BioNTech SE · NASDAQ:BNTX
BioNTech — Q1 2024 Earnings Presentation
35 slides from BioNTech's earnings presentation, May 6, 2024
Slide 1: 1st Quarter 2024 Financial Results & Corporate Update
1st Quarter 2024 Financial Results & Corporate Update May 6, 2024
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 2024 Highlights
1 1st Quarter 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer 2 Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer 3 Financial Results Jens Holstein, Chief Financial Officer 4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 4: 1st Quarter 2024 Highlights
1 1st Quarter 2024 Highlights Ugur Sahin, Founder & Chief Executive Officer
Slide 5: 2024 Strategic Priorities and Achievements in Q1 2024
2024 Strategic Priorities and Achievements in Q1 2024 Clinical Execution in Oncology First patient dosed in Phase 3 clinical trial evaluating our HER2 ADC BNT323/DB-13031 in HR+/HER2-low breast cancer Presented clinical data at AACR for our mRNA cancer vaccines autogene cevumeran (BNT122)2 in PDAC a
Slide 6: Addressing the Fundamental Challenge in Cancer Treatment
Addressing the Fundamental Challenge in Cancer Treatment Intraindividual variability & intratumoral heterogeneity driving Cancer cells evasion and secondary resistance mechanism Mutations DNA Mutation Mutations Mutations Healthy Mutations Cell Mutations Individual patients 5-20 years – up to 10,000
Slide 7: Our Oncology Approach
Our Oncology Approach Goals Strategy Address the continuum of cancer Portfolio covering compound classes with synergistic mechanisms of action Bring novel therapies to cancer patients and establish new treatment paradigms • Immunomodulators Open up novel options to combine platforms and • Targeted t
Slide 8: Towards a Potentially Curative Approach to Cancer: Differentiated Combinations
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations Immunomodulators • Focus on the most relevant and crucial IO Immunomodulators pathways Novel checkpoint inhibitors, • Targeting different complementary players in the complex cancer immunity cycle may promote a cytokines,
Slide 9: Our Next Stage of Growth in Oncology
Our Next Stage of Growth in Oncology 2024 2025 2026+ 10+ potentially registrational Plan to start combination trials trials in 2024 Pivotal data updates in 2025 and beyond to support potential submissions Potential launches in multiple Build out commercial organization ahead of potential launches in
Slide 10: Pipeline Update
2 Pipeline Update Özlem Türeci, Co-Founder & Chief Medical Officer
Slide 11: Our Multi-Platform Immuno-Oncology Pipeline Today
Our Multi-Platform Immuno-Oncology Pipeline Today Phase 1 Phase 1/2 Phase 2 Phase 3 BNT116 BNT142 (CD3xCLDN6) BNT1112 BNT316/ONC-392 (gotistobart)4 (CTLA-4) Adv. NSCLC Multiple CLDN6-pos. adv. solid tumors aPD(L)1-R/R melanoma, + cemiplimab anti-PD-1/PD-L1 experienced NSCLC Autogene cevumeran (BNT12
Slide 12: Focus on Clinical Trial Execution in Oncology
Focus on Clinical Trial Execution in Oncology Select ongoing mid- to late-stage trials Average quarterly patient enrollment in trials* BNT316/ONC-392 (gotistobart)1 Phase 600 anti-PD-1/PD-L1-experienced NSCLC 3 BNT323/DB-13032 500 Phase # of Patients Enrolled HR+, HER2-low met. breast cancer 3 400 +
Slide 13: BNT327/PM8002: a PD-L1/VEGF-A Targeting Bispecific Antibody
BNT327/PM80021: a PD-L1/VEGF- A Targeting Bispecific Antibody Ongoing trials across several indications Plan to start 2 pivotal trials Strong single compound activity, and high ORRs and favorable safety profile established in end 2024/begin 2025 observed in combination with CTx in various in > 600 p
Slide 14: BioNTech – Full Exploitation of Cancer Vaccine Target Space
BioNTech – Full Exploitation of Cancer Vaccine Target Space Artificial intelligence- Individual driven Individualized patient samples neoantigen immuno- Neo- Individualized (blood and tissue) prediction therapy antigens therapy 10.3% Mutant Neoantigen iNeST1,* TNBC, BNT114 TNBC-MERIT trial individua
Slide 15: High-Magnitude, Sustained Immunity upon Neoantigen mRNA Vaccination
High-Magnitude, Sustained Immunity upon Neoantigen mRNA Vaccination Vaccine-induced T cells persist over multiple years T cells are high-magnitude T cells are multiclonal T cells are functional Vaccine Booster P01 PPP1R15B(S278T) Percentage of all blood cells 6 Multimer+ Per cent of CD8+ COX7A2(A84V
Slide 16: Growing Portfolio of Cancer Vaccine Candidates Across Multiple Solid Tumors
Growing Portfolio of Cancer Vaccine Candidates Across Multiple Solid Tumors Six ongoing Phase 2 trials with cancer vaccine candidates in multiple disease settings Individualized vaccine: iNeST1 FixVac Adjuvant 1L R/R R/R Post-adj. Neo-adj, mCR 1L Multiple settings CRC PDAC Melanoma Solid Tumors Mela
Slide 17: Autogene Cevumeran (BNT122) Phase 2 Trial in Adjuvant Colorectal Cancer
Autogene Cevumeran (BNT122)1 Investigated in a Phase 2 Randomized Trial vs Watchful Waiting in Adjuvant Colorectal Cancer Phase 2, multi-site, open-label, randomized, controlled trial (NCT04486378) Inclusion criteria Adjuvant SoC chemotherapy for 12–24 weeks Autogene cevumeran (BNT122) 15 doses: 6×q
