogenicity and preliminary anti-tumor activity of BNT122/autogene cevumeran as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors is fully enrolled and follow-up is ongoing.
c) RiboMab
Our RiboMab product candidate is an mRNA that encodes cancer cell targeting antibodies. These fully-owned product candidate leverages our proprietary optimized mRNA technology combining nucleoside modifications to
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minimize immunogenicity with our improved mRNA backbone designs with the aim of maximizing protein expression. Our RiboMab product candidate is formulated using liver-targeting lipid nanoparticles (LNPs) for intravenous delivery.
i. BNT142 codes for a T cell engaging bispecific antibody targeting Claudin 6 (CLDN6) and is being studied in an ongoing, open-label, multi-center Phase 1/2 clinical trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors that have exhausted available standard therapy or are not eligible for such available therapy. The study is actively recruiting patients in Europe, the United States and Singapore.
d) RiboCytokines
Our RiboCytokine product candidates are designed to address the limitations of recombinantly expressed cytokines, including limited serum half-life and production costs. BNT151 and BNT152+153 are nucleoside-modified mRNAs encoding human cytokines fused to human serum albumin. The modified mRNA is formulated with liver-targeting LNPs for intravenous delivery. BNT151 encodes an IL-2 variant, BNT152 encodes IL-7 and BNT153 encodes IL-2.
i.BNT151 – A first-in-human, open-label, multi-center Phase 1/2 clinical trial (NCT04455620) in multiple solid tumor indications is ongoing.
ii. BNT152+153 – A first-in-human, open-label, multi-center Phase 1 clinical trial (NCT04710043) evaluating a combination of BNT152 and BNT153 in patients with various solid tumors is ongoing.
2. Cell Therapy Product Candidates in Oncology
a) Chimeric antigen receptor (CAR) T-cell therapy - CAR-T
i.BNT211 consists of two investigational medicinal products: our first CAR-T cell product candidate, which targets Claudin-6 (CLDN6)-positive solid tumors, in combination with a CAR-T cell-amplifying RNA vaccine (CARVac) encoding CLDN6. As with FixVac and iNest, CARVac is also based on a pharmacologically optimized-backbone equipped uRNA delivered in our proprietary RNA-LPX formulation. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity for the tumor-specific carcino-embryonic antigen CLDN6. CARVac is intended to support in vivo expansion of transferred CAR-T cells to increase their persistence and efficacy. BNT211 has been granted Priority Medicines (PRIME) designation by the European Medical Agency for the third- or later-line treatment of testicular germ cell tumors.
•A first-in-human, open-label, multi-center Phase 1/2 dose escalation and dose expansion basket trial (NCT04503278) evaluating CLDN6 CAR-T cells as monotherapy or in combination with CLDN6 CARVac in patients with CLDN6-positive relapsed or refractory solid tumors is ongoing. A data update from the ongoing clinical trial was presented at the 2023 ESMO Annual Meeting describing the interim results from a repeat dose escalation of CLDN6 CAR-T cells manufactured with an automated process with and without CLDN6-encoding mRNA vaccine for treatment of relapsed/refractory solid tumors. CLDN6 CAR-T cells ± CLDN6 CARVac demonstrated encouraging signs of clinical activity. In several patients treated with CARVac, an increased persistence of cancer-specific CAR-T cells was observed. The rate of treatment-dependent adverse event was dose-dependent. After determination of the recommended Phase 2 dose, we plan to initiate a pivotal trial in germ cell tumors.
b) Neoantigen-Targeting T-Cell therapy
i.BNT221 is our autologous, fully personalized, polyspecific T-cell therapy directed against selected sets of individual neoantigens. BNT221 is based on expanded neoantigen-specific memory T cells and induced naive T cells.
•A first-in-human Phase 1 dose escalation clinical trial (NCT04625205) in patients with checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. Part 1 of the trial consists of a monotherapy dose escalation of BNT221. Recruitment and treatment of patients in Part 1 is complete. In Part 2, BNT221 will be dosed in combination with anti-PD-1 therapy after first-line treatment. First monotherapy data from the dose-escalation phase of this trial was presented at ESMO and SITC Congresses in October and November 2023. These initial results showed a manageable safety profile and encouraging activity signs of tumor regression in several patients with anti-PD-1 and anti-CTLA-4 pretreated advanced or metastatic melanoma.
3. Antibody Product Candidates in Oncology
a) Next-Generation Immune Checkpoint Modulators
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We are developing, in collaboration with Genmab, antibodies that function as tumor-targeted and dual immunomodulators, applying Genmab’s proprietary technologies in combination with our joint target identification and product concept expertise.
i.BNT311/GEN1046 is a potential first-in-class bispecific antibody product candidate combining PD-L1 checkpoint inhibition with 4-1BB checkpoint activation.
•A Phase 2 clinical trial evaluating BNT311/GEN1046 in endometrial cancer has been initiated.
•An open-label, multi-center, randomized Phase 2 clinical trial of BNT311/GEN1046 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 objective response rate (ORR) according to RECIST v1.1. Secondary endpoints include duration of response (DOR), time to response, progression free survival (PFS), OS, and safety.
•An open-label, single-arm Phase 1/2 clinical trial with expansion cohorts in patients with solid tumors is ongoing.
ii. BNT312/GEN1042 is a potential first-in-class bispecific antibody product candidate designed to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells.
•Two Phase 1/2 clinical trials (NCT05491317; NCT04083599) in patients with solid tumors are ongoing evaluating BNT312/GEN1042 in combination with pembrolizumab (Merck’s Keytruda) with or without chemotherapy. We continue to actively recruit patients into the expansion cohorts across a range of solid tumors.
•In November, at the SITC Annual Meeting, we and Genmab presented preclinical data demonstrating in vivo antitumor activity and peripheral immune modulation of an Fc-inert mouse-human chimeric variant of BNT312/GEN1042. Establishment of this model has enabled ongoing preclinical exploration of the hypothesis that combining BNT312/GEN1042 with PD-1 blockade and a platinum-based chemotherapy doublet will potentiate antitumor activity through complementary immune modulatory effects. These data support ongoing clinical studies evaluating the combination of BNT312/GEN1042 with pembrolizumab and chemotherapy in patients with advanced solid tumors.
iii. BNT313/GEN1053 is an immune modulating CD27 agonist antibody product candidate that promotes anti-tumor immunity by inducing T-cell responses.
