MOLOGEN AG. Our research for you. Annual Results Analysts Call March 21, 2013

Transcription

1 Our research for you. Annual Results 2012 Analysts Call March 21, 2013

2 Disclaimer Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication. V

3 Agenda Major achievements 2012 Product pipeline Overview MGN cancer immuno-therapy MGN1601 therapeutic vaccination against cancer Key financials 2012 and outlook

4 Major achievements 2012 Outstanding data from two clinical trials for MGN1703 (phase II in colorectal cancer) and MGN1601 (phase I/II in renal cancer) Application for phase II trial with MGN1703 in lung cancer Successful capital increases 25 million Collaboration with Max Delbrück Centrum and Charité in clinical study on skin cancer

5 Advanced product pipeline with lead product against colorectal cancer Product Research Pre-clinic Phase I Phase II Phase III Approval Oncology MGN1703-CRC colorectal cancer MGN1703-NSCLC non-small cell lung cancer MGN1703 other solid tumors MGN1601-RCC renal cell carcinoma Infectious Diseases MGN1331 leishmaniasis MGN1333 hepatitis B Collaborations MGN1404 malignant melanoma

6 cancer immuno-therapy MGN

7 MGN1703 IMPACT colorectal cancer trial Study design Phase II study to evaluate efficacy and safety of a maintenance therapy with MGN1703 after standard first-line therapy in patients with metastatic colorectal cancer disease control? if so: stop first-line therapy tumor progression? if so: stop maintenance therapy, start second line therapy First-line therapy duration: c months Maintenance therapy MGN1703 or placebo Second-line therapy evaluation of progression-free survival (period in which a cancer disease does not get worse)

8 MGN1703 Progression free survival (PFS) Intent-to-treat population PFS rate Patients Events Risk group MGN Placebo Log-rank test: p-value HR = 0.53 [95% CI: 0.27; 1.06] Months [95% CI] PFS MGN1703 Placebo Median PFS 25% quartile 75% quartile 2.8 [2.8; 6.6] 2.1 [1.6; 2.8] 7.4 [2.9;15.6] 2.6 [2.5; 2.8] 2.2 [1.7; 2.6] 2.8 [2.6; 2.9] Number at risk MGN1703 Placebo Months Abbreviations: HR, Hazard ratio; CI, Confidence interval

9 MGN1703 Progression free survival (PFS) Good risk subgroup PFS rate Patients Events Risk group MGN Placebo Log-rank test: p-value HR = 0.39 [95% CI: 0.18; 0.85] Months [95% CI] PFS MGN1703 Placebo Median PFS 25% quartile 75% quartile 5.8 [2.8; 12.5] 2.8 [1.8; 4.1] 12.5 [5.8;15.6] 2.7 [2.5; 2.8] 2.5 [2.2; 2.8] 2.8 [2.6; 2.9] Number at risk MGN1703 Placebo Months Abbreviations: HR, Hazard ratio; CI, Confidence interval

10 MGN1703 High revenue potential of MGN1703 Global cancer market 2009: c. $50bn (+6%), forecast: CAGR >7% between CRC incidence EU/USA: c. 380,000; CRC prevalence EU/USA: c. 1.2 million; comparable numbers for NSCLC Peak sales expectations for MGN1703 in CRC and NSCLC: 1-2 billion each Peak sales total > 3-4bn for success in all solid tumor types Deal expectations: significant upfront and milestone payments, royalties License talks and negotiations with pharma companies ongoing

11 therapeutic vaccination against cancer MGN

12 MGN1601 ASET renal cancer trial Study design Clinical trial phase I/II (safety study), initially 24 patients planned Open-label, multi-center Intradermal injection Commenced in December 2010 Excellent tolerability: early completion of recruitment in November 2011 after inclusion of 19 patients Inclusion criteria Disease Control? Extension phase Endpoints Patients with advanced renal cell cancer Treatment phase 8 applications in 12 weeks Max 5 applications in week 24, 36, 48, 72, and 120 Safety Pharmacodynamics Immunological data Radiological and clinical response

13 MGN1601 ASET renal cancer trial Excellent survival data Very good safety and tolerability Only mild and moderate adverse events, e.g. fever Very promising efficacy data on overall survival TPP group Patients received 8 injections 7 of 10 alive Median overall survival > 16 months non-tpp group Patients dropped out prematurely 0 of 9 alive Median overall survival < 3 months

14 KEY FINANCIALS 2012 AND OUTLOOK

15 Key financials 2012 (IFRS) Solid funding: gross proceeds from capital increases totaling 25 million Equity ratio: 97% (2011: 89%) Average monthly cash utilization: 0.7 million (2011: 0.6 million) 47 employees (average, excl. management; 2011: 45) R&D expenses EBIT Funds [ million]

16 MOLOGEN is well prepared for the future Milestones 2013 License deal with pharma partner Further advancement of product pipeline Pursue clinical development programs for MGN1703 (colorectal cancer, lung cancer) and MGN1601 (renal cancer) Initiate clinical development programs for vaccine projects

17 Corporate Calendar May 15, 2013 Quarterly Report as of March 31, 2013 August 14, 2013 Half-Year Report as of June 30, 2013 November 11, 2013 Quarterly Report as of September 30, 2013 November 11, November 13, 2013 German Equity Forum 2013 Analyst and Investor Conference, Frankfurt/Main, German Fabeckstraße 30 D Berlin Germany Phone: Fax: V1-6 info@mologen.com MOLOGEN, MIDGE and dslim are registered trademarks of the 16