COVID-19 Vaccine Demand and Revenue - Demand for the COVID-19 vaccine is expected to decrease in the near future, impacting revenue heavily reliant on vaccine sales [30]. - The company has experienced significant reductions in demand for COVID-19 vaccination as the virus has entered an endemic stage [31]. - Future revenues from the COVID-19 vaccine are expected to decrease as overall demand for vaccination wanes, prompting the company to invest heavily in research and development to diversify its therapeutic area footprint [100]. - The company continues to generate revenue from sales of its COVID-19 vaccine, with expectations to maintain revenue, although future demand is uncertain due to factors like new virus variants and public health measures [91]. - The company faces risks related to catastrophic global events, including natural disasters and political crises, which could adversely affect operations and supply chains [129]. Regulatory and Compliance Risks - The company is subject to ongoing regulatory oversight, which may reveal new safety issues affecting commercialization efforts [41]. - The company faces significant risks related to regulatory compliance, which could lead to product recalls, suspensions, or fines if not adhered to [43]. - The overall regulatory approval pathway for the company's product candidates is complex, expensive, and lengthy, with no guarantee of success [167]. - The company acknowledges that mRNA drug development carries substantial clinical and regulatory risks, with limited prior approvals for mRNA immunotherapies [147]. - The company faces challenges in obtaining favorable pricing and reimbursement for its products in various jurisdictions, particularly in the European Union where pricing is subject to governmental control [89]. Financial Performance and Market Conditions - Reported commercial revenue is based on preliminary estimates from Pfizer, which may change and affect financial results [35]. - The market price of the company's ADSs may decline if revenues or financial metrics do not meet investor expectations [34]. - The company has incurred tax losses in Germany and the United States, which may limit the ability to utilize net operating losses (NOLs) and tax credits until assessed by tax authorities [104]. - The company anticipates significant and increasing operating expenses as it continues to expand research, clinical trials, and manufacturing capabilities [101]. - The company may require substantial additional financing to achieve its goals, with potential delays or reductions in product development if capital is not obtained on acceptable terms [109]. Product Development and Commercialization Challenges - Successful commercialization of product candidates is heavily dependent on obtaining adequate reimbursement from governmental and private payors [44]. - Market acceptance of products is uncertain and depends on factors such as efficacy, pricing, and third-party reimbursement availability [74]. - The company faces challenges in scaling up manufacturing processes for mRNA therapies, which may lead to batch failures and delays in clinical trials [160]. - Clinical trials are lengthy and expensive, with potential delays due to various factors, including patient recruitment difficulties and unforeseen events [161]. - The company is dependent on the successful development and regulatory approval of product candidates, with the marketing approval process being expensive and time-consuming [138]. Competition and Market Dynamics - Competition in the COVID-19 vaccine market is intense, with several manufacturers having greater resources and experience [56]. - The company’s COVID-19 vaccine is sensitive to storage conditions, which could lead to supply chain challenges and affect market competitiveness [59]. - The market opportunities for some product candidates may be limited due to the rarity of diseases targeted, impacting profitability [67]. - Future profitability depends on the company's ability and that of its collaborators to penetrate global markets, facing regulatory burdens and uncertainties [72]. - The company faces significant risks in clinical trials, with many product candidates potentially failing to demonstrate safety and efficacy, impacting future development efforts [42]. Insurance and Liability Concerns - The company has received product liability claims related to the COVID-19 vaccine and expects to continue facing such claims [41]. - The company has clinical trial and product liability insurance, but coverage may not be adequate as the pipeline moves towards commercialization [206]. - The company maintains insurance coverage for various risks, but increasing costs and potential inadequacies in coverage could adversely affect financial condition [133]. - Product liability claims related to the COVID-19 vaccine have been received, with expectations for additional claims in the future, which could incur substantial liabilities [205]. Environmental, Social, and Governance (ESG) Factors - The company has set near-term science-based emissions reduction targets for its operations and supply chain, validated by the Science Based Targets initiative (SBTi) in early February 2024 [214]. - Companies are increasingly judged on their ESG performance, and failure to comply with standards could have a material adverse effect on reputation and financial condition [218]. - The company faces unexpected costs and reputational harm due to evolving ESG expectations, which could adversely affect its financial condition and cash flows [212]. - Increasing regulatory requirements regarding human rights risks are being addressed, including compliance with the German LkSG and potential EU legislation [215]. - The company is subject to heightened ESG-related transparency and reporting obligations, including the EU Corporate Sustainability Reporting Directive and potential SEC rules [216].

