EX-99.2 3 ex99-4thquarterandfullye.htm EX-99.2 ex99-4thquarterandfullye
March 10, 2025 4th Quarter and Full Year 2024 Financial Results & Corporate Update Exhibit 99.2


 
2 This Slide Presentation Includes Forward-Looking Statements 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 preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating activities; BioNTech's expectations regarding upcoming payments relating to litigation settlements; and BioNTech's expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit / (loss). In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward- looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 20-F for the period ended December 31, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. Furthermore, certain statements contained in this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and BioNTech’s own internal estimates and research. While BioNTech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, any market data included in this presentation involves assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While BioNTech believes its own internal research is reliable, such research has not been verified by any independent source. In addition, BioNTech is the owner of various trademarks, trade names and service marks that may appear in this presentation. Certain other trademarks, trade names and service marks appearing in this presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this presentation may be referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. An abbreviation directory of defined terms can be found at the end of the presentation.


 
Financial Update Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer2 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer1


 
1 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer


 
Building a Global Immunotherapy Powerhouse Translating Science into Survival


 
6 1. Partnered with Genentech, a member of the Roche Group; 2. Phase 2 data were reported for BNT111 (PR, 30 July 2024), Phase 1/2 and Phase 2 data for BNT113 (ESMO), Phase 1 data for BNT116 (AACR); BNT327 data included: Phase 1/2 in TNBC (ESMO, SABCS) and Phase 2 in NSCLC (ASCO). 3. In collaboration with Regeneron; 4. Partnered with Pfizer; 5. Consists of cash and cash equivalents of €9,761.9 million, current security investments of €6,536.2 million and non- current security investments of €1,061.1 million, as of December 31, 2024. Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the NIH are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the first quarter of 2025. The settlement payment of $467 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company’s second quarter 2025 financial results. In connection with these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026. Advancing Toward Our Vision: Key Achievements in 2024 Secured global control of BNT327, expanded pipeline and strengthened in-house immunotherapy capabilities mRNA cancer immunotherapies BNT327 Corporate development COVID-19 and infectious disease vaccines Financial strength Initiated a new Phase 2 trial evaluating autogene cevumeran1 and reported data2 for BNT1113, BNT113 and BNT1163 Presented multiple datasets2 for BNT327 and announced pivotal trials targeting unmet needs in SCLC, TNBC, and NSCLC Maintained leading COVID-19 vaccine4 market share globally and progressed early-stage infectious disease pipeline Delivered a strong balance sheet : ~€ 17.4 bn total cash and cash equivalents plus security investments as of December 31, 20245


 
7 1. Partnered with Genentech, a member of the Roche Group. 2025 Will Be an Important Year for Our Oncology Portfolio PD-L1/VEGF-A antibody BNT327 Novel mRNA cancer immunotherapy Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and cancer mutations FixVac & iNeST1 Our next-generation IO-backbone Resected cancers (adjuvant, ctDNA+) Neoadjuvant, 1L advanced/metastatic Late stage, refractory cancers Clinical stage candidates for combination therapy ADCs Cell and gene therapiesIO molecules mRNA immunotherapies Important Readouts for Priority Programs in 2025


 
Biotheus Acquisition Provides Opportunity to Accelerate BNT327 Development Acceleration and expansion of BNT327 development Establishment of clinical development capability in Mainland China Full pipeline and platform ownership Manufacturing site supporting initial launch cGMP manufacturing facility with multiple 2000L bioreactors Comprehensive E2E bispecific antibody discovery and development capabilities 6 clinical stage assets Pre-clinical ADC pipeline ~80-person clinical development organization in China with demonstrated execution ability Global control of BNT327 development and commercialization program Expedite execution of BNT327 + ADC development plans Advancing BNT327 in multiple indications, aiming for first-to-market approvals Anti-VEGF-A Anti-PD-L1 VHH 8


