BioNTech SE · NASDAQ:BNTX
BioNTech — FY2021 Earnings Presentation
37 slides from BioNTech's earnings presentation, Mar 30, 2022
Slide 1: 4th Quarter & Full Year 2021 Financial Results & Corporate Update
4th Quarter & Full Year 2021 Financial Results & Corporate Update March 30, 2022 Exhibit 99.2
Slide 2: This Slide Presentation Includes Forward-looking Statements
Titelmasterformat durch Klicken bearbeitenThis Slide Presentation Includes Forward-looking Statements 2 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
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 2-dose series, 3 weeks apart. I
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: Agenda
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Oncology Pipeline Update Özlem Türeci, CMO COVID-19 Vaccine Update Özlem Türeci, CMO Fourth Quarter and Full Year 2021 Highlights Ugur Sahin, CEO 5
Slide 6: Our Vision: Harnessing The Power Of The Immune System To Fight Human Diseases
Titelmasterformat durch Klicken bearbeiten Our Vision: Harnessing The Power Of The Immune System To Fight Human Diseases 6 Multi-Platform, Technology Agnostic Strategy Diversified Product Pipeline Fully Integrated Biotechnology Company Immunotherapy Powerhouse expanding the therapeutic universe Glob
Slide 7: 2021 Key Highlights of Progress Towards Vision
Titelmasterformat durch Klicken bearbeiten 2021 Key Highlights of Progress Towards Vision STRONG FINANCIAL PERFORMANCE €19.0 Bn Total 2021 Revenues2 €39.63 Diluted EPS2 EXPANDED GLOBAL ORGANIZATION 3,000+ team members >1 Bn to low- and middle- income countries1 Increased footprint with new offices i
Slide 8: Multi-platform Strategy | Technology Agnostic Innovation Engine
Multi-platform Strategy | Technology Agnostic Innovation Engine Strengthening platform with collaborations and strategic M&A SELECTIVE TLR-7 ANTAGONISM SMALL MOLECULES TARGETED CANCER THERAPIES ANTIBODIES NEXT GEN IMMUNO- MODULATORS • Bispecific antibodies *mRNA encoded cancer-targeting antibodies a
Slide 9: 2022 Strategic Priorities
Titelmasterformat durch Klicken bearbeiten 2022 Strategic Priorities 9 POC, proof of concept; FIH, first–in-human; HSV 2, herpes simplex virus type 2 • Initiate 4 FIH vaccine trials: Expand in Infectious Disease • First randomized Phase 2 readout • Prepare for registrational trials • POC data for CA
Slide 10: Global Social Responsibility at Our Core
Titelmasterformat durch Klicken bearbeiten Global Social Responsibility at Our Core 10 SBTi, Science Based Targets initiative (in line with Paris agreement) 1 base year: 2021 2 encompasses adhering to ten principles on human rights, the environment and anti-corruption COVID-19 vaccine pledge to COVA
Slide 11: Agenda: COVID-19 Vaccine Update
05 Corporate Outlook Ryan Richardson, Chief Strategy Officer 04 Financial Results Jens Holstein, CFO 03 Oncology Pipeline Update Özlem Türeci, CMO COVID-19 Vaccine Update Özlem Türeci, CMO 01 Fourth Quarter and Full Year 2021 Highlights Ugur Sahin, CEO 11
Slide 12: COVID-19 Vaccine Accomplishments Position Company for Continued Success in 2022
COVID-19 Vaccine Accomplishments Position Company for Continued Success in 2022 12 Pediatrics • 5 to <12 yrs: • Obtained approvals in multiple markets1 for 2-dose regimen for BNT162b2 • Evaluating third dose • 6 mo to <5 yrs: • Evaluating 3-dose regimen; data expected in April 2022 • Data will be su
Slide 13: Need for Pandemic Vaccination Continues
Need for Pandemic Vaccination Continues 13 1 shot 2 shots 3 or more shots Unvaccinated • ~36% of the world population remains completely unvaccinated • Only 19% of the world population has received a booster vaccination (3+ shots) • Infection rates remain high, driven by Omicron variant • Global wee
