Financial Data and Key Metrics Changes - The company reported total revenues of approximately EUR188 million for Q1 2024, a significant decrease from approximately EUR1.3 billion in Q1 2023 [95] - The loss per share for Q1 2024 was EUR1.31, compared to a diluted profit per share of EUR2.05 in the prior year [40] - The net loss for Q1 2024 was EUR315 million, compared to a net profit of approximately EUR502 million for the same period last year [97] Business Line Data and Key Metrics Changes - Research and development expenses increased to EUR508 million in Q1 2024 from EUR334 million in the prior year, primarily due to advancing clinical studies in the oncology pipeline [96] - Sales and marketing expenses were EUR16 million in Q1 2024, up from EUR12 million in the prior year [117] Market Data and Key Metrics Changes - The company expects to recognize approximately 90% of its full-year revenues in the last month of 2024, mostly in Q4 [118] - The company maintained a strong financial position with EUR16.9 billion in total cash and security investments at the end of the quarter [116] Company Strategy and Development Direction - The company aims to have over 10 pivotal trials running by the end of 2024, focusing on oncology products expected to reach the market by 2026 [40][122] - The strategy includes building a global commercialization team to support multiple oncology launches beginning in 2026 [60][82] - The company is focused on clinical execution this year while remaining open to synergistic assets for potential partnerships [32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the oncology pipeline, with multiple product launches anticipated [5][6] - The company is entering a catalyst-rich period with data updates expected from various product candidates across different classes [121] - Management highlighted the importance of improving capabilities to execute clinical trials effectively [26] Other Important Information - The company is preparing to launch a variant-adapted COVID-19 vaccine in over 80 geographies worldwide, with regulatory approvals expected in late July and August [50] - The company plans to present new clinical data at the upcoming ASCO conference, including updates on various oncology programs [114] Q&A Session Summary Question: What data should be expected at ASCO for the Genmab compound? - The company plans to present data for around 100 patients in the second-line non-small cell lung cancer trial with BNT311 [103] Question: What is the plan moving forward with the oncology pipeline? - The focus this year is on clinical execution, with an emphasis on synergistic assets and partnerships to enhance growth [32] Question: Can you recap a hypothetical list of the 10 potentially registrational trials? - The company is evaluating multiple scenarios and will provide updates on specific trials as they progress [132]

Financial Performance - Net cash used in operating activities for Q1 2024 was €317.3 million, with a loss before tax of €331.8 million[4]. - The company reported a loss of €315.1 million for the three months ended March 31, 2024, compared to a profit of €502.2 million for the same period in 2023[71]. - Revenues for the three months ended March 31, 2024, were €187.6 million, a decrease of 85.3% compared to €1,277.0 million for the same period in 2023[91]. - COVID-19 vaccine revenues for Q1 2024 were €124.2 million, a significant decrease of 90.2% compared to €1,263.5 million in Q1 2023[136]. - The operating loss for the three months ended March 31, 2024, was €507.2 million, compared to an operating income of €654.4 million for the same period in 2023[91]. - The comprehensive loss for the period, net of tax, was €292.8 million for the three months ended March 31, 2024[94]. - Basic earnings per share for the three months ended March 31, 2024, were €(1.31), compared to €2.07 for the same period in 2023[91]. Cash Flow and Assets - The net cash flows used in operating activities amounted to €317.3 million for the current period, a decrease from €677.4 million in the previous year[71]. - The company reported a decrease in cash and cash equivalents to €8,976.6 million as of March 31, 2024, down from €12,143.9 million a year earlier[71]. - Total cash outflow for Q1 2024 was €2,629.5 million, compared to €1,704.1 million in Q1 2023, indicating an increase of 54.3%[126]. - As of March 31, 2024, total assets decreased to €22,256.8 million from €23,006.3 million as of December 31, 2023, reflecting a decline of approximately 3.2%[118]. - Total equity decreased to €19,968.2 million as of March 31, 2024, down from €20,245.9 million at the end of 2023, a decline of approximately 1.4%[118]. - Cash and cash equivalents decreased to €8,976.6 million as of March 31, 2024, from €11,663.7 million as of December 31, 2023, a decline of 23.1%[118]. Research and Development - The company plans to invest heavily in research and development to diversify its therapeutic area footprint and enhance capabilities through acquisitions and technologies[65]. - Research and development expenses increased to €507.5 million for the three months ended March 31, 2024, compared to €334.0 million for the same period in 2023, reflecting a 52% increase[91]. - The company incurred significant losses and negative cash flows from operations primarily due to high research and development expenses and investments in manufacturing capabilities[82]. - The company has entered into various agreements for research and development, including collaborations with universities and contract research organizations[7]. Market Dynamics and Competition - Demand for the COVID-19 vaccine is expected to decrease in the near future, impacting revenue heavily reliant on vaccine sales[10]. - The ability to generate revenue from the COVID-19 vaccine is uncertain due to unpredictable market dynamics and variant developments[40]. - The company faces intense competition from other COVID-19 vaccines and potential pricing pressures from governmental authorities[16]. - The company faces high barriers to market entry due to intense downward pressure on healthcare costs and pricing controls in various jurisdictions[56]. Regulatory and Legal Challenges - Significant adverse events during clinical trials could delay or prevent regulatory approval of product candidates[11]. - The company is actively seeking marketing approvals and reimbursement for its product candidates, indicating a focus on regulatory strategies[127]. - The company continues to face legal challenges regarding its intellectual property rights, which may impact its operational strategies and financial outlook[139]. - The company is currently involved in various contingencies, including intellectual property disputes and product liability claims, but does not believe these will have a material adverse effect on its financial position[197]. Future Outlook - Future funding requirements will depend on research results, regulatory compliance costs, and manufacturing expansion[8]. - The financial condition and operating results are expected to fluctuate significantly, making future results difficult to predict[12]. - The company’s future financial results will depend on the success of its commercial products and its ability to obtain funding through various means[83]. - The company may face challenges in obtaining adequate coverage and reimbursement from third-party payors, impacting product marketability[33]. - The enactment of the IRA in August 2022 is expected to reduce prices and reimbursement for the company's products in the U.S.[57].

