Merck KGaA · XETR:MRK
Merck KGaA — Technical Presentation (September 2020)
49 slides from Merck KGaA's technical presentation, Sep 25, 2020
Slide 1: R&D Update Call 2020
R&D Update Call 2020 Luciano Rossetti, Global Head of Research & Development Rehan Verjee, Head of the Global Innovative Medicine Franchises & President of EMD Serono Joern-Peter Halle, Head of Research Klaus Edvardsen, Head of Oncology Development September 25, 2020 MeRck
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: Today's Call Participants - R&D and Commercial Leadership
Today‘s Call Participants - R&D and Commercial Leadership Luciano Rossetti Rehan Verjee Joern-Peter Halle Klaus Edvardsen Global Head of Research & Head of the Global Innovative Head of Research Head of Oncology Development Development Medicine Franchises & President of EMD Serono ▪ Joined Merck in
Slide 4: Today's Call Agenda
Today‘s Call Agenda 1 4 CMD 2020 Refresher Oncology - Clinical Pipeline & Healthcare Pipeline – Commercial Update One of the „BIG3“ growth drivers Bavencio® (Avelumab) for the Group Bintrafusp alfa (anti-PD-L1/TGF-ß Trap) Tepotinib (MET kinase inhibitor) DDR Portfolio 2 5 Research at Merck Neurology
Slide 5: CMD 2020 Refresher: Three main drivers of growth to 2022 and beyond
CMD 2020 Refresher Group - Three main drivers of growth to 2022 and beyond poised for low-teens org. growth deliver ~€2 bn pipeline poised for >80% of ambition mid to high single-digit growth org. growth from “BIG3” 1 2019 Healthcare Process Semiconductor Other 2022 >>> Pipeline Solutions Solutions
Slide 6: CMD 2020 Refresher: Healthcare – On track to becoming a Global Specialty Innovator
CMD 2020 Refresher Healthcare – On track to becoming a Global Specialty Innovator Business today …and tomorrow ▪ H1 2020: Growing organically, resilient Oncology and General Medicine portfolio, visibly strong June signals COVID-19 recovery ▪ Bavencio®: Transformative UC1L data presented at ASCO; str
Slide 7: Increasing momentum from R&D
Increasing momentum from R&D Innovating new medicines 10 NMEs1 with First-in-Class, Significant growth in Assets reviewed under 3 new medicines Significant increase Best-in-Disease or contribution to multiple accelerated approved across in sales & further Best-in-Class potential prestigious scientif
Slide 8: Today's Call Participants - R&D and Commercial Leadership
Today‘s Call Participants - R&D and Commercial Leadership Luciano Rossetti Rehan Verjee Joern-Peter Halle Klaus Edvardsen Global Head of Research & Head of the Global Innovative Head of Research Head of Oncology Development Development Medicine Franchises & President of EMD Serono ▪ Joined Merck in
Slide 9: Research at Merck Healthcare: Bedside to Bench and Bench to Bedside
Research at Merck Healthcare Bedside to Bench and Bench to Bedside RESEARCH Functional Screens Bio Informatics Drug Discovery Platforms Disease Biology Quantitative Modelling & Simulation Highly PATIENT/ Differentiated BED Drug Candidate Predisposition M Company sponsored trials Real World Evidence
Slide 10: Translational Innovation Platforms (TIPs) advance our science to first-in-man
Research at Merck Healthcare Translational Innovation Platforms (TIPs) advance our science through to first-in-man across our therapeutic areas Therapeutic Focus Disease biology areas1 Examples of Output Areas Oncogenic Signaling Tepotinib (MET kinase inhibitor) TIP Oncology – DNA damage response (D
Slide 11: Innovation Management Process
Innovation Management Process Fostering innovation at early stage, applying stringent quality criteria to enter development and advance successful clinical candidates RESEARCH DEVELOPMENT Advanced by TIPs and supported by Central Discovery Technology Platforms Hit Discovery Hit Optimization Explorat
Slide 12: Pipeline Prioritization
Pipeline Prioritization Rigorous portfolio & partnering decisions to maximise value Selected examples – NOT exhaustive Selected DDR M9831 Multi-factorial dimensions External assets (incl. M6620/ (formerly assess both scientific rigor VX984)3 and development feasibility: Berzosertib) 1. Strategic fit
