BioNTech SE · NASDAQ:BNTX
BioNTech — FY2020 Earnings Presentation
36 slides from BioNTech's earnings presentation, Mar 30, 2021
Slide 1: Corporate update and financial results: Fourth Quarter and Full Year 2020
Corporate update and financial results March 30, 2021 Fourth Quarter and Full Year 2020 Harnessing the full potential of the immune system to solve global health problems Exhibit 99.2
Slide 2: This slide presentation includes forward-looking statements
This slide presentation includes forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including BioNTech’s expected revenues and net profit related to sales of BioNTech and Pfizer’s C
Slide 3: Safety Information
Safety Information 3 AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in indiv
Slide 4: Agenda
Agenda 4 Full Year 2020 Highlights Oncology Pipeline Update Financial Results COVID-19 Vaccine Update Strategic Outlook
Slide 5: 2020: A momentous year for BioNTech
2020: A momentous year for BioNTech First commercial product 5
Slide 6: BioNTech's capabilities were transformed in 2020
BioNTech’s capabilities were transformed in 2020 6 * as of March 23, 2021
Slide 7: What 2020 has demonstrated to us
What 2020 has demonstrated to us 7
Slide 8: The Opportunity Ahead
The Opportunity Ahead Accelerate and expand our Launch multiple innovative pipeline new products in the next 5 years Build a 21st century global immunotherapy powerhouse BIONT=CrH
Slide 9: mRNA technology today and tomorrow
9 Today Tomorrow mRNA vaccines established as a New Drug Class Diversification and maturation of our mRNA technology enabled the accelerated development of our COVID-19 vaccine mRNA to open up new opportunities Beyond the Horizon Autoimmune diseases Allergy Inflammation Regenerative medicine Other t
Slide 10: Agenda
Agenda 10 COVID-19 Vaccine Update Full Year 2020 Highlights Oncology Pipeline Update Financial Results Strategic Outlook
Slide 11: Strong clinical results
Strong clinical results 95% effective against symptomatic COVID-19 infections1 94% efficacy in participants >65 years Well tolerated safety profile High titers of neutralizing antibodies Robust and poly-epitopic CD8+ and Th1 CD4+ T-cell responses2 1Polack FP, et al. NEJM 2020, 383:2603-2615 2Sahin U
Slide 12: Compelling real-world evidence
Compelling real-world evidence Two weeks post-dose 2 About 97% effective in preventing symptomatic COVID-19 severe/critical COVID 19 Hospitalizations Deaths 94% effective against asymptomatic infection Protective against B.1.1.7 variant Real-World-Data announced by The Israel Ministry of Health (MoH
Slide 13: Re-boostings and variant-specific vaccines may be required
Re-boostings may be required Variant-specific vaccines may be needed mRNA vaccines are well suited for long-term challenge COVID-19 will likely become endemic. Re-vaccination may also be required. 13 Waning immune responses Variants are driving new infections New mRNA vaccines can be rapidly designe
Slide 14: Focused on six key levers to expand COVID-19 vaccine reach
14 Focused on six key levers to expand COVID-19 vaccine reach
Slide 15: Flexible manufacturing allows rapid adaptation to variants
Flexible manufacturing allows rapid adaptation to variants 15 mRNA production Drug substance purification and concentration LNP formulation Sterile filtration & filling 1 2 3 4 ~1-2 Days ~1-2 Days ~3-4 Days ~1-2 Days Quality control and release 4-5 weeks ~1-2 Days DNA template production 5
Slide 16: 1.4 billion doses contracted to date for 2021
16 1.4 billion doses contracted to date for 2021 Scaling up manufacturing capacity to address pandemic demand Puurs, Belgium Marburg facility Up to 1 billion doses in annual run-rate capacity First vaccines scheduled for distribution in April Up to 2.5 billion doses* manufacturing capacity *We along
Slide 17: Agenda
Agenda 17 Full Year 2020 Highlights Oncology Pipeline Update Financial Results COVID-19 Vaccine Update Strategic Outlook
Slide 18: Rationally designed multi-platform immuno-oncology strategy
18 Rationally designed multi-platform immuno-oncology strategy Multiple blockbuster opportunities with synergistic combinations mRNA Cancer Vaccines Antibodies Small Molecule Immunomodulators + FixVac and iNeST Multi-specificity, multi-valency, high (neo)antigen specific T cell responses with unprec
Slide 19: Multiple oncology trials with registrational potential starting in 2021
Multiple oncology trials with registrational potential starting in 2021 19 Planned randomized trial start in 2021 1L, first-line; CRC, Colorectal Cancer; BNT111: Phase 2 to start in 1H 2021 BNT311: Data update in 2H 2021 BNT312: Data update in 2H 2021 BNT113: Phase 2 to start in 1H 2021 BNT122: Phas
Slide 20: Next wave oncology advancing innovation beyond current boundaries
Next wave oncology advancing innovation beyond current boundaries 20 BNT211 (CLDN 6 CAR) Next generation CAR-T targeting CLDN6 with CARVac “primer” CARVac CAR-T cell amplifying mRNA therapy for solid tumors1 BNT221 (PBMC derived ex vivo T cell therapy) NEOSTIM T cell therapy Individualized Neoantige