 
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer


 
Building an Oncology Pipeline Focused on Late-Stage Programs with Transformational Potential Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. MediLink Therapeutics; 4. OncoC4; 5. DualityBio. 6. In collaboration with Regeneron; 7. Trial ongoing in China only. BNT327 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx BNT316/ONC-392 (gotistobart)4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HR+/HER2-low met. breast cancer BNT1116 aPD-(L)1-R/R melanoma, + cemiplimab BNT113 1L rel./met. HPV16+ PD-L1+ HNC, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 1L adv. melanoma, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 Adj. ctDNA+ stage II or III CRC BNT1166 1L adv. PD-L1  50% NSCLC, + cemiplimab Autogene cevumeran (BNT122/RO7198457)1 Adj. PDAC, + atezolizumab + mFOLFIRINOX BNT316/ONC-392 (gotistobart)4 (CTLA-4), PROC, + pembrolizumab BNT327 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 Adj. MIUC, + nivolumab BNT327 (PD-L1 x VEGF-A) 2L SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx7 BNT327 (PD-L1 x VEGF-A) EGFR TKI experienced, EGFRm NSCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L MPM, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L HCC + CTx7 BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx7 Phase 3Phase 2 mRNA immunotherapy Next generation IO Targeted therapy BNT327 (PD-L1 x VEGF-A) 1L SCLC, + CTx NEW BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx NEW BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx PLANNED BNT211 (CLDN6) CLDN6+ testicular cancer PLANNED BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HER2+ endometrial cancer PLANNEDBNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 10


 
BNT327: Synergistic Targeting of PD-L1 and VEGF Local neutralization of angiogenic and immunosuppressive VEGF-A effects Selected NSCLC IHC2 Bispecific MOA Combined tumor targeting1 1. Khan KA Nat Rev Clin Oncol 2018; 2. IHC data: Human Protein Atlas. VEGF-A PD-L1 Targeting the TME and block of PD- 1/PD-L1 signaling by anti-PD-L1 Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) VEGF-A dimer in the TME PD-L1 ligand on tumor cells Tumor microenvironment (TME) BNT327 VEGF-A dimer in the TME Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) PD-L1 ligand on tumor cells 11


 
12 Partnered with: 1. DualityBio; 2. MediLink. Accelerating BNT327 Global Clinical Development Explore potential of BNT327 in three waves of focused development • Phase 2 in TNBC • Phase 2 in SCLC • Phase 2/3 in NSCLC • Phase 3 in SCLC Ongoing Planned • Phase 3 in TNBC for 2025 3 Broaden2 Combine1 Establish Ongoing Planned BNT327 + chemo: Establish in combination with CTx in potential fast-to-market indications BNT327 + ADC: Explore expansion to novel combinations with ADCs in high unmet need indications BNT327 + novel assets: Broaden to further indications • Phase 1/2 with BNT323/DB-13031 (HER2) • Phase 1/2 with BNT324/DB-13111(B7H3) • Phase 1/2 with BNT326/YL2022 (HER3) • Additional combinations in 2025+ • Phase 1/2 with BNT325/DB-13051 (TROP2) in solid tumors Portfolio of 20+ clinical oncology assets in-house • Combine with IO bispecifics • Combine with cell therapies • Combine with novel ADCs


 
Program Setting Study BNT327 1L ES-SCLC Phase 2 BNT327 2L ES-SCLC Phase 2 Small Cell Lung Cancer is One of Our Priority Indications for Clinical Development of BNT327 Response Efficacy Evaluation Population ITT (n=36) IO-naïve (n=22) IO- treated (n=14) ORR, % 61.1 72.7 42.9 DCR, % 86.1 81.8 92.9 -90 -70 -50 -30 -10 10 30 50 70 PD SD PR CR SCLC Incidence1 By 2030: ~60k in U.S., EU4, U.K. High unmet need for ES-SCLC patients as long-term survival outcomes remain very poor Phase 2 (NCT05879068): BNT327 Combined with Paclitaxel Shows Efficacy in 2L SCLC​ Ying Cheng et al. Presented at ESMO 2023. Poster#1992P 5-year survival2 • ES-SCLC: 3% • Limited-stage SCLC: 20% 1.Incidence from: SEER data for diagnosed SCLC incidence in US; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 2.Statistics from Dayen et al (2019); CancerMPact® Patient Metrics US & EU5, accessed February 2024. *Due to limited survival data in EU5, U.S. survival data is reported; 13


