BioNTech SE · NASDAQ:BNTX
BioNTech — Corporate Update (December 2020)
28 slides from BioNTech's corporate update, Dec 22, 2020
Slide 1: Update on our COVID-19 vaccine
Update on our COVID-19 vaccine December 22, 2020 Exhibit 99.1
Slide 2: Forward-Looking Statements
This slide presentation includes forward-looking statements Forward-Looking Statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company’s views with respect to its efforts to combat COVID-19; the collaboratio
Slide 3: Safety information
Safety information Authorized use in the U.S.: The Pfizer-BioNTech COVID-19 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 indivi
Slide 4: Conditional market authorization in European States for a COVID-19 vaccine
Conditional market authorization in 27 European States on 21 December for a COVID-19 vaccine Received Approval for Emergency Use / Temporary Use / Conditional Approval in more than 45 countries worldwide (incl. the EU) COMIRNATY® is our official name of our mRNA vaccine in the EU and Switzerland Rec
Slide 5: COMIRNATY – The BioNTech-Pfizer COVID-19 vaccine
COMIRNATY® – The BioNTech-Pfizer COVID-19 vaccine : COVID-19 + mRNA + Community + Immunity Developed 1,000 potential names in April Recommended up to 3 names (Primary + two backups) Creative rationale
Slide 6: A concerted and large-scale global effort
A concerted and large-scale global effort Approved Emergency Use Authorization / Temporary Use Approval Rolling application for emergency use authorization to further countries underway. Conditional Marketing Authorization in the EU and Switzerland1 Vaccination with our COVID-19 vaccine already unde
Slide 7: Up to 1.3 billion doses by end of 2021
Up to 1.3 billion by end of 2021 Commitment to equitable supply of vaccine globally Target of 50 million supply doses by the end of 2020 Global allocation according to existing supply agreements North America Europe Other countries: EU‘s dose allocation is based on the member states‘ population as a
Slide 8: Vaccine transportation: minimal changes to pre-existing cold chain
Vaccine transportation: minimal changes to pre-existing cold chain Vaccine vials Insulated lid Payload sleeve Outer carton Dry ice pod Pre-packed boxes are transported and distributed to vaccination centers GPS trackers and thermo-sensors relay temperature data to ensure safe delivery At vaccination
Slide 9: Vaccine storage: administered like many other vaccines
Vaccine storage: administered like many other vaccines Administration to vaccinees at room temperature Injected intramuscular (arm); no additional equipment needed for administration at mass vaccination center Once removed from the freezer, the unopened vaccine can be stored for up to 5 days at 2 °C
Slide 10: Example: decentralized distribution in Germany
Example: decentralized distribution in Germany: BioNTech delivers to 25 distribution centers, run by federal states Accountability of the federal states BioNTech 25 Distribution centers 294 Districts 450 Vaccination centers 100 Mobile vaccination locations delivers to
Slide 11: Example: comprehensive information provided to professionals and vaccination centers in Germany
Example: comprehensive information provided to professionals and vaccination centers in Germany Virtual Service Agent (AI chatbot) BioNTech Service Center Medical Information Center (HCP) Vaccination Center Starter Kit
Slide 12: COMIRNATY: A journey from scientific discovery to approval
COMIRNATY®: A journey from scientific discovery to approval
Slide 13: Project Lightspeed – a 10-month journey to an effective and safe vaccine
Project Lightspeed – a 10-month journey to an effective and safe vaccine SARS-CoV-2 Genetic Sequence Made Public January 12, 2020 COVID-19 mRNA Vaccine Program Initiation January 27, 2020 Collaborations Fosun Pharma: March 16, 2020 Pfizer: March 17, 2020 Phase 1 / 2 Trial Germany Started April 23, 2
Slide 14: Data from Phase 3 study shows 95% efficacy
Data from Phase 3 study shows 95% efficacy Analysis indicates efficacy rate of 95% in participants with and without prior SARS-CoV-2 infection Final analysis of unblinded data by independent data monitoring committee conducted on Nov 18, 2020 Vaccinated participants will continue to be monitored for
