[Financial Statements](index=4&type=section&id=1.%20Financial%20Statements) [Interim Condensed Consolidated Statements of Profit or Loss](index=4&type=section&id=1.1.%20Interim%20Condensed%20Consolidated%20Statements%20of%20Profit%20or%20Loss) The company's total revenue and profit for Q1 2023 significantly decreased year-over-year, primarily due to reduced commercial revenues | Metric | Three Months Ended March 31, 2023 (million Euros) | Three Months Ended March 31, 2022 (million Euros) | | :--- | :--- | :--- | | **Total Revenue** | 1,277.0 | 6,374.6 | | **Cost of Sales** | (96.0) | (1,294.1) | | **Research and Development Expenses** | (334.0) | (285.8) | | **Selling and Marketing Expenses** | (12.2) | (14.3) | | **General and Administrative Expenses** | (119.4) | (90.8) | | **Other Operating Expenses** | (118.1) | (71.6) | | **Other Operating Income** | 57.1 | 134.7 | | **Operating Profit** | 654.4 | 4,752.7 | | **Finance Income** | 82.3 | 272.1 | | **Finance Expenses** | (29.0) | (6.7) | | **Profit Before Income Tax** | 707.7 | 5,018.1 | | **Income Tax** | (205.5) | (1,319.3) | | **Profit for the Period** | 502.2 | 3,698.8 | | **Basic Earnings Per Share** | 2.07 | 15.13 | | **Diluted Earnings Per Share** | 2.05 | 14.24 | - 2023年第一季度总收入同比下降**80%**，本期利润同比下降**86%**[469](index=469&type=chunk)[624](index=624&type=chunk) [Interim Condensed Consolidated Statements of Comprehensive Income](index=5&type=section&id=1.2.%20Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) The company's total comprehensive income for Q1 2023 significantly decreased to **501.8 million Euros** from **3,702.4 million Euros** in Q1 2022 | Metric | Three Months Ended March 31, 2023 (million Euros) | Three Months Ended March 31, 2022 (million Euros) | | :--- | :--- | :--- | | **Profit for the Period** | 502.2 | 3,698.8 | | **Other Comprehensive Income (to be reclassified to profit or loss)** | | | | Exchange Differences | (2.1) | 3.7 | | Net Gain on Cash Flow Hedges | 1.7 | — | | **Other Comprehensive Income (not to be reclassified to profit or loss)** | | | | Remeasurement Loss on Defined Benefit Plans | — | (0.1) | | **Total Comprehensive Income for the Period** | 501.8 | 3,702.4 | - 2023年第一季度综合收益净额同比下降**86.5%**[471](index=471&type=chunk)[482](index=482&type=chunk) [Interim Condensed Consolidated Statements of Financial Position](index=7&type=section&id=1.3.%20Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) As of March 31, 2023, the company's total assets and liabilities decreased, while total equity slightly increased | Metric | As of March 31, 2023 (million Euros) | As of December 31, 2022 (million Euros) | | :--- | :--- | :--- | | **Non-current Assets** | 1,992.9 | 1,357.1 | | **Current Assets** | 20,086.1 | 21,922.0 | | **Total Assets** | 22,079.0 | 23,279.1 | | **Total Equity** | 20,265.3 | 20,055.6 | | **Non-current Liabilities** | 262.8 | 272.9 | | **Current Liabilities** | 1,550.9 | 2,950.6 | | **Total Liabilities** | 1,813.7 | 3,223.5 | - 截至2023年3月31日，总资产较2022年12月31日下降**5.15%**，总负债下降**43.75%**，总权益增长**1.05%**[499](index=499&type=chunk) [Interim Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=1.4.%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) As of March 31, 2023, total stockholders' equity increased to **20,265.3 million Euros**, driven by profit for the period, partially offset by share repurchases | Metric | As of March 31, 2023 (million Euros) | As of March 31, 2022 (million Euros) | | :--- | :--- | :--- | | **Equity at January 1** | 20,055.6 | 11,893.6 | | **Profit for the Period** | 502.2 | 3,698.8 | | **Other Comprehensive Income/(Loss)** | (0.4) | 3.6 | | **Share Repurchase Program** | (282.0) | — | | **Share-Based Payments** | 10.9 | 12.2 | | **Equity at March 31** | 20,265.3 | 15,910.6 | - 2023年第一季度，本期利润为**502.2 million Euros**，股份回购计划导致**282.0 million Euros**的减少[484](index=484&type=chunk) [Interim Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=1.5.%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2023, the company reported net cash outflows of **677.4 million Euros** from operating activities, **735.4 million Euros** from investing activities, and **291.3 million Euros** from financing activities, resulting in a net decrease of **1,704.1 million Euros** in cash and cash equivalents | Metric | Three Months Ended March 31, 2023 (million Euros) | Three Months Ended March 31, 2022 (million Euros) | | :--- | :--- | :--- | | **Net Cash Flows from Operating Activities** | (677.4) | 4,050.2 | | **Net Cash Flows from Investing Activities** | (735.4) | 287.4 | | **Net Cash Flows from Financing Activities** | (291.3) | 80.3 | | **Net Increase/(Decrease) in Cash and Cash Equivalents** | (1,704.1) | 4,417.9 | | **Cash and Cash Equivalents at Period End** | 12,143.9 | 6,164.1 | - 2023年第一季度，经营活动现金流由2022年同期的净流入**4,050.2 million Euros**转为净流出**677.4 million Euros**[475](index=475&type=chunk)[118](index=118&type=chunk) - 投资活动现金流净流出**735.4 million Euros**，主要用于金融证券投资[475](index=475&type=chunk)[665](index=665&type=chunk) [Notes to Interim Condensed Consolidated Financial Statements](index=12&type=section&id=2.%20Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Corporate Information](index=12&type=section&id=2.1.%20Corporate%20Information) BioNTech SE is a global next-generation immunotherapy company headquartered in Mainz, Germany, focused on developing novel medicines for cancer, infectious diseases, and other serious illnesses - BioNTech SE是一家全球性的下一代免疫疗法公司，致力于开发针对癌症、传染病及其他严重疾病的新型药物[477](index=477&type=chunk) - 公司总部位于德国美因茨，并已建立起涵盖mRNA疫苗和疗法、细胞和基因疗法、靶向抗体和小分子免疫调节剂等多个技术平台[477](index=477&type=chunk)[485](index=485&type=chunk) [Basis of Preparation, Significant Accounting Policies and Further Accounting Topics](index=12&type=section&id=2.2.%20Basis%20of%20Preparation%2C%20Significant%20Accounting%20Policies%20and%20further%20Accounting%20Topics) These interim condensed consolidated financial statements are prepared in accordance with IAS 34 and IFRS, with accounting policies generally consistent with the 2022 annual report, except for income tax accounting, requiring significant management judgments, estimates, and assumptions - 简明合并财务报表按照国际会计准则（IAS）34《中期财务报告》编制，并遵循国际财务报告准则（IFRS）[487](index=487&type=chunk)[485](index=485&type=chunk) - 会计政策与2022年年度报告中的审计合并财务报表保持一致，但所得税核算除外[490](index=490&type=chunk) - 管理层在

BioNTech SE (NASDAQ:BNTX) Q4 2022 Results Conference Call March 27, 2023 8:00 AM ET Company Participants Michael Horowicz - IR and Strategy Ugur Sahin - CEO and Co-Founder Özlem Türeci - Chief Medical Officer and Co-Founder Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Tazeen Ahmad - Bank of America Daina Graybosch - SVB Securities Matthew Harrison - Morgan Stanley Yaron Werber - Cowen Jessica Fye - JP Morgan Michael Horowicz Good morning and afternoon. Thank you ...

