Financial Data and Key Metrics Changes - For the full year 2025, the company recorded revenues of $62.6 billion, a 2% operational decline from $63.6 billion in the previous year. Excluding COVID-19 products, operational revenue growth was 6% [29] - Adjusted gross margins for the full year expanded to 76%, aligning with expectations, while diluted EPS was reported at $1.36 compared to $1.41 last year, and adjusted diluted EPS increased to $3.22 from $3.11 [29][30] - In Q4 2025, revenues were $17.6 billion, a 3% operational decline year-over-year, primarily due to a 40% decline in COVID product sales. Non-COVID product performance grew 9% operationally [30][31] Business Line Data and Key Metrics Changes - Recently launched and acquired products generated $10.2 billion in revenues for 2025, growing approximately 14% operationally [30] - The decline in COVID product sales was attributed to reduced demand for COMIRNATY and PAXLOVID due to lower infection rates [30] Market Data and Key Metrics Changes - The company anticipates stable revenue contributions from its non-COVID product portfolio, with an expected revenue compression of approximately $1.5 billion due to anticipated generic entry in 2026 [39] - The market for obesity treatments, particularly for the ultra-long-acting GLP-1 receptor agonist, is projected to be $150 billion, with significant opportunities in both mature and emerging markets [51] Company Strategy and Development Direction - The company aims for industry-leading growth as key products lose patent or regulatory exclusivity in the coming years, focusing on maximizing the value of in-line product portfolios and accelerating pipeline development [7][12] - Strategic acquisitions, including Seagen, Metsera, and Biohaven, are seen as transformative for the company, with a commitment to invest in R&D and maintain a robust dividend [7][12][37] - The company is scaling artificial intelligence across various functions to improve productivity and accelerate innovation [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong financial performance despite challenges, highlighting the resilience of the business and the successful execution of strategic priorities [5][27] - The company expects to face headwinds from loss of exclusivity (LOE) for several products but remains focused on investing in key assets to drive growth by the end of the decade [39][40] Other Important Information - The company achieved significant cost savings through manufacturing optimization programs, with expectations of additional savings in the coming years [31][34] - The company plans to advance over 20 pivotal studies in 2026, targeting potential approvals starting in 2028 for its obesity portfolio [23][25] Q&A Session Summary Question: Can you elaborate on the tolerability seen in VESPER-3 data? - Management indicated that the tolerability data will be shared at ADA, noting that the distribution of adverse events was encouraging, with no significant increase in discontinuations when switching to monthly dosing [43][45] Question: What role do you see for the drug with solid weight loss but potentially below competitors? - Management believes that the combination of competitive efficacy and a lower medication burden through monthly dosing will resonate well with patients and providers, enhancing the drug's market potential [49] Question: Did the placebo arm gain or lose weight in VESPER-3? - The placebo arm remained stable, showing no significant weight gain or loss, with detailed data to be presented at ADA [65] Question: What are the expectations for the upcoming phase III studies? - Management expressed confidence in the ongoing studies, highlighting the promising data observed so far and the potential for differentiation in the market [84][90]

COVID-19 Vaccine Impact - BioNTech distributed over 5 billion COVID-19 vaccine doses to over 180 countries and territories[7, 11] - A real-world study of 27 million adults showed a 74% lower risk of death from severe COVID-19 over 45 months in vaccinated individuals[11] - BioNTech maintained leadership with over 50% market share in the global COVID-19 vaccine market during the fall 2025 vaccination season[9, 11] Financial Performance and Strategy - BioNTech expects its revenues for the full 2025 financial year to be in the range of €2600 - €2800 million[9] - BioNTech has €172 billion in cash, cash equivalents, and securities as of December 31, 2025[9, 17] - BioNTech anticipates a modest decline in Comirnaty revenues in 2026 compared to 2025[18] Oncology Pipeline and Development - BioNTech has over 25 ongoing Phase 2 & 3 oncology trials[7, 9] - There are 12+ combination trials with chemotherapy and 10+ novel-novel combinations trials ongoing with Pumitamig[42] - Gotistobart Phase 3 data shows a 54% reduction in the risk of death compared with docetaxel in CPI-Treated Squamous NSCLC[62]

