BioNTech SE · NASDAQ:BNTX
BioNTech — Shareholder Meeting (May 2023)
38 slides from BioNTech's shareholder meeting presentation, May 25, 2023
Slide 1: Annual General Meeting May 25, 2023
Annual General Meeting May 25, 2023 English Convenience Translation: German language is the official version.
Slide 2: Management Report
MANAGEMENT REPORT AGENDA NO. 1 Operations Development 2022 / Q1 2023 1 and Operations Outlook 2023 Prof. Dr. Ugur Sahin, Chief Executive Officer & Founder Financial Development 2022 / Q1 2023 2 and Financial Outlook 2023 Jens Holstein, Chief Financial Officer
Slide 3: Operations Development 2022 & Q1 2023 and Operations Outlook 2023
Operations Development 2022 & Q1 2023 1 and Operations Outlook 2023 Prof. Dr. Ugur Sahin, CEO & Founder
Slide 4: This Slide Presentation Includes Forward-Looking Statements
This 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: BioNTech's expected revenues and net profit
Slide 5: Safety Information
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 the population aged 6 months and older. In people from 5 years of age and older the vaccine is adm
Slide 6: Safety Information
Safety Information 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
Slide 7: Our Vision
OUR VISION U S I N G T H E F U L L P OT E N T I A L O F T H E I M M U N E S YS T E M TO D E V E LO P N E W I M M U N OT H E R A P I E S A N D VAC C I N E S
Slide 8: BioNTech Today
BioNTech Today New technologies for research Global organization on 5 continents innovations Presence in Europe, North America, Africa, Asia and Australia >1,500 research and development professionals Significant R&D budget of €2.4 - 2.6bn in 2023 Broad pipeline across 4 drug classes Expertise in th
Slide 9: Vision: A Global Next-Generation Immunotherapy Company
Vision: A Global Next-Generation Immunotherapy Company LEADERSHIP IN INNOVATIVE AND HEALTHCARE INNOVATION COVID-19 DIVERSIFIED AND SOCIAL AT SCALE VACCINES PIPELINE RESPONSIBILITY DEVELOPMENT Build and expand a Develop potent and Contribute to We want to establish long-term and precise medicines to
Slide 10: Advancing Towards Our Vision
Advancing Towards Our Vision Globally first-to-market BA.4-5-adapted COVID-19 Next-generation and combination Deepen COVID-19 vaccine vaccine COVID-19 vaccines leadership Oncology Infectious diseases Multiple oncology and infectious disease Approved products across product launches in next 3-5 years
Slide 11: BioNTech Achievements in 2022 & 2023
BioNTech Achievements in 2022 & 2023 Launch of variant- Development of Ramped up R&D Acquired Expanded global adapted vaccine advanced oncology investment complementary, organization and further label programs and made strategic synergistic in Europe, the U.S., expansion and expansion of investments
Slide 12: 2022 & 2023: Global Growth
2022 & 2023: Global Growth >4,500 >1,900 50 % professionals >80 36 of total new hires globally1 nationalities average age workforce are in 2022 female Israel Pandemic preparedness and development of United Kingdom innovative medicines Collaboration with UK government Taiwan with the target to delive
Slide 13: Global Social Responsibility at Our Core
Global Social Responsibility at Our Core Democratizing Access to Novel Medicines and Upholding Social Responsibility 13 CSR governance and regulation For diseases with medical care gaps • CSR core strategy: integration of sustainability in all responsible business areas Development programs for infe
Slide 14: COVID-19 Vaccine: Global Leadership
COVID-19 VACCINE G LO BA L L E A D E R S H I P
Slide 15: 2022: Continued Leadership against COVID-19
2022: Continued Leadership against COVID-19 Invoiced ~2 billion doses of vaccine First to market BA.4-5 variant-adapted vaccine1 ~2 months from recommendations of regulatory authorities to vaccine delivery Shipped ~550 million doses of variant-adapted vaccine2 COMIRNATY market share: ~64%3 Broadest