Financial Performance - Total revenues for the year ended December 31, 2022, were €17,310.6 million, a decrease of 8.8% compared to €18,976.7 million for the prior year[8]. - Net profit for the year ended December 31, 2022, was €9,434.4 million, down 8.3% from €10,292.5 million in the previous year[16]. - Total revenues for Q4 2022 were €4,278.3 million, a decrease of 22.7% compared to €5,532.5 million in Q4 2021[60]. - Commercial revenues decreased to €4,271.3 million in Q4 2022 from €5,525.9 million in Q4 2021, representing a decline of 22.7%[60]. - Profit for the period in Q4 2022 was €2,278.7 million, down from €3,166.2 million in Q4 2021, a decrease of 28.1%[60]. - Basic profit for the period per share was €9.38 in Q4 2022, compared to €12.96 in Q4 2021, a decline of 27.5%[60]. - Full year 2022 revenues reached €17.3 billion, with a net profit of €9.4 billion and fully diluted earnings per share of €37.77[65]. Research and Development - BioNTech plans to continue investing heavily in R&D and is open to mergers and acquisitions to drive future growth[4]. - Research and development expenses increased to €509.8 million in Q4 2022, up from €271.5 million in Q4 2021, reflecting an increase of 87.7%[60]. - The company expanded its oncology pipeline to 20 programs with 24 ongoing clinical trials, including five randomized Phase 2 trials[65]. - Estimated R&D expenses for 2023 are projected to be between €2,400 million and €2,600 million[70]. - BioNTech initiated multiple clinical trials in 2022, including programs for non-small cell lung cancer and a herpes simplex virus vaccine candidate[27][24]. - BioNTech plans to start a Phase 3 trial of ONC-392 in NSCLC patients in 2023, following an exclusive licensing agreement with OncoC4, Inc.[39]. - The company announced a licensing agreement with OncoC4 to enhance its oncology portfolio, with a Phase 3 trial planned for 2023[65]. Vaccine Development and Sales - BioNTech expects COVID-19 vaccine revenues for the 2023 financial year to be approximately €5 billion[11]. - BioNTech and Pfizer invoiced approximately 2 billion doses of the COMIRNATY vaccine globally in 2022, including around 550 million doses of the adapted bivalent vaccine[19]. - The company launched the world's first Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in 2022 and progressed nine new programs into clinical trials[1]. - Approximately 2 billion doses of COMIRNATY were invoiced in 2022, including around 550 million doses of Omicron-adapted bivalent COVID-19 vaccines[65]. Financial Position - Total assets increased to €23,279.1 million as of December 31, 2022, from €15,830.8 million as of December 31, 2021, an increase of 47.0%[50]. - Total current assets rose to €21,922.0 million in 2022 from €15,072.3 million in 2021, an increase of 45.0%[50]. - Total equity increased to €20,055.6 million in 2022 from €11,893.7 million in 2021, representing an increase of 68.5%[50]. - Cash and cash equivalents significantly increased to €13,875.1 million in 2022 from €1,692.7 million in 2021, a rise of 718.5%[50]. - Total liabilities decreased to €32,223.5 million in 2022 from €39,371.1 million in 2021, a reduction of 18.2%[50]. - Net cash flows from operating activities for the year were €13,577.4 million, compared to €889.7 million in the previous year[63]. Expenses - The cost of sales for the year ended December 31, 2022, was €2,995.0 million, a slight increase of 2.9% from €2,911.5 million in the prior year[2]. - General and administrative expenses for the year ended December 31, 2022, were €484.7 million, an increase of 69.5% from €285.8 million in the prior year[9]. - Research and development expenses for Q4 2022 were €509.8 million, compared to €271.5 million in the same period last year, reflecting an increase of 87.7%[67]. Strategic Initiatives - BioNTech's acquisition of InstaDeep Ltd. is expected to add approximately 240 skilled professionals to its workforce, enhancing capabilities in AI and machine learning[39]. - BioNTech's share repurchase program authorized up to $0.5 billion, with a total of approximately $1.3 billion spent to repurchase 9,166,684 ADSs at an average price of $142.04[38]. - BioNTech's ESG report for 2022 was published on March 27, 2023, detailing the company's sustainability efforts[40]. - The first six ISO-sized shipping containers for the BioNTainer were completed and shipped to Kigali in March 2023[39]. - BioNTech completed the construction of its first proprietary plasmid DNA manufacturing facility in Marburg in February 2023[39].

