BioNTech SE · NASDAQ:BNTX
BioNTech — Q3 2022 Earnings Presentation
37 slides from BioNTech's earnings presentation, Nov 7, 2022
Slide 1: 3rd Quarter 2022 Financial Results & Corporate Update
3rd Quarter 2022 Financial Results & Corporate Update November 07, 2022 Exhibit 99.2
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 and important 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 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents
Slide 4: Safety Information: Authorized use in the U.S.
Safety Information 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
Slide 5: Agenda and presenters
5 Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, Chief Financial Officer COVID-19 Vaccine & Pipeline Update Özlem Türeci, Chief Medical Officer 3rd Quarter 2022 Highlights Ugur Sahin, Chief Executive Officer
Slide 6: Q3 Highlights: Corporate & Oncology Pipeline
Q3 Highlights: Corporate & Oncology Pipeline 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 as well as the Quarterly Report as of and for the three and nin
Slide 7: Q3 Highlights: COVID-19 Vaccine
1 As of mid of October 2022; includes BA1- and BA4./5 bivalent adapted vaccines; - 2 Approved for prevention of COVID-19 as a 2-dose series in individuals 5 yrs of age and older and as a 3-dose series in individuals 6 months through 4 years of age; for all existing and future indications and formula
Slide 8: Rapid Omicron Response: Months from Regulator Recommendation to Launch
Rapid Omicron Response: ~ 2 Months from Regulator Recommendation to Launch 1 as of October 25, 2022 VRBP = Vaccines and Related Biological Products; CMC = chemistry, manufacturing and controls; ICMRA = International Coalitions of Medicines Regulatory Agencies Clinical & preclinical data presented to
Slide 9: Epidemiology and Scientific Data Support Need for Omicron BA.4/BA.5-Adapted Bivalent Booster
Epidemiology and Scientific Data Support Need for Omicron BA.4/BA.5-Adapted Bivalent Booster BA.4/BA.5 and sublineages continue to be dominant strains1 Original/Omicron BA.4/BA.5-adapted bivalent boosters may • Provide broad protection against currently circulating Omicron sublineages and the WT vir
Slide 10: Long-Term Need for Annually Adapted Boosters Anticipated
Long-Term Need for Annually Adapted Boosters Anticipated Booster vaccination restores waning immunity5 Long-term health consequences of COVID-19 infections significant, but still not fully understood Continuous evolution of SARS-CoV-2 creates possibility of waves driven by new immune-evasive strains
Slide 11: Framework in Place for Building a Sustainable Business for COVID-19 and Other Infectious Diseases
Framework in Place for Building a Sustainable Business for COVID-19 and Multi-Product Opportunities in Other Infectious Diseases 11 Built on BioNTech’s validated platform of proven science, discovery, development, manufacturing & commercialization
Slide 12: Agenda and presenters
12 Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, Chief Financial Officer COVID-19 Vaccine & Pipeline Update Özlem Türeci, Chief Medical Officer 3rd Quarter 2022 Highlights Ugur Sahin, Chief Executive Officer
Slide 13: Multi-Pronged Strategy for Continued Innovation
Multi-Pronged Strategy for Continued Innovation 13 Vaccine Boosters to Address Evolving Virus Vaccine for Seasonal Protection with Convenient Single-Dose Administration Vaccines Designed for Extended Durability and Breadth of Protection Innovation supported by insights from continuous variant survei
Slide 14: Omicron BA.4/BA.5-Adapted Bivalent Vaccine Approved in 45+ Countries
Omicron BA.4/BA.5-Adapted Bivalent Vaccine Approved in 45+ Countries1 14 FDA EUA2 EC Marketing Authorization3 FDA Submission EMA Submission Phase 1/2/3 Clinical Trial BA.4/5-Adapted Ages 12+ yrs Ongoing4 Ages 5-11 yrs Ongoing5 Ages 6 mo-4 yrs Planned for 1Q 2023 Planned for 1Q 2023 Ongoing5 BA.1-Ada
Slide 15: Positive Data in Omicron BA.4/BA.5-Adapted Vaccine Study
Positive Data from 30 Day Time Point in Omicron BA.5/BA.5-Adapted Vaccine Study Omicron BA.4/BA.5-adapted bivalent vaccine substantially increased Omicron BA.4/BA.5 neutralizing antibody titers above pre-booster levels in adults 18+ 15 Randomized, controlled, Phase 2/3 trial in healthy volunteers ag
Slide 16: Bivalent Vaccine Demonstrates Strong Immune Response in Adults 18+
Omicron BA.4/BA.5 Adapted Bivalent Vaccine Demonstrates Strong Immune Response in Adults 18+ Improved responses with bivalent vaccine most pronounced in elderly and baseline negative individuals Vaccine Group (as randomized) BNT162b2 Bivalent (WT/OMI BA.4/BA.5)1 30 μg BNT162b21 30 μg Age 18-55 Years
Slide 17: Phase 1 Combination Trial of Influenza mRNA Vaccine + Bivalent COVID-19 Vaccine
Initiated Phase 1 Combination Trial of Influenza mRNA Vaccine + Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine1 17 Quadrivalent Influenza (qFlu) modRNA vaccine (2 type A strains, 2 type B strains selected annually) Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine 30 µg qFlu 30 µg Omicron BA.
