MediGene AG · LS:A40ESG
MediGene — Q1 2016 Earnings Presentation
32 slides from MediGene's earnings presentation, May 12, 2016
Slide 1: Analyst Conference Call: Results for the first 3 months of 2016
ANALYST CONFERENCE CALL Results for the first 3 months of 2016 Prof. Dolores J. Schendel, CEO/CSO Dave Lemus, COO
Slide 2: Safe Harbor Statement
"Safe Harbor" Statement This presentation contains forward-looking statements - that is, statements related to future, not past, events. These statements may be identified either orally or in writing by words as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates", "will",
Slide 3: Major events in 2016 to date
Major events in 2016 to date Patient recruitment and safety evaluation of Phase I IIT clinical data part of AML study completed presented at AACR – study moved into Phase II by academic partner Collaborations with University of Lausanne and DC patent portfolio EUFETS for TCRs strengthened Sale of 50
Slide 4: Medigene's new Management since Q1
Medigene’s new Management since Q1 Prof. Dolores J. Schendel Dave Lemus CEO/CSO COO Dr. Kai Pinkernell Dr. Dr. Olav Zilian Dr. Markus Dangl SVP /Chief Medical SVP Corporate SVP Research & Pre- Officer Development Clinical Development 4
Slide 5: Medigene's Immunotherapy Programs: Clinical Progress and Outlook
Medigene‘s Immunotherapy Programs Clinical Progress and Outlook
Slide 6: Medigene's immunotherapy pipeline and current IIT trials
Medigene’s immunotherapy pipeline and current IIT trials PRECLINICAL/ PROJECT INDICATION PHASE I PHASE II PHASE III RESEARCH DC Vaccine Study AML Medigene 0 TCR Study undisclosed 2017 TCR Study undisclosed 2018 T-cell leukemias TABs + new applications DC Vaccine Study Prostate cancer* IIT DC Vaccine
Slide 7: Further progress in Medigene's own DC trial in AML
Further progress in Medigene’s own DC trial in AML: Phase II part started in April 2016 Trial design: Phase I/II: open-label, prospective, non-randomized trial 20 AML patients: 6 phase I + 14 phase II, complete remission after chemotherapy, not eligible for allo-transplantation Patients selected wit
Slide 8: Treatment scheme of Medigene's DC trial
Treatment scheme of Medigene’s DC trial PHASE I PHASE II 6 patients DSMB approval 14 patients Phase II started in April 2016 Treatments with Medigene‘s DC vaccines week 1-4 w6 w 10 w 18 w 22 w 46 8 w 14 w 26 w 30 w 34 w 38 w 42 w 50
Slide 9: IITs using Medigene's DC vaccine technology
IITs using Medigene’s DC vaccine technology Study Sponsor Status Clinical Study, Investigator-initiated Prof. M. Subklewe Phase I completed • AML, intermediate and high-risk patients. Ludwig-Maximilians Phase II opened • Phase I/IIa University Munich Data presented at: • Opened: Q1/2014 NCT01734304
Slide 10: Clinical data from IIT presented by Oslo University at AACR April 2016
Clinical data from IIT presented by Oslo University at AACR conference in April 2016 Preliminary data from ongoing phase I/II investigator-initiated trial in high risk prostate cancer First adjuvant DC vaccine study with 20 enrolled patients: Use of two different maturation cocktails The last five o
Slide 11: AML Compassionate Use data presented by Oslo University at CIMT
AML Compassionate Use data presented by Oslo University at CIMT conference Compassionate Use patients receive dendritic cell (DC) vaccines for the treatment of AML at OUH: DC vaccines targeting WT-1 and PRAME Vaccines made with Medigene’s new generation monocyte-derived fast dendritic cells Five pat
Slide 12: Medigene's TCR studies in preparation
Medigene’s TCR studies in preparation Developments to start own clinical TCR studies: Identification of TCRs and pre-clinical work GMP-conform patient treatment development Medigene‘s first company sponsored trial: Additional viral vector production capacities secured at EUFETS GmbH In process of se
Slide 13: Outlook for Medigene's clinical programs
Outlook for Medigene’s clinical programs DCs: Continuation of Phase I treatment to completion of all patients at 50 weeks Sequential initiation of observation period for Phase I as patients complete treatment Recruitment and treatment of DC vaccinated AML patients at Oslo University Hospital for Pha
Slide 14: Excursion on IITs
medigene Excursion on IITs
Slide 15: Experience in IITs accelerates Medigene's own pipeline developments
Experience in IITs accelerates Medigene’s own pipeline developments Use experience Early insight into potential toxicity Logistics setup (i.e. cross-border) Logistics Safety Acquiring adequate patient Patient groups to be materials treated Dosing scheme Clinical trial Feasibility Q
Slide 16: Limitations of investigator initiated trials (IITs)
