BioNTech SE · NASDAQ:BNTX
BioNTech — Q2 2023 Earnings Presentation
31 slides from BioNTech's earnings presentation, Aug 7, 2023
Slide 1: 2nd Quarter 2023 Financial Results & Corporate Update
2nd Quarter 2023 Financial Results & Corporate Update August 7, 2023
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 2nd Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer 2 COVID-19 & Pipeline Update Özlem Türeci, Chief Medical Officer 3 Financial Results Jens Holstein, Chief Financial Officer 4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 4: 2nd Quarter 2023 Highlights
1 2nd Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer
Slide 5: 2023 Strategic Priorities and Achievements in Q2 2023
2023 Strategic Priorities and Achievements in Q2 2023 COVID-19 franchise1 Immuno-oncology Infectious diseases 2023 Strategic Priorities Sustain leadership in COVID-19 vaccines Advance platforms for solid tumors Initiate and accelerate clinical programs for high medical need indications Advance next-
Slide 6: SARS-CoV-2 Activity is Expected to Increase Again this Fall/Winter
SARS-CoV-2 Activity is Expected to Increase Again this Fall/Winter and Become a Seasonal Disease Disease activity has peaked between November and April1 Weekly Seasonality of Similar patterns seen for influenza, RSV, and other respiratory viruses2 Confirmed Viral Infections England and Wales, 1989 –
Slide 7: Better-Matched Vaccines are Required to Improve Protection Against Severe COVID-19
Better-Matched Vaccines are Required to Improve Protection Against Severe COVID-19 Absolute vaccine effectiveness against hospitalization11 Immunocompetent adults, VISION Network, Sep 2022 – Apr 2023, U.S. CDC • XBB sublineages are dominant Time Since Vaccination Adjusted VE, % (95% CI) globally and
Slide 8: Multi-Technology Innovation Engine
Multi-Technology Artificial Intelligence, Machine Learning and Innovation Engine OFF-THE- Computational Medicine Internal capabilities & InstaDeep SHELF mRNA CANCER Core principles of our VACCINES technology strategy INDIVIDUA- LIZED mRNA FixVac RIBO- LOGICALS1 IMMUNO- THERAPY CANCER RiboCytokines T
Slide 9: Antibody-Drug Conjugates: A Proven Technology with Untapped Potential
Antibody-Drug Conjugates: A Proven Technology with Untapped Potential ADCs are composed of three key components Mode of Action Jabbour E. et al. Nat Rev Clin Oncol. 2021 Coleman N.et al. npj Precis. Onc. 2023 Payload Antibody Classical ADC MoA Bystander killing effect Each of these three components
Slide 10: COVID-19 Vaccine & Pipeline Update
2 COVID-19 Vaccine & Pipeline Update Özlem Türeci, Chief Medical Officer
Slide 11: The Current COVID-19 Epidemiologic Landscape is Dominated by XBB Sublineages
The Current COVID-19 Epidemiologic Landscape is Dominated by XBB Sublineages XBB sublineages remain dominant across all the Circulating XBB sublineages are antigenically similar territories1,2 and have greater immune escape than prior circulating Dominante XBB sublineages: XBB.1.5, XBB.1.9.2, XBB.1.
Slide 12: Monovalent XBB.1.5 Booster Elicits Highest XBB Sublineage Neutralization Response in Mice
Monovalent XBB.1.5 Booster Elicits Highest XBB Sublineage Neutralization Response in Mice Experimental Design 106 ~4-fold increase D0 D21 D105 D134 D160 ~5-fold increase 105 50% Neutralization Titer ~5-fold increase WT WT WT + WT + 104 3766 3020 BA.4/5 BA.4/5 1800 or 733 621 XBB.1.5 444 103 Preclini
Slide 13: Oncology Pipeline: Achievements in Q2 2023
Oncology Pipeline: Achievements in Q2 2023 Drug Class Phase 1 Phase 1/2 Phase 2 Phase 3 BNT116 BNT1123 BNT1113 Autogene cevumeran Metastatic NSCLC Prostate cancer aPD(L)1-R/R melanoma, (BNT122)2 + cemiplimab 1L Adv. melanoma, BNT122 (Autogene cevumeran)2 BNT142 (CLDN6) + Pembrolizumab Multiple solid
Slide 14: MoA Designed to Allow Higher Dosing and Longer Treatment Duration with BNT316/ONC-392
MoA Designed to Allow Higher Dosing and Longer Treatment Duration with BNT316/ONC-392 (gotistobart)1 Mode of Action Monotherapy (10 mg/kg) in platinum- BNT316/ONC-392 (3 or 6 mg/kg) in Liu Y. et al. Abstract # 231, SITC 2021. resistant ovarian cancer patients combination with pembrolizumab Hays J et
Slide 15: ASCO 2023: Results Support Initiation of a Pivotal Phase 3 Study Evaluating BNT316/ONC-392
Phase 3 ASCO 2023: Results Support Initiation of a Pivotal Phase 3 Study Evaluating trial in NSCLC BNT316/ONC-392 (gotistobart)1 in ICI-resistant NSCLC ongoing PRESERVE-001: Phase 1/2a multicenter, non-randomized, open-label, multiple-dose, FIH study (NCT04140526) He K. et al. presented at ASCO 2023