Slide 21: BNT211: CLDN6-CAR demonstrates potent and robust target recognition
BNT211: CLDN6-CAR demonstrates potent and robust target recognition Directed against new carcino-embryonic antigen CLDN6 2nd generation CAR functionalized with antibody-derived CLDN6-binding domain (αCLDN6-scFv) Binding domain mediates exclusive specificity and high sensitivity for CLDN6 Costimulato
Slide 22: BNT211: Repeated CARVac dosing enables tunable expansion of CAR-T cells
BNT211: Repeated CARVac dosing enables tunable expansion of CAR-T cells 22 CAR-T cell Amplifying RNA Vaccine (CARVac) drives in vivo expansion and efficacy of CAR-T against solid tumors CLDN6, Claudin-6; CAR-T cells, chimeric antigen receptor engineered T cells; RNA-LPX, RNA-lipoplex; APCs, antigen
Slide 23: BNT211: First-in-human CARVac trial with first data expected this year
BNT211: First-in-human CARVac trial with first data expected this year 23 NSCLC, Non-Small Cell Lung Cancer; CLDN6, Claudin-6; CAR-T cells, Chimeric Antigen Receptor engineered T cells; RNA-LPX, RNA-lipoplex; MTD, maximum tolerated dose; RP2D, recommended Phase 2 dose; NOS, not otherwise specified (
Slide 24: BNT151: Optimized mRNA-encoded IL-2
BNT151: Optimized mRNA-encoded IL-2 BNT151 is nucleoside-modified mRNA encoding human IL-2 variant fused to human albumin IL-2 is a key cytokine in T cell immunity, supporting differentiation, proliferation, survival and effector functions of T cells BNT151 stimulates anti-tumoral T cells without ex
Slide 25: BNT151-01 Phase 1/2a first-in-human trial
BNT151-01 Open-label, multicenter Phase 1/2a, first-in-human trial 25 Evaluation of dose escalation, safety, pharmacokinetics and pharmacodynamics of BNT151 with expansion cohorts in multiple solid tumor indications Part 2: Combination Therapy Expansions Part 2a Part 2b SCCHN HCC SCCHN + HCC MTD/RP2
Slide 26: Agenda
Agenda 26 Full Year 2020 Highlights Oncology Pipeline Update Financial Results COVID-19 Vaccine Update Strategic Outlook
Slide 27: 2020 Full Year Financial Results – Statement of Operations
2020 Full Year Financial Results – Statement of Operations 27 *Numbers have been rounded, numbers presented may not add up precisely to the totals and may have been adjusted in the table context. Presentation of the statement of operations is condensed.
Slide 28: 2020 COVID-19 vaccine deliveries drove revenue growth
28 *Represents estimated figure based on preliminary data shared between Pfizer and BioNTech. Changes in our share of the collaboration partner’s gross profit will be recognized prospectively. 2020 COVID-19 vaccine deliveries drove revenue growth
Slide 29: 2021 Financial Outlook: COVID-19 vaccine revenues
2021 Financial Outlook 29 Estimated COVID-19 vaccine revenues to BioNTech upon delivery of currently signed orders (~1.4 billion doses): ~€9.8 billion Estimate reflects: Expected revenues from direct COVID-19 vaccine sales to customers in our territories Expected revenues from sales to our collabora
Slide 30: 2021 Financial Outlook: expenses and capex
30 2021 Financial Outlook R&D expenses: €750 million – €850 million SG&A expenses: Up to €200 million Capital expenditures: €175 million – €225 million Ranges reflect current base case projections Ramp-up of R&D investment in 2H 2021 and beyond planned to broaden and accelerate pipeline development
Slide 31: Agenda
Agenda 31 Full Year 2020 Highlights Oncology Pipeline Update Financial Results COVID-19 Vaccine Update Strategic Outlook
Slide 32: Our strategic priorities for 2021
Our strategic priorities for 2021 1 32 Continue to execute while driving iterative innovation against COVID-19 Execute against our goal to deliver our COVID-19 vaccine to more than 1 billion people in 2021 Continue to innovate to build sustained global market leadership position Broaden and diversif
Slide 33: Expected pipeline milestones in 2021
Expected pipeline milestones in 2021 33 Multiple BNT162b2 updates BNT311: Bi-specific CPI: PD-L1 x 4-1bb in solid tumors BNT312: Bi-specific checkpoint Immunomodulator CD40 x 4-1bb in solid tumors BNT211: CLDN-6 CAR-T + CARVac in solid tumors BNT411: TLR-7 Agonist +/- CPI in solid tumors BNT111: Fix
Slide 34: BioNTech Capital Markets Day, second half 2021
COMING SOON 34 BioNTech Capital Markets Day SECOND HALF 2021 34
Slide 35: Better positioned than ever to bring innovation to patients
Better positioned than ever to bring innovation to patients 35 Re-invest BNT162b2 proceeds to build long-term value for Patients, Shareholders, and Society Expand global footprint in the U.S., Europe, and Asia Establish new offices in strategic locations globally Expand clinical, commercial and manu
Slide 36: © Copyright BioNTech SE 2021. All Rights Reserved. An der Goldgrube 12 55131 Mainz
© Copyright BioNTech SE 2021. All Rights Reserved. An der Goldgrube 12 55131 Mainz Germany M: investors@biontech.de