BioNTech SE · NASDAQ:BNTX
BioNTech — Q1 2022 Earnings Presentation
31 slides from BioNTech's earnings presentation, May 12, 2022
Slide 1: 1st Quarter 2022 Financial Results & Corporate Update
1st Quarter 2022 Financial Results & Corporate Update May 9, 2022 Exhibit 99.1
Slide 2: Forward-looking Statements
Titelmasterformat durch Klicken bearbeitenThis 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: ou
Slide 3: Safety Information
Safety Information 3 COMIRNATY® ▼(the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorization (CMA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 5 years of age. The vaccine is administered as a primary course of 2 doses, 3 we
Slide 4: Safety Information: Authorized Use in the U.S.
Safety Information 4 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-2) in individuals 16 years of age and old
Slide 5: First Quarter 2022 Highlights
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 5
Slide 6: Our Vision: Harnessing the Power of the Immune System
Titelmasterformat durch Klicken bearbeitenOur Vision: Harnessing The Power Of The Immune System To Fight Human Diseases Multi-Platform, Technology Agnostic Strategy Diversified Product Pipeline Fully Integrated Biotechnology Company Immunotherapy powerhouse expanding the therapeutic universe Global
Slide 7: Highlights in Q1 2022
Titelmasterformat durch Klicken bearbeiten Highlights in Q1 2022 • Reported Q1 total revenues of €6.4 bn1 • Signed pandemic preparedness contract with Federal Republic of Germany through 2027 • Multiple new deals signed: • Matinas lipid nanocrystal collaboration • Regeneron collaboration to advance
Slide 8: Proactive Approach to Managing COVID-19 at a Global Scale
Titelmasterformat durch Klicken bearbeiten Proactive Approach to Managing COVID-19 at a Global Scale Delivered nearly 3.4 bn1 doses cumulatively to >175 countries and regions On track to achieve pledge to deliver a total of 2 bn doses to low- and middle-income countries by end of 2022 • Optimized fo
Slide 9: Waves of Innovation Propel Us Toward Our Vision
Titelmasterformat durch Klicken bearbeiten Waves of Innovation Propel Us Toward Our Vision COVID-19 Vaccine Oncology Infectious Diseases New Disease Areas Driving Transformation TODAY… Near- and Mid-Term… Long-Term 5 RANDOMIZED PHASE 2 TRIALS 1 MARKETED VACCINE 10+ PRECLINICAL PROGRAMS 1 PHASE 1 PRO
Slide 10: Pipeline Update
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 10
Slide 11: COVID-19 Vaccine R&D Strategy to Drive Pandemic Preparedness
Titelmasterformat durch Klicken bearbeiten COVID-19 Vaccine R&D Strategy to Drive Pandemic Preparedness 1 bioRxiv. Omicron breakthrough infection drives cross-variant neutralization and memory B cell formation; April 1, 2022. Available at: https://www.biorxiv.org/content/10.1101/2022.04.01.486695v1.
Slide 12: Comprehensive Clinical Response Strategy to Omicron Variant
Titelmasterformat durch Klicken bearbeiten Omicron-adapted vaccine or Comprehensive Clinical Response Strategy to Omicron Variant 3rd dose or 3rd+4th dose 4th dose Omicron-adapted vaccine 3-dose primary regimen Omicron-adapted vaccine Evaluating different Omicron-adapted monovalent vaccine regimens
Slide 13: Oncology: Advancement Across Multiple Modalities and Indications
Oncology: Advancement Across Multiple Modalities and Indications 1BNT115 is currently being studied in an investigator-initiated Phase 1 trial. 2Collaboration with Genentech 3Collaboration with Sanofi. 4Collaboration with Genmab. SMIM, Small Molecule Immunomodulators Drug class Platform Product cand
Slide 14: Focused Execution in 2022 Across Phase Programs
Titelmasterformat durch Klicken bearbeitenFocused Execution in 2022 Across 5 Phase 2 Programs in Various Solid Tumor Types BNT111 Platform Program BNT113 Autogene cevumeran BNT1221 BNT3112 Autogene cevumeran BNT1221 R/R Melanoma HPV16+ HNSCC Adjuvant colorectal cancer R/R NSCLC1L Melanoma • Potentia
Slide 15: BNT211: CAR-T Cell Program Targeting Solid Tumors
Titelmasterformat durch Klicken bearbeitenBNT211: CAR-T Cell Program with Potential Targeting Multiple High-Need 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, not otherwise specifie
Slide 16: CLDN6 CAR-T Cells Well Tolerated as Monotherapy or with CARVac
