Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (June 2024)
39 slides from Merck &'s investor day presentation, Jun 3, 2024
Slide 1: ASCO Investor Event
PRESENT ASCO Investor Event June 3, 2024
Slide 2: Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA
Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA This presentation of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These state
Slide 3: Opening Remarks
Opening Remarks Dr. Dean Li President, Merck Research Laboratories
Slide 4: Agenda
Agenda Dr. Dean Li Opening Remarks | Dr. Dean Li President, Merck Research Laboratories Strategy Overview, Earlier Stage Cancers, IO | Dr. Eliav Barr Dr. Eliav Barr SVP, Head of Global Clinical Development & Tissue Targeting & Precision Molecular Targeting | Dr. Marjorie Green Chief Medical Officer
Slide 5: Significant progress since 2021 in providing benefit for patients and delivering upon our strategy
Significant progress since 2021 in providing benefit for patients and delivering upon our strategy 2021 Objective Strategy Progress 20213 TODAY Approvals in additional indications1 53 40 Leverage KEYTRUDA as a foundation to advance 2021 2024 standard-of-care for patients, diversify our Approvals in
Slide 6: In earlier stage disease, KEYTRUDA is the only IO to demonstrate significant OS benefit
In earlier stage disease, KEYTRUDA is the only IO to date to demonstrate significant OS benefit in 4 studies, and to receive 9 approvals Lung Renal Skin Breast Cervical Bladder KN-671 KN-564 KN-054 KN-522 KN-A18 Perioperative Adjuvant Adjuvant Perioperative KN-057 FIGO 2014 stage III- Stage II, IIIA
Slide 7: Strategy Overview, Earlier Stage Cancers, Immuno-oncology
Strategy Overview, Earlier Stage Cancers, Immuno-oncology Dr. Eliav Barr SVP, Head of Global Clinical Development & Chief Medical Officer
Slide 8: Leveraging solid foundation to build a strong future in Oncology
Leveraging solid foundation to build a strong future in Oncology In 2021 we had… Today we have… a pipeline encompassing multiple an immunotherapy-based portfolio … mechanisms of action … … focused on metastatic and late-stage … spanning disease stages (early stage, disease … metastatic / late-stage)
Slide 9: Uniquely positioned to advance cancer care by progressing curated pipeline of oncology candidates
Uniquely positioned to advance cancer care by progressing curated pipeline of oncology candidates Immuno-oncology Precision Molecular Targeting Tissue Targeting Boost anti-tumor immune Impact pathways that can drive Increase cancer cell sensitivity responses cancer growth with ADCs and immune-engage
Slide 10: More than a dozen novel candidates have advanced to late phase development
More than a dozen novel candidates have advanced to late phase development Immuno-oncology Precision Molecular Targeting Tissue Targeting Boost anti-tumor immune Impact pathways that can drive Increase cancer cell sensitivity responses cancer growth with ADCs and immune-engagers 2 3 sac-TMT6 HER3-DX
Slide 11: >30 ongoing late-phase oncology read-outs expected across pipeline candidates
>30 ongoing late-phase1 oncology read-outs expected across pipeline candidates with additional studies being planned LAG3 TIGIT CTLA4 B7H3 ROR1 CYP11A1 INT MK-4280A3 MK-7684A5 MK-1308A7 MK-24002 MK-214010 MK-568411 V94013 2024 2025 2026 2027 2027 2028 2029 2 4 1 1 1 2 3 HER3 PD-1 (subQ) LSD1 TROP2 B
Slide 12: Extensive ongoing, late-phase clinical development program for earlier stages of cancer
Extensive ongoing, late-phase clinical development program for earlier stages of cancer1 Esophageal Head & Neck KN-975 KN-689 Lung Breast KN-091 KV-006 INTerpath-002 KN-522 KN-242 KN-671 KL-012 TroFuse-019 OLYMPIA TroFuse-012 KN-867 KL-013 KN-756 Approximately Liver Gastric 30,000 patients2 KN-937 L
Slide 13: KEYTRUDA is the only IO therapy to demonstrate overall survival benefit in four earlier-stage cancers
KEYTRUDA is the only immuno-oncology therapy to date that has demonstrated overall survival benefit in four earlier-stage cancers KEYNOTE-671 KEYNOTE-564 Women’s Cancers • KEYNOTE-A18: KEYTRUDA plus chemoradiotherapy significantly improved overall survival in patients with newly diagnosed high-risk
