Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Investor Day (May 2024)
89 slides from Newamsterdam Pharma's investor day presentation, May 16, 2024
Slide 1: Welcome to R&D Day
Welcome to R&D Day May 16, 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 securiti
Slide 3: 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 4: Growing Team of Cardiometabolic Experts
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 5: Our Mission is Clear and Simple
Our Mission is Clear and Simple At NewAmsterdam Pharma, we are advancing a new era of life-saving treatment for cardiovascular disease and other lipid-related conditions. By prioritizing patients with high unmet needs and those who are underserved by current therapies, we are working toward a realit
Slide 6: Today's Focus
NewAmsterdam Pharma R&D Day 2024 Phase 3 Clinical Update: Our Clinical Program and Path Forward 9:15am Michael Davidson, MD, CEO, NewAmsterdam Science Update: New Research on Obicetrapib’s Potential Benefits Beyond LDL-C 9:30am John Kastelein, MD, PhD, FESC, CSO, NewAmsterdam TODAY’S 10:15am Commerc
Slide 7: CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines
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 8: High LDL-C Continues to be Associated with MACE
Despite Advanced Treatments and Patient Lifestyle Changes, High LDL-C Continues to be Associate with MACE Average of Clinical Trial Results Risk of CV Death, MI, Stroke 18 15 ≥70 LDL-C 16 25% RRR = 3.4% ARR 55-≤70 LDL-C 14 Cumulative incidence rate (%) % Subjects with CVD Event 40-≤55 LDL-C 12 10 ≤2
Slide 9: Multiple Sources of Residual Risk Need to be Addressed
Multiple Sources of Residual Risk Need to be Addressed by Additional Therapies Despite contemporary evidence-based therapies, residual risk of ASCVD events persists Residual Residual Residual Residual Residual Residual ApoB, Small-LDL-P, Cholesterol Risk Inflammatory Risk Thrombotic Risk Lp(a) Risk
Slide 10: Obicetrapib Well Suited to Address Multiple Sources of Residual Risk
Obicetrapib is Well Suited to Address Multiple Sources of Residual Risk Residual Residual Residual Residual Residual Residual ApoB, Small-LDL-P, Cholesterol Risk Inflammatory Risk Thrombotic Risk Lp(a) Risk Diabetes Risk Remnant Cholesterol Risk Biological Issue Weight Critical HbA1c LDL-C ≥55 mg/dL
Slide 11: 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) LDL-C data 2026E Approval Approved Approved Approved (CVOT data 2029E) MACE Benefit 7% 13% 15% TBD Observed LDL-C 50-59% 25% 17% 45-50% Reduction (~20% with food) Oral Oral Injectabl
Slide 12: 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+ 43% patients in US are not mean LDL-C achieving LDL-C lowering lowering as goals despite standard-of-care monotherapy* Simple, once-daily, low-dose CETP inhibitor
Slide 13: 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 14: 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 18.1% 14.6% 17.7 RR decrease 17.2 RR decrease RR decrease 15 15.9 16.2 16.3 RR d
Slide 15: Phase 2 Efficacy Applied to PREVAIL Baseline Indicates at Least 20% MACE Benefit
Phase 2 Efficacy Applied to PREVAIL Baseline Data Indicates at Least 20% MACE Benefit Projection Across Multiple Biomarkers LDL-C Non-HDL-C ApoB 103 43% ~ 44 133 34% ~45 98 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 Absol
Slide 16: Our Data-Driven Clinical Program and Path Forward
PHASE 3 CLINICAL UPDATE: Our Data-Driven Clinical Program and Path Forward 16
Slide 17: Two Potential Indications Supported by Three Clinical Trials
