BioNTech Results Presentation Deck

Made public by

sourced by PitchSend

11 of 11

Creator

biontech logo
Biontech

Category

Healthcare

Published

May 2020

Slides

Transcriptions

#1First Quarter 2020 Corporate update and financial results May 12, 2020 X 121 40 11 BIONTECH#2Forward-looking statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company's views with respect to the potential for mRNA therapeutics; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's BNT111, BNT113, iNeST (BNT122), BNT 141, BNT142, BNT 151, BNT 152/153, BNT 161, BNT 162, BNT211 and BNT411; expectations for data announcements with respect to BioNTech's BNT111, BNT114, iNeST (BNT 122), BNT131, BNT 162 and BNT311 clinical trials; the development of commercial capabilities and the transition of BioNTech to a fully integrated biopharmaceutical company; its expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech's or its collaborators' current or future drug candidates; expected royalty and milestone payments in connection with BioNTech's collaborations; BioNTech's anticipated cash usage for fiscal year 2020; the creation of long-term value for BioNTech shareholders; and the ability of BioNTech to successfully develop and commercialize a vaccine for COVID-19 in partnership with Pfizer and Fosun Pharma, constitute forward-looking statements, and the impact of COVID-19 on our clinical trials and business operations. Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward-looking statements. Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech, and are subject to change. The Company will not necessarily inform you of such changes. These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company's actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the Company's ability to discover and develop its novel product candidates, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates; actions of collaborators regarding continued product development and product commercialization; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates; the Company's ability to obtain, maintain and protect intellectual property, the Company's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; competition from others using technology similar to the Company's and others developing products for similar uses; the Company's ability to manage operating expenses; the Company's ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives; the Company's dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products; the outcome of litigation, and unexpected expenditures. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority. 2 BIONTECH#33 Next generation immunotherapy Harnessing the full potential of the immune system 0000 2 Broad suite of novel technology platforms Immunotherapies for cancer and infectious diseases Fully integrated with in-house GMP manufacturing Industry-leading global collaborations BIONTECH#4Update on COVID-19 program - BNT162 4 ✓ Global development program established with new collaboartions with Pfizer and Fosun Pharma Four vaccine candidates selected for clinical trials following preclinical testing Ongoing Phase 1/2 clinical trials in US and Germany - first cohorts dosed Clinical trial supply from BioNTech's GMP-certified mRNA manufacturing facilities in Europe - Scale-up of BioNTech manufacturing network underway First clinical data expected in June/July 2020 BIONTECH#5BNT162 mRNA vaccine program Three mRNA formats Uridine mRNA (uRNA) 5 SAR-COV-2 Cap UTR S-Antigen Nucleoside-modified mRNA (modRNA) Cap 면 면면 Cap VUTR SAR-COV-2 UTR S-Antigen UTR A30-L-A70 Replicase ثلاثا UTR Self-amplifying mRNA (saRNA) A30-L-A70 SAR-COV-2 SGP S-Antigen VUTRA30-L-A70 Lipid nanoparticle formulation LITNI LITN LINI 22 Two different antigens Receptor Binding Domain (RBD) Spike-Antigen Whole Protein SARS-COV-2 Spike Protein 3D Structure (Wrapp et al., 2020, Science) BIONTECH#6Global BNT162 clinical development program ongoing Phase 1/2 trials ongoing in Europe and US Testing of 4 vaccine candidates across different countries ● ● ● ● ● Designs Europe: dose escalation part up to 200 healthy subjects aged 18 to 55 US: seamless study design with several thousand subjects; Initial dose-finding part up to 360 healthy subjects aged 18-85 Dose range 1 µg to 100 µg Single-dose and 2-dose regimens to be tested in initial trial ● ● ● Evaluating safety, efficacy and optimal dose Evaluating effects of repeated immunization for 3 candidates using uRNA or modRNA and one prime-only using saRNA 6 Potentially accelerated approval pathways being discussed with global. regulators First cohorts dosed in each geography First clinical data expected June/July 2020 Prime / boost vaccine Boost Injektion-2 Strong Immunity Protecting Immunity No Immunity Strong Immunity Prime-only vaccine 1. Injektion Protecting Immunity Prime Injektion-1 No Immunity Weeks Weeks Months Months Immunity Immunity Years Years BIONTECH#7Significant newsflow expected over next 12-18 months Indication (Target) mRNA Others Platform Fix Vac iNeST Intratumoral Immunotherapy RiboMabs RiboCytokines CAR-T Cells Next-Gen CP Immunomodulators TLR7 Ligand Infectious and Rare Diseases Candidate BNT111 BNT112 BNT113 BNT114 RO7198457 (BNT122) SAR441000 (BNT131) BNT141 BNT142 BNT151 BNT152/153 BNT211 BNT311 BNT411 BNT161 BNT162 Advanced Melanoma Prostate Cancer HPV16+ H&N Cancer Triple Negative Breast Cancer 1L Melanoma with CPI Multiple ST (basket trial) NSCLC (adjuvant) undisclosed (adjuvant) Solid tumors (IL-12sc, IL-15sushi, GM-CSF, IFN a) Multiple ST Multiple ST (CD3+CLDN6) Multiple ST (Optimized IL-2) Multiple Solid Tumors (IL-7, IL-2) Multiple ST (CLDN6) Multiple ST (PD-L1x4-1BB) Multiple ST (TLR7) Influenza COVID-19 Up to 10 Infectious Disease Indications 5 Rare Disease Indications Expected data readout / update Next milestones 3 Start Phase 2 with registrational potential in 2H 2020 Report Phase 1: publication upcoming Start Phase 2 with registrational potential in 2H 2020 Data update Phase 1 in 2H 2020 4 Enrollment update in 2H 2020 1 Data update Phase 1/2 at AACR Virtual II in June Start Phase 2 in 2H 2020 Start Phase 2 in 2H 2020 Data update Phase 1/2 in 2H 2020 ² Start Phase 1 in 1H 2021 Start Phase 1 in 1H 2021 Start Phase 1 in 1H 2021 Start Phase 1 in 1H 2021 Start Phase 1/2 in 2H 2020 Data update Phase 1/2 in 2H 2020 Start Phase 1 in 2H 2020 Start first study in 1H 2021 Data update in June/July 2020 Start phase 1 in 1H 2021 Start first Phase 1 in 1H 2021 7 ¹We expect this update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021; 2As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi. ³Our expectations for timing of milestones beyond 2020 are premised on and subject to the achievement of earlier milestones on their expected timelines. Press releases will be issued once first patient has been dosed. ST: solid tumors. 4BNT 122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42);#8BNT162 Manufacturing Update Clinical supply BioNTech to manufacture all drug substance for clinical supply at its GMP manufacturing facilities in Idar-Oberstein and Mainz (both in Germany, partially 24/7 manufacturing) Global pandemic and commercial supply capacities Joint establishment of pandemic supply capacities at many network sites BioNTech: At Idar-Oberstein and Mainz facilities in Germany Pfizer: At least at three U.S. sites (Massachusetts, Michigan, Missouri) and at Puurs facility (Belgium) BioN Tech and Pfizer working closely together (joint teams) on scale-up, supply chain and network planning ● ● Drug product supply initially supported by BioNTech's formulation partner Polymun, with Pfizer and BioNTech ramping up own capacity 8 ● ● BIONTECH#9First Quarter 2020 Financial Results (unaudited) - Profit and Loss ● ● ● ● 9 Cash and cash equivalents of EUR 452m (USD 495m) as of March 31, 2020 Additional EUR 217m (USD 236m) due in 2Q 2020 from Pfizer and Fosun Pharma (equity investments and non-dilutive deal upfront payments, partially received already) Net cash used in operating activities and investments into property, plant and equipment on track with previous guidance of EUR 300m (USD 329m¹) for base business plan (prior to impact of Neon Therapeutics acquisition and BNT162 program) Majority of BioNTech development costs for BNT162 program in 2020 will be funded via Pfizer and Fosun Pharma cost sharing, equity investments and upfront payments. (in million) Revenues resulting from collaboration and license agreements Revenues from other sales transactions Total revenues Cost of sales Gross profit Research and development expenses Sales and marketing expenses General and administrative expenses Other operating income less expenses Finance income less expenses Income taxes Loss for the period 1 Rate German Central Bank as of March 31, 2020 Three months ended March 31, 2019 € 21.9 4.3 € 26.2 2020 € 21.2 6.5 € 27.7 (5.9) € 21.8 (65.1) (0.5) (15.8) 0.3 5.9 € (53.4) (3.3) € 22.9 (57.2) (0.5) (9.3) 0.3 3.0 € (40.8) BIONTECH#10Building a next generation immunotherapy company 10 ✓ ✓ Rapid progress in key pipeline programs in both oncology and infectious diseases Multiple data read-outs & late-stage trial starts anticipated in 2H 2020 Expanded transatlantic operations with newly established R&D hub in Cambridge, U.S. Strong momentum toward our vision of building a global immunotherapy company BIONTECH#11HD=INO12 11 Q&A

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare