BioNTech SE · NASDAQ:BNTX
BioNTech — Q1 2021 Earnings Presentation
30 slides from BioNTech's earnings presentation, May 10, 2021
Slide 1: Corporate update and financial results First Quarter 2021
Corporate update and financial results May 10, 2021 First Quarter 2021 Harnessing the full potential of the immune system Exhibit 99.2
Slide 2: 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 includingBioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regar
Slide 3: Safety Information
Safety Information AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individ
Slide 4: Agenda
First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook Agenda 4
Slide 5: Transformed into a Fully Integrated, Global Immunotherapy Company
Transformed into a Fully Integrated, Global Immunotherapy Company 5 Deep Immunology Expertise Broad Suite of Novel Technologies Bioinformatics Approach In-House Manufacturing ICON Fully Integrated Structure Commercial Capabilities Next-Gen Immunotherapies & Vaccines Oncology, Infectious Disease and
Slide 6: Building a 21st Century Global Immunotherapy Powerhouse
Building a 21st Century Global Immunotherapy Powerhouse 6 Increase global footprint Expand integrated infrastructure Rapidly advance pipeline Continue investment in innovation to support future product launches Invest in clinical, commercial and manufacturing, and digital capabilities Attract and re
Slide 7: Highlights From First Quarter 2021 and Beyond
Highlights From First Quarter 2021 and Beyond Next generation CAR-T in combination with CARVac (BNT211) NEO-STIM Neoantigen-targeting T cell therapy (BNT221) Ribocytokine (BNT151) First Patients Dosed in Multiple First-in-Human Studies >450M doses shipped to 91 countries and territories worldwide* ~
Slide 8: Six Key Levers to Expand COVID-19 Vaccine Reach
Additional Populations Increased Manufacturing Capacity Additional Geographies Broadened & Decentralized Vaccine Access Addressing SARS-CoV-2 Variants Addressing Waning Immune Responses Focused on Six Key Levers to Expand COVID-19 Vaccine Reach Up to 3 billion doses by end of 2021; more than 3 billi
Slide 9: Preemptive strategy to be prepared for addressing SARS-CoV-2 Variants
Preemptive strategy to be prepared for addressing SARS-CoV-2 Variants 9 *B.117 (UK variant), B.1.351 (South African variant), and P.1 lineage (Brazilian variant) Liu et al., NEJM, Mar. 8, 2021 Safety & immunogenicity data expected in Q2 2021 Dose 3 BNT162b2SA Dose 3 BNT162b2 Dose 3 BNT162b2 Dose 2 B
Slide 10: Strong Order Book Growth in Q1
Strong Order Book Growth in Q1 10 ~1.8 billion doses contracted for 2021 Expanding vaccine access to new populations & geographies with first supply contracts for post-2021
Slide 11: Manufacturing Capacity Increased to Address Worldwide Vaccine Need
Manufacturing Capacity Increased to Address Worldwide Vaccine Need BioNTech now targeting 3 billion doses in 2021* Manufacturing capacity in 2022 to exceed 3 billion doses BioNTech contributing more than 50% of drug substance Marburg site launch brings BioNTech manufacturing capacity to 1 billion do
Slide 12: Agenda
First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook Agenda 12
Slide 13: Tackling Multiple Diseases with Different Therapeutic Modalities
Immunomodulation Tackling Multiple Diseases with Different Therapeutic Modalities mRNA Cancer Vaccines Antibodies Small Molecule Immunomodulators + Multi-specificity, multi-valency, high (neo)antigen specific T cell responses with unprecedented potency Ongoing Phase 2 randomized trial (iNeST) CARVac
Slide 14: Multiple Oncology Trials with Registrational Potential Starting in 2021
Multiple Oncology Trials with Registrational Potential Starting in 2021 BNT111: Phase 2 to start in 1H 2021 BNT311: Data update in 2H 2021 BNT312: Data update in 2H 2021 BNT113: Phase 2 to start in 1H 2021 BNT122: Phase 2 to start in 2H 2021 (adjuvant CRC) Near-Term Milestones Advanced Oncology Pipe
Slide 15: Next Wave Oncology Advancing Innovation Beyond Current Boundaries
BNT211 (CLDN 6 CAR) Next generation CAR-T targeting CLDN6 with CARVac Next Wave Oncology Advancing Innovation Beyond Current Boundaries FPD, First patient dosed; CLDN6, Claudin-6, CAR-T cells, Chimeric antigen receptor T cells; IL-2, interleukin 2; IL-7, Interleukin 7; PBMC, peripheral blood mononuc
Slide 16: BNT111: FixVac Melanoma Compelling Preliminary Data