Two Potential Indications Supported by Three Clinical Trials LIPID MACE Indication Indication Adjunct to diet alone* or in Reduce risk of cardiovascular death, combination with other lipid- myocardial infarction, stroke and coronary lowering therapies, in adults with revascularization in adults with
Slide 18: Study Design and Baseline Characteristics
Study Design and Baseline Characteristics Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies: A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants with a History of HeFH and LDL-C ≥70 mg/dL who are Not Adequately Con
Slide 19: Study Design and Baseline Characteristics
Study Design and Baseline Characteristics Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants with Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (AS
Slide 20: Alzheimer's Disease Sub-study Provides Opportunity to Explore Additional Biomarkers
Alzheimer’s Disease Sub-study Provides Opportunity to Further Explore Effects of Obicetrapib on Additional Biomarkers Initial data for obicetrapib 10mg observed to decrease 24s- & 27s-hydroxycholesterol (“OH”) in both plasma and cerebrospinal fluid (“CSF”) in phase 2a study (n=13) Obicetrapib was ob
Slide 21: Study Design and Baseline Characteristics
Study Design and Baseline Characteristics Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are Not Adequately Controlled Despite Ma
Slide 22: Phase 3 Study Design
Phase 3 Study Design Rationale: Pivotal Study for obicetrapib/ezetimibe fixed-dose combination product Objective: To evaluate the effect of obicetrapib 10 mg/ezetimibe 10 mg on top of maximum LMT on LDL-C in patients with ASCVD Study Design Inclusion Criteria • LDL-C ≥ 70 mg/dL • ASCVD or ASCVD risk
Slide 23: New Research on Obicetrapib's Potential Benefits Beyond LDL-C
SCIENCE UPDATE: New Research on Obicetrapib’s Potential Benefits Beyond LDL-C 23
Slide 24: New Research Validates Obicetrapib's Mechanism and Potential Impact Beyond LDL-C
New Research Validates Obicetrapib’s Mechanism, Synergistic Effect and Potential Impact Beyond LDL-C 1 Obicetrapib Reduction of Lp(a) Clinical Results 2 Obicetrapib and Ezetimibe Mechanism and Combination Studies 3 Obicetrapib and the Reduction of Atherosclerotic Development Pre-clinical Study 4 CET
Slide 25: Residual Lp(a) Risk
Residual Lp(a) Risk Residual Lp(a) Risk 25
Slide 26: Lp(a) Concentrations Associated with Incidence and Risk of ASCVD
Lp(a) Concentrations Have Been Associated with Incidence and Risk of ASCVD Incidence and Risk of Atherosclerotic Cardiovascular Even with high prevalence, there are currently no Disease and Lp(a) (lipoprotein[a]) Concentration pharmacologic therapies approved for reducing Lp(a) A B 8 2.5 Lp(a) distr
Slide 27: Previous CETP Inhibitors and Approved Therapies Have Limited Effect on Lp(a)
Previous CETP Inhibitors and Approved Lipid-Lowering Therapies Have Limited Effect on Lp(a) 200,000 Blue shaded area (<30mg/dL): US Recommendation represents negligible risk for CVD and CAVS Previous CETP inhibitors: ~-20 to -25% Target obicetrapib patients (Lp(a) 30-80 mg/dL) Frequency Distribution
Slide 28: Over 50% of Patients on Obicetrapib Achieved >60% Reduction in Lp(a)
Over 50% of Patients on Obicetrapib Achieved >60% Reduction in Lp(a) Obicetrapib 10mg Lp(a) Waterfall plot (% change from baseline) 25 ROSE ROSE2 (n=79) (n=48) Obicetrapib 0 -56.5% -47.2% 10mg Placebo +4.0% +2.3% % Change 57.1% median difference in % -50 50% change, corrected for PBO in pooled analy
Slide 29: Lp(a) Response Compared to Previously Published Data
