BioNTech SE(BNTX) - 2022 Q2 - Quarterly Report

Cover Information Unaudited Interim Condensed Consolidated Financial Statements Interim Condensed Consolidated Statements of Profit or Loss BioNTech's interim condensed consolidated statements of profit or loss show total revenue decreased 40% to €3,196.5 million for three months but increased 30% to €9,571.1 million for six months, with profit for the period showing similar trends Interim Condensed Consolidated Statements of Profit or Loss (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Total Revenue | €3,196.5 | €5,308.5 | -40% | €9,571.1 | €7,356.9 | 30% | | Commercial Revenue | €3,166.3 | €5,280.5 | -40% | €9,528.5 | €7,308.0 | 30% | | Research and Development Revenue | 30.2 | 28.0 | 8% | 42.6 | 48.9 | -13% | | Operating Income | €2,209.6 | €4,198.4 | -47% | €6,962.3 | €5,860.6 | 19% | | Profit Before Tax | €2,319.3 | €4,022.8 | -42% | €7,337.4 | €5,665.1 | 30% | | Profit for the Period | €1,672.0 | €2,787.2 | -40% | €5,370.8 | €3,915.3 | 37% | | Basic Earnings Per Share | €6.86 | €11.42 | -40% | €22.00 | €16.07 | 37% | | Diluted Earnings Per Share | €6.45 | €10.77 | -40% | €20.69 | €15.14 | 37% | Interim Condensed Consolidated Statements of Comprehensive Income BioNTech's interim condensed consolidated statements of comprehensive income show profit for the period at €1,672.0 million and €5,370.8 million for the three and six months ended June 30, 2022, respectively, with other comprehensive income primarily driven by foreign currency translation differences Interim Condensed Consolidated Statements of Comprehensive Income (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Profit for the Period | €1,672.0 | €2,787.2 | €5,370.8 | €3,915.3 | | Other comprehensive income (that may be reclassified to profit or loss in subsequent periods) | | | | | | Exchange differences on translation of foreign operations | 9.8 | (1.1) | 13.5 | 3.4 | | Other comprehensive income/(loss) (that may be reclassified to profit or loss in subsequent periods) | €9.8 | €(1.1) | €13.5 | €3.4 | | Other comprehensive loss (that will not be reclassified to profit or loss in subsequent periods) | | | | | | Remeasurement losses on defined benefit plans | — | — | (0.1) | — | | Other comprehensive loss (that will not be reclassified to profit or loss in subsequent periods) | €— | €— | €(0.1) | €— | | Total comprehensive income/(loss) for the period (net of tax) | €9.8 | €(1.1) | €13.4 | €3.4 | | Total comprehensive income for the period (net of tax) | €1,681.8 | €2,786.1 | €5,384.2 | €3,918.7 | Interim Condensed Consolidated Statements of Financial Position As of June 30, 2022, BioNTech's total assets increased to €21,155.4 million, a 33.6% rise from December 31, 2021, primarily driven by a significant increase in cash and cash equivalents to €9,334.8 million, while total equity grew 41.5% to €16,830.7 million Interim Condensed Consolidated Statements of Financial Position (in € million) | Metric (in € million) | June 30, 2022 (Unaudited) | December 31, 2021 | | :-------------------- | :------------------------ | :---------------- | | Assets | | | | Non-current Assets | €947.3 | €758.5 | | Current Assets | €20,208.1 | €15,072.3 | | Thereof: Cash and Cash Equivalents | 9,334.8 | 1,692.7 | | Thereof: Trade and Other Receivables | 10,382.9 | 12,381.7 | | Total Assets | €21,155.4 | €15,830.8 | | Equity and Liabilities | | | | Equity | €16,830.7 | €11,893.7 | | Non-current Liabilities | €401.0 | €455.5 | | Current Liabilities | €3,923.7 | €3,481.6 | | Total Liabilities | €4,324.7 | €3,937.1 | | Total Equity and Liabilities | €21,155.4 | €15,830.8 | Interim Condensed Consolidated Statements of Changes in Stockholders' Equity For the six months ended June 30, 2022, BioNTech's stockholders' equity increased from €11,893.7 million to €16,830.7 million, primarily driven by profit for the period and capital reserve increases from share issuance and convertible note redemption, partially offset by share repurchases and dividend payments Interim Condensed Consolidated Statements of Changes in Stockholders' Equity (in € million) | Metric (in € million) | Share Capital | Capital Reserves | Treasury Shares | Retained Earnings | Other Reserves | Total Equity | | :-------------------- | :------------ | :--------------- | :-------------- | :---------------- | :------------- | :----------- | | January 1, 2022 | €246.3 | €1,674.4 | €(3.8) | €9,882.9 | €93.9 | €11,893.7 | | Profit for the Period | — | — | — | 5,370.8 | — | 5,370.8 | | Other Comprehensive Income | — | — | — | — | 13.4 | 13.4 | | Issuance of Share Capital | 0.5 | 67.1 | — | — | — | 67.6 | | Redemption of Convertible Notes | 1.8 | 233.2 | — | — | — | 235.0 | | Share Buyback Program | — | (284.8) | (2.1) | — | — | (286.9) | | Dividends | — | — | — | (484.3) | — | (484.3) | | Share-based Payments | — | — | — | — | 21.5 | 21.5 | | June 30, 2022 | €248.6 | €1,689.8 | €(5.9) | €14,769.4 | €128.8 | €16,830.7 | Interim Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2022, BioNTech's net cash flows from operating activities significantly increased to €7,969.3 million, while net cash flows from investing activities turned positive at €209.0 million due to maturing cash deposits, and net cash flows