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BioNTech SE(BNTX) - 2025 Q2 - Earnings Call Presentation
2025-08-04 12:00
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 ...
Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union
Globenewswire· 2025-07-25 06:30
Core Viewpoint - Pfizer and BioNTech have received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY LP.8.1, aimed at preventing COVID-19 in individuals aged 6 months and older, in response to the evolving SARS-CoV-2 variants [1][2][6]. Group 1: Vaccine Development and Approval - The LP.8.1-adapted vaccine is designed to improve immune responses against multiple circulating SARS-CoV-2 lineages, including XFG and NB.1.8.1, compared to previous vaccine formulations [2][6]. - The European Commission is expected to make a final decision on the marketing authorization soon, with manufacturing already initiated to ensure supply readiness for the upcoming vaccination season [1][6]. - Over a billion doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally, demonstrating a favorable safety and efficacy profile supported by extensive data [6]. Group 2: Regulatory and Market Context - The CHMP's recommendation is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world data, affirming the safety and efficacy of the vaccine [2][4]. - The companies are actively monitoring the epidemiology of COVID-19 to adapt to global public health needs and have submitted data for the updated vaccine to regulatory authorities worldwide [3][4]. - The LP.8.1-adapted vaccine will be available for individuals aged 6 months and older upon authorization by the European Commission [6].
BioNTech (BNTX) Earnings Call Presentation
2025-07-03 14:26
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]
BioNTech SE(BNTX) - 2025 Q1 - Earnings Call Presentation
2025-05-05 12:04
Oncology Pipeline Updates - BNT327 Phase 2 data in 1L SCLC was presented, and first BNT327+ADC combo data with TROP2-targeting ADC, BNT325/DB-1305 was reported[11] - Phase 1 data for BNT116 in NSCLC was reported[11] - BNT323/DB-1303 is preparing for regulator discussions with planned BLA submission by the end of 2025, pending regulatory feedback[11] - BNT327 combined with chemotherapy indicated encouraging efficacy in 1L TNBC with a confirmed ORR of 738% (95% CI: 580, 861), median PFS of 135 months (95% CI: 94, 193), 12-month OS rate of 808% (95% CI: 653, 899), and 18-month OS rate of 697% (95% CI: 527, 816) in a Phase 1/2 study[34] - BNT327 combined with chemotherapy indicated encouraging efficacy in 1L ES-SCLC with a confirmed ORR of 854% (95% CI: 722, 939), median PFS of 69 months (95% CI: 434, 821), and median OS of 168 months (95% CI: 143, --) in a Phase 2 study[37] - In a Phase 1b/2a study, BNT327 indicated single-agent activity in 1L NSCLC with an ORR of 47%, DCR of 100%, and mPFS of 136 months[45] Financial Results - Total revenues for Q1 2025 were €183 million, compared to €188 million in Q1 2024[52] - Net loss for Q1 2025 was €416 million, compared to €315 million in Q1 2024, with a basic and diluted loss per share of €173 compared to €131[52] - Cash and cash equivalents plus security investments as of March 31, 2025, reached approximately €159 billion, comprising €101849 million cash and cash equivalents, €35420 million current security investments, and €21275 million non-current security investments[11, 52] - Planned FY 2025 total revenues are guided at €17 billion – €22 billion, with R&D expenses between €26 billion – €28 billion and SG&A expenses between €650 million – €750 million[53]