BioNTech SE (NASDAQ:BNTX) Q4 2023 Earnings Conference Call March 20, 2024 8:00 AM ET Company Participants Victoria Meissner - VP, Strategy and IR Ugur Sahin - Co-Founder and CEO Ozlem Tureci - Chief Medical Officer and Co-Founder Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Daina Graybosch - Leerink Partners Bill Maughan - Canaccord Ivy Wang - Jefferies Yaron Werber - TD Cowen Etzer Darout - BMO Capital Jessica Fye - JPMorgan Simon Baker - Redburn Sara Vernizzi - ...

FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered or to be registered, pursuant to Section 12(b) of the Act | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each excha ...

Financial Performance - Total revenues for Q4 2023 were €1,479.0 million, a decrease of 65.4% compared to €4,278.3 million in Q4 2022. For the full year 2023, total revenues were €3,819.0 million, down 78.0% from €17,310.6 million in 2022[20]. - Net profit for Q4 2023 was €457.9 million, a decline of 80.0% from €2,278.7 million in Q4 2022. For the full year 2023, net profit was €930.3 million, down 90.2% from €9,434.4 million in 2022[7]. - Diluted earnings per share for Q4 2023 were €1.90, compared to €9.26 in Q4 2022, representing a decrease of 79.5%. For the full year 2023, diluted earnings per share were €3.83, down 89.9% from €37.77 in 2022[8]. - Operating profit for the three months ended December 31, 2023, was €457.9 million, compared to €205.3 million for the same period in 2022, representing a 122% increase[96]. - Profit before tax for the three months ended December 31, 2023, was €663.2 million, down from €3,172.6 million in the same period of 2022, indicating a significant decline[96]. Research and Development - Research and development (R&D) expenses for Q4 2023 were €577.8 million, an increase of 13.3% from €509.8 million in Q4 2022. For the full year 2023, R&D expenses were €1,783.1 million, up 15.9% from €1,537.0 million in 2022[22]. - BioNTech aims to achieve product approvals in ten oncological indications by 2030, with plans for ten or more potentially registrational oncology trials running by the end of 2024[19]. - The company has 10 ongoing Phase 2 and 3 trials in its oncology pipeline, with plans for its first oncology launch in 2026 and aims for ten indication approvals by 2030[56]. - A pivotal Phase 2 clinical trial in relapsed/refractory germ cell tumors is planned to start in 2024[41]. - BioNTech initiated three first-in-human Phase 1 clinical trials for vaccine candidates addressing shingles, tuberculosis, and mpox in 2023[68]. Cash and Investments - Cash and cash equivalents, along with security investments, reached €17.7 billion as of December 31, 2023, comprising €11.7 billion in cash and €6.0 billion in security investments[24]. - Cash and cash equivalents as of December 31, 2023, were €11,663.7 million, down from €13,875.1 million at the end of the previous year[97]. - The company reported finance income of €162.2 million in Q4 2023, a significant increase from €38.8 million in Q4 2022[78]. - Net cash flows from operating activities for the three months ended December 31, 2023, were €850.9 million, slightly up from €829.2 million in the previous year[96]. - Net cash flows used in investing activities for the three months ended December 31, 2023, were €(2,695.1) million, compared to €(161.0) million in the same period of 2022[97]. Strategic Partnerships and Collaborations - The company delivered over 400 million COVID-19 vaccine doses worldwide in 2023, including the XBB.1.5 variant-adapted monovalent COVID-19 vaccine[15]. - BioNTech's collaboration with Pfizer is crucial for revenue generation, with potential impacts from inventory write-downs by Pfizer affecting BioNTech's revenues[52]. - BioNTech aims to reach up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030 through a partnership with the UK government[69]. - The company has established a multi-year partnership with the State of Victoria, Australia, to set up a clinical-scale mRNA manufacturing facility and an mRNA Innovation Center in Melbourne[69]. Corporate Governance and ESG - BioNTech's ESG rating from ISS is "Prime" with an overall corporate rating of B-, placing it among the top 10% of rated companies in the pharmaceutical sector[46]. - BioNTech's near-term science-based emissions reduction targets have been approved by the Science Based Targets initiative, aligning with the UN's Paris Climate Agreement[72]. Future Outlook - The 2024 revenue guidance is set between €2.5 billion and €3.1 billion, with R&D expenses projected at €2.4 billion to €2.6 billion[11]. - BioNTech expects group revenue for the full 2024 financial year to be in the range of €2.5 - €3.1 billion, reflecting various assumptions including COVID-19 vaccine uptake and regulatory approvals[52]. - The company plans to invest in a research and development hub in Cambridge, UK, which is expected to employ over 70 additional scientists[69]. Acquisitions and Enhancements - The acquisition of InstaDeep Ltd added approximately 290 skilled professionals to BioNTech, enhancing its capabilities in AI and ML technologies[69]. - The company completed construction of its first proprietary plasmid DNA manufacturing facility in Marburg, Germany, enhancing its production capabilities[44].