from financing activities were negative €701.2 million due to share repurchases and dividend payments Interim Condensed Consolidated Statements of Cash Flows (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Cash Flows from Operating Activities | €3,919.1 | €(100.3) | €7,969.3 | €(411.6) | | Net Cash Flows from Investing Activities | (78.4) | (29.8) | 209.0 | (58.1) | | Net Cash Flows from Financing Activities | (781.5) | 152.9 | (701.2) | 148.4 | | Net increase/(decrease) in cash and cash equivalents | 3,059.2 | 22.8 | 7,477.1 | (321.3) | | Effect of exchange rate changes on cash and cash equivalents | 111.5 | (0.2) | 165.0 | 25.2 | | Cash and cash equivalents at beginning of period | 6,164.1 | 891.5 | 1,692.7 | 1,210.2 | | Cash and cash equivalents at end of period | €9,334.8 | €914.1 | €9,334.8 | €914.1 | Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements 1 Corporate Information BioNTech SE is a global biotechnology company registered in Germany, focused on novel drug development at the intersection of immunology and synthetic biology, with diverse technology platforms and recent corporate developments - BioNTech SE is a global biotechnology company focused on novel drug development at the intersection of immunology and synthetic biology, with diverse technology platforms including mRNA vaccines, cell and gene therapies[20][21] - In February 2022, BioNTech Innovation GmbH was established as a wholly-owned subsidiary of BioNTech SE[22] - In June 2022, the Annual General Meeting re-elected Helmut Jeggle to the Supervisory Board and elected Prof Dr Anja Morawietz and Prof Dr Rudolf Staudigl as new members, with Helmut Jeggle re-elected as Chairman[23] 2 Basis of Preparation, Significant Accounting Policies and Further Accounting Topics These interim condensed consolidated financial statements are prepared in accordance with IAS 34 and consistent with 2021 annual report accounting policies, with management making significant judgments and estimates, particularly regarding revenue recognition from the Pfizer collaboration, while continuously assessing COVID-19 and gas supply impacts - The unaudited interim condensed consolidated financial statements are prepared in accordance with IAS 34 "Interim Financial Reporting" and are consistent with the accounting policies in the 2021 Annual Report, with income tax accounted for using the expected annual tax rate[25][32] - Management made significant judgments and estimates in preparing the financial statements, particularly regarding revenue recognition from the Pfizer collaboration agreement, which may be adjusted based on final data[29][31] - The COVID-19 pandemic caused delays in the initiation of some clinical trials (e.g., BNT111, BNT113, BNT122), but the company initiated several new clinical trials in 2021 and 2022[35][182] - The company is monitoring the gas supply situation and evaluating alternative energy measures, expecting no impact on commercial mRNA production from gas shortages, but R&D and clinical development activities currently rely on gas, and mitigation measures have been taken[36][38] 3 Revenues from Contracts with Customers For the three months ended June 30, 2022, total revenue decreased 40% to €3,196.5 million due to a reduced gross profit share from COVID-19 vaccines, while for the six months, total revenue increased 30% to €9,571.1 million driven by increased product sales to collaboration partners and direct sales, with R&D revenue primarily from Sanofi and Genentech collaborations and a new upfront payment from Pfizer for shingles vaccine development Revenues from Contracts with Customers (in € million) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Commercial Revenue | €3,166.3 | €5,280.5 | €9,528.5 | €7,308.0 | | COVID-19 Vaccine Revenue | 3,152.7 | 5,266.0 | 9,505.8 | 7,281.6 | | Sales to Collaboration Partners | 608.3 | 138.1 | 1,211.5 | 202.0 | | Direct Product Sales to Customers | 557.0 | 1,035.6 | 1,720.1 | 1,235.4 | | Collaboration Partner's Gross Profit Share and Sales Milestones | 1,987.4 | 4,092.3 | 6,574.2 | 5,844.2 | | Other Sales | 13.6 | 14.5 | 22.7 | 26.4 | | Research and Development Revenue | €30.2 | €28.0 | €42.6 | €48.9 | | Total | €3,196.5 | €5,308.5 | €9,571.1 | €7,356.9 | - For the three months ended June 30, 2022, total revenue decreased by 40%, primarily due to a 51% reduction in collaboration partner's gross profit share and sales milestones[39][188] - For the six months ended June 30, 2022, total revenue increased by 30%, primarily driven by a 500% increase in sales to collaboration partners and a 39% increase in direct product sales to customers[39][188] - Research and development revenue primarily stems from collaborations with Sanofi S.A. and Genentech Inc., with a new €67.5 million upfront payment from Pfizer for shingles vaccine development[47] 4 Income and Expenses This section details BioNTech's income and expenses for the three and six months ended June 30, 2022, highlighting fluctuating cost of sales influenced by COVID-19 vaccine costs and inventory write-downs, significant increases in R&D and G&A expenses reflecting growth, and substantial changes in other operating income/expenses and finance income/expenses driven by foreign exchange