MediGene AG · LS:A40ESG
MediGene — Q1 2019 Earnings Presentation
24 slides from MediGene's earnings presentation, May 14, 2019
Slide 1: Living Immunotherapies – 3-months 2019 Earnings Call
Living Immunotherapies 3-months 2019 Earnings Call May 14, 2019 Prof. Dolores J. Schendel, CEO/CSO Axel Malkomes, CFO/CBDO Dr. Kai Pinkernell, CMO/CDO
Slide 2: "Safe Harbor" Statement
"Safe Harbor" Statement All of the information herein has been prepared by the Company solely for use in this presentation. The information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no relian
Slide 3: Major events since the beginning of 2019
Major events since the beginning of 2019 Treatment of first patient with T cell receptor-modified T cell immunotherapy MDG1011, first of additional new trial sites opened Strategic partnership with Roivant/Cytovant for the research and development of cellular immunotherapies in Asia Sale of remainin
Slide 4: Strategic R&D partnership with Roivant/Cytovant for cellular therapies in Asia
Strategic R&D partnership with Roivant/Cytovant for cellular therapies in Asia It’s Medigene’s strategy to generate tailored TCRs and license them out to certain territories and markets Cytovant licenses rights for Greater China, South Korea and Japan for a research-stage TCR against the tumor antig
Slide 5: Sale of remaining rights and stocks of legacy product Veregen to Aresus Pharma
Sale of remaining rights and stocks of legacy product Veregen® to Aresus Pharma The sale of the non-core product Veregen® completes Medigene’s transformation into a pure play immunotherapy company Aresus takes over all existing relevant contracts with distribution partners and external service provi
Slide 6: bluebird bio presented data and clinical plans on the first TCR
bluebird bio presented data and clinical plans on the first TCR Selected TCR candidate targets the MAGE-A4 tumor antigen which is expressed on a variety of solid tumor types Preclinical data confirm high antigen sensitivity and strong recognition of tumor cell lines MAGE-A4 TCR showed functional res
Slide 7: Source: bluebird bio presentation
Source: http://investor.bluebirdbio.com/static-files/5dda1939-2a1c-417b-aec9-7cdff58fe093 7
Slide 8: Source: bluebird bio presentation
Source: http://investor.bluebirdbio.com/static-files/5dda1939-2a1c-417b-aec9-7cdff58fe093 8
Slide 9: Medigene's immunotherapy pipeline
Medigene’s immunotherapy pipeline INDICATION PROJECT PRECLINICAL PHASE I PHASE II Partners (TARGET) DC vaccine Acute myeloid leukemia (WT-1 / PRAME ) TCR 1 (MDG1011) AML, MDS,MM (PRAME) TCR-IIT * Multiple myeloma (MAGE-A1) Start 2019e TCR 2 Post-HSCT** relapse (HA-1) TCR Cytovant Undisclosed (NY-ESO
Slide 10: MDG1011 First TCR therapy clinical trial started
medigene MDG1011 First TCR therapy clinical trial started
Slide 11: First patient in Phase I/II trial dosed – Clinical trial center expansion
First patient in Phase I/II trial dosed – Clinical trial center expansion In February 2019, the first patient in this first-in-human clinical trial was dosed with the TCR therapy candidate MDG1011 T cell receptor (TCR)-modified T cells targeting the tumor antigen PRAME (PReferentially expressed Anti
Slide 12: Phase I/II clinical trial of MDG1011 in myeloid and lymphoid malignancies
Phase I/II clinical trial of MDG1011 in myeloid and lymphoid malignancies Target: PRAME is a well characterized tumor antigen overexpressed in multiple hematological and solid tumor indications The drug, MDG1011: T cells expressing a HLA-A*02:01-restricted T cell receptor specific for PRAME Trial ou
Slide 13: Outline of Phase I trial
Outline of Phase I trial Multi-center study at currently three sites (University of Regensburg, Würzburg, Erlangen and Dresden & more to be added) with approx. 12 patients (+3) ≥1 AML/MDS, ≥1 MM (+3) up to (+3) 5x106 cells/kg 1x107 cells/kg 1x106 cells/kg additional 3 patients 1x105 cells /kg (+3) {
Slide 14: DC vaccine trial in AML
DC vaccine trial in AML medigene 14
Slide 15: Abstract on previously published topline data accepted at EHA conference
Abstract on previously published topline data accepted at EHA conference Medigene will present data on the 12 months interim analysis at the European Hematology Association (EHA) conference in June First topline data published on 19 Dec 2018: Very good feasibility for manufacture of vaccines from pa
Slide 16: Financial Report 3M-2019
medigene Financial Report 3M-2019
Slide 17: Financial overview for the first months of 2019
Financial overview for the first 3 months of 2019 Increase in R&D expenses € 2.1m Stable total revenues +28% due to progress in clinical programs & manufacturing Stable revenues from € 1.4m +43% immunotherapies € 65.6m Cash & cash equivalents Financial guidance 2019 Increase in EBITDA € -5.0m loss
Slide 18: Increase in R&D expenses by 28% reflect progress in preclinical and clinical development
Increase in R&D expenses by 28% reflect progress in preclinical and clinical development R&D expenses Steady progress of DC clinical trial Ongoing clinical trial for MDG1011 +28% Expansion of clinical team and of internal TCR discovery platform (headcount increase, expansion of 5.5 4.3 activities) D
Slide 19: Increased general & administrative costs due to BD activities and transactions
Increased general & administrative costs due to BD activities and transactions SG&A costs General and administrative expenses remained stable Increase in selling costs, mainly due to 9% business development activities 1.6 1.8 in m € 3M 2018 3M 2019 19
Slide 20: Increased EBITDA loss as planned
Increased EBITDA loss as planned EBITDA in m € 3M 2018 3M 2019 Comparison of EBITDA to previous period EBITDA loss increased by 31% due to -3.8 -5.0 higher R&D costs € 1.2 m -31% Net result of the period in m € 3M 2018 3M 2019 Differences between EBITDA and net result Foreign exchange, depreciation,
Slide 21: Revised financial guidance 2019 due to recent transactions
Revised financial guidance 2019 due to recent transactions 2018 GUIDANCE 2019 REVISED GUIDANCE 2019 Total revenues € 7.8 m € 5.5-6.5 m € 10-11 m R&D expenses € 17.1 m € 24-29 m € 24-29 m EBITDA loss € 16.3 m € 23-28 m € 23-28 m Liquid assets and time deposits as of March 31, 2019 amounted to € 65.6
Slide 22: Outlook 2019
Outlook 2019 MDG1011, Medigene’s first TCR trial: Treatment of first dose cohorts Medigene’s DC trial in AML: Analysis of 1-year-treatment (half of treatment period) to be presented at EHA in June 2019 Final read-out (2-years-treatment) expected end of 2019/early 2020 HA-1 TCR: Further preclinical e
Slide 23: Questions & Answers
medigene Questions & Answers 23
Slide 24: IR Contact and IR Calendar 2019
IR Contact IR Calendar 2019 Julia Hofmann Annual General Meeting 22/05/2019 Head of IR and PR Half-year Report 07/08/2019 T +49 89 2000 3333 24 Q3 Report 13/11/2019 [email protected] Dr Robert Mayer Senior Manager IR and PR T +49 89 2000 3333 01 [email protected] Medigene AG www.medigene.com