Slide 16: 3rd-generation ADCs with improved safety and efficacy
3rd-generation ADCs Superior in vitro plasma stability in human Sustained tumor-selective drug release in with improved safety and plasma tumor-bearing mice BNT323/DB-1303 released payload in serum and tumor Change of DAR from baseline efficacy may bring added Concentration (ng/ml) 120 Payload Cmax
Slide 17: ASCO 2023: First Clinical Data for BNT323/DB-1303 Demonstrated Anti-Tumor Activity
ASCO 2023: First Clinical Data for BNT323/DB-13031 Demonstrated Anti-Tumor Activity in Heavily Pretreated HER2-Expressing Patients Phase 1/2a multicenter, non-randomized, open-label, multiple-dose, FIH study (NCT05150691) Moore K. et al. Presented at ASCO 2023. Abstract #3023. Anti-tumor activity in
Slide 18: BNT211: A CLDN6 CAR T-cell Therapy + CLDN6-Encoding CARVac
BNT211: A CLDN6 CAR T-cell Therapy + CLDN6-Encoding CARVac That Enhances Expansion and Persistence of the Infused CAR T Cells Potent 2nd-generation CAR T cells with high sensitivity Combined with CARVac (CAR-T cell amplifying RNA vaccine) and specificity to target APCs Reinhard K, et al. Science 202
Slide 19: ASCO 2023: BNT211 – A Potential First-in-Class Approach for CLDN6+ Solid Tumors
ASCO 2023: BNT211 – A Potential First-in-Class Approach for CLDN6+ Solid Tumors BNT211 in multiple solid tumors Mackensen A et al. presented at ASCO 2023. Abstract #2518. Aim of the current Clinical activity (n=17) Safety and analysis: efficacy: Determine the safety and Best response after CLDN6 CAR
Slide 20: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 21: YTD 2023 Key Financial Figures
YTD 2023 Key Financial Figures1 Total revenues2 Operating result € 1.4 bn € 91 mn Diluted EPS Total cash plus security investments3 € 1.28 € 16.8 bn 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard comme
Slide 22: Q2 and YTD 2023 Financial Results: Profit or Loss
Q2 and YTD 2023 Financial Results: Profit or Loss (in millions €, except per share data)1 Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 Commercial revenues2 166.4 3,166.3 1,442.9 9,528.5 Research & development revenues 1.3 30.2 1.8 42.6 Total revenues 167.7 3,196.5 1,444.
Slide 23: 2023 Financial Year Guidance Updated
2023 Financial Year Guidance Updated1 Updated Guidance COVID-19 vaccine Estimated BioNTech COVID-19 vaccine revenues ~ €5 bn ~ €5 bn revenues for FY 2023 R&D expenses2 €2,400 – 2,600 m €2,000 – 2,200 m Planned FY 2023 SG&A expenses €650 – 750 m €600 – 700 m expenses and capex Capital expenditure for
Slide 24: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 25: Readiness to Supply Omicron XBB.1.5-adapted Monovalent COVID-19 Vaccine Booster
Readiness to Supply Omicron XBB.1.5-adapted Monovalent COVID-19 Vaccine Booster Vaccine distribution can Completed key begin immediately upon Positioned to maintain regulatory submissions regulatory approval leadership in major markets Submissions: Expected launch: Major contract serving the USA, EU
Slide 26: InstaDeep will Accelerate and Enhance BioNTech's AI Vision
InstaDeep will Accelerate and Enhance BioNTech's AI Vision Immediate access to world-class AI technology Broaden our access to world-class existing InstaDeep capabilities Fuel our AI research engine Access to AI research talent already working for industry leaders such as Google and collaborating wi
Slide 27: InstaDeep will Operate as an Independent Subsidiary of BioNTech
InstaDeep will Operate as an Independent Subsidiary of BioNTech InstaDeep: BioNTech’s AI / ML Company 1 AI-Enabled Drug Discovery Pipeline 2 Cost Efficiencies 3 Third Party Business Plan to apply AI / ML technologies across Potential for cost efficiency benefits in the AI / ML Technology solutions a
Slide 28: Selected Pipeline Milestones Expected in 2023 and Beyond
Selected Pipeline Milestones Expected in 2023 and Beyond Modality Indication Program Select Milestones Anticipated Timing COVID-19 – influenza BNT162b2 + BNT161 Trial update 2023 Combination1,2 Malaria BNT165 Phase 1 data update 2H 2023 mRNA vaccines for infectious disease HSV3 BNT163 Phase 1 data u
Slide 29: Second Half 2023 Strategic Outlook
Second Half 2023 Strategic 1 Launch Omicron XBB.1.5-adapted monovalent COVID-19 vaccine globally Outlook 2 Initiate multiple potentially registrational oncology clinical trials 3 Expand our infectious disease pipeline with data updates expected this year 4 Scale up activity in highly strategic growt
Slide 30: Innovation Series Day
SAVE THE DATE Innovation Series Day November 7, 2023
Slide 31: Thank you
Thank you BIONT=CrH