BioNTech SE · NASDAQ:BNTX
BioNTech — Q1 2023 Earnings Presentation
34 slides from BioNTech's earnings presentation, May 8, 2023
Slide 1: 1st Quarter 2023 Financial Results & Corporate Update
1st Quarter 2023 Financial Results & Corporate Update May 8, 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 EU marketing authorization
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-do
Slide 4: Authorized Use in the U.S.
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 Update Özlem Türeci, Chief Medical Officer2 1st Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer1
Slide 6: 1st Quarter 2023 Highlights
1st Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer
Slide 7: 2023 Strategic Priorities and Achievements in Q1 2023
2023 Strategic Priorities and Achievements in Q1 2023 7 COVID-19 franchise1 Infectious diseasesImmuno-oncology 1. Partnered with Pfizer; 2. Collaboration with Bill & Melinda Gates Foundation; 3. Partnered with Pfizer. ADC = Antibody-drug conjugate; CTLA-4 = Cytotoxic T-Lymphocyte-Associated Protein
Slide 8: Long-Term Strategy: Expand Treatment Options for Solid Tumor Patients
Long-Term Strategy: Expand Treatment Options for Solid Tumor Patients 8 1. Partnered with Genentech, member of Roche Group; 2. Partnered with Genmab; 3. Partnered with DualityBio; 4. Partnered with OncoC4. ADC = antibody-drug conjugate. mRNA cancer vaccines Cell therapies ADCs Solid tumor growth seg
Slide 9: A New Drug Class – ADCs: Now Part of our Technology Toolkit
A New Drug Class – ADCs: Now Part of our Disruptive Technology Toolkit to Fight Human Diseases 9 1 mRNA encoded cancer-targeting antibodies and cytokines. AI = Artificial intelligence; ML = Machine learning; CAR = chimeric antigen receptor; TLR = Toll-like receptor; STING = stimulator of interferon
Slide 10: Antibody-Drug Conjugates: A Proven Technology with Untapped Potential
Antibody-Drug Conjugates: A Proven Technology with Untapped Potential 10 1. Jabbour E. et al. Nat Rev Clin Oncol. 2021. 2. Coleman N.et al. npj Precis. Onc. 2023. ADC = Antibody-drug conjugate; Ig = Immunoglobuline; MoA = Mode of action. Each of these three components can vary between different ADCs
Slide 11: Our 3rd Generation ADCs May Overcome Hurdles of Approved ADCs
11 3rd generation ADCs with pharmacokinetic properties that may contribute to an increased therapeutic window:5 • superior systemic stability • rapid systemic clearance of released payload • efficient bystander killing • sustained tumor-selective drug release • well-tolerated in animal models at rep
Slide 12: Advancing Toward Our Vision
12 ID = Infectious disease; IND = Investigational new drug. Advancing Toward Our Vision Infectious diseases 6 Phase 2 trials Globally successful marketed COVID-19 vaccine with first-to-market BA.4-5-adapted booster 7 programs in 8 clinical trials 20 programs in 24 clinical trials Maintain and deepen
Slide 13: Pipeline & COVID-19 Vaccines Update
Pipeline & COVID-19 Vaccines Update Özlem Türeci, Chief Medical Officer
Slide 14: Well-Positioned with our Cancer Vaccine Portfolio Across Multiple Solid Tumors
Well-Positioned with our Cancer Vaccine Portfolio Across Multiple Solid Tumors 14 1 Partnered with Genentech, member of Roche Group. iNeST = individualized NeoAntigen Specific Immunotherapy; ADT = androgen deprivation therapy; 1L = First line; R/R = relapsed/refractory; NSCLC = Non-small cell lung c
Slide 15: Oncology Pipeline: Achievements in Q1 2023
Oncology Pipeline: Achievements in Q1 2023 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; 6. Partnered with DualityBio. NSCLC = Non-small cell
Slide 16: MoA Designed to Allow Higher Dosing of BNT316 (ONC-392)
MoA Designed to Allow Higher Dosing & Longer Duration of BNT316 (ONC-392) Treatment1 16 1. Partnered with OncoC4. MTD = Maximum tolerated dose; RP2D = Recommended phase 2 dose; DLT = Dose-limiting toxicity; TRAE = Treatment related adverse event; NSCLC = Non-small cell lung cancer; irAE = immune-rel
Slide 17: First Phase 3 Study planned: BNT316 (ONC-392) in IO R/R NSCLC
First Phase 3 Study planned: BNT316 (ONC-392) in IO R/R NSCLC1 17 1. Partnered with OncoC4.. PD-1 =Programmed cell death protein 1; IO = immuno-oncology; NSCLC = Non-small cell lung cancer; R/R = Relapsed/Refractory; Q3W = Every three weeks; OS = Overall survival; ORR = Objective response rate; PFS
Slide 18: BNT323 (DB-1303) preclinical properties