Financial Data and Key Metrics Changes - The company maintained a leading position in the COVID-19 vaccine market with a global market share above 50% [4] - The balance sheet was strengthened through strong financial performance and disciplined cash spending [4] Business Line Data and Key Metrics Changes - The oncology portfolio advanced into late-stage development with 15 ongoing Phase II and Phase III clinical trials [3] - Data was presented on BNT327, a bispecific anti-PD-L1 anti-VEGF antibody, showing high clinical potential across multiple indications [10] Market Data and Key Metrics Changes - The company identified a significant medical need in populations where current treatments do not provide optimal results, particularly in PD-L1 negative tumors [15] - The potential market for BNT327 includes approximately 1.5 million cases annually in PD-L1 positive indications and around 1.4 million cases in PD-L1 negative indications [15] Company Strategy and Development Direction - The vision is to transform cancer medicine into personalized and individualized treatments, leveraging deep genomics, immunology expertise, and AI capabilities [5] - The strategy includes establishing three phases of clinical registration trials for BNT327, focusing on replacing current standards of care and exploring combination therapies [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of BNT327 to serve as a backbone for immuno-oncology therapy, with expectations for multiple approvals in oncology products across various indications by 2025 [32][33] - The company aims to maintain its leadership in COVID-19 vaccines while advancing its oncology pipeline and preparing for commercialization of upcoming products [32] Other Important Information - The company has developed two platforms for mRNA cancer immunotherapies, focusing on individualized neoantigen-specific immunotherapy and shared tumor antigens [19][20] - Ongoing studies are expected to provide data readouts in 2025 and 2026, with a focus on addressing high medical needs in cancer patients [31] Q&A Session Summary Question: How can the bispecific molecule address populations where PD-1 works well? - Management indicated that data shows encouraging clinical response and progression-free survival (PFS) rates that are better than current standards of care, with ongoing trials outside of China to validate these findings [35] Question: Will the randomized adjuvant colon cancer data support accelerated approval? - Management stated that the study is large and if strong signals are observed, they would be open to discussions with regulators regarding approval [37]

BioNTech SE (NASDAQ:BNTX) Q3 2024 Earnings Conference Call November 4, 2024 8:00 AM ET Company Participants Michael Horowicz - Director, Investor Relations Ugur Sahin - Chief Executive Officer & Co-Founder Özlem Türeci - Chief Medical Officer & Co-Founder Jens Holstein - Chief Financial Officer Ryan Richardson - Chief Strategy Officer Conference Call Participants Tazeen Ahmad - Bank of America Securities Daina Graybosch - Leerink Partners Suzanne van Voorthuizen - VLK Terence Flynn - Morgan Stanley Yaron We ...

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Exhibit 99.1 https://files.reportify.cc/media/production/BNTXddcf2ca2a8b2317ecc8b6088b8b48208.jpg BioNTech SE Quarterly Report of BioNTech SE for the three and nine months ended September 30, 2024 A C T I N G T O G E T H E R — C R E A T I N G S Y N E R G I E S Exhibit 99.1 Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, o ...

We expect BioNTech SE (BNTX) to surpass expectations when it reports third-quarter 2024 results on Nov. 4, before the opening bell.Let’s see how things have shaped up for the quarter to be reported.Factors at PlayBioNTech’s top line currently includes sales from its mRNA-based COVID-19 vaccine, Comirnaty, developed in partnership with Pfizer (PFE) . The vaccine is approved in several countries and has been a key contributor to BioNTech’s top line. The Zacks Consensus Estimate for revenues stands at $651.8 m ...