Lp(a) Response with Obicetrapib Compared to Previously Published Data from CETP Inhibitors and Approved LDL-C Lowering Agents 10 Statins Ezetimibe 5 2 0 -10 Obicetrapib 10 mg on top of high- intensity statin significantly lowered -20 % Change in Lp(a) Inclisiran Lp(a) by 57% vs. Placebo, in Niacin -
Slide 30: Preclinical Mechanism of Action Study
Residual Lp(a) Risk Preclinical Mechanism of Action Study 30
Slide 31: Mouse Study Designed to Assess Obicetrapib and Ezetimibe Synergistic Effect
Mechanism of Action Study in Mice Designed to Assess Obicetrapib and Ezetimibe Synergistic Effect Assessed the Impact of Obicetrapib and/or Ezetimibe on Clearance of LDL-Like Particles in Female APOE*3-Leiden.CETP Mice t=-4 t=0 t=4 t=6 t=8 Control (n=10) † Diet T + Obicetrapib 2 mg/kg/d (n=10) † 0.0
Slide 32: Obicetrapib Blocked CETP Activity and Decreased Non-HDL-C in Mice
Obicetrapib was Observed to Block CETP Activity and Decreased Non-HDL-Cholesterol Levels in Mice 80 25 20 Non-HDL-cholesterol (mmol/L) 60 CETP activity (mmol/h/mL) 15 40 * 10 * * 20 * * 5 * * † *† * * † 0 * * * 0 0 4 8 0 4 6 8 Time (weeks) Time (weeks) Control Obicetrapib Ezetimibe Obicetrapib + Eze
Slide 33: Obicetrapib and Ezetimibe Synergistic Effect on Clearance of LDL-Like Particles
Combination of Obicetrapib and Ezetimibe were Observed to have Unique Synergistic Effect on Clearance of LDL-Like Particles in Mice LDL-like Particles 120 100 80 % of injected dose 60 * 40 * 20 ** 0 ** 0 5 10 15 20 Time (min) Control Obicetrapib Ezetimibe Obicetrapib + Ezetimibe *P<0.05 vs control g
Slide 34: Obicetrapib Decreased LDL-like Particles by Increasing Hepatic LDLR in Mice
Obicetrapib Decreased LDL-like Particles by Increasing Hepatic LDLR Levels in Mice 2.5 * 2 * Hepatic LDLR Protein Normalized LDL-C lowering by obicetrapib is thought to be accomplished by for Tubulin (AU) 1.5 increasing LDLR expression on hepatocytes, leading to increased clearance of LDL-particles
Slide 35: CETPi Upregulates LDLR and Improves LDL-C and ApoB Clearance
CETPi Upregulates LDLR and Improves LDL-C and ApoB Clearance Through the Liver Same mechanism of action as existing LDL-C lowering drugs Most current LDL-C lowering therapies work by promoting LDL-C receptor upregulation PCSK9i STATINS EZETIMIBE OBICETRAPIB CETPi Blocks Decreases Decreases Designed
Slide 36: Obicetrapib + Ezetimibe Combination
Residual Lp(a) Risk Obicetrapib + Ezetimibe Combination 36
Slide 37: Obicetrapib and Ezetimibe may Synergistically Enhance Removal of Cholesterol
Obicetrapib and Ezetimibe may Synergistically Enhance Removal of Cholesterol CETPi Intestine MICE ROSE2 Obicetrapib + Ezetimibe Synergistically Obicetrapib + Ezetimibe Synergistically Decreased non-HDL-C in Mice Decreased LDL-C in ROSE2 LDL-C levels further drop Ezetimibe + Obi 10 mg + Eze Obicetrap
Slide 38: Greater LDL-C Lowering with Obicetrapib/Ezetimibe Combo vs Other Combinations
Greater LDL-C Lowering Observed with Ezetimibe in Obicetrapib Combo vs Ezetimibe with Statins and Ezetimibe with Bempedoic Acid Due to Synergistic MOA for Obi/Eze Combo Simvastatin/Ezetimibe Bempedoic Acid/Ezetimibe Obicetrapib/Ezetimibe 200 -36.1% 180 -17.0% 160 140 -18.1% -16.0% LDL-C Levels (mg/d
Slide 39: Preclinical Atherosclerosis Study
Residual Lp(a) Risk Preclinical Atherosclerosis Study 39
Slide 40: Mice Atherosclerosis Study Design in the Aortic Root
Mice Atherosclerosis Study Designed to Assess Impact of Obicetrapib and/or Ezetimibe on Atherosclerosis in the Aortic Root t=-3 t=0 t=4 t=8 t=12 t=16 t=20 t=24 t=28 Control † Diet T + Obicetrapib 2 mg/kg/d † 0.05% cholesterol Ezetimibe 0.1 mg/kg/d Ezetimibe 0.2 mg/kg/d Ezetimibe 1 mg/kg/d Ezetimibe
