BioNTech SE · NASDAQ:BNTX
BioNTech — FY2024 Earnings Presentation
32 slides from BioNTech's earnings presentation, Mar 10, 2025
Slide 1: 4th Quarter and Full Year 2024 Financial Results & Corporate Update
March 10, 2025 4th Quarter and Full Year 2024 Financial Results & Corporate Update
Slide 2: This Slide Presentation Includes Forward-Looking Statements
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/
Slide 3: Agenda
1 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer 2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer 3 Financial Update Jens Holstein, Chief Financial Officer 4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 4: 4th Quarter and FY 2024 Highlights
1 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer
Slide 5: Building a Global Immunotherapy Powerhouse
Building a Global Immunotherapy Powerhouse Translating Science into Survival
Slide 6: Advancing Toward Our Vision: Key Achievements in 2024
Advancing Toward Our Vision: Key Achievements in 2024 mRNA cancer Initiated a new Phase 2 trial evaluating autogene cevumeran1 immunotherapies and reported data2 for BNT1113, BNT113 and BNT1163 Presented multiple datasets2 for BNT327 and announced BNT327 pivotal trials targeting unmet needs in SCLC,
Slide 7: 2025 Will Be an Important Year for Our Oncology Portfolio
2025 Will Be an Important Year for Our Oncology Portfolio Novel mRNA cancer immunotherapy Our next-generation IO-backbone FixVac & iNeST1 PD-L1/VEGF-A antibody BNT327 Next-generation of personalized cancer therapy targeting Potential to become the next-generation IO-backbone tumor associated antigen
Slide 8: Biotheus Acquisition Provides Opportunity to Accelerate BNT327 Development
Biotheus Acquisition Provides Opportunity to Accelerate BNT327 Development Anti-VEGF-A Advancing BNT327 in multiple indications, aiming for first-to-market approvals Anti-PD-L1 VHH Acceleration and Establishment of clinical Manufacturing site Full pipeline and platform expansion of BNT327 developmen
Slide 9: Oncology Pipeline Update
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer
Slide 10: Building an Oncology Pipeline Focused on Late-Stage Programs
Building an Oncology Pipeline Focused on Late-Stage Programs with Transformational Potential Phase 2 Phase 3 Autogene cevumeran (BNT122/RO7198457)1 BNT327 (PD-L1 x VEGF-A) BNT327 (PD-L1 x VEGF-A) NEW 1L adv. melanoma, + pembrolizumab 1L/2L+ (ES-)SCLC, + CTx 1L SCLC, + CTx Autogene cevumeran (BNT122/
Slide 11: BNT327: Synergistic Targeting of PD-L1 and VEGF
BNT327: Synergistic Targeting of PD-L1 and VEGF Combined tumor targeting1 Selected NSCLC IHC2 Bispecific MOA Tumor microenvironment VEGF-A VEGF-A dimer (TME) Local neutralization of in the TME PD-L1 ligand angiogenic and on tumor cells immunosuppressive Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) VEGF-A effe
Slide 12: Accelerating BNT327 Global Clinical Development
Accelerating BNT327 Global Clinical Development Explore potential of BNT327 in three waves of focused development 1 Establish 2 Combine 3 Broaden Ongoing Ongoing Portfolio of 20+ clinical oncology • Phase 2 in TNBC • Phase 1/2 with BNT325/DB-13051 assets in-house • Phase 2 in SCLC (TROP2) in solid t
Slide 13: Small Cell Lung Cancer is One of Our Priority Indications
Small Cell Lung Cancer is One of Our Priority Indications for Clinical Development of BNT327 Phase 2 (NCT05879068): BNT327 Combined High unmet need for ES-SCLC patients as with Paclitaxel Shows Efficacy in 2L SCLC long-term survival outcomes remain very poor Ying Cheng et al. Presented at ESMO 2023
Slide 14: Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space
Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space with Two Approaches Artificial Individual intelligence-driven Individualized patient samples neoantigen immuno- Individualized (blood and tissue) prediction therapy 10.3% Neoantigens therapy Mutant Neoantigen TNBC,
Slide 15: Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC CRC PDAC Melanoma Solid tumors Melanoma HPV16+ HNSCC NSCLC Phase 2
