BioNTech SE · NASDAQ:BNTX
BioNTech — J.P. Morgan Healthcare Conference 2022
26 slides from BioNTech's conference presentation, Jan 11, 2022
Slide 1: J.P. Morgan Healthcare Conference
1 January 11th 2022 J.P. MORGAN HEALTHCARE CONFERENCE Exhibit 99.1
Slide 2: This slide presentation includes forward-looking statements
2 Titelmasterformat durch Klicken bearbeiten 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:
Slide 3: Safety Information (EU)
Titelmasterformat durch Klicken bearbeiten Safety Information COMIRNATY® ▼(COVID-19 mRNA Vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 5 years of age and older. EMA’s human medicines commit
Slide 4: Safety Information (US authorized use)
Titelmasterformat durch Klicken bearbeiten Safety Information AUTHORIZED USE IN THE U.S. COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
Slide 5: Harnessing the power of the immune system to fight human diseases
5 Harnessing the power of the immune system to fight human diseases 5
Slide 6: BioNTech 2021 Highlights | A Year of Historic Impact
6 BioNTech 2021 Highlights | A Year of Historic Impact ~ 2.6 bn doses shipped2, 3 First ever approved mRNA therapy1 > 1 bn individuals vaccinated4 Trillions of dollars of global economic impact5 > 160 countries / regions reached 1Approved for emergency use/temporary supply or Conditional Marketing A
Slide 7: BioNTech 2021 Highlights (cont.) | A Year of Historic Impact
7 BioNTech 2021 Highlights (cont.) | A Year of Historic Impact Pipeline expansion Global presence Production capacity Commercial infrastructure R&D expansion Financial performance 9 oncology clinical trial starts, including 4 Phase 2 trials and 5 FIH studies Acquired and integrated new site in Gaith
Slide 8: BioNTech Commercial Revenues
8 BioNTech Commercial Revenues (M€)2 Enabled by early scale up of production capacity: ~3 bn doses manufactured in 2021 Estimated COMIRNATY market share 74% in U.S. and 80% in Europe1 Outlook for COVID-19 vaccine revenues booked by BioNTech FY 2021 guidance: €16-17 bn FY 2022 estimate: €13-17 bn 1As
Slide 9: BioNTech Today | A 21st Century Immunotherapy Powerhouse
9 BioNTech Today | A 21st Century Immunotherapy Powerhouse Multi-Platform Strategy • Technology agnostic innovation engine • Entering a new era of mRNA technology & synthetic biologyFully Integrated Biotechnology Company • Digitalization & automation poised to transform R&D • 4 GMP manufacturing fac
Slide 10: Multi-Platform Strategy
S NF MULTI-PLATFORM STRATEGY BIONT=CH
Slide 11: Multi-Platform Strategy | Technology Agnostic Innovation Engine
11 mRNA Vaccines Targeted Antibodies Small Molecule Immunomodulators • Targeting immune checkpoint molecules • Engineered bispecific antibodies • Enginereed MOAs Cell & Gene Therapies Next Generation Immunomodulators Ribologicals • Against highly selective cancer cell surface antigens for high preci
Slide 12: Entering a New Era of mRNA Technology & Synthetic Biology
12 Titelmasterformat durch Klicken bearbeiten In vivo engineered cell therapies Precision anti-bacterials CAR-T cell amplifying mRNA vaccines Systemic mRNA encoded immuno-therapies mRNA vaccines Autoimmune diseases mRNA vaccines validated as a new drug class Entering a New Era of mRNA Technology & S
Slide 13: Diversified Product Pipeline
bbe DIVERSIFIED | PRODUCT PIPELINE
Slide 14: Significant Pipeline Expansion and Maturation in 2022
14 FixVac – 1L Melanoma FixVac – HPV16+ Cancers iNeST2 – 1L Melanoma iNeST2 – Adjuvant CRC Bispecific AB PD-L1x4-1BB3 Phase 1 ongoing Phase 2 ongoing Significant Pipeline Expansion and Maturation in 2022 COVID-19 Vaccine1 Infectious DiseasesImmuno-Oncology New AreasG O A L S 5 mRNA vaccines in human
Slide 15: BNT162b2 Poised for Continued Global Impact in 2022