Pipeline and Programs - BioNTech has 16 clinical programs in oncology and 7 clinical programs in infectious diseases[14] - Pumitamig, a PD-L1 x VEGF-A bispecific antibody, showed an objective response rate (ORR) of 76.9% in PD-L1 negative, 56.3% in PD-L1 low, and 100% in PD-L1 high TNBC patients when combined with chemotherapy[57] - In EGFRmut NSCLC post EGFR TKI, pumitamig combined with chemo showed an ORR of 39.3% in PD-L1 negative, 60.9% in PD-L1 low, and 92.3% in PD-L1 high patients[60] - BNT324/DB-1311, an anti-B7H3 ADC, showed an ORR of 54.5% at 6 mg/kg and 58.8% at 9 mg/kg in SCLC patients who received prior IO but no prior TOP1i[209] Clinical Trials and Strategy - BioNTech is executing a three-wave strategy for Pumitamig, including foundational registrational trials, expanding into multiple disease indications, and synergistic novel-novel combinations[64] - BioNTech has over 1,400 patients dosed across pumitamig monotherapy and chemo combination studies[141] - A Phase 3 trial is evaluating Gotistobart versus docetaxel in 600 patients with 2L squamous non-small cell lung cancer[83, 179] Financials and Partnerships - BioNTech increased its 2025 revenue guidance to a range of €26 to €28 billion[437] - BioNTech has €167 billion in cash, cash equivalents, and securities[437] - BioNTech's partnership with BMS includes $35 billion upfront and non-contingent payments, plus $76 billion in milestone payments for Pumitamig[443]

Financial Data and Key Metrics Changes - For Q3 2025, the company recorded revenues of $16.7 billion, a decrease of 7% operationally compared to the same period last year, primarily driven by a decline in COVID products [23] - Reported diluted earnings per share (EPS) was $0.62, while adjusted diluted EPS was $0.87, exceeding expectations due to strong gross margin and cost management performance [24] - Adjusted gross margin for Q3 was approximately 76%, reflecting product mix and strong cost management [25] Business Line Data and Key Metrics Changes - Non-COVID product performance grew 4% operationally compared to the same period last year, with solid contributions from ELIQUIS, the VYNDAQEL family, and NURTEC [23][24] - The VYNDAQEL family achieved 7% year-over-year global operational growth, while NURTEC led the oral CGRP class in primary care penetration in the U.S. [14][15] - PADCEV achieved 13% year-over-year global operational growth, establishing itself as a standard of care for patients with locally advanced metastatic urothelial cancer [15] Market Data and Key Metrics Changes - In international markets, the company achieved 40% growth in total patients on treatment for the VYNDAQEL family [15] - The vaccines portfolio, particularly the PREVNAR family, saw 17% year-over-year international operational growth [16] - The company expects the lung cancer market to reach approximately $70 billion by 2023, with strong growth in its lung cancer portfolio [12] Company Strategy and Development Direction - The company is focused on strategic investments in innovation and growth, highlighted by the proposed acquisition of Metsera and the licensing agreement with 3SBio [6][8] - The company aims to enhance its R&D pipeline and commercial capabilities, particularly in the high-growth therapeutic area of obesity [8] - The recent agreement with the U.S. Government aims to lower prescription drug costs while allowing the company to focus on business and innovation [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to deliver value for patients and shareholders, despite challenges in the COVID product line [5] - The company raised its adjusted diluted EPS guidance for the full year 2025, reflecting strong performance and efficient cost structure [33] - Management noted that the agreement with the U.S. Government will have a diluted impact on the 2026 financial outlook but does not affect the 2025 guidance [32] Other Important Information - The company expects to achieve $1.5 billion in savings from the manufacturing optimization program by the end of 2027 [26] - Total adjusted operating expenses for Q3 were $7 billion, an increase of 21% operationally compared to last year, largely due to acquired in-process R&D expenses from the 3SBio transaction [28] - The company plans to continue investing in key products and markets to offset losses from upcoming LOEs [25] Q&A Session Summary Question: Insights on VYNDAMAX performance amid competition - Management acknowledged new competition but emphasized VYNDAMAX's unique benefits and strong market access, noting that volume growth was offset by gross-to-net headwinds [40][41] Question: Legal process regarding Metsera acquisition - Management refrained from discussing specific legal timelines but reiterated their belief that Novo's acquisition attempt is anti-competitive [47][49] Question: Plans if Metsera acquisition does not proceed - Management indicated ongoing efforts to identify potential acquisition candidates across therapeutic areas, emphasizing a proactive approach to business development [51][53] Question: Impact of manufacturing investments under the MFN agreement - Management highlighted the importance of investing in U.S. production while also improving operational cost efficiencies [59][61] Question: Clarification on PAXLOVID pricing dynamics - Management noted no significant change in pricing but acknowledged variations in channel mix affecting sales [76] Question: Guidance on COVID-19 sales for the year - Management expressed cautious optimism regarding COVID-19 sales, noting potential spikes in utilization due to future waves of the virus [88]