Slide 41: Atherosclerotic Lesions Remain Main Contributor to Risk for Heart Attack and Stroke
Atherosclerotic Lesions Remain Main Contributor to Risk for Heart Attack and Stroke Type I – Early fatty streak Type II – Regular fatty streak Type III – Mild plaque Up to 10 foam cells in the intima Over 10 foam cells present in the intima Extension of foam cells into the media with presence of a f
Slide 42: Obicetrapib Decreases Non-HDL Cholesterol in Humanized Mouse Model
Obicetrapib Decreases Non-HDL Cholesterol in Humanized Mouse Model 20 400 Non-HDL Cholesterol Exposure (mmol/l weeks) Non-HDL Cholesterol (mmol/L) 15 300 * 200 * 10 *† 5 100 † † † † † † ** 0 ** ** ** ** ** ** 0 0 5 10 15 20 25 30 Time (weeks) Control Obicetrapib Ezetimibe Obicetrapib + Ezetimibe *P<
Slide 43: Obicetrapib Decreased Atherosclerotic Lesion Area in Mice
Obicetrapib Decreased Atherosclerotic Lesion Area in the Aortic Root in Mice 400 120 100 * Lesion severity (% of segments) 300 (*1000 Ꙡm2/cross-section) 80 Total Lesion Area 200 60 * 40 100 * * 20 * *† 0 0 Mild lesions Severe lesions (type I-III) (type IV-V) Control Obicetrapib Ezetimibe Obicetrapib
Slide 44: Overview of Human Plaque Progression: A Case Study
Overview of Human Plaque Progression: A Case Study Baseline Follow-Up 44
Slide 45: REMBRANDT: Effect of FDC on Coronary Plaque Characteristics
REMBRANDT- Effect of FDC Obicetrapib/Ezetimibe on Top of Maximally Tolerated Lipid- Modifying Therapy on Coronary Plaque Characteristics in Participants with or at High Risk for Atherosclerotic Cardiovascular Disease Main inclusion criteria Rationale: Despite reducing the progression of coronary ath
Slide 46: REMBRANDT CT Angio Study Designed to Provide Insight into FDC Potential
REMBRANDT CT Angio Study Designed to Provide Insight into Fixed- Dose Combination’s Potential Increased utilization of CTA for diagnosis of cardiovascular disease • Provide evidence that the reduction of LDL-C translates into benefit associated with underlying disease (atherosclerosis) Positive trac
Slide 47: Residual Diabetes Risk
Residual Lp(a) Risk Residual Diabetes Risk 47
Slide 48: Statins Caused a Dose-dependent Increase in New Diagnosis of Type-2 Diabetes
Statins Caused a Dose-dependent Increase in New Diagnosis of Type-2 Diabetes Irrespective of Age, Sex, BMI and Blood Sugar Levels High-intensity statin regimen resulted in a 36% increased risk of new-onset diabetes Events (% per annum) Observed-expected Statin Placebo o-e Var (o-e) Rate ratio (CI) F
Slide 49: CETP Inhibition Has the Potential to Reverse Diabetes Risk
CETP Inhibition Has the Potential to Reverse Diabetes Risk, Potentially Ameliorating Key Concerns About High Dose Statins While statins increase diabetes, CETP inhibition has been observed to reverse existing diabetes, decrease new-onset diabetes and improve glucose control in third-party clinical t
Slide 50: LDL-P Research
Residual Lp(a) Risk LDL-P Research 50
Slide 51: LDL-P Believed to Be Robust Predictor of Cardiovascular Risk
LDL-P Believed to Be Robust Predictor of Cardiovascular Risk 1.00 • Small dense LDL-P are more likely to be trapped 0.98 in arterial wall than larger-sized LDL-P 0.96 • High LDL-P levels typically signify that a patient 0.94 has a higher proportion of small dense LDL-P vs. Low LDL-P confers a lower
Slide 52: Reduction in LDL-P and Increase in LDL-P Size Observed with Obicetrapib