gains/losses and convertible note adjustments 4.1 Cost of Sales Cost of Sales (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Cost of Sales Related to COVID-19 Vaccine Revenue | €753.3 | €872.1 | -14% | €2,041.6 | €1,095.3 | 86% | | Other Sales Related Costs | 11.3 | 11.7 | -3% | 17.1 | 21.6 | -21% | | Total Cost of Sales | €764.6 | €883.8 | -13% | €2,058.7 | €1,116.9 | 84% | - For the three months ended June 30, 2022, cost of sales decreased by 13% year-over-year, but for the six months, it increased by 84%[49][195] - Changes in cost of sales are primarily due to COVID-19 vaccine-related costs, including gross profit share payable to Pfizer, as well as inventory write-downs and contract manufacturing organization (CMO) capacity redundancy charges resulting from the introduction of new vaccine formulations and increased internal capacity[195] 4.2 Research and Development Expenses Research and Development Expenses (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Purchased Services | €230.0 | €99.9 | 130% | €361.4 | €241.8 | 49% | | Wages, Benefits and Social Security Contributions | 85.5 | 68.2 | 25% | 156.3 | 115.7 | 35% | | Laboratory Supplies | 48.1 | 16.5 | 192% | 105.7 | 27.9 | 279% | | Depreciation and Amortization | 11.6 | 7.1 | 63% | 22.4 | 14.6 | 53% | | Other | 24.4 | 9.4 | 160% | 39.6 | 17.3 | 129% | | Total Research and Development Expenses | €399.6 | €201.1 | 99% | €685.4 | €417.3 | 64% | - For the three months ended June 30, 2022, research and development expenses increased by 99% to €399.6 million, and for the six months, they increased by 64% to €685.4 million[50][197] - The increase is primarily due to the recognition of production costs for pre-release Omicron vaccine candidates as R&D expenses, and higher wages, benefits, and social security contributions due to increased headcount[197] 4.3 General and Administrative Expenses General and Administrative Expenses (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Wages, Benefits and Social Security Contributions | €43.0 | €17.1 | 151% | €70.5 | €31.4 | 125% | | Purchased Services | 34.6 | 11.5 | 201% | 64.9 | 23.5 | 176% | | IT and Office Equipment | 22.5 | 5.4 | 317% | 33.8 | 8.0 | 323% | | Insurance Premiums | 8.5 | 4.4 | 93% | 14.5 | 8.7 | 67% | | Other | 21.4 | 9.4 | 128% | 37.1 | 15.1 | 146% | | Total General and Administrative Expenses | €130.0 | €47.8 | 172% | €220.8 | €86.7 | 155% | - For the three months ended June 30, 2022, general and administrative expenses increased by 172% to €130.0 million, and for the six months, they increased by 155% to €220.8 million[52][199] - The increase is primarily due to higher expenses for purchased external services and increased wages, benefits, and social security contributions resulting from increased headcount[199] 4.4 Other Operating Expenses Other Operating Expenses (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Losses from Fair Value Changes of Derivative Financial Instruments (recognized in profit or loss) | €229.7 | €— | — | €299.0 | €— | — | | Other | 11.0 | 0.3 | n.m. | 10.5 | 0.9 | n.m. | | Total | €240.7 | €0.3 | n.m. | €309.5 | €0.9 | n.m. | - For the three and six months ended June 30, 2022, other operating expenses significantly increased, primarily due to losses from fair value changes of foreign exchange forward contracts not designated as hedging instruments[53][201] 4.5 Other Operating Income Other Operating Income (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Net Exchange Differences | €517.0 | €34.4 | n.m. | €641.0 | €75.1 | 754% | | Government Grants | — | 0.1 | -100% | — | 68.0 | -100% | | Other | 48.8 | 1.7 | n.m. | 56.7 | 4.4 | n.m. | | Total | €565.8 | €36.2 | n.m. | €697.7 | €147.5 | 373% | - For the three and six months ended June 30, 2022, other operating income significantly increased, primarily due to higher net exchange differences arising from the valuation of USD-denominated trade receivables, partially offset by foreign exchange effects on USD-denominated trade payables and license agreement obligations[54][201] - Government grants recognized in the prior period did not recur in the corresponding period of 2022[201] 4.6 Finance Income Finance Income (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Net Exchange Differences | €114.0 | €— | — | €168.8 | €24.2 | 598% | | Interest Income | 1.5 | 0.3 | 400% | 2.0 | 0.6 | 233% | | Fair Value Adjustments of Financial Instruments (measured at fair value) | — | — | — | 216.8 | — | — | | Total | €115.5 | €0.3 | n.m. | €387.6 | €24.8 | n.m. | - For the three and six months ended June 30, 2022, finance income significantly increased, primarily due to net exchange differences arising from the valuation of USD-denominated cash and cash equivalents, and fair value adjustments of embedded derivatives in convertible notes[56][57][203] 4.7 Finance Expenses Finance Expenses (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Interest Expenses Related to Financial Assets | €5.1 | €— | — | €8.3 | €— | — | | Interest Expenses Related to Lease Liabilities | 0.7 | 0.5 | 40% | 1.6 | 1.2 | 33% | | Amortization of Financial Instruments | — | 4.7 | -100% | 2.6 | 7.2 | -64% | | Fair Value Adjustments of Financial Instruments (measured at fair value) | — | 170.4 | -100% | — | 211.9 | -100% | | Net Exchange Differences | — | 0.3 | -100% | — | — | — | | Total | €5.8 | €175.9 | -97% | €12.5 | €220.3 | -94% | - For the three and six months ended June 30, 2022, finance expenses significantly decreased, primarily due to fair value adjustments of embedded derivatives in convertible notes being recognized as finance income in 2022 compared to an expense in 2021, and reduced amortization of financial instruments[58][203] 5 Income Tax For the six months ended June 30, 2022, BioNTech's effective income tax rate decreased to 26.8% from 30.9% in the prior year, primarily due to lower average trade tax rates in Mainz, Marburg, and Idar-Oberstein, while a valuation allowance is maintained for deferred tax assets of the U.S. tax group due to insufficient future taxable profits Income Tax (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Current Income Tax | €597.8 | €1,257.0 | €1,932.9 | €1,752.1 | | Deferred Taxes | 49.5 | (21.4) | 33.7 | (2.3) | | Income Tax | €647.3 | €1,235.6 | €1,966.6 | €1,749.8 | - For the six months ended June 30, 2022, the effective income tax rate was approximately 26.8%, lower than 30.9% in the prior year, partly due to a decrease in the average trade tax rate in Mainz, Marburg, and Idar-Oberstein starting in 2022[59][204] - The company continues to maintain a valuation allowance for deferred tax assets of its U.S. tax group, as future taxable profits are not sufficient to utilize unused tax losses and temporary differences in accordance with IAS 12[59][206] 6 Financial Assets and Financial Liabilities As of June 30, 2022, BioNTech's total financial assets decreased to €10,434.5 million, primarily due to a reduction in trade and other receivables, while total financial liabilities decreased to €1,343.4 million, mainly due to the redemption of convertible notes, with foreign exchange risk on USD-denominated trade receivables managed through undesignated foreign exchange forward contracts whose fair value adjustments are recognized in other operating expenses Financial Assets (in € million) | Metric (in € million) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | Derivative Financial Instruments (not designated as hedging instruments) | | | | Foreign Exchange Forward Contracts | €— | €5.7 | | Equity Instruments (designated as measured at fair value through OCI) | | | | Unlisted Equity Investments | 46.5 | 19.5 | | Financial Assets Measured at Amortized Cost | | | | Trade and Other Receivables | 10,382.9 | 12,381.7 | | Cash Deposits with an Original Maturity of Six Months | — | 375.2 | | Other Financial Assets | 5.1 | 2.5 | | Total | €10,434.5 | €12,784.6 | | Total Current Portion | 10,383.0 | 12,763.3 | | Total Non-current Portion | 51.5 | 21.3 | Financial Liabilities (in € million) | Metric (in € million) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | Loans and Borrowings | €238.9 | €301.5 | | Other Financial Liabilities | 1,104.5 | 1,356.5 | | Total | €1,343.4 | €1,658.0 | | Total Current Portion | 1,130.7 | 1,480.3 | | Total Non-current Portion | 212.7 | 177.7 | - Trade and other receivables slightly decreased, primarily comprising receivables from the Pfizer COVID-19 collaboration and direct product sales in Germany and Turkey[65] - The convertible notes were fully redeemed on March 1, 2022, through the exercise of an early redemption right, leading to the recognition of fair value adjustments of related embedded derivatives as finance income[67][68][71][72] - Foreign exchange forward contracts are used to manage foreign exchange risk related to USD-denominated trade receivables but are not designated as hedging instruments, with their fair value adjustments recognized in other operating expenses[73] 7 Inventories As of June 30, 2022, BioNTech's total inventories decreased to €367.7 million from €502.5 million at December 31, 2021, with the company recognizing €247.1 million (three months) and €403.1 million (six months) in write-downs and provisions for COVID-19 vaccine-related inventories due to plans for new vaccine formulations and a potential shift to Omicron-adapted bivalent vaccines Inventories (in € million) | Metric (in € million) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | Raw Materials and Supplies | €264.0 | €248.3 | | Work in Progress | 95.4 | 84.5 | | Finished Goods | 8.3 | 169.7 | | Total | €367.7 | €502.5 | - For the three and six months ended June 30, 2022, the company recognized write-downs and provisions for COVID-19 vaccine-related inventories of €247.1 million and €403.1 million, respectively, due to plans for new COVID-19 vaccine formulations and a potential shift to Omicron-adapted bivalent vaccines, which were recognized in cost of sales[79] 8 Issued Capital and Reserves BioNTech underwent several capital changes in the first half of 2022, including Pfizer's acquisition of 497,727 ordinary shares for €110.6 million, resulting in a €67.1 million net increase in capital reserves, the redemption of convertible notes leading to the issuance of 1,744,392 ordinary shares and a €233.2 million increase in capital reserves, the initiation of a $1.5 billion ADS share buyback program, and the payment of a €2.00 per share special cash dividend totaling €484.3 million - In