BioNTech SE · NASDAQ:BNTX
BioNTech — FY2022 Earnings Presentation
39 slides from BioNTech's earnings presentation, Mar 27, 2023
Slide 1: 4th Quarter and Full Year 2022 Financial Results & Corporate Update
4th Quarter and Full Year 2022 Financial Results & Corporate Update 27.03.2023
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 authorization in the European Union
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 the population aged 6 months and older. In people from 5 years of age and older the vaccine is administered as a 2-dos
Slide 4: Authorized use in the U.S. COMIRNATY
AUTHORIZED USE IN THE U.S. COMIRNATY® (COVID-19 Vaccine, mRNA) • 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 12 yea
Slide 5: Agenda
Financial Results Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Pipeline & COVID-19 Vaccines Update Özlem Türeci, Chief Medical Officer2 4th Quarter and Full Year 2022 Highlights Ugur Sahin, Chief Executive Officer1
Slide 6: 4th Quarter and Full Year 2022 Highlights
1 4th Quarter and Full Year 2022 Highlights Ugur Sahin, Chief Executive Officer
Slide 7: Continued Leadership against COVID-19 in 2022
~2 billion doses invoiced in 20221 ~550 million doses of variant adapted vaccines shipped2 >60% market share3 `` Broadest label amongst COVID-19 vaccines4 7 Continued Leadership against COVID-19 in 2022 1. Partnered with Pfizer, 2. As of Dec. 16, 2022, 3. Pfizer/BioNTech cumulative global COVID-19 m
Slide 8: Continued Execution in Oncology and Infectious Diseases R&D in 2022
Continued Execution in Oncology and Infectious Diseases R&D in 2022 8 1. Partnered with Genmab, 2. Partnered with Genentech, member of Roche Group, 3. Partnered with Pfizer, 4. Collaboration withPFE and subject to reaching agreement with our partners, 5.Partnered with University of Pennsylvania CLDN
Slide 9: Continued to Transform BioNTech
Infectious disease: 6 programs in 10 ongoing trials Broadened pipeline1 Oncology: 20 programs in 24 ongoing trials Continued to Transform BioNTech 9 1. As of February 2023, 2. As of December 31, 2022 Grew team by2 >1,500 employees Expanded partnerships 4 new collaborations accessing a variety of tec
Slide 10: Enhancing Our Disruptive Technology Toolkit to Fight Human Diseases
Enhancing Our Disruptive Technology Toolkit to Fight Human Diseases 10 1. mRNA encoded cancer-targeting antibodies and cytokines Core principles of our technology strategy Technology agnostic approach rooted in deep fundamental understanding of biology Build novel platforms with the ability to produ
Slide 11: 2023 Strategic Priorities
2023 Strategic Priorities 11 1. Partnered with Pfizer, 2. Collaboration with PFE and subject to reaching agreement with our partners, 3. Partnered with Genentech, member of Roche Group, 4. Partnered with Genmab, 5. Partnered with OncoC4, 6. Collaboration with University of Pennsylvania, 7. Collabora
Slide 12: Anti-CTLA-4 Antibody: A Promising New Addition to Our Checkpoint Portfolio
Anti-CTLA-4 Antibody: A Promising New Addition to our Growing Immuno- Oncology Checkpoint Portfolio 12 1. As of March 2023; 2. Refers to approved anti-CTLA-4 monoclonal antibodies. CTLA-4 = cytotoxic T-lymphocyte protein 4, FDA = Food and Drug Administration • First FDA approval of ipilimumab in 201
Slide 13: Pipeline & COVID-19 Vaccines Update
2 Pipeline & COVID-19 Vaccines Update Özlem Türeci, Chief Medical Officer
Slide 14: Multiple Clinical Data Readouts Reported at Major Medical Meetings in 2022
Multiple Clinical Data Readouts Reported at Major Medical Meetings in 2022 14 1. Partnered with Genentech, member of Roche Group, 2. Investigator initiated study, 3. Partnered with Genmab HPV = Human papilloma virus, HNSCC = Head and neck squamous-cell carcinoma, PDAC = Pancreatic ductal adenocarcin