A Reduction in LDL-P and an Increase in LDL-P Size was Observed with Obicetrapib with and without Ezetimibe Change in Total LDL-P, % Change in Small LDL-P, % Change in LDL-P Size, % 10 3 0 0 -10 -5.7 -8.3 2 -20 1.8 -20 1.5 Change from baseline, % Change from baseline, % Change from baseline, % -30 -
Slide 53: ROSE2 Demonstrated Reductions in Atherogenic Lipoproteins Beyond LDL-C
ROSE2 Demonstrated Reductions in Atherogenic Lipoproteins Beyond LDL-C Obicetrapib reduced atherogenic lipoprotein particles and cholesterol concentrations normalizing the lipoprotein profile to reflect a physiological profile ApoB Total LDL-P Small LDL-P sdLDL-C 0 -2.1 -3.7 -5.7 -8.3 -20 % Change f
Slide 54: Total LDL-P, Small LDL-P and LDL-P Size Reached Optimal Levels
Total LDL-P, Small LDL-P and LDL-P Size Reached Optimal Levels for Patients Taking Obicetrapib Alone or in Combination with Ezetimibe NMR Relative Risk ROSE2 Results Lipoprotein Obicetrapib Optimal Moderate High Placebo Obicetrapib 10 mg fractionation 10 mg/Eze 10 mg LDL-P <935 935-1816 >1816 1013 4
Slide 55: Mortality and HDL-C
Residual Lp(a) Risk Mortality and HDL-C 55
Slide 56: Cumulative Lifetime Risk for All Cause Mortality by HDL-C Levels
Cumulative Lifetime Risk for All Cause Mortality by HDL–C Levels UK Biobank Participants: N=447,651; 31,215 Deaths (any fatal event); Median follow-Up 12.5 years 40 HDL-C 30-35 mg/dL 35 Cumulative Lifetime Risk of All Cause Mortality 30 (%) by HDL-C Levels 25 HDL-C 40-45 mg/dL 20 HDL-C 50-55 mg/dL H
Slide 57: Cumulative Lifetime Risk for MACE by HDL-C Levels
Cumulative Lifetime Risk for MACE by HDL–C Levels UK Biobank Participants: N=447,651; 29,876 Major Cardiovascular Events; includes both events (and age at event) occurring before and after enrolment to estimate lifetime risk of major coronary events by HDL-c level 35 HDL-C 30-35 mg/dL Cumulaive Life
Slide 58: Safety of Treatment with Anacetrapib in the REVEAL Trial
Safety of Treatment with Anacetrapib in the REVEAL Trial HR Type of Event with 95% CI Fatal Events Cancer Death 1.00 [ 0.86, 1.16] In REVEAL, Anacetrapib increased HDL-C by 104% relative to placebo, this Infection Death 1.03 [ 0.78, 1.37] led to no increase in any fatal or non-fatal event Any Non-Ca
Slide 59: Preparing for a Transformational Launch
COMMERCIAL UPDATE: Preparing for a Transformational Launch 59
Slide 60: A Quick Introduction
A Quick Introduction • 30 years of commercial and launch experience in big pharma and start-up biotech • Led several blockbuster launches 60
Slide 61: A Quick Introduction
A Quick Introduction • 30 years of commercial and launch experience in big pharma and start-up biotech • Led several blockbuster launches • NewAmsterdam opportunity is unprecedented - Obicetrapib is well positioned to make a profound impact on patients with high unmet need - Pursuit of a bold ambiti
Slide 62: Lipid Lowering Therapy Market is a Massive Opportunity
Lipid Lowering Therapy (LLT) Market is a Massive Opportunity 1 2 3 4 5 11.0% 1.3% 0.1% Patients on Lipid lowering Therapy3 Patients on Non-statin4 Treatment Patients on Branded5 Treatment 56MM 4.0MM 700K 72 million1 4.3% Growth 19.6% Growth 31% Growth Adults in US diagnosed with 600K 5.4% hyperchole
Slide 63: Success has Been Limited in the Cardiovascular Space
Success has Been Limited in the Cardiovascular Space Launch Performance by Therapy Area 100% 90% Dermatology Proportion of Drugs Meeting/Beating Expectation Systemic Anti-infectives 80% Oncology Rare Disease 70% Gastro-intestinal 60% Central Nervous System 50% Endocrine Respiratory 40% Genito-urinar
Slide 64: Why Haven't We Seen More Success in The LLT Market?