January 2022, Pfizer acquired 497,727 ordinary shares through an equity investment, paying €110.6 million, resulting in a net increase of €67.1 million in capital reserves[81] - In March 2022, the company redeemed convertible notes and subsequently issued 1,744,392 ordinary shares in April, increasing share capital by €1.7 million and capital reserves by €233.2 million[82] - In March 2022, the Management Board and Supervisory Board authorized an ADS share buyback program of up to $1.5 billion, with the first tranche initiated on May 2, resulting in the repurchase of 2,078,207 ADSs for a total consideration of €286.9 million by June 30[83][229] - In June 2022, the Annual General Meeting approved a special cash dividend of €2.00 per share, totaling €484.3 million paid out[84][230] 9 Share-Based Payments For the three and six months ended June 30, 2022, BioNTech's share-based payment expenses were €14.8 million and €25.0 million, respectively, a decrease from the prior year, primarily stemming from equity-settled arrangements like employee share purchase plans and Management Board awards, with 109,202 Restricted Cash Units (RSUs) granted under the European plan in 2022 and Management Board awards modified to cash-settled Share-Based Payment Expenses (in € million) | Metric (in € million) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Expenses Arising from Equity-Settled Share-Based Payment Arrangements | €12.8 | €17.3 | €25.0 | €32.5 | | Employee Share Purchase Plan | 4.5 | 7.1 | 9.2 | 11.6 | | CEO Award | 0.9 | 1.6 | 1.8 | 3.3 | | Management Board Awards | 1.7 | 0.4 | 2.7 | 0.9 | | BioNTech 2020 Employee Equity Plan for Employees Outside North America | 5.7 | 8.2 | 11.3 | 16.7 | | Income/(Expenses) Arising from Cash-Settled Share-Based Payment Arrangements | 2.0 | 9.8 | — | 11.9 | | Employee Share Purchase Plan | 0.5 | — | 0.3 | — | | Management Board Awards | (0.4) | 1.2 | (1.2) | 1.3 | | BioNTech North America Employee Restricted Stock Unit Plan | 1.9 | 8.6 | 0.9 | 10.6 | | Total | €14.8 | €27.1 | €25.0 | €44.4 | | Thereof: Cost of Sales | 0.7 | 1.9 | 1.5 | 3.6 | | Research and Development Expenses | 9.7 | 18.8 | 17.0 | 30.9 | | Selling and Marketing Expenses | 0.3 | 0.3 | 0.4 | 0.3 | | General and Administrative Expenses | 4.1 | 6.1 | 6.1 | 9.6 | - In January 2022, 109,202 Restricted Cash Units (RSUs) were granted under the European plan, with a weighted average fair value of €203.22[91] - In May 2022, Management Board awards were modified from equity-settled to cash-settled share-based payment arrangements, resulting in a reclassification of €3.5 million[93] 10 Provisions and Contingencies As of June 30, 2022, BioNTech's total provisions amounted to €304.5 million, primarily for contractual disputes, and the company recognized €207.8 million in capacity redundancy obligations due to new COVID-19 vaccine formulations and increased internal capacity, while also facing patent infringement lawsuits from Alnylam and CureVac, for which it believes it has strong defenses but acknowledges significant uncertainty regarding outcomes - As of June 30, 2022, the company estimated potential economic outflows of €304.5 million arising from contractual disputes, which have been reclassified as current provisions[99][212] - Due to plans for new COVID-19 vaccine formulations, a potential shift to Omicron-adapted bivalent vaccines, and increased internal manufacturing capacity, the company recognized €207.8 million in contract manufacturing organization (CMO) capacity redundancy obligations[100] - The company faces patent infringement lawsuits filed by Alnylam Pharmaceuticals, Inc. concerning cationic lipids used in the COMIRNATY vaccine, and has filed counterclaims[103][104][216][217] - The company also faces patent infringement lawsuits filed by CureVac AG regarding the COMIRNATY vaccine and has filed a declaratory judgment action of non-infringement with Pfizer in the U.S[107][219] - The company believes it has strong defenses against all patent infringement allegations, but the outcome of these proceedings remains highly uncertain, making it difficult to estimate potential losses[105][108][218][220] 11 Related Party Disclosures For the three and six months ended June 30, 2022, related party transactions between BioNTech and ATHOS KG and its controlled entities had no material impact on the interim condensed consolidated financial statements, with no significant changes compared to the 2021 annual report disclosures - ATHOS KG is the sole shareholder of AT Impf GmbH and the beneficial owner of BioNTech's ordinary shares, with its controlled entities primarily providing leasing, property management, and sales of property, plant, and equipment services[109] - For the three and six months ended June 30, 2022, the aggregate amount of transactions with ATHOS KG or its controlled entities had no material impact on the interim condensed consolidated financial statements[109][207] 12 Events After the Reporting Period Subsequent to the reporting period, BioNTech established a wholly-owned subsidiary, BioNTech BioNTainer Holding GmbH, in July 2022 - In July 2022, BioNTech BioNTainer Holding GmbH (formerly BioNTech Barracuda Holding GmbH) was established as a wholly-owned subsidiary