Slide 18: Autogene Cevumeran (BNT122) Phase 2 Trial vs SoC in Resected PDAC
Autogene Cevumeran (BNT122)1 Investigated in a Phase 2 Randomized Trial vs SoC in Resected PDAC IMCODE003: Phase 2, open-label, multicenter, randomized trial (NCT05968326) Inclusion criteria Randomization Treatment phases and dosing schedules • Patients with resected 6-12 weeks During the study, pat
Slide 19: Autogene Cevumeran (BNT122) Vaccine Response Correlates with Delayed PDAC Recurrence
Autogene Cevumeran (BNT122)1 Vaccine Response Correlates with Delayed PDAC Recurrence Phase 1, investigator-initiated trial in resectable PDAC: 3-year follow-up data Balachandran V et al. Presented at AACR 2024. # CT025 & Rojas et al. Nature. 2023. 1.5-year median follow-up 3-year median follow-up I
Slide 20: FixVac: Identification of Shared Tumor Antigen Sets
FixVac: Identification of Shared Tumor Antigen (TAA) Sets that Cumulatively Cover a Major Proportion of Patients Target selection for BNT116 – lung cancer1 Expression of tumor-associated antigens2,3,4 RNAseq Databases TCGA: 466 lung adenocarcinoma Next (LUAD) 261 Candidates Generation TCGA: 415 lung
Slide 21: BNT116: Broad Evaluation in NSCLC as Monotherapy and in Combination
BNT116: Broad Evaluation in NSCLC as Monotherapy and in Combination LuCa-MERIT-1: EmpowerVax-Lung1: FIH, Open Label Phase I Trial Evaluating Safety, Tolerability, and Preliminary Phase 2 Study of Cemiplimab in Combination with BNT116 vs. Cemiplimab Efficacy of BNT116 Alone and in Combinations in NSC
Slide 22: Preliminary Results of BNT116 Show Encouraging Antitumor Activity
Preliminary Results of BNT116 Show Encouraging Antitumor Activity and Manageable Safety Profile in Combination with Docetaxel Phase 1 FIH study (NCT05142189): Clinical activity and tolerability Öven BB. et al. Presented at AACR 2024. #CT051. Best overall response 30 Cohort 3 60 Change of target lesi
Slide 23: BioNTech at ASCO 2024
BioNTech at ASCO 2024 Related Program Indication Study BNT311/ 2L non-small cell lung cancer Phase 2 GEN1046 (acasunlimab)1 Across portfolio Cervical cancer and platinum- BNT327/PM80022 Phase 1/2 Data for making informed resistant ovarian cancer decisions about the direction of further development B
Slide 24: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 25: Q1 2024 Key Financial Figures
Q1 2024 Key Financial Figures1 Total revenues (Loss) before tax € 188 m € (332) m (Loss) per Share Total cash plus security investments2 € (1.31) € 16.9 bn 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standar
Slide 26: Q1 2024 Financial Results
Q1 2024 Financial Results Three months ended March 31st Three months ended March 31st (in millions €, except per share data)1 2024 2023 Revenues2 187.6 1,277.0 Cost of sales (59.1) (96.0) Research and development expenses (507.5) (334.0) Sales and marketing expenses (15.6) (12.2) General and adminis
Slide 27: 2024 Financial Year Guidance Reiterated
2024 Financial Year Guidance Reiterated1 FY 2024 Guidance FY 2024 Total revenues €2,500 – €3,100 m revenues R&D expenses2 €2,400 – €2,600 m FY 2024 expenses, operating income and SG&A expenses3 €700 – €800 m capex4 Capital expenditure for operating activities €400 – €500 m • Vaccination rates and pr
Slide 28: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 29: COVID-19 Vaccine Market Dynamics and Outlook
COVID-19 Vaccine Market Dynamics and Outlook1 Potential expedited timeline for variant-adapted vaccine development Vaccine WHO/ICMRA and EMA Expected regulatory Expected Launch & Shipment shortly Development strain recommendations submissions after approvals received for JN.1 variant Possible EU Pos
Slide 30: Innovative and Diversified Pipeline Poised to Drive Long-Term Growth
Innovative and Diversified Pipeline Poised to Drive Long-Term Growth Investing in innovative therapies across drug classes with blockbuster potential Data Potential Update(s) First Drug Class Potential Market Opportunity1 Expected in Submission 2024 or 2025 Year mRNA cancer Establish new pillar of i
Slide 31: Investing Through Waves of Innovation with the Aim to Transform Medicine
Investing Through Waves of Innovation with the Aim to Transform Medicine Near Term Mid Term Long Term Multi-product immunotherapy Company 10+ mid- to late- 1st wave of oncology launches Goal of 10 indication stage trials in 2024: planned from 2026 onwards approvals in oncology by 2030 Build out comm
Slide 32: Save the date
Save the date Annual General Meeting May 17, 2024 Innovation Series: Digital & AI October 1, 2024 Innovation Series November 14, 2024
Slide 33: Thank you
—_ Thank you BIONT=Cr
Slide 34: Appendix
__. Appendix BIONT=Cr
Slide 35: Advancing our Pipeline: Select Data Milestones in 2024
Advancing our Pipeline: Select Data Milestones in 2024 Program Indication Targeted Milestone BNT311/GEN1046 (acasunlimab)1 R/R met. NSCLC, +/- pembrolizumab Phase 2 data BNT312/GEN10421 Multiple solid tumors Ph1/2 expansion cohort data BNT316/ONC-392 (gotistobart)2 Multiple solid tumors Ph1/2 expans