MediGene AG · LS:A40ESG
MediGene — H1 2016 Earnings Presentation
32 slides from MediGene's earnings presentation, Aug 5, 2016
Slide 1: Analyst Conference Call: Results for the first 6 months of 2016
ANALYST CONFERENCE CALL Results for the first 6 months of 2016 Prof. Dolores J. Schendel, CEO/CSO Dave Lemus, COO Dr. Kai Pinkernell, SVP Medical Affairs and CMO
Slide 2: Safe Harbor Statement
"Safe Harbor" Statement This presentation contains forward-looking statements, which are based on our current expectations and assumptions. Due to various risks and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations an
Slide 3: Immunotherapy Programs Progress and Outlook
Immunotherapy Programs Progress and Outlook
Slide 4: Highlights of the first 6 months 2016 at a glance
Highlights of the first 6 months 2016 at a glance Positive DSMB recommendation and start of Phase II of our DC vaccine clinical study in AML Updated clinical results on IIT studies of DC vaccines using our technologies presented at AACR and CIMT conferences by academic partners Granting of two new U
Slide 5: New IP relating to Medigene's platform technologies
New IP relating to Medigene’s platform technologies DC Platform • Patent US9,238,063: Use of semi-allogeneic anti-tumor vaccines with HLA haplo-identical antigen presenting cells • Medigene holds an exclusive license to this patent from the German Research Center for Environmental Health Announced i
Slide 6: US patent granted for identification of CD4+ T cell antigens and epitopes
US patent granted for identification of CD4+ T cell antigens and epitopes Medigene expands TCR platform with patent US9,341,617B2: Method for identification of antigens and epitopes recognized by CD4+ T cells The patent, with an expected life-span until 2030, can be used to rapidly and efficiently i
Slide 7: A method for the identification of antigens recognized by CD4+ T cells
A method for the identification of antigens recognized by CD4+ T cells Simple and fast method to characterize antigens/epitopes presented on MHC class II molecules and recognized by CD4+ T helper cells cDNA fragments of chosen antigens or from total tumor-derived RNA are expressed as fusion proteins
Slide 8: Medigene's immunotherapy pipeline
Medigene’s immunotherapy pipeline PRECLINICAL PROJECT INDICATION PHASE I PHASE II PHASE III RESEARCH DC Vaccine AML TCR Undisclosed Start 2017 TCR Undisclosed Start 2018 T-cell leukemias TABs + new applications TCR-IIT* Multiple Myeloma Start 2017 * Investigator-initiated study (IIT) of a publicly f
Slide 9: Medigene cooperates with MDC and Charité Hospital on the first TCR study in Germany
Medigene cooperates with MDC and Charité Hospital on the first TCR study in Germany First investigator initiated trial (IIT) with T cell receptors (TCRs) in Germany For patients with refractory or relapsed multiple myeloma (RR/MM) Patient’s own T cells are equipped with tumor-specific TCRs Grant-fun
Slide 10: MAGE-A1 as the tumor-associated target antigen for TCR clinical study
MAGE-A1 as the tumor-associated target antigen for TCR clinical study Melanoma-Associated antiGEn 1 MAGE-A1 expression seen in various tumor types* Member of the MAGE A gene family Multiple Myeloma 71% A cancer-testis antigen with unknown Melanoma 47% function Gastric 33% Tumor-specificity: no known
Slide 11: Characteristics of the MAGE-A1-specific TCR
Characteristics of the MAGE-A1-specific TCR MAGE-A1 TCR was generated In vitro using a non-tolerant mouse Proof of Concept model with a humanized TCR antigen recognition system MAGE-A1 TCR In vivo (T1367) induced Tumor recognition tumor regression in mice (HHDxRag-/-) MAGE-A1 transduced human PBL T
Slide 12: About multiple myeloma (MM)
About multiple myeloma (MM) Multiple myeloma is a cancer of plasma cells, a type of white blood cell normally responsible for producing antibodies to fight infections Prevalence of multiple myeloma: 60,000 patients in the EU 70,000 in the USA Multiple myeloma is the second most common hematological
Slide 13: The clinical trial: First TCR study in RR/MM in Germany
The clinical trial: First TCR study in RR/MM in Germany Autologous, MAGE-A1-transduced cells in patients with relapsed and refractory multiple myeloma Single center trial and single site of production Trial design will follow typical Phase I approach to assess safety and feasibility of cellular immu
Slide 14: Status of Medigene's contribution to the Berlin TCR IIT collaboration
Status of Medigene’s contribution to the Berlin TCR IIT collaboration Medigene contributed to TCR characterization: MAGE-A1 and TCR epitope expression in tumors / Expitope® Regulatory advice meetings held with competent authorities Investigational Medicinal Product Dossier (IMPD) in preparatio
Slide 15: What will Medigene gain from this IIT study?