of BioNTech SE[110] Operating and Financial Review and Prospects Operating Results BioNTech is dedicated to developing novel immunotherapies for cancer and infectious diseases, having successfully commercialized its first mRNA vaccine, BNT162b2, and boasts over 17 clinical-stage products and 30+ research programs, with a strategic focus on next-generation COVID-19 vaccines, accelerated oncology and infectious disease clinical development, and global expansion through strategic collaborations and acquisitions Overview - BioNTech was founded in 2008 to develop treatments for diseases with unmet medical needs, with a vision to harness the immune system for novel cancer and infectious disease therapies[113] - The company possesses diverse technology platforms, including mRNA vaccines, cell and gene therapies, and targeted antibodies, having developed its first commercial product, BNT162b2 (COMIRNATY), and boasts over 17 clinical-stage products and more than 30 research programs[114] - The company focuses on developing next-generation COVID-19 vaccines, accelerating clinical development in oncology and infectious diseases, and expanding into autoimmune, inflammatory, cardiovascular, neurodegenerative diseases, and regenerative medicine[117][118] - The company plans to strengthen its technology platforms and digital capabilities through strategic collaborations and acquisitions, and enhance its infrastructure and manufacturing capabilities[119] Corporate Development - In April 2022, the company secured a pandemic preparedness contract with the German Federal Government and established an exclusive research collaboration with Matinas Biopharma[121] - In June 2022, the company began constructing its first African mRNA vaccine manufacturing facility in Kigali, Rwanda, with initial BioNTainer deliveries expected by the end of 2022, aiming for an initial annual capacity of approximately 50 million COVID-19 vaccine doses[121] - In June 2022, the Annual General Meeting approved a special cash dividend of €2.00 per share, and the company initiated an ADS share buyback program of up to $1.5 billion, having repurchased 2,078,207 ADSs[121] - The company is evaluating the European gas supply situation and implementing measures to ensure business continuity, expecting no impact on commercial mRNA production from gas shortages, but R&D and clinical development activities currently rely on natural gas[121] Key Pipeline Updates Infectious Diseases BioNTech is expanding its infectious disease mRNA vaccine pipeline to address global health challenges, including COVID-19, influenza, shingles, HSV 2, tuberculosis, and malaria vaccine programs, aiming to be a leader in infectious disease mRNA vaccines and committed to global mRNA drug accessibility COVID-19 Vaccine Program – BNT162 BioNTech's BNT162b2 vaccine, developed with Pfizer, has delivered over 3.6 billion doses globally, with ongoing label expansion and next-generation vaccine development, including the production of Omicron BA.1 and BA.4/5 adapted vaccines and planned clinical trials for an Omicron BA.4/5 adapted bivalent vaccine in H2 2022, alongside regulatory approvals for expanded EUA in children and sBLA for adolescents Commercial Updates - As of early July 2022, BioNTech and Pfizer had delivered over 3.6 billion doses of the COVID-19 vaccine to 180 countries or regions[129] - In the first half of 2022, approximately 1.2 billion vaccine doses were invoiced, and orders for approximately 2.5 billion doses for 2022 were signed[129] - From January 1 to July 20, 2022, the company's vaccine share in all markets increased from approximately 52% to 63%, and in developed markets from approximately 59% to 68%[131] - BioNTech and Pfizer have delivered over 1.5 billion doses of the COVID-19 vaccine to low- and middle-income countries[131] - In May 2022, an agreement with the European Commission adjusted the COVID-19 vaccine delivery schedule, deferring doses originally planned for June-August to September-Q4, without impacting the full-year 2022 revenue guidance[131] - In June 2022, a new vaccine supply agreement was signed with the U.S. government to provide 105 million doses (including Omicron-adapted adult vaccines), with an option to purchase an additional 195 million doses, totaling 300 million doses for $3.2 billion[131] Manufacturing Updates - BioNTech and Pfizer have commenced manufacturing bivalent Omicron BA.1 and BA.4/5 adapted vaccines, with deliveries expected as early as October 2022 to meet autumn booster demand[132] Clinical Development and Regulatory Updates - In May 2022, the U.S. FDA expanded the EUA to authorize BNT162b2 for use as a booster dose in children aged 5-11 years[133] - In June 2022, the U.S. FDA revised the EUA to authorize BNT162b2 for use in children aged 6 months to 4 years[133] - In July 2022, the U.S. FDA approved the sBLA, expanding the license for BNT162b2 to include individuals aged 12-15 years[133] - BioNTech and Pfizer announced positive safety and immunogenicity data for two Omicron BA.1-adapted vaccine candidates, showing significantly higher neutralizing antibody responses against Omicron BA.1 compared to BNT162b2[135] - Preclinical studies demonstrated that the Omicron BA.4/5-adapted