Financial Data and Key Metrics Changes - Total revenues for Q2 2024 reached approximately €129 million, down from approximately €168 million in Q2 2023, reflecting a seasonal decline in COVID-19 vaccine demand [35] - Cost of sales decreased to approximately €60 million in Q2 2024 from approximately €163 million in the prior-year period [35] - Research and development expenses increased to approximately €585 million in Q2 2024 from approximately €373 million in the prior-year period, with 90% of R&D spend focused on non-COVID initiatives [36] - Net loss for Q2 2024 was approximately €808 million, compared to a net loss of about €190 million in the prior-year period, resulting in a loss per share of €3.36 [37] Business Line Data and Key Metrics Changes - The COVID-19 vaccine franchise continues to evolve with the launch of a new variant-adapted vaccine, with expectations for additional approvals [4][8] - Significant progress in the oncology pipeline, particularly with the BNT111 melanoma vaccine, which met its primary endpoint in a Phase 2 trial [5][18] - The company is expanding its oncology portfolio with new combination therapies and trials, including the BNT327 bispecific antibody [27][30] Market Data and Key Metrics Changes - The JN.1 lineage has become the predominant COVID-19 variant, leading to updates in vaccine formulations recommended by regulatory authorities [7][8] - The company anticipates a significant portion of COVID-19 vaccine demand to come from outside the United States, with new private markets emerging in regions like the UK and Japan [43] Company Strategy and Development Direction - The company aims to establish a sustainable vaccine ecosystem in Africa through partnerships, including a commitment of up to US$145 million from CEPI for mRNA vaccine manufacturing in Rwanda [6] - The oncology strategy focuses on a technology-agnostic approach, leveraging multiple modalities to enhance treatment efficacy and patient outcomes [10][12] - The company plans to initiate multiple combination trials in solid tumor indications over the next 12 months, emphasizing the development of novel therapies [45] Management's Comments on Operating Environment and Future Outlook - Management expects Q2 2024 to be the low point for COVID-19 vaccine uptake, with a significant revenue increase anticipated in Q4 following expected FDA approvals [35][39] - The company maintains a strong cash position of approximately €18.5 billion, providing strategic flexibility for long-term growth investments [38] - Management reiterated the expectation of a net loss for the 2024 financial year while continuing to invest in proprietary assets and technologies [39] Other Important Information - The company is scaling up manufacturing capabilities for both off-the-shelf and personalized mRNA vaccines, with a pilot facility being built in Mainz, Germany [26] - Upcoming presentations at major conferences will provide updates on key assets, including BNT113 and BNT327, with a focus on safety and efficacy data [34] Q&A Session Summary Question: Potential launches in 2026 - Management highlighted BNT323 and BNT122 as potential candidates for accelerated approval and launch in 2026, pending further FDA discussions [48][49] Question: Historical controls for BNT111 - Management indicated that BNT111 is being compared against standard-of-care treatments for melanoma, with a focus on achieving clinically meaningful benefits [51][52] Question: Phase 3 COVID Flu combo data - Management expects safety and efficacy data by the end of the year, which will inform potential submission for the 2025/2026 season [54][55] Question: Internal oncology program benefits - Management noted multiple programs in non-small-cell lung cancer that could benefit from recent data, with a focus on portfolio strategy [58][59] Question: Margin progression - Management discussed the current high margins from the COVID-19 partnership with Pfizer and indicated that oncology margins will align more closely with industry standards as the pipeline progresses [63][66]

