Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (June 2025)
44 slides from Merck &'s investor day presentation, Jun 2, 2025
Slide 1: ASCO Investor Event
June 2, 2025 ASCO Investor Event Merck & Co., Inc., Rahway, N.J., USA 1
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 Y. Li Executive Vice President and President, Research Laboratories 3
Slide 4: Proven track record of advancing standards of care in oncology
Unparalleled Breadth and depth of activity 35 Phase 3 oncology trials demonstrated statistically significant overall survival 56 FDA approved indications >3.4 million patients treated1 1. Patients treated with commercially available products as of December 2024 Proven track record of advancing stand
Slide 5: KEYTRUDA is a foundational immunotherapy with increasing patient impact in earlier stage disease
KEYTRUDA is a foundational immunotherapy with increasing patient impact in earlier stage disease 41 38 Metastatic indication 32 33 Earlier stage indication Demonstrated OS benefit 26 KN-689 in HNSCC PDUFA June 23, 2025 20 14 KN-716 Melanoma 9 KN-629 cSCC 4 KN-564 KN-671 RCC NSCLC 1 2 KN-054 KN-057 K
Slide 6: KEYTRUDA learnings provide roadmap to ongoing and future oncology development
KEYTRUDA learnings provide roadmap to ongoing and future oncology development Curative intent setting Improving access and enabling new paradigms of treatment PD-1 and chemotherapy combinations Pursuing next generation chemotherapy (ADCs) Chemotherapy-free regimens Replacing invasive chemotherapy re
Slide 7: Agenda
ASCO and Recent Data Updates | Dr. Marjorie Green Development Strategy | Dr. Eliav Barr Agenda Commercial Opportunity | Chirfi Guindo Closing Remarks | Dr. Dean Li Q&A | All 7
Slide 8: ASCO and Recent Data Updates
ASCO and Recent Data Updates Dr. Marjorie Green Senior Vice President, Head of Oncology Clinical Development 8
Slide 9: Subcutaneous pembrolizumab with berahyaluronidase alfa noninferior to IV, with ~2 minute administration
Subcutaneous pembrolizumab with berahyaluronidase alfa noninferior to IV, with ~2 minute administration in pivotal MK-3475A-D77 trial MK-3475A-D77 • Subcutaneous pembrolizumab with mNSCLC berahyaluronidase alfa plus chemotherapy demonstrated noninferior pharmacokinetics compared to IV pembrolizumab
Slide 10: KEYNOTE-689 further supports ambition of treating patients in earlier stages of disease
KEYNOTE-689 further supports ambition of treating patients in earlier stages of disease KEYNOTE-689 EFS: All participants • Neoadjuvant/adjuvant pembrolizumab added to SOC significantly improved EFS in resectable LA HNSCC in all prespecified analysis populations Patient Hazard CI P-value population
Slide 11: KANDLELIT-001: Encouraging activity for KRAS G12C inhibitor in mNSCLC and mCRC
KANDLELIT-001: Encouraging activity for KRAS G12C inhibitor in mNSCLC and mCRC supports best-in-class combination potential 1L mNSCLC - Arm 2: MK-1084 + pembrolizumab mCRC - Arm 6: MK-1084 + cetuximab + mFOLFOX6 Total (n = 29a) 0 Prior Lines of 1 Prior Line of Therapy (n = 12a) Therapy (n = 17a) 100
Slide 12: Zilovertamab vedotin demonstrates encouraging efficacy and safety data in DLBCL
Zilovertamab vedotin demonstrates encouraging efficacy and safety data in DLBCL waveLINE-003 (Phase 2 portion) Best Percentage Change From Baseline SPD for Target Lesions • Recommended dose determined to be 1.75 mg/kg • ORR (56%) and CRR (50%) of zilovertamab vedotin (ZV) plus rituximab and gemcitab
Slide 13: Data for sacituzumab tirumotecan in EGFRm NSCLC support ongoing global Phase 3
Compelling data for sacituzumab tirumotecan (sac-TMT) in EGFRm NSCLC support ongoing global Phase 3 studies Phase 2 OptiTROP-Lung03 Study1 3L+ EGFRm NSCLC HR 0.30 (95% CI: 0.20, 0.46) Sac-TMT Docetaxel P ＜ 0.0001 (n = 91) (n = 46) • Demonstrated statistically significant and clinically PFS events, n
Slide 14: Sac-TMT data in TNBC build on previous evidence and support ongoing Phase 3 studies
Sac-TMT data in TNBC build on previous evidence and further support ongoing global Phase 3 studies Phase 2 OptiTROP-Breast05 Study1 1L advanced or mTNBC • Demonstrated promising anti-tumor All patients mTNBC (N = 41) activity as 1L treatment for patients with advanced or metastatic TNBC irrespective
Slide 15: Development Strategy
Development Strategy Dr. Eliav Barr Senior Vice President, Head of Global Clinical Development & Chief Medical Officer 15
