Merck & Company, Inc. · NYSE:MRK
Merck & — Merger or Acquisition (April 2023)
31 slides from Merck &'s merger presentation, Apr 17, 2023
Slide 1: Acquisition of Prometheus Biosciences
Acquisition of Prometheus Biosciences April 17, 2023
Slide 2: Agenda
Agenda Rob Davis Chairman & Chief Executive Officer Strategic Rationale | Rob Davis Dr. Dean Li President, Merck Research Scientific Overview | Dean Li Laboratories Dr. Eliav Barr Clinical Profile | Eliav Barr SVP, Head of Global Clinical Development & Chief Medical Officer Commercial Opportunity |
Slide 3: Important Information About the Transaction
Important Information About the Transaction Merck & Co., Inc. (“Merck”), through a subsidiary, has agreed to acquire Prometheus Biosciences, Inc. (“Prometheus Biosciences”). The acquisition is subject to Prometheus Biosciences’ shareholder approval. The closing of the transaction will be subject to
Slide 4: 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 5: Strategic Rationale
Strategic Rationale Rob Davis Chairman & Chief Executive Officer
Slide 6: Merck continues to advance science-led strategy through acquisition of Prometheus Biosciences
Merck continues to advance science-led strategy through acquisition of Prometheus Biosciences Potentially transformational, first-in-class, late-stage candidate, in a disease area with significant unmet medical need + Opportunity to potentially transform standard of care for certain patients sufferi
Slide 7: Scientific Overview
Scientific Overview Dr. Dean Li President, Merck Research Laboratories
Slide 8: Prometheus is well-aligned to Merck's R&D strategy
Prometheus is well-aligned to Merck’s R&D strategy Prometheus augments and accelerates Merck’s research efforts in immunology Translating breakthrough • Advancing novel mechanisms science into • Transforming standard of care medicines and vaccines • Leveraging precision medicine that save and improv
Slide 9: IBD is a devastating disease in need of new treatment options for patients
IBD is a devastating disease in need of new treatment options for patients Patients often cycle through existing therapies due to sub-optimal response and poor tolerability • Prevalence increasing globally Sphingosine-1- • Major quality of life impacts Phosphate Receptor 5-amino- salicyclic acid Mod
Slide 10: Prometheus complements and accelerates Merck's immunology presence
Prometheus complements and accelerates Merck’s immunology presence • Deep expertise in clinical • Focused expertise in trial design and execution immunology + • Global clinical trial scale • Deep genetic and biological insights from Prometheus • Proven track record of 360 Data Science Platform devel
Slide 11: Clinical Profile
Clinical Profile Dr. Eliav Barr SVP, Head of Global Clinical Development & Chief Medical Officer
Slide 12: PRA023 has potential to be the first and best TL1A inhibitor
PRA023 has potential to be the first and best TL1A inhibitor • TL1A has strong genetic association to both UC and CD • PRA023 is a potential first and best-in-class TL1A with a dual mechanism of action (anti-inflammatory and anti-fibrotic) • In Phase 2a: − Outstanding efficacy − Favorable safety and
Slide 13: ARTEMIS-UC Phase 2 study design
ARTEMIS-UC Phase 2 study design Cohort 1: Evaluation of efficacy in all comers Key Inclusion Criteria Induction Primary • Moderately to severely active UC Endpoint • No/insufficient response and/or intolerance to conventional or advanced therapy Randomization: PRA023 (N=60) Open Label • Dx status (+
Slide 14: ARTEMIS-UC Phase 2 study showed strong efficacy across primary and secondary endpoints
ARTEMIS-UC Phase 2 study showed strong efficacy across primary and secondary endpoints ARTEMIS-UC Primary and Key Secondary Endpoints with PRA023 Treatment Compared to Placebo • 12 weeks of PRA023 induction treatment led to at Week 12 Δ 43.8% statistically significant increases in clinical remission
Slide 15: APOLLO-CD Phase 2a study design
APOLLO-CD Phase 2a study design Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Open Label Extension Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Responders: (decrease in CDAI of ≥100 points or CDAI < 150) PRA023 250mg IV Q4
Slide 16: APOLLO-CD Phase 2a study showed strong efficacy across primary and secondary endpoints