• A Phase 1/2 clinical trial (NCT05435339) evaluating the safety, tolerability, and preliminary efficacy of CD27-targeting antibody BNT313/GEN1053 on solid tumors as monotherapy is ongoing.
iv. BNT314/GEN1059 is a potential first-in-class bispecific antibody product candidate designed to boost antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity.
•In October, at the 2023 ESMO Annual Meeting, we and Genmab presented preclinical data that characterized the mechanism of action of BNT314/GEN1059, the first public disclosure of this program. In pre-clinical studies, BNT314/GEN1059 enhanced T-cell activation, proliferation, and effector functions in vitro and ex vivo and promoted antitumor activity in vivo. These results suggest that BNT314/GEN1059 may boost antitumor immunity in cancer patients with EpCAM-positive tumors.
•A first-in-human Phase 1/2 clinical trial sponsored by BioNTech is planned to start by early 2024 to investigate the safety and preliminary antitumor activity of BNT314/GEN1059 in patients with advanced or metastatic solid tumors.
v. BNT322/GEN1056 is an antibody product candidate being co-developed with Genmab for the treatment of solid tumors and for use in combination with other products.
•A first-in-human Phase 1 clinical trial (NCT05586321) in patients with advanced solid tumors is ongoing and recruiting.
BNT311/GEN1046, BNT312/GEN1042, BNT313/GEN1053, BNT314/GEN1059 and BNT322/GEN1056 are partnered with Genmab as part of a 50:50 collaboration in which development costs and future profits are shared.
vi. BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc., or OncoC4. BNT316/ONC-392 (gotistobart) is designed to offer a differentiated safety profile that may allow for higher dosing and longer duration of treatment both as monotherapy and in combination with other therapies. The program received Fast Track Designation from the FDA in 2022.
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•A two-stage, open-label, randomized Phase 3 clinical trial, PRESERVE-003 (NCT05671510), to evaluate the efficacy and safety of BNT316/ONC-392 (gotistobart) as monotherapy in metastatic NSCLC patients who have progressed on anti-PD-1/PD-L1 antibody-based therapy compared to standard-of-care chemotherapy (docetaxel) is ongoing.
•A Phase 2 clinical trial (NCT05446298) evaluating BNT316/ONC-392 (gotistobart) therapy in combination with pembrolizumab in platinum-resistant ovarian cancer is ongoing.
•A Phase 2 clinical trial (NCT05682443) is planned to evaluate the safety and efficacy of BNT316/ONC-392 (gotistobart) in combination with lutetium Lu-177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patients who have disease progressed on androgen receptor pathway inhibition.
•A first-in-human Phase 1/2 open-label dose escalation clinical trial (NCT04140526) evaluating BNT316/ONC-392 (gotistobart) as a single agent and in combination with pembrolizumab in patients with advanced or metastatic solid tumors is ongoing. We and OncoC4 presented an abstract at the SITC Annual Meeting from the ongoing Phase 1/2 trial showing that BNT316/ONC-392 (gotistobart) monotherapy has a manageable safety profile. Early readout of the expansion cohort showed encouraging clinical activity in patients with immunotherapy-resistant NSCLC.
b) Targeted Cancer Antibodies & Antibody-Drug Conjugates
i.BNT321 is a fully human IgG1 monoclonal antibody product candidate 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.
•An open-label, multi-center, non-randomized dose escalation and expansion Phase 1 clinical trial (NCT02672917) of BNT321 monotherapy and in combination with modified FOLFIRINOX in pancreatic cancer and other CA19-9 expressing solid tumors is ongoing.
ii. BNT323/DB-1303 is a topoisomerase-1 inhibitor-based HER2-targeted ADC candidate, being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd., or DualityBio.
•An open-label, multi-center, randomized Phase 3 clinical trial (NCT06018337) is planned to evaluate BNT323/DB1303 versus investigator's choice of chemotherapy in advanced or metastatic HR+, HER2-low breast cancer subjects whose disease has progressed on at least 2 lines of prior endocrine therapy (ET) or within 6 months of first line ET + CDK4/6 inhibitor and no prior chemotherapy. The study aims to enroll approximately 532 patients.
•BNT323/DB-1303 is being evaluated in an ongoing multicenter, non-randomized, open-label, multiple dose, first-in-human Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. Data from the ongoing trial were presented at the 2023 European Congress on Gynaecological Oncology Annual Meeting focusing on patients with advanced/metastatic endometrial cancer. BNT323/DB-1303 showed a manageable safety profile and no new safety signals were observed. BNT323/1303 demonstrated encouraging antitumor activity in patients (n=17) with advanced, recurrent or metastatic HER2-expression endometrial cancer with an objective response rate (ORR; confirmed and unconfirmed) of 58.8% and disease control rate (DCR) of 94.1%.
iii. BNT324/DB-1311 is a topoisomerase-1 inhibitor-based ADC candidate being developed in collaboration with DualityBio.
•A first-in-human, open-label Phase 1/2a clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors has been initiated and the first patient was dosed in September.
iv. BNT325/DB-1305 is a topoisomerase-1 inhibitor-based TROP2-targeted ADC candidate being developed in collaboration with DualityBio.
•A Phase 1/2a clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. First-in-human data from the ongoing trial were presented at the 2023 ESMO Annual Meeting suggesting a manageable safety profile at lower dose levels. Encouraging preliminary activity of BNT325/DB-1305 was observed with an ORR of 30.4% (7/23), both unconfirmed, and DCR of 87.0% (20/23), both unconfirmed at the time of the presentation. Thirteen NSCLC patients had an unconfirmed ORR of 46.2% (6/13), and an unconfirmed DCR of 92.3% (12/13).
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v. BNT326/YL202 is a topoisomerase-1 inhibitor-based HER3-targeted ADC candidate being developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd.
•A multicenter, open-label, first-in-human Phase 1 clinical trial (NCT05653752) evaluating BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative breast cancer is ongoing.
4. Small Molecule Immunomodulator Candidates in Oncology
i.BNT411 is a small molecule TLR7 agonist product candidate. BNT411 is designed to activate both the adaptive and innate immune system through the TLR7 pathway.
•A first-in-human, open-label Phase 1/2 dose-escalation clinical 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 (ES-SCLC) has completed enrollment.
