Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (July 2025)
33 slides from Merck &'s investor day presentation, Jul 17, 2025
Slide 1: HIV Investor Event
HIV Investor Event Merck & Co., Inc., Rahway, N.J., USA July 17, 2025
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: Agenda
Strategy Overview | Dr. Eliav Barr Research Update | Dr. Liz Rhee Agenda Commercial Opportunity | Chirfi Guindo Closing Remarks | Dr. Eliav Barr Q&A | All 3
Slide 4: Strategy Overview
Strategy Overview Dr. Eliav Barr Senior Vice President, Head of Global Clinical Development & Chief Medical Officer 4
Slide 5: Merck has been at the forefront of anchor medicine development in HIV
Merck has been at the forefront of anchor medicine development in HIV Merck scientists Launch of Merck scientists Pediatric Launch of DORAVIRINE establish and CRIXIVAN demonstrate ISENTRESS Approved for use as a publish structure Era of InSTIs block HIV formulations single entity (PIFELTRO) of prote
Slide 6: Substantial global unmet need remains in HIV
Substantial global unmet need remains in HIV Current State1 UNAIDS 2030 Goals 40M Only 77% of people living with HIV are treated 95% 95% 95% People living Diagnosed People living People living with HIV with HIV with HIV with HIV treated suppressed ~3,500 new HIV infections daily 1.3M ~66% aged 20-40
Slide 7: Our ambition is to deliver first and best-in-class NRTTIs for HIV-1 treatment and PrEP
Our ambition is to deliver first and best-in-class NRTTIs for HIV-1 treatment and PrEP Key prospective attributes: • High barrier to resistance Reverse • High potency with the potential for low dose regimens transcription • Long half-life supporting long-acting options • Favorable efficacy, safety a
Slide 8: Efforts across our portfolio and pipeline in treatment and PrEP
Efforts across our portfolio and pipeline in treatment and PrEP Now Near Next DOR ISL Two-Drug Regimen, Daily Oral Treatment In-line portfolio: Filed in U.S. – PDUFA April 28, 2026 ISENTRESS ISL LEN1 Additional ongoing efforts Two-Drug Regimen, Weekly Oral Treatment Phase 3 ongoing in research and e
Slide 9: Additional ongoing efforts in research and early development for HIV treatment, PrEP and cure
Additional ongoing efforts in research and early development for HIV treatment, PrEP and cure Next Efforts ongoing to bring forward longer Path towards a cure is tied to eliminating acting options in HIV treatment and the latent viral reservoir PrEP, with the ultimate ambition of • RT-TACK (Reverse
Slide 10: Research Update
Research Update Dr. Liz Rhee Vice President, Clinical Research, Infectious Disease 10
Slide 11: Advancing our novel treatment and PrEP regimens
Advancing our novel treatment and PrEP regimens Phase 1 Phase 2 Phase 3 Filed Latest update Filed in U.S. (for adults with suppressed DOR ISL virus) – PDUFA April 28, 2026 MK-8591A Protocol 053 (treatment naïve adult Daily Oral Treatment population) ongoing ISL LEN1 Phase 3 studies in adults with su
Slide 12: First two-drug regimen to demonstrate non-inferior efficacy to BIC/FTC/TAF in a Phase 3 study
First two-drug regimen to demonstrate non-inferior efficacy DOR ISL to BIC/FTC/TAF in a Phase 3 pivotal study Daily Oral Treatment Protocol 051: Switching to DOR/ISL (100/0.25 mg) was non-inferior to continuing baseline ART in people living with HIV-1 infection that is virologically suppressed for ≥
Slide 13: Evaluating two once weekly two-drug oral treatment regimens anchored by islatravir
Evaluating two once weekly two-drug oral treatment regimens anchored by islatravir ISL LEN1 ISL ULO NRTTI / Capsid Inhibitor NRTTI / NNRTI Currently in Phase 3 development for adults Currently in Phase 2b development for adults PCDs: April 2026 PCD: September 2027 PLWH with suppressed virus and PLWH
Slide 14: Positive Phase 2 islatravir + lenacapavir weekly oral data supported advancement to Phase 3
Positive Phase 2 islatravir + lenacapavir weekly oral data ISL LEN1 supported advancement to Phase 3 Weekly Oral Treatment Week 48 data2 100 94.2% 92.3% ISL + LEN; n=52 • Participants in both treatment groups Proportion of participants, % B/F/TAF; n=52 80 maintained high rates of virologic suppressi
Slide 15: Phase 3 ISLEND program in adults completed recruitment ahead of schedule
Phase 3 ISLEND program in adults completed recruitment ISL LEN1 ahead of schedule Weekly Oral Treatment PLWH with suppressed virus2 PLWH with suppressed virus2 ISL/LEN QW vs. BIC/FTC/TAF QD ISL/LEN QW vs. baseline ART QD Blinded, randomized, switch Open-label, randomized, switch Completed enrollment
Slide 16: Ulonivirine: Novel NNRTI moving forward in clinical development with islatravir
Ulonivirine: Novel NNRTI moving forward in clinical development ISL ULO in combination with islatravir as once weekly oral treatment Weekly Oral Treatment • Phase 1b study demonstrated >1 log HIV-1 reduction at 1 week after a single dose • Prior Phase 2b ULO dose-ranging study with a higher dose (20
Slide 17: Important opportunity to broaden options for PrEP
Important opportunity to broaden options for PrEP MK-8527 Monthly Oral PrEP MK-8527 has the potential to provide: Unique molecule developed only for PrEP Discreet monthly oral dosing Fast onset of protection within 1 hour for a Small single tablet with no requirement for month of protection
Slide 18: Phase 2 MK-8527 once monthly oral data support advancement to Phase 3
Phase 2 MK-8527 once monthly oral data support advancement MK-8527 to Phase 3 Monthly Oral PrEP • Large Phase 2 dose-ranging study in participants with low likelihood of HIV-1 exposure presented at IAS 2025 • Safety profile of MK-8527 doses evaluated was similar to placebo • Pharmacokinetics of MK-8
Slide 19: Initiating the Phase 3 EXPrESSIVE program for once monthly MK-8527
Initiating the Phase 3 EXPrESSIVE program for once monthly MK-8527 MK-8527 Monthly Oral PrEP EXPrESSIVE-10 EXPrESSIVE-11 Adolescent girls and young women at People at greater likelihood greater likelihood of HIV-1 exposure of HIV-1 exposure N ~4,580 N ~4,390 Kenya, South Africa and Uganda Across 16
Slide 20: Commercial Opportunity
Commercial Opportunity Chirfi Guindo Chief Marketing Officer, Human Health 20
Slide 21: HIV market growth and transformation driven by global unmet need and fast-growing PrEP market
HIV market growth and transformation driven by global unmet need and fast-growing PrEP market Treatment PrEP ~1.2M people who could benefit ~40M people living with HIV globally from PrEP in the U.S. Epidemiology ~1.3M new infections annually globally ~500K people currently using PrEP in the U.S. Glo
Slide 22: Changing landscape of HIV: unmet need and value drivers
Changing landscape of HIV: unmet need and value drivers Support people aging Growing use of Additional treatment Reduce stigma and with HIV, of whom two-drug regimens choice and optimization allow for discreet 1/3 have comorbidities Individuals looking to simplify are needed dosing regimen with impr
Slide 23: Well positioned to meet evolving market needs and drive meaningful progress
Well positioned to meet evolving market needs and drive meaningful progress for people affected by HIV DOR ISL ISL LEN1 ISL ULO MK-8527 Treatment PrEP Our portfolio has the potential to: MK-8527 has the potential to provide: Address need for two-drug regimens Fast onset of protection within 1 ho
Slide 24: >$5B opportunity by the mid-2030s, with four new product approvals anticipated
>$5B opportunity by the mid-2030s, with four impactful new product approvals anticipated over the near-term MK-8527 >$5B Pipeline opportunity DOR ISL Monthly Oral PrEP NRTTI Phase 3 ready Potential first long-acting oral PrEP approval ISL ULO by the mid-2030s1 Daily DOROral Treatment ISL NNRTI/NRTTI
Slide 25: Closing Remarks
Closing Remarks Dr. Eliav Barr Senior Vice President, Head of Global Clinical Development & Chief Medical Officer 25
Slide 26: A new era in HIV treatment and prevention
A new era in HIV treatment and prevention Pioneering novel innovations – NRTTI anchor acts via unique mechanism – Potential to enable treatment with two-drug regimens & prevention with discreet monthly oral dosing Focused on development of new options with 4 potential new approvals anticipated in th
Slide 27: Q&A
Q&A Dr. Eliav Barr Dr. Liz Rhee Chirfi Guindo SVP, Head of Global VP, Clinical Research, Chief Marketing Clinical Development Infectious Disease Officer, Human Health & Chief Medical Officer Kathryn Hayward Peter Dannenbaum SVP, U.S. Pharma SVP, Investor Relations 27
Slide 28: Appendix
Appendix 28
Slide 29: Acronyms & Abbreviations
Acronyms & Abbreviations ART = Antiretroviral therapy PDUFA = Prescription Drug User Fee Act AZT = azidothymidine PK = Pharmacokinetics BIC = bictegravir PLWH = People living with HIV CI = Confidence interval PrEP = Pre-Exposure Prophylaxis DDI = Drug-drug interaction RT-TACK = Reverse Transcriptase
Slide 30: 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 31: Liz Rhee, MD
Liz Rhee, MD Vice President, Clinical Research, Infectious Disease Dr. Elizabeth (Liz) Rhee is vice president and therapeutic area head of Infectious Disease Clinical Research in Global Clinical Development at Merck Research Laboratories. She leads the late-stage development of infectious disease pi
Slide 32: 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 33: Kathryn Hayward
Kathryn Hayward Senior Vice President, U.S. Pharma BU Kathryn leads the Pharma Business Unit for the U.S market. She is responsible for the overall performance of the business unit’s in-line portfolio and planning for pipeline products. These include products for infectious disease, cardiovascular a