BERENBERG AND GOLDMAN SACHS 7 TH GERMAN CORPORATE CONFERENCE

Transcription

1 BERENBERG AND GOLDMAN SACHS 7 TH GERMAN CORPORATE CONFERENCE DR IGNACIO FAUS MUNICH, 25 SEPTEMBER

2 DISCLAIMER This presentation does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace the prospectus. This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States of America (the United States ), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this announcement will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act ) and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities Act. There will be no public offer of the securities in the United States. Subject to certain exceptions, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States. Note about risk for future predictions Certain statements in this presentation 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 presentation 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 forwardlooking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication. 2

3 MOLOGEN SNAPSHOT Based in Berlin, Germany; founded 1998 Frankfurt Stock Exchange Prime Standard Approx. 50 employees One of the pioneers in immunotherapies for the treatment of cancer and HIV Focus on family of TLR9 agonists: Lead product: lefitolimod Follow-up technology: EnanDIM Highly attractive end-markets Structure of lefitolimod Structure of EnanDIM Long established network with scientific institutions and experts in immuno-oncology 3

4 EXECUTIVE BOARD: CLEAR COMMERCIAL FOCUS & SUCCESSFUL TRACK RECORD Dr Ignacio Faus CEO Walter Miller CFO Dr Matthias Baumann CMO Over 25 years of experience in the life sciences industry Valuable experience in fundraising, organizational planning, strategic project evaluation, operational efficiency, business development & licensing BMS, Ferrer International, Grupo Uriach More than 20 years industry as well as financial expertise from leadership positions at Nuvisan and Santhera Pharmaceuticals AG Successful IPO of Santhera Almost 30 years industry expertise R&D and corporate leadership positions in pharma, CRO and biotech Boehringer Mannheim, Roche, FOCUS, NOXXON Highly experienced senior leadership team focused on value generation 4 Legend: IPO initial public offering CRO contract research organization

5 CURRENT SHAREHOLDER STRUCTURE Shareholder Structure as at August 2018 (estimates) <25% Global Derivative Trading GmbH, DE Axxion S.A., LUX Deutsche Balaton Aktiengesellschaft, DE 59% 4% 4% 3% 5% Baloise Holding AG, DE SIGNAL IDUNA Krankenversicherung a.g., DE Freefloat 5

6 SUMMARY HIGHLIGHTS Advanced immunotherapy player Strong management with clear commercial focus and strong track record in prior positions Leading German research player transitioning to global market ready company Lead product lefitolimod in phase III pivotal clinical trial study Safe & well tolerated lead product Encouraging safety data from more than 450 treated study participants Monotherapy potential in oncology as well as infectious diseases Combination therapy potential augmenting other existing effective treatments Multi-billion dollar target markets Global partnership with ONCOLOGIE for lefitolimod Broad range of target indications for lead compound lefitolimod: cancer and HIV Global oncology market: expected to be the dominant therapy segment by 2024; primarily driven by immuno-oncology drugs Lefitolimod offers significant potential in combination therapies which enables the molecule to potentially penetrate large parts of the overall market Potential total deal value of ~ 1 billion plus low double digit royalties on net sales Near-term consideration of 23 million plus commitment to cover specific further expenses for regulatory and market production activities of approx. 20 million Significant part of funding for the pivotal IMPALA study until read-out would be secured Upon successful completion of the capital increase no additional financing required until mid 2020 (time point of expected read-out of IMPALA) 6 Legend: HIV human immuno-deficiency virus

7 MULTI-BILLION US$ MARKETS IN ONCOLOGY: STRONG FUNDAMENTALS AND SIGNIFICANT UNMET NEEDS WW Prescription Drugs 1 WW Oncology Drugs 1 Sales in US$ billion CAGR +6.4% CAGR +12.2% Oncology is expected to be among the largest and fastest growing therapeutic areas worldwide Cancer immunotherapies represent a huge market potential: ~US$ 35 billion Colorectal Cancer 2 Lung Cancer 3 SCLC 4 36 CAGR +13.5% CAGR +3% CAGR +27.7% Source: 1 EvaluatePharma GlobalData Healthcare, Jan 2017 (8 EU, US, Japan & China) 3 Apr GlobalData, Jan 2016 (5 EU, US, Japan) Legend: CAGR Compound Annual Growth Rate I WW worldwide

