BioNTech SE · NASDAQ:BNTX
BioNTech — Q3 2024 Earnings Presentation
30 slides from BioNTech's earnings presentation, Nov 4, 2024
Slide 1: 3rd Quarter 2024 Financial Results & Corporate Update
3rd Quarter 2024 Financial Results & Corporate Update November 4, 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: Agenda and presenters
1 3rd Quarter 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer 2 COVID-19 & Oncology 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: 3rd Quarter 2024 Highlights
1 3rd Quarter 2024 Highlights Ugur Sahin, Founder & Chief Executive Officer
Slide 5: Q3 2024 Highlights
Q3 2024 Highlights Execution in COVID-19 Franchise1 Successfully launched variant-adapted COVID-19 vaccines1 for the 2024/2025 vaccination season in multiple regions Progress in Oncology Pipeline BNT327/PM80022 mRNA Cancer Vaccine Candidates Presented clinical data for BNT327/PM80022 showcasing pan-
Slide 6: Developing the Next Generation of Cancer Medicines
Developing the Next Generation of Cancer Medicines: Leveraging Our Multi-Modal Technology Portfolio for Combination Approaches Immunomodulators BNT327/PM80021 Space for Space for synergies synergies Space for potentially curative approaches Targeted mRNA therapies Space for vaccines FixVacs synergie
Slide 7: COVID-19 & Oncology Pipeline Update
2 COVID-19 & Oncology Pipeline Update Özlem Türeci, Chief Medical Officer
Slide 8: Continuous Evolution of SARS-CoV-2 Has Led to Differing Regulatory Recommendations Globally
The Continuous Evolution of SARS-CoV-2 Has Led to Differing Regulatory Recommendations Globally EC UK U.S. Canada Japan JN.1-adapted KP.2-adapted mRNA vaccine technology enables us to rapidly meet regulators’ specific recommendations in different regions and allows for timely availability of vaccine
Slide 9: COVID-19 and Influenza Disease Burden Show Different Seasonality Patterns
COVID-19 and Influenza Disease Burden Show Different Seasonality Patterns 10 COVID-19 Susceptibility to Hospitalization rate per 100,000 population 8 Influenza infection remains a 2023 - 2024 6 concern after the winter vaccination 4 season. 2 0 Potential need for 12 additional vaccination 10 later i
Slide 10: Oncology Pipeline with Three New Phase 2 Trials
Oncology Pipeline with Three New Phase 2 Trials: BNT327/PM80026 and Autogene Cevumeran (BNT122/RO7198457)1 Phase 1 Phase 1/2 Phase 2 Phase 3 BNT116 BNT142 (CD3xCLDN6) BNT1117 BNT316/ONC-392 (gotistobart)3 (CTLA-4) Adv. NSCLC Multiple CLDN6-pos. adv. solid tumors aPD(L)1-R/R melanoma, + cemiplimab an
Slide 11: BNT327/PM8002 - A Next-Gen Investigational IO Agent
BNT327/PM80021 – A Next-Gen Investigational IO Agent that Combines Two Clinically Validated MoAs Dual blockade of PD-L1 and VEGF-A has “Two-in-one” mechanism of action demonstrated clinical synergy Anti-VEGF-A (IgG) • Encouraging safety/activity profile with over 700 patients treated to date • Monot
Slide 12: BNT327/PM8002 Investigated in More Than 700 Patients Across 10+ Indications
BNT327/PM80021 Mono and Combo Have Been Investigated in More Than 700 Patients Across 10+ Indications Mono Combo Mono Combo 1L NSCLC WT PD-L1+ Breast 1L TNBC (+ Nab-Paclitaxel) 2L+ NSCLC (+ Pemetrexed/Carboplatin) 1L HCC (+ FOLFOX4) EGFRm Lung Gastro- intestinal 2L SCLC (+ Paclitaxel) Advanced BTC 1
Slide 13: Extensive Clinical Data Demonstrates Pan-Tumor Potential of BNT327/PM8002
Extensive Clinical Data Collection Demonstrates Pan-Tumor Potential of BNT327/PM80021 TNBC2 SCLC3 NSCLC4,5 CC6 PROC6 ccRCC7 nccRCC7 2L 2L/3L 1L 1L4 2L4 2L+ 1L+ 2L 1L Overall EGFRm 5 BNT327 nab- carboplatin + mono or paclitaxel mono mono mono mono mono mono paclitaxel pemetrexed combination N 42 36 1
Slide 14: BNT327/PM8002 Efficacy in Metastatic Triple Negative Breast Cancer
BNT327/PM80021 Shows Clinically Meaningful Efficacy in Metastatic Triple Negative Breast Cancer (mTNBC) Phase 1/2 (NCT05918133): clinical activity in combination with nab-paclitaxel by PD-L1 status in 1L TNBC Yanchun Meng et al., ESMO 2024, Presentation #348MO 40 PD-L1 PD-L1 PD-L1 Best Change from B
Slide 15: Global Clinical Development Strategy for BNT327/PM8002