 
14 1 Partnered with Genentech, a member of the Roche Group. 2 Antigens vary across programs; 3. T-cell responses analyzed by ex vivo multimer staining analysis in blood. Individual patient samples (blood and tissue) Artificial intelligence-driven neoantigen prediction On-demand tailored RNA manufacturing Individualized immuno- therapy Mapping of mutations Fixed combination of shared tumor antigens2 Multi-antigen approach tailored to each indication Neoantigens Individualized therapy Multiple shared antigens Off-the-shelf therapy iNeST1 FixVac individualized Neoantigen- Specific immunotherapy Fixed Antigen Vaccine ANTIGEN 1 ANTIGEN 2 ANTIGEN 3 ANTIGEN 4 Strong vaccine- induced ,poly- epitope ex vivo CD8+ T-cell responses across different cancer types3 10.3% 10.1% HPV16-E7 Head & Neck Cancer BNT113, HARE40 trial Mutant Neoantigen TNBC, BNT114 TNBC-MERIT trial 5% MAGE-A3 Melanoma, BNT111, Lipo-MERIT trial 2.1% NY-ESO-1 Melanoma , BNT111, Lipo-MERIT trial mRNA- lipoplex platform Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space with Two Approaches Described in Castle et al., Cancer Res 2011 Described in Sahin et al., Nature 2017


 
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios 15 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phase 1 Melanoma Phase 2 HPV16+ HNSCC Phase 2 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab + Atezolizumab + Cemiplimab + Pembrolizumab Monotherapy, + Cemiplimab or CTx or aCTLA4 Recruitment ongoing Recruitment ongoing Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024 Recruitment ongoing Data presented from investigator-initiated Ph 1 trial at ASCO 2022 & AACR 2024 and published (Rojas et al., Nature 2023) Follow up published in February 2025 (Sethna et al., Nature 2025) Study completed Ph 1 data on prototype vaccine published (Sahin et al., Nature 2017) Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data expected at future medical meeting. Enrollment completed Data presented at AACR 2020. Data ​published (Lopez et al., Nature Medicine 2025) Enrollment completed Positive topline data announced in 2024 Data presented from Ph 1 at multiple conferences incl. SITC 2021 and published (Sahin et al., Nature 2020)​ Recruitment ongoing Ph 2 data presented at multiple conferences incl.​ ESMO-IO 2022 Data from safety run-in of Ph 2 trial and Ph 1/2 IIT presented at ESMO 2024 Recruitment ongoing in Ph 2 in 1L NSCLC2 Ph 1 trial ongoing ​ Data presented at SITC 2023, AACR 2024 ​, and SITC 2024


 
B a s e li n e T C R c lo n o ty p e s Post-induction TCR clonotypes (log10) Autogene Cevumeran1 Induces Neoantigen Specific T cells in a Broad Range of Cancers 1. Partnered with Genentech, a member of the Roche Group P: Pre-existing D: De-novo a u to g e n e c e v u m e ra n T R B F re q u e n c y ( % ) a u to g e n e c e v u m e ra n + a te z o li z u m a b T R B F re q u e n c y ( % ) #TCRs 0P 0D n.d. # Neoantigens # Neoantigens Neoantigen-specific TCRs in post-induction blood and on-treatment tumor tissue #TCRs 0P 0D First-in-human study (NCT03289962) in advanced and metastatic solid tumors Autogene cevumeran1 monotherapy (n=30) Combination with atezolizumab (n=183) • Well tolerated safety profile • Strong neoantigen responses across broad spectrum of cancers • Poly-epitopic, long-lasting neoantigen specific responses (CD4+, CD8+) in 71% of patients • Expansion of pre-existing neoantigen T cells as well as induction of de novo T-cell responses • Immune therapy-induced T cells were found in biopsies of post-treatment tumor lesions Lopez et al. Autogene cevumuran with or without atezolizumab in advanced solid tumors, a Phase1 trial. Nature Medicine, 2025 16


 
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios 17 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phase 1 Melanoma Phase 2 HPV16+ HNSCC Phase 2 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab + Atezolizumab + Cemiplimab + Pembrolizumab Monotherapy, + Cemiplimab or CTx or aCTLA4 Recruitment ongoing Recruitment ongoing Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024. Recruitment ongoing Data presented from investigator-initiated Ph 1 trial at ASCO 2022 & AACR 2024 and published (Rojas et al., Nature 2023). Follow up published in February 2025 (Sethna et al., Nature 2025). Study completed Ph 1 data on prototype vaccine published (Sahin et al., Nature 2017). Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data expected at future medical meeting. Enrollment completed Data presented at AACR 2020. Data ​published (Lopez et al., Nature Medicine 2025) Enrollment completed Positive topline data announced in 2024​. Data presented from Ph 1 at multiple conferences incl. SITC 2021 and published (Sahin et al., Nature 2020)​. Recruitment ongoing Ph 2 data presented at multiple conferences incl.​ ESMO-IO 2022 Data from safety run-in of Ph 2 trial and Ph 1/2 IIT presented at ESMO 2024. Recruitment ongoing in Ph 2 in 1L NSCLC2 Ph 1 trial ongoing. ​ Data presented at SITC 2023, AACR 2024 ​, and SITC 2024.


