Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Goldman Sachs 45th Annual Global Healthcare Conference (June 2024)
19 slides from Newamsterdam Pharma's conference presentation, June 2024
Slide 1: Corporate Presentation
Corporate Presentation June 2024 Nasdaq: NAMS
Slide 2: Disclaimer
Disclaimer This presentation (together with oral statements made in connection herewith, this “Presentation”) is for informational purposes only. This Presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of securities
Slide 3: Obicetrapib Designed to Address Significant Unmet Need
Obicetrapib Designed to Address Significant Unmet Need Significant unmet need for oral LDL-C lowering therapy as adjunct to statins 30mm+ >800 pts patients in US are not of tolerability data, with achieving LDL-C lowering blinded data in >10,000 goals despite standard-of-care pts Simple, once-daily,
Slide 4: Previous 12 Months Were a Time of Groundwork, Goals and Growth
Previous 12 Months Were a Time of Groundwork, Goals and Growth Completed and exceeded Building a world-class Doubled in size with new enrollment expectations for commercial function, hires and offices in BROOKLYN, BROADWAY and including MSLs on the Amsterdam, NL, Miami, FL, PREVAIL Phase 3 studies g
Slide 5: Obicetrapib Designed to Address the ~30M Patients in US on Drug but not at Goal
Obicetrapib Designed to Address the ~30M Patients in US on Drug but not at Goal ~43 million ~18 million Treated primary prevention Not at goal of LDL-C patients <100mg/dl Of the ~30M treated patients not at goal, ~72 million ~19 million ~8 million ~18M were “far from Adults in US diagnosed with Trea
Slide 6: Lipid Lowering Therapy (LLT) Market is a Growing Opportunity
Lipid Lowering Therapy (LLT) Market is a Growing Opportunity 1 2 3 4 11.0% 1.3% 0.1% Patients on Lipid lowering Therapy2 Patients on Non-statin3 Treatment Patients on Branded4 Treatment 56MM 4.0MM 700K 19.6% 31% 4.3% Growth Growth Growth 5.4% 600K Growth 51MM 3.5MM 26.3% 500K Growth 17.8% Growth 400
Slide 7: Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets
Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets Primary prevention HeFH ASCVD patients with an Very high risk ASCVD Despite availability of patients with LDL-C target of LDL<70 or patients with an LDL-C treatments continue to see an LDL-C target <100 mg/dL <55 mg/dL (2017-2018)2 targ
Slide 8: CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines in 2013
CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines in 2013 CVD Mortality Trends for US Males and Females, 1980 to 20201 Trends in Prevalence of High LDL-C in US Adults, NHANES 1999-2018 with History of ASCVD2 550 100 530 LDL-C Goals Removed In LDL-C ≥70 mg/dL, % 510 75 2013 490 50
Slide 9: Physicians Left with Limited Options that Meet the Needs of Patients
Physicians Left with Limited Options that Meet the Needs of Patients Ezetimibe(1) Nexletol(2) PCSK9i(3) Oral PCSK9(4) Obicetrapib(5) Obi + Eze (5) LDL-C data 2026E LDL data 2024E Approval Approved Approved Approved (CVOT data 2029E) LDL data 2025E (CVOT data 2026E) MACE Benefit 7% 13% 15% TBD TBD TB
Slide 10: Obicetrapib program designed to overcome limitations of prior CETP inhibitors
Obicetrapib program designed to overcome limitations of prior CETP inhibitors Torcetrapib(1) Dalcetrapib(2) Evacetrapib(3) Anacetrapib(4) Obicetrapib(5) Observed LDL-C reduction 20% 7% 11-21% 17% 43% CETP inhibition 35% 30% 65% 80% 97% Dosing 60mg 600mg 100mg 100mg 10mg Blood pressure increase Yes N
Slide 11: Obicetrapib Phase 1/2 studies: Consistent benefits observed in lipid biomarkers
Obicetrapib Phase 1/2 studies: Consistent benefits observed in lipid biomarkers Phase 1 MAD TA-8995-06 TULIP ROSE ROSE2 Japan Pooled data N=10 per arm N=13 per arm N=35 per arm N=40 per arm N=26 per arm N=26 per arm N=132 Median LS Mean 11 Source: Company data for obicetrapib 10mg monotherapy, Poole
Slide 12: PREVAIL Designed to Apply Lessons Learned from Previous CVOTs
PREVAIL Designed to Apply Lessons Learned from Previous CVOTs to Reduce Risk and Demonstrate Obicetrapib’s Full Benefit Greater LDL-C lowering activity anticipated Higher absolute LDL-C reduction expected to lead Targeting higher baseline LDL-C patients to greater MACE benefit Longer duration of fol
Slide 13: Phase 2 Efficacy Applied to PREVAIL Baseline Data Predicts at Least 20% MACE Benefit
Phase 2 Efficacy Applied to PREVAIL Baseline Data Predicts at Least 20% MACE Benefit Projection Across Multiple Biomarkers LDL-C Non-HDL-C ApoB 103 43% ~ 44 133 34% ~45 97 27% ~26 mg/dL(1) mg/dL mg/dL mg/dL mg/dL mg/dL LDL-C LDL-C lowering in Expected to result in Non-HDL-C Non-HDL-C lowering Absolu
Slide 14: Multiple potential pivotal data readouts in next months
Multiple potential pivotal data readouts in next 12 months 2022 2023 2024 2025 2026 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono Study BROADWAY Ph3 (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; n=2,532) LDL regulatory filing Phase 3 BROOKLYN Trial BROOKLYN Ph3 Lipid Mono Study Obicetrapib (He
Slide 15: Study Design and Baseline Characteristics of Phase 3 Trials
Study Design and Baseline Characteristics of Phase 3 Trials 1º endpoint – week 12 N = 354 1º endpoint – week 12 N = 2532 LDL-C endpoint N = 9541 Obicetrapib 10 mg (2:1 randomization) Obicetrapib 10 mg13-months (2:1 randomization) Obicetrapib 10 mg (1:1 randomization) Placebo Placebo Placebo 13-month
Slide 16: REVEAL Long-term Follow-up Identified Risk Enhancers Important for PREVAIL
REVEAL Long-term Follow-up Identified Risk Enhancers Important for PREVAIL HIGHER RISK subgroups observed to have higher event rates and larger treatment effects 15.6% 11.9% 11.3% 15.5% 19.2 RR decrease 18.5 RR decrease 17.7 18.1% 15 15.9 RR decrease 17.2 RR decrease 16.2 14.6% 16.3 RR decrease RR d
Slide 17: 2023 Achievements Pave the Way for Potential 2024 Value Inflection Milestones
2023 Achievements Pave the Way for Potential 2024 Value Inflection Milestones 2Q 2023 3Q 2023 2H 2023 Initial Alzheimer’s 2023 Complete enrollment for BROOKLYN Phase 3 Present ROSE2 full data at NLA Complete enrollment for BROADWAY Phase 3 Topline Japan Phase 2b results Phase 2a data Select formulat
Slide 18: Growing Team of Cardiometabolic Experts with Deep Experience
Growing Team of Cardiometabolic Experts with Deep Experience Across Clinical Development and Commercialization Michael Davidson, M.D. John Kastelein, M.D. Douglas Kling William ‘BJ’ Jones Ian Somaiya Louise Kooij Juliette Audet CEO CSO COO CCO CFO CAO CBO Jim Jacobson Sheng Cui Marc Ditmarsch, M.D.
Slide 19: Thank You
Thank You 19