B. Infectious Disease Programs
1. Next-generation COVID-19 Vaccine Programs - BNT162b5 and BNT162b2 + BNT162b4
i.BNT162b6/7 – This is one of multiple vaccine candidates with an engineered design aimed to increase the magnitude and breadth of antibody neutralization response to better protect against COVID-19.
•A randomized, active controlled, observer-blind Phase 2 clinical trial to evaluate the safety, tolerability and immunogenicity of a stabilized spike antigen vaccine candidate is ongoing.
ii. BNT162b2 + BNT162b4 – The aim of this program is to develop a vaccine candidate that enhances and broadens SARS-CoV-2 T-cell responses. BNT162b4 is a next-generation COVID-19 vaccine component designed to elicit T-cell immunity across epitopes. BNT162b4 encodes variant-conserved, immunogenic segments of the SARS-CoV-2 nucleocapsid, membrane, and ORF1ab proteins, targeting diverse human leukocyte antigen (HLA) alleles.
•A Phase 1 clinical trial to evaluate the safety, tolerability and immunogenicity of BNT162b4, in combination with BNT162b2 is ongoing.
Both programs are being developed in collaboration with Pfizer.
2. Combination Vaccine Programs
We and Pfizer are investigating respiratory combination vaccine approaches that aim to simplify immunization practices for health care providers and recipients, helping to reduce the burden of these diseases. Combination vaccines have been an effective approach in overcoming barriers to vaccination by allowing for simple scheduling and fewer injections compared to vaccinations administered separately and/or at different visits to healthcare providers.
i.COVID-19 – Influenza Combination mRNA Vaccine Program – BNT162b2 + BNT161
The combination vaccine candidate consists of our Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine and Pfizer’s quadrivalent modified RNA (modRNA) influenza vaccine candidate. The program is in partnership with Pfizer and has received Fast Track designation from the U.S. FDA. Further development is subject to reaching agreement.
•In October, we and Pfizer announced top-line results were from a Phase 1/2 clinical trial (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial the vaccine candidates were compared to licensed influenza vaccines and the Pfizer-BioNTech COVID-19 Omicron BA.4/BA.5 adapted bivalent vaccine given separately at the same visit. The data from the trial demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, as well as a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine. A pivotal Phase 3 trial is expected to be initiated in the coming months.
3. Influenza Vaccine Program - BNT161
In 2018, we and Pfizer entered into an agreement to collaborate on an mRNA program in influenza for an initial period of three years, which ended in 2021. Pfizer has since had the sole responsibility, authority and control of the development, manufacturing and commercialization of all candidates and products related to the program. Upon potential approval and commercialization, BioNTech is eligible to receive a royalty on Pfizer’s sales.
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•A Pfizer-initiated randomized Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of a quadrivalent modRNA influenza vaccine candidate is ongoing.
4. HSV Vaccine Program – BNT163
We have a research collaboration with the University of Pennsylvania under which we have the exclusive option to develop and commercialize mRNA vaccine candidates against up to 10 infectious disease indications. As part of this collaboration, we are developing a Herpes Simplex Virus (HSV) vaccine candidate.
•A first-in-human, controlled, dose-escalation Phase 1 clinical trial (NCT05432583) evaluating the safety, tolerability and immunogenicity of BNT163, an HSV vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1, is ongoing.
5. Tuberculosis Vaccine Program – BNT164
We have collaborated with the Bill and Melinda Gates Foundation since 2019 to develop vaccine candidates aimed at preventing tuberculosis infection and disease.
•Two randomized, controlled, dose-finding Phase 1 clinical trials (NCT05537038, Germany and NCT05547464, Republic of South Africa) evaluating BNT164 are ongoing. The NCT05547464 clinical trial had its first subject dosed in August 2023. Both clinical trials will assess the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against tuberculosis. This program is run in partnership with the Bill & Melinda Gates Foundation.
6. Malaria Vaccine Program – BNT165
Our Malaria program aims to develop a well-tolerated and highly effective mRNA vaccine with durable immunity to prevent blood-stage malaria infection, thereby reducing morbidity and mortality as well as onward transmission. We plan to assess several vaccine candidates, featuring known targets such as circumsporozoite protein (CSP), conserved, immunogenic segments of liver stage-expressed proteins as well as other antigens.
•A first-in-human Phase 1 clinical trial (NCT05581641) to evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1, the first candidate from our BNT165 program, is ongoing.
7. Mpox Vaccine Program - BNT166
Our fully-owned BNT166 program aims to deliver an effective, well-tolerated and accessible vaccine for the prevention of mpox. The multivalent BNT166 mRNA vaccine candidates encode surface antigens that are expressed in the two infectious forms of the monkeypox virus to efficiently fight virus replication and infectivity. The program is supported through a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to provide equitable access to the vaccine, if successfully developed and approved, in low- and middle-income countries.
•A Phase 1/2 trial clinical trial (NCT05988203) evaluating the safety, tolerability, reactogenicity and immunogenicity of two mRNA-based multivalent vaccine candidates has been initiated and the first subject was dosed in October. The trial aims to enroll 96 healthy participants with and without prior history of known or suspected smallpox vaccination.
8. Shingles Vaccine Program - BNT167
We are collaborating with Pfizer to develop the first mRNA-based vaccine candidate against shingles (also known as herpes zoster). While there are currently approved vaccines for shingles, the goal is to develop an mRNA vaccine candidate that potentially shows high efficacy and better tolerability and is more efficient to produce globally.
•A randomized, controlled, dose-selection Phase 1/2 clinical trial (NCT05703607) to evaluate the safety, tolerability, and immunogenicity of BNT167 in healthy volunteers 50 through 69 years of age is ongoing. A trial update is expected in 2024.
9. Anti-bacterial Programs
BioNTech R&D (Austria) GmbH is a wholly owned subsidiary of BioNTech SE focused on developing novel anti-bacterial drugs to treat persistent bacterial infections. The development programs are based on our proprietary LysinBuilder platform, which allows the targeted development of precision anti-bacterials. Our development pipeline focuses on chronic bacterial infections where antibiotics fail to cure or destroy the natural microbiomes.