BioNTech SE (NASDAQ:BNTX) Q3 2023 Earnings Call Transcript November 8, 2023 8:00 AM ET Company Participants Victoria Meissner - VP, Strategy & IR Ugur Sahin - Co-Founder & CFO Ozlem Tureci - Chief Medical Officer & Co-Founder Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Daina Graybosch - Leerink Partners Tazeen Ahmad - Bank of America Chris Shibutani - Goldman Sachs Yaron Werber - TD Cowen Jessica Fye - JPMorgan Bill Maughan - Canaccord Genuity Simon Baker - Redb ...

BA.2.86 remains low worldwide Growing dominance of the XBB-descendent EG.5.1 XBB.1.5-adapted monovalent vaccine elicits potent neutralization against various sublineages: XBB.1.5, EG.5.1, BA.2.86, XBB.1.16 and XBB.2.3 1. Partnered with Pfizer. 2.COMIRNATY approved for prevention of COVID-19 as a single dose for individuals 5 years of age and older and as a 3-dose series in individuals 6 months through 4 years of age. 3. COMIRNATY may be administered as a booster in people aged 12 years and older who have re ...

[Unaudited Interim Condensed Consolidated Financial Statements](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Interim Condensed Consolidated Statements of Profit or Loss](index=4&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Profit%20or%20Loss) The company's Q3 and YTD 2023 financial performance significantly declined, with total revenues sharply decreasing and diluted EPS falling to **€0.67** for Q3 and **€1.94** YTD Q3 & YTD 2023 vs 2022 Profit or Loss (in millions €) | Financial Metric | Q3 2023 (unaudited) | Q3 2022 (unaudited) | YTD Q3 2023 (unaudited) | YTD Q3 2022 (unaudited) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | 895.3 | 3,461.2 | 2,340.0 | 13,032.3 | | **Operating Income** | 73.1 | 2,387.5 | 164.2 | 9,349.8 | | **Profit for the period** | 160.6 | 1,784.9 | 472.4 | 7,155.7 | | **Diluted EPS (€)** | 0.67 | 6.98 | 1.94 | 27.70 | [Interim Condensed Consolidated Statements of Comprehensive Income](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) The company reported a net other comprehensive loss for Q3 and YTD 2023, resulting in total comprehensive income for Q3 2023 of **€152.0 million**, a steep decline from **€1,795.8 million** in Q3 2022 Comprehensive Income Summary (in millions €) | Metric | Q3 2023 (unaudited) | Q3 2022 (unaudited) | YTD Q3 2023 (unaudited) | YTD Q3 2022 (unaudited) | | :--- | :--- | :--- | :--- | :--- | | **Profit for the period** | 160.6 | 1,784.9 | 472.4 | 7,155.7 | | **Other comprehensive income/(loss)** | (8.6) | 10.9 | (0.8) | 24.3 | | **Comprehensive income for the period** | 152.0 | 1,795.8 | 471.6 | 7,180.0 | [Interim Condensed Consolidated Statements of Financial Position](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) As of September 30, 2023, total assets decreased to **€22.21 billion** from **€23.28 billion** at year-end 2022, driven by a sharp reduction in current trade and other receivables Statement of Financial Position (in millions €) | Item | Sep 30, 2023 (unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | 22,207.2 | 23,279.1 | | Total Non-Current Assets | 3,458.1 | 1,357.1 | | Total Current Assets | 18,749.1 | 21,922.0 | | **Total Equity** | 19,866.8 | 20,055.6 | | **Total Liabilities** | 2,340.4 | 3,223.5 | | **Total Equity and Liabilities** | 22,207.2 | 23,279.1 | - Key changes in assets include a significant increase in non-current intangible assets (from **€158.5 million** to **€665.5 million**) and other financial assets (from **€80.2 million** to **€1,292.7 million**), while current trade and other receivables decreased sharply (from **€7,145.6 million** to **€2,002.0 million**)[1](index=1&type=chunk) [Interim Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Total equity decreased from **€20.06 billion** at the start of 2023 to **€19.87 billion** by September 30, primarily due to a **€738.5 million** share repurchase program offsetting period profit Changes in Equity for Nine Months Ended Sep 30, 2023 (in millions €) | Description | Amount | | :--- | :--- | | **Equity as of Jan 1, 2023** | **20,055.6** | | Profit for the period | 472.4 | | Other comprehensive loss | (0.8) | | Share repurchase program | (738.5) | | Share-based payments | 5.2 | | Treasury shares used for acquisition | 103.7 | | Current and deferred taxes | (30.8) | | **Equity as of Sep 30, 2023** | **19,866.8** | [Interim Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities for the nine months ended September 30, 2023, significantly decreased to **€4.52 billion**, leading to a net decrease in cash and cash equivalents of **€504.6 million** Cash Flow Summary for Nine Months Ended Sep 30 (in millions €) | Cash Flow Activity | 2023 (unaudited) | 2022 (unaudited) | | :--- | :--- | :--- | | **Net cash from operating activities** | 4,520.5 | 12,748.2 | | **Net cash from / (used in) investing activities** | (4,259.4) | 125.7 | | **Net cash used in financing activities** | (765.7) | (1,354.6) | | **Net increase / (decrease) in cash** | (504.6) | 11,519.3 | | **Cash and cash equivalents at end of period** | 13,495.8 | 13,423.7 | [Selected Explanatory Notes to the Unaudited Interim Condensed Consolidated Financial Statements](index=13&type=section&id=Selected%20Explanatory%20Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Corporate Information](index=13&type=section&id=1%20Corporate%20Information) BioNTech SE is a German-incorporated global immunotherapy company pioneering