Slide 18: Next Generation Vaccine Approaches to Provide Durable, Broad Protection
Next Generation Vaccine Approaches to Provide Durable, Broad Protection Constructs designed to engage different arms of the immune system including antibodies and T cells 18 Targets highly-conserved non-spike proteins and aims to • Increase immune resilience • Enhance and broaden T cell response • P
Slide 19: Infectious Disease Pipeline: Multiple Opportunities Built on Proven Platform
Infectious Disease Pipeline: Multiple Opportunities Built on Proven Platform 1 Collaboration with Pfizer 2 University of Pennsylvania collaboration 3 Collaboration with Bill & Melinda Gates Foundation. BioNTech holds worldwide distribution rights except developing countries where BMG holds distribut
Slide 20: Oncology Pipeline: Significant Progress and Expansion
Oncology Pipeline: Significant Progress and Expansion in 2022 1 Collaboration with Genentech, a member of the Roche Group 2 Investigator-initiated Phase 1 trial FPD = First patent dosed, SMIM = small molecule immunomodulators, NSCLC = non-small cell lung cancer 20 Drug class Platform Product candida
Slide 21: BNT211: CAR-T Cell Program Targeting High-Need Solid Tumors
BNT211: CAR-T Cell Program with Potential Targeting Multiple High-Need Solid Tumors Reinhard K, et al. Science 2020; 367:446-453 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
Slide 22: BNT211: Follow-up Data Presented at ESMO 2022
CLDN6 CAR-T cells as monotherapy or combined with CARVac well tolerated at dose levels evaluated to date (1x107 and 1x108 CAR-T) • Mostly grade 1-2 CRS seen in 45% of patients, manageable by administration of tocilizumab if needed • 2 DLTs observed, both patients fully recovered and showed clinical
Slide 23: Dose Dependent CAR-T Expansion Seen in All Patients
Dose Dependent CAR-T Expansion Seen in All Patients 23 0 50 100 150 200 250 300 350 104 105 106 107 108 109 1010 Days post infusion T o ta l C A R -T c o u n ts 6 12 18 24 30 360 Weeks post infusion 42 48 LLOQ DL2 Part 1 Part 2 0 5 0 1 0 0 1 5 0 2 0 0 2 5 0 3 0 0 3 5 0 1 0 4 105 106 107 108 109 1010
Slide 24: Robust Tumor Shrinkage and Durable Responses in Testicular Cancer Patients
Robust Tumor Shrinkage and Durable Responses observed in Testicular Cancer Patients 24 Data cut-off: 16 Aug 2022. CR = complete response; DCR = disease-control rate; DL = dose level; LD = lymphodepletion; ORR = overall response rate. Grey lines indicate patients w/o LD. Red lines indicate ongoing as
Slide 25: Rapid Advancement of Next Generation Immuno-Modulators for Cancer
Rapid Advancement of Next Generation Immuno-Modulators for Cancer 1 Collaboration with Genmab based on 50/50 sharing of costs and profits 2 HexaBody® technology owned by Genmab Designed to prime and activate anti-tumor T cell and Natural Killer cell function Phase 1/2: Advanced solid tumors • Data u
Slide 26: Agenda and presenters
26 Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, Chief Financial Officer COVID-19 Vaccine & Pipeline Update Özlem Türeci, Chief Medical Officer 3rd Quarter 2022 Highlights Ugur Sahin, Chief Executive Officer
Slide 27: Key Highlights for 3Q 2022