Slide 13: Pre-Clinical Pipeline: M1231 bispecific antibody-drug conjugate
Pre-Clinical Pipeline Ph 0 (Pre-clinical) M1231: Potential first-in-class bispecific antibody-drug conjugate targeting EGFR and MUC11 Limitations of conventional ADCs Bispecific concept to potentially increase tumor selectivity and payload delivery • Off-target uptake and catabolism 1. Loss of membr
Slide 14: New-to-Clinic: M3258 LMP7 Inhibitor
New-to-Clinic (Phase I) Ph I M3258: Potent and selective LMP7 Inhibitor demonstrating high efficacy in multiple myeloma models1 Limitations of current proteasome inhibitors Strong scientific data package showing differentiation vs pan-proteasome inhibitors Efficacy: Nonclinical Safety: M3258: A uniq
Slide 15: New-to-Clinic: M6223 anti-TIGIT antibody
New-to-Clinic (Phase I) Ph I M6223: Internally developed IgG1 anti-TIGIT antibody holding combination potential with internal assets and SoC M6223 Preclinical Anti–Tumor Activity TIGIT M6223 Blocking of TIGIT/ligands interaction counteracts immune 1 suppression mediated by TIGIT/PVR axis Blockade wi
Slide 16: New-to-Clinic: M4344 oral ATRi
New-to-Clinic (Phase I) Ph I M4344 (oral ATRi): Pre-clinical evidence for synthetic lethality in combination with PARPi supports clinical development TNBC (PARPi +/- M4344)1 M4344 Preclinical Anti–Tumor Activity Study Design: ▪ ATR kinase is an important regulator of replication stress and double M4
Slide 17: Today's Call Participants - R&D and Commercial Leadership
Today‘s Call Participants - R&D and Commercial Leadership Luciano Rossetti Rehan Verjee Joern-Peter Halle Klaus Edvardsen Global Head of Research & Head of the Global Innovative Head of Research Head of Oncology Development Development Medicine Franchises & President of EMD Serono ▪ Joined Merck in
Slide 18: Oncology Portfolio: Update on selected assets
Oncology Portfolio Update on selected assets Bintrafusp alfa (anti-PD-L1/TGF-β Trap) DDR (DNA Damage Response) Portfolio 18 Healthcare R&D Update Call | September 25, 2020
Slide 19: Bavencio (Avelumab): FDA approval as UC 1L maintenance treatment
Bavencio® (Avelumab) Approved by FDA as UC 1L maintenance treatment on June 30 2020, transformative OS data recently published in NEJM „Avelumab Maintenance Therapy for Advanced ESMO 2020 – Additional analyses support the use of or Metastatic Urothelial Carcinoma”, Powles et al., Bavencio® as a new
Slide 20: Bintrafusp alfa: Development approach, multiple shots-on-goal
Bintrafusp alfa (anti-PD-L1/TGF-β Trap) Development approach: Multiple shots-on-goal to evaluate co- localized inhibition of TGF-β / PD-L1 hypotheses RT combo to counteract Tumor Tumor biology / biology/ Target aberrant Impact on CT combo to initiate PD-L1 & TGF-β mediated Target TGF-β-mediated TGF-
Slide 21: Bintrafusp alfa: ESMO 2020 long-term follow-up data
Bintrafusp alfa (anti-PD-L1/TGF-β Trap) ESMO 2020: Long-term follow-up data shows encouraging and durable responses across multiple tumor types Three-year follow-up for second-line (2L) Long-term follow-up of bintrafusp alfa in patients with treatment of non-small cell lung cancer (NSCLC)1 pretreate
Slide 22: Tepotinib: First-in-class launch in MET Exon14
Tepotinib (MET kinase inhibitor) First-in-class launch in MET Exon14 sets foundation for EGFRm/ METamp opportunity and exploration in other tumor types • Highly competitive data set presented at ASCO 2020 and published in New England Journal of Medicine in May 2020 (99 patients with a follow up ≥9 m
Slide 23: Tepotinib: EGFRmut/METamp market, INSIGHT 1 data
Tepotinib (MET kinase inhibitor) Tapping into the rapidly evolving EGFRmut/METamp market - Encouraging INSIGHT 1 data INSIGHT 2 – Tepotinib + Osimertinib in A solid foundation - Encouraging INSIGHT 1 data Osimertinib Relapsed METamp NSCLC (18-months follow-up presented at WCLC 2019)1 • Study design
Slide 24: DDR Portfolio: Leading portfolio with a broad clinical program