novel medicines for cancer and infectious diseases by harnessing the immune system through diverse technology platforms - BioNTech SE is a limited company incorporated and domiciled in Mainz, Germany[31](index=31&type=chunk) - The company is a next-generation immunotherapy company focused on developing novel medicines against cancer, infectious diseases, and other serious diseases by harnessing the power of the immune system[63](index=63&type=chunk) [Basis of Preparation and Significant Accounting Policies](index=13&type=section&id=2%20Basis%20of%20Preparation%2C%20Significant%20Accounting%20Policies%20and%20further%20Accounting%20Topics) The interim financial statements were prepared under **IAS 34**, consistent with 2022 policies, except for a Q2 2023 change in estimate to capitalize pre-launch Comirnaty inventory - The financial statements have been prepared in accordance with International Accounting Standard (IAS) 34 Interim Financial Reporting[64](index=64&type=chunk) - Beginning in Q2 2023, the company changed its accounting estimate for pre-launch Comirnaty product inventory, which now meets the criteria for capitalization as an asset under IFRS. This change is treated as a change in estimate[66](index=66&type=chunk) - The preparation of financial statements requires management to make judgments and estimates, particularly in determining the share of gross profits from collaboration partners, which may be based on preliminary data[48](index=48&type=chunk) [Revenues from Contracts with Customers](index=14&type=section&id=3%20Revenues%20from%20Contracts%20with%20Customers) Total revenues for Q3 2023 significantly decreased to **€895.3 million** from **€3,461.2 million** in Q3 2022, driven by lower COVID-19 vaccine demand and reduced gross profit share from Pfizer Disaggregated Revenue (in millions €) | Revenue Category | Q3 2023 | Q3 2022 | YTD Q3 2023 | YTD Q3 2022 | | :--- | :--- | :--- | :--- | :--- | | **Commercial Revenues** | **893.7** | **3,394.8** | **2,336.6** | **12,923.3** | | COVID-19 Vaccine Revenues | 885.0 | 3,378.1 | 2,306.7 | 12,883.9 | | *Share of partners' gross profit* | *707.0* | *2,554.2* | *1,916.9* | *9,128.4* | | *Direct product sales* | *195.7* | *564.5* | *260.9* | *2,284.6* | | **R&D Revenues** | **1.6** | **66.4** | **3.4** | **109.0** | | **Total Revenues** | **895.3** | **3,461.2** | **2,340.0** | **13,032.3** | - The decrease in commercial revenues corresponds with lower COVID-19 vaccine market demand. Write-downs by collaboration partner Pfizer significantly reduced the gross profit share, negatively impacting revenues for Q3 2023[9](index=9&type=chunk) [Income and Expenses](index=17&type=section&id=4%20Income%20and%20Expenses) Q3 2023 saw cost of sales decrease to **€161.8 million** in line with lower revenues, while R&D expenses increased to **€497.9 million** due to advancing clinical studies, and finance income rose significantly Key Income and Expense Items (in millions €) | Item | Q3 2023 | Q3 2022 | YTD Q3 2023 | YTD Q3 2022 | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | (161.8) | (752.8) | (420.7) | (2,811.5) | | R&D Expenses | (497.9) | (341.8) | (1,205.3) | (1,027.2) | | G&A Expenses | (144.5) | (141.0) | (386.6) | (361.8) | | Finance Income | 156.3 | 60.9 | 363.2 | 448.5 | - R&D expenses for the nine months ended Sep 30, 2023, increased to **€1,205.3 million** from **€1,027.2 million** in the prior year, primarily due to higher purchased services[57](index=57&type=chunk)[74](index=74&type=chunk) - Finance income for Q3 2023 was **€156.3 million**, a significant increase from **€60.9 million** in Q3 2022, mainly driven by interest income from debt security investments and fair value adjustments of money market funds[232](index=232&type=chunk)[247](index=247&type=chunk) [Business Combination](index=19&type=section&id=5%20Business%20Combination) In July 2023, BioNTech acquired AI company InstaDeep Ltd. for **€517.5 million**, recognizing **€306.5 million** in goodwill to build AI-driven drug discovery capabilities - The acquisition of InstaDeep Ltd. was completed in July 2023 to build capabilities in AI-driven drug discovery and development[249](index=249&type=chunk) InstaDeep Acquisition Consideration (in millions €) | Consideration Component | Fair Value | | :--- | :--- | | Cash paid | 358.1 | | Cash to be paid in 2024 | 4.0 | | Designated FX-Hedge | (8.1) | | Shares transferred | 103.7 | | Contingent consideration | 31.8 | | Previously-held equity investment | 27.9 | | **Total Consideration** | **517.5** | - The acquisition resulted in the recognition of **€187.6 million** in intangible assets (primarily DeepChain technology) and **€306.5 million** in goodwill[235](index=235&type=chunk)[251](index=251&type=chunk) [Income Taxes](index=22&type=section&id=6%20Income%20Taxes) The effective income tax rate for the nine months ended September 30, 2023, significantly decreased to **9.7%** from **26.8%** in 2022, primarily due to deferred tax effects from an internal IP reorganization - The effective income tax rate for the nine months ended Sep 30, 2023, was **9.7%**, down from **26.8%** in the prior-year period[238](index=238&type=chunk) - The decrease in the effective tax rate was primarily due to a reorganization of intellectual property rights within the group, effective June/July 2023, which led to the recognition of deferred tax assets in Germany, the US, and