Title of each classTrading Symbol(s)Name of each exchange on which registered Ordinary shares, no par value, with a notional amount attributable to each ordinary share of €1* — The Nasdaq Stock Market LLC* FORM 20-F Securities registered or to be registered, pursuant to Section 12(b) of the Act Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Page GENERAL INFORMATION 3 CAUTIONARY STATEMENT RE ...

BioNTech SE (NASDAQ:BNTX) JP Morgan Annual Healthcare Conference January 10, 2023 12:45 PM ET Company Participants Ugur Sahin - Chief Executive Officer & Co-Founder Ryan Richardson - Chief Strategy Officer Conference Call Participants Jessica Fye - JPMorgan Jessica Fye Great. Good morning, everyone. My name is Jess Fye. I'm the large cap biotech analyst at JPMorgan, and we're delighted to be continuing the conference today with BioNTech. [Operator Instructions] So with that, let me turn it over to BioNTech ...

Financial Data and Key Metrics Changes - Total revenues for Q3 2022 reached €3.5 billion, contributing to total revenues of €13 billion for the first nine months of the year, reflecting strong performance in the COVID-19 vaccine franchise [11][67] - The company raised its 2022 financial guidance for COVID-19 vaccine revenues to €16 billion to €17 billion, up from a previous estimate of €13 billion to €17 billion [12][79] - Net profit for Q3 2022 was €1.8 billion, compared to €3.2 billion for the same period in 2021, while net profit for the first nine months of 2022 was €7.2 billion, slightly up from €7.1 billion in 2021 [77][78] Business Line Data and Key Metrics Changes - COVID-19 vaccine revenues for Q3 2022 were €3.4 billion, with €12.9 billion for the first nine months, driven by the Omicron-adapted vaccine launches [69][70] - Research and development expenses for Q3 2022 were €34.8 million, significantly lower than €260.4 million in the same period in 2021, while total R&D expenses for the first nine months reached €1 billion, up from €0.7 billion in 2021 [74][75] Market Data and Key Metrics Changes - The company invoiced approximately 300 million doses of the BA.4/BA.5-adapted bivalent vaccine as of mid-October 2022, with approvals for use in over 45 countries [16][18] - The company expects to invoice up to 2.1 billion doses of COVID-19 vaccines in 2022, reflecting some rephasing of deliveries to early 2023 [85] Company Strategy and Development Direction - BioNTech aims to establish a fully integrated global immunotherapy powerhouse, focusing on a technology-agnostic, solution-focused multi-platform strategy [9][10] - The company is expanding its mRNA manufacturing network and has signed a letter of intent for a strategic partnership to establish an mRNA research and innovation center in Victoria, Australia [12][13] Management's Comments on Operating Environment and Future Outlook - Management highlighted the dynamic nature of the COVID-19 pandemic and the need for ongoing adaptation of vaccines to emerging variants [26][27] - The company anticipates a shift in the COVID-19 vaccine market towards a hybrid public-private model in 2023, with expected pricing for adult vaccines in the range of $110 to $130 per dose [86][87] Other Important Information - The company completed the first tranche of its share repurchase program, repurchasing 6,945,530 ADSs at an average price of $143.98 [81][82] - The company plans to submit data to regulatory agencies for its Omicron-adapted bivalent vaccine for children aged six months to four years in early 2023 [36] Q&A Session Summary Question: Duration of BA 4/5 bivalent shot effectiveness and shipment delays - Management indicated that the effectiveness of the BA 4/5 Omicron-adapted vaccines depends on the virus's evolution and ongoing cross-neutralization assays [96][97] - A significant portion of shifted doses were donation doses, and contracts are flexible, allowing for either current or future vaccines to fulfill orders [98][99] Question: PFS difference expectations for melanoma data - Management stated it is too early to define a specific threshold for PFS improvement and emphasized the need for alignment with progress in the field [102][103] Question: Potential distribution of COVID vaccine in China - Management confirmed positive discussions regarding potential distribution in China but stated it is too early to predict specifics about approval and pricing [107] Question: COVID vaccine market volume expectations - Management acknowledged the difficulty in predicting future COVID vaccine volumes but noted the potential for a flu-like business model in the future, with a significant market opportunity [111][113]

[Unaudited Interim Condensed Consolidated Financial Statements](index=3&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Interim Condensed Consolidated Statements of Profit or Loss](index=3&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Profit%20or%20Loss) BioNTech's Q3 2022 revenues and net profit significantly decreased year-over-year, while nine-month figures showed a slight revenue decline and marginal profit increase Consolidated Statements of Profit or Loss (Q3 & 9M 2022 vs 2021) | Indicator (in millions €) | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **€3,461.2** | **€6,087.3** | **€13,032.3** | **€13,444.2** | | Commercial Revenues | €3,394.8 | €6,040.1 | €12,923.3 | €13,348.1 | | R&D Revenues | €66.4 | €47.2 | €109.0 | €96.1 | | **Operating Income** | **€2,387.5** | **€4,723.5** | **€9,349.8** | **€10,584.1** | | **Profit for the period** | **€1,784.9** | **€3,211.0** | **€7,155.7** | **€7,126.3** | | Diluted EPS (€) | €6.98 | €12.35 | €27.70 | €27.46 | [Interim Condensed Consolidated Statements of Comprehensive Income](index=4&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) Total comprehensive income for Q3 2022 decreased significantly year-over-year, while the nine-month period showed a slight increase, primarily influenced by foreign exchange differences Consolidated Statements of Comprehensive Income (Q3 & 9M 2022 vs 2021) | Indicator (in millions €) | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 | | :--- | :--- | :--- | :--- | :--- | | **Profit for the period** | €1,784.9 | €3,211.0 | €7,155.7 | €7,126.3 | | **Other comprehensive income** | €10.9 | €2.9 | €24.3 | €6.3 | | **Total Comprehensive Income** | **€1,795.8** | **€3,213.9** | **€7,180.0** | **€7,132.6** | [Interim Condensed Consolidated Statements of Financial Position](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) Total assets and equity significantly increased as of September 30, 2022, primarily