Financial Data and Key Metrics Changes - Total revenues for Q2 2025 reached approximately €261 million, a significant increase from €129 million in Q2 2024, primarily driven by higher revenues from the COVID-19 vaccine collaboration [41] - Research and development expenses decreased to approximately €585 million in Q2 2025 from €709 million in the prior year, reflecting a reprioritization of clinical trials [42] - The net loss for Q2 2025 was €387 million, compared to a net loss of €88 million in Q2 2024, with a basic and diluted loss per share of €1.6 compared to €3.3 in the prior year [43] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: mRNA cancer immunotherapies (Sigvec and INEST) and bispecific antibody BNT327, which are expected to enhance patient outcomes across multiple cancer indications [8][10] - The acquisition of BioThese has fully integrated BNT327 into the pipeline, with a global co-development collaboration with BMS initiated to accelerate its clinical development [10][14] Market Data and Key Metrics Changes - The company anticipates lower COVID-19 vaccination rates in the U.S. compared to the previous year, estimating around 20% vaccination rates, which may impact revenue guidance [47][58] - Despite lower vaccination rates, the company expects to maintain similar market share and pricing as compared to 2024 [47] Company Strategy and Development Direction - The overarching vision is to build an immunotherapy powerhouse and become a fully integrated biopharmaceutical company with multiple approved therapies, focusing on combination therapies to improve cancer treatment outcomes [7] - The company is investing significantly in clinical development and commercial infrastructure to support future launches in key markets [9][10] - A strategic transaction to acquire QVAC aims to enhance capabilities in mRNA design and manufacturing [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of BNT327 to establish new standards of care across multiple tumor types, with ongoing clinical trials expected to yield meaningful data [19][20] - The company is preparing for the global commercial rollout of a new variant-adapted COVID-19 vaccine, pending regulatory approvals, and has expanded partnerships to enhance R&D activities [13][14] Other Important Information - The company maintains a strong financial position with €16 billion in cash and securities, providing flexibility to pursue long-term strategies [43] - The anticipated financial implications of the collaboration with BMS include an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [45][46] Q&A Session Summary Question: Clarity on vaccine development and future vaccination rates - Management acknowledged lower vaccination rates and emphasized the continued priority of the COVID-19 vaccine business while exploring next-generation concepts and combination vaccines [56][58] Question: Details on the BNT327 trial and data release timing - Management confirmed that details on doses for the Phase II portion of the BNT327 trial will be discussed later this year, with top-line data expected before year-end [64][65] Question: Insights on BNT327 in frontline TNBC and ADC combinations - Management highlighted the potential of BNT327 in triple-negative breast cancer (TNBC) and ongoing studies to evaluate its efficacy in combination with ADCs [67][68] Question: R&D spending evolution post-Bristol collaboration - Management indicated that R&D spending will increase in priority areas, particularly for late-stage programs, while decreasing in non-priority areas [71][73] Question: Assumptions on lower vaccination rates and revenue guidance - Management reiterated expectations for lower vaccination rates but maintained revenue guidance, anticipating a phased revenue recognition towards the end of the year [78][80]

2nd Quarter 2025 Financial Results & Corporate Update August 4th, 2025 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit/(loss) related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collab ...

Oncology Pipeline & Strategy - BioNTech has a multiplatform oncology portfolio with over 20 ongoing Phase 2 or 3 trials[7] - BNT327, a PD-L1/VEGF-A antibody, is a priority program with potential as a next-generation IO-backbone, with clinical activity observed across multiple indications in over 750 patients enrolled in 20+ clinical trials[7, 19, 20] - BNT327 combined with chemo in 1L TNBC showed an objective response rate (ORR) of 769% in PD-L1 negative, 563% in PD-L1 low, and 100% in PD-L1 high patients[25] - FixVac and iNeST are novel mRNA cancer immunotherapies targeting tumor-associated antigens and cancer mutations[7, 37] COVID-19 Vaccine & Financials - BioNTech anticipates maintaining a high market share in the U S, EU, and Japan for its COVID-19 vaccine[49] - The company expects total revenues between €1700 million and €2200 million for the financial year 2025[51] - R&D expenses for FY 2025 are projected to be between €2600 million and €2800 million[51] - SG&A expenses are estimated to be between €650 million and €750 million, with capital expenditure for operating activities between €250 million and €350 million[51] Financial Position - As of December 31, 2024, BioNTech's total cash plus security investments amounted to €174 billion, including €97619 million in cash and cash equivalents, €65362 million in current security investments, and €10611 million in non-current security investments[7, 8]

Core Insights - BioNTech will present clinical trial data from its oncology portfolio at the ASCO Annual Meeting, showcasing progress in mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies [1][4] Group 1: Clinical Trial Highlights - The company is advancing over 20 active Phase 2 and 3 clinical trials, focusing on investigational mRNA cancer immunotherapies and the next-generation immunomodulator BNT327 [4] - BNT327, an investigational anti-PD-L1xVEGF-A antibody, will have three presentations detailing data from ongoing clinical trials, including a Phase 2 trial for malignant mesothelioma and Phase 3 trials for small cell lung cancer [5][8] - Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, will be presented, indicating early clinical activity in heavily pre-treated castration-resistant prostate cancer [5][8] Group 2: Future Directions - BioNTech aims to become a diversified multi-product oncology company, with multiple data readouts expected in 2025 and 2026 [4] - The company emphasizes the potential of its assets to improve patient outcomes through innovative therapeutic modalities [2][4] - The presentations at ASCO are part of BioNTech's strategy to shape the future of cancer medicine through complementary mechanisms and innovative molecules [2]