Why Haven’t We Seen More Success in The LLT Market? Poor Product Understanding Limited Market Low Prioritization/ Differentiation the Market Access Under-investment PRODUCT PROFILE COMMERCIAL LAUNCH EXCELLENCE NewAmsterdam and obicetrapib address each barrier head on 64
Slide 65: 1. Poor Product Differentiation at Launch
1. Poor Product Differentiation at Launch Obicetrapib CARD AND PCP ORAL Significant LDL-C lowering EZETIMIBE NEXLETOL PCSK9i OBICETRAPIB OBI + EZE TREATMENT PRIORITIES PCSK9 shown in Five Phase 2 trials Large Phase 3 program MACE Outcomes Data • (4 pivotal trials) ≥40% LDL-C Reduction • • • • Safety
Slide 66: 2. Understanding the (Evolving) Market
2. Understanding the (Evolving) Market Tailwinds Commercial Strategy Will Target Specialists/PCPs Prescribing physician specialty Increased awareness % of Patients receiving the majority of their LLT scripts from each specialty of LDL-C goals and the need to meet SECONDARY PREVENTION SECONDARY PREVE
Slide 67: 3. Limited Market Access
3. Limited Market Access 1 2 3 Recent Guideline and Increased Payer (and Increased Access Drives Label Expansion Patient) Access Increased Volume • 2022: ACC updated guidelines1 PCSK9s have to target LDL-C <55 mg/dl in reset pricing and high-risk patients in line with achieved broad ESC/EAS access •
Slide 68: 4. Low Prioritization/Under-Investment
4. Low Prioritization/ Under-Investment PCSK9 route of administration challenges limited early adoption beyond specialists Recent oral non-statin LLT executed a suboptimal launch with questionable differentiation Initial promotion and sales force issues, including COVID, muted launch uptake Primary
Slide 69: NOAC Market Penetration with Multiple Branded Entrants
Case Study #1 NOAC Market Penetration with Multiple Branded Entrants 45,000,000 40,000,000 35,000,000 30,000,000 Branded Trx 25,000,000 1 Branded medications 20,000,000 penetrate the generic anti- coagulant market over time 15,000,000 10,000,000 5,000,000 0 2010 2011 2012 2013 2014 2015 2016 2017 20
Slide 70: NOAC Market Penetration with Multiple Branded Entrants
Case Study #1 NOAC Market Penetration with Multiple Branded Entrants 2 45,000,000 100% Warfarin market share decline 100% 94% accelerates as additional 90% molecules enter the market 90% 40,000,000 84% 80% 35,000,000 76% Warfarin Market Share 69% 70% 30,000,000 Branded Trx 61% 60% 25,000,000 53% 1 5
Slide 71: Similar Market Penetration with Multiple Branded Entrants
Case Study #2 Similar Market Penetration with Multiple Branded Entrants 5,000,000 100% 4,500,000 93% 95% 4,000,000 90% Generic Market Share 88% 90% 3,500,000 85% 83% 85% 3,000,000 80% Branded TRx 78% 2,500,000 80% 76% 2,000,000 75% 1,500,000 70% 1 1,000,000 Branded medications penetrate ~25% of the
Slide 72: Similar Market Penetration with Multiple Branded Entrants - Migraine
Case Study #2 Similar Market Penetration with Multiple Branded Entrants - Migraine 5,000,000 100% 1 2 4,500,000 Oral CGRPs rapidly 93% 95% overtake injectables in volume 4,000,000 90% and share Generic Market Share 88% 90% 3,500,000 85% 83% 85% 3,000,000 80% Branded TRx 78% 2,500,000 80% 76% 2,000,0
Slide 73: NOAC Market Value
Case Study #3 NOAC Market Value Oral Anticoagulants 140 120 100 TRx (Million) 80 1 Introduction of NOAC’s increases 60 overall size of market by 75% from 30MM TRx to 50 MM TRx 40 20 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Warfarin TRx NOAC TRx 73 Source: IQVIA NPA dat
Slide 74: NOAC Market Value
Case Study #3 NOAC Market Value Oral Anticoagulants $30.6 B 140 30 2 120 Value of the market grows to over 43 25 times the original value 100 Gross Sales (Billion USD) 20 TRx (Million) 80 1 15 Introduction of NOAC’s increases 60 overall size of market by 75% from 30MM TRx to 50 MM TRx 10 40 5 20 $0.