Austria[238](index=238&type=chunk)[255](index=255&type=chunk) - Following the IP reorganization, the company determined it is highly probable that future taxable profits will be available in the U.S., allowing for the recognition of previously unrecognized U.S. federal and state deferred tax assets[255](index=255&type=chunk) [Financial Assets and Financial Liabilities](index=23&type=section&id=8%20Financial%20Assets%20and%20Financial%20Liabilities) As of September 30, 2023, total financial assets (excluding cash) decreased to **€5.55 billion** from **€7.42 billion** at year-end 2022, while total financial liabilities decreased to **€784.7 million** from **€1.21 billion** - Trade and other receivables decreased significantly to **€2.0 billion** as of Sep 30, 2023, from **€7.1 billion** as of Dec 31, 2022. These predominantly comprise trade receivables from the COVID-19 collaboration with Pfizer[240](index=240&type=chunk)[241](index=241&type=chunk) - The company held **€3.47 billion** in security investments as of Sep 30, 2023, which were not held at the end of 2022. These are measured at amortized cost[240](index=240&type=chunk)[287](index=287&type=chunk) - Other financial liabilities at amortized cost, which mainly include obligations from license agreements for COVID-19 vaccine sales, decreased from **€785.1 million** to **€296.6 million**[288](index=288&type=chunk)[290](index=290&type=chunk) [Issued Capital and Reserves](index=26&type=section&id=10%20Issued%20Capital%20and%20Reserves) As of September 30, 2023, BioNTech had **237.7 million** shares outstanding and completed two share repurchase programs in 2023, including a new **$0.5 billion** program 2023 Share Repurchase Program Summary | Program | Period | ADSs Purchased | Avg. Price per ADS | Net Amount Spent | | :--- | :--- | :--- | :--- | :--- | | **2022 Program (2nd Tranche)** | Jan-Mar 2023 | 2,221,171 | - | $302.1 million | | **2023 Program** | Jun-Sep 2023 | 4,646,965 | $107.58 | $500.0 million | [Contingencies](index=29&type=section&id=12%20Contingencies) The company is involved in multiple significant intellectual property disputes and patent infringement lawsuits related to its COVID-19 vaccine, Comirnaty, with uncertain outcomes and no provisions recorded - BioNTech is a defendant in multiple patent infringement lawsuits concerning its COVID-19 vaccine, Comirnaty[275](index=275&type=chunk) - - **Alnylam Proceedings:** Lawsuits in the U.S. alleging infringement of patents related to cationic lipids used in Comirnaty[300](index=300&type=chunk) - **CureVac Proceedings:** Lawsuits in Germany, the U.S., and the U.K. alleging infringement of patents and utility models related to mRNA technology[279](index=279&type=chunk)[316](index=316&type=chunk) - **Moderna Proceedings:** Lawsuits in Germany, the U.K., the U.S., and other European countries alleging infringement of patents related to mRNA technology[318](index=318&type=chunk)[319](index=319&type=chunk) - **Arbutus and Genevant Proceedings:** A lawsuit in the U.S. alleging infringement of patents related to lipid nanoparticle technology[325](index=325&type=chunk) - The company believes it has strong defenses but considers the outcomes substantially uncertain. No provisions have been recognized, and these matters are treated as contingent liabilities for which a reliable estimate of loss is not currently possible[277](index=277&type=chunk)[306](index=306&type=chunk)[324](index=324&type=chunk) [Events after the Reporting Period](index=33&type=section&id=14%20Events%20after%20the%20Reporting%20Period) After Q3, BioNTech entered two strategic collaborations, including a **$70 million** upfront deal with MediLink Therapeutics for an ADC candidate and a **$55 million** upfront deal with Biotheus Inc. for a bispecific antibody - On October 11, 2023, BioNTech signed a strategic collaboration and license agreement with MediLink Therapeutics to develop a next-generation ADC candidate against HER3. The deal includes a **$70 million** upfront payment and potential milestones over **$1 billion**[343](index=343&type=chunk) - On October 26, 2023, BioNTech signed an exclusive global license and collaboration agreement with Biotheus Inc. to develop, manufacture, and commercialize PM8002, a bispecific antibody targeting PD-L1 and VEGF. The agreement includes a **$55 million** upfront payment[330](index=330&type=chunk) [Operating and Financial Review and Prospects](index=35&type=section&id=Operating%20and%20Financial%20Review%20and%20Prospects) [Overview](index=35&type=section&id=Overview) BioNTech is a next-generation immunotherapy company focused on developing novel cancer and infectious disease therapies, leveraging diverse technology platforms and a robust pipeline, including Comirnaty - The company's vision is to harness the power of the immune system to develop novel therapies against cancer and infectious diseases, utilizing a broad toolkit of technology platforms[332](index=332&type=chunk) - - **Strategic Focus:** Developing next-generation COVID-19 vaccines, accelerating the oncology pipeline, and diversifying into new therapeutic areas - **Growth Strategy:** Strengthening technology platforms and digital capabilities through strategic partnerships and acquisitions - **Global Reach:** Building a global development organization and democratizing access to novel medicines [Corporate