Slide 16: Autogene Cevumeran Induces Neoantigen Specific T cells in a Broad Range of Cancers
Autogene Cevumeran1 Induces Neoantigen Specific T cells in a Broad Range of Cancers First-in-human study (NCT03289962) in advanced and metastatic solid tumors Baseline TCR clonotypes Autogene cevumeran1 monotherapy (n=30) Combination with atezolizumab (n=183) • Well tolerated safety profile • Strong
Slide 17: Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC CRC PDAC Melanoma Solid tumors Melanoma HPV16+ HNSCC NSCLC Phase 2
Slide 18: Evaluating Autogene Cevumeran in the Adjuvant Treatment Setting
Evaluating Autogene Cevumeran1 in the Adjuvant Treatment Setting for Cancers of High Unmet Need Rationale for adjuvant setting Unmet medical need Colorectal Cancer (CRC) Low tumor mass with 11 months median DFS observed Randomized Phase 2 trial ongoing residual cancer cells in ctDNA+ CRC after surge
Slide 19: Financial Update
3 Financial Update Jens Holstein, Chief Financial Officer
Slide 20: 2024 Financial Execution Highlights
2024 Financial Execution Highlights1 Total revenues Loss before tax € 2.8 bn € 678 m Diluted loss per share Total cash plus security investments2 € (2.77) € 17.4 bn 1. Numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. 2. Consists of cash and cash
Slide 21: Q4 and FY 2024 Financial Results
Q4 and FY 2024 Financial Results (in millions €, except per share data)1 Three months ended December 31, Years ended December 31, 2024 2023 2024 2023 Total Revenues 1,190 1,479 2,751 3,819 Cost of sales (244) (179) (541) (600) Research and development expenses (612) (578) (2,254) (1,783) Sales and m
Slide 22: Full Year 2024 Results Compared to Full Year 2024 Financial Guidance
Full Year 2024 Results Compared to Full Year 2024 Financial Guidance Guidance November 2024 FY 2024 Results1 FY 2024 €2,500 – €3,100 m Total revenues €2,751 m revenues Expected to be at low end R&D expenses €2,400 – €2,600 m €2,254 m FY 2024 SG&A expenses €600 – €700 m €599 m expenses and capex Capi
Slide 23: 2025 Financial Year Guidance
2025 Financial Year Guidance1 FY 2025 Guidance Planned FY 2025 revenues Total revenues €1,700 – €2,200 m R&D expenses €2,600 – €2,800 m Planned FY 2025 SG&A expenses €650 – €750 m expenses and capex4 Capital expenditure for operating activities €250 – €350 m • Our revenue guidance assumes relatively
Slide 24: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 25: Strategic Priority Areas in 2025
Strategic Priority Areas in 2025 mRNA Cancer Immunotherapy Commercial Readiness in Oncology » Expect first randomized data in » Advance BNT323/DB-13031 the adjuvant setting (CRC) towards BLA submission » Execute 7 ongoing Phase 2 trials » Continue to build targeted and first novel combination trials
Slide 26: Selected Pipeline Milestones for 2025 and Beyond
Selected Pipeline Milestones for 2025 and Beyond Program Indication 2025+ Milestone 1L SCLC China Phase 2 data Next-generation BNT327 1L/2L SCLC Global Phase 2 dose optimization data immunomodulator 1L/2L TNBC Global Phase 2 dose optimization data BNT327 + BNT3251 Solid tumors Global Phase 1 data Au
Slide 27: Save the date
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
Slide 28: Thank you
—_ Thank you BIONT=Cr
Slide 29: Appendix
__. Appendix BIONT=Cr
Slide 30: BioNTech's Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Phase 2 Phase 3 Autogene cevumeran (BNT122/RO7198457)1 BNT327 (PD-L1 x VEGF-A) BNT327 (PD-L1 x VEGF-A) NEW 1L adv. melanoma, + pembrolizumab 1L/2L+ (ES-)SCLC, + CTx 1L SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 BNT327 (PD-L1
Slide 31: BioNTech's Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials
BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials Phase 1 Phase 1/2 Autogene cevumeran (BNT122/RO7198457)1 BNT142 (CD3xCLDN6) BNT327 (PD-L1 x VEGF-A) Multiple solid tumors Multiple CLDN6-pos. adv. solid tumors 1L TNBC7 BNT116 BNT312/GEN10422 (CD40x4-1BB) BNT327 (PD-L1 x VEGF-A) Ad
Slide 32: Abbreviation Directory
Abbreviation Directory nL 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