DNA Damage Response (DDR) Portfolio Leading DDR portfolio with a broad clinical program Strategy presented at R&D • Only ATR-inhibitor with a POC from an RCT Berzosertib/M6620 Update Call 2019 (formerly VX-970) • Multiple NCI studies in various tumor types ATRi M4344 (formerly VX-803) • Two oral ATR
Slide 25: Berzosertib (M6620): Data in SCLC and ovarian cancer
DNA Damage Response (DDR) Portfolio Berzosertib (M6620) - Promising data in Small Cell Lung Cancer (SCLC) and Ovarian Cancer support further clinical development First report of an ATRi-chemo combination – SCLC First randomized study of an ATR inhibitor in any tumor type (Berzosertib + Topotecan)1 –
Slide 26: Bavencio: Strong early USA launch performance
Bavencio® (Avelumab) Strong early USA launch performance validates significance of 1L UC overall survival (OS) advantage Bavencio® data ushering in Successful introduction in a new era in 1L mUC unique COVID context Significance of Bavencio® data recognized through major • Leading share of voice (SO
Slide 27: Neurology & Immunology: Update on selected assets
Neurology & Immunology Update on selected assets Evobrutinib (oral BTK-inhibitor) M5049 (TLR7/8 antagonist) 27 Healthcare R&D Update Call | September 25, 2020
Slide 28: Evobrutinib: Leading in a novel class with significant growth potential
Evobrutinib (Investigational oral BTK-inhibitor) Leading in a novel class with significant growth potential Unmet need in Multiple Worldwide MS B-Cell Targeting + Sclerosis (MS) – Market [€ bn]1 High-Efficacy (HE) Orals Need for new mechanisms to represent >60% of MS sales control disease 20 19 • ~5
Slide 29: Evobrutinib: Most extensive efficacy and safety data among BTKis in MS
Evobrutinib (Oral BTK-inhibitor) Most extensive efficacy and safety data among BTKis in MS Efficacy and Safety CNS Effect on Profile Maintained Optimal Dose Selection Highly Selective Progression Long Term (Ph II) Phase II: 108 weeks OLE Evobrutinib may impact The largest and most Evobrutinib is a p
Slide 30: M5049 (TLR7/8 antagonist): Drivers of SLE pathology and COVID-19
M5049 (TLR7/8 antagonist) TLR7/8 are drivers of SLE pathology and possibly of COVID-19 2 • M5049 (discovered in-house) is a potentially first-in class small molecule that blocks activation of Toll-like receptors TLR7 and TLR8, two innate immune sensors that detect single-stranded (ss) RNA from virus
Slide 31: M5049: Similarities between SLE and COVID-19
M5049 (TLR7/8 antagonist) Similarities between SLE and COVID-19 Similarities between SLE and COVID-191 Phase II study started in July 2020 Rational: • Investigate if M5049 intervention at critical point in course of COVID-19 disease may prevent or ameliorate hyper- inflammatory response in patients
Slide 32: Mavenclad: ECTRIMS data and recovering launch momentum
Mavenclad® Data at ECTRIMS further characterize unique profile, and launch momentum is recovering well globally after peak COVID-19 impact Mavenclad® Real World Evidence US launch progress New Mavenclad® data at ACTRIMS-ECTRIMS highlight • Prescription trends: New Rx regaining momentum, adding rapid
Slide 33: Executive Summary
Executive Summary Increasing momentum across the innovative medicines pipeline 10 NMEs with First-in-Class, Best-in-Disease or Best-in-Class potential progressed to the clinic in the last 6 years 3 new medicines approved across 6 indications since 2017 Confidence to generate ~€2 bn pipeline sales by
Slide 34: Q&A Participants - R&D and Commercial Leadership
Q&A Participants - R&D and Commercial Leadership Luciano Rossetti Rehan Verjee Joern-Peter Halle Klaus Edvardsen Global Head of Research & Head of the Global Innovative Head of Research Head of Oncology Development Development Medicine Franchises & President of EMD Serono ▪ Joined Merck in 2014 afte
Slide 35: 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 constantin.fest@merckgroup.com svenja.bundschuh@merckgroup.com alessandra.heinz@merckgroup.com ILJA DOERING GUNNAR
Slide 36: Appendix
Appendix • Healthcare pipeline • Additional information on selected assets • Trial summaries by asset
Slide 37: Healthcare Pipeline
