BioNTech SE · NASDAQ:BNTX
BioNTech — J.P. Morgan Healthcare Conference 2023
36 slides from BioNTech's conference presentation, Jan 10, 2023
Slide 1: January 10, 2023 Ugur Sahin, CEO and Co-Founder
January 10, 2023 Ugur Sahin, M.D. CEO and Co-Founder
Slide 2: 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 related to sales of BioNTech's COVID-19 vaccine, referred to
Slide 3: COMIRNATY EU authorization and safety information
COMIRNATY®▼(the Pfizer-BioNTech COVID-19 vaccine) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 6 months and older. The vaccine is administered as a 2-dose series 3 weeks apart, in people aged 5 years a
Slide 4: Authorized use in the U.S.
AUTHORIZED USE IN THE U.S. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original And Omicron BA.4/BA.5) • Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single b
Slide 5: Harnessing the power of the immune system to fight human diseases
Harnessing the power of the immune system to fight human diseases
Slide 6: Translating Vision into Strong Performance
6 Translating Vision into Strong Performance Scientific & Clinical Execution Corporate Execution Commercial & Market Leadership with COVID-19 Franchise1 1 Partnered with Pfizer
Slide 7: Commercial & Market Leadership with COVID-19 Franchise
7 Translating Vision into Strong Performance Commercial & Market Leadership with COVID-19 Franchise1 >60% market share3 ~2 billion doses invoiced in 2022 ~550 million doses of variant-adapted vaccine2 shipped Broadest label amongst COVID-19 vaccines 1 Partnered with Pfizer 2 As of Dec. 16, 2022 3 Pf
Slide 8: Scientific & Clinical Execution
first cell therapy for solid tumors next-gen checkpoint immunomodulator 8 Translating Vision into Strong Performance 1 Partnered with Genmab 2 Partnered with Pfizer 3 Partnered with University of Pennsylvania Scientific & Clinical Execution Clinical POC across multiple modalities: BNT211 BNT3121 Im
Slide 9: Corporate Execution
9 Translating Vision into Strong Performance 1 As of Oct. 15, 2022 Corporate Execution Rapid deployment ~2 months from regulator recommendations to vaccine delivery Expanded partnerships 4 new collaborations accessing a variety of technologies Broadened pipeline 22 programs in 26 ongoing trials Grew
Slide 10: 2023 Strategic Priorities
2023 Strategic Priorities Infectious diseases Initiate and accelerate clinical programs for high need indications Tuberculosis6 Shingles1 COVID-19 franchise1 Immuno-oncology Sustain leadership in COVID-19 Advance next-gen vaccines Variant-adapted T-cell enhancing Combinations + Advance disruptive pl
Slide 11: Global Powerhouse Built on People, Presence and Strategic Collaborations
Global Powerhouse Built on People, Presence and Strategic Collaborations Rwanda, Senegal, South Africa Planned mRNA manufacturing facilities Memorandum of Understanding for new collaboration Collaboration BioNTech site2 Manufacturing site2 11 United Kingdom Health-system-wide collaboration with UK g
Slide 12: Focused on Five Innovation Pillars
12 Focused on Five Innovation Pillars Deep understanding of the immune system Multi-platform innovation engine Manufacturing and automation Target discovery and characterization Digital & AI/ML
Slide 13: Our Disruptive Technology Toolkit to Fight Human Diseases
Infectious disease Enabling technology Our Disruptive Technology Toolkit to Fight Human Diseases 1 mRNA encoded cancer-targeting antibodies and cytokines Individualized therapies SELECTIVE TLR-7 ANTAGONISM NEXT GEN IMMUNO- MODULATORS Bispecific antibodies TARGETED CANCER THERAPIES RIBOLYSINS Precisi
Slide 14: Uniquely Positioned to Individualize Cancer Medicine
AI & Digitally-integrated target & drug discovery and development Individualized treatment platforms to address inter-individual variability Deep genomics & immunology expertise to leverage patient data Automated manufacturing to serve patients on time and globally Integrated model for immuno-oncolo
Slide 15: Landmark UK Collaboration to Implement Personalized Medicine
Individual genomic profiles mRNA vaccines Targeted antibodies Small molecule immunomodulators Cell & gene therapies Next-generation immunomodulators Ribologicals Goal: 10,000 personalized therapies to reach patients by 2030 Individualized immunotherapy is poised to disrupt cancer care and requires i
Slide 16: BioNTech uses AI and ML in all its pillars since 2008
BioNTech uses AI and ML in all its pillars since its creation in 2008 Deep understanding of the immune system: Understanding and exploiting immunological mechanisms through Data Science and ML since early days, including TRON collaboration since 2010 Target discovery and characterization: Exploiting
Slide 17: InstaDeep, Leader in Artificial Intelligence
Founded in 2014 with London HQ and offices in Cambridge (U.S.), Paris, Tunis, Lagos, Dubai, and Cape Town Approx. 240 engineers and tech professionals, including world-class AI & ML researchers. Published in all major ML conferences (NeurIPS, ICLR, ICML) Successful research collaborations with DeepM
Slide 18: InstaDeep's Planned Acquisition to Accelerate BioNTech's AI-First Strategy
Improved neoantigen prediction over current BioNTech model AI-based computer vision system improved Immune Response evaluation accuracy and speed Improved success rate for AI-driven platform DNA/RNA synthesis together with 40x increase in monthly throughput DeepChainTM designed RiboLogicals validate
Slide 19: Long-term leadership for our COVID-19 vaccine franchise
Long-term leadership for our COVID-19 vaccine franchise
Slide 20: First-to-Market BA.4/5-Adapted Bivalent Vaccine Launch
Omicron-adapted vaccine in ~2 months from regulator recommendation to market First-to-Market BA.4/5-Adapted Bivalent Vaccine Launch: Scientific and Manufacturing Preparation Leads to Rapid Execution 1 Including conditional approvals as of December 15, 2022 2 Pfizer-BioNTech COVID-19 Vaccine is FDA a
Slide 21: COVID-19 Franchise: Being Actionable in the Face of a Dynamic Virus
Innovation supported by insights from continuous variant surveillance and robust clinical program COVID-19 a leading cause of death – 250,000+ in the U.S. in 20221,2 21 COVID-19 Franchise: Being Actionable in the Face of a Dynamic Virus Evolution and Building for Continued Success 1 https://www.cdc.