Slide 14: BNT162b2 Boosters to Address Partial Immune Escape by Omicron
Titelmasterformat durch Klicken bearbeiten BNT162b2 Boosters to Address Partial Immune Escape by Omicron 14 Potential to replace traditional treatment modalities Future pandemic preparedness: Monitoring of emerging variants Rapid data-guided vaccine adaptation 1 Collie SH, et al. N Engl J Med 2022;
Slide 15: Need for Vaccine-Adaptation to Omicron and Future Emerging Variants
Titelmasterformat durch Klicken bearbeitenNeed for Vaccine-Adaptation to Omicron and Potentially Future Emerging Variants Potential to replace traditional treatment modalities Annual and/or seasonal boosters with variant adapted vaccines expected for the foreseeable future for pandemic preparedness1
Slide 16: Clinical Program to Assess Omicron-Adapted Vaccine
Titelmasterformat durch Klicken bearbeiten Omicron-based vaccine or Clinical Program to Assess Safety, Tolerability and Immunogenicity of an Omicron-Adapted Vaccine 3rd dose or 3rd+4th dose 4th dose Omicron-based vaccine 3-dose primary regimen Omicron-based vaccine 1 BioNTech. Available at: https://
Slide 17: Agenda: Oncology Pipeline Update
05 Corporate Outlook Ryan Richardson, Chief Strategy Officer 04 Financial Results Jens Holstein, CFO Oncology Pipeline Update Özlem Türeci, CMO 02 COVID-19 Vaccine Update Özlem Türeci, CMO 01 Fourth Quarter and Full Year 2021 Highlights Ugur Sahin, CEO 17
Slide 18: Strong Clinical Execution in Oncology in 2021
Titelmasterformat durch Klicken bearbeiten Strong Clinical Execution in Oncology in 20211 R/R, refractory/relapsed; HNSCC, head and neck squamous cell carcinoma; NSCLC, non-small cell lung cancer; FPD, first patient dosed; 1 Includes updates through March 30, 2022; 2 BNT311 (Gen1046) and BNT312 (Gen
Slide 19: Immunologic Responses Supportive of Mechanism of Action in CPI-experienced NSCLC
Titelmasterformat durch Klicken bearbeiten Peripheral and Tumoral Immunologic Responses Supportive of Proposed Mechanism of Action in CPI-experienced NSCLC Patients • PD-L1 Inhibitor–Pre-treated patients • 25 NSCLC patients with evaluable baseline tumors SITC 2021 BNT311 Phase 1/2: First-in-Human St
Slide 20: BNT311: Phase 1/2 Trial Targeting CPI-experienced PD-L1+ R/R NSCLC
Titelmasterformat durch Klicken bearbeiten BNT311: Phase 2 Trial Targeting CPI-experienced PD-L1+ R/R NSCLC 20 Partnered with Genmab; 50:50 profit/loss collaboration R/R, refractory/relapsed; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; SOC, Standard of Care; CPI, check point
Slide 21: BNT311 & BNT312: Phase 1/2 Expansion Cohorts Ongoing
Titelmasterformat durch Klicken bearbeiten BNT311 & BNT312: Phase 1/2 Expansion Cohorts Ongoing 21 Next Generation Immunomodulators designed to prime & activate anti-tumor T-cell and NK cell function • Melanoma • NSCLC • PDAC • HNSCC Combination expansion cohorts are currently recruiting Part 1: Dos
Slide 22: BNT211: CAR-T Cell Program Targeting Multiple High-Need 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 23: BNT211: CAR-T Engraftment and Tolerable Safety Profile
Titelmasterformat durch Klicken bearbeitenBNT211: CAR-T Engraftment and Tolerable Safety Profile with CLDN6 CAR-T without and with CARVac Data cutoff = NOV 18, 2021; CRS, cytokine release syndrome; DL, dose level; DLT, dose-limiting toxicity; HDCT, high dose chemotherapy; ASCT, autologous stem cell
Slide 24: Agenda: Financial Results
05 Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO 03 Oncology Pipeline Update Özlem Türeci, CMO 02 COVID-19 Vaccine Update Özlem Türeci, CMO 01 Fourth Quarter and Full Year 2021 Highlights Ugur Sahin, CEO 24