Titelmasterformat durch Klicken bearbeiten CLDN6 CAR-T cells as monotherapy or combined with CARVac well tolerated at dose levels evaluated to date (1x107 and 1x108 CAR-T) • Grade 1-2 CRS seen in 70% of patients at 1x108 CAR-T dose, manageable by administration of tocilizumab • 2 DLTs observed, both
Slide 17: Robust CAR-T Engraftment Seen in All Patients
Titelmasterformat durch Klicken bearbeiten 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] 0 50 100 150 104 105 106 107 108 109 1010 Days post infusion C A R -T c e ll s [ to ta l c o u n ts ] 0 50 100 150 104 105 106 107 108 109 1010 Days post i
Slide 18: Efficacy Observed at Weeks Post Infusion
Efficacy Observed at 6 Weeks Post Infusion Data cut-off: MAR 10, 2022. DL1: 1x107 CAR-T; DL2: 1x108 CAR-T DL, dose level; CR, complete response; DCR, disease control rate; EoT, end of trial (due to PD); ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease, SD
Slide 19: Continuing Responses in Testicular Cancer
Titelmasterformat durch Klicken bearbeiten Continuing Responses in Testicular Cancer with One PR Deepening to CR Best response Durability of responses Testicular cancer patients: DL1: 1x107 CAR-T mono DL1: 1x107 CAR-T + CARVac DL2: 1x108 CAR-T + CARVac Testicular Ovarian Others 19 PR, partial respon
Slide 20: Responses in Two Testicular Cancer Patients with Relapse
Titelmasterformat durch Klicken bearbeitenResponses in Two Testicular Cancer Patients with Relapse After Prior Treatment Data cut-off: MAR 10, 2022 AFP, alpha-fetoprotein; CR, complete response; CLDN6, Claudin-6. Baseline 6 weeks post infusion 12 weeks post infusion Patient 1 Patient 2 56-year-old m
Slide 21: Financial Results
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 21
Slide 22: Key Highlights for Q1 2022
Titelmasterformat durch Klicken bearbeiten €6.4 bn €4.8 bn €6.2 bn + €12.7 bn Key Highlights For Q1 2022 Total Revenues1 Operating Result Diluted EPS Cash and Trade Receivables €14.24 22 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further de
Slide 23: First Quarter 2022 COVID-19 Vaccine Commercial Revenues
Titelmasterformat durch Klicken bearbeiten First Quarter 2022 COVID-19 Vaccine Commercial Revenues Strong Q1 2022 - BioNTech reiterates 2022 financial year guidance COVID-19 vaccine sales to collaboration partners of products manufactured by BioNTech Direct COVID-19 vaccine sales to customers in Bio
Slide 24: Q1 2022 Financial Results – Profit or Loss
Titelmasterformat durch Klicken bearbeiten Q1 2022 Financial Results – Profit or Loss (in millions, except per share data)1 Q1 2022 Q1 2021 Research & development revenues €12.4 €20.9 Commercial revenues2 6,362.2 2,027.5 Total revenues €6,374.6 €2,048.4 Cost of sales (1,294.1) (233.1) Research and d
Slide 25: 2022 Financial Year Guidance Reiterated
Titelmasterformat durch Klicken bearbeiten 2022 Financial Year Guidance Reiterated 1 Ranges reflect current base case projections and do not include potential effects caused by or driven from additional collaborations or potential M&A transactions. 2 BioNTech Group estimated annual effective income
Slide 26: Corporate Outlook
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO First Quarter 2022 Highlights Ugur Sahin, CEO 26
Slide 27: Significant Pipeline Expansion and Maturation Expected in 2022
Titelmasterformat durch Klicken bearbeiten Significant Pipeline Expansion and Maturation Expected in 2022 • Initiate 4 FIH vaccine trials • 10+ additional mRNA vaccine programs • Precision antibacterials Expand in Infectious Disease • First randomized Phase 2 readout • Prepare for registrational tri
Slide 28: COVID-19 Vaccine Outlook 2022
Titelmasterformat durch Klicken bearbeiten COVID-19 Vaccine Outlook 2022 Upcoming Data BNT162b2 Timing • Data for 4th dose in adults, aged 16 to 65 years2 ongoing • Data for 3-dose regimen in children, aged 6 months to <5 years coming weeks Follow-on and next generation vaccines • Omicron-adapted va
Slide 29: Further Expected Pipeline Milestones in 2022
Titelmasterformat durch Klicken bearbeiten Further Expected Pipeline Milestones in 2022 HSV 2, Herpes simplex virus type 2; FPD, first patient dosed; CLDN, Claudin; NSCLC, non-small cell lung cancer 1 Partnered with Pfizer, 2 Collaboration with BMGF, 3 Partnered with Genentech Infectious Diseases Ti
Slide 30: Save the Date: Capital Markets Day and AGM
30 SAVE THE DATE Virtual Capital Markets Day Annual General Meeting June 29, 2022 June 1, 2022 30
Slide 31: Thank You
THANK YOU BIONT=CrH