Merck KGaA · XETR:MRK

Merck KGaA — Technical Presentation (October 2015)

28 slides from Merck KGaA's technical presentation, Oct 1, 2015

  1. Slide 1: Merck Healthcare – R&D Update Call

    Merck Healthcare – R&D Update Call Marcus Kuhnert, CFO Luciano Rossetti di Valdalabero, Global Head of Research & Development Andrew Schiermeier, Head of Global Oncology & General Manager Merck-Pfizer Immuno-Oncology Alliance 1 October 2015

  2. Slide 2: Disclaimer

    Disclaimer Remarks All comparative figures relate to the corresponding last year’s period. Important information This presentation does not constitute an offer of securities for sale or a solicitation of an offer to purchase securities in the United States. The shares referred to herein have not bee

  3. Slide 3: Agenda

    Agenda Healthcare – Strategy recap Progress in the R&D pipeline Immuno-Oncology and avelumab Executive Summary

  4. Slide 4: Delivering on promises from Capital Markets Day in September 2014

    Delivering on promises from Capital Markets Day in September 2014 Vision 2018 Maximize existing franchises Growth initiatives and pipeline ENFORCE  Market positioning STABILITY IN 1. EXISTING  Regions / emerging markets capabilities BUSINESSES  Life-cycle management including Rebif superior devic

  5. Slide 5: Maximize existing franchises – delivering stable to slightly growing top-line

    Maximize existing franchises – delivering stable to slightly growing top-line  Taken back full promotional responsibility in Japan Stable to slight organic growth 2  Liquid biomarker RAS test with Sysmex introduced in testing centre in Spain Consumer  Ongoing 3x3 strategy implementation Q2 1.803

  6. Slide 6: New revenue streams from pipeline projects and additional growth initiatives

    New revenue streams from pipeline projects and additional growth initiatives Oncology market Immunology Immuno-Oncology Growth initiatives and pipeline without I-Onc market4 market5 Growth3 Growth3 Growth3 Rebif Erbitux +12% +16% +63% Fertility ~ €71.5 bn market 20143 ~ €5.4 bn market 20143 ~ €1 bn

  7. Slide 7: New revenue streams from pipeline projects and additional growth initiatives

    New revenue streams from pipeline projects and additional growth initiatives 4 4 4 4 Preclinical Phase I Phase II Phase III Growth initiatives and pipeline Immunology Rebif Erbitux Oncology Fertility Immuno- Oncology General Medicine2 Status quo1 2018E 4 Broad and well structured pipeline with promi

  8. Slide 8: Agenda

    Agenda Healthcare – Strategy recap Progress in the R&D pipeline Immuno-Oncology and avelumab Executive Summary

  9. Slide 9: Focused approach to scientific innovation drives differentiation

    Focused approach to scientific innovation drives differentiation Oncology Immuno-Oncology Immunology & Neurology Ambition Ambition Ambition  Leverage presence in oncology  Become a leader in Lupus with a best-in- to deliver the best benefit possible  Develop new therapies that will help disease t

  10. Slide 10: Revamped and focused R&D pipeline shows further progress

    Revamped and focused R&D pipeline shows further progress Immunology Oncology Immuno-Oncology avelumab BTK-i (f.i.m.) tepotinib (solid tumors) P70S6K/Akt-i (solid tumors) avelumab (ovarian) (mesothelioma) evofosfamide (hematologic avelumab anti IL-17 (f.i.m.) avelumab (gastric) 3 malignancies, solid

  11. Slide 11: Several pipeline compounds have advanced and will add to long-term momentum

    Several pipeline compounds have advanced and will add to long-term momentum Avelumab DNA-PK inhibitor - M3814  Thought to block interaction of PD-L1 with known ligand PD-1  Small molecule inhibitor of key enzyme in double  May enable the activation of T-cells and the adaptive strand break (DSB) r

  12. Slide 12: Tepotinib – leveraging biomarker science to achieve growth inhibition and regression of tumors

    Tepotinib – leveraging biomarker science to achieve growth inhibition and regression of tumors Ligand HGF Potential mechanism Highlights & milestones  c-Met receptor tyrosine kinase is thought to SEMA domain  Initiated phase II enrollment in Asia for HCC and c-Met control key signaling pathway in

  13. Slide 13: DNA-PK inhibitor – targeting DNA double strand break (DSB) repair for cancer therapy

    DNA-PK inhibitor – targeting DNA double strand break (DSB) repair for cancer therapy Potential mechanism Highlights & milestones  DNA-PK is a relevant enzyme in an important  100% cure rate in a head & neck cancer model in DSB repair pathway combination with radiotherapy in a clinically relevant s