driven by a substantial rise in cash and cash equivalents Consolidated Statements of Financial Position | Indicator (in millions €) | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **€22,660.6** | **€15,830.8** | | Cash and cash equivalents | €13,423.7 | €1,692.7 | | Trade and other receivables | €7,309.4 | €12,381.7 | | **Total Liabilities** | **€4,294.3** | **€3,937.1** | | **Total Equity** | **€18,366.3** | **€11,893.7** | [Interim Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Total equity significantly increased by September 30, 2022, primarily due to net profit, partially offset by share repurchases and dividend payments - Total equity increased to **€18,366.3 million** as of September 30, 2022, primarily due to the profit for the period of **€7,155.7 million**[15](index=15&type=chunk) - Significant equity transactions during the first nine months of 2022 included a share repurchase program (**€930.7 million**), dividend payments (**€484.3 million**), and issuance of share capital related to the redemption of a convertible note and an equity investment by Pfizer[15](index=15&type=chunk) [Interim Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities significantly increased for the nine months ended September 30, 2022, driven by trade receivable collections, leading to a strong cash position Consolidated Statements of Cash Flows (9M 2022 vs 2021) | Indicator (in millions €) | 9M 2022 | 9M 2021 | | :--- | :--- | :--- | | **Net cash from operating activities** | **€12,748.2** | **€1,089.2** | | Net cash from / (used in) investing activities | €125.7 | €(466.2) | | Net cash from / (used in) financing activities | €(1,354.6) | €143.1 | | **Net increase in cash** | **€11,519.3** | **€766.1** | | Cash and cash equivalents at end of period | €13,423.7 | €2,025.7 | [Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements](index=12&type=section&id=Selected%20Explanatory%20Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Corporate Information](index=12&type=section&id=1%20Corporate%20Information) BioNTech is a global biotechnology company focused on novel medicines, expanding its corporate structure with new subsidiaries in Germany and Rwanda in 2022 - BioNTech is a fully integrated global biotechnology company specializing in novel medicines, with a broad toolkit including mRNA vaccines, cell and gene therapies, and targeted antibodies[21](index=21&type=chunk) - In 2022, the company expanded its corporate structure by establishing new subsidiaries in Germany (BioNTech Innovation GmbH, BioNTech BioNTainer Holding GmbH, BioNTech Idar-Oberstein Services GmbH) and Rwanda (BioNTech Rwanda Ltd.)[22](index=22&type=chunk)[24](index=24&type=chunk) [Basis of Preparation and Significant Accounting Policies](index=12&type=section&id=2%20Basis%20of%20Preparation%2C%20Significant%20Accounting%20Policies%20and%20further%20Accounting%20Topics) Financial statements adhere to IAS 34, consistent with 2021 policies, noting Pfizer collaboration profit estimates, COVID-19 trial delays, and no anticipated energy disruptions to manufacturing - The determination of the company's share of gross profits from its collaboration with Pfizer relies on preliminary data from the partner, and these estimates may be adjusted prospectively in future periods[30](index=30&type=chunk) - The COVID-19 pandemic caused delays in the commencement of several clinical trials, including for BNT111, BNT113, and BNT122, though multiple Phase 1 and 2 trials were initiated in 2021 and 2022[38](index=38&type=chunk) - The company monitors the natural gas supply situation in Europe but does not anticipate energy-related disruptions to its commercial COVID-19 vaccine production, as it can be powered by alternative fuel sources if needed[39](index=39&type=chunk) [Revenues from Contracts with Customers](index=15&type=section&id=3%20Revenues%20from%20Contracts%20with%20Customers) Total revenues for Q3 2022 and the first nine months were primarily driven by COVID-19 vaccine sales, with a significant portion from the company's share of partners' gross profit Disaggregated Revenues (in millions €) | Revenue Stream | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 | | :--- | :--- | :--- | :--- | :--- | | **COVID-19 Vaccine Revenues** | **€3,378.1** | **€6,021.6** | **€12,883.9** | **€13,303.2** | | Sales to collaboration partners | €259.4 | €312.3 | €1,470.9 | €514.3 | | Direct product sales | €564.5 | €1,350.8 | €2,284.6 | €2,586.2 | | Share of partners' gross profit | €2,554.2 | €4,358.5 | €9,128.4 | €10,202.7 | | **R&D Revenues** | **€66.4** | **€47.2** | **€109.0** | **€96.1** | | **Total Revenues** | **€3,461.2** | **€6,087.3** | **€13,032.3** | **€13,444.2** | [Income and Expenses](index=16&type=section&id=4%20Income%20and%20Expenses) Major cost components include decreased Q3 cost of sales but increased nine-month cost of sales, significant rises in R&D and G&A expenses, and increased other operating income from foreign exchange gains [Cost of Sales](index=16&type=section&id=4.1%20Cost%20of%20Sales) Cost of sales decreased in Q3 2022 but increased for the nine-month period, primarily driven by COVID-19 vaccine revenues Cost of Sales (in millions €) | Period | Cost of Sales | YoY Change | | :--- | :--- | :--- | | Q3 2022 | €752.8 | -38% | | 9M 2022 | €2,811.5 | +21% | [Research and Development Expenses](index=16&type=section&id=4.2%20Research%20and%20Development%20Expenses) R&D expenses significantly increased in both Q3 and the nine-month period of 2022, driven by higher spending on supplies and increased personnel costs Research and Development Expenses (in millions €) | Period | R&D Expenses | YoY Change | | :--- | :--- | :--- | | Q3 2022 | €341.8 | +31% | | 9M 2022 | €1,027.2 | +52% | [General and Administrative Expenses](index=17&type=section&id=4.3%20General%20and%20Administrative%20Expenses) General and administrative expenses more than doubled in Q3 and the nine-month period of 2022, primarily due to increased costs for purchased services, IT, and personnel General and Administrative Expenses (in millions €) | Period | G&A Expenses | YoY Change | | :--- | :--- | :--- | | Q3 2022 | €141.0 | +107% | | 9M 2022 | €361.8 | +134% | [Other Operating Expenses](index=17&type=section&id=4.4%20Other%20Operating%20Expenses) Other operating expenses significantly increased in Q3 2022, primarily driven by losses on derivative instruments related to foreign exchange forward contracts - Losses on derivative instruments at fair value, related to foreign exchange forward contracts, were the primary driver