 
18 1. Partnered with Genentech, a member of the Roche Group; 2. Nakamura et al., Nature Medicine, 2024; 3. Jones et al., JAMA Surgery 2019; 4. Conroy et al., JAMA Oncology 2022; 5:. Bajorin et al., 2021 NEJM. Evaluating Autogene Cevumeran1 in the Adjuvant Treatment Setting for Cancers of High Unmet Need Rationale for adjuvant setting Low tumor mass with residual cancer cells Healthier immune system and uncompromised T-cell function Resistance mechanisms, clonal heterogeneity and immune suppression not fully established Pancreatic Ductal Adenocarcinoma (PDAC) 69−75% relapse rate within 5 years after adjuvant therapy3,4 Phase 1 trial ongoing & published Rojas et al., ​Nature 2023 Sethna et al., Nature 2025 Randomized Phase 2 trial ongoing 11 months median DFS observed in ctDNA+ CRC after surgery2 Reinacher-Schick et al., ASCO 2024 Randomized Phase 2 trial ongoing First data expected in late 2025 / early 2026 Colorectal Cancer (CRC) Unmet medical need 40% of patients relapse within 2 years after adjuvant nivolumab5 Muscle-Invasive Urothelial Cancer (MIUC) FPI in Dec 2024 Randomized Phase 2 trial ongoing Micrometastasis


 
Financial Update Jens Holstein, Chief Financial Officer3


 
2024 Financial Execution Highlights1 20 Loss before tax €(2.77) €678m €2.8 bn €17.4 bn Total revenues Diluted loss per share Total cash plus security investments2 1. Numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. 2. Consists of cash and cash equivalents of €9,761.9 million, current security investments of €6,536.2 million and non-current security investments of €1,061.1 million, as of December 31, 2024. Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the NIH are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the first quarter of 2025. The settlement payment of $467 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company’s second quarter 2025 financial results. In connection with these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026.


 
General and administrative expenses (124) (531) Other operating result (54) (671) Operating profit / (loss) 526 (1,314) Sales and marketing expenses (18) (68) Cost of sales (179) (541) Years ended December 31, (495) (188) 690 (63) (600) Research and development expenses (578) (2,254) (1,783) Finance result 137 637 496 Income taxes (205) 12 (256) Net profit / (loss) 458 (665) 930 Earnings / (Loss) per share <blank> Total Revenues 1,479 2,751 3,819 2023 2024 2023 Three months ended December 31, Basic earnings / (loss) per share 1.90 (2.77) 3.87 Diluted earnings / (loss) per share 1.88 (2.77) 3.83 (in millions €, except per share data) 2024 1,190 (244) (612) (21) (111) (54) 149 153 (42) 260 1.08 1.08 <blank><blank> <blank> Q4 and FY 2024 Financial Results 1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table. Presentation of the consolidated statements of profit or loss has been condensed. More information can be found in BioNTech’s Report on Form 20-F for the year ended December 31, 2024, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/. 1 21


 
22 Full Year 2024 Results Compared to Full Year 2024 Financial Guidance FY 2024 revenues Total revenues €2,500 – €3,100 m Expected to be at low end €2,751 m FY 2024 expenses and capex R&D expenses €2,400 – €2,600 m €2,254 m SG&A expenses €600 – €700 m €599 m Capital expenditures for operating activities €300 – €400 m €307 m Guidance November 2024 FY 2024 Results1 1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table. Presentation of the consolidated statements of profit or loss has been condensed. More information can be found in BioNTech’s Report on Form 20-F for the year ended December 31, 2024, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/.