What will Medigene gain from this IIT study? Scientific benefit: Validation of Medigene’s in silico work on selected target antigens Validation of several in vitro functional assays for TCR assessment Regulatory benefit: Experience on critical regulatory activities and first hand feedback Advanced t
Slide 16: Selected therapies for MM in development or on the market
Selected therapies for MM in development or on the market Proteasome inhibitor Monoclonal antibodies Velcade/Bortezomib (market) Darzalex/Daratumumab (anti-CD38, market) Kyprolis/Carfilzomib (market) Empliciti/Elotuzumab Ninlaro/ Ixazomib (market) (SLAMF7 mab, market) Immune modulators Adoptive T ce
Slide 17: Adoptive T cell therapies for MM
Adoptive T cell therapies for MM Target Expression Multiple Myeloma Normal B cells CART-19 Yes (2.5%1) Yes (loss of Ig) (University of Penn.) CART-BCMA Yes (100%2) Yes (loss of Ig) (NIH-Kochenderfer) NY-ESO TCR No (no loss of B Yes (32%3) (Adaptimmune) cells reported) WT-1 CTL Yes (11%4) Not detecte
Slide 18: MAGE-A1 represents an optimal target antigen in MM for TCRs
MAGE-A1 represents an optimal target antigen in MM for TCRs Source: www.ebi.ac.uk 18
Slide 19: Medigene's immunotherapy pipeline
Medigene’s immunotherapy pipeline PRECLINICAL PROJECT INDICATION PHASE I PHASE II PHASE III RESEARCH DC Vaccine AML TCR Undisclosed Start 2017 TCR Undisclosed Start 2018 T-cell leukemias TABs + new applications TCR-IIT* Multiple Myeloma Start 2017 * Investigator-initiated study (IIT) of a publicly f
Slide 20: Status Quo of preparations for first own TCR Study in 2017
Status Quo of preparations for first own TCR Study in 2017 Selection Manufacturing GMP-process Clinical trial of lead TCR process development application Start of candidate Vector development at CMO (CTA) clinical study Currently in progress 2017 2017 20
Slide 21: Clinical outlook and milestones for 2016/17
Clinical outlook and milestones for 2016/17 MAGE-A1 TCR IIT, Berlin: IMPD submission as part of the clinical trial application and approval/start of IIT TCR-Study in Berlin Medigene‘s first TCR trial: GMP process finalization and validation Clinical trial application and approval Study s
Slide 22: Financial Report 6M-2016
medigene Financial Report 6M-2016
Slide 23: Financial overview for the first 6 months of 2016
Financial overview for the first 6 months of 2016 + 62% Total revenues increased by 62% due to EndoTAG® + 23% R&D expenses Increase in R&D expenses sale by 23% 6% Improvement in EBITDA loss € 48.7m Cash & cash equivalents up by 6% by 4% to € 48.7 m Confirmation of financial guidance 2016 23
Slide 24: Increase in R&D expenses for immunotherapies by 68% due to progress in clinical programs
Increase in R&D expenses for immunotherapies by 68% due to progress in clinical programs R&D expenses Immunotherapy costs Other R&D expenses 5.1 +23% 0.8 R&D expenses of € 5.1 m 4.1 for 6M-2016 1.5 Increase in expenses for DC and TCR immunotherapies (6M-2016: € 4.3 m; 6M-2015: € 2.6 m) 4.3 Decrease
Slide 25: Higher General & Administrative Expenses relate to management changes
Higher General & Administrative Expenses relate to management changes +15% Planned increase in SG&A costs Hirings and expanded management team Stable selling and administration costs in Q2 2016 compared to Q2 2015 in €m 25
Slide 26: Increase in total revenue by 62% influenced by sale of EndoTAG
Increase in total revenue by 62% influenced by sale of EndoTAG® 5.5 Increase in other operating 3.4 income due to one-off effect: EndoTAG sale +62% (2016: 2.4 m, 2015: 0.0 m) in €m 26
Slide 27: EBITDA loss reduced by 6%
EBITDA loss reduced by 6% EBITDA Net result of the period 6M 2015 6M 2016 6M 2015 6M 2016 In € m . 0.4 4.3 4.0 6.1 -95% -6% Decrease in EBITDA and net loss in spite of higher expenditures for immunotherapies mainly due to EndoTAG® sale EBITDA loss for 6M-2016 without one-time effect: € 6.4 m Net res
Slide 28: Milestone payment to former contributing shareholders of Medigene Immunotherapies
Milestone payment to former contributing shareholders of Medigene Immunotherapies Treatment start of first phase II-patient in Medigene‘s ongoing phase I/II trial with DC vaccine in AML in April 2016 triggered 2nd milestone Payment of approx. €3.2 m made by Medigene to former contributing shareholde
Slide 29: Medigene realized €6m by partial sale of stake in Immunocore in April 2016
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 m) on 4th April 2016 Significant increase in value: Medigene held 64,815 ordinary shares in Immunocore which were valued at GBP 2.8 m (approx. €
Slide 30: Financial guidance 2016 - Outlook
Financial guidance 2016 - Outlook 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 No changes in guidance 30
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)