vaccine candidate significantly increased neutralizing responses against all Omicron sublineages[135] - The company plans to initiate a clinical trial for an Omicron BA.4/5-adapted bivalent vaccine in August 2022[135] - In July 2022, an application for an Omicron BA.1-based bivalent COVID-19 vaccine was submitted to the EMA[135] - The company is developing next-generation COVID-19 vaccines, including the enhanced SARS-CoV-2 spike antigen vaccine BNT162b5, and plans to advance T-cell-enhanced and pan-SARS-CoV-2 vaccine candidates into clinical trials in the second half of 2022[137] Additional Infectious Disease Programs BioNTech is actively advancing its infectious disease pipeline, including influenza and shingles vaccine programs with Pfizer, and wholly-owned HSV 2, tuberculosis, and malaria vaccine programs, with several projects expected to initiate clinical trials in the second half of 2022 or early 2023 Influenza Vaccine Program - The Phase 1/2 clinical trial for BNT161 (quadrivalent nucleoside-modified RNA influenza vaccine) is ongoing, with Phase 2 extension studies showing significant induction of CD4+ and CD8+ T-cell responses in subjects aged 65 and older[140] - Based on positive T-cell responses and seroconversion, a Phase 3 study for the quadrivalent modified mRNA influenza vaccine is planned to start in the second half of 2022[140] - A clinical trial for a self-amplifying mRNA (saRNA) influenza vaccine was initiated in collaboration with Pfizer to evaluate its safety, tolerability, and immunogenicity[140] Shingles Vaccine Program - The first mRNA shingles vaccine candidate is being developed in collaboration with Pfizer, with clinical trials expected to commence in the second half of 2022[141] HSV 2 Vaccine Program – BNT163 - Clinical trials for the HSV 2 vaccine candidate BNT163, developed in collaboration with the University of Pennsylvania, are expected to commence in the second half of 2022[142] Tuberculosis Vaccine Program – BNT164 - Clinical trials for the tuberculosis vaccine candidate BNT164, developed in collaboration with the Bill & Melinda Gates Foundation, are planned to start in the second half of 2022 or early 2023[143] Malaria Vaccine Program – BNT165 - Clinical trials for the malaria vaccine candidate BNT165 are planned to start in the second half of 2022 or early 2023[145] Research Collaboration with University of Pennsylvania - The collaboration with the University of Pennsylvania aims to develop and commercialize up to 10 prophylactic mRNA immunotherapies for infectious disease indications[146] Oncology BioNTech's immuno-oncology strategy leverages multiple complementary technologies, including mRNA therapeutic vaccines, cell therapies, mRNA-encoded effector molecules, and next-generation immune checkpoint inhibitors, with 18 clinical-stage oncology product candidates across 23 clinical trials, including 5 in randomized Phase 2, and anticipates further pipeline advancement and data readouts in the remainder of 2022 FixVac FixVac is BioNTech's off-the-shelf cancer immunotherapy, utilizing a uRNA backbone to encode cancer-specific shared antigens, designed to induce potent antigen-specific immune responses, with BNT111 (advanced melanoma) and BNT113 (HPV16+ head and neck cancer) in Phase 2 trials, BNT112 (prostate cancer) patient enrollment temporarily suspended due to supply issues, and BNT116 (advanced non-small cell lung cancer) having initiated a Phase 1 clinical trial in July 2022 - BNT111 (advanced melanoma) is undergoing a global three-arm Phase 2 trial evaluating its efficacy in combination with cemiplimab[152] - Patient enrollment for the Phase 1/2 trial of BNT112 (prostate cancer) has been temporarily suspended due to supply issues with the BNT112 investigational medicinal product[155] - BNT113 (HPV16+ head and neck cancer) is undergoing a randomized Phase 2 trial evaluating its efficacy in combination with pembrolizumab as a first-line treatment[155] - A Phase 1 clinical trial for BNT116 (advanced non-small cell lung cancer) was initiated in July 2022 to assess its safety, tolerability, and preliminary efficacy as a monotherapy and in combination with cemiplimab or docetaxel[156] Individualized Neoantigen Specific Immunotherapies, or iNeST The iNeST approach, based on uRNA and RNA-LPX formulations, customizes vaccines for each patient, encoding their tumor mutations to generate neoantigen-specific T-cell responses, with lead candidate autogene cevumeran (BNT122) in Phase 2 trials for advanced melanoma and colorectal cancer in collaboration with Genentech, and showing positive preliminary data in a Phase 1 trial for pancreatic ductal adenocarcinoma - autogene cevumeran (BNT122) is being co-developed with Genentech for an open-label Phase 2 trial in advanced melanoma, with data updates expected in the first half of 2023[159][160] - BNT122 is also undergoing a randomized Phase 2 trial for colorectal cancer, evaluating its efficacy in ctDNA-positive, surgically resected Stage II/III patients[162] - In June 2022, BNT122 showed positive preliminary data in a Phase 1 clinical trial for pancreatic ductal adenocarcinoma, inducing high-intensity de novo neoantigen-specific T-cell responses associated with longer recurrence-free