Slide 16: COVID-19 Franchise: Building for Continued Success
COVID-19 Franchise: Building for Continued Success Ability to rapidly Comprehensive Leveraging AI and Investments in Development of a roll out new COVID-19 research ML for pandemic combination variant-adapted vaccines at program preparedness vaccines and next- vaccine for 2023 commercial scale gener
Slide 17: Deaths and Hospitalizations due to COVID-19 and Flu (2022)
Deaths and Hospitalizations due to COVID-19 and Flu (2022) • A leading cause of death worldwide, estimated to exceed 6.8 million deaths1 Deaths, hospitalizations and administered/distributed vaccine doses in the U.S.: • A leading cause of respiratory disease COVID-19 vs. Influenza in 20226-8 hospita
Slide 18: Diversified Product Pipeline
DIVERSIFIED PRODUCT PIPELINE
Slide 19: Technology Agnostic Innovation Engine
Technology Agnostic Innovation Engine OFF-THE- AI & Machine Learning – SHELF mRNA Core principles of our CANCER VACCINES Internal capabilities & InstaDeep technology strategy INDIVIDUA- FixVac RIBO- IMMUNO- LIZED mRNA LOGICALS1 THERAPY CANCER RiboCytokines TARGET VACCINES RiboMabs MULTI- DISCOVERY R
Slide 20: Long-Term Strategy: Expand Treatment Options for Solid Tumor Patients
Long-Term Strategy: Expand Treatment Options for Solid Tumor Patients Vision: Drug classes: Focus programs: -With first- and best-in-class potential mRNA-cancer- Address the full vaccines aPD1-R/R melanoma, continuum of cancer + Pembro treatment INDIVIDUALIZED NEXT GEN mRNA CANCER IMMUNO- Cell thera
Slide 21: Oncology Pipeline
Oncology Pipeline Drug Class Phase 1 (5 First-in-Human) Phase 1/2 Phase 2 BNT111 BNT112 BNT111 Advanced melanoma Prostate cancer aPD1-R/R melanoma, + pembrolizumab BNT116 BNT1131 BNT113 2L NSCLC HPV16+ head and neck cancer 1L rec./met. HPV16+ PDL1+ head and neck cancer, + pembrolizumab Autogene cevu
Slide 22: Infectious Diseases: Important Growth Area Addressing High Medical and Global Health Need
Infectious Diseases: Important Growth Area Addressing High Medical and Global Health Need Ongoing clinical Influenza HSV-2 Malaria Tuberculosis Shingles programs: 290,000 – 650,000 ~491 million people ~247 million cases ~10.6 million cases ~95% deaths aged 15 – 49 in 2021 worldwide in 2021 worldwide
Slide 23: Infectious Disease Pipeline
Infectious Disease Pipeline Phase 1 Phase 2 Phase 3 Commercial BNT162b4 + BNT162b21 BNT162b51 BNT1615 COMIRNATY1 (T-cell enhancing) (Enhanced spike antigen) Influenza COVID-19 COVID-19 COVID-19 Pfizer Partnered BNT162b2+BNT1612 BNT162b2 (Original/Omicron (qFlu + BA.4-5-adapted bivalent) BA.4-5-adapt
Slide 24: Outlook 2023
OUTLOOK 2023 BIONT=CrH
Slide 25: 2023 Strategic Priorities
2023 Strategic Priorities Acceleration & development of pipeline COVID-19 Franchise1,2 Immuno-oncology Infectious diseases Strengthen market leadership in COVID-19 Start of potential pivotal studies Initiation of clinical programs for high need Advance next-gen vaccines indications Continued product
Slide 26: Financial Development 2022 & Q1 2023 and Financial Outlook 2023
Financial Development 2022 & Q1 2023 2 and Financial Outlook 2023 Jens Holstein, CFO
Slide 27: Highlights in FY 2022
Highlights in FY 2022 COVID-19 vaccine revenues R&D expenses guidance guidance € 16 - 17 bn € 1.5 bn Share repurchase program spending Dividend $ 1.3 bn € 0.5 bn 27
Slide 28: Key financial figures for FY 2022
Key financial figures for FY 2022 Total revenues1 € 17.3bn Operating cashflow € 13.6 bn Diluted EPS € 37.77 Cash and cash equivalents2 € 13.9 bn 1. BioNTech's share of profit is estimated as further described in the 2022 Annual Report based on preliminary data exchanged between Pfizer and BioNTech.