Development](index=36&type=section&id=Corporate%20Development) During and after Q3 2023, BioNTech completed the InstaDeep acquisition, signed a UK partnership for cancer treatments, expanded an ADC collaboration, appointed a new CLO, and completed its **$0.5 billion** share repurchase program - - **Acquisition:** Completed the acquisition of InstaDeep Ltd. in July 2023 to build world-leading capabilities in AI-driven drug discovery - **Partnerships:** Signed a long-term partnership with the UK government for personalized cancer treatments and expanded its ADC collaboration with DualityBio - **Capital Allocation:** Completed its **$0.5 billion** share repurchase program in September 2023, having repurchased **4.65 million** ADSs - **Management:** Appointed James Ryan, Ph.D. as Chief Legal Officer to the Management Board, effective September 1, 2023 [Pipeline of Product Candidates](index=39&type=section&id=Pipeline%20of%20Product%20Candidates) BioNTech provided updates on its extensive clinical pipeline of over **25** candidates, including progress in oncology trials for BNT111 and BNT122, and regulatory approvals for its Omicron XBB.1.5-adapted COVID-19 vaccine - The company's clinical pipeline includes over **25** clinical stage product candidates and more than **30** research programs across oncology and infectious diseases[332](index=332&type=chunk) - - **Oncology (FixVac):** The Phase 2 trial of BNT111 in advanced melanoma achieved full enrollment in September - **Oncology (iNeST):** The first patient was dosed in a randomized Phase 2 trial of BNT122 in resected pancreatic cancer in October - **Oncology (CAR-T):** Presented encouraging interim data for BNT211 in solid tumors at the 2023 ESMO Annual Meeting, with plans to initiate a pivotal trial in germ cell tumors - **Infectious Disease (COVID-19):** The Omicron XBB.1.5-adapted monovalent vaccine was approved and launched in the U.S., Europe, and other key markets - **Infectious Disease (Combination Vaccine):** Announced positive top-line results from a Phase 1/2 trial of its mRNA-based combination vaccine for influenza and COVID-19, with a pivotal Phase 3 trial expected to start soon [Financial Operations Overview](index=48&type=section&id=Financial%20Operations%20Overview) BioNTech's Q3 and YTD 2023 financial results show a significant downturn from 2022, with total revenues falling **82%** to **€2.34 billion** and profit dropping to **€472.4 million** due to lower vaccine demand and increased R&D expenses YTD 2023 vs YTD 2022 Financial Performance (in millions €) | Metric | YTD Q3 2023 | YTD Q3 2022 | Change (€) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | 2,340.0 | 13,032.3 | (10,692.3) | (82)% | | **Cost of Sales** | 420.7 | 2,811.5 | (2,390.8) | (85)% | | **R&D Expenses** | 1,205.3 | 1,027.2 | 178.1 | 17% | | **G&A Expenses** | 386.6 | 361.8 | 24.8 | 7% | | **Profit for the period** | 472.4 | 7,155.7 | (6,683.3) | (93)% | - The decrease in commercial revenues was in line with lower COVID-19 vaccine market demand. The share of gross profit from collaboration partners fell **79%** for the nine-month period[402](index=402&type=chunk) - Research and development expenses increased by **17%** year-over-year for the nine-month period, mainly influenced by progressing clinical studies for pipeline candidates and the development of next-generation COVID-19 vaccines[173](index=173&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, BioNTech maintained strong liquidity with **€13.5 billion** in cash and **€3.5 billion** in security investments, despite a net cash decrease from operating, investing, and financing activities Cash Flow Summary for Nine Months Ended Sep 30 (in millions €) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | **Operating Activities** | 4,520.5 | 12,748.2 | | **Investing Activities** | (4,259.4) | 125.7 | | **Financing Activities** | (765.7) | (1,354.6) | | **Total Cash Inflow (Outflow)** | (504.6) | 11,519.3 | - The company's capital allocation strategy includes significant and increasing operating expenses to advance its preclinical and clinical programs, invest in technology platforms, and expand manufacturing and commercial capabilities[107](index=107&type=chunk)[496](index=496&type=chunk) - A new share repurchase program of up to **$0.5 billion** was authorized in March 2023 and concluded on September 18, 2023, with **€456.5 million** spent[480](index=480&type=chunk) [Risk Factors](index=69&type=section&id=Risk%20Factors) [Risks Related to COVID-19 Vaccine and Commercialization](index=70&type=section&id=Risks%20Related%20to%20our%20COVID-19%20Vaccine%20and%20the%20Commercialization%20of%20our%20Pipeline) The company faces significant commercial risks for its COVID-19 vaccine, including decreasing demand, intense competition, pricing uncertainty, and reliance on Pfizer's estimates, alongside broader pipeline commercialization challenges - Demand for the COVID-19 vaccine is expected to continue to decrease, which will impact revenue that is heavily dependent on these sales. This creates challenges in managing production and potential inventory write-downs[502](index=502&type=chunk) - The company faces significant competition from other COVID-19 vaccine makers and may be unable to maintain a competitive market share[100](index=100&type=chunk) - Successful commercialization depends on obtaining and maintaining adequate coverage and reimbursement from government