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Financial Operations Overview
The following table shows our unaudited interim condensed consolidated statements of profit or loss for each period presented:
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||||||
| (in millions €, except per share data) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||||||
| Revenues | ||||||||||||||||||||
| Commercial revenues | 893.7 | 3,394.8 | 2,336.6 | 12,923.3 | ||||||||||||||||
| Research & development revenues | 1.6 | 66.4 | 3.4 | 109.0 | ||||||||||||||||
| Total revenues | 895.3 | 3,461.2 | 2,340.0 | 13,032.3 | ||||||||||||||||
| Cost of sales | (161.8) | (752.8) | (420.7) | (2,811.5) | ||||||||||||||||
| Research and development expenses | (497.9) | (341.8) | (1,205.3) | (1,027.2) | ||||||||||||||||
| Sales and marketing expenses | (14.4) | (12.8) | (44.7) | (44.9) | ||||||||||||||||
| General and administrative expenses | (144.5) | (141.0) | (386.6) | (361.8) | ||||||||||||||||
| Other operating expenses | (31.4) | (285.1) | (223.7) | (594.6) | ||||||||||||||||
| Other operating income | 27.8 | 459.8 | 105.2 | 1,157.5 | ||||||||||||||||
| Operating income | 73.1 | 2,387.5 | 164.2 | 9,349.8 | ||||||||||||||||
| Finance income | 156.3 | 60.9 | 363.2 | 448.5 | ||||||||||||||||
| Finance expenses | (2.0) | (4.3) | (4.5) | (16.8) | ||||||||||||||||
| Profit before tax | 227.4 | 2,444.1 | 522.9 | 9,781.5 | ||||||||||||||||
| Income taxes | (66.8) | (659.2) | (50.5) | (2,625.8) | ||||||||||||||||
| Profit for the period | 160.6 | 1,784.9 | 472.4 | 7,155.7 | ||||||||||||||||
| Earnings per share | ||||||||||||||||||||
| Basic earnings for the period per share | 0.67 | 7.43 | 1.96 | 29.47 | ||||||||||||||||
| Diluted earnings for the period per share | 0.67 | 6.98 | 1.94 | 27.70 | ||||||||||||||||
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, 2022.
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Comparison of the three and nine months ended September 30, 2023, and 2022
Revenues
The following is a summary of revenues recognized for the periods indicated:
| Three months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Revenues | |||||||||||||||||
| Commercial revenues | 893.7 | 3,394.8 | (2,501.1) | (74) | |||||||||||||
| COVID-19 vaccine revenues | 885.0 | 3,378.1 | (2,493.1) | (74) | |||||||||||||
Sales to collaboration partners(1) | (17.7) | 259.4 | (277.1) | (107) | |||||||||||||
| Direct product sales to customers | 195.7 | 564.5 | (368.8) | (65) | |||||||||||||
| Share of collaboration partners' gross profit | 707.0 | 2,554.2 | (1,847.2) | (72) | |||||||||||||
| Other sales | 8.7 | 16.7 | (8.0) | (48) | |||||||||||||
| Research & development revenues from collaborations | 1.6 | 66.4 | (64.8) | (98) | |||||||||||||
| Total revenues | 895.3 | 3,461.2 | (2,565.9) | (74) | |||||||||||||
(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.
| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Revenues | |||||||||||||||||
| Commercial revenues | 2,336.6 | 12,923.3 | (10,586.7) | (82) | |||||||||||||
| COVID-19 vaccine revenues | 2,306.7 | 12,883.9 | (10,577.2) | (82) | |||||||||||||
Sales to collaboration partners(1) | 128.9 | 1,470.9 | (1,342.0) | (91) | |||||||||||||
| Direct product sales to customers | 260.9 | 2,284.6 | (2,023.7) | (89) | |||||||||||||
| Share of collaboration partners' gross profit | 1,916.9 | 9,128.4 | (7,211.5) | (79) | |||||||||||||
| Other sales | 29.9 | 39.4 | (9.5) | (24) | |||||||||||||
| Research & development revenues from collaborations | 3.4 | 109.0 | (105.6) | (97) | |||||||||||||
| Total revenues | 2,340.0 | 13,032.3 | (10,692.3) | (82) | |||||||||||||
(1) Represents sales to our collaboration partners of products manufactured by us and reflects manufacturing costs and variances to the extent identified.
Commercial Revenues
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023, commercial revenues decreased by €2,501.1 million, or 74%, from €3,394.8 million to €893.7 million as well as decreased by €10,586.7 million, or 82%, from €12,923.3 million during the nine months ended September 30, 2022 to €2,336.6 million during the nine months ended September 30, 2023, in line with a lower COVID-19 vaccine market demand. 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. Pfizer has marketing and distribution rights worldwide with the exception of China, Germany and Turkey. 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.
Sales to collaboration partners represent sales of products manufactured by us to collaboration partners. Whenever responsibilities in the manufacturing and supply process of the COVID-19 vaccine shift and the COVID-19 vaccine is transferred, the vaccine is sold from one partner to the other. Under the collaboration with Pfizer, from time to time, those sales are significantly influenced by amounts due to write-downs of inventories as well as costs related to production capacities derived from contracts with Contract Manufacturing Organizations (CMOs) that became redundant. Those costs represent accrued manufacturing variances and are charged to our partner once finally materialized. These manufacturing variances are reflected as transfer price adjustment once identified. The regular reassessment of these manufacturing variances might result in minor reversals of the respective prior period revenues. Sales to collaboration partners during the three and nine months ended September 30, 2023, amounted to
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€(17.7) million and €128.9 million, respectively. During the three and nine months ended September 30, 2022 the sales to collaboration partners amounted to €259.4 million and €1,470.9 million, respectively. During the three and nine months ended September 30, 2023 those sales included €(72.5) million and €44.4 million, respectively, related to the aforementioned manufacturing variances (€161.6 million and €956.8 million with respect to sales during the three and nine months ended September 30, 2022).
By supplying our territories during the three and nine months ended September 30, 2023, we recognized €195.7 million and €260.9 million of revenues, respectively, from direct COVID-19 vaccine sales in Germany. During the three and nine months ended September 30, 2022, recognized revenues derived from those sales amounted to €564.5 million and €2,284.6 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 seasonally-affected net figure and is recognized as collaboration revenue during the commercial phase. When determining the gross profit, manufacturing cost variances either reflected as transfer price adjustment as described above, or resulting from costs expected to be incurred by the partner were considered. During the three and nine months ended September 30, 2023, €707.0 million and €1,916.9 million, respectively, in gross profit share was recognized as revenues. During the three and nine months ended September 30, 2022, €2,554.2 million and €9,128.4 million, respectively, in gross profit share was recognized as revenues.