Slide 16: Uniquely positioned to advance cancer care with differentiated portfolio and pipeline
Uniquely positioned to advance cancer care with differentiated portfolio and pipeline 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-T
Slide 17: Our strategy to maximize benefit to patients
Our strategy to maximize benefit to patients: unambiguous efficacy, informed combinations, biomarker enrichment, curative intent settings Best outcomes occur when non- Predictive biomarkers enable Early treatment improves chance cross resistant therapies are stratification that can improve for bette
Slide 18: Leveraging unique portfolio to continually advance standards of care for patients
Leveraging unique portfolio to continually advance standards of care for patients Now Near Next Develop novel mechanisms and Robust discovery and early phase Establish beachhead unique combinations pipeline further advances SoC Earlier- KEYTRUDA + sacTMT1 or KEYTRUDA OS benefit in stage intismeran a
Slide 19: Building on foundational regimens with novel combination strategies in earlier stage cancers
Building on foundational regimens with novel combination strategies in earlier stage cancers KEYTRUDA-based studies Ongoing combination studies KN-0911 intismeran autogene3 Adjuvant stage IB (T2a ≥4 cm), II or INTerpath-002 Lung IIIA NSCLC Adj NSCLC KN-6711 intismeran autogene3 sac-TMT2 INTerpath-00
Slide 20: Building on KEYNOTE-B96 with novel combination strategy in ovarian cancer
Building on KEYNOTE-B96 with novel combination strategy to improve outcomes for patients with ovarian cancer KEYNOTE-B96 MK-5909 (R-DXd) • KEYTRUDA plus chemotherapy with or without Phase 1 study: previously treated ovarian cancer bevacizumab demonstrated statistically significant and clinically mea
Slide 21: Building on KEYNOTE-189 with novel combination strategy in NSCLC
Building on KEYNOTE-189 with novel combination strategy to improve outcomes for patients with NSCLC MK-1084 + KEYTRUDA KN-189 KEYTRUDA + chemotherapy • MK-1084 selectively targets KRAS G12C containing Non-squamous KRAS G12C tumors inhibiting proliferation signaling NSCLC 14%1 • Potent, oral KRAS G12
Slide 22: Gocatamig and I-DXd are two highly active agents for SCLC
Gocatamig and I-DXd are two highly active agents with potential to improve outcomes for patients with SCLC • In the U.S., ~34K patients per year are Clinical data diagnosed with SCLC1, representing ~15% of all lung cancers gocatamig I-DXd3 • Median OS from start of first therapy is Phase 1 data (SCL
Slide 23: Rapidly advancing one of the industry's broadest ADC programs
Rapidly advancing one of the industry’s broadest ADC programs MK-2870 MK-2400 MK-5909 MK-1022 MK-2140 MK-3120 MK-2750 MK-6204 MK-6837 sacituzumab ifinatamab raludotatug patritumab zilovertamab Generic Name tirumotecan deruxtecan deruxtecan deruxtecan Undisclosed Undisclosed Undisclosed Undisclosed v
Slide 24: Comprehensive development strategy for sac-TMT
Comprehensive development strategy for sac-TMT with potential first-in- class opportunities in majority of study populations Combo/ Registrational Potential Biomarker Tumor Type Patient Population Novel Study First-in-Class Approach Approach TroFuse-004 NSCLC 3L EGFRm NSCLC TroFuse-005 Endometrial P
Slide 25: Series of upcoming pivotal read-outs with >60 registrational trials across 16 assets
Series of upcoming pivotal read-outs with >60 registrational trials across 16 assets Immuno-oncology 2025 2026 2027 2028 2029 + Precision Molecular Targeting Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Tissue Targeting PCD passed KEYNOTE-689 KEYNOTE-123 KEYNOTE-B96 KEYNOTE-866 KEYNOTE-6
Slide 26: Series of upcoming pivotal read-outs with >60 registrational trials across 16 assets
Series of upcoming pivotal read-outs with >60 registrational trials across 16 assets Immuno-oncology 2025 2026 2027 2028 2029 + Precision Molecular Targeting Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Tissue Targeting TroFuse-015 TroFuse-004 TroFuse-010 TroFuse-005 TroFuse-007 TroFuse-
Slide 27: MK-2010: significant opportunity based on promising science of PD1xVEGF bispecific
MK-2010: significant opportunity based on promising science of PD1xVEGF bispecific coupled with our unique experience and pipeline MK-2010 - mechanism of action • Tetravalent IgG-VHH targeting VEGF and PD-1 with a • ‘Advantaged’ company to fully explore potential of the structure consists of two IgG
