BioNTech SE · NASDAQ:BNTX
BioNTech — Q2 2024 Earnings Presentation
36 slides from BioNTech's earnings presentation, Aug 5, 2024
Slide 1: 2nd Quarter 2024 Financial Results & Corporate Update
2nd Quarter 2024 Financial Results & Corporate Update August 5, 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
1 2nd 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: 2nd Quarter 2024 Highlights
1 2nd Quarter 2024 Highlights Ugur Sahin, Founder & Chief Executive Officer
Slide 5: Achievements in Q2 2024
Achievements in Q2 2024 COVID-19 Leadership Initiated global commercial roll-out of variant-adapted COVID-19 vaccines1 for the upcoming vaccination season Execution in Oncology Announced positive topline Phase 2 results for mRNA cancer vaccine FixVac candidate BNT1112 in cutaneous melanoma Presented
Slide 6: Lineage-Adapted Vaccines Expected to Improve Protection Against Severe COVID-19
Our SARS-CoV-2 Lineage-Adapted Vaccines are Expected to Improve Protection Against Severe COVID-19 Development of SARS-CoV-2 variants between June 2023 and May U.S. hospitalization real-world data Sep 25, 2023 - Feb 29, 2024 20241 No. of cases in total = 28,095 (17% of total ARI episodes)2 Percentag
Slide 7: Expedited Submissions Enable Timely Delivery of Adapted Vaccines
8/5/2024 Expedited Submissions Enable Timely Delivery and Earlier Availability of Vaccines Adapted to the Most Current SARS-CoV-2 Variants 13 June 26 June Mid September Monitoring of FDA KP.2 COMIRNATY1 KP.2 COMIRNATY1 KP.2 emerging SARS- CoV-2 variants recommendation Rolling FDA FDA approval & subm
Slide 8: Towards a Potentially Curative Approach to Cancer Based on Multiple Modalities
Towards a Potentially Curative Approach to Cancer based on Multiple Modalities and Differentiated Novel/Novel Therapeutic Combinations Autogene cevumeran (BNT122) BNT2111,2 + atezolizumab3,4,5 mRNA Cancer Cancer CAR + vaccines vaccine + IO vaccine Space for Space Space for synergies for synergies po
Slide 9: Pipeline Update
2 Pipeline Update Özlem Türeci, Chief Medical Officer
Slide 10: Our Multi-modality Immuno-Oncology Pipeline Today
Our Multi-modality 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 11: Focus on Clinical Trial Execution in Oncology
Focus on Clinical Trial Execution in Oncology Average quarterly patient enrollment in trials* 700 600 # of patients enrolled 500 400 300 200 100 0 1 2 3 4 5 6 Quarterly average per year * Includes Biontech and partnered trials On track to deliver 10+ potentially registrational trials running by YE 2
Slide 12: Six Ongoing Phase 2 Trials with Cancer Vaccine Candidates
Six Ongoing Phase 2 Trials with Cancer Vaccine Candidates in Multiple Disease Settings Select iNeST and FixVac trials based on BioNTech’s mRNA technology and mRNA-LPX platform Individualized vaccine: iNeST1 FixVac Adjuvant 1L R/R R/R 1L Multiple settings CRC PDAC Melanoma Solid Tumors Melanoma HPV16
Slide 13: Primary Endpoint Met: BNT111 in Combination with Cemiplimab
Primary Endpoint Met: BNT111 (FixVac)1 in Combination with Cemiplimab Demonstrated Improved ORR Compared to Historical Control Phase 2 open-label, randomized, multi-site trial to evaluate efficacy, tolerability and safety of BNT111 and cemiplimab in combination or as single agents in patients with l
Slide 14: Proof-of-Concept Data in Patients with Advanced Melanoma
Phase 1 BNT111 +/- PD1 inhibitor Proof-of-Concept Data on Activity and Potentially Durable Responses in Patients with Advanced Melanoma FIH dose escalation and expansion trial to evaluate safety and tolerability of tetravalent RNA-lipoplex cancer vaccine in patients with advanced melanoma (Lipo-MERI
Slide 15: Treatment Options Needed to Address CPI Refractory Advanced Melanoma
Treatment Options Needed to Address CPI Refractory Advanced Melanoma Frontline CPI immunotherapy induces durable Melanoma remains the deadliest skin cancer1,2 responses in 29−36% of clinical trial patients3 Incidence Death Survival No established SoC for patients with CPI resistant/refractory diseas
Slide 16: High Unmet Medical Need in Early-Stage Cancer Indications
High Unmet Medical Need in Early-Stage Cancer Indications Pancreatic ductal adenocarcinoma Colorectal cancer 69−75% relapse rate within 5 years after adjuvant therapy1,2 20-35% relapse rate within 5 years after adjuvant therapy6 Projected to become the 2nd leading cause of cancer-related 5-year surv
Slide 17: Functional Vaccine-Induced T cells Long-Lived One Year After Last Vaccination
Functional Vaccine-Induced T cells were Long-Lived and Detected One Year After Last Vaccination in All 7 Patients with Corresponding Data Kinetics and persistence of T-cell responses to vaccine-encoded neoantigens Elena Elez, et. al., Biomarker sub-study results of autogene cevumeran (BNT122)1 Phase
Slide 18: Investing in Innovation in our mRNA Cancer Vaccine Platforms
Continuing to Invest and Drive Innovation in our mRNA Cancer Vaccine Platforms Scaling up personalized and bulk mRNA manufacturing capacities to support late-stage clinical development and commercialization Personalized mRNA production facility, Mainz, Germany Bulk mRNA production facility, Marburg,