Slide 14: Building on foundational regimens with novel combination strategies in earlier stage cancers
Building on foundational regimens with novel combination strategies in earlier stage cancers with the goal of improving outcomes for patients KEYTRUDA-based approvals1 Ongoing combination studies Lung KN-091 V9403 MK-28702 Adjuvant INTerpath-002 TroFuse-019 Stage IB (T2a ≥4 cm), II or IIIA NSCLC Adj
Slide 15: V940 (mRNA-4157) demonstrated sustained clinical benefit in stage III/IV melanoma
V940 (mRNA-4157) demonstrated sustained clinical benefit in stage III/IV melanoma Recurrence-free survival (RFS) • V940 (mRNA-4157) and pembrolizumab demonstrated a durable clinically significant improvement in RFS & DMFS vs pembrolizumab in patients with stage III/IV melanoma following complete res
Slide 16: Tissue Targeting & Precision Molecular Targeting
Tissue Targeting & Precision Molecular Targeting Dr. Marjorie Green SVP, Head of Oncology Clinical Development
Slide 17: Advancing one of the industry's broadest ADC programs
Advancing one of the industry’s broadest ADC programs MK-1022 MK-2870 MK-2400 MK-5909 MK-1200 MK-3120 Target HER3 TROP2 B7H3 CDH6 Claudin 18.2 Nectin-4 Current Tumor EGFRm NSCLC, ES-SCLC, Advanced Advanced Solid NSCLC, Breast Ovarian GI Tumors Types2 Breast Solid Tumors Tumors Status Phase 31 Phase
Slide 18: sac-TMT: comprehensive TROP2 development strategy
sac-TMT: comprehensive TROP2 development strategy Registrational studies Signal finding studies Biomarker approach TroFuse-004 TroFuse-009 EGFRm 3L+ EGFRm 2L Planning for First to market TroFuse-005 TroFuse-015 MK-9999-02A MK-3475-06B additional BTC, Pancreatic, opportunities Endometrial Gastric CRC
Slide 19: sac-TMT: Phase 3 data primarily in Chinese patients with TNBC demonstrates potential
sac-TMT: Phase 3 data primarily in Chinese patients with TNBC demonstrates potential Overall survival (OS) • Demonstrated a statistically significant and clinically meaningful improvement in both OS and PFS in patients with advanced TNBC vs physician’s choice of chemotherapy • Clinical benefit was o
Slide 20: Advancing three potential first-in-class ADCs
Advancing three potential first-in-class ADCs MK-1022 (HER3) MK-2400 (B7H3) MK-5909 (CDH6) Phase 2 data (EGFRm NSCLC) Phase 1/2 data (SCLC) Phase 1 data (ovarian cancer) Snapshot data cutoff, 18 May 2023. Data presented at WCLC 2023 Data cutoff data: July 14, 2023 Data presented at ESMO 2023 Data cu
Slide 21: MK-6070: A DLL3-targeted T cell engager with clinical activity in SCLC and neuroendocrine tumors
MK-6070: A DLL3-targeted T cell engager with clinical activity in SCLC and neuroendocrine tumors Mechanism of action • Acts independently of MHC expression or co- stimulation • Redirects T cells to kill DLL3-expressing cancer cells • Small protein (~50kDa) to potentially enable efficient solid tumor
Slide 22: Two highly active agents with potential to improve outcomes for patients with SCLC
Two highly active agents with potential to improve outcomes for patients with SCLC Clinical data • In the U.S., ~34K patients per MK-6070 MK-24003 year are diagnosed with SCLC1, Phase 1 data (SCLC) Phase 1/2 data (SCLC) representing ~15% of all lung cancers • Median OS from start of first therapy is
Slide 23: MK-1084: potential best-in-class KRAS G12C inhibitor with pembrolizumab
MK-1084: potential best-in-class combination of KRAS G12C inhibitor with pembrolizumab based on encouraging Phase 1 data Mechanism of Action Clinical Development • MK-1084 selectively targets KRAS G12C mutant and Phase 1 Study – Objective response rate inhibits KRAS G12C-mediated signaling, which ha
Slide 24: WELIREG: robust clinical development program across settings and tumor types
WELIREG: robust clinical development program evaluating potential across different settings and tumor types LITESPARK- LITESPARK- LITESPARK- LITESPARK- LITESPARK- LITESPARK- 004 005 011 012 022 015 Phase 2 3 3 3 3 2 2L+ 2L+ Setting 1L (post IO & (post IO) 1L Adjuvant 1L TKI) + Pembro & Treatment Mon
Slide 25: Commercial Update
Commercial Update Chirfi Guindo Chief Marketing Officer, Human Health
Slide 26: Driving patient benefits and global growth across a broad portfolio of commercial therapies
