MediGene AG · LS:A40ESG
MediGene — 9M 2014 Earnings Presentation
25 slides from MediGene's earnings presentation, Nov 21, 2014
Slide 1: Analyst conference call: Results for the first 9 months of 2014
Analyst conference call Results for the first 9 months of 2014 21 November 2014 Dr. Frank Mathias, CEO Prof. Dolores J. Schendel, CSO Peter Llewellyn-Davies, CFO
Slide 2: Forward-looking statements
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", "may" or words of simila
Slide 3: Pivotal events since beginning of 2014
Pivotal events since beginning of 2014 Acquisition & integration of Trianta Immunotherapies €15.9 m secured with capital increase Partnered drug candidates/marketed drugs RhuDex® outlicensed to Falk Pharma Veregen® continued market outreach 3
Slide 4: Marketed drug - Veregen
Marketed drug - Veregen® Activities with worldwide partners: Market launch in Sweden, the Czech Republic, Slovakia, Hungary, Poland, Belgium, Denmark, Finland and Canada Commercialisation agreement for UK and Ireland Filing of marketing authorization applications in eight additional European countri
Slide 5: Partnered drug candidates
Partnered drug candidates RhuDex®: Licensing agreement with Falk Pharma in hepatology and gastroenterology Falk Pharma is conducting a comprehensive development programme with the aim of developing RhuDex optimally in the indication primary biliary cirrhosis (PBC) Start of clinical trials will be a
Slide 6: Change in strategic focus
Change in strategic focus Products Innovation marketed / partnered immuntherapies R&D DC-Vaccines Veregen® Partners TCR-modified T cells EndoTAG® Anti-TCR antibodies (TABs) RhuDex® AAVLP technology Trianta Immunotherapies renamed to Medigene Immunotherapies 6
Slide 7: T cell oriented immunotherapy with three complementary platforms
T cell oriented immunotherapy with three complementary platforms DC vaccines Dendritic cell (DC) vaccines: induce the maturation of own, cancer-specific dendritic cells and trigger both T cells and natural killer (NK) cells to attack the tumour TCR-modified Adoptive T cell therapy with TCRs: T cells
Slide 8: Highlights since beginning of 2014 and outlook
Highlights since beginning of 2014 and outlook
Slide 9: DC Vaccines
DC Vaccines Ongoing investigator-initiated trials US patent relating to the manufacturing of mature dendritic cells granted m4 Award project on development of optimized DC vaccine formulation for prostate cancer successfully completed Publication of preclinical and initial clinical data at scientifi
Slide 10: TCR
TCR Patent in the USA and Australia for a T-cell receptor which targets the tumour-associated antigen tyrosinase which is exclusively licensed to Medigene Extension of research funding by the German Research Foundation (DFG) for the Collaborative Research Centre for adoptive T-cell therapy Presentat
Slide 11: TABs
TABs German Ministry of Education and Research (BMBF) grant received as part of the m4 Leading Edge Cluster Initiative Continuation of preclinical development with the aim of delivering proof of principle New research collaborations with Max Delbrück Centre for Molecular Medicine and Helmholtz Zentr
Slide 12: Outlook for immunotherapy platforms
Outlook for immunotherapy platforms DC vaccines: Continuation of investigator-initiated trials Compassionate use programme to test DC vaccine at Oslo University Hospital ongoing – Initial clinical results to be presented at ASH (early Dec.) Initiation of a further clinical study in AML in 2014 Addit