of other operating expenses, totaling **€581.7 million** for the first nine months of 2022[53](index=53&type=chunk) [Other Operating Income](index=17&type=section&id=4.5%20Other%20Operating%20Income) Other operating income more than doubled in Q3 2022, primarily due to net foreign exchange gains from valuing U.S. dollar-denominated trade receivables - Net foreign exchange differences were the main component of other operating income, amounting to **€1,090.1 million** for the first nine months of 2022, largely due to the valuation of U.S. dollar trade receivables[54](index=54&type=chunk) [Finance Income](index=18&type=section&id=4.6%20Finance%20Income) Finance income significantly increased for the nine months ended September 30, 2022, driven by fair value adjustments of financial instruments and net foreign exchange differences - Fair value adjustments of **€216.8 million** in 9M 2022 were derived from remeasuring the derivative embedded in the company's convertible note and the equity investment from Pfizer[56](index=56&type=chunk)[57](index=57&type=chunk) [Finance Expenses](index=18&type=section&id=4.7%20Finance%20Expenses) Finance expenses dramatically decreased for the nine months ended September 30, 2022, due to the absence of large fair value adjustments on the convertible note derivative seen in 2021 - The significant decrease in finance expenses year-over-year is due to the absence of large fair value adjustments on the convertible note derivative that were present in 2021[58](index=58&type=chunk) [Income Tax](index=18&type=section&id=5%20Income%20Tax) The effective income tax rate decreased for the first nine months of 2022, partly due to lower trade tax rates and the recognition of a significant deferred tax asset from an ESOP settlement change - The effective income tax rate for the first nine months of 2022 was **26.8%**, compared to **31.0%** for the same period in 2021[59](index=59&type=chunk) - A change in the settlement mechanism for the company's ESOP resulted in the recognition of a deferred tax asset of **€395.2 million** as of September 30, 2022, with **€372.0 million** recognized directly in equity[62](index=62&type=chunk) [Financial Assets and Financial Liabilities](index=20&type=section&id=6%20Financial%20Assets%20and%20Financial%20Liabilities) Financial assets as of September 30, 2022, were primarily Pfizer trade receivables, while total financial liabilities decreased due to convertible note redemption, with currency risk managed by forward contracts - Trade and other receivables decreased to **€7,309.4 million** from **€12,381.7 million** at the end of 2021. These receivables predominantly relate to the gross profit share from the COVID-19 collaboration with Pfizer[65](index=65&type=chunk)[67](index=67&type=chunk) - The company fully redeemed its convertible note with a fund associated with Temasek in March 2022 by issuing ordinary shares[71](index=71&type=chunk)[75](index=75&type=chunk) - Foreign exchange forward contracts are used to manage transaction exposure related to U.S. dollar-denominated trade receivables[76](index=76&type=chunk) [Inventories](index=26&type=section&id=7%20Inventories) Inventories decreased as of September 30, 2022, following significant write-offs and reserves totaling €559.4 million, primarily due to the transition to the Omicron-adapted bivalent vaccine - Inventory write-offs and reserves of **€559.4 million** were recognized in the first nine months of 2022. This was mainly due to the transition to an Omicron-adapted bivalent vaccine and reserves for raw materials[83](index=83&type=chunk) [Issued Capital and Reserves](index=26&type=section&id=8%20Issued%20Capital%20and%20Reserves) The company's capital structure in the first nine months of 2022 was impacted by a Pfizer equity investment, convertible note redemption, a $1.5 billion share repurchase program, and a special cash dividend - Pfizer made an equity investment of **€110.6 million** for **497,727** ordinary shares in connection with a collaboration to develop an mRNA-based shingles vaccine[84](index=84&type=chunk) - A share repurchase program of up to **$1.5 billion** was authorized. In the first nine months of 2022, **6,545,030** ADSs were repurchased for a total of **$945.4 million** (**€930.7 million**)[86](index=86&type=chunk) - Shareholders approved a special cash dividend of **€2.00** per share, resulting in an aggregate payment of **€484.3 million** in June 2022[87](index=87&type=chunk) [Share-Based Payments](index=27&type=section&id=9%20Share-Based%20Payments) Share-based payment expenses increased for the nine months ended September 30, 2022, influenced by a new LTI program and a reclassification of the Management Board Grant to cash-settled arrangements Share-Based Payment Expenses (in millions €) | Period | Total Expense | YoY Change | | :--- | :--- | :--- | | Q3 2022 | €61.4 | +109% | | 9M 2022 | €86.4 | +17% | - The Management Board Grant for 2022 was modified from an equity-settled to a cash-settled arrangement, resulting in a reclassification of **€3.5 million** from equity to liabilities[96](index=96&type=chunk) [Provisions and Contingencies](index=30&type=section&id=10%20Provisions%20and%20Contingencies) Provisions for contractual disputes and redundant CMO capacities totaled €359.1 million and €321.2 million respectively as of September 30, 2022, with patent infringement lawsuits ongoing and uncertain outcomes - Provisions for contractual disputes increased to **€359.1 million** as of September 30, 2022, from **€177.9 million** at the end of 2021[104](index=104&type=chunk) - A provision of **€321.2 million** was recognized for obligations to CMOs for production capacities that became redundant due to the switch to the Omicron-adapted bivalent vaccine[105](index=105&type=chunk) - The company is defending against patent infringement lawsuits filed by Alnylam, CureVac, and Moderna. It considers these matters as contingencies and has not recorded a provision, stating it has strong defenses but the outcomes are uncertain[108](index=108&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) [Related Party Disclosures](index=33&type=section&id=11%20Related%20Party%20Disclosures) Transactions with related parties, primarily ATHOS KG controlled entities, were not significant to the financial statements for the reporting period - Transactions with related party ATHOS KG and its controlled entities, mainly for rental and property management, did not have a significant impact on the financial statements[117](index=117&type=chunk) [Events after the