Slide 19: BNT327/PM8002 – A Next-Gen IO Agent Combining Two Validated MoA
BNT327/PM80021 – A Next-Gen IO Agent that Combines Two Clinically Validated MoA Dual blockade of PD-L1 and VEGF-A mechanism of “Two in one” MoA synergies with ADCs action has been proven synergistic Anti-VEGF-A (IgG) • Compelling profile with over 600 patients treated to date • Monotherapy activity
Slide 20: BNT327/PM8002 Potential in NSCLC, SCLC and TNBC
BNT327/PM80021 Has Potential to Address Unmet Medical Need in NSCLC, SCLC and TNBC Phase 1/2 study (NCT05918445): Phase 2 (NCT05879068): clinical activity Phase 2 (NCT05918133): clinical activity in efficacy signals in 1L NSCLC in combination with paclitaxel in 2L SCLC combination with nab-paclitaxe
Slide 21: Accelerating Broad Clinical Development Program for BNT327/PM8002
Accelerating Broad Clinical Development Program for BNT327/PM80021 Global and regional trials initiated Additional pivotal and novel combination trials planned for 2024 and 2025 SCLC TNBC NSCLC Ovarian Cancer Cervical Cancer 2L+ 1L+ 1L+ 1L+ Multiple Multiple Multiple Platinum Multiple 2L+ Multiple l
Slide 22: Upcoming Clinical Data Updates in 2H 2024
Upcoming Clinical Data Updates in 2H 2024* BNT113 Phase 1/2 HPV16-driven carcinomas BNT327/PM80022 Phase Advanced RCC 1/2 BNT327/PM80022 Phase EGFR-mutated NSCLC 2 BNT327/PM80022 Phase Locally advanced or metastatic TNBC 1/2 BNT211 Phase CLDN6-positive tumors 1/2 * Not exhaustive 1. Partnered with G
Slide 23: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 24: Q2 and H1 2024 Financial Results
Q2 and H1 2024 Financial Results (in millions €, except per share data)1 Three months ended June 30 Six months ended June 30 2024 2023 2024 2023 Revenues 128.7 167.7 316.3 1,444.7 Cost of sales (59.8) (162.9) (118.9) (258.9) Research and development expenses (584.6) (373.4) (1,092.1) (707.4) Sales a
Slide 25: 2024 Financial Year Guidance Reiterated
2024 Financial Year Guidance1 Reiterated FY 2024 Guidance FY 2024 Total revenues €2,500 – €3,100 m revenues R&D expenses2 €2,400 – €2,600 m Planned FY 2024 SG&A expenses €700 – €800 m expenses and capex Capital expenditure for operating activities €400 – €500 m • Vaccination rates and price levels i
Slide 26: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 27: Commercial Roll-out of Variant-Adapted COVID-19 Vaccines Under Way
Commercial Roll-out of Variant-Adapted COVID-19 Vaccines Under Way Launched first-to-market JN.1-adapted vaccine in EU in July allowing for coordinated Flu and COVID-19 vaccination campaigns Initiated Rapid Launch On track to begin distribution of KP.2-adapted vaccine upon expected approval in the U
Slide 28: Personalized mRNA Cancer Vaccines Potential New Paradigm in Cancer Treatment
Personalized mRNA Cancer Vaccines Have Potential to Establish a New Paradigm in Cancer Treatment Individual AI-driven Individualized patient samples neoantigen immuno- (blood and tissue) prediction therapy Mapping of On-demand mutations tailored RNA manufacturing Aims to address the root cause of ca
Slide 29: Outlook | Select Clinical Data Updates & Planned Regulatory Submissions
Outlook | Select Clinical Data Updates & Planned Regulatory Submissions 2H 2H 2024 2024 2025+ 2025+ COVID-19 / Flu COMIRNATY1 Combination vaccine1 BNT327/PM80023 COMIRNATY1 COVID-19 / Flu BNT323/DB-13034 Updated variant-adapted NSCLC, ES-SCLC, RCC Updated variant-adapted Combination vaccine1 2L+ HER
Slide 30: Our Next Stage of Growth in Oncology
Our Next Stage of Growth in Oncology 2024 2025 2026+ 10 potentially registrational Pivotal data updates in 2025 and beyond to support potential trials targeted by year end submissions Initiate first novel Aim for pivotal combination trials in 2025+ combination trials Potential launches in multiple B
Slide 31: Save the date
Save the date Innovation Series: AI Day October 1, 2024 Innovation Series November 14, 2024
Slide 32: Thank you
Thank you BIONT=CrH
Slide 33: Appendix
__. Appendix BIONT=Cr
Slide 34: 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 BNT113 Advanced HPV16+ HNSCC Phase 1/2 and Phase 2 2024 Autogene cevumeran (BNT122) Adjuvant ctDNA+ stage II (high risk)/III CRC Phase 2 2025+ BNT211 CLDN6+ tumors Phase 1
Slide 35: Program Updates Expected in 2024 and Beyond
Program Updates Expected in 2024 and Beyond Program Indication Trial Phase Anticipated Timing BNT1611+BNT1622 Influenza COVID-19 Combination Phase 3 2024 Infectious Disease BNT163 HSV Phase 1 2024 BNT1672 Shingles Phase 1 2024 1. Out-licensed to Pfizer 2. Partnered with Pfizer. 35
Slide 36: Abbreviations
Abbreviations nL nth line ESMO European Society for Medical Oncology PDAC Pancreatic ductal adenocarcinoma AACR American Association for Cancer Research ES-SCLC Extensive-stage small cell lung cancer PD-L1 Programmed cell death protein ligand 1 ADC Antibody-drug conjugate FDA Food and Drug Administr