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Financial Performance - Revenues for Q2 2024 were €128.7 million, a decrease of 23.2% compared to €167.7 million in Q2 2023[5] - The operating loss for Q2 2024 was €966.2 million, compared to a loss of €563.3 million in Q2 2023[5] - The net loss for the period in Q2 2024 was €807.8 million, compared to a loss of €190.4 million in Q2 2023[7] - Total revenues for the three months ended June 30, 2024, were €128.7 million, down from €167.7 million in the same period of 2023, with COVID-19 vaccine revenues at €71.9 million compared to €158.2 million[25] - For the six months ended June 30, 2024, total revenues were €316.3 million, significantly lower than €1,444.7 million in the same period of 2023[25] - The company reported a basic loss per share of €3.36 for Q2 2024, compared to a loss of €0.79 per share in Q2 2023[5] - The company experienced a comprehensive loss of €915.4 million for Q2 2024, compared to a loss of €182.2 million in Q2 2023[7] Research and Development - Research and development expenses increased significantly to €584.6 million in Q2 2024, up 56.5% from €373.4 million in Q2 2023[5] - The company is focusing on expanding its research and development efforts, as indicated by the significant increase in R&D expenses[5] - BioNTech's research and development efforts continue to focus on mRNA vaccines and therapeutics, cell and gene therapies, and other innovative approaches to address unmet medical needs[15] - Research and development expenses increased by €211.2 million (57%) to €584.6 million for the three months and by €384.7 million (54%) to €1,092.1 million for the six months, driven by clinical studies and increased headcount[29] Cash and Assets - Total assets decreased to €22,237.9 million as of June 30, 2024, down from €23,006.3 million at the end of 2023[9] - Cash and cash equivalents were €10,376.7 million as of June 30, 2024, a decrease from €11,663.7 million at the end of 2023[9] - Cash and cash equivalents as of June 30, 2024, were €10,376.7 million, down from €14,166.6 million at the end of June 2023[13] - The company reported a net cash inflow from operating activities of €1,627.2 million for the three months ended June 30, 2024, compared to €4,386.7 million in the same period of 2023[13] Equity and Liabilities - Total equity decreased to €19,072.3 million as of June 30, 2024, down from €20,245.9 million at the end of 2023[9] - The total carrying amount of financial assets measured at fair value was €5,411.0 million, with money market funds contributing €5,409.7 million[46] - As of June 30, 2024, the total financial liabilities not measured at fair value amounted to €1,088.4 million, including lease liabilities of €254.6 million and trade payables of €881.5 million[46] - Total provisions amounted to €372.9 million, up from €278.1 million as of December 31, 2023, representing a 34% increase[58] Legal Matters - The company is involved in multiple ongoing intellectual property disputes, with significant uncertainties regarding potential liabilities[62] - The Düsseldorf Regional Court has suspended infringement rulings related to several patents pending validity decisions, indicating ongoing legal complexities[68] - The Federal Patent Court of Germany nullified the EP'122 Patent, with an appeal currently pending from CureVac[70] - BioNTech is currently involved in multiple patent litigations, including cases filed by Moderna in the US, UK, Netherlands, Ireland, and Belgium, with outcomes remaining uncertain[85] COVID-19 Vaccine Developments - BioNTech's COVID-19 vaccine, Comirnaty, has been authorized or approved in over 180 countries, with more than 4.8 billion doses shipped globally as of December 2023[104] - The company is preparing for the commercial launch of a SARS-CoV-2 variant-adapted vaccine for the 2024/2025 fall and winter season, pending regulatory approval[106] - The Omicron JN.1 sublineages account for the majority of COVID-19 cases globally, necessitating updated vaccines for better protection against symptomatic and severe disease[107] - The European Medicines Agency recommended marketing authorization for the Omicron JN.1-adapted monovalent COVID-19 vaccine for individuals 6 months and older[109] Corporate Strategy and Partnerships - BioNTech's corporate strategy includes strengthening its clinical pipeline and technology platforms through strategic partnerships and acquisitions[100] - The company is actively pursuing market expansion and new product development to enhance its portfolio and address global health challenges[15] - BioNTech's management emphasizes the importance of collaboration with partners, such as Pfizer, to optimize revenue sharing and enhance product offerings[19] Clinical Trials and Product Pipeline - The company has a robust and diversified product pipeline across oncology and infectious diseases, leveraging multiple technology platforms[98] - BioNTech is developing BNT211 for germ cell tumors, with a pivotal Phase 2 trial expected to start in 2025 based on encouraging Phase 1 data[138] - The ongoing Phase 2 trial of autogene cevumeran (BNT122) in adjuvant colorectal cancer is expected to enroll about 200 patients, with primary endpoint being disease-free survival (DFS)[126] - A randomized Phase 2 trial for autogene cevumeran in pancreatic ductal adenocarcinoma (PDAC) is recruiting 260 patients, with DFS as the primary endpoint[129]

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