Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (2019)
27 slides from Merck &'s investor day presentation, 2019
Slide 1: Welcome & Introductions agenda
Welcome & Introductions Ken Frazier, Chairman and Chief Executive Officer Financial & Value Creation Overview Rob Davis, Chief Financial Officer and Head of Global Services Commercial Growth Drivers: KEYTRUDA & Beyond Frank Clyburn, Chief Commercial Officer Animal Health Innovation Rick DeLuca, Pres
Slide 2: Broad Oncology Strategy to Improve Outcomes for Cancer Patients Globally
BROAD ONCOLOGY STRATEGY TO IMPROVE OUTCOMES FOR CANCER PATIENTS GLOBALLY 1 Broadly explore Advance pipeline and Identify patients Dr. Roy Baynes combinations to reach pursue strategic most likely to benefit more patients collaborations and using biomarkers acquisitions to expand portfolio Establish
Slide 3: KEYTRUDA: Broad Activity in >25 Cancer Types
KEYTRUDA: BROAD ACTIVITY IN >25 CANCER TYPES Melanoma NSCLC H&N Urothelial TNBC Gastric cHL 100 100 100 100 100 100 100 Change from baseline in tumor size (%) 0 0 0 0 0 0 0 -100 -100 -100 -100 -100 -100 -100 = cancer types NHL PMBCL Mesothelioma Ovarian SCLC Esophageal NPC Anal with approved 100 100
Slide 4: KEYTRUDA: Repeated Overall Survival Benefits in Monotherapy and Combination
KEYTRUDA: REPEATED OVERALL SURVIVAL BENEFITS IN MONOTHERAPY AND IN COMBINATION Ipi-Naive Melanoma, 2L Bladder, Any PD-L1 2L+ NSCLC, TPS ≥50% 2L+ NSCLC, TPS ≥1% 1L NSCLC, TPS ≥50% 1L RCC, Any PD-L1 Any PD-L1 KEYNOTE-045 KEYNOTE-010 KEYNOTE-010 KEYNOTE-024 KEYNOTE-426 KEYNOTE-006 Pembro vs Chemo Pembr
Slide 5: KEYTRUDA: Still in Early Innings of Development
KEYTRUDA: STILL IN EARLY INNINGS OF DEVELOPMENT >600 Combination trials >100 Trials in >1,000 adjuvant / neoadjuvant Ongoing Dr. Roy Baynes clinical and earlier lines trials >75 Registrational trials underway Continuing to build a wall of data 51
Slide 6: KEYTRUDA: Robust I-O Program in Adjuvant / Neoadjuvant and Earlier Lines
KEYTRUDA: ROBUST I-O PROGRAM IN ADJUVANT / NEOADJUVANT AND EARLIER LINES OF THERAPY 2018 2021 2023 2025 Adjuvant Melanoma (KN-054) NSCLC Adjuvant (KN-091) Gastric & Esophageal Adjuvant Adjuvant / Neoadjuvant MIBC (KN-866) APPROVED HNSCC Adjuvant / / Neoadjuvant (KN-585) Adjuvant / Neoadjuvant MIBC (
Slide 7: KEYTRUDA: Early Evidence in Breast Cancer; Ongoing Trials
KEYTRUDA: EARLY EVIDENCE IN BREAST CANCER; 10 ONGOING TRIALS 100 90 ypT0 ypN0 ypT0/Tis ypN0 Pathological Complete 80 Response (%) 70 60 50 40 Dr. Roy Baynes N = 60 30 K = KEYTRUDA Np = Nab-pac 20 A = doxorubicin C = cyclophosphamide Cb = carboplatin 10 T = paclitaxel Cohort A: Cohort B: Cohort C: Co
Slide 8: KEYTRUDA: Early Stage Prostate Cancer Data Inform Phase Development Program
KEYTRUDA: EARLY STAGE PROSTATE CANCER DATA INFORM PHASE 3 DEVELOPMENT PROGRAM KEYNOTE-365 Cohort A KEYNOTE-365 Cohort B KEYNOTE-365 Cohort C KEYTRUDA+Lynparza KEYTRUDA+Docetaxel KEYTRUDA+Enzalutamide • 11/25 (44%) experienced reduction in tumor burden • 6/25 (24%) experienced reduction ≥ 30% Dr. Roy
Slide 9: Broadest Prostate Cancer Program with Multiple Ph Trials
BROADEST PROSTATE CANCER PROGRAM WITH MULTIPLE PH 3 TRIALS ADDRESSING 40% OF PATIENTS Biochemical Met HSPC mCRPC mCRPC mCRPC Primary Adjuvant Recurrence (BCR) (incl de novo) Pre-CTx CTx Post-CTx Non-metastatic KN-365 Cohort CRPC C KN-921 Ph3 KN-199 Cohort (M0) Pembro / 1-3 Ph3 mHSPC Pembro / KN-199