Slide 15: Phase 3 trial data suggest rapid onset of protection against COVID-19
1 https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home 2 Individuals may not be fully protected until 7 days after their second dose of vaccine. Phase 3 trial data suggest rapid onset of protection against COVID-19 People are vaccinated twice with 30 µg of mRNA, 21 days apart prot
Slide 16: COVID-19 occurrence from 7 days after dose 2 by comorbidity status
1Subjects without evidence of infection prior to 7 days after dose 2 Clinical data indicate COVID-19 Occurrence From 7 Days After Dose 2 by Comorbidity Status1 BNT162b2 (30 μg) N=18,198 Placebo N=18,325 n Surveillance Time (n) n Surveillance Time (n) VE (%) (95% CI) Overall 8 2.214 (17,411) 162 2.22
Slide 17: Clinical trial data indicates vaccine is highly efficacious with a favorable safety profile
Clinical trial data indicates vaccine is highly efficacious with a favorable safety profile Gold standard of clinical research – randomized large-scale clinical trial – to ensure safety and efficacy. We took important steps in parallel to accelerate the process together with the authorities – withou
Slide 18: How mRNA works: A deep dive into the technology
How mRNA works: A deep dive into the technology
Slide 19: What is messenger RNA?
What is messenger RNA? The first molecule of life, involved in almost all aspects of cell biology Can be synthesized and engineered to resemble mRNA molecules as they occur naturally in the cytoplasm of human cells and transiently deliver proteins of interest mRNA has a transient messenger function
Slide 20: High purity and animal material free precision vaccine
High purity and animal material free Precision vaccine Virus-free Non-integrating into DNA Non-infectious Natural molecule studied for > 50 years with well-characterized bio-safety properties Does not require addition of adjuvants or use of a viral vector for administration Highly scalable productio
Slide 21: How mRNA vaccines work – training the immune system for a real infection
How mRNA vaccines work – training the immune system for a real infection modRNA formulated in LNP enters cell 1 2 mRNA is released 3 Spike protein is made and processed 4 APCs present Spike protein fragments CD4+ Helper T Cell CD8+ Cytotoxic T Cell Eliminates virus infected cells; potentially increa
Slide 22: Multiple levers of immune response: strong antibody and robust T cell responses observed
Multiple levers of immune response: Strong antibody and robust T cell responses observed Immunogenicity*3 Tolerability*4 Antibody Responses*4 T Cell Responses*5 No or only transient viral shedding in SARS-CoV-2 Virus Challenge Local reactions and systemic events mostly mild to moderate and transient
Slide 23: BNT162b2 induced antibodies cross-neutralize mutant SARS-CoV-2 variants in pVNT assay
BNT162b2 induced Antibodies cross-neutralize mutant SARS-COV-2 variants in pVNT assay 1 Sahin U, et al. medRxiv 2020.12.09.20245175; doi: https://doi.org/10.1101/2020.12.09.20245175 [preprint]. Accessed December 2020. .
Slide 24: What does COMIRNATY contain – and why?
What does COMIRNATY® contain – and why? mRNA* Salt Sugar Lipids 4 different salts Sucrose These buffer the vaccines to stabilize the pH, so that it matches the pH in our bodies. This is a cryoprotectant. It ensures the lipids don’t get too sticky at cold storage temperatures. 4 different molecules A
Slide 25: What COMIRNATY contains in detail – from the prescribers information
What COMIRNATY® contains in detail – from the prescribers information mRNA: Active Ingredient mRNA Salt: 4 different salts potassium chloride potassium dihydrogen phosphate sodium chloride disodium phosphate dihydrate Sugar: Sucrose Sucrose Lipids: 4 different molecules ((4-hydroxybutyl)azanediyl)bi
Slide 26: Q&A
Q&A
Slide 27: BioNTech investor contact details
An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-1074 M: investors@biontech.de
Slide 28: Thank you for your participation!
Thank you for your participation! The press conference has now ended.