APOLLO-CD Phase 2a study showed strong efficacy across primary and secondary endpoints APOLLO-CD Primary and Key Secondary Endpoints with PRA023 Treatment at Week 12 • 12 weeks of PRA023 induction treatment led to (placebo-adjusted basis using historical controls) statistically significant increases
Slide 17: PRA023 UC and CD remission rates comparable or superior to available therapies
Phase 2 PRA023 data suggests UC and CD remission rates comparable or superior to available therapies, on a cross-trial comparison basis Induction Clinical Remission Rate (Placebo Adjusted) • Phase 2 PRA023 induction efficacy 33% comparable or superior to leading approved agents 25%* 25% 24%** 21% •
Slide 18: Interim analysis showed clinical remission in biomarker positive sub-population in UC
Interim analysis showed clinical remission in biomarker positive sub-population in UC Biomarker (+) vs All Comers in UC Clinical Remission Induction Phase UC biomarker (+) population performance: % of subjects achieving clinical remission 37.5% +12.5% • Biomarker (+) population prevalence was ~24% (
Slide 19: Continued progress across PRA023 program
Continued progress across PRA023 program Maintenance Studies Phase 3 Development Plans • Maintenance portion of the Phase 2 ARTEMIS-UC • Productive End of Phase 2 meeting with FDA and APOLLO-CD studies ongoing • Look forward to initiating Phase 3 • Early data to date are encouraging development prog
Slide 20: Prometheus strengthens existing immunology portfolio and pipeline
Prometheus is highly complementary to and strengthens existing immunology portfolio and pipeline • Seeking to expand assets PRA023 PRA052 MK-6194 into additional indications Phase 2 Phase 1 Phase 1 Status complete ongoing ongoing • Multiple preclinical development assets Mechanism anti-TL1A anti-CD3
Slide 21: Commercial Opportunity
Commercial Opportunity Chirfi Guindo Chief Marketing Officer, Human Health
Slide 22: Significant unmet medical need remains in IBD
Significant unmet medical need remains in IBD • Approximately 2 million patients in the U.S. have been diagnosed with UC and CD, of which nearly 1 million have moderate to severe disease IBD is a chronic, • UC and CD can be devastating diseases with adverse inflammatory and impacts on patients’ phys
Slide 23: PRA023 represents a potentially meaningful and durable commercial opportunity
PRA023 represents a potentially meaningful and durable commercial opportunity IBD Market Opportunity PRA023 Opportunity • Immunology market is expected to surpass • UC and CD indications each have potential for $140 billion by 20281 multi-billion dollar peak sales • UC and CD market was ~$23 billion
Slide 24: Financial Overview
Financial Overview Caroline Litchfield Chief Financial Officer
Slide 25: Financial overview of the Prometheus Biosciences acquisition
Financial overview of the Prometheus Biosciences acquisition • Merck has agreed to acquire all outstanding shares of Prometheus Biosciences for a purchase price of $200 per share • Total transaction value of ~$10.8 billion (~$10.3 billion net of ~$650 million of cash and investments, as well as Tran
Slide 26: Q&A
Q&A Rob Davis Dr. Dean Li Dr. Eliav Barr Chirfi Guindo Caroline Litchfield Dr. Aileen Pangan Peter Dannenbaum Chairman & Chief President, SVP, Head of Global Chief Marketing Chief Financial VP, Late-Stage VP, Investor Relations Executive Officer Merck Research Clinical Development Officer, Officer I
Slide 27: Appendix
x INVENTING FOR LIFE Appendix
Slide 28: Eliav Barr, M.D.
Eliav Barr, M.D. Senior Vice President Head of Global Clinical Development, Chief Medical Officer Eliav Barr is senior vice president and head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories (MRL). He leads all late-stage clinical development for Merck’s human
Slide 29: 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 30: Aileen Pangan, M.D.
Aileen Pangan, M.D. Vice President Late-Stage Immunology Aileen L. Pangan, M.D. is vice president of Global Clinical Development of Late-Stage Immunology. Aileen is a rheumatologist with 17 years of experience leading cross-functional teams through design and execution of clinical trials. She joined
Slide 31: Acronyms
Acronyms AtD = Atopic dermatitis CD = Crohn’s disease IBD = Inflammatory bowel disease JAKi = Janus kinase inhibitor mAb = Monoclonal antibody PBO = Placebo PCD = Primary completion date SLE = Systemic lupus erythematosus SNP = Single nucleotide polymorphism SSc-ILD = Systemic sclerosis-associated i