Reporting Period](index=33&type=section&id=12%20Events%20after%20the%20Reporting%20Period) Post-reporting period events include the founding of a new subsidiary in Australia and the authorization of a second $0.5 billion share repurchase program tranche - In November 2022, the Management and Supervisory Boards authorized a second tranche of the share repurchase program for up to **$0.5 billion**, starting December 7, 2022[118](index=118&type=chunk) [Operating and Financial Review and Prospects](index=34&type=section&id=Operating%20and%20Financial%20Review%20and%20Prospects) [Operating Results](index=34&type=section&id=Operating%20Results) BioNTech advances its global immunotherapy strategy with successful Omicron-adapted vaccine launches, manufacturing expansion in Africa, and significant progress across its broad oncology and infectious disease pipeline - The company is advancing its global presence with the construction of an mRNA vaccine manufacturing facility in Rwanda and a new research and manufacturing center in Australia[129](index=129&type=chunk) - The first tranche of the share repurchase program, valued at up to **$1.0 billion**, was completed, and a second tranche of up to **$0.5 billion** was authorized for December 2022[129](index=129&type=chunk) - The company's pipeline includes over **19** clinical-stage candidates across infectious diseases and oncology, with plans to provide up to **ten** clinical trial updates in Oncology in 2023[122](index=122&type=chunk)[169](index=169&type=chunk) [Infectious Disease Pipeline](index=39&type=section&id=Infectious%20Disease%20Pipeline) The infectious disease pipeline, a core growth pillar, launched Omicron-adapted COVID-19 vaccines and expanded with new clinical trials for combination COVID-19/influenza, standalone influenza, shingles, HSV 2, and malaria - Successfully launched Original/Omicron BA.1 and BA.4/BA.5-adapted bivalent COVID-19 vaccines in Q3 2022, with approximately **300 million** doses invoiced as of mid-October 2022[137](index=137&type=chunk)[139](index=139&type=chunk) - A Phase 1 trial for a combined COVID-19/influenza mRNA vaccine was initiated in October 2022[156](index=156&type=chunk) - Multiple new infectious disease clinical trials are expected to start in late 2022 or early 2023 for shingles (HZV), herpes (HSV 2), malaria (BNT165), and tuberculosis (BNT164)[159](index=159&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Oncology Pipeline](index=43&type=section&id=Oncology%20Pipeline) BioNTech's oncology pipeline, leveraging multiple platforms, initiated three first-in-human trials in Q3 2022 and presented encouraging CAR-T therapy data with a 57% overall response rate in testicular cancer patients - The oncology pipeline includes **19** product candidates in **24** ongoing clinical trials, with **five** randomized Phase 2 trials[168](index=168&type=chunk) - Presented encouraging data for CAR-T therapy BNT211 at ESMO 2022, with an overall response rate (ORR) of **57%** and a disease control rate (DCR) of **85%** in testicular cancer patients at dose level 2[186](index=186&type=chunk) - Initiated three first-in-human trials in Q3 2022: BNT116 (FixVac for NSCLC), BNT142 (RiboMab for solid tumors), and BNT313 (HexaBody targeting CD27 for solid tumors)[168](index=168&type=chunk)[193](index=193&type=chunk) [Financial Operations Overview](index=52&type=section&id=Financial%20Operations%20Overview) Q3 2022 revenues decreased significantly due to pandemic dynamics and order re-phasing, while R&D and G&A expenses increased, leading to lower nine-month operating income despite a slight revenue decline - The decrease in Q3 2022 revenues is attributed to the dynamic pandemic situation, the switch to Omicron-adapted vaccines, and a re-phasing of orders, with an expected uptake in demand in Q4 2022[206](index=206&type=chunk) - Cost of sales for the nine months of 2022 was impacted by inventory write-offs and expenses for redundant CMO production capacities resulting from the switch to the Omicron-adapted vaccine[213](index=213&type=chunk) - R&D expenses for the nine months of 2022 increased by **52%** to **€1,027.2 million**, driven by clinical program advancement and increased headcount[215](index=215&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=Liquidity%20and%20Capital%20Resources) BioNTech maintained a strong liquidity position as of September 30, 2022, with capital allocated to R&D, global expansion, and acquisitions, alongside significant share repurchases and dividend payments - Cash and cash equivalents stood at **€13,423.7 million** as of September 30, 2022. The company collected an additional **€3,185.9 million** in trade receivables by October 15, 2022[243](index=243&type=chunk) - Key financing activities in the first nine months of 2022 included a share repurchase program (**€930.7 million** outflow) and a special cash dividend (**€484.3 million** outflow)[251](index=251&type=chunk)[252](index=252&type=chunk) - Future cash commitments for the remainder of 2022 include **€30.7 million** for CMO purchase obligations and **€10.6 million** for lease payments[269](index=269&type=chunk) [Risk Factors](index=71&type=section&id=Risk%20Factors) The company faces extensive risks, including heavy dependence on uncertain COVID-19 vaccine revenues, intense competition, adverse events, adaptation challenges, and complexities across its mRNA development, manufacturing, intellectual property, regulatory, and financial operations - A summary of key risks includes: - Heavy dependence on uncertain future revenues from the COVID-19 vaccine - Potential for unsuccessful adaptation of the vaccine to new variants - Significant competition from other COVID-19 vaccine makers - Risks of adverse events during clinical trials or post-approval - Challenges to intellectual property rights from other companies - Fluctuations in operating results and potential need for substantial additional financing - Risks associated with novel mRNA drug development and manufacturing complexities[275](index=275&type=chunk)

BioNTech SE (NASDAQ:BNTX) Q2 2022 Earnings Conference Call August 8, 2022 8:00 AM ET Company Participants Sylke Maas - Vice President, Investor Relations and Strategy Ugur Sahin - Chief Executive Officer and Co-Founder Ozlem Tureci - Chief Medical Officer and Co-Founder Jens Holstein - Chief Financial Officer Ryan Richardson - Chief Strategy Officer Conference Call Participants Matthew Harrison - Morgan Stanley Tazeen Ahmad - Bank of America Daina Graybosch - SVB Securities Zhiqiang Shu - Berenberg Operator ...