Healthcare Pipeline As of July 31, 2020 Phase I Phase II Phase III berzosertib (M6620) bintrafusp alfa peposertib (M3814) avelumab avelumab ATR inhibitor TGFbeta trap/anti-PD-L1 DNA-PK inhibitor anti-PD-L1 mAb anti-PD-L1 mAb Solid tumors Solid tumors Rectal cancer Solid tumors2 Non-small cell lung c
Slide 38: Bavencio: Urgent need for a 1L treatment strategy
Bavencio® (Avelumab) Urgent need for a 1L treatment strategy that maintains and reinforces the initial benefit of induction chemotherapy Durable responses to standard of care (1L chemotherapy) are rare with most patients experiencing progression within 9 months of treatment1 Carboplatin or Complete
Slide 39: Evobrutinib: Superior efficacy with BID dosing
Evobrutinib (Oral BTK-inhibitor) Superior efficacy with BID dosing, based on the most comprehensive BTKi Phase 2 in Multiple Sclerosis1 Increasing % subjects achieving >95% Steady State BTKO 0 20 40 60 80 100 0 98% Only BTKi Phase 2 study in MS 0,1 ARR = 0.11 that studied both QD and BID dosing 75mg
Slide 40: Bavencio (Avelumab) Phase III Clinical Trials
Bavencio® (Avelumab) Selected trials – List not exhaustive Phase III Clinical Trials NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date III Avelumab in First-line Non-Small Cell Lung Cancer NCT02576574 Active, not recruiting April 23, 2021 (JAVELIN Lung 100) III A S
Slide 41: Bintrafusp alfa Clinical Trials
Bintrafusp alfa (anti-PD-L1/TGF-β Trap) Selected trials – List not exhaustive Clinical Trials NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date I MSB0011359C (M7824) in Subjects With Metastatic NCT02699515 Active, not recruiting December 31, 2020 or Locally Advance
Slide 42: Bintrafusp alfa Clinical Trials (continued)
Bintrafusp alfa (anti-PD-L1/TGF-β Trap) Selected trials – List not exhaustive Clinical Trials (continued) NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date II Bintrafusp Alfa Monotherapy in Platinum- NCT04246489 Recruiting May 16, 2022 Experienced Cervical Cancer I
Slide 43: Tepotinib Clinical Trials
Tepotinib (MET kinase inhibitor) Selected trials – List not exhaustive Clinical Trials NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date II Tepotinib Phase II in Non-small Cell Lung Cancer NCT02864992 Recruiting December 9, 2021 (NSCLC) Harboring MET Alterations (V
Slide 44: DDR Portfolio: Selected Clinical Trials – Berzosertib
DNA Damage Response (DDR) Portfolio Selected trials – List not exhaustive Selected Clinical Trials – Berzosertib (M6620) NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date I M6620 and Irinotecan Hydrochloride in Treating NCT02595931 Recruiting April 30, 2021 Patient
Slide 45: DDR Portfolio: Selected Clinical Trials – Peposertib
DNA Damage Response (DDR) Portfolio Selected trials – List not exhaustive Selected Clinical Trials – Peposertib (M3814) NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date I/II Study of M3814 in Combination With Capecitabine NCT03770689 Recruiting July 31, 2021 and R
Slide 46: DDR Portfolio: Clinical Trials – Oral ATRi's M4344 & M1774
DNA Damage Response (DDR) Portfolio Clinical Trials – Oral ATRi‘s M4344 & M1774 NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date I First in Human Study of M4344 in Participants With NCT02278250 Recruiting June 30, 2021 Advanced Solid Tumors I M1774 in Participants
Slide 47: Evobrutinib Clinical Trials
Evobrutinib (oral BTKi) Selected trials – List not exhaustive Clinical Trials NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date III Study of Evobrutinib in Participants With Relapsing NCT04338022 Recruiting September 18, 2023 Multiple Sclerosis (evolutionRMS 1) III
Slide 48: M5049 Clinical Trials
M5049 (TLR7/8 antagonist) Clinical Trials NCT number Est. Primary Phase Study Recruitment Status (hyperlinked) completion date I Single Ascending Dose (SAD) and Multiple NCT03676322 Completed Actual: Ascending Dose (MAD) Study of M5049 in Healthy July 26, 2019 Participants II M5049 Study in Particip
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