BioNTech SE · NASDAQ:BNTX
BioNTech — Investor Presentation (January 2021)
22 slides from BioNTech's investor presentation, Jan 11, 2021
Slide 1: Next Generation Immunotherapy
Ugur Sahin, M.D. January 2021 Next Generation Immunotherapy 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 the potential for mRNA therapeutics; the planned
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: Harnessing the immune system's full potential to fight human disease
Harnessing the immune system’s full potential to fight human disease 4
Slide 5: 2020: A Transformational Year for BioNTech
2020: A TRANSFORMATIONAL YEAR FOR BIONTECH 5 * COMIRNATY® is the brand name for BNT162b2 in the EU and Switzerland, where it has received conditional marketing authorization
Slide 6: Opportunity in 2021 and beyond
6 Deep expertise in immunology Cutting edge platforms across 4 drug classes Bioinformatics driven approach leveraging AI and machine learning In-house GMP manufacturing of mRNA and cell therapies OPPORTUNITY IN 2021 AND BEYOND Poised to usher in new era of vaccines and immunotherapies in multiple th
Slide 7: COMIRNATY: Leading the fight against COVID-19
First vaccine authorized for use in the US and the EU Authorization for Emergency Use / Temporary Use or Conditional Approval in > 45 countries 32.9m million doses shipped1 Global phase 3 trial data indicates vaccine is highly efficacious and generally well tolerated 95% vaccine efficacy in 43,000+
Slide 8: Supply up to two billion vaccine doses in 2021
SUPPLY UP TO TWO BILLION VACCINE DOSES IN 2021 8 FY 2021 manufacturing capacity target: 2.0 billion doses* Committed Doses for 2021: >1 billion doses 50:50 gross profit share with Pfizer (worldwide ex-China); 35-40% gross profit share with Fosun Pharma in China 6 manufacturing sites in Pfizer and Bi
Slide 9: Multiple strategic levers to expand COMIRNATY access
MULTIPLE STRATEGIC LEVERS TO EXPAND COMIRNATY ACCESS 9 Increase Supply Capacity 6-dose vial Continous process improvements New sites, suppliers and CMOs Expand label Pediatric indications Pregnant women Additional sub-populations Broaden global distribution Develop optimized formulations Further sta
Slide 10: COVID-19 will likely become an endemic disease
Compelling efficacy & safety in all tested age groups Ability to create re-engineered vaccine in 6 weeks1 mRNA vaccine well-suited for re-vaccination COVID-19 WILL LIKELY BECOME AN ENDEMIC DISEASE 10 Safety & Efficacy Emergence of new viral variants Naturally waning immune response 1 2 3 Unmet Medic
Slide 11: Infectious diseases represent a long-term growth pillar
INFECTIOUS DISEASES REPRESENT A LONG-TERM GROWTH PILLAR 11 Unmet Medical Needs Increasing number of highly unaddressed indications Only 7 infectious disease vaccines approved by the FDA from 2017 to 2020 Many high incident infections with no vaccine or therapy approved Efficacy of multiple approved
Slide 12: mRNA technology poised to revolutionize immunotherapy
mRNA TECHNOLOGY POISED TO REVOLUTIONIZE IMMUNOTHERAPY 12 mRNA Today mRNA Tomorrow mRNA in the Future Today mRNA vaccines established as a New Drug Class Today mRNA technology to Displace traditional modalities CAR-T cell amplifying mRNA vaccine mRNA cancer vaccines Systemic mRNA encoded immuno-thera
Slide 13: Rationally designed multi-platform IO strategy
13 RATIONALLY DESIGNED MULTI-PLATFORM IO 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 unprecedented poten
Slide 14: FixVac: leveraging shared antigens to break immune tolerance
FIXVAC: LEVERAGING SHARED ANTIGENS TO BREAK IMMUNE TOLERANCE Multi-valency + Off-the-shelf Applicable for almost all types of tumor antigens 10.1% Novel Structure Product candidate2 Preclinical Phase 1 Phase 2 MELANOMA1 14 Fixvac
Slide 15: iNeST: tailored treatment to exploit individual targets
Ongoing Phase 2 trial in 1L melanoma iNeST: TAILORED TREATMENT TO EXPLOIT INDIVIDUAL TARGETS LATE-LINE METASTATIC 1L METASTATIC ADJUVANT Normal DNA Tumor DNA iNeST Single agent activity in melanoma1 and gastric2 Cancer Encouraging efficacy signal validates iNeST potential in early settings Residual
Slide 16: BNT311 demonstrated single agent anti-tumor activity
BNT311 DEMONSTRATED SINGLE AGENT ANTI-TUMOR ACTIVITY 16 1 Data cut-off: October 12, 2020. One PR was not confirmed yet by a subsequent scan. Includes all patients who had at least one post-baseline tumor assessment (schedule is every 6 weeks), and thus could be assessed for clinical benefit; 6 of 12
Slide 17: Advancing innovation beyond current boundaries
BNT 211 (CLDN 6 CAR) CARVac1 CAR-T cell amplifying mRNA therapy for solid tumors BNT 221 (PBMC derived ex vivo T cell therapy) NEOSTIM T cell therapy Individualized Neoantigen specific T cell therapy BNT 151 (modified IL2) BNT152 & 153 (IL-2/IL-7) RiboCytokines mRNA encoded Cytokines BNT 141 (undisc
Slide 18: CARVac: opening up CAR-T therapy for solid tumors
Potential to enhance persistence and safety of CAR-T cell therapy CARVAC: OPENING UP CAR-T THERAPY FOR SOLID TUMORS 18 First program BNT 211 targeting CLDN-6 antigen in solid tumors CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo1 1Reinhard et al, Science 2020
Slide 19: mRNA vaccines for autoimmune diseases
19 A therapeutic approach to emulate natural immune tolerance Induced considerable reduction in pro-inflammatory effector T cell infiltration in CNS Led to strong autoimmunity suppression without broad immune suppression Correlated with CNS function restoration and disease regression in preclinical
Slide 20: Key pipeline milestones expected in 2021
COMIRNATY updates Next-gen immunomodulator: BNT311 (GEN1046) BNT312 (GEN1042) CLDN6 CARVac: BNT211 Small molecule: BNT411 FixVac melanoma: BNT111 FixVac HPRV16+ head and neck cancer: BNT113 iNeST: BNT122 (RO7198457) RiboMabs: BNT141, BNT142 RiboCyokines: BNT151, BNT152+BNT153 CLDN6 CARVac: BNT211 NE
Slide 21: Better placed than ever to bring innovation to patients
BETTER PLACED THAN EVER TO BRING INNOVATION TO PATIENTS 21
Slide 22: © Copyright BioNTech SE 2020. All Rights Reserved. November 10, 2020 An der Goldgrube
© Copyright BioNTech SE 2020. All Rights Reserved. November 10, 2020 An der Goldgrube 12 55131 Mainz Germany M: investors@biontech.de