Slide 28: Commercial Opportunity
Commercial Opportunity Chirfi Guindo Chief Marketing Officer, Human Health 28
Slide 29: Driving patient benefits and global growth with our commercial execution engine
Driving patient benefits and global growth with our commercial execution engine 56 FDA approved indications2 44 approvals in EU >3.4 million Strong market access 41 approvals in Japan patients have been treated with commercially available medicines1 25 capabilities and reimbursement across tumor typ
Slide 30: In earlier stage disease, KEYTRUDA is the only IO to demonstrate significant OS benefit in 4 studies
In earlier stage disease, KEYTRUDA is the only IO to date to demonstrate significant OS benefit in 4 studies, and to receive 9 approvals Earlier stage approvals Opportunity in resectable locally advanced HNSCC Lung Renal Skin Breast Cervical Bladder HNSCC • KN-689 PDUFA June 23, 2025 • First Phase 3
Slide 31: Subcutaneous pembrolizumab may provide important benefits to multiple stakeholders
Subcutaneous pembrolizumab may provide important benefits to multiple stakeholders and represents a meaningful global opportunity U.S. PDUFA September 23rd 2025 Patients Demonstrated consistent pharmacokinetic, efficacy and safety profile to IV KEYTRUDA in MK-3475A- Seeking approval across all adult
Slide 32: Significant commercial opportunity from late-phase pipeline across tumor types
Significant commercial opportunity from late-phase pipeline across tumor types Mid-2030s Revenue Opportunity by Tumor >$25B Pipeline opportunity Genitourinary All Other ~10% Women's Cancers Cancers ~30% by the mid-2030s1, ~15% more than half in ADCs Growing presence in women’s cancers and hematologi
Slide 33: Sac-TMT addresses a broad range of disease areas and treatment settings
Sac-TMT addresses a broad range of disease areas and treatment settings with several potential first-in-class opportunities Gynecologic Breast NSCLC GI Endometrial Ovarian Cervical HR+ TNBC EGFRwt EGFRm Gastric TroFuse-032 45-55K TroFuse-019 Earlier Stage 15-20K TroFuse-012 3-5K TroFuse-007 TroFuse-
Slide 34: Potential first-in-class portfolio of ADCs with significant revenue opportunity
Potential first-in-class portfolio of ADCs with significant revenue opportunity and initial registrational studies underway HER3-DXd I-DXd R-DXd zilovertamab vedotin HER3 ADC1 B7H3 ADC1 CDH6 ADC1 ROR1 ADC IDeate- IDeate- REJOICE- Study TBA3 IDeate-Lung02 waveLINE-003 waveLINE-010 Esophogeal01 Prosta
Slide 35: Closing Remarks
Closing Remarks Dr. Dean Y. Li Executive Vice President and President, Research Laboratories 35
Slide 36: Advancing broad, deep pipeline by leveraging industry-leading capabilities and leadership in IO
Advancing broad, deep pipeline by leveraging industry-leading capabilities and leadership in IO Pursuing a focused strategy… …to profoundly improve patient outcomes >60 registrational oncology trials across 16 Further improve efficacy assets and 3 pillars of biology Combine or sequence therapies wit
Slide 37: Q&A
Q&A Dr. Dean Y. Li Dr. Eliav Barr Dr. Marjorie Green President, Merck SVP, Head of Global SVP, Head of Oncology Research Laboratories Clinical Development Clinical Development & Chief Medical Officer Chirfi Guindo Joanne Monahan Peter Dannenbaum Chief Marketing SVP, U.S. Oncology SVP, Investor Relat
Slide 38: Appendix
Appendix 38
Slide 39: Acronyms
Acronyms ADC = Antibody-drug conjugate ES = Extensive-stage ORR = Objective response rate AE = Adverse event ESCC = Esophageal squamous cell carcinoma OS = Overall survival aRCC = Advanced renal cell carcinoma GI = Gastrointestinal PARPi = Poly-ADP ribose polymerase inhibitor B7H3 = B7 homolog 3 HER
Slide 40: Dean Li, MD, Ph.D.
Dean Li, MD, 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 le
Slide 41: Eliav Barr, MD
Eliav Barr, MD 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 he
Slide 42: Marjorie Green, MD
Marjorie Green, MD Senior Vice President, Head of Oncology Clinical Development Dr. Marjorie Green is senior vice president and head of oncology global clinical development at Merck Research Laboratories. Marjorie joined Merck from Seagen, where she was senior vice president and head of late-stage o
Slide 43: 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 44: 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