Slide 29: FY 2022 Guidance vs. Actuals
FY 2022 Guidance vs. Actuals Updated guidance (as published in Q3 2022 Financial Results and Corporate Update) Actual FY 2022 COVID-19 Estimated BioNTech COVID-19 vaccine revenues vaccine revenues1 €16 – 17 bn €17.1 bn R&D expenses €1,400 – 1,500 m €1,537 m Expenses and capex SG&A expenses €450 – 55
Slide 30: FY 2022 Financial Results – Profit and Loss
FY 2022 Financial Results – Profit and Loss (in millions €, except per share data)1 Year ended December 31, 2022 2021 Commercial revenues2 17,194.6 18,874.0 Research & development revenues 116.0 102.7 Total revenues 17,310.6 18,976.7 Cost of sales (2,995.0) (2,911.5) Research and development expense
Slide 31: Q1 2023 Key Highlights
Q1 2023 Key Highlights Total revenues1 € 1.3 bn Operating result € 0.7 bn Diluted EPS € 2.05 Total cash and cash equivalents plus security investments2 1. BioNTech's share of profit is estimated as further described in the 2022 Annual Report based on preliminary data exchanged between Pfizer and Bio
Slide 32: Q1 2023 Financial Results – Profit and Loss
Q1 2023 Financial Results – Profit and Loss (in millions €, except per share data)1 Three months ended March 31, 2023 2022 Commercial revenues2 1,276.5 6,362.2 Research & development revenues 0.5 12.4 Total revenues 1,277.0 6,374.6 Cost of sales (96.0) (1,294.1) Research and development expenses (33
Slide 33: FY 2022 and Q1 2023 Return to Shareholders
FY 2022 and Q1 2023 Return to Shareholders 2022: Dividend for FY 2021 Dividend in the amount of €0.5 bn paid 2022 & 2023: Share Repurchase Program Repurchase American Depositary Shares (ADS) in the amount of up to $1.5 bn Repurchased ADSs are to be used in part to satisfy settlement obligations unde
Slide 34: FY 2022 Capital Transactions
FY 2022 Capital Transactions Fulfillment Number of ordinary Share of issued Issue/settle- Total issue period shares issued share capital1 ment price amount Capital increases from authorized or conditional capital with the exclusion of subscription rights Pfizer Inc. (authorized capital with simplifi
Slide 35: FY 2023 Financial Guidance
FY 2023 Financial Guidance Key Assumptions and Considerations Expected transition from an advanced purchase 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.
Slide 36: 2023 FY Guidance Reiterated
2023 FY Guidance Reiterated1 COVID-19 vaccine Estimated BioNTech COVID-19 vaccine revenues ~ €5 bn revenues for FY 2023 R&D expenses2 €2,400 – 2,600 m Planned FY 2023 SG&A expenses €650 – 750 m expenses and capex Capital expenditure for operating activities3 €500 – 600 m Estimated FY 2023 tax assump
Slide 37: FY 2023 Capital Allocation Framework
FY 2023 Capital Allocation Framework R&D activities Main focus remains on the acceleration of our R&D activities in oncology and infectious diseases. M&A and business development Strengthen pipeline, technology platforms and digital capabilities by collaborations and potential complementary M&A. Ret
Slide 38: Thank you
Thank you BIONT=CrH