15 BNT162b2 Poised for Continued Global Impact in 2022 • >3 billion people globally not yet vaccinated1 • > 25% of global population ages 0-142 • First vaccine to launch for children 6 mths – 5 yrs of age pending marketing authorization • > 600 m people already boosted3 • Booster vaccination vital t
Slide 16: COVID-19: The long road to an endemic disease
16 COVID-19: The long road to an endemic disease Protection of Individuals with immune compromises and medical conditions at risk Risk for Long COVID and organ damage associated even with mild / moderate infections2 Waning of protection over time in broader population Risk of MIS-C; incidence of 0.5
Slide 17: Early Computational Detection of High Risk SARS-CoV-2 Variants
17 Early Computational Detection of High Risk SARS-CoV-2 Variants* Early Warning System (EWS) combines Spike protein structural modeling with artificial intelligence (AI) to detect and monitor high risk SARS-CoV-2 variants a lt e re d a n ti b o d y e p it o p e s EWS identifies and scores >90% of n
Slide 18: Infectious Disease Product Strategy Rooted in Global Social Responsibility
18 Titelmasterformat durch Klicken bearbeiten Infectious Disease Product Strategy Rooted in Global Social Responsibility mRNA-based vaccines and therapeutics Malaria: 229 million cases and 409,000 deaths annually1 Tuberculosis*: 10 million people contracted TB in 20192 HIV*: 37.7 million people livi
Slide 19: mRNA Vaccines in Human Trials in 2022
19 Titelmasterformat durch Klicken bearbeiten 5 mRNA Vaccines in Human Trials in 2022 3 mRNA vaccines partnered w/Pfizer 10+ other infectious disease programs Platform Pre-clinical Phase 1 Phase 2 Commercial Economics COVID-19 Vaccine Cost / Gross profit split Influenza Milestones and royalties Shin
Slide 20: Oncology Pipeline Expected to Significantly Expand
20 Oncology Pipeline Expected to Significantly Expand Drug class Platform Product candidate Indication (targets) Pre-clinical Phase 1 Phase 2 Phase 3 Partner mRNA FixVac* (fixed combination of shared cancer antigens) BNT111 Advanced melanoma (Adjuvant & Metastatic) BNT112 Prostate cancer BNT113 HPV1
Slide 21: BNT211: Phase 1/2 Trial Evaluating Next Generation CAR-T Targeting Claudin-6
Titelmasterformat durch Klicken bearbeitenBNT211: Phase 1/2 Trial Evaluating Next Generation CAR-T Targeting Claudin-6 with CARVac in Solid Tumors CLDN6, Claudin-6; CAR-T cells, chimeric antigen receptor engineered T cells; scFv, single chain variable fragment; RP2D, recommended Phase 2 dose; NOS, n
Slide 22: ESMO-IO 2021/BNT211 Phase 1/2: CAR-T Engraftment and Tolerable Safety Profile
Titelmasterformat durch Klicken bearbeitenESMO-IO 2021/BNT211 Phase 1/2: CAR-T Engraftment and Tolerable Safety Profile with CLDN6 CAR-T without (Part 1) and with (Part 2) CARVac Data cutoff = NOV 18, 2021; CRS, cytokine release syndrome; DL, dose level; DLT, dose-limiting toxicity; Haanen J., et al
Slide 23: BNT211 Phase 1/2: First Indications of Clinical Activity
BNT211 Phase 1/2: First Indications of Clinical Activity - 4 PR, 4 SD+, 1 SD at 6 Weeks Post Infusion (ORR 4/10, DCR 9/10) Data cutoff = NOV 18, 2021. Haanen J., et al. Oral presentation at the ESMO Immuno-Oncology Congress, December 08–14, 2021; Haanen J. et al., Anals fo Concology (2021) 32 (suppl
Slide 24: Outlook: 2022 and Beyond
OUTLOOK 2022 AND BEYOND
Slide 25: Outlook 2022 and Beyond
Outlook 2022 and Beyond Further COVID-19 vaccine launches of new formulation, pediatric dosage form, and potentially variant adapted vaccine Accelerate late- stage Oncology programs towards the market and expand earlier stage pipeline Ramp up R&D investment and make strategic investments in cutting
Slide 26: Thank You
THANK YOU BIONT=CH