[Cover Information](index=1&type=section&id=Exhibit%2099.1) [Unaudited Interim Condensed Consolidated Financial Statements](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Interim Condensed Consolidated Statements of Profit or Loss](index=3&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Profit%20or%20Loss) 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](index=4&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) 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](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) 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](index=8&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) 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](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=12&type=section&id=Selected%20Explanatory%20Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [1 Corporate Information](index=12&type=section&id=1%20Corporate%20Information) 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](index=20&type=chunk)[21](index=21&type=chunk) - In February 2022, BioNTech Innovation GmbH was established as a wholly-owned subsidiary of BioNTech SE[22](index=22&type=chunk) - 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](index=23&type=chunk) [2 Basis of Preparation, Significant Accounting Policies and Further Accounting Topics](index=12&type=section&id=2%20Basis%20of%20Preparation,%20Significant%20Accounting%20Policies%20and%20further%20Accounting%20Topics) 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](index=25&type=chunk)[32](index=32&type=chunk) - 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](index=29&type=chunk)[31](index=31&type=chunk) - 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](index=35&type=chunk)[182](index=182&type=chunk) - 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](index=36&type=chunk)[38](index=38&type=chunk) [3 Revenues from Contracts with Customers](index=15&type=section&id=3%20Revenues%20from%20Contracts%20with%20Customers) 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](index=39&type=chunk)[188](index=188&type=chunk) - 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](index=39&type=chunk)[188](index=188&type=chunk) - 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](index=47&type=chunk) [4 Income and Expenses](index=17&type=section&id=4%20Income%20and%20Expenses) 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](index=17&type=section&id=4.1%20Cost%20of%20Sales) 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](index=49&type=chunk)[195](index=195&type=chunk) - 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](index=195&type=chunk) [4.2 Research and Development Expenses](index=17&type=section&id=4.2%20Research%20and%20Development%20Expenses) 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](index=50&type=chunk)[197](index=197&type=chunk) - 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](index=197&type=chunk) [4.3 General and Administrative Expenses](index=19&type=section&id=4.3%20General%20and%20Administrative%20Expenses) 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](index=52&type=chunk)[199](index=199&type=chunk) - 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](index=199&type=chunk) [4.4 Other Operating Expenses](index=19&type=section&id=4.4%20Other%20Operating%20Expenses) 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](index=53&type=chunk)[201](index=201&type=chunk) [4.5 Other Operating Income](index=19&type=section&id=4.5%20Other%20Operating%20Income) 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](index=54&type=chunk)[201](index=201&type=chunk) - Government grants recognized in the prior period did not recur in the corresponding period of 2022[201](index=201&type=chunk) [4.6 Finance Income](index=20&type=section&id=4.6%20Finance%20Income) 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](index=56&type=chunk)[57](index=57&type=chunk)[203](index=203&type=chunk) [4.7 Finance Expenses](index=20&type=section&id=4.7%20Finance%20Expenses) 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](index=58&type=chunk)[203](index=203&type=chunk) [5 Income Tax](index=20&type=section&id=5%20Income%20Tax) 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](index=59&type=chunk)[204](index=204&type=chunk) - 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](index=59&type=chunk)[206](index=206&type=chunk) [6 Financial Assets and Financial Liabilities](index=21&type=section&id=6%20Financial%20Assets%20and%20Financial%20Liabilities) 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](index=65&type=chunk) - 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](index=67&type=chunk)[68](index=68&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) - 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](index=73&type=chunk) [7 Inventories](index=24&type=section&id=7%20Inventories) 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](index=79&type=chunk) [8 Issued Capital and Reserves](index=25&type=section&id=8%20Issued%20Capital%20and%20Reserves) 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](index=81&type=chunk) - 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](index=82&type=chunk) - 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](index=83&type=chunk)[229](index=229&type=chunk) - In June 2022, the Annual General Meeting approved a special cash dividend of **€2.00** per share, totaling **€484.3 million** paid out[84](index=84&type=chunk)[230](index=230&type=chunk) [9 Share-Based Payments](index=26&type=section&id=9%20Share-Based%20Payments) 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](index=91&type=chunk) - 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](index=93&type=chunk) [10 Provisions and Contingencies](index=29&type=section&id=10%20Provisions%20and%20Contingencies) 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](index=99&type=chunk)[212](index=212&type=chunk) - 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](index=100&type=chunk) - The company faces patent infringement lawsuits filed by Alnylam Pharmaceuticals, Inc. concerning cationic lipids used in the COMIRNATY vaccine, and has filed counterclaims[103](index=103&type=chunk)[104](index=104&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) - 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](index=107&type=chunk)[219](index=219&type=chunk) - 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](index=105&type=chunk)[108](index=108&type=chunk)[218](index=218&type=chunk)[220](index=220&type=chunk) [11 Related Party Disclosures](index=30&type=section&id=11%20Related%20Party%20Disclosures) 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](index=109&type=chunk) - 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](index=109&type=chunk)[207](index=207&type=chunk) [12 Events After the Reporting Period](index=30&type=section&id=12%20Events%20after%20the%20Reporting%20Period) 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](index=110&type=chunk) [Operating and Financial Review and Prospects](index=31&type=section&id=Operating%20and%20Financial%20Review%20and%20Prospects) [Operating Results](index=31&type=section&id=Operating%20Results) 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](index=31&type=section&id=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](index=113&type=chunk) - 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](index=114&type=chunk) - 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](index=117&type=chunk)[118](index=118&type=chunk) - The company plans to strengthen its technology platforms and digital capabilities through strategic