Slide 25: Key Highlights For 2021 Financial Year
Titelmasterformat durch Klicken bearbeiten €19.0 bn €15.3 bn €39.63 €2.1 bn2 + €12.4 bn 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021. Any changes in the
Slide 26: COVID-19 Vaccine Commercial Revenues
Titelmasterformat durch Klicken bearbeiten Direct COVID-19 vaccine sales to customers in BioNTech’s territory Share of gross profit and sales milestones from COVID-19 vaccine sales in the Pfizer and Fosun Pharma territory (100% gross margin) €1.0 bn €3.0 bn €14.8 bn FY 2021 1 BioNTech’s profit share
Slide 27: Funds to Finance our Growth
Titelmasterformat durch Klicken bearbeiten Key Highlights For 2021 Financial Year Funds to Finance our Growth2 1 Cash deposit with an original term of six months are presented as other financial assets. 2 Additional influencing factors (i.e. cash outlays) as well as certain collection risk with trad
Slide 28: Comparison Guidance To Actuals 2021 Financial Year
Titelmasterformat durch Klicken bearbeiten Comparison Guidance To Actuals 2021 Financial Year 28 Guidance as of Nov 2021 Actual result FY 2021 Drivers COVID-19 vaccine revenues € 16 - 17 bn € 19 bn • ~2.6bn doses delivered in 2021 vs. up to 2.5bn doses guided • Higher proportion of doses than estima
Slide 29: Q4 2021 And FY 2021 Financial Results – Profit or Loss
Titelmasterformat durch Klicken bearbeiten Q4 2021 And FY 2021 Financial Results – Profit or Loss 29 (in millions, except per share data)1 4Q 2021 4Q 2020 FY 2021 FY 2020 Research & development revenues €6.6 €65.4 €102.7 €178.8 Commercial revenues2 5,525.9 280.0 18,874.0 303.5 Total revenues €5,532.
Slide 30: 2022 Financial Year Guidance
Titelmasterformat durch Klicken bearbeiten 2022 Financial Year Guidance 30 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 tax rate
Slide 31: Capital Allocation Framework
Titelmasterformat durch Klicken bearbeiten Accelerate R&D activities in the years to come Strengthen technology platforms and digital capabilities by collaborations and potential add-on M&A Develop global footprint and invest in manufacturing capabilities for key technologies Expect to authorize a s
Slide 32: Agenda: Corporate Outlook
Corporate Outlook Ryan Richardson, Chief Strategy Officer 04 Financial Results Jens Holstein, CFO 03 Oncology Pipeline Update Özlem Türeci, CMO 02 COVID-19 Vaccine Update Özlem Türeci, CMO 01 Fourth Quarter and Full Year 2021 Highlights Ugur Sahin, CEO 32
Slide 33: Outlook for 2022
Titelmasterformat durch Klicken bearbeiten Outlook for 2022 33 Global footprint & organization Corporate Development Expect data updates for up to 3 additional pipeline programs Global Development Organization transformation underway to support pipeline expansion and potential initiation of registra
Slide 34: Expected Pipeline Milestones in 2022 (1 of 2)
Titelmasterformat durch Klicken bearbeiten Expected Pipeline Milestones in 2022 (1 of 2) 34 BNT162b2 Timing • Data for 4th dose in adults, aged 16 to 65 years ongoing • Data for 3rd dose in children, aged 5 to <12 years ongoing • Data for 3-dose regimen in children, aged 6 months to <5 years April N
Slide 35: Expected Pipeline Milestones in 2022 (2 of 2)
Titelmasterformat durch Klicken bearbeiten Expected Pipeline Milestones in 2022 (2 of 2) 35 Infectious Diseases Timing • Shingles vaccine1 2H • Tuberculosis vaccine2 2H • HSV 2 vaccine 2H • Malaria vaccine 2H Oncology • BNT141 – RiboMab, solid tumors FPD in January • BNT142 – RiboMab, solid tumors 1
Slide 36: Save the Date: Capital Markets Day and Annual General Meeting
36 SAVE THE DATE Capital Markets Day Annual General Meeting June 29, 2022 June 1, 2022 36
Slide 37: Thank You
THANK YOU BIONT=CrH