authorities and private payors, which is uncertain and subject to downward pricing pressure from healthcare reform legislation like the U.S. Inflation Reduction Act[489](index=489&type=chunk)[103](index=103&type=chunk) [Risks Related to Financial Condition and Capital Requirements](index=81&type=section&id=Risks%20Related%20to%20our%20Financial%20Condition%20and%20Capital%20Requirements) BioNTech's financial stability faces risks from fluctuating operating results, a history of losses, anticipated increased R&D expenses requiring additional financing, and limitations on using net operating loss carryforwards - The company's operating results may fluctuate significantly, making future performance difficult to predict. Factors include the size and timing of COVID-19 vaccine orders and progress in clinical trials[104](index=104&type=chunk) - The company expects to incur significant and increasing operating expenses as it invests heavily in R&D, expands its clinical trials, and builds out its infrastructure. This may require substantial additional financing in the future[135](index=135&type=chunk)[496](index=496&type=chunk) - The ability to use net operating loss (NOL) carryforwards in Germany and the U.S. to offset future taxable income may be subject to certain limitations and review by tax authorities[512](index=512&type=chunk) [Risks Related to Business and Operations](index=88&type=section&id=Risks%20Related%20to%20our%20Business) The company faces operational risks from managing rapid growth, compliance costs, potential non-compliance with trade regulations, exposure to catastrophic events, AI development risks, and increasing ESG scrutiny - The company must manage its rapid development and expansion, which requires improving managerial, operational, and financial systems and recruiting qualified personnel[136](index=136&type=chunk) - Business could be adversely impacted by catastrophic global events, including political crises like the conflict in Ukraine, which could affect energy supplies for manufacturing[138](index=138&type=chunk) - The company faces risks related to the development and use of Artificial Intelligence (AI), including an uncertain regulatory environment, and increasing expectations regarding Environmental, Social, and Governance (ESG) matters[195](index=195&type=chunk)[196](index=196&type=chunk) [Risks Related to Clinical Development and Regulatory Approval](index=92&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Regulatory%20Approval) BioNTech's success depends on a lengthy, uncertain clinical development and regulatory approval process, facing risks from novel mRNA technology, potential side effects, patient enrollment challenges, and evolving regulatory landscapes for gene and cell therapies - Clinical development is a lengthy, expensive process with an uncertain outcome. Delays can occur due to regulatory holds, difficulty enrolling patients, or inconclusive results[535](index=535&type=chunk) - mRNA drug development carries substantial clinical and regulatory risks due to limited regulatory experience with this technology, aside from the COVID-19 vaccines[140](index=140&type=chunk) - Product candidates may cause undesirable side effects or have other properties that could delay or prevent regulatory approval. If significant adverse events are observed, trials may be suspended or terminated[532](index=532&type=chunk)[541](index=541&type=chunk) - Results from early-stage clinical trials are not necessarily predictive of future success in later-stage trials, and a number of companies have suffered significant setbacks despite promising initial data[144](index=144&type=chunk)[145](index=145&type=chunk) [Risks Related to Manufacturing and Supply Chain](index=112&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Supply%20Chain) The company faces significant manufacturing risks due to complex mRNA processes, including scale-up difficulties, stability issues, single-source supplier dependence, and GMP compliance, potentially leading to delays and inventory write-downs - The manufacturing processes for the company's product candidates are novel and complex, presenting potential difficulties in scaling up, product release, shelf life, testing, and storage[184](index=184&type=chunk)[186](index=186&type=chunk) - The company depends on single-source suppliers for some specialty raw materials and components, creating risks of supply disruption, price increases, and delays[223](index=223&type=chunk)[669](index=669&type=chunk) - Manufacturing facilities are subject to extensive regulation and must comply with Good Manufacturing Practices (GMP). Failure to meet these requirements could result in significant delays, costs, and potential product recalls[226](index=226&type=chunk) - The company has faced and continues to face the risk of inventory write-downs or redundant production capacity for its COVID-19 vaccine due to changing demand and new formulations[191](index=191&type=chunk) [Risks Related to Reliance on Third Parties](index=118&type=section&id=Risks%20Related%20to%20our%20Reliance%20on%20Third%20Parties) BioNTech's business heavily relies on third parties like Pfizer, CROs, and licensors, introducing risks of non-performance, agreement termination, lack of control over quality, and IP disputes, which could jeopardize critical technology access - The company relies on third parties, such as