collaborations and acquisitions, and enhance its infrastructure and manufacturing capabilities[119](index=119&type=chunk) [Corporate Development](index=32&type=section&id=Corporate%20Development) - 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](index=121&type=chunk) - 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](index=121&type=chunk) - 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](index=121&type=chunk) - 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](index=121&type=chunk) [Key Pipeline Updates](index=33&type=section&id=Key%20Pipeline%20Updates) [Infectious Diseases](index=33&type=section&id=Infectious%20Diseases) 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](index=34&type=section&id=COVID-19%20Vaccine%20Program%20%E2%80%93%20BNT162) 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](index=34&type=section&id=Commercial%20updates) - 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](index=129&type=chunk) - 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](index=129&type=chunk) - 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](index=131&type=chunk) - BioNTech and Pfizer have delivered over **1.5 billion** doses of the COVID-19 vaccine to low- and middle-income countries[131](index=131&type=chunk) - 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](index=131&type=chunk) - 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](index=131&type=chunk) [Manufacturing Updates](index=36&type=section&id=Manufacturing%20updates) - 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](index=132&type=chunk) [Clinical Development and Regulatory Updates](index=36&type=section&id=Clinical%20development%20and%20regulatory%20updates) - 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](index=133&type=chunk) - In June 2022, the U.S. FDA revised the EUA to authorize BNT162b2 for use in children aged 6 months to 4 years[133](index=133&type=chunk) - In July 2022, the U.S. FDA approved the sBLA, expanding the license for BNT162b2 to include individuals aged 12-15 years[133](index=133&type=chunk) - 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](index=135&type=chunk) - Preclinical studies demonstrated that the Omicron BA.4/5-adapted vaccine candidate significantly increased neutralizing responses against all Omicron sublineages[135](index=135&type=chunk) - The company plans to initiate a clinical trial for an Omicron BA.4/5-adapted bivalent vaccine in August 2022[135](index=135&type=chunk) - In July 2022, an application for an Omicron BA.1-based bivalent COVID-19 vaccine was submitted to the EMA[135](index=135&type=chunk) - 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](index=137&type=chunk) [Additional Infectious Disease Programs](index=39&type=section&id=Additional%20Infectious%20Disease%20Programs) 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](index=39&type=section&id=Influenza%20Vaccine%20Program) - 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](index=140&type=chunk) - 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](index=140&type=chunk) - 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](index=140&type=chunk) [Shingles Vaccine Program](index=39&type=section&id=Shingles%20Vaccine%20Program) - 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](index=141&type=chunk) [HSV 2 Vaccine Program – BNT163](index=39&type=section&id=HSV%202%20Vaccine%20Program%20%E2%80%93%20BNT163) - 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](index=142&type=chunk) [Tuberculosis Vaccine Program – BNT164](index=39&type=section&id=Tuberculosis%20Vaccine%20Program%20%E2%80%93%20BNT164) - 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](index=143&type=chunk) [Malaria Vaccine Program – BNT165](index=40&type=section&id=Malaria%20Vaccine%20Program%20%E2%80%93%20BNT165) - Clinical trials for the malaria vaccine candidate BNT165 are planned to start in the second half of 2022 or early 2023[145](index=145&type=chunk) [Research Collaboration with University of Pennsylvania](index=40&type=section&id=Research%20Collaboration%20with%20University%20of%20Pennsylvania) - The collaboration with the University of Pennsylvania aims to develop and commercialize up to **10** prophylactic mRNA immunotherapies for infectious disease indications[146](index=146&type=chunk) [Oncology](index=40&type=section&id=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](index=40&type=section&id=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](index=152&type=chunk) - 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](index=155&type=chunk) - 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](index=155&type=chunk) - 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](index=156&type=chunk) [Individualized Neoantigen Specific Immunotherapies, or iNeST](index=41&type=section&id=Individualized%20Neoantigen%20Specific%20Immunotherapies,%20or%20iNeST) 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](index=159&type=chunk)[160](index=160&type=chunk) - 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](index=162&type=chunk) - 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](index=162&type=chunk) [mRNA Intratumoral Immunotherapy](index=42&type=section&id=mRNA%20Intratumoral%20Immunotherapy) 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](index=163&type=chunk) [RiboCytokines](index=42&type=section&id=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](index=165&type=chunk) - 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](index=165&type=chunk) [RiboMabs](index=42&type=section&id=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](index=169&type=chunk) - 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](index=169&type=chunk) [CAR-T Cell Immunotherapy](index=44&type=section&id=CAR-T%20Cell%20Immunotherapy) 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](index=170&type=chunk) - Preliminary efficacy data show a disease control rate of **86%** and an overall response rate of **43%**, with a favorable safety profile[170](index=170&type=chunk) - In June 2022, the EMA granted Priority Medicines (PRIME) designation to BNT211 for the treatment of testicular germ cell tumors[170](index=170&type=chunk) - Further data updates from the Phase 1/2 trial are expected in the second half of 2022[170](index=170&type=chunk) [Neoantigen-Targeting T Cell Therapy](index=44&type=section&id=Neoantigen-Targeting%20T%20Cell%20Therapy) 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](index=171&type=chunk) [Next-Generation Immunomodulators](index=45&type=section&id=Next-Generation%20Immunomodulators) 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](index=174&type=chunk) - 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](index=174&type=chunk) - 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](index=175&type=chunk) [Targeted Cancer Antibodies](index=45&type=section&id=Targeted%20Cancer%20Antibodies) 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](index=176&type=chunk) [Small Molecule Immunomodulators](index=45&type=section&id=Small%20Molecule%20Immunomodulators) 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](index=177&type=chunk) [Rare Disease

BioNTech SE (NASDAQ:BNTX) Q1 2022 Earnings Conference Call May 9, 2022 8:00 AM ET Company Participants Sylke Maas - VP, IR and Business Strategy Ugur Sahin - Co-Founder & CEO Ozlem Tureci - Co-Founder & Chief Medical Officer Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Matthew Harrison - Morgan Stanley Cory Kasimov - JPMorgan Chase & Co. Christopher Zopf - Goldman Sachs Group Akash Tewari - Jefferies Zhiqiang Shu - Berenberg Daina Graybosch - SVB Leerink Operator ...