Slide 10: Lynparza: Showing Efficacy Beyond Women's Cancers
LYNPARZA: SHOWING EFFICACY BEYOND WOMEN’S CANCERS Tumor Tumor Agnostic • mCRPC, All Comers (KEYLYNK-010) agnostic • mCRPC, HRRm (PROfound) • mCRPC, All Comers Combo + Abiraterone • 1L, nonBRCA, KEYTRUDA combo (KEYLYNK-001) (PROpel) Lung Lung • 1L Maintenance BRCA+ (SOLO-1) - Approved cancer Cancer •
Slide 11: Lenvima: Potential Across Broad Range of Tumor Types
LENVIMA: POTENTIAL ACROSS BROAD RANGE OF TUMOR TYPES • 1L and 2L: Planning Stages • 1L NSQ Combo with KEYTRUDA Basket and Chemo (LEAP-006) trial • 1L PD-L1+ (LEAP-007) Head & neck • 2L NSQ (LEAP-008) cancer Urothelial • TNBC cancer • Gastric Lung • 1L (LEAP-001) • Ovarian cancer • 2L (Study 309 / KN
Slide 12: Extensive Oncology Pipeline Covering All Aspects of the Tumor Environment
EXTENSIVE ONCOLOGY PIPELINE COVERING ALL ASPECTS OF THE TUMOR ENVIRONMENT CD27 CCR5 CTLA4 CXCR2 CVA21 GITR Other cancer IDO/TDO vaccines and viruses ILT3 PCVs ILT4 RIG-I IL10 STING LAG-3 Dr. Roy Baynes PD-1 PD-1/LAG-3 bi-specific Pi3K-delta TGFβ TIGIT TLR4 CDK ERK 58
Slide 13: Establishing Leadership in Growing Oncology Market
ESTABLISHING LEADERSHIP IN GROWING ONCOLOGY MARKET Global oncology market potential ($B) • Largest I-O clinical development $300 program in the industry IO/PARP/VEGF/R $250 • Sizable long-term opportunity in Cytotoxic, CD20, CDK, BTK, CD38 new tumor types, including TNBC $200 Hormonal, EGFR, HER 2/3
Slide 14: Early Stage Represents Significant Portion of Cancer Prevalence
EARLY STAGE – INCLUDING ADJUVANT / NEOADJUVANT – REPRESENTS SIGNIFICANT PORTION OF CANCER PREVALENCE HEAD AND NECK BLADDER BREAST Metastatic Metastatic Early stage Metastatic Unknown Unknown Unknown Early stage Early stage MELANOMA RENAL LUNG Mike Nally Early stage Early stage Metastatic Early stage
Slide 15: Addressing Tumor Types with Highest Incidence, Including Breast and Prostate
ADDRESSING TUMOR TYPES WITH HIGHEST INCIDENCE, INCLUDING BREAST AND PROSTATE Breast cancer market expected Global incidence to grow to $38B by 20281 of top tumor types • TNBC represents 10-15% and ER+/HER2- represents ~65% of all breast cancers Lung 2,093,876 (11.6%) • Program addresses different st
Slide 16: Extensive Vaccines Pipeline Targeting Diseases with Significant Unmet Need
EXTENSIVE VACCINES PIPELINE TARGETING DISEASES WITH SIGNIFICANT UNMET NEED HPV PCV RSV CMV Dengue Ebola Others GARDASIL V114 Adults & Peds MK-1654 V160 V181 V920 V116 V172 (Moderna) Instituto Butantan Other PCVs Dr. Roy Baynes • Supporting global • Need for • Major unmet • Leading non- • Major cause
Slide 17: Growing Global Demand for Vaccines Provides Sustainable Market Opportunity
GROWING GLOBAL DEMAND FOR VACCINES PROVIDES SUSTAINABLE MARKET OPPORTUNITY Growth over the next decade Global vaccines market potential ($B)1 driven by: • Increasing Coverage: Driving penetration $55 - $65 +6% of inline products in high income markets (U.S./EU) $40 - $45 • Globalization: Expanding m
Slide 18: Unique Pneumococcal Portfolio Targeting Protection in Adults and Children