Slide 13: Projected timelines for clinical development of immunotherapy platforms
Summary of projected timelines for clinical development of Medigene’s immunotherapy platforms 2014 2015 2016 2017 2018 DCs: Investigator-initiated trial – AML, Interim Final immune Ongoing data*** monitoring Phase I/IIa Trial* (single center) DCs: Investigator-initiated trial – Interim Final immune
Slide 14: Financial Report 9M 2014
medigene Financial Report 9M 2014
Slide 15: Financial overview for the first 9 months of 2014
Financial overview for the first 9 months of 2014 Increase in revenue: Total revenue up by 64% to €8.4 m (9M 2013: €5.1 m) Veregen® revenue increased by 29% to €3.7 m (9M 2013: €2.8 m) Reduction of loss: EBITDA reduced by 46% to €-3.3 m (9M 2013: € -6.1 m) Net loss reduced by 27% to €-5.6 m (9M 2013
Slide 16: Increase in revenue
Increase in revenue In € m Veregen® In-market sales Total Veregen® revenue Total revenue 12.2 -3% 11.9 8.4 5.1 +64% 2.8 +29% 3.7 9M 2013 9M 2014 9M 2013 9M 2014 9M 2013 9M 2014 Revenue (in € k) 9M 2013 9M 2014 Change Veregen® Royalties 1,889 1,747 -8% Product revenue (supply chain) 735 1,200 63% Mil
Slide 17: Increase in Veregen sales in Q3
Increase in Veregen® sales in Q3 In € m In € K Veregen in-market sales Q3 Total Veregen Revenue Q3 +17% +17% 4.9 959 1,118 4.2 Q3 2013 Q3 2014 Q3 2013 Q3 2014 Revenue (in € k) Q3 2013 Q3 2014 Change Veregen® Royalties 646 729 13% Product revenue (supply chain) 181 364 101% Milestone payments 132 25
Slide 18: Operating expenses within plan
Operating expenses within plan In € m R&D expenses SG&A expenses +1% +5% 5.1 5.4 5.6 5.6 9M 2013 9M 2014 9M 2013 9M 2014 R&D expenses: SG&A expenses: Decrease due to lower costs for Higher costs due to Trianta acquisition preclinical, CMC and clinical trials of Continued lower fixed costs partnered
Slide 19: Reduction of loss
Reduction of loss In € m EBITDA 9-Months net result -3.3 -5.6 -6.1 -46% -7.7 -27% 9M 2013 9M 2014 9M 2013 9M 2014 Loss reduction primarily due to increase in total revenue by €2.8 m 9-Months net result influenced by foreign exchange non-cash book loss 19
Slide 20: Improved cash position
Improved cash position Cash position at 30 September 2014 of €16.7 m (31 December 2013: €10.2 m) Cash usage from operating activities decreased by 35% to €7.1 m (9M 2013: cash outflow of €10.8 m) Average monthly cash usage 9M 2014 €0.8 m (9M 2013: €1.2 m) 20
Slide 21: Financial guidance 2014 confirmed
Financial guidance 2014 confirmed Improvement Actual 2013 Guidance 2014 2014 Double-digit Total revenue €7.6 m 20 - 30% percentage increase Veregen® €4.2 m €5 - 6 m > 20% EBITDA loss €8.3 m €4 - 6 m > 25% Total revenue consists mainly of Revenue Veregen® Increase from R&D funding; grants Non
Slide 22: Shareholder Structure
Shareholder Structure* 10,1% 5,5% Aviva 4,4% SynCore 3,2% DJS Montana Ridgeback Freefloat (< 3%) 76,8% Key share information • Listed on the FSE (Prime Standard) • Number of shares: 13,920,226 • Current market cap of approx. ~ €55 m * as of 31 October 2014 22
Slide 23: Medigene
medigene &TRANSFORMAT
Slide 24: Questions & Answers
medigene Questions & Answers
Slide 25: Medigene AG contact details
Medigene AG MediGene AG T +49 - 89 - 20 00 33 - 0 Lochhamer Straße 11 F +49 - 89 - 20 00 33 - 2920 82152 Planegg Planegg/Martinsried / Martinsried investor@medigene.com Germany www.medigene.com Listed on Frankfurt Stock Exchange (MDG1, (MDG, Prime PrimeStandard) Standard)