Slide 15: Oncology Pipeline: Significant Progress and Expansion in 2022
Oncology Pipeline: Significant Progress and Expansion in 2022 15 1. Investigator-initiated / Investigator-initiated and sponsored trial, 2. Partnered with Genentech, member of Roche Group, 3. Partnered with Sanofi, 4. Partnered with Genmab, 5. Partnered with OncoC4 NSCLC = Non-small cell lung cancer
Slide 16: Differentiated Mechanism with Potential to Become Best-in-Class Anti-CTLA-4 Antibody
Avoiding lysosomal degradation of CTLA-4 for safer and more effective immunotherapy may lead to an uncoupling of cancer therapeutic effect from immunotherapy-related adverse effects Differentiated Mechanism with Potential to Become Best-in-Class Anti-CTLA-4 Antibody 16 FcR = fragment crystallizable
Slide 17: PRESERVE-001: Study Design and Safety
Combination: Dose Escalation (Hu-Lieskovan et al. Poster #594. Presented at SITC 2022) Monotherapy: Dose Finding (Li T. et al. Poster #949, Presented at SITC 2021) MoA Designed to Allow Higher Dosing & Longer Duration of Treatment withONC-392 PRESERVE-001: Study Design and Safety (NCT04140526) 17 Q
Slide 18: PRESERVE-001: Clinical Efficacy
ONC-392 (3 or 6 mg/kg) in combination with pembrolizumab Hu-Lieskovan et al. Poster #594. Presented at SITC 2022 Monotherapy (10 mg/kg) in platinum- resistant ovarian cancer patients Hays J et al. Poster #564. Presented at SITC 2022 % C h a n g e fr o m B a s e li n e in T a rg e t L e s io n s 30%
Slide 19: Infectious Disease Pipeline: Expansion in 2022
Phase 1 BNT162b2 (Original/Omicron BA.4-5-adapted bivalent) COVID-19 mRNA vaccines partnered with Pfizer COMIRNATY COVID-19 BNT162b2 (Original/Omicron BA.1-adapted bivalent) COVID-19 BNT162b5 (Enhanced spike antigen) COVID-19 BNT162b4 + BNT162b2 (T-cell enhancing) COVID-19 BNT163 HSV-23 Infectious D
Slide 20: Broadest Label of COVID-19 Vaccines
Broadest Label of COVID-19 Vaccines 20 1. Partnered with Pfizer MA = Marketing authorization, BLA = Biologics license application, EUA = Emergency use application MA/BLA Approval granted EUA granted Europe (full MA) U.S. (BLA and EUA) Population Population Vaccine Strain Use ≥ 6 months ≥ 5 years ≥ 1
Slide 21: Initiated Phase 1/2 Trial of Varicella Zoster Virus modRNA Vaccine Candidate
Initiated Phase 1/2 Trial of Varicella Zoster Virus modRNA Vaccine Candidate1 21 1 Trial being conducted by Pfizer as part of the ongoing collaboration, NCT05703607 Dose Level 3 Candidate 1 (Frozen) 0, 6 month Dose Level 1 Candidate 1 (Lyophilized) 0, 2 month - Candidate 2 (Frozen) 0, 2 month Dose L
Slide 22: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 23: FY 2022 Key Highlights
FY 2022 Key Highlights 23 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, 2022 filed on March 27, 2023 with the SEC. Any changes in the estimated share of the c
Slide 24: FY 2022 Financial Year Guidance vs. Actuals
FY Financial Year Guidance vs. Actuals 24 1. BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTechas further described in the Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 27, 2023 with the SEC. Any changes in the estimated
Slide 25: Full Year 2022 COVID-19 Vaccine Revenues
Full Year 2022 COVID-19 Vaccine Revenues 25 €17.1 bn €12.7 bn €3.2 bn €1.2 bn Direct COVID-19 vaccine sales to customers in BioNTech’s territory Share of gross profit from COVID-19 vaccine sales in the Pfizer and Fosun Pharma territory (100% gross margin)1 COVID-19 vaccine sales to collaborationpart
Slide 26: Q4 and FY 2022 Financial Results – Profit or Loss
Q4 and FY 2022 Financial Results – Profit or Loss 26 1. Numbers have been rounded, numbers presented may not add up precisely to the totals and may have been adjusted in the table context. Presentation of the consolidated statements of profit or loss has been condensed. 2. BioNTech’s profit share is