UNIQUE PNEUMOCOCCAL PORTFOLIO TARGETING PROTECTION IN ADULTS AND CHILDREN PNEUMOVAX 23 V114 V116 OTHER PCVs Foundation of adult Advancing protection Targeted approach Aiming for broadest prevention across pediatric and to adult prevention protection for pediatric adult populations population • Uniqu
Slide 19: Pneumococcal Market Expected to Remain Large
PNEUMOCCOCAL MARKET EXPECTED TO REMAIN LARGE WITH SIGNIFICANT ADDITIONAL OPPORTUNITY PEDIATRICS ADULTS • Represent two-thirds of market • Significant remaining opportunity driven by aging • Even with vaccine progress, still close to 500,000 deaths population, limited National Immunization Programs a
Slide 20: Multiple Programs Targeting a Market of Over $10B Globally
MULTIPLE PROGRAMS TARGETING A MARKET OF OVER $10B GLOBALLY • Most common respiratory pathogen in infants with >50,000 hospitalizations each year in the U.S. alone and >3 million hospitalizations globally RSV • RSV infection occurs in up to 10% of adults 65 and over in the U.S. each year, resulting i
Slide 21: Years of HIV Innovation Continues
30 YEARS OF HIV INNOVATION CONTINUES 1980s 1990s 2000s 2010s 2020+ 1983 1996 2000 2017 CONTINUING TO INNOVATE Dr. Roy Baynes HIV is discovered ACHAP1 Partnership with MK-8591: Investigational Botswana and Bill NRTTI for the treatment and Melinda Gates and prevention of HIV 1989 1998 2018 Role of pro
Slide 22: MK-8591: Unique Pharmacology Enabling Long Duration Therapy
MK-8591: UNIQUE PHARMACOLOGY ENABLING POTENTIAL LONG DURATION THERAPY Long-Duration Oral Oral & Implantable Monthly Implantable Daily Weekly Elimination Dr. Roy Baynes Radical Maximize simplicity, Continue to simplify Free patients from simplification potency and Aspiring to cure HIV care daily dosi
Slide 23: HIV Remains a Paramount Worldwide Health Threat
HIV REMAINS A PARAMOUNT WORLDWIDE HEALTH THREAT 36.9M 1.8M 940K People Mike Nally Number AIDS- newly of people related infected living deaths in with HIV with HIV 2017 in 2017 69
Slide 24: MK-8591: Unique Attributes Align Well with Unmet Need
MK-8591: UNIQUE ATTRIBUTES ALIGN WELL WITH UNMET NEED MK-8591 HIV UNMET NEED Extended coverage for missed doses (forgiveness) Simple, efficacious regimens that Pill fatigue Mike Nally support lifelong Reduced toxicity therapy with high QoL Easy, effective options for PrEP 70
Slide 25: Gefapixant (MK-7264): Exploring Role of P2X3 Pathway
GEFAPIXANT (MK-7264): EXPLORING ROLE OF P2X3 PATHWAY IN DISORDERS OF SENSORY PATHOLOGY Development focused on the role Sensory Pathology P2X3 Blockade • Headache/migraine of P2X3 receptor mediated • Hypertension • Pathologic cough signaling in: • Bronchoconstriction • Breathlessness • Unexplained or
Slide 26: Gefapixant (MK-7264): Opportunity for Broad Applicability
GEFAPIXANT (MK-7264): OPPORTUNITY FOR BROAD APPLICABILITY ~29 million Americans suffer from sleep apnea, of which 80% are undiagnosed Other sensory functions 10% global prevalence for chronic Sleep cough, of which ~20% are refractory chronic cough or apnea unexplained chronic cough Endometrial- rela
Slide 27: Diverse Pipeline with Strong Growth Potential Through Next Decade
DIVERSE PIPELINE WITH STRONG GROWTH POTENTIAL THROUGH NEXT DECADE HOSPITAL / ONCOLOGY VACCINES SPECIALTY Mike Nally Broadest I-O program Durable business with Innovative pipeline with strong pipeline of extensive portfolio, and targeting areas of oncology products to pipeline and global significant