Cost of Sales
The following table summarizes our cost of sales for the periods indicated:
| Three months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Cost of sales | |||||||||||||||||
| Cost of sales related to COVID-19 vaccine revenues | 160.9 | 737.8 | (576.9) | (78) | |||||||||||||
| Cost related to other sales | 0.9 | 15.0 | (14.1) | (94) | |||||||||||||
| Total cost of sales | 161.8 | 752.8 | (591.0) | (79) | |||||||||||||
| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Cost of sales | |||||||||||||||||
| Cost of sales related to COVID-19 vaccine revenues | 412.0 | 2,779.4 | (2,367.4) | (85) | |||||||||||||
| Cost related to other sales | 8.7 | 32.1 | (23.4) | (73) | |||||||||||||
| Total cost of sales | 420.7 | 2,811.5 | (2,390.8) | (85) | |||||||||||||
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023, our cost of sales decreased by €591.0 million, or 79%, from €752.8 million to €161.8 million, as well as decreased by €2,390.8 million, or 85%, from €2,811.5 million during the nine months ended September 30, 2022 to €420.7 million during the nine months ended September 30, 2023 in line with decreasing COVID-19 vaccine revenues.
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 €) | 2023 | 2022 | € | % | |||||||||||||
| Research and development expenses | |||||||||||||||||
| Purchased services | 319.9 | — | 319.9 | — | |||||||||||||
| Wages, benefits and social security expense | 103.3 | 122.8 | (19.5) | (16) | |||||||||||||
| Laboratory supplies | 28.8 | 191.3 | (162.5) | (85) | |||||||||||||
| Depreciation and amortization | 18.3 | 13.6 | 4.7 | 35 | |||||||||||||
| Other | 27.6 | 14.1 | 13.5 | 96 | |||||||||||||
| Total research and development expenses | 497.9 | 341.8 | 156.1 | 46 | |||||||||||||
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| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Research and development expenses | |||||||||||||||||
| Purchased services | 658.9 | 361.4 | 297.5 | 82 | |||||||||||||
| Wages, benefits and social security expense | 287.9 | 279.1 | 8.8 | 3 | |||||||||||||
| Laboratory supplies | 131.6 | 297.0 | (165.4) | (56) | |||||||||||||
| Depreciation and amortization | 46.7 | 36.0 | 10.7 | 30 | |||||||||||||
| Other | 80.2 | 53.7 | 26.5 | 49 | |||||||||||||
| Total research and development expenses | 1,205.3 | 1,027.2 | 178.1 | 17 | |||||||||||||
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023 research and development expenses increased by €156.1 million, or 46%, from €341.8 million to €497.9 million as well as increased by €178.1 million, or 17%, from €1,027.2 million during the nine months ended September 30, 2022 to €1,205.3 million during the nine months ended September 30, 2023 mainly influenced by progressing clinical studies for pipeline candidates, the development of variant adapted as well as next generation COVID-19 vaccines and expanding R&D headcount.
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 €) | 2023 | 2022 | € | % | |||||||||||||
| General and administrative expenses | |||||||||||||||||
| Wages, benefits and social security expense | 44.2 | 37.8 | 6.4 | 17 | |||||||||||||
| IT and office equipment | 41.5 | 23.7 | 17.8 | 75 | |||||||||||||
| Purchased services | 28.6 | 38.7 | (10.1) | (26) | |||||||||||||
| Depreciation and amortization | 8.1 | 4.6 | 3.5 | 76 | |||||||||||||
| Other | 22.1 | 36.2 | (14.1) | (39) | |||||||||||||
| Total general and administrative expenses | 144.5 | 141.0 | 3.5 | 2 | |||||||||||||
| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| General and administrative expenses | |||||||||||||||||
| Wages, benefits and social security expense | 125.3 | 108.3 | 17.0 | 16 | |||||||||||||
| IT and office equipment | 102.6 | 57.5 | 45.1 | 78 | |||||||||||||
| Purchased services | 87.4 | 103.6 | (16.2) | (16) | |||||||||||||
| Depreciation and amortization | 23.0 | 10.5 | 12.5 | 119 | |||||||||||||
| Other | 48.3 | 81.9 | (33.6) | (41) | |||||||||||||
| Total general and administrative expenses | 386.6 | 361.8 | 24.8 | 7 | |||||||||||||
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023, our general and administrative expenses increased by €3.5 million, or 2%, from €141.0 million to €144.5 million and increased by €24.8 million, or 7%, from €361.8 million during the nine months ended September 30, 2022 to €386.6 million during the nine months ended September 30, 2023 mainly influenced by increased expenses for IT services as well as expanding the G&A 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 €) | 2023 | 2022 | € | % | |||||||||||||
| Other operating result | |||||||||||||||||
| Other operating income | 27.8 | 459.8 | (432.0) | (94) | |||||||||||||
| Gain on derivative instruments at fair value through profit or loss | 17.3 | — | 17.3 | — | |||||||||||||
| Foreign exchange differences, net | — | 449.1 | (449.1) | (100) | |||||||||||||
| Other | 10.5 | 10.7 | (0.2) | (2) | |||||||||||||
| Other operating expenses | (31.4) | (285.1) | 253.7 | (89) | |||||||||||||
| Foreign exchange differences, net | (26.1) | — | (26.1) | — | |||||||||||||
| Loss on derivative instruments at fair value through profit or loss | — | (282.7) | 282.7 | (100) | |||||||||||||
| Other | (5.3) | (2.4) | (2.9) | 121 | |||||||||||||
| Total other operating result | (3.6) | 174.7 | (178.3) | (102) | |||||||||||||
| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Other operating result | |||||||||||||||||
| Other operating income | 105.2 | 1,157.5 | (1,052.3) | (91) | |||||||||||||
| Gain on derivative instruments at fair value through profit or loss | 71.8 | — | 71.8 | — | |||||||||||||
| Foreign exchange differences, net | — | 1,090.1 | (1,090.1) | (100) | |||||||||||||
| Other | 33.4 | 67.4 | (34.0) | (50) | |||||||||||||
| Other operating expenses | (223.7) | (594.6) | 370.9 | (62) | |||||||||||||
| Foreign exchange differences, net | (213.8) | — | (213.8) | — | |||||||||||||
| Loss on derivative instruments at fair value through profit or loss | — | (581.7) | 581.7 | (100) | |||||||||||||
| Other | (9.9) | (12.9) | 3.0 | (23) | |||||||||||||
| Total other operating result | (118.5) | 562.9 | (681.4) | (121) | |||||||||||||
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023, our total other operating result decreased by €178.3 million from a positive operating result of €174.7 million to a negative operating result of €3.6 million, as well as by €681.4 million from a positive operating result of €562.9 million during the nine months ended September 30, 2022 to a negative operating result of €118.5 million during the nine months ended September 30, 2023. The other operating result reflected the change in foreign exchange rates and included net negative foreign exchange differences during three and nine months ended September 30, 2023 compared to net positive foreign exchange differences during the previous year period that related to our U.S. dollar denominated trade receivables which were mainly incurred under our COVID-19 collaboration with Pfizer, U.S. dollar denominated trade payables as well as U.S. dollar denominated other financial liabilities which mainly relate to obligations incurred from our license agreements. The amounts were offset by recording the change in fair value of foreign exchange forward contracts that were entered to manage some of our transaction exposures but were not designated as hedging instruments under IFRS.