Slide 22: Expanding and accelerating our pipeline
Expanding and accelerating our pipeline
Slide 23: Infectious Diseases: Important Growth Area
23 Infectious Diseases: Important Growth Area Addressing High Medical and Global Health Need All figures from World Health Organization fact sheets. https://www.who.int/news-room/fact-sheets (accessed June 09, 2022). Ongoing clinical programs Planned 2023 trial starts COVID-19 Influenza+ BNT161: Inf
Slide 24: Accelerating high-priority programs into potentially registrational trials
Accelerating high-priority programs into potentially registrational trials across multiple modalities
Slide 25: The Tools we Have Developed to Treat Cancer
25 The Tools we Have Developed to Treat Cancer 19 Clinical Programs in 22 ongoing Clinical Trials mRNA technology Cell and gene therapies Antibodies Small molecules
Slide 26: Planned Advancement of mRNA Cancer Vaccines in 2023
Individualized Vaccine BNT1221 randomized Phase 2 trials ongoing in 1L melanoma & adjuvant colorectal cancer BNT1221 randomized Phase 2 planned in pancreatic cancer based on encouraging Ph 1 data2 BNT1221 Phase 1/ 2 in multiple tumor types completed IVAC Phase 1 in adjuvant TNBC completed FixVac BNT
Slide 27: iNeST Autogene Cevumeran (BNT122): Randomized Trial in Adjuvant Colorectal Cancer
iNeST ǀ Autogene Cevumeran (BNT122): Phase 2 Randomized Trial vs Watchful Waiting in Adjuvant Colorectal Cancer 1 WHO factsheet on cancer. 2018 4 Loupakis F, et al. JCO Precis Oncol 2021; 5:PO.21.00101 2 Seer database 5 Reinert T, et al. JAMA Oncology, 2019; 5:1124−1131. 3 Fan G, et al. PLoS One 201
Slide 28: GEN1042/BNT3121 Next Generation Checkpoint Immuno-modulators
Multiple data updates from ongoing expansion cohorts expected in 2023 GEN1042/BNT3121 Intercepting Immune-Immune & Immune-Tumor Interactions: Next Generation Checkpoint Immuno-modulators with Pan-Tumor Potential 1 Collaboration with Genmab based on 50/50 sharing of costs and profits Expansion cohor
Slide 29: BNT211: Autologous CAR-T +/- CARVac targeting CLDN6+ solid tumors
Additional data readout and Phase 2 trial planned for 2023 BNT211: Autologous CAR-T +/- CARVac targeting CLDN6+ solid tumors Bringing Cell Therapy to Solid Tumors: Combining the Potential of a Novel Highly Selective Target and a CAR T Cell Amplifying Vaccine CLDN6, claudin 6 Reinhard K, et al. Scien
Slide 30: Outlook 2023 and beyond
Outlook 2023 and beyond BIONT=CH
Slide 31: Multiple Late- and Early-stage Pipeline Milestones Expected in 2023
Multiple Late- and Early-stage Pipeline Milestones Expected in 2023 1 Partnered with Pfizer 5 Collaboration with Genmab based on 50/50 sharing of costs and profits 2 Partnered with University of Pennsylvania FPD = First Patient Dosed 3 Collaboration with BMGF 4 Partnered with Genentech Modality Indi
Slide 32: Advancing Toward Realizing Our Vision
Advancing Toward Realizing Our Vision 32 Infectious diseases 5 randomized Phase 2 trials Globally successful marketed COVID-19 vaccine with first-to-market BA.4/5-adapted booster 10+ preclinical programs, 2 FIH trials to start in 2023 3 Phase 1 programs19 programs in 24 clinical trials Maintain and
Slide 33: Thank You
THANK YOU BIONT=CrHi
Slide 34: BioNTech
BIONT=CH
Slide 35: Infectious Disease Pipeline
Infectious Disease Pipeline: Multiple Opportunities Built on Proven Platform 1 Partnered with Pfizer 2 Partnered with University of Pennsylvania 3 Collaboration with BMGF. BioNTech holds worldwide distribution rights except developing countries where BMGF holds distribution rights. Indication Produc
Slide 36: Oncology Pipeline: Significant Progress and Expansion in 2022
Oncology Pipeline: Significant Progress and Expansion in 2022 1 Partnered with Genentech 2 Investigator-initiated Phase 1 trial 3 Partnered with Genmab FPD = First patent dosed, SMIM = small molecule immunomodulators, NSCLC = non-small cell lung cancer Drug class Platform Product candidate Indicatio