BNT111: FixVac Melanoma Compelling Preliminary Data Sahin et al, Nature 2020 Tolerable safety as monotherapy and in combination with CPI Durable Objective Responses in CPI-experienced patients with evaluable disease at baseline ORR 35% for combination therapy (BNT111 + anti-PD1): 6/17 patients High-
Slide 17: BNT111: FixVac Phase 2 Clinical Trial in anti-PD1 R/R Melanoma Patients
BNT111: FixVac Phase 2 Clinical Trial in anti-PD1 R/R Melanoma Patients BNT111-01 Patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma n=60 n=30 n=30 Addition of cemiplimab upon disease progression Addition of BNT111 upon disease progression Secondary EP Primary EP Arm 1
Slide 18: BNT211: Next Generation CAR-T Targeting CLDN6 with CARVac
BNT211: Next Generation CAR-T Targeting CLDN6 with CARVac New 2nd generation CAR directed against CLDN6, a new highly cancer cell specific carcino-embryonic antigen CLDN6 is expressed in multiple solid cancers with high medical need tumor types CARVac drives in vivo expansion, persistence and effica
Slide 19: BNT211: Next Generation CAR-T Therapy in Solid Tumors
BNT211: Next Generation CAR-T Therapy in Solid Tumors An open-label Phase 1/2a study of BNT211 in patients with advanced solid tumors Evaluation of safety and tolerability Ongoing Phase 1/2a study Monotherapy dose level 1 completed (3 patients) CLDN6, Claudin-6; CAR-T cells, Chimeric Antigen Recepto
Slide 20: BNT211: CAR-T Engraftment and Stable Disease in First Patients
BNT211: CAR-T Engraftment and Stable Disease in First 2 Patients DLT, dose limiting toxicity; Pat, patient; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; LD, lymphodepletion; FIGO, International Federation of Gynecology and Obstetrics; CLDN6, Claudin-6; AE
Slide 21: BNT221: NEO-STIM Personalized Neoantigen-Targeted Adoptive Cell Therapy
BNT221: NEO-STIM® Personalized Neoantigen-Targeted Adoptive Cell Therapy T cells induced from peripheral blood (NEO-STIM) No gene engineering or viral vectors Targets each patient´s personal tumor neoantigens Multiple specific CD8+ and CD4+ T cell populations that are functional and have a favorable
Slide 22: Agenda
Agenda 22 First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook
Slide 23: First Quarter 2021 Financial Results (unaudited) – Profit or Loss
First Quarter 2021 Financial Results (unaudited) – Profit or Loss 23 Research & development revenues Commercial revenues 2021 €20.9 2,027.5 2020 €21.2 6.5 (19.9) (514.2) 5.9 - €4.64 €4.39 €(0.24) €(0.24) Cost of sales Research and development expenses Sales and marketing expenses General and adminis
Slide 24: First Quarter 2021 COVID-19 Vaccine Deliveries Drove Revenue Growth
24 *Represents an estimated figure based on preliminary data shared between Pfizer and BioNTech. Changes in share of the collaboration partner’s gross profit will be recognized prospectively. First Quarter 2021 COVID-19 Vaccine Deliveries Drove Revenue Growth Commercial revenues – identified revenue
Slide 25: On Track with Previously Stated Financial Outlook
On Track with Previously Stated Financial Outlook Estimated COVID-19 vaccine revenues to BioNTech upon delivery of signed supply contracts as of May 4, 2021 (~1.8 billion doses): ~€12.4 billion Update on Current Signed COVID-19 Vaccine Order Book 25
Slide 26: Agenda
Agenda 26 First Quarter 2021 Highlights COVID-19 Vaccine Update Oncology Pipeline Update Financial Results Corporate Update & Outlook
Slide 27: Increasing Our Global Footprint
Increasing Our Global Footprint First location in Asia: regional headquarters in Singapore to house mRNA manufacturing facility with support from Singapore Economic Development Board Growing international workforce with teams in United States, an affiliate in Turkey and commercial organization, incl
Slide 28: Significant Pipeline Milestones expected in 2021
Significant Pipeline Milestones expected in 2021 5+ Trial Updates BNT162b2: Multiple updates BNT311: Bi-specific CPI: PD-L1 x 4-1bb in solid tumors BNT312: Bi-specific checkpoint immunomodulator CD40 x 4-1bb in solid tumors BNT211: CLDN-6 CAR-T + CARVac in solid tumors BNT411: TLR-7 agonist +/- CPI
Slide 29: Strong Financial Position Enable Execution on Strategic Priorities for 2021
Strong Financial Position, Fully-Integrated Structure Enable Execution on Strategic Priorities for 2021 Continue to execute while driving iterative innovation against COVID-19 Deliver COVID-19 vaccine to >1 billion people globally Broaden and diversify early- and late-stage pipeline of next generati
Slide 30: An der Goldgrube 55131 Mainz Germany M: investors@biontech.de
An der Goldgrube 12 55131 Mainz Germany M: investors@biontech.de