Driving patient benefits and global growth across a broad portfolio of commercial therapies >2.6 million patients have been treated with Foundational cancer First-in-class commercially available medicines1 treatment in HIF-2α inhibitor numerous cancers 53 FDA approved indications2 39 approvals in EU
Slide 27: Strong uptake across earlier stage cancer indications
Strong uptake across earlier stage cancer indications based on differentiated clinical profile 10 FDA approvals to date KN-716 Adjuvant • Earlier stage indications continue to be Stage IIB or IIC Melanoma important driver of growth – Represented ~20% of overall KEYTRUDA KN-564 revenue in 2023 ~20% I
Slide 28: Establishing broad portfolio in areas of unmet need
Establishing broad portfolio in areas of unmet need Indication Earlier Stage NSCLC mNSCLC EGFRm mNSCLC EGFRm mNSCLC (approved) (approved) (PDUFA: June 26th)1 (earlier lines of therapy) NSCLC Regimen -based regimens HER3-DXd2 Indication Adjuvant MIBC NMIBC Advanced Advanced (positive topline results)
Slide 29: Opportunity for patient impact and value creation from a diversified pipeline
Opportunity for patient impact and value creation from a diversified pipeline of innovative programs Antibody-Drug Conjugates Oncology Pipeline Opportunity of Individualized Neoantigen Therapy >$20B in sales approaching mid-2030s1 Small Molecules 1. Non-risk adjusted annual sales by the mid-2030s; e
Slide 30: Closing Remarks
Closing Remarks Dr. Dean Li President, Merck Research Laboratories
Slide 31: Uniquely positioned to advance cancer care by progressing curated pipeline of oncology candidates
Uniquely positioned to advance cancer care by progressing curated pipeline of oncology candidates Immuno-oncology Precision Molecular Targeting Tissue Targeting Boost anti-tumor immune Impact pathways that can drive Increase cancer cell sensitivity responses cancer growth with ADCs and immune-engage
Slide 32: Q&A
Q&A Dr. Dean Li Dr. Eliav Barr Dr. Marjorie Green President, SVP, Head of Global SVP, Head of Oncology Merck Research Clinical Development & Clinical Development Laboratories Chief Medical Officer Chirfi Guindo Joanne Monahan Peter Dannenbaum Chief Marketing Officer, SVP, U.S. Oncology SVP, Investor
Slide 33: Appendix
INVENTING FOR LIFE Appendix
Slide 34: Acronyms
Acronyms ADC = Antibody-drug conjugate ESCC = Esophageal squamous cell carcinoma ORR = Objective response rate AE = Adverse event GI = Gastrointestinal OS = Overall survival aRCC = Advanced renal cell carcinoma HER2 = Human epidermal growth factor receptor 2 PARPi = Poly-ADP ribose polymerase inhibi
Slide 35: Dean Li, M.D., Ph.D.
Dean Li, M.D., Ph.D. President, Merck Research Laboratories Dr. Dean Li serves as executive vice president and president of Merck Research Laboratories. He leads the company’s worldwide human vaccines and therapeutics research and development organization. Since joining Merck in 2017, Dean has held
Slide 36: Eliav Barr, M.D.
Eliav Barr, M.D. Senior Vice President Head of Global Clinical Development, Chief Medical Officer Dr. Eliav Barr is senior vice president and head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories. He leads all late-stage clinical development for Merck’s human h
Slide 37: Marjorie Green, M.D.
Marjorie Green, M.D. Senior Vice President Head of Oncology Clinical Development Dr. Marjorie Green is senior vice president and head of late-stage oncology at Merck Research Laboratories. She leads all late-stage clinical development programs for oncology. Marjorie joined Merck from Seagen, where s
Slide 38: Chirfi Guindo
Chirfi Guindo Chief Marketing Officer, Human Health Chirfi Guindo is chief marketing officer for Merck. He is responsible for leading the development and implementation of the company’s long-term strategy for the human health portfolio spanning oncology, vaccines, pharmaceutical and pipeline product
Slide 39: Joanne Monahan
Joanne Monahan Senior Vice President, U.S. Oncology Joanne Monahan is Senior Vice President, U.S. Oncology, Merck. She leads the operations, commercialization and P&L for Merck’s U.S. Oncology business, including KEYTRUDA, and oversees partnerships with AstraZeneca and Eisai to jointly market Lynpar