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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) | 2023 | 2022 | € | % | |||||||||||||
| Finance result | |||||||||||||||||
| Finance income | 156.3 | 60.9 | 95.4 | 157 | |||||||||||||
| Interest income | 92.5 | 7.7 | 84.8 | n.m. | |||||||||||||
| Fair value adjustments of financial instruments measured at fair value | 56.0 | — | 56.0 | — | |||||||||||||
| Foreign exchange differences, net | 7.8 | 53.2 | (45.4) | (85) | |||||||||||||
| Finance expenses | (2.0) | (4.3) | 2.3 | (53) | |||||||||||||
| Other | (2.0) | (4.3) | 2.3 | (53) | |||||||||||||
| Total finance result | 154.3 | 56.6 | 97.7 | 173 | |||||||||||||
| Nine months ended September 30, | Change | ||||||||||||||||
| (in millions €) | 2023 | 2022 | € | % | |||||||||||||
| Finance result | |||||||||||||||||
| Finance income | 363.2 | 448.5 | (85.3) | (19) | |||||||||||||
| Interest income | 237.2 | 9.7 | 227.5 | n.m. | |||||||||||||
| Fair value adjustments of financial instruments measured at fair value | 120.2 | 216.8 | (96.6) | (45) | |||||||||||||
| Foreign exchange differences, net | 5.8 | 222.0 | (216.2) | (97) | |||||||||||||
| Finance expenses | (4.5) | (16.8) | 12.3 | (73) | |||||||||||||
| Other | (4.5) | (16.8) | 12.3 | (73) | |||||||||||||
| Total finance result | 358.7 | 431.7 | (73.0) | (17) | |||||||||||||
From the three months ended September 30, 2022 compared to the three months ended September 30, 2023, our total finance result increased by €97.7 million from €56.6 million to €154.3 million as well as decreased by €73.0 million from €431.7 million during the nine months ended September 30, 2022 to €358.7 million during the nine months ended September 30, 2023. During the three and nine months ended September 30, 2023, our finance result was driven by interest income mainly derived from our security investments as well as bank deposits and the fair value adjustments derived from remeasuring our money market funds. During the three and nine months ended September 30, 2022 our finance result was mainly influenced by foreign exchange differences arising on financing items (i.e. U.S. dollar denominated bank deposits and cash accounts). In addition, during the nine months ended September 30, 2022, the fair value adjustments derived from remeasuring the derivative embedded in our convertible note significantly affected our finance result.
Income Taxes
For the nine months ended September 30, 2023 and 2022, income taxes were calculated based on the best estimate of the weighted average annual income tax rates expected for the full financial years (estimated annual effective income tax rates) on ordinary income before tax adjusted by the tax effect of any discrete items. The income tax asset represents the portion of prepayments for corporate income taxes and trade taxes in Germany that have been paid for the full financial year 2023 but not yet offset by income tax expenses calculated for the nine months ended September 30, 2023. For the nine months ended September 30, 2023 and 2022, our effective income tax rates were approximately 9.7% and 26.8%, respectively. The decrease of the effective income tax rate was mainly driven by the transaction within the BioNTech Group described below. During the nine months ended September 30, 2023 and 2022, current income taxes were mainly recognized with respect to the German tax group. Deferred tax effects were recognized with respect to identified discrete items as well as share-based payments programs during the nine months ended September 30, 2023 and 2022.
A reorganization of the intellectual property rights within the group has become effective June 30, 2023 and July 1, 2023 which led to deferred tax effects in Germany, the US and Austria. As a result BioNTech SE recognized deferred tax assets and deferred tax income at the time of the transaction. In addition this transaction led to a revaluation of
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previously unrecognized U.S. federal and state deferred tax assets, including unused tax losses and unused tax credits. As of December 31, 2022, there were unrecognized U.S. federal and state deferred tax assets of €128.9 million. As of September 30, 2023, 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. Therefore we no longer continue to maintain the full non-recognition of deferred tax assets of our U.S. tax group as there will be future taxable profits available against which the unused tax losses and temporary differences can be utilized. As of September 30, 2023, we maintain the non-recognition of deferred tax assets for unused U.S. federal and state tax losses at an amount of €20.1 million and €1.6 million, respectively, as there is not sufficient probability in terms of IAS 12 that there will be future taxable income available against which these unused tax losses can be utilized.
Related Party Transactions
Related party transactions that occurred during the three and nine months ended September 30, 2023, and 2022 are explained in Note 13 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, 2023 have been prepared in accordance with IAS 34 Interim Financial Reporting.
Our critical accounting policies and the use of estimates are explained in Note 2 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report and further discussed in Note 3 to our audited consolidated financial statements of our Annual Report on Form 20-F as of and for the year ended December 31, 2022.
Legal Proceedings
Our contingencies include, but are not limited to, intellectual property disputes and product liability and other product-related litigation. From time to time, in the normal course and conduct of our business, we may be involved in discussions with third parties about considering, for example, the use and/or remuneration for use of such third party’s intellectual property. As of September 30, 2023, none of such intellectual property-related considerations that we have been notified of, and for which potential claims could be brought against us or our subsidiaries in the future, fulfill the criteria for recording a provision. We are subject to an increasing number of product liability claims. Such claims often involve highly complex issues related to medical causation, correctness and completeness of product information (Summary of Product Characteristics/package leaflet) as well as label warnings and reliance thereon, scientific evidence and findings, actual and provable injury, and other matters. These complexities vary from matter to matter. As of September 30, 2023, none of these claims fulfill the criteria for recording a provision. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions. We currently do not believe that any of these matters will have a material adverse effect on our financial position, and will continue to monitor the status of these and other claims that may arise. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid. We will continue to evaluate whether, if circumstances were to change in the future, the recording of a provision may be needed and whether potential indemnification entitlements exist against any such claim.
