BioNTech SE · NASDAQ:BNTX
BioNTech — Q1 2025 Earnings Presentation
30 slides from BioNTech's earnings presentation, May 5, 2025
Slide 1: 1st Quarter 2025 Financial Results & Corporate Update
May 5th, 2025 1st Quarter 2025 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: 1st Quarter 2025 Update
1 1st Quarter 2025 Update 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: 1st Quarter 2025 Updates
1 1st Quarter 2025 Updates 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: Progress in Q1 2025 Towards Our Strategic Goals
Progress in Q1 2025 Towards Our Strategic Goals Execution in Oncology Presented Phase 2 data1 for BNT327 in 1L SCLC BNT327 Reported first BNT327+ADC combo data1 with TROP2- targeting ADC, BNT325/DB-13052 Reported Phase 1 data1 for BNT1163 in NSCLC mRNA Cancer Immunotherapies Published two manuscript
Slide 7: We are Uniquely Positioned to Combine Approaches to Transform Cancer Care
We are Uniquely Positioned to Combine Approaches to Transform Cancer Care Immunomodulators • Focus on the critical IO pathways Immunomodulators • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect Synergy1 Synergy1 Targeted therapies mRNA canc
Slide 8: Our Priorities are Novel mRNA Cancer Immunotherapy and Next-Generation IO-Backbone
Our Priorities are Novel mRNA Cancer Immunotherapy and Next-Generation IO-Backbone 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
Slide 9: Oncology Pipeline Update
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer
Slide 10: Advancing Towards Commercial Stage in Oncology
Advancing Towards Commercial Stage in Oncology mRNA Cancer BNT327 Immunotherapies BNT323/DB-13031 BNT327 data continue to support Updates for off-the-shelf and Advance BNT323/DB-13031 towards potential as a next-generation IO- individualized mRNA cancer BLA submission backbone for combination approa
Slide 11: BNT327: Synergistic Targeting of PD-L1 and VEGF
BNT327: Synergistic Targeting of PD-L1 and VEGF NSCLC IHC1 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 effects BNT327 Anti-PD-L1 (VHH) Anti-VE
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: BNT327 Combined With Chemotherapy in 1L TNBC
BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L TNBC Irrespective of PD-L1 Status in Phase 1/2 Study Unmet medical need remains high for patients with TNBC Patients with Stage IV TNBC1 have a 5-year survival rate of 10% Phase 1/2 Study (NCT05918133): Interim overall survival
Slide 14: BNT327 Combined With Chemotherapy in 1L ES-SCLC
BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L ES-SCLC in Phase 2 Study Unmet medical need remains high for patients with ES-SCLC Patients with ES-SCLC1 have a 5-year survival rate of 3% Phase 2 Study (NCT05844150): Emerging efficacy profile Ying Cheng et al. presented at EL
Slide 15: Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally
Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1 2030 U.S., EU4, U.K. Treatment outcomes vary based on histology and PD-L1 levels in NSCLC projected incidence1 ~415k 1L NSCLC patients without actionable genomic alterations Non-squamous (~ 70%)3 Squamous (~ 30%)3 NSCLC Sta
Slide 16: BNT327 Indicates Single Agent Activity in 1L NSCLC
BNT327 Indicates Single Agent Activity in 1L NSCLC in Phase 1b/2a Study Phase 1b/2a (NCT05918445); Cohort 1: 1L NSCLC (EGFR & ALK WT) Wu, C. et al. presented at ASCO 2024 60 PD-L1 ≥50% SD 50 SD PR Best change from baseline (%) 40 PD-L1 1–49% PR PD On Treatment 30 Change from baseline (%) 20 10 0 −10
Slide 17: ROSETTA Lung-02 – Our First Global Registrational Trial in NSCLC
ROSETTA Lung-02 – Our First Global Registrational Trial in NSCLC A Phase 2/3, multisite, randomized global trial of BNT327 in combination with chemotherapy in first-line non-small cell lung cancer (NCT06712316) Key eligibility criteria Phase 2 (n=40) Phase 3 (n=942) • Treatment naïve Stage IIIB/IIIC
Slide 18: BioNTech at ASCO 2025
BioNTech at ASCO 2025 Related Program Indication Content Phase 2/3 TiP BNT327 1L NSCLC (ROSETTA Lung-02) Across portfolio Phase 3 TiP BNT327 1L SCLC (ROSETTA Lung-01) Data for making informed decisions about the BNT327 1L Mesothelioma Phase 2 data direction of further development BNT3161 2L+ Melanom
Slide 19: Financial Update
3 Financial Update Jens Holstein, Chief Financial Officer
Slide 20: Q1 2025 Financial Results
Q1 2025 Financial Results Three months ended March 31 (in millions €, except per share data)1 2025 2024 Total Revenues 183 188 Cost of sales (84) (59) Research and development expenses (526) (508) Sales and marketing expenses (14) (16) General and administrative expenses (107) (117) Other operating
Slide 21: 2025 Financial Year Guidance Confirmed
2025 Financial Year Guidance Confirmed1 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
Slide 22: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 23: 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 » Continue to execute 7 ongoing » Continue to build targeted Phase 2 trials and first novel AI-ena
Slide 24: Save the date
Save the date Annual General Meeting May 16, 2025 Innovation Series R&D Day November 11, 2025
Slide 25: Thank you
—_ Thank you BIONT=Cr
Slide 26: Appendix
__. Appendix BIONT=Cr
Slide 27: Selected Pipeline Milestones in 2025 and Beyond
Selected Pipeline Milestones in 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 + BNT325/DB-13051 Solid tumors Global Phase 1
Slide 28: 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 BNT327 (PD-L1 x VEGF-A) NEW Autogene cevumeran (BNT122/RO7198457)1 BNT327 (PD-L1 x VEGF-A) Adj. ctDNA+ stage II or III CRC 2L NSCLC, + CTx 1L SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 BNT327 (PD-L1 x VEGF-A)
Slide 29: 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 30: Abbreviation Directory
Abbreviation Directory nL nth line EU4(5) Includes Germany, France, Italy, Spain (UK) OX40 CD134 AACR American Association for Cancer Research Fab Fragment antigen binding PD Progressive disease ADC Antibody-drug conjugate FixVac Fixed Antigen Vaccine PDAC Pancreatic ductal adenocarcinoma adj. Adjuv