Slide 75: NOAC Market Value
Case Study #3 NOAC Market Value Oral Anticoagulants $30.6 B 140 30 2 120 Value of the market grows to over 43 25 times the original value 100 Gross Sales (Billion USD) 20 TRx (Million) 80 1 15 Introduction of NOAC’s increases 60 overall size of market by 75% from 30MM TRx to 50 MM TRx 10 40 5 20 $0.
Slide 76: Commercial Marching Orders
Commercial Marching Orders MISSION OBJECTIVE Transform the health of people living with CVD risk Maximize the value of NewAmsterdam Pharma and obicetrapib Prepare Prepare Prepare THE COMPANY THE MARKET THE BRAND Establish the vision, talent and Advance awareness, understanding Develop the insights,
Slide 77: Why NewAmsterdam is Poised for Success
Why NewAmsterdam is Poised for Success Clinical Excellence Agile Approach Make decisions and act quickly Continuously optimize execution BROOKLYN BROADWAY PREVAIL TANDEM Phase 3 Phase 3 CVOT FDC Facilitate cross-functional collaboration Innovation at Launch Commercial Launch Team Team has laun
Slide 78: We're Off to a Strong Start
We're Off to a Strong Start MSL Team Building Cultivating Elevating Enabling Activated Awareness Relationships Corporate Profile Access • 12-person Medical • HCP-targeted • Establishing strong • Executing public • Launching with expected Science Liaison team communications to partnerships with relat
Slide 79: Headwinds in the past, tailwinds for the future
Setting the Stage for Obicetrapib's Transformational Launch Headwinds in the past, tailwinds for the future... 1. 2. 3. 4. Differentiated Key Understanding of the Accelerate Invest Product Market and Patient Needs Market Access to Win 79
Slide 80: Q&A Session
$2:2 R&D DAY 80 ‘She: 2024
Slide 81: Break in Progress
Break in Progress 81
Slide 82: Patient Care in a World with Obicetrapib
KOL DISCUSSION: Patient Care in a World with Obicetrapib 82
Slide 83: KOL Panelists
Jorge Plutzky,MD Ann Marie Navar, MD, PhD Ashish Sarraju, MD Director, Preventive Cardiology, Brigham and Associate Professor of Cardiology, Cardiologist in the Section of Preventive Cardiology Women’s Hospital, Harvard Medical School UT Southwestern Medical Center at the Cleveland Clinic’s Tomsich
Slide 84: Operating from a Position of Strength
FINANCIAL UPDATE: Operating from a Position of Strength 84
Slide 85: Cash Position ($USD M)
Cash Position ($USD M) Operating from a Position of Strength: $481M as of 1Q24 Financing Extended Cash Runway BROOKLYN trial in 3Q24 BROADWAY trial in 4Q24 TANDEM trial in 1Q25 PREVAIL trial in 2026 REMBRANDT trial in 2027 85
Slide 86: Closing
Closing 86
Slide 87: The NewAmsterdam Value Proposition
The NewAmsterdam Value Proposition Clinical Expertise: Data driven clinical development increases probability of success Differentiated Target Product Profile: Phase 2 data demonstrates obicetrapib’s potential impact on multiple CVD risk factors Unmet Need: Significant need for a potent, convenient,
Slide 88: What to Expect in Next 12 Months
What to Expect in Next 12 Months with Milestones Hitting as Momentum Continues to Build BROOKLYN Phase 3 BROADWAY Phase 3 PREVAIL CVOT TANDEM FDC Phase 3 trial LDL-C, Lp(a), ApoB, BP vitals LDL-C, Lp(a), Safety, ABPM Full baseline details LDL-C, LDL-p, Lp(a), ApoB Completed and published Completed a
Slide 89: Thank You
NewAmsterdam Pharma ts’