8 MULTI-BILLION US$ MARKETS IN HIV: INCREASING NUMBER OF PATIENTS LIVING WITH HIV AIDS-Related Deaths (in million) People Living with HIV on ART (in million) < < Better diagnostics Improved treatment regimens Price reductions of medication Growing patient population ART represents no cure Patients remain infectious People living with HIV have opened a market for drugs like lefitolimod Eradicating HIV would prevent risks of further transmission and of viremia, while improving QOL 8 Source: UNAIDS; Global AIDS Update (worldwide), 2017 ART antiretroviral therapy QOL Quality of Life

9 UNIQUE VALUE PROPOSITION The challenge: only 15-20% patients respond to current immunotherapies The solution: Combination of various anti-cancer agents Specifically, an increased number of patients can benefit from combinations of immunotherapies Our immunotherapeutic agent lefitolimod has great potential in mono- and combination therapy: The mode of action of lefitolimod is ideally suited to enhance the anti-tumor effect of certain widely used immunotherapeutic agents (e.g. OPDIVO and KEYTRUDA ) MOLOGEN has generated scientific data that supports the above statement Significant potential for MOLOGEN s TLR9 agonist, lefitolimod, in combination therapy 9

10 CANCER IMMUNOTHERAPY VALUE PROPOSITION: IMPROVE LONG-TERM OVERALL SURVIVAL; COMBINATION THERAPIES Traditional Chemotherapy Immunotherapy Combination Therapy Potential Fast effect in many patients Effect not lasting Needs time to be effective Long-lasting effect in a subgroup of patients Combination treatments aim to combat a disease through various synergistic ways Lefitolimod uniquely positioned as potential combination partner of choice Immunotherapies target improving OS at the long end of the curve Combination therapies are the latest advancement in the fight against several global diseases including cancer & HIV 10 Source: "Immuno-oncology: The new weapon in the war against cancer, Alistair Campbell; Berenberg Equity Highlights, February Legend: OS overall survival

11 PRODUCT PIPELINE - FOCUS ON CANCER IMMUNOTHERAPIES WITH WIDE RANGE OF POTENTIAL INDICATIONS LEFITOLIMOD - DNA-based TLR9 agonist (ISR) STUDY Preclinical PHASE I PHASE II PHASE III mcrc Monotherapy SCLC (extensive disease) Monotherapy IMPALA IMPULSE Advanced solid tumors IO-combination therapy 1 with ipilimumab HIV 2 Monotherapy 3 HIV 2 Combination therapy 4 Solid tumors IO-combination therapy TEACH TITAN EnanDIM - DNA-based TLR9 agonist (ISR) Oncology & Anti-infectives MGN Therapeutic vaccine (cell-line) Renal cancer ASET Oncology Infectious diseases Oncology combination trials Oncology and infectious diseases 11 Notes: 1 Collaboration with MD Anderson-Cancer Center, Texas, US 2 Collaboration with University Hospital Aarhus, Denmark 3 HIV patients under antiretroviral therapy (ART) 4 With broadly neutralizing antibodies I IO Immuno Oncology I ISR Immune Surveillance Reactivator I mcrc metastatic colorectal cancer I SCLC Small cell lung cancer

12 LEFITOLIMOD (MGN1703) BEST-IN-CLASS TLR9-AGONIST Unique Molecular Structure Superior Characteristics Dumbbell-shaped DNA molecule No unnatural components due to covalentlyclosed structure (116 nucleotiodes) 3 effective non-methylated CG motifs in each loop Stability against enzymatic degradation w/o chemical modification Unique immunomodulation profile Combination of efficacy & safety by design Large potential for clinical benefit Broad immunologic activation combined with favorable safety profile given lefitolimod s specific molecular composition Pure natural DNA Strong induction of Type I IFN response w/o triggering generalized inflammatory reaction Absence of toxicity seen with other chemically-modified TLR9 agonists Broad therapeutic window Systemic (s.c.) & intratumoral administration High dosing schedules over prolonged periods of time Safety established with more than 20,000 administrations in over 450 subjects to-date 12 Notes: Light blue area Motifs recognized by TLR9 receptor

13 LATE-STAGE PRODUCT LEFITOLIMOD WITH UNIQUE PROFILE AND HUGE MARKET POTENTIAL Best in class TLR9 agonist and most advanced in mcrc (pivotal trial) Viable long-term treatment Promising in various indications (mcrc, SCLC, HIV ) Superior safety and tolerability Blockbuster potential Suitable for mono- and combination therapy Patient selection via biomarker 13 mcrc metastatic colorectal cancer SCLC small cell lung cancer