Key Highlights for 3Q 2022 27 Total Revenues1 Operating Result €3.5 bn €2.4 bn €13.4 bn + €7.3 bn€6.98 Diluted EPS Cash and Trade Receivables 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
Slide 28: 3Q and YTD 2022 COVID-19 Vaccine Revenues
28 €3.4 bn Q3 2022 €2.5 bn €0.6 bn €0.3 bn €12.9 bn YTD 2022 €9.1 bn €2.3 bn €1.5 bn 3Q and YTD 2022 COVID-19 Vaccine Revenues 3Q 2022 revenues in line with our expectations Direct COVID-19 vaccine sales to customers in BioNTech’s territory Share of gross profit from COVID-19 vaccine sales in the Pf
Slide 29: Income statement (in millions, except per share data)
(in millions, except per share data)1 Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Commercial revenues2 €3,394.8 €6,040.1 €12,923.3 €13,348.1 Research & development revenues 66.4 47.2 109.0 96.1 Total revenues €3,461.2 €6,087.3 €13,032.3 €13,444.2 Cost of sale
Slide 30: 2022 Financial Year Guidance Update
2022 Financial Year Guidance Update 30 COVID-19 Vaccine Revenues for FY 20221 Estimated BioNTech COVID-19 vaccine revenues € 16 – 17 bn (previously € 13 – 17 bn) Planned FY 2022 Expenses and Capex1 R&D expenses € 1,400 - 1,500 m SG&A expenses € 450 - 550 m Capital expenditure € 450 - 550 m Estimated
Slide 31: Share Repurchase Program
Share Repurchase Program 31 Period Number of acquired ADS Percentage of share capital1 Average price (in $) Volume (in million $) May 2, 2022 to October 10, 2022 6,945,513 2.8% 143.98 1,000.0 1 For the share repurchase, the "percentage of share capital" ratio is calculated based on the shares issued
Slide 32: Agenda and presenters
32 Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, Chief Financial Officer COVID-19 Vaccine & Pipeline Update Özlem Türeci, Chief Medical Officer 3rd Quarter 2022 Highlights Ugur Sahin, Chief Executive Officer
Slide 33: Outlook for COVID-19 Vaccine Franchise
2022 year-to-date recap Outlook for COVID-19 Vaccine Franchise 1 Distribution of COVID-10 vaccine in collaboration with Pfizer 2 As of mid of October 2022; includes BaA1- and BA4./5 bivalent adapted vaccines ~300 m variant adapted vaccine doses invoiced since August 2022 with approvals in >45 countr
Slide 34: Select COVID-19 and Infectious Disease Pipeline Milestones
Select COVID-19 and Infectious Disease Pipeline Milestones 1 Partnered with Pfizer 2 University of Pennsylvania collaboration 3 Collaboration with BMGF HSV 2 = Herpes simplex virus type 2; FPD = first patient dosed 34 2023 Outlook Up to 5 new Infectious Disease trial initiations Program Milestone An
Slide 35: Select Oncology Pipeline Milestones
Select Oncology Pipeline Milestones 1 Collaboration with Genmab 2 Trial sponsored by Regeneron 3 Collaboration with Genentech, a member of the Roche group 35 2023 Outlook Up to 10 Oncology clinical trial updates Program Milestone Anticipated Timeline First-in-Human Trial Starts BNT313 (GEN1053) Phas
Slide 36: 2023 Outlook
2023 Outlook Once in a generation opportunity to transform medicine 36 Focused on creating long-term value to patients, shareholders and society Expand reach of vaccine franchise and deliver data for next- generation candidates Catalyst-heavy 2023 expected with multiple late-stage data readouts and
Slide 37: Thank You
THANK YOU + BiIONT=Cri