CROs and medical institutions, for significant aspects of its preclinical studies and clinical trials, which reduces direct control over these activities[217](index=217&type=chunk)[218](index=218&type=chunk) - Existing and future collaboration arrangements, such as the one with Pfizer, may not be successful. Collaborators may not perform their obligations, may terminate agreements, or may develop competing products[230](index=230&type=chunk)[245](index=245&type=chunk) - The company is heavily reliant on licenses for third-party intellectual property. Disputes with licensors or failure to comply with license obligations could result in the loss of rights that are important to the business[599](index=599&type=chunk)[687](index=687&type=chunk) [Risks Related to Intellectual Property](index=126&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) The company's competitive position relies heavily on IP, facing substantial risks from ongoing patent litigation by competitors like Moderna and CureVac, and uncertainty in the complex mRNA patent landscape regarding protection and freedom to operate - The company is involved in numerous ongoing patent infringement lawsuits related to its COVID-19 vaccine with competitors such as Alnylam, CureVac, and Moderna, which could be expensive and unsuccessful[580](index=580&type=chunk)[582](index=582&type=chunk)[621](index=621&type=chunk) - The patent position of biopharmaceutical companies is highly uncertain and involves complex legal questions. There is no guarantee that patent applications will issue or that issued patents will provide sufficient protection[565](index=565&type=chunk) - Third-party IP rights could adversely affect the ability to commercialize products, potentially requiring litigation or licensing from third parties, which may not be available on reasonable terms[583](index=583&type=chunk)[617](index=617&type=chunk) - Changes in patent law in the U.S. and other countries, such as the America Invents Act, could diminish the value of patents and impair the ability to protect products[637](index=637&type=chunk)[638](index=638&type=chunk) [Risks Related to Government Regulation](index=143&type=section&id=Risks%20Related%20to%20Government%20Regulation) BioNTech faces significant regulatory risks due to the complex and evolving landscape for novel technologies, including potential classification of mRNA candidates as gene therapies, uncertain approval pathways, and stringent compliance requirements for healthcare fraud, data privacy, and EHS laws - The regulatory landscape for the company's product candidates, particularly those based on novel technologies like mRNA, is uncertain and evolving, which could lead to delays or unexpected costs[704](index=704&type=chunk) - Some product candidates are classified as gene therapies by the FDA and EMA, which could result in increased regulatory burdens and negative public perception, despite mechanistic differences[700](index=700&type=chunk)[701](index=701&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute), which could expose it to substantial penalties if business practices are found to be non-compliant[726](index=726&type=chunk)[727](index=727&type=chunk) - The company is subject to stringent data privacy laws, such as the GDPR in Europe, which impose strict requirements on the processing of personal and health data, with significant penalties for non-compliance[735](index=735&type=chunk)[740](index=740&type=chunk) [Risks Related to Ownership of the ADSs](index=154&type=section&id=Risks%20Related%20to%20Ownership%20of%20the%20ADSs) Ownership of BioNTech's ADSs carries risks including significant price volatility, substantial control by principal shareholders, potential dilution from preemptive rights issues, and limitations on judicial forum choice due to Articles of Association - The market price of the company's ADSs has experienced and may continue to experience significant volatility, influenced by news regarding COVID-19 vaccines and clinical data[750](index=750&type=chunk) - Principal shareholders and management own a majority of ordinary shares, enabling them to exert significant control over matters subject to shareholder approval[761](index=761&type=chunk) - Under German law, ADS holders may not be able to participate in future preemptive subscription rights issues, which could cause dilution to their holdings[759](index=759&type=chunk)

BioNTech SE (NASDAQ:BNTX) Q2 2023 Earnings Conference Call August 7, 2023 8:00 AM ET Company Participants Victoria Meissner - VP, Strategy & IR Ugur Sahin - Co-Founder & CFO Ozlem Tureci - Chief Medical Officer & Co-Founder Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Daina Graybosch - Leerink Partners Tazeen Ahmad - Bank of America Chris Shibutani - Goldman Sachs Brendan Smith - TD Cowen Terence Flynn - Morgan Stanley Bill Maughan - Canaccord Simon Baker - Redbu ...

Quarterly Report of BioNTech SE for the Three And Six Months Ended June 30, 2023 Unaudited Interim Condensed Consolidated Financial Statements Interim Condensed Consolidated Statements of Changes in Stockholders' Equity 4 2 Basis of Preparation, Significant Accounting Policies and further Accounting Topics 6 6 Intangible Assets 12 10 Share-Based Payments 15 Operating and Financial Review and Prospects The accompanying notes form an integral part of these interim consolidated financial statements. 1 2 3 4 Th ...