  14. Slide 14: BTK inhibitor – selective inhibitor

    BTK inhibitor – selective inhibitor Potential mechanism Highlights & milestones  BTK is expressed by multiple cell types, including  BTK seems to prevent immune complex-mediated signalling B lymphocytes and macrophages and production of inflammatory cytokine in macrophages and glycoprotein VI sign

  15. Slide 15: Agenda

    Agenda Healthcare – Strategy recap Progress in the R&D pipeline Immuno-Oncology and avelumab Executive Summary

  16. Slide 16: Immuno-Oncology pipeline aims to deliver novel combinations from internal and external innovation

    Immuno-Oncology pipeline aims to deliver novel combinations from internal and external innovation Immune checkpoint T-cell therapies modulators Metabolism Treg inhibitors modulators Novel Combinations Cancer stem cells – targeting NMEs* Cancer inflammation modifiers Targeted cytokines Preclinical Pr

  17. Slide 17: M7824 – novel bi-functional immunotherapy

    M7824 – novel bi-functional immunotherapy M7824 Highlights & milestones  Rapid progression through development cycle:  Moved from preclinical to First-in-Human within 11 months  Expansion cohorts expected to start in H2 2016 Potential mechanism  Novel, first-in-class bi-functional immunotherapy

  18. Slide 18: CAR-T – T-Cell therapies could be the next cornerstone of cancer immunotherapy

    CAR-T – T-Cell therapies could be the next cornerstone of cancer immunotherapy CAR-T – Intrexon Highlights & milestones  Considered as next cornerstone of cancer immunotherapy  CAR T cells have shown clinical response rate with up to 91% complete remission in certain hematological indications (ALL

  19. Slide 19: Avelumab – milestones and next steps

    Avelumab – milestones and next steps Key milestones so far  Development pipeline progressing rapidly; large range of potential combination candidates  Orphan drug designation for MCC received in September 2015  Preclinical testing on multiple combinations under way for completion by end-2015 at M

  20. Slide 20: Avelumab – JAVELIN clinical development program initiated and planned as of 1 Oct 2015

    Avelumab – JAVELIN clinical development program initiated and planned as of 1 Oct 2015 Running and planned trials in 2015 Planned trials in 2016 Completed efficacy avelumab+Xalkori/ Solid tumors NSCLC 1L Gastric mBreast NSCLC 2L N=150 / cohort Iorlatinib Dose NSCLC 1L ALK+ Signal detection Urothelia

  21. Slide 21: Avelumab shows promising clinical activity in five indications supporting further clinical development

    Avelumab shows promising clinical activity in five indications supporting further clinical development 1  Treatment with avelumab led to early and durable responses (ORR 14%) as a 2nd line treatment  Longer median PFS and OS were observed for PDL1+ patients 1. NSCLC  Phase III head-to-head trial

  22. Slide 22: Avelumab development program covers a broad range of tumor types

    Avelumab development program covers a broad range of tumor types Total # of tumor types targeted with PDL1 compounds Merck KGaA/Pfizer  Avelumab is well represented and is currently investigated across more than 15 tumor types and lines of therapy Competitor 1  It tackles a similar range as compet

  23. Slide 23: Avelumab plays predominantly in attractive and differentiated niches

    Avelumab plays predominantly in attractive and differentiated niches NSCLC avelumab 80 Number of trials per indication 65 Melanoma Gastric/Esophageal 40 Head & Neck RCC 30 Pancreas CRC Breast Bladder NHL 20 Ovarian HL Glioblastoma 10 SCLC Prostate Multiple Myeloma AML Liver / HCC Mesothelioma CLL 0

  24. Slide 24: Avelumab – Differentiation strategy varies according to chosen target indication and market

    Avelumab – Differentiation strategy varies according to chosen target indication and market Ambition: Smart leader UNSATURATED  Indications (Merkel cell) or markets (Asia for gastric)  Quick to market strategy, e.g. ODD for MCC in 1. AND/OR NICHE INDICATIONS September 2015  Small, but unchallenge

  25. Slide 25: Agenda

    Agenda Healthcare – Strategy recap Progress in the R&D pipeline Immuno-Oncology and avelumab Executive Summary

  26. Slide 26: Executive Summary

    Executive Summary BROAD Merck has a broad and well-structured pipeline in its focus R&D PIPELINE areas Immuno-Oncology, Oncology and Immunology VISIBLE Since the Capital Markets Day 2014, several promising PROGRESS earlier-stage assets have made visible progress BROAD I-ONC Merck’s immuno-oncology p

  27. Slide 27: Appendix

    Appendix

  28. Slide 28: avelumab – an Anti PD-L1 drug to improve natural immune response: targeting principle

    avelumab – an Anti PD*-L1 drug to improve natural immune response: targeting principle Suppression of immune Re-invigoration of natural  Fully human IgG1 response anti-tumor response  Blocks interaction of PD-L1 Suppressor immune cell with its known ligands PD-1  Exhibits Antibody Effector T cell

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