Global Clinical Development Strategy for BNT327/PM80021 Explore potential of BNT327/PM80021 in three waves of focused development 1 2 3 Combine with SoC chemotherapy in potential Fast-to-Market indications Explore novel combinations with ADCs in high unmet need indications Ongoing Ongoing Expand che
Slide 16: Positive FixVac Topline Data and Start of iNeST Phase 2 MIUC Trial
Positive FixVac Topline Data and Start of iNeST Phase 2 MIUC Trial Highlight Execution in Cancer Vaccine Portfolio Select iNeST and FixVac trials based on BioNTech’s mRNA-LPX technology platform Individualized vaccine: iNeST1 FixVac Adjuvant 1L R/R R/R 1L Multiple settings MIUC CRC PDAC Melanoma Sol
Slide 17: Evaluating Autogene Cevumeran in the Adjuvant Treatment Setting
Evaluating Autogene Cevumeran in the Adjuvant Treatment Setting for Cancers of High Unmet Need Rationale for adjuvant setting Unmet medical need Pancreatic Ductal Adenocarcinoma Colorectal Cancer Low tumor mass with 69−75% relapse rate within 5 years 20-35% relapse rate within 4 years residual cance
Slide 18: Phase 2 Trial Evaluating Autogene Cevumeran in Adjuvant MIUC
Phase 2 Trial Evaluating Autogene Cevumeran1 in the Adjuvant Setting in MIUC Unmet medical need Clinical trial design Inclusion criteria Part A: Safety run-in Part B: Randomized Standard of care phase • Age 18 years • Neoadjuvant chemotherapy, followed • Histologically confirmed MIUC or Autogene E
Slide 19: Financial Update
3 Financial Update Jens Holstein, Chief Financial Officer
Slide 20: Q3 and YTD 2024 Financial Results
Q3 and YTD 2024 Financial Results (in millions €, except per share data)1 Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Revenues 1,244.8 895.3 1,561.1 2,340.0 Cost of sales (178.9) (161.8) (297.8) (420.7) Research and development expenses (550.3) (497.9) (1,642
Slide 21: 2024 Financial Year Guidance
2024 Financial Year Guidance1 Revenues Expected to be at Low End of Range and Reduced SG&A Expenses and Capex Guidance1 Guidance Guidance March 2024 November 2024 Commentary FY 2024 Expected to be at revenues Total revenues €2,500 – 3,100 m €2,500 – €3,100 m..... low end R&D expenses2 €2,400 – 2,600
Slide 22: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 23: Launch Progress in Q3 Reiterates Strength of COVID-19 Franchise
Launch Progress in Q3 Reiterates Strength of COVID-19 Franchise1 EC UK U.S. Canada Japan JN.1-adapted KP.2-adapted Dose switching from JN.1- to KP.2-adapted vaccines underway or expected in countries with both approved Vaccination rates are higher in the U.S. versus the comparable period in 20232 Sh
Slide 24: COVID-19 Vaccine Market Presents a Long-term Business Opportunity
COVID-19 Vaccine Market Presents a Long-term Business Opportunity Global Market Leadership Anticipate maintenance of high market share in U.S., EU and Japan Lean Fixed Cost Base Business Low OpEx leveraging partners’ global commercial infrastructure and sharing R&D expenses Potential for Cashflow Ge
Slide 25: Clinical Data Updates & Planned Regulatory Submissions in 2025 on Track
Clinical Data Updates & Planned Regulatory Submissions in 2025 on Track Based on Strong Execution in 2H 2024 2H 2H 2024 2024 2025+ 2025+ COMIRNATY1 COVID-19 / Flu BNT327/PM80022 COMIRNATY1 BNT323/DB-13033 BNT327/PM80022 Updated variant-adapted Combination vaccine1 NSCLC, TNBC, RCC Updated variant-ad
Slide 26: Save the date
Save the date Innovation Series November 14, 2024 26
Slide 27: Thank you
Thank you BIONT=CrH
Slide 28: Appendix
__. Appendix BIONT=Cr
Slide 29: Program Updates Expected in 2024 and Beyond
Program Updates Expected in 2024 and Beyond Program Indication Trial Phase Anticipated Timing BNT1111 R/R Melanoma Phase 2 2025 BNT116 Advanced NSCLC Phase 1/2 2024 Autogene cevumeran Adjuvant ctDNA+ stage II (high risk)/III Phase 2 2025+ (BNT122/RO7198457)2 CRC BNT312/GEN10423 Multiple solid tumors
Slide 30: Abbreviations
Abbreviations nL nth line EpCAM Epithelial cell adhesion molecule NSCLC Non-small cell lung cancer AACR American Association for Cancer Research ESMO European Society for Medical Oncology NR Not reported ADC Antibody-drug conjugate GI Gastrointestinal (c)ORR (Confirmed) objective response rate adj.