Slide 27: Full Year 2022 Return to Shareholders
Full Year 2022 Return to Shareholders 27 1. For the share repurchase, the "percentage of share capital" ratio is calculated based on the shares issued as of April 30,2022 (248,552,200 ordinary shares). Dividend 2022 Period Number of acquired ADSs Percentage of share capital1 Average price (in $) Vol
Slide 28: 2023 Financial Guidance Key Assumptions
28 • Expected transition from an advanced purchased agreement environment to commercial market ordering starting in 2023 and a regulatory recommendation to adapt the COVID-19 vaccines to newly circulating variants or sublineages of SARS- CoV-2 • Revenue guidance reflects expected deliveries under ex
Slide 29: 2023 Financial Year Guidance
2023 Financial Year Guidance 29 1. Numbers reflect current base case projections, include potential effects caused by or driven from additional collaborations or potential M&A transactions to the extent they have been disclosed and are calculated based on constant currency rates. COVID-19 vaccine re
Slide 30: Capital Allocation Framework
Capital Allocation Framework 30 R&D activities M&A and business development Main focus remains the acceleration of our R&D activities in oncology and infectious diseases Strengthen pipeline, technology platforms and digital capabilitiesby collaborations and potential complementary M&A Return capital
Slide 31: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 32: 2023 Strategic Outlook
2023 Strategic Outlook 32 Infectious disease pipelineCOVID-19 franchise Oncology pipeline
Slide 33: Mid-term Growth Potential for COVID-19 Vaccine Franchise
Mid-term Growth Potential for COVID-19 Vaccine Franchise 33 ACIP = Advisory Committee on Immunization Practices; VRBPAC = Vaccines and Related Biological Products Advisory Committee • First commercial market opening expected in 2H 2023 in the United States, likely to be shaped by ACIP and VRBPAC rec
Slide 34: 2022 COVID-19 Deaths and Hospitalizations Exceeded Those from Influenza in the U.S.
2022 COVID-19 Deaths and Hospitalizations Greatly Exceeded Those from Influenza in the United States 34 1. WHO Coronavirus (COVID-19) Dashboard 2. Since October 2022; https://www.cdc.gov/coronavirus /2019-ncov/covid-data/covi dview/index.html; 3. Portmann et al. Jama Netw Open. 2023;6(2):e2255599; 4
Slide 35: Advancing Broader Infectious Disease Vaccine Portfolio
Advancing Broader Infectious Disease Vaccine Portfolio 35 1. Licenced to Pfizer, 2. Partnered with Pfizer, 3. Collaboration with University of Pennsylvania, 4. Collaboration with Bill & Melinda Gates Foundation HSV-2 = Herpes Simplex Virus 2, • Advancing 2 additional clinical stage mRNA vaccine prog
Slide 36: 2023 Strategic Outlook in Oncology
2023 Strategic Outlook in Oncology 36 1. Partnered with Genentech, member of Roche Group, 2. Partnered with Genmab, 3. Partnered with OncoC4 NSCLC = Non-small cell lung cancer, CLDN = Claudin, HPV16 = Human papillomavirus 16, 1L = first line, R/R = Relapsed/Refractory, Plat.-R = Platinum-resistant B
Slide 37: Multiple Late- and Early-Stage Pipeline Milestones Expected in 2023
Multiple Late- and Early-Stage Pipeline Milestones Expected in 2023 37 1. Partnered with Pfizer; 2. Collaboration with Pfizer and subject to reaching agreement with our partners, 3. Partnered with University of Pennsylvania; 4. Collaboration with Bill & Melinda Gates Foundation; 5. Partnered with Ge
Slide 38: Annual General Meeting and Innovation Series Day
Annual General Meeting May 25, 2023 Innovation Series Day November 7, 2023 SAVE THE DATE
Slide 39: Thank you
Thank you BIONT=CrH