Oncology Program Highlights - Pumitamig is executing a broad pan-tumor development plan, with potential launches before the end of the decade[12] - The company is progressing late-stage trials for FixVac and iNeST mRNA cancer immunotherapies, with recent randomized Phase 2 updates[12] - Pumitamig has registrational trials ongoing in 3 high-impact tumors, including SCLC, with broad pan-tumor applicability with standard-of-care chemotherapy[19] - BNT111 FixVac Phase 2 data in PD-(L)1 melanoma showed a statistically significant improvement in ORR of 181% versus an assumed historical control ORR of 10%[30] Financial Performance - The company reported revenues of €1519 million for the three months ended September 30, 2025, compared to €1245 million in 2024[37] - Research and development expenses were €565 million for the quarter[37] - The company has a strong balance sheet with approximately €167 billion in total cash and cash equivalents plus security investments as of September 30, 2025[12, 38] - The company increased its full-year 2025 revenue guidance to €2600 – €2800 million and reduced R&D expenses guidance to €2000 – €2200 million[39]

Financial Performance - Second quarter 2025 revenues reached €261 million, compared to €129 million in the second quarter of 2024[61] - First half 2025 revenues totaled €444 million, an increase from €316 million in the first half of 2024[61] - The company reported a net loss of €387 million for the second quarter of 2025, compared to a net loss of €808 million for the same period in 2024[61] - Research and Development expenses for the second quarter of 2025 were €509 million, compared to €585 million for the second quarter of 2024[61] - Cash and cash equivalents plus security investments reached approximately €160 billion as of June 30, 2025[12,61] Strategic Collaboration - BioNTech and Bristol Myers Squibb (BMS) entered into a strategic collaboration for BNT3271, with an upfront cash payment of $15 billion expected in Q3 2025[12,62] - The collaboration with BMS includes non-contingent anniversary cash payments of $20 billion from 2026 to 2028[62] - Potential development, regulatory, and commercial milestone cash payments from BMS could reach up to $76 billion[62] Pipeline Development - A Phase 2 study of BNT3271 combined with chemotherapy in 1L ES-SCLC showed an objective response rate (ORR) of 854% and a median overall survival (OS) of 168 months[29] - In a Phase 1b/2a study, BNT3271 monotherapy in 1L NSCLC (EGFR & ALK WT) showed an ORR of 47% and a median PFS of 136 months[34] - A Phase 1/2 study of BNT3271 combined with chemotherapy in 1L TNBC showed an ORR of 738% and a median PFS of 135 months[35]

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].

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]

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]

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 collaboration partners, particularly for those figures that are derived from ...