survival[162] mRNA Intratumoral Immunotherapy BioNTech, in collaboration with Sanofi, is developing the intratumoral immunotherapy SAR441000 (BNT131), a modified mRNA encoding immunomodulatory cytokines for direct intratumoral injection, currently in a Phase 1 clinical trial as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor for advanced solid tumors - SAR441000 (BNT131) is an intratumoral immunotherapy developed in collaboration with Sanofi, currently undergoing a Phase 1 clinical trial as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor for advanced solid tumors[163] RiboCytokines RiboCytokines product candidates BNT151 and BNT152+153 are nucleoside-modified mRNAs encoding human cytokines, designed to address the short half-life and high production costs of recombinant cytokines, with Phase 1 clinical trials for BNT151 (IL-2 variant) and BNT152 (IL-7) + BNT153 (IL-2) ongoing for various solid tumor indications - Phase 1/2 clinical trials for BNT151 (encoding an IL-2 variant) are ongoing for various solid tumor indications[165] - Phase 1 clinical trials for the combination of BNT152 (encoding IL-7) and BNT153 (encoding IL-2) are ongoing for patients with various solid tumors[165] RiboMabs RiboMabs product candidates BNT141 and BNT142 leverage mRNA technology to encode antibodies targeting cancer cells, aiming to overcome the limitations of expensive manufacturing and poor pharmacokinetics of recombinant antibodies, with BNT141 (targeting Claudin18.2) in a Phase 1/2 dose-escalation trial and BNT142 (targeting CD3 and CLDN6) having initiated a Phase 1/2 trial in July 2022 - Phase 1/2 dose-escalation, safety, and pharmacokinetic trials for BNT141 (encoding an antibody targeting Claudin18.2) are ongoing for patients with Claudin 18.2-positive tumors[169] - A Phase 1/2 trial for BNT142 (encoding a bispecific T-cell engaging antibody targeting CD3 and CLDN6) was initiated in July 2022 for patients with CLDN6-positive advanced solid tumors[169] CAR-T Cell Immunotherapy BNT211, BioNTech's first CAR-T cell product candidate, targets CLDN6-positive solid tumors and incorporates a CAR-T cell amplifying RNA vaccine (CARVac), with ongoing Phase 1/2 trials showing preliminary efficacy data of 86% disease control rate and 43% overall response rate, and EMA granting PRIME designation for BNT211 in testicular germ cell tumors in June 2022 - BNT211 targets CLDN6-positive solid tumors and incorporates CARVac, with Phase 1/2 trials currently underway[170] - Preliminary efficacy data show a disease control rate of 86% and an overall response rate of 43%, with a favorable safety profile[170] - In June 2022, the EMA granted Priority Medicines (PRIME) designation to BNT211 for the treatment of testicular germ cell tumors[170] - Further data updates from the Phase 1/2 trial are expected in the second half of 2022[170] Neoantigen-Targeting T Cell Therapy BNT221 (NEO-PTC-01) is BioNTech's individualized neoantigen-targeting T cell therapy for cancer, currently in a Phase 1 dose-escalation trial for patients with checkpoint inhibitor-unresponsive or refractory metastatic melanoma - BNT221 (NEO-PTC-01) is an individualized neoantigen-targeting T cell therapy, with a Phase 1 dose-escalation trial ongoing for patients with checkpoint inhibitor-unresponsive or refractory metastatic melanoma[171] Next-Generation Immunomodulators BioNTech, in collaboration with Genmab, is developing bispecific antibodies, including BNT311 (GEN1046) and BNT312 (GEN1042), as tumor-targeting and dual immunomodulators, with BNT311 in Phase 2 trials and BNT312 in Phase 1/2 recruitment, and an expanded collaboration to develop the CD27 antibody BNT313 (GEN1053), with a Phase 1 trial expected to start in H2 2022 - BNT311 (GEN1046) is a bispecific antibody combining PD-L1 checkpoint inhibition with 4-1BB checkpoint activation, with a Phase 2 trial ongoing for relapsed/refractory metastatic NSCLC[174] - BNT312 (GEN1042) aims to induce conditional immune activation by cross-linking CD40 and 4-1BB positive cells, with a Phase 1/2 trial currently recruiting patients with solid tumors[174] - The collaboration with Genmab has expanded to develop the CD27 antibody BNT313 (GEN1053), with a Phase 1 trial expected to start in the second half of 2022[175] Targeted Cancer Antibodies BNT321 (MVT-5873) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), currently in Phase 1 clinical development for pancreatic cancer and other CA19-9 expressing solid tumors - BNT321 (MVT-5873) is a monoclonal antibody targeting sLea, currently in Phase 1 clinical development for pancreatic cancer and other CA19-9 expressing solid tumors[176] Small Molecule Immunomodulators BNT411, BioNTech's novel small molecule TLR7 agonist product candidate, aims to activate adaptive and innate immune systems via the TLR7 pathway, currently in a Phase 1/2 dose-escalation trial for solid tumors as monotherapy and in combination with atezolizumab, carboplatin, and etoposide for chemotherapy-naive extensive-stage small cell lung cancer - BNT411 is a novel small molecule TLR7 agonist, with a Phase 1/2 dose-escalation trial ongoing for solid tumors as monotherapy and in combination with atezolizumab, carboplatin, and etoposide for ES-SCLC[177] [Rare Disease