 
23 1. Excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization, as well as potential changes to the law or governmental policy, including public health policy, at the state or national level, and evolving public sentiment around vaccines and mRNA technology, in the United States and/or elsewhere. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year. 2025 Financial Year Guidance1 Revenue guidance considerations • Our revenue guidance assumes relatively stable vaccination rates, pricing and market share as compared to 2024. We also anticipate a revenue phasing similar to 2024 with the last 3-4 months driving the full year revenue figure. • Inventory write-downs and other charges are estimated to be ~15% of BioNTech’s share of gross profit from COVID-19 vaccines sales in Pfizer’s territory • Anticipated revenues related to service businesses include InstaDeep, JPT Peptide and IMFS as well as revenues from the German pandemic preparedness agreement Planned FY 2025 revenues Total revenues €1,700 – €2,200 m Planned FY 2025 expenses and capex4 R&D expenses €2,600 – €2,800 m SG&A expenses €650 – €750 m Capital expenditure for operating activities €250 – €350 m FY 2025 Guidance


 
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer


 
25 Partnered with: 1. DualityBio; 2. Pfizer. Strategic Priority Areas in 2025 mRNA Cancer Immunotherapy BNT327 Commercial Readiness in Oncology COVID-19 Vaccine2 » Expect first randomized data in the adjuvant setting (CRC) » Execute 7 ongoing Phase 2 trials and first novel combination trials » Advance 3 global registration- enabling trials in potential fast-to-market indications » Generate first BNT327+ ADC combination datasets » Advance BNT323/DB-13031 towards BLA submission » Continue to build targeted AI-enabled commercialization team in key markets » Maintain global COVID-19 vaccine market leadership » Advance next-gen and combination vaccine programs 2025


 
26 Partnered with: 1. DualityBio; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron. Selected Pipeline Milestones for 2025 and Beyond Program Indication 2025+ Milestone Next-generation immunomodulator BNT327 1L SCLC China Phase 2 data 1L/2L SCLC Global Phase 2 dose optimization data 1L/2L TNBC Global Phase 2 dose optimization data BNT327 + BNT3251 Solid tumors Global Phase 1 data mRNA cancer immunotherapy Autogene cevumeran (BNT122 / RO7198457)2 ctDNA+ adj. CRC Phase 2 data BNT1113 2L+ melanoma Phase 2 data BNT1163 PD-L1 > 1% NSCLC Phase 1 data Targeted therapy BNT3231 2L+ HER2 EC Phase 2 data Regulatory submission


 
Save the date Annual General Meeting May 16, 2025 Innovation Series Digital & AI Day October 1, 2025 Innovation Series R&D Day November 18, 2025


 
Thank you


 
Appendix


 
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. MediLink Therapeutics; 4. OncoC4; 5. DualityBio. 6. In collaboration with Regeneron; 7. Trial ongoing in China only. BNT327 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx BNT316/ONC-392 (gotistobart)4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HR+/HER2-low met. breast cancer BNT1116 aPD(L)1-R/R melanoma, + cemiplimab BNT113 1L rel./met. HPV16+ PDL-1+ HCN, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 1L adv. melanoma, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 Adj. ctDNA+ stage II or III CRC BNT1166 1L adv. PD-L1  50% NSCLC, + cemiplimab Autogene cevumeran (BNT122/RO7198457)1 Adj. PDAC, + atezolizumab + mFOLFIRINOX BNT316/ONC-392 (gotistobart)4 (CTLA-4), PROC, + pembrolizumab BNT327 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 Adj. MIUC, + nivolumab BNT327 (PD-L1 x VEGF-A) 2L SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx7 BNT327 (PD-L1 x VEGF-A) EGFR TKI experienced, EGFRm NSCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L MPM, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L HCC + CTx7 BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx7 Phase 3Phase 2 mRNA immunotherapy Next generation IO Targeted therapy BNT327 (PD-L1 x VEGF-A) 1L SCLC, + CTx NEW BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx NEW BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx PLANNED BNT211 (CLDN6) CLDN6+ testicular cancer PLANNED BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HER2+ endometrial cancer PLANNEDBNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 30


