Merck Kgaa · XETR:MRK
Merck Kgaa — Investor Presentation (June 2016)
16 slides from Merck Kgaa's investor presentation, Jun 20, 2016
Slide 1: Biopharma Pipeline Update
BIOPHARMA PIPELINE UPDATE Luciano Rossetti Global Head of Research & Development, Biopharma Rehan Verjee Chief Marketing and Strategy Officer, Healthcare June 20, 2016
Slide 2: Disclaimer
Disclaimer Cautionary Note Regarding Forward-Looking Statements and financial indicators This communication may include “forward-looking statements.” Statements that include words such as “anticipate,” “expect,” “should,” “would,” “intend,” “plan,” “project,” “seek,” “believe,” “will,” and other wor
Slide 3: Vision 2018 – Delivering on promises
Vision 2018 – Delivering on promises Maximize existing franchises 1 Market positioning Growth initiatives and pipeline Enforce stability Regions / emerging markets capabilities in existing businesses Life-cycle management including superior devices Rebif Erbitux Generate new revenue streams 2 Fertil
Slide 4: Existing product portfolio delivers stable to slight organic growth
Existing product portfolio delivers stable to slight organic growth Sales Org. growth rate Product portfolio m€ 1.646 Q1 2016 +5.4% 1.686 Consumer Health 1.737 +2.6% Q4 2015 1.717 1.708 +1.9% Q3 2015 1.684 1.803 +1.5% Q2 2015 1.651 1.686 +0.3% Q1 2015 1.569 Current year Prior-year 4
Slide 5: Merck pipeline (focus today)
Merck pipeline (focus today) Pending Phase I Phase II Phase III Submission/Review Tepotinib M2736 (ATX-MS-1467) Avelumab1 - Anti-PD-L1 mAb Cladribine Tablets – c-Met kinase inhibitor Immune tolerizing agent Non-small cell lung cancer 1L3 Lymphocyte targeting agent Solid tumors Multiple sclerosis Rel
Slide 6: Cladribine tablets – MAA submission to EMA planned for H1 2016
Cladribine tablets – MAA submission to EMA planned for H1 2016 Background Potential for differentiation • Targets lymphocytes (both B and T cells), integral to MS pathogenesis • Two Phase III and one Phase IIIb extension studies conducted in RRMS and early MS1,2,3; Phase II study in patients failing
Slide 7: MCC 2L: Clinical results support avelumab as potential therapeutic option
MCC 2L: Clinical results support avelumab as potential therapeutic option – planned to apply for marketing authorization in H2 2016 Encouraging response rates1 Potential for differentiation • ORR: 31.8% • Largest international multicenter, open-label study of anti-PD- L1/PD-1 reported in this patien
Slide 8: Execution of Phase III trials progressing as planned (example NSCLC 2L)
Execution of Phase III trials progressing as planned (example NSCLC1 2L) Study design Status and outlook • High unmet medical need avelumab • Open-label, multicenter trial in subjects with NSCLC that has progressed after a platinum-containing doublet • Primary endpoint: Overall survival in patients
Slide 9: Going forward, avelumab combinations will drive differentiation strategy
Going forward, avelumab combinations will drive differentiation strategy Combinations • Phase III, RCC 1L (avelumab + Inlyta) • Phase Ib/II, NSCLC 1L ALK+ (avelumab + Xalkori/Lorlatinib) Monotherapy • Phase I/II (avelumab + 4-1BB) • Phase Ib/II, ovarian (avelumab + Entinostat; Syndax collaboration)
Slide 10: PD-L1–TGF-beta indicates potential to move beyond checkpoint inhibitors
PD-L1–TGF-beta indicates potential to move beyond checkpoint inhibitors Four focus areas for exploration Status and next steps • Novel, first-in-class bifunctional immunotherapy Replace Identify • Bifunctional mode should result in broader application current opportunities vs. respective mono-functi
Slide 11: Update on selected assets (1/2)
Update on selected assets (1/2) • Binds to receptors of two cytokines regulating maturation, function, and survival of B cells (B-lymphocyte stimulator (BLyS) & a proliferation-inducing ligand (APRIL)) • ADDRESS II (Ph IIb) in SLE patients aiming to show reduction in disease activity – 279 patients
Slide 12: Update on selected assets (2/2)
Update on selected assets (2/2) • M3814 is a selective and potent inhibitor of DNA-PK, a kinase mediating DNA double strand break repair1 • Preclinical PoC showing complete responses and/or increased PFS in combination with radiotherapy in several Analysis of Phase I data DNA-PK xenograft models (SC
Slide 13: Outlook – Two submissions planned in 2016
Outlook – Two submissions planned in 2016 Cladribine Expected submission H1 2016 Avelumab (MCC 2L) Expected submission H2 2016 Atacicept Phase III decision H2 2016 BTK Start three Phase II trials H2 2016 PD-L1–TGF-beta Signals of activity in cohorts H1 2017 DNA-PK inhibitor Analysis of Phase I data
Slide 14: Healthcare is well set for future growth
Healthcare is well set for future growth Stable existing Business and market specific initiatives in place business to maximize existing business franchises Diversified but focused pipeline with high quality assets Strong R&D in the areas Immuno-Oncology, Oncology and Immunology pipeline healthily s
Slide 15: Slide 15
Slide 16: Investor Relations contacts
CONSTANTIN FEST SVENJA BUNDSCHUH ALESSANDRA HEINZ Head of Investor Relations Assistant Investor Relations Assistant Investor Relations +49 6151 72-5271 +49 6151 72-3744 +49 6151 72-3321 [email protected] [email protected] [email protected] ANNETT WEBER JULIA