18 Lin S. et al. Abstract #252. Presented at EORTC-NCI-AACR in 2022. 1. Partnered with DualityBio. ADC = Antibody-drug conjugate; HER = human epidermal growth factor receptor; cmax = maximum concentration; DAR = Drug antibody ratio. Superior in vitro plasma stability in human plasma Sustained tumor-
Slide 19: BNT323 (DB-1303): Preclinical Data Show Anti-Tumor Effect and Favorable Safety
BNT323 (DB-1303): Preclinical Data Show Anti-Tumor Effect and Favorable Safety Profile in HER2 Positive & HER2 Low Tumor Models and Toxicity Studies1 19 Lin S. et al. Abstract #252. Presented at EORTC-NCI-AACR in 2022. 1. Partnered with DualityBio. HER = human epidermal growth factor receptor; ILD =
Slide 20: FIH Phase 1/2 of BNT323 (DB-1303) in Advanced HER2+ Solid Tumors
FIH Phase 1/2 to Evaluate Safety and Tolerability of BNT323 (DB-1303) in Patients with Advanced HER2+ Solid Tumors1 1. Partnered with DualityBio. IHC = immunohistochemistry; FIH = First in human; Q3W = every three weeks; DLT = dose limiting toxicity; HER2 = human epidermal growth factor 2; HR = horm
Slide 21: Infectious Disease Pipeline: Achievements in Q1 2023
Phase 1 BNT162b2 (Original/Omicron BA.4-5-adapted bivalent)1 COVID-19 Pfizer Partnered Programs COMIRNATY1 COVID-19 BNT162b2 (Original/Omicron BA.1-adapted bivalent)1 COVID-19 BNT162b51 (Enhanced spike antigen) COVID-19 BNT162b4 + BNT162b21 (T-cell enhancing) COVID-19 BNT1633 HSV-2 Infectious Diseas
Slide 22: Initiated Phase 1/2 Trial of Tuberculosis mRNA-LNP Vaccine Candidates
Initiated Phase 1/2 Trial of Tuberculosis mRNA-LNP Vaccine Candidates1 22 1. Collaboration with BMGF; 2. WHO, Tuberculosis Report 2021. 3. NCT05537038. Unmet medical need Objective of vaccine development Target population & trial design3 Tuberculosis is the second leading infectious killer worldwide
Slide 23: COVID-19 Franchise: Being Actionable in the Face of Dynamic Virus Evolution
COVID-19 Franchise: Being Actionable in the Face of a Dynamic Virus Evolution and Building for Continued Success 23 HLA = Human Leukocyte Antigen; ORF = open reading frame T cell immune response may continue to contribute to prevention or limitation of severe disease Muik A. et al. bioRxiv pre-print
Slide 24: BNT162b4 Encoding Conserved Non-Spike Antigens Protects Animals from Severe COVID-19
Next-Generation COVID-19 Vaccine Component Candidate BNT162b4 Encoding Conserved Non-Spike Antigens Protects Animals from Severe COVID-191 24 Arieta C. et al. Cell.2023. DOI: 10.1016/j.cell.2023.04.007 1. Partnered with Pfizer. In animal models Elicits polyfunctional CD4+ and CD8+ T cell responses N
Slide 25: Financial Results
Financial Results Jens Holstein, Chief Financial Officer
Slide 26: Q1 2023 Key Highlights
Q1 2023 Key Highlights1 26 1 Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. 2 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as furt
Slide 27: Q1 2023 Financial Results: Profit or Loss
Q1 2023 Financial Results: Profit or Loss 27 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 unaudited interim consolidated statements of profit or loss has been condensed. 2 BioNTech’s profit
Slide 28: 2023 Financial Year Guidance Reiterated
2023 Financial Year Guidance Reiterated1 28 2 Numbers include effects identified from additional collaborations or potential M&A transactions to the extent disclosed and will be updated as needed. ~ €5 bnEstimated BioNTech COVID-19 vaccine revenues COVID-19 vaccine revenues for FY 2023 €2,400 – 2,60
Slide 29: Strategic Outlook
Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 30: Outlook for COVID-19 Vaccine Franchise in 2023
Outlook for COVID-19 Vaccine Franchise in 2023 30 WHO = World Health Organisation; ICMRA = International Coalition of Medicines Regulatory Authorities; VRBPAC = Vaccines and Related Biological Products Advisory Committee; FDA = Food and Drug Administration; EMA = European Medicines Agency Expected W
Slide 31: COVID-19 Market Outlook: 2023 market dynamics & outlook
2023 market dynamics & outlook Potential mid-term growth drivers COVID-19 Market Outlook 31 • Doses already shipped to >70 countries and regions • Increased deliveries in middle-income and low-income countries in Q1 2023 • Increased contribution from pediatric segment in Q1 2023 • U.S. commercial ma
Slide 32: Multiple Late- and Early-Stage Pipeline Milestones Expected in 2023
Multiple Late- and Early-Stage Pipeline Milestones Expected in 2023 32 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 33: Upcoming events: AGM and Innovation Series Day
Annual General Meeting May 25, 2023 Innovation Series Day November 7, 2023 SAVE THE DATE
Slide 34: Thank you
Thank you BIONT=CH