14 STRATEGY PROGRESS DEVELOPMENT OF LEAD COMPOUND LEFITOLIMOD Together with our partner ONCOLOGIE: advance the development of our lead compound lefitolimod, for which we expect exceptional market potential. Focus our joint development activities on lefitolimod aiming to reach the market in the midterm: Progress pivotal phase III clinical trial IMPALA in metastatic colorectal cancer to completion by ca. April 2020 Explore further development potential in SCLC (small cell lung cancer) on the basis of data from the phase II IMPULSE trial Expand the potential of lefitolimod by conducting additional immuno-oncological combination studies in solid tumors Continue the development of lefitolimod in HIV, based on data from the exploratory TEACH trial 14

15 EVOLUTION OF COLLABORATION WITH ONCOLOGIE REGARDING GLOBAL DEVELOPMENT OF LEFITOLIMOD (1/4) 1. Step - February 2018 Signing of a license and co-development agreement License agreement for lefitolimod for Greater China Global co-development agreement to fully exploit the potential of lefitolimod in oncology 2. Step - August 2018 Signing a term sheet for global partnership Transfer of all rights for and joint global development of lefitolimod Further financing of IMPALA secured Additional immuno-oncology studies to reveal the full potential of lefitolimod Potential deal value: payments of above 1 billion in milestones plus royalties Near-term consideration of 23 million Coverage of future development, regulatory and commercialization expenses 3. Step - By end of Q1/19 Closing of final agreement expected 15

16 OVERVIEW ONCOLOGIE (2/4) Delivering Innovative Cancer Medicines Using cutting edge approaches to patient selection and clinical trial design, Oncologie is developing nextgeneration biologics and small molecules. Oncologie's portfolio covers the spectrum of the cancer immunology landscape Objective to develop novel personalized medicines in the field of immuno-oncology Dedicated to biomarker-driven development of large and small molecules for immunooncology Strong leadership team of industry veterans - ex - Imclone, Lilly, BMS, Sanofi, Daiichi Headquartered in Boston, US, with operations in Boston and Shanghai, China Backed by a strong investor group: Pivotal bioventure Partners China Fund, Nan Fung Life Sciences, China Merchant Bank Investments and Volcanics Ventures Increasing our investment in lefitolimod furthers ONCOLOGIE s mission to acquire and develop innovative oncology drugs globally. We have great confidence in the value this agreement with MOLOGEN can bring to our growing pipeline, and the positive impact our continued collaboration can have on the lives of cancer patients around the world, Dr Laura Benjamin, CEO of ONCOLOGIE. 16

17 KEY FINANCIAL TERMS (3/4) Elements of considerations In m Comments Near-term consideration 23 (1) Initial purchase price 3 (2) Payments for MGN s budgeted development expenses To finance IMPALA study until read-out and extend development in further combinations and indications 7 Mainly for IMPALA (3) Funding of additional studies 9 Combination studies in immuno-oncology (4) Issuance of convertible bonds 4 Mandatory conversion, premium of 30%, interest free, 5 year term First convertible bond ( 2 m) expected 31 August 18 Second convertible bond ( 2 m) signing of final contract Coverage of additional expenses ~20 Future development activities, including regulatory interactions and production of drug material to support the future commercialization of lefitolimod Development milestones 200 Based on success of IMPALA and additional indications Commercial milestones 900 Depending on sales Tiered royalties on a low double-digit percentage average n/a Peak royalty rate at 16% 17

18 IMPACT ON MOLOGEN (4/4) Strong long-term partnership for lefitolimod Substantial contribution to the further financing Significant long-term financial upside of lefitolimod secured Unleash the full potential of lefitolimod in immuno-oncology Future focus on follow up compounds 18

19 KEY FINANCIALS H1/Q In m Q Q % H H Revenues n.a n.a. R&D expenses EBIT CF from operating activities CF from financing activities Monthly cash burn % In m 30 June Dec 2017 Total assets Cash & cash equivalents Equity Equity ratio -41% -60% 32 % 19 Legend: CF cash flows

20 FINANCIAL CALENDAR 2018 AND CONTACT DETAILS 8 November 2018 Quarterly Statement as of 30 September 2018 Claudia Nickolaus Head of Investor Relations & Corporate Communications Phone: Fax: investor@mologen.com 20 MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the MOLOGEN AG

21 BERENBERG AND GOLDMAN SACHS 7 TH GERMAN CORPORATE CONFERENCE DR IGNACIO FAUS MUNICH, 25 SEPTEMBER