Innovation Series: R&D Day 2025 Introductory Remarks 1 Douglas Maffei, PhD, Vice President, Strategy and Investor Relations This Slide Presentation Includes Forward-Looking Statements November 11th, 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 ...

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 ...