 
BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. In collaboration with Regeneron; 4. MediLink Therapeutics; 5. OncoC4; 6. DualityBio. 7. Trial ongoing in China only. Phase 1/2Phase 1 BNT211 (CLDN6) Multiple solid tumors BNT312/GEN10422 (CD40x4-1BB) Multiple solid tumors BNT316/ONC-392 (gotistobart)5 (CTLA-4) Multiple solid tumors BNT142 (CD3xCLDN6) Multiple CLDN6-pos. adv. solid tumors BNT325/DB-13056 (TROP-2) Multiple solid tumors BNT323/DB-13036 (trastuzumab pamirtecan) (HER2) Multiple solid tumors BNT324/DB-13116 (B7-H3) Multiple solid tumors BNT221 Refractory metastatic melanoma BNT116 Adv. NSCLC BNT314/GEN10592 (EpCAMx4-1BB) Multiple solid tumors BNT326/YL2024 (HER3) Multiple solid tumors BNT316/ONC-392 (gotistobart)5 (CTLA-4) mCRPC, + radiotherapy BNT315/GEN10552 (OX40) Multiple solid tumors BNT327 / BNT3256 combination Multiple solid tumors BNT327 (PD-L1 x VEGF-A) 1L TNBC7 BNT327 (PD-L1 x VEGF-A) Multiple solid tumors7 BNT152 + BNT153 (IL-7, IL-2) Multiple solid tumors BNT327 / PM1009 combination 1L HCC7 mRNA immunotherapy Next generation IO Targeted therapy BNT3173 Multiple solid tumors NEW BNT322/GEN10562 Multiple solid tumors BNT327 / BNT3236 (trastuzumab pamirtecan) combination Multiple solid tumors NEW BNT327 / BNT3246 combination Multiple solid tumors PLANNED BNT327 / BNT3264 combination Multiple solid tumors PLANNED Autogene cevumeran (BNT122/RO7198457)1 Multiple solid tumors 31


 
Abbreviation Directory n L nth line Fab Fragment antigen binding NY-ESO-1 New York esophageal squamous cell carcinoma-1 AACR American Association for Cancer Research FPI First patient in ORR Objective response rate ADC Antibody-drug conjugate GI Gastrointestinal OS Overall survival adj. Adjuvant cGMP Current Good manufacturing practice PD Progressive disease AI Artificial intelligence HCC Hepatocellular carcinoma PDAC Pancreatic ductal adenocarcinoma AIOM Associazione Italiana di Oncologia Medica HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PD-L1 Programmed cell death protein ligand 1 ASCO American Society of Clinical Oncology HNC Head and neck cancer PFS Progression-free survival BLA Biologics License Applications HNSCC Head and neck squamous cell carcinoma PR Partial response CLDN6 Claudin 6 HPV Human papilloma virus PROC Platinum-resistant ovarian cancer CPI Checkpoint inhibitor HR Hormone receptor RCC Renal cell carcinoma CR Complete response IHC Immunohistochemistry R&D Research and development CRC Colorectal cancer IIT Investigator initiated trial R/R Relapsed/refractory CRPC Castration resistant prostate cancer iNeST Individualized NeoAntigen-Specific Therapy SABCS San Antonio Breast Cancer Symposium ctDNA Circulating tumor DNA IO Immuno-oncology SG&A Selling, general and administrative expenses CTLA Cytotoxic T-lymphocyte-associated protein ITT Intention to treat SCLC Small cell lung cancer CTx Chemotherapy JAMA Journal of the American Medical Association SD Stable disease DCR Disease control rate MAGE-A3 Melanoma antigen A3 SITC Society of Immunotherapy of Cancer DFS Disease-free survival met Metastatic TCR T-cell receptor DO Dose optimization MIUC Muscle-invasive urothelial carcinoma TKI Tyrosine kinase inhibitor E2E End to end MoA Mechanism of Action TME Tumor microenvironment EC Endometrial cancer MPM Malignant pleural mesothelioma TNBC Triple-negative breast cancer EGFR Epidermal growth factor receptor mRNA Messenger ribonucleic acid TROP2 Trophoblast cell-surface antigen 2 elcc European Lung Cancer Congress NCT National clinical trial UC Urothelial cancer EpCAM Epithelial cell adhesion molecule NEJM The New England Journal of Medicine UK United Kingdom ESMO European Society for Medical Oncology NEN Neuroendocrine neoplasm U.S. United States ES-SCLC Extensive-stage small cell lung cancer NIH National Institutes of Health VEGF-A Vascular endothelial growth factor A EU4 Includes Germany, France, Italy and Spain NSCLC Non-small cell lung cancer VHH Heavy chain variable 32