Certain pending matters to which we are a party are discussed below.
Alnylam Proceedings
In March 2022, Alnylam Pharmaceuticals, Inc., or Alnylam, filed a lawsuit against Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that an existing patent owned by Alnylam, U.S. Patent No. 11,246,933, or the ‘933 Patent, is infringed by the cationic lipid used in Comirnaty, and seeking monetary relief, which is not specified in their filings. We filed a counterclaim to become party to the Alnylam proceeding, and in June 2022, Alnylam added to its claims allegations that we induced infringement of the ‘933 Patent. Additionally, in July 2022, Alnylam filed a lawsuit against us, our wholly owned subsidiary, BioNTech Manufacturing GmbH, Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging that we also induced infringement of a newly issued patent, U.S. Patent No. 11,382,979, or the ‘979 Patent, which is a
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continuation of the ‘933 Patent. The two lawsuits were consolidated on July 28, 2022 and are currently pending. In May 2023, Alnylam filed a third lawsuit against Pfizer Inc. and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480; 11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. We filed a counterclaim to become party to the new proceeding, and in July 2023, Alnylam added to its claims allegations that we induced infringement of the four new patents. All of the proceedings have been consolidated and are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Alnylam’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
CureVac Proceedings
Germany
Infringement Proceedings – EP’122, DE’961, DE‘974, DE’575, and EP’668
In July 2022, CureVac AG, or CureVac, filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP1857122B1, or the EP’122 Patent, and three Utility Models DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac added European Patent EP3708668B1, or the EP’668 Patent, to its German lawsuit.
On August 15, 2023, the Düsseldorf Regional Court held a hearing on the issue of alleged infringement with respect to all five IP rights. At the hearing, the Court suspended its infringement ruling with respect to EP’122 until December 28, 2023, after the Federal Patent Court is expected to issue its validity decision on EP’122 in the related ongoing nullity proceeding. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the remaining four IP rights (DE’961, DE’974, DE’575, and EP’668) pending validity decisions in the DE’961, DE’974, and DE’575 cancellation proceedings before the German Patent and Trademark Office and in the EP’668 opposition proceedings before the Opposition Division of the European Patent Office. In the September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions are reached, while contemporaneously noting concerns regarding the validity of DE’961, DE’974, DE’575, and EP’668.
Infringement Proceedings – EP’755, DE’123, and DE’130
In July 2023, CureVac SE filed a second lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP4023755B1, or the EP’755 Patent, and two Utility Models DE202021004123U1, and DE202021004130U1.
Nullity Proceedings – EP’122
In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that the EP’122 Patent is invalid. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122 nullity action in support of the validity of the EP’122 Patent. The preliminary opinion did not address any infringement of the EP’122 Patent. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non-binding. The first instance decision of the court in the EP’122 nullity action is expected in December 2023, and is appealable.
Cancellation Proceedings– DE’961, DE‘974, and DE’575
In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in the German Patent and Trademark Office.
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United States
In July 2022, we and Pfizer filed a complaint for a declaratory judgment in the U.S. District Court for the District of Massachusetts, seeking a judgment of non-infringement by Comirnaty of U.S. Patent Nos. 11,135,312, 11,149,278 and 11,241,493. In May 2023, the action in the U.S. District Court for the District of Massachusetts was transferred to the U.S. District Court for the Eastern District of Virginia, where CureVac filed counterclaims asserting infringement of six additional U.S. patents, U.S. Patent Nos. 10,760,070; 11,286,492; 11,345,920; 11,471,525; 11,576,966; and 11,596,686. In July 2023, CureVac filed amended counterclaims to assert an additional U.S. patent, U.S. Patent No. 11,667,910.
United Kingdom
In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against the EP’122 Patent and the EP’668 Patent in the Business and Property Courts of England and Wales. In October 2022, CureVac responded by filing a counterclaim alleging infringement of the EP’122 and EP’668 patents in the Business And Property Courts of England and Wales.
All of the above proceedings are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility models and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of CureVac’s claims is ongoing and complex, and we believe the ultimate outcomes remain substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Moderna Proceedings
Germany
Infringement Proceedings – EP’949 and EP’565
In August 2022, Moderna filed a lawsuit against us and Pfizer and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Manufacturing Belgium NV, Pfizer Ireland Pharmaceuticals and Pfizer Inc. in the Düsseldorf Regional Court alleging Comirnaty’s infringement of two European Patents, 3590949B1, or the EP’949 Patent, and 3718565B1, or the EP’565 Patent. Opposition proceedings against the EP'949 Patent and EP'565 Patent are currently pending.
United Kingdom
In August 2022, Moderna filed a lawsuit asserting Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the Business and Property Courts of England and Wales. In September 2022, we and Pfizer filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of the EP’949 Patent and EP’565 Patent.
United States
U.S. District Court Litigation
In August 2022, Moderna filed a lawsuit in the United States District Court for the District of Massachusetts against us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging Comirnaty’s infringement of U.S. Patent Nos. 10,898,574, 10,702,600 and 10,933,127 and seeking monetary relief.
Inter Partes Review
In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127 before the United States Patent Trial and Appeal Board.
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Netherlands
In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc. in the District Court of The Hague alleging Comirnaty’s infringement of the EP ‘949 Patent and the EP ’565 Patent. The District Court of the Hague held a hearing on October 6, 2023 on infringement and validity with respect to the EP ’949 Patent. A first instance decision is expected in January 2024.
Ireland
In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals International C.V. alleging Comirnaty’s infringement of the EP’949 Patent and EP’565 Patent in the High Court of Ireland.
Belgium
In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc. and Pfizer Manufacturing Belgium alleging Comirnaty’s infringement of the EP’949 Patent and the EP’565 Patent in the Brussels Dutch-speaking Enterprise Court.
All of the above proceedings are currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Arbutus and Genevant Proceedings
In April 2023, Arbutus Biopharma Corp., or Arbutus, and Genevant Sciences GmbH, or Genevant, filed a lawsuit against Pfizer and us in the U.S. District Court for the District of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid nanoparticle technology and methods for producing such lipids in Comirnaty, and seeking monetary relief. This proceeding is currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Promosome Proceedings
In June 2023, Promosome LLC filed a lawsuit against Pfizer, us, and BioNTech Manufacturing GmbH in the U.S. District Court for the Southern District of California alleging that Pfizer and our Comirnaty vaccine has infringed U.S. Patent No. 8,853,179, and seeking monetary relief. On October 4, 2023, the parties filed a joint stipulation of dismissal, dismissing the lawsuit with prejudice. As part of this stipulation of dismissal, Promosome agreed to a covenant not to assert U.S. Patent No. 8,853,179 against Pfizer and us or any of their products, including Comirnaty. This matter is considered closed.
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 as a fully integrated global biotechnology company. On the research and development (R&D) front, we continue to be committed to rapidly advancing our oncology pipeline towards late-stage development. Furthermore, we are focused on developing our infectious disease
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vaccine pipeline including the development of variant-adapted and next generation COVID-19 vaccines to maintain leadership and pandemic preparedness as well as broaden the label of and access to the COVID-19 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, 2023, we had cash and cash equivalents of €13,495.8 million and security investments of €3,471.8 million. Our trade receivables remained outstanding as of September 30, 2023 mainly due to the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer as described in Note 8 to the unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report. As of September 30, 2023, our trade receivables included, in addition to the profit share for the third quarter of 2023, trade receivables which related to the gross profit share for the second quarter of 2023. The payment settling our gross profit share for the second quarter of 2023 (as defined by the contract) in the amount of €565.0 million was received from our collaboration partner subsequent to the end of the reporting period on October 16, 2023.
Cash and cash equivalents and financial securities are invested in accordance with our asset management and investment policy, primarily with a focus on liquidity and capital preservation, and consist primarily of cash in bank accounts and on hand as well as long- and short-term financial investments.
In November 2020, we entered into a sales agreement, or the Sales Agreement, with Jefferies LLC and SVB Leerink LLC (now known as Leerink Partners 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. We did not sell any ADS during three and nine months ended September 30, 2023. As of September 30, 2023, the remaining capacity under the Sales Agreement is $207.1 million. Under the at-the-market offering program ADSs are sold via the stock exchange and therefore no shareholders’ subscription rights are affected. We do not intend to make additional sales.
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.
In March 2023, our Management Board and Supervisory Board authorized a new share repurchase program of ADSs, with a value of up to $0.5 billion, which commenced on June 2, 2023 and concluded on September 18, 2023. The amount spent in repurchasing ADSs under this program during three and nine months ended September 30, 2023 amounted to €302.5 million and €456.5 million, respectively.
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 €) | 2023 | 2022 | 2023 | 2022 | ||||||||||||||||
| Net cash flows from / (used in): | ||||||||||||||||||||
| Operating activities | 811.2 | 4,778.9 | 4,520.5 | 12,748.2 | ||||||||||||||||
| Investing activities | (1,232.2) | (83.3) | (4,259.4) | 125.7 | ||||||||||||||||
| Financing activities | (311.0) | (653.4) | (765.7) | (1,354.6) | ||||||||||||||||
| Total cash inflow (outflow) | (732.0) | 4,042.2 | (504.6) | 11,519.3 | ||||||||||||||||
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, 2023, 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 8 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, as of October 16,
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2023, we further improved our cash position as we received the settlement payment of our gross profit share for the second quarter of 2023 (as defined by the contract).
Net cash generated from operating activities for the three months ended September 30, 2023 was €811.2 million, comprising a profit before tax for the period of €227.4 million, negative non-cash adjustments of €110.3 million, a net positive change in assets and liabilities of €639.4 million and income taxes paid of €10.2 million. Non-cash items primarily included net foreign exchange differences as well as fair value adjustments of derivatives without cash-effect. The net positive change in assets and liabilities was primarily due to a decrease in 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, 2022 was €4,778.9 million, comprising a profit before tax for the period of €2,444.1 million, positive non-cash adjustments of €205.6 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. 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 from operating activities for the nine months ended September 30, 2023 was €4,520.5 million, comprising a profit before tax of €522.9 million, negative non-cash adjustments of €490.1 million, a net positive change in assets and liabilities of €6,378.6 million and income taxes paid of €1,292.4 million. Non-cash items primarily included net foreign exchange differences as well as non-cash fair value adjustments of derivatives. 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 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 €168.6 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.
Investing Activities
Net cash used in investing activities for the three months ended September 30, 2023 was €1,232.2 million. Thereof, the amount caused by or driven from in-licensing arrangements, collaborations or M&A transactions amounted to €382.6 million.
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 for the nine months ended September 30, 2023 was €4,259.4 million. Thereof, the amount caused by or driven from in-licensing arrangements, collaborations or M&A transactions amounted to €620.4 million.
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 deposits which returned to cash upon maturity of their original
investments' term offset by €192.6 million attributable to the purchase of property, plant and equipment.
Financing Activities
During the three months ended September 30, 2023, net cash used in financing activities was €311.0 million, primarily resulting from the share repurchase program.
During the three months ended September 30, 2022, net cash used in financing activities was €653.4 million, primarily resulting from the share repurchase program.
During the nine months ended September 30, 2023, net cash used in financing activities was €765.7 million, primarily resulting from the share repurchase program.
During the nine months ended September 30, 2022, net cash used in financing activities was €1,354.6 million, primarily resulting from the share repurchase program and a special cash dividend.
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Operation and Funding Requirements
As part of our capital allocation strategy, we expect to continue to incur significant and increasing operating expenses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we and our collaborators:
•continue or expand our research or development of our programs in preclinical development;
•continue or expand the scope of our clinical trials for our product candidates;
•initiate additional preclinical, clinical, or other trials for our product candidates, including under our collaboration agreements;
•continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;
•change or increase our manufacturing capacity or capability;
•change or add additional suppliers;
•add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as a public company and our product development and commercialization efforts, including 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 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.
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 are in ongoing discussions with two such third parties, the University of Pennsylvania and the National Institute of Health, or NIH, concerning additional royalties allegedly owed on sales of our COVID-19 vaccine since commercialization. While we disagree with the positions being taken by the University of Pennsylvania and NIH, we cannot guarantee that our interpretation of the applicable license agreements will prevail or that we will not ultimately need to pay some or all of the royalty amounts in dispute.
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 2023 is related to lease payments amounting to €44.5 million. Further, we have lease payment obligations of €177.6 million for the years 2024 and beyond.
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;
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