Slide 1: Clesrovimab Sell-Side Analyst Call
Clesrovimab Sell-Side Analyst Call October 22, 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: Agenda
Agenda Dr. Paula Annunziato SVP, Head of Infectious Diseases and Vaccines, Global Clinical Development Clesrovimab differentiation | Dr. Paula Annunziato Dr. Macaya Douoguih Protocol 004: Phase 2b/3 trial results | Dr. Macaya Douoguih VP, Vaccines, Global Clinical Development RSV patient dynamics an
Slide 4: Clesrovimab is a differentiated candidate to help protect infants from RSV
Clesrovimab is a differentiated candidate to help protect infants from RSV Extended half-life mAb developed as a passive immunization for the prevention of RSV Same single dose injection for infants regardless of weight Protection through an infant’s first full RSV season (5-6 months) Site of action
Slide 5: Protocol 004: Phase 2b/3 trial design
Protocol 004: Phase 2b/3 trial design Randomized, Double-Blind, Placebo-Controlled, Pivotal Trial Phase 3 Phase 2b First 1,350 participants followed through day 515 Followed through day 515 Remaining participants followed through day 365 Study Population Clesrovimab Clesrovimab 105 mg IM 105 mg IM P
Slide 6: Protocol 004: a single dose of clesrovimab protected against RSV disease through 5 months
Protocol 004: a single dose of clesrovimab protected against RSV disease through 5 months Efficacya through 5 months (150 days) Endpoint Clesrovimab Placebo RSV-Associated Endpoint Observed Efficacy Designation (n = 2,398) (n = 1,201) %, (95% CI) # of Cases # of Cases 91.7 Severe MALRI Tertiary 2 12
Slide 7: Protocol 004: met all prespecified endpoints with data through 6-months
Protocol 004: met all prespecified endpoints with data through 6-months Efficacya through 6 months (180 days) Endpoint Clesrovimab Placebo RSV-Associated Endpoint Observed Efficacy Designation (n = 2,398) (n = 1,201) %, (95% CI) # of Cases # of Cases 91.7 Severe MALRI Tertiary 2 12 (62.9, 98.1) 91.2
Slide 8: Clesrovimab had a safety profile generally comparable to placebo
Clesrovimab had a safety profile generally comparable to placebo Clesrovimab Placebo N=2409 N=1202 % Difference vs. placebo Key Takeaways n (%) n (%) Estimate, (95% CI) Overall AEs (Days 1-365) ≥1 AE 1816 (75.4) 918 (76.4) -1.0 (3.9, 2.0) • The majority of AEs were grade 1 or 2 (mild or Drug-related
Slide 9: Clesrovimab program conclusions
Clesrovimab program conclusions Efficacy Safety Clesrovimab, administered as a single dose, regardless of Clesrovimab had a safety profile generally comparable to weight, helped protect against a range of RSV disease placebo and was consistent across infant populations in for infants entering their
Slide 10: RSV is the leading cause of hospitalization among infants
RSV is the leading cause of hospitalization among infants Significant unmet need clesrovimab RSV infections in children ≤1 year old cause ~12.9 million lower respiratory infections with: • ~2.2 million hospitalizations per year, designed to protect infants for the most of which take place during the
Slide 11: Q&A
Q&A Dr. Paula Annunziato SVP, Head of Infectious Diseases and Vaccines, Global Clinical Development Dr. Macaya Douoguih VP, Vaccines, Global Clinical Development Art Hirt SVP, U.S. Vaccines Peter Dannenbaum SVP, Investor Relations
Slide 12: Acronyms
Acronyms AE = Adverse event AESI = Adverse event of special interest ARI = Acute respiratory infection CI = Confidence interval GA = Gestational age IA = Interim analysis IM = Intramuscular LB = Lower bound LRI = Lower respiratory tract infection mAb = Monoclonal antibody MALRI = Medically Attended
Slide 13: Paula Annunziato, MD
Paula Annunziato, MD SVP, Head of Infectious Diseases and Vaccines, Global Clinical Development Paula Annunziato, MD joined Merck Research Laboratories (MRL) in 2002 as Director, Biologics and Vaccine Clinical Research and has held positions of Product Development Team Leader, Section Head, and Ther
Slide 14: Macaya Douoguih, MD, MPH
Macaya Douoguih, MD, MPH VP, Vaccines, Global Clinical Development Macaya Douoguih, MD, MPH joined Merck Research Laboratories (MRL) in December 2023 as Vice President and Therapeutic Area Head for Vaccine Global Clinical Development. Prior to joining Merck, Macaya was Global Head of Late Developmen
Slide 15: Art Hirt
Art Hirt SVP, U.S. Vaccines Art joined Merck in 1997 and over that time has held business leadership roles in the US market, global, and ex-US subsidiaries and regions. Prior to his current position, Art was the SVP, Hospital & Specialty Business Unit, after spending time in the US Oncology team wit