Limitations of investigator initiated trials (IITs) Little or no influence on clinical trial design, feasibility, execution of the trial and timelines No or limited data ownership; access to trial data at the investigator’s discretion Dependence on investigator’s communication and publication plans
Slide 17: Major events in 2016 to date
Major events in 2016 to date Patient recruitment and safety evaluation of Phase I IIT clinical data part of AML study completed presented at AACR – study moved into Phase II by academic partner Collaborations with University of Lausanne and DC patent portfolio EUFETS for TCRs strengthened Sale of 50
Slide 18: Granted patent for the treatment of stem cell or bone-marrow transplanted patients
Granted patent for the treatment of stem cell or bone-marrow transplanted patients US patent 9,238,063 was granted by the US Patent Office in February 2016 The patent claims a method of treating a tumor disease in patients by using semi-allogeneic antigen presenting cells of an HLA halpo-identical d
Slide 19: DC vaccination before and after stem cell transplantation in AML
DC vaccination before and after stem cell transplantation in AML T cell response to vaccine Patient DCs Patient Patient T cells After stem cell transplantation SCT T cell response in new immune system of patient Donor DCs HLA-haplo family donor Donor T cells in the SCT patient 19
Slide 20: Financial Report Q1 2016
medigene Financial Report Q1 2016
Slide 21: Financial overview for the first 3 months of 2016
Financial overview for the first 3 months of 2016 R&D expenses for Total revenues increased immunotherapies increased by 132% by 64% EBITDA loss reduced Cash & cash equivalents of by 54% €46.3 m Confirmation of financial guidance 2016 21
Slide 22: Increase in R&D expenses for immunotherapies by 64%
Increase in R&D expenses for immunotherapies by 64% due to progress in clinical programs R&D costs R&D immunotherapies Other R&D costs 2.4 0.5 Increase due to: 1.9 Medigene’s progressing DC study 0.7 Preparation of clinical 1.9 development of TCRs +64% New hirings 1.2 in €m 3M 2015 3M 2016 22
Slide 23: Higher General & Administrative Expenses relate to management changes
Higher General & Administrative Expenses relate to management changes SG&A expenses general administrative expenses selling expenses 2.3 1.7 0.7 0.5 +37% 1.6 1.2 in €m 3M 2015 3M 2016 23
Slide 24: Increase in total revenue by 132% influenced by sale of EndoTAG
Increase in total revenue by 132% influenced by sale of EndoTAG® Total revenues EndoTAG sale other revenue 3.9 Veregen income 0.6 Increase in other operating +132% income due to one-off effect: 0.9 EndoTAG income sale license (2016: €2.4 m, 2015: €0.0 m) 1.7 0.7 2.4 1.0 in €m 3M 2015 3M 2016 24
Slide 25: EBITDA loss reduced by 54%
EBITDA loss reduced by 54% 3M 2015 3M 2016 3M 2015 3M 2016 In € m -0,9 -1.4 -2,0 -3.7 -54% -62% EBITDA 3-months result Decrease in EBITDA and net loss in spite of higher expenditures for immunotherapies mainly due to EndoTAG sale Difference between EBITDA and net result due to: - financial result -
Slide 26: Balance sheet – Strong cash position
Balance sheet – Strong cash position Development of assets, shareholders' equity and 31/03/2016 31/12/2015 Change liabilities (in € k) Assets Non-current assets 45.231 51.552 -12% Current assets thereof: Cash and cash equivalents and time deposits 46.310 46.759 -1% Inventories and trade accounts rec
Slide 27: Medigene realized €6m by partial sale of stake in Immunocore
Medigene realized € 6m by partial sale of stake in Immunocore in April 2016 Sale of 50% in private biotech company Immunocore, UK, for GBP4.9 m (approx. €6.1 m) on 4th April 2016 Significant increase in value: Medigene held 64,815 ordinary shares in Immunocore which were valued at GBP2.8 m (approx.
Slide 28: Start of phase II in DC vaccine trial triggers milestone payment in new shares
Start of phase II in DC vaccine trial triggers milestone payment in new shares Treatment start of first phase II-patient in Medigene‘s ongoing phase I/II trial with DC vaccine in AML announced on 1st April 2016 Milestone payment of approx. €3.2 m to be made by Medigene to former contributing shareho
Slide 29: Financial guidance 2016 confirmed
Financial guidance 2016 confirmed 2015 Guidance 2016 Total revenues €6.8 m Stable/increasing Veregen® total revenue* €3.1 m €3 - 4 m R&D expenses €5.5 m €9 -11 m Immunotherapies EBITDA loss €9.5 m €10 - 12 m * assuming constant exchange rates 29
Slide 30: Medigene: clinical-stage immunotherapies
medigene clinical-stage immunotherapies
Slide 31: Questions & Answers
medigene Questions & Answers
Slide 32: Medigene AG
Medigene AG MediGene AG T +49 - 89 - 20 00 33 - 0 Lochhamer Straße 11 F +49 - 89 - 20 00 33 - 2920 82152 Planegg/Martinsried Planegg / Martinsried investor@medigene.com Germany www.medigene